DEVELOPMENT AND VALIDATION OF A SURGICAL WOUND ASSESSMENT TOOL FOR USE IN VIETNAM
DO THI THU HIEN RN, BN, MN
Submitted in fulfilment of the requirements for the degree of Doctor of Philosophy
School of Nursing Faculty of Health
Queensland University of Technology 2019
Keywords
Evaluation, reliability, surgical site infection, surgical wounds, surgical wound assessment tool, validity.
Development and validation of a surgical wound assessment tool for use in vietnam i Abstract
Background: Wounds are a major source of morbidity for patients and a financial burden for healthcare providers (Fletcher, 2010). Recovery from these wounds costs billions of dollars and the cost increases when wound complications occur (Franz, Steed, & Robson, 2007). There are a number of complications associated with surgical wounds, such as surgical site infection (SSI) seroma, haematoma, ischaemic, and dehiscence (World Union of Wound Healing Societies, 2016a). SSI is one of the most common complications of surgical wounds (Allegranzi et al., 2011; European Wound Management Association, 2005). It is estimated that at least 5% of patients who experience a surgical procedure will go on to develop a SSI (National Institute for Clinical Excellence, 2008). The impact of a SSI is a significant economic burden in terms of the extra postoperative length of stay in hospital, increased costs of treatment, reduced patient quality of life, and higher mortality rates compared to patients without a SSI (Andersson, Bergh, Karlsson, & Nilsson, 2010; de Lissovoy et al., 2009; Tovar & Badia, 2014; World Health Organization, 2016a)
Prevention, detection, and management of surgical wound complications are important (National Institute for Clinical Excellence, 2008). Evidence-based wound assessment is essential to facilitate early detection of complications and guide management to promote early healing. Inappropriate management may result in delayed healing and an increased risk of complications (Fletcher, 2010). However, in Vietnam, no standard tool currently exists to assist nurses with assessing and recording surgical wound information to guide appropriate surgical wound management.
Aim: This project aimed to develop and validate a surgical wound assessment tool for use in Vietnam.
Method: The research was undertaken in Vietnam and involved three studies. The first study included a retrospective chart audit and a think aloud interview technique to determine current surgical wound assessment and documentation in Vietnam. The development of a surgical wound assessment tool (SWAT) was then undertaken in the second study, which included two phases. In Phase One an initial SWAT was developed based on international evidence-based guidelines and a
ii Development and validation of a surgical wound assessment tool for use in vietnam comprehensive literature review. Vietnamese surgeons then evaluated the initial SWAT. In Phase Two, Vietnamese wound care nurse experts used an interactive Delphi process to develop and refine a final version of the SWAT. The final study involved a prospective evaluation of the SWAT. Exploratory factor analysis was used to examine construct validity. Intraclass correlation coefficient and Cohen’s kappa were used to evaluate reliability. General linear regression was applied to identify which risk factors in the SWAT predicted surgical wound complications at post- operative day five.
Results: The first study indicated that the current practice approach to surgical wound assessment was inadequate. Nurses evaluated surgical wounds based on their experience and observation, without using a standard guideline for their assessments, leading to only a few wound components, such as wound edge, peri-wound skin, volume of exudate, and signs of infection being assessed. Other wound characteristics and risk factors associated with wound healing were less frequently assessed by nurses. Regarding surgical wound assessment documentation, among the 200 records that were audited, less than 10% of pre-operative risk factors related to delayed wound healing were documented. Furthermore, there was no documentation about incision location, wound dimension, wound bed (in wounds healing by secondary intention), or odour during the first five days post-operation. Pain and wound appearance (swelling, or erythema) were documented in less than 40% of charts.
The SWAT was developed in the second study. In Phase One, 22 items were developed and included. The initial SWAT was evaluated by 10 surgeons and had item-content validity index (I-CVI) scores of 1.00 in 17 out of 22 items. The remaining items had an I-CVI ranking of 0.8 to 0.9. The overall scale-content validity index was 0.97. Surgeons recommended eight more items to be included in the SWAT, increasing the total to 30 items. In Phase Two (Delphi process), 21 Vietnamese nurse wound care experts completed all three rounds of the Delphi process. After three rounds, 24 out of 30 items reached full consensus, and six items did not reach consensus.
In the evaluation study (Study Three), the results of the exploratory factor analysis supported a three-component structure of the SWAT. The intraclass correlation coefficient value of the overall scale was 0.81 (95% CI 0.68-0.89, p< 0.001), confirming excellent inter-rater reliability. Cohen’s kappa value ranged from 0.5-1, demonstrating moderate to an almost perfect level of agreement for individual
Development and validation of a surgical wound assessment tool for use in vietnam iii items, with the exception of the wound pain item. Five items made a unique and statistically significant contribution to surgical wound complications at post-operative day five, including body mass index, diabetes, surgical duration, surgical wound contamination classification, and type of surgery.
Conclusion: The SWAT was deemed a valid tool for monitoring the status of surgical wound healing and detecting early factors that may increase the risk of surgical wound complications. Furthermore, the tool demonstrated excellent inter- rater reliability. Application of the SWAT will improve the assessment of surgical wounds in daily nursing practice in Vietnam, which will promote improved postoperative wound management. It is an easy and practical tool for enhancing inter- disciplinary communication and care outcomes for all patients with surgical wounds. However, further modification and testing is required to strengthen the tool.
iv Development and validation of a surgical wound assessment tool for use in vietnam Table of Contents
Keywords ...... i Abstract ...... ii Table of Contents ...... v List of Figures ...... ix List of Tables ...... x List of Abbreviations ...... xi Statement of Original Authorship ...... xii Acknowledgements ...... xiii Chapter 1: Introduction ...... 1 1.1 Background ...... 1 1.2 Vietnamese Context ...... 2 1.2.1 Inadequate nursing educational preparation ...... 4 1.2.2 Overcrowded hospitals ...... 6 1.2.3 Few career development opportunities ...... 7 1.3 Aims and Research Questions ...... 8 1.3.1 Specific objectives ...... 9 1.3.2 Research questions ...... 9 1.4 Overview of Methdology ...... 10 1.5 Significance of the Study ...... 11 1.6 Thesis Outline ...... 12 Chapter 2: Literature Review of Surgical Wounds ...... 14 2.1 Introduction ...... 14 2.2 Prevalence of Surgical Wounds ...... 14 2.3 Surgical Wound Healing ...... 16 2.3.1 Phases of wound healing ...... 17 2.3.2 Factors affecting surgical wound healing ...... 18 2.4 Surgical Wound Complications ...... 37 2.4.1 Haematoma/seromas ...... 37 2.4.2 Surgical site infection ...... 38 2.4.3 Wound dehiscence ...... 40 2.5 Summary of Literature on Surgical Wounds ...... 41 Chapter 3: Literature Review: Wound Assessment Tools and Documentation 42 3.1 Introduction ...... 42 3.2 The Role of Wound Assessment Tools...... 42 3.3 Wound Assessment Tools ...... 44 3.3.1 Elements of wound assessment ...... 44 3.3.2 Tools to measure healing in all types of wounds ...... 48
Development and validation of a surgical wound assessment tool for use in vietnam v 3.3.3 Tools to measure surgical wound healing ...... 49 3.3.4 Tools to measure chronic wound healing ...... 51 3.3.5 Summary of literature on wound assessment tools ...... 55 3.4 Wound Documentation ...... 56 3.4.1 Nursing documentation ...... 56 3.4.2 Current wound documentation ...... 57 3.5 Chapter Summary ...... 58 Chapter 4: Conceptual Framework ...... 60 4.1 Introduction ...... 60 4.2 Conceptual framEworks ...... 61 4.2.1 The MEASURE framework ...... 61 4.2.2 TIME framework ...... 62 4.2.3 Surgical Wound Care Algorithms Framework ...... 63 4.3 Chapter Summary ...... 68 Chapter 5: Study One - Exploratory Study ...... 69 5.1 Introduction ...... 69 5.2 Study 1A: Surgical Wound Assessment ...... 70 5.2.1 Research design ...... 70 5.2.2 Method ...... 70 5.2.3 Setting ...... 71 5.2.4 Sample ...... 72 5.2.5 Procedure and data management ...... 72 5.2.6 Data analysis ...... 74 5.2.7 Ethical considerations ...... 77 5.2.8 Results ...... 77 5.2.9 Study 1A Discussion ...... 87 5.3 Study 1B: Surgical Wound Assessment Documentation ...... 92 5.3.1 Research design ...... 92 5.3.2 Method ...... 92 5.3.3 Sample size ...... 92 5.3.4 Procedure and data management ...... 93 5.3.5 Data analysis ...... 95 5.3.6 Results ...... 95 5.3.7 Study 1B Discussion ...... 98 5.4 Strengths and Limitations of Study One ...... 100 5.5 Chapter Summary ...... 101 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool ...... 102 6.1 Introduction ...... 102 6.2 Objectives and Research Questions ...... 102 6.3 Phase One: Development of Initial Surgical Wound Assessment Tool ...... 104 6.3.1 Development of SWAT items ...... 104 6.3.2 Development of item response options ...... 106 6.3.3 Translation process ...... 110 6.4 Phase One: Consultation with Surgeons ...... 111 6.4.1 Method ...... 111
vi Development and validation of a surgical wound assessment tool for use in vietnam 6.4.2 Data analysis ...... 112 6.4.3 Ethical consideration ...... 113 6.4.4 Results ...... 113 6.5 Chapter Summary ...... 122 Chapter 7: Study Two - Phase Two: The Delphi Study ...... 123 7.1 Introduction ...... 123 7.2 Objectives and Research Questions ...... 123 7.3 Method ...... 123 7.3.1 Research design ...... 123 7.3.2 Delphi methods ...... 124 7.3.3 The Delphi rounds ...... 126 7.3.4 The panel of experts ...... 126 7.3.5 Expert panel size ...... 127 7.3.6 Level of consensus ...... 128 7.3.7 Procedure and data management ...... 130 7.3.8 Data analysis ...... 132 7.3.9 Ethical considerations ...... 133 7.4 DELPHI Results ...... 133 7.4.1 Timeline and response rate for the three Delphi rounds ...... 133 7.4.2 Demographic characteristics of nurse wound care expert panel members completing all three rounds ...... 133 7.4.3 Round One ...... 135 7.4.4 Round Two ...... 147 7.4.5 Round Three ...... 154 7.5 Scoring System for the Surgical Wound Assessment Tool ...... 159 7.6 Discussion ...... 164 7.7 Strengths and Limitations ...... 167 7.8 Chapter Summary ...... 168 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 170 8.1 Introduction ...... 170 8.2 Objectives and Research Questions ...... 170 8.3 Method ...... 171 8.3.1 Research design ...... 171 8.3.2 Validity ...... 171 8.3.3 Reliability ...... 172 8.3.4 Risk factors at postoperative day 5 ...... 172 8.3.5 Settings ...... 173 8.3.6 Sample ...... 173 8.3.7 Procedure and data management ...... 174 8.3.8 Data analysis ...... 176 8.3.9 Ethics consideration ...... 179 8.4 Results ...... 179 8.4.1 Demographic characteristics ...... 179 8.4.2 Inter-rater reliability ...... 183 8.4.3 Construct validity ...... 185 8.4.4 Risk factors predicting surgical wound complications at post-operative day five ...... 186
Development and validation of a surgical wound assessment tool for use in vietnam vii 8.5 Discussion ...... 189 8.6 Strengths and Limitations ...... 196 8.7 Chapter Summary ...... 196 Chapter 9: Discussion and Conclusion ...... 198 9.1 Introduction ...... 198 9.2 Summary of Key Findings ...... 198 9.2.1 Study One aim: To identify and describe surgical wound assessment and documentation practices in Vietnam ...... 198 9.2.2 Study Two aim: To develop a surgical wound assessment tool ...... 200 9.2.3 Study Three aim: To evaluate validity and reliability of the SWAT ...... 202 9.3 Strengths and limitations ...... 206 9.4 Recommendations ...... 207 9.4.1 Clinical practice ...... 207 9.4.2 Education ...... 208 9.4.3 Future research and ongoing development of the tool ...... 208 9.4.4 Proposed strategies to implement the surgical wound assessment tool in clinical practice in Vietnam ...... 209 9.5 Conclusion ...... 213 References ...... 214 Appendices ...... 252
viii Development and validation of a surgical wound assessment tool for use in vietnam List of Figures
Figure 1.1: Study Flow Diagram ...... 13 Figure 4.1: The Surgical Wound Care Algorithm Framework ...... 64 Figure 4.2: Modified version of Surgical Wound Care Algorithm Framework (Han & Choi-Kwon, 2011) combined with the TIME framework (Leaper et al., 2012) for surgical wound assessment ...... 67 Figure 5.1: Coding example ...... 77 Figure 5.2: Documentation of patient factors related to surgical wound healing recorded before an operation ...... 97 Figure 6.1: The process for the development of the surgical wound assessment tool for Study Two ...... 103 Figure 7.1: Summary of the actions and results of Round One ...... 146 Figure 7.2: Summary of the actions and results of Round Two...... 153 Figure 7.3: Summary of the actions and results of Round Three...... 158 Figure 9.1: The triangle of surgical wound assessment for surgical wounding heal by primary intension...... 204 Figure 9.3: The adapted CSI model implementation process ...... 212
Development and validation of a surgical wound assessment tool for use in vietnam ix List of Tables
Table 3.1: Surgical wound healing outcomes ...... 46 Table 5.1: Line-by-line coding example ...... 76 Table 5.2: Surgical nurses’ demographic characteristics ...... 78 Table 5.3: Categories resulting from the think aloud technique and the interviews on surgical wound assessment ...... 79 Table 5.4: Demographic characteristics of patients ...... 96 Table 5.5: Surgical wound characteristics documentation during first five post- operative days ...... 98 Table 6.1: Items of the initial SWAT ...... 105 Table 6.2: The initial SWAT (Version 1) ...... 109 Table 6.3: The demographic characteristics of surgeons ...... 114 Table 6.4: Importance as items rated by each surgeon ...... 116 Table 7.1: Percentage of expert panel participation ...... 133 Table 7.2: Demographic characteristics of nursing wound care expert panel ...... 134 Table 7.3: Items that reached full consensus in Round One ...... 136 Table 7.4: Items that reached partial consensus in Round One ...... 137 Table 7.5: Items that did not reach consensus in Round One ...... 138 Table 7.6: The response options of wound edges item ...... 144 Table 7.7: Items that reached full consensus in Round Two ...... 148 Table 7.8: Items that reached partial consensus in Round Two ...... 149 Table 7.9: Items that did not reach consensus in Round Two ...... 150 Table 7.10: Items that achieved full consensus in Round Three ...... 155 Table 7.11: Items that did not reach consensus in Round Three ...... 156 Table 7.12: The surgical wound assessment tool with scoring ...... 161 Table 8.1: SWAT patient and disease factors: sample characteristics ...... 180 Table 8.2: SWAT surgical procedural factors: sample characteristics ...... 181 Table 8.3: SWAT surgical wound characteristics: sample characteristics ...... 182 Table 8.4: Inter-rater reliability results of the surgical wound assessment tool ...... 184 Table 8.5: Factor structure of the first two domains associated with risk factors in the surgical wound assessment tool ...... 185 Table 8.6: Factor structure of the surgical wound characteristics domain in the surgical wound assessment tool ...... 186 Table 8.7: General linear model analysis of predictors of surgical wound complications at post-operative day 5...... 188
x Development and validation of a surgical wound assessment tool for use in vietnam List of Abbreviations
The following abbreviations are used throughout this document.
BMI Body Mass Index
BWAT Bates-Jensen Wound Assessment Tool
EFA Exploratory Factor Analysis
EWMA European Wound Management Association
GLM General Linear Model
HbA1c Haemoglobin A1c
ICC Intraclass Correlation Coefficient
I-CVI Item-content Validity Index
LUMT Leg Ulcer Measurement Tool
NNIS National Nosocomial Infection Surveillance System
OR Odds Ratio
PUSH Pressure Ulcer Scale for Healing
PSST Pressure Sore Status Tool
PWAT Photographic Wound Assessment Tool
S-CVI Content Validity of the Overall Scale
SS Sessing Scale
SWAT Surgical Wound Assessment Tool
SWHT Sussman Wound Healing Tool
WHS Wound Healing Scale
Development and validation of a surgical wound assessment tool for use in vietnam xi Statement of Original Authorship
The work contained in this thesis has not been previously submitted to meet requirements for an award at this or any other higher education institution. To the best of my knowledge and belief, the thesis contains no material previously published or written by another person except where due reference is made.
Signature: QUT Verified Signature
Date: May 2019
xii Development and validation of a surgical wound assessment tool for use in vietnam Acknowledgements
This thesis would not have been possible without the help and support of many people. I would like to take this opportunity to acknowledge and express my gratitude to those people for their support and encouragement over the last three years of my PhD journey.
My most profound gratitude goes to my brilliant supervisory team; Professor Helen Edwards and Dr Kathleen Finlayson, for their knowledgeable guidance, direction, ongoing support, encouragement, and their belief that I would make it to the end of this journey.
I would like to acknowledge QUT Postgraduate Awards for the financial support that provided me with the opportunity to undertake my PhD research. I would also like to thank the Faculty of Health Services staff for their assistance throughout my PhD journey. My thanks also go to the Research Methods Group and Ms Lee Jones for her patience, support, and advice on data analysis.
Further appreciation goes to Mr. Martin Reese for his support with academic writing. I am also grateful to professional editor, Ms. Kylie Morris, who provided copyediting and proofreading services according to the guidelines laid out in the university-endorsed guidelines and the Australian Standards for editing research theses.
My sincere thanks are extended to the translation team (Ms Oanh, Ms Tuan, Ms Lan, and Ms Mai), surgeons, and nurses in Vietnam for their contributions to the development of the research instruments. I would also like to thank the leaders of Haiduong Medical Technical University and Haiduong General Hospital for their support throughout the data collection for this research. I am in debt to my participants for their valuable time
I would like to express special thanks to Professor Genevieve Gray, former Director of the Vietnam Nursing Project, for her advice, support, and encouragement. She also provided me with the inspiration and confidence to keep studying. Without her support from the beginning, I would not be who I am today.
Development and validation of a surgical wound assessment tool for use in vietnam xiii I also wish to extend my grateful appreciation and special thanks to the wonderful group of researchers and clinicians in the Nursing Wound Healing Group at QUT, IHBI, School of Public Health, and School of Nursing for their support, and for sharing in and listening to my experience.
Finally, but most importantly, my grateful thanks go to my family. To my husband, Pham Chung, for his love, motivation, encouragement, and deep understanding to keep me going when the journey got tough. Many thanks to my parents and my mother-in-law for their support and help caring for my child, which allowed me to concentrate on and finish this journey.
xiv Development and validation of a surgical wound assessment tool for use in vietnam Chapter 1: Introduction
This aim of this research was to develop and validate a surgical wound assessment tool for use in Vietnam. This chapter introduces the study’s background and outlines the context of the research. The research aims, objectives, and research questions used to guide the research are then outlined, followed by a discussion about the significance of the study. Finally, an outline of the remaining chapters of the thesis is presented.
1.1 BACKGROUND
Worldwide, at least 312.9 million surgical procedures were performed in 2012 (Weiser et al., 2015), and Rose et al. (2015) estimated that at least 321.5 million additional surgical procedures would be needed to address the burden of disease for a global population. Most surgical procedures result in wounds that can heal by primary intention. However, even if primary closure is achieved, the incision may be associated with surgical site complications, including surgical site infection (SSI), seroma, haematoma, ischaemia, and dehiscence (World Union of Wound Healing Societies [WUWHS], 2016a).
SSI is one of the most common complications of surgical wounds and can be associated with any type of surgical procedure (Allegranzi et al., 2011; European Wound Management Association [EWMA], 2005). According to a report from the World Health Organization (WHO) (2016a) on the global burden of endemic SSIs for low-and-middle-income countries, the pooled SSI incidence was 11.2 per 100 surgical patients (95% CI: 9.7-12.8). The high prevalence of SSI in low and middle-income countries was also reported in one international, multicentre cohort study of 12,539 patients who underwent gastrointestinal surgeries from 343 hospitals in 66 countries (Bhangu et al., 2018). The incidence of SSI varied between countries with 9.4% for high, 14.0% for middle and 23.2% for low-income countries. This figure increased to 39.8% after contaminated or dirty surgeries were included. This means that in the most contaminated surgical wounds, one in three patients from low and middle-income countries had a SSI (Bhangu et al., 2018). The impact of SSI is a significant economic burden regarding the extra postoperative length of stay in the hospital and increased
Chapter 1: Introduction 1 costs of treatment (de Lissovoy et al., 2009; Weber et al., 2008; WHO, 2009). Moreover, SSI has been found to be associated with high rates of death, with a three- fold increase from 1.5% in patients without a SSI to 4.7% in patients with a SSI (Bhangu et al., 2018).
Strategies are therefore required to reduce surgical wound complications, particularly in low- and middle-incomes countries. It has been suggested that effective wound management must start with an accurate and holistic assessment of the patient’s ability to heal, the likelihood of complications, the wound factors affecting healing, and the environmental factors that impact optimum wound management (Burton, 2006; Cooper et al., 2010). Wound assessment is central to appropriate wound management (Greatrex-White & Moxey, 2013). Appropriate wound management results in reducing the risk of wound complications and prevents wounds from developing into chronic wounds (Gillespie, Chaboyer, Allen, Morely, & Nieuwenhoven, 2014).
However, inappropriate wound assessment can result in ineffective wound management, leading to patients suffering from failure to heal. As a consequence, the wound is present longer than is necessary, with an increased risk of complications (Eagle, 2009; Fletcher, 2010). Thus, the best approach to define wounds’ status is by conducting a holistic and comprehensive wound assessment (Wounds Australia, 2016). However, according to a current systematic review conducted by Ding, Lin, and Gillespie (2016) on surgical wound assessment and documentation, surgical wound assessment and documentation are insufficient and lack standardisation practices worldwide. There are no clear guidelines or available surgical wound assessment tools for the assessment of surgical wounds (Ding et al., 2016). These findings demonstrate a significant gap in surgical wound assessment practice worldwide and indicate the need for further investigation. The following section outlines the Vietnamese context and current gaps in the literature, which led to this research being undertaken in Vietnam.
1.2 VIETNAMESE CONTEXT
Vietnam is a low middle-income country. It is located in South-East Asia, with a population of approximately 90 million people (WHO, 2016b). The gross domestic product is US$200 per capita per year (WHO, 2016b). However, in 1986, Vietnam
2 Chapter 1: Introduction implemented an open-door policy, and this resulted in steadily increasing economic growth, at an annual rate of about 6-7% GPD (M. P. Nguyen, Mirzoev, & Le, 2016). Regarding the health care system in Vietnam, it is organised at four administrative levels, including national (Ministry of Health), provincial (Department of Health), district (health centres), and commune (commune health stations) (WHO, 2016b).
Over 400,000 health care professionals work in the public sector, in which doctors, assistant doctors, nurses, and technicians contribute to 80% of healthcare staff (WHO, 2016b). Doctors comprise 16% of healthcare staff in the public sector. The density of doctors in Vietnam is 7.61 per 10,000 people (WHO, 2016b). Nurses constitute 23% of the total healthcare staff. However, 86% of nurses graduate at a secondary level (2 year nursing training programmes), and only 8.3% nurses are educated at colleges (3 year nursing programmes) and universities (4 year nursing programmes), because 3-year or 4-year nursing programmes only commenced in the last 15 years (WHO, 2016b). Nurses with a higher qualification, such as a Masters or PhD degree account for only 0.5% of nurses who graduated with a Bachelor of Nursing. The most highly qualified nurses often hold a position in training institutions or in management (WHO, 2013).
The nurse-to-doctor ratio has increased from 1.19 in 2008 to 1.34 in 2012 (WHO, 2016b). However, when comparing nurse to doctor ratios with other countries in Asia, Vietnam has the lowest rate of nurses per doctors, and Indonesia has the highest rate, with a ratio of 6.8 to 1 (Kanchanachitra et al., 2011). Even though there is no global standard for nurse-to-doctor ratio, a low ratio could suggest inadequacies in the health system (Kanchanachitra et al., 2011). For example, according to a study conducted by M. P. Nguyen et al. (2016), the density of doctors, nurses, midwives, and pharmacists in Vietnam has shown statistically significant evidence on improvement into life expectancy and decreased mortality rates among infant and children under-five years.
Like most middle-income countries, Vietnam is facing a double burden of communicable and non-communicable diseases (WHO, 2011). The current disease pattern of Vietnam has shifted from communicable diseases to non-communicable diseases (V. Nguyen, 2017). The prevalence of communicable diseases declined from 37.63% in 1996 to 25.33% in 2013. However, the impact of non-communicable disease increased rapidly (WHO, 2016b). In 2013, the non-communicable disease
Chapter 1: Introduction 3 incidence, including cardiovascular disease, diabetes, hypertension, and cancer, was 61.69% (WHO, 2016b). The increase in these chronic conditions has led to a macroeconomic burden on patients and healthcare systems in Vietnam (V. Nguyen, 2017). In addition to the burden of communicable and non-communicable diseases, road traffic injuries are also becoming a significant public health issue as a result of fast economic development and motorisation in recent years (Nagata et al., 2011).
One field has emerged as an indispensable tool for treating non-communicable diseases –surgery. It has been projected that 11% of global disease caused by injuries alone can be treated with surgery, and these figures would to be greater if other surgical conditions were included (Ozgediz, Jamison, Cherian, & McQueen, 2008). Surgery is crucial to the prevention of death and disability, to the preservation of economic productivity, and cost-effective care in low-middle incomes countries (Grimes, Henry, Maraka, Mkandawire, & Cotton, 2014). Together with the growing recognition about the significance of surgical intervention, in recent years, access to essential surgical care has been considered part of the basic human right to health, and part of a comprehensive health strategy (Grimes et al., 2014; McQueen et al., 2010). An example of the increasing demand for surgery was reported in one national surgical hospital in Vietnam (Dung, Chinh, Hanh, & Notter, 2016). It was estimated that approximately 200 operations were carried out daily, with a further 200 new patients needing wounds examined, and nurses in the hospital provide wound care to an average of 900 patients each day (Dung et al., 2016). In this context of the increased demand for and complexity of surgical events, post-surgical wound care should be given significant attention in wound care management. However, Vietnamese nurses face several challenges when caring for patients with surgical wounds. These challenges are discussed below.
1.2.1 Inadequate nursing educational preparation Nursing education in Vietnam provides inconsistent training preparation for nursing students in terms of multiple levels of nursing education programs, inadequate content associated with nursing science, lack of human resources, and limited training facilities. First, nursing training in Vietnam involves three levels: secondary schools, colleges, and universities. Training time for each level varies. A Bachelor of Nursing is taught for four years at universities. Colleges offer three-year degree programmes in nursing and two-year secondary nursing programmes (WHO, 2016b). Although
4 Chapter 1: Introduction there are multiple levels of education for nurses, all nurses who have graduated from a different level of nursing training program work at the same level, with the same scope of practice in the clinical setting, resulting in inconsistent standards in patient care and overall misperceptions about and dissatisfaction within the nursing profession (Harvey, Calleja, & Thi, 2013)
In addition to multiple levels of nursing educational programs, insufficient content associated with nursing sciences and management of the nursing curriculum is another issue. The Ministry of Education and Training provide the nursing curriculum framework for educational institutions and allow each institute to vary as much as 40% in its curriculum (Hill & Crow, 2013). The first year of most nursing education is committed to compulsory subjects, such as Ho Chi Minh Ideology and Principles of Marxist-Leninist Philosophy. The second-year incorporates supportive subjects, such as general anatomy, physiology, and techniques for primary care. The third and fourth years focus on disease and biomedical treatments. The topics of nursing research and management are briefly introduced in the third or fourth year and are only provided for college programs and bachelor degree students (Hill & Crow, 2013). Thus, it has been suggested that the curricula for health professionals in Vietnam are mostly traditional, didactic in style, knowledge-based, and lack flexibility (WHO, 2016b).
In relation to wound care, nurses do not have in-depth knowledge and skills in the assessment and management of a patient with wounds. This lack of knowledge and expertise in wound care management can clearly be seen in inadequately designed nursing curriculum programs for the following reasons: (1) wound care management is not provided in the nursing curriculum (University of Medicine and Pharmacy at Ho Chi Minh city, 2017); (2) wound care is only integrated into a fundamental nursing subject in which dressing change procedures are the primary focus rather than wound assessment and identifying the risk factors associated with delayed wound healing (Do & Tran, 2010); and (3) wound care is only mentioned again in a surgical subject; however, this subject focuses on treatment, nursing diagnoses, and caring for general surgical patients rather than focussing on surgical wound assessment and management (T. C. Nguyen, 2008). The lack of content related to the pathology of wound healing, wound assessment, and management makes it challenging for nurses to be independent in developing a wound care plan for their patients.
Chapter 1: Introduction 5 Faculty capacity and infrastructure also do not always meet training needs. Many healthcare students graduate from a small number of universities in Vietnam each year. For example, in 2013, around 6,889 medical doctors graduated from only 18 medical universities (WHO, 2016b). The number of educators does not meet the requirements of an increasing number of students, with one instructor supervising more than 50 students in practical training (Truong, 2015). Training infrastructure, such as in laboratories and skill-labs, teaching instruments, and equipment for practical training do not always meet training needs (WHO, 2016b).
Finally, there is a lack of highly-qualified nursing teachers in universities in Vietnam, and this is another problem for nursing programs. It is estimated that only 30% of nursing educators in colleges and universities are nurses, and the remainder are doctors (Ministry of Health, 2012). In the case of physicians as an educator, medical management of the disease is typically the focus, rather than nursing care (Harvey et al., 2013). Thus, most nurses primarily focus on technical skills, and consequently, may not be sufficiently equipped with background nursing knowledge, symptom assessment, and management skills, and have no foundational research principles. Nursing practice is also assigned by tasks rather than by patients, which may prevent nurses from developing a holistic approach to individual patients (L. T. Nguyen, Annoussamy, & LeBaron, 2017). For example a few nurses are assigned to administer medication, and another nurse is responsible for the dressing changes for every patient in the unit. Therefore, with inadequate content related to nursing science or nursing management, the nursing programs do not prepare nurses to become clinicians, managers, teachers, or leaders in nursing (P. S. Jones, O'Toole, Hoa, Chau, & Muc, 2000).
1.2.2 Overcrowded hospitals Overcrowding in central and specialised hospitals is a significant problem in Vietnam (World Health Organization and the Ministry of Health, 2012). Minimal staff are responsible for large numbers of patients in the central hospital, and two or three patients sometimes share one bed due to an inadequacy of beds and patient overcrowding (P. S. Jones et al., 2000). This was evident in the case of a hospital that was designed for only 1,705 beds, while the number of patients was up to 2,700 (To, Graves, Huynh, & Le, 2011). This increased workload may result in higher risk of patients developing hospital-acquired infections and reduce the quality of patient care
6 Chapter 1: Introduction (Islam et al., 2015; To et al., 2011). In a hospital setting, nurses frequently share their perception of pressures associated with the significant number of patients in Vietnam (Ng'ang'a, Byrne, & Ngo, 2014). Research shows that there are several significant consequences of high nursing workloads. A heavy nursing workload adversely affects patient safety (Lang, Hodge, Olson, Romano, & Kravitz, 2004; Magalhães, Dall'Agnol, & Marck, 2013) such as bed-related falls (Carlesi, Padilha, Toffoletto, Henriquez-Roldán, & Juan, 2017), medical errors (Hayes et al., 2012; Shahrokhi, Ebrahimpour, & Ghodousi, 2013), and hospital-acquired infection (Islam et al., 2015; Magalhães et al., 2013). Overcrowded patients and large workloads lead to less time spent with each patient.
In Vietnamese hospitals, after an operation, a patient with stable vital signs is transferred to a surgical ward or intensive care unit for further monitoring. It is recommended that the original surgical dressing should remain intact for the first 48- 72 hours (Canadian Association of Wound Care, 2017). However, in most cases, the first dressing change is undertaken 24 hours after the operation, and the surgical wound is assessed at the first dressing change. Dressing change procedure and aseptic techniques have guidelines that are available in hospitals to guide nurses while caring for patients with wounds (Do & Tran, 2010). These guidelines focus on the process of dressing change rather than wound assessment and wound management. Even though the Ministry of Health in Vietnam has issued current guidelines on the diagnosis, treatment, and nursing care of 26 common diseases in Vietnam, there are no clear guidelines for specific wound assessment (Ministry of Health, 2016). Thus, it is assumed that undertaking wound assessment without standard guidelines may lead to inaccuracy, inconsistency, and the omission of essential information, resulting in an ineffective wound care plan that will impact on wound healing outcomes.
1.2.3 Few career development opportunities Research has shown that there are two main learning strategies nurses often apply to enhance their competencies in the hospital, including formal learning and informal learning. It seems that learning from work experience, the daily reflective process, and feedback from peers/colleagues are common strategies used by Vietnamese nurses to update their knowledge (Ha & Nuntaboot, 2016). However, formal learning is limited for nurses to upgrade their nursing certificates and competencies due to lack of nursing education programs at the bachelor level and
Chapter 1: Introduction 7 higher in Vietnam (Ha & Nuntaboot, 2016). This is similar to other developing nations, where physicians and nurses have stated that they do not have opportunities for formal training or refresher training after their graduation, resulting in inability to provide good quality of care (Islam et al., 2015). In addition to formal and informal learning strategies to enhance knowledge and skills, research studies indicate that evidence- based practice is the bridge between research and practice, and it is recognised as a useful tool to improve health outcomes (Brady & Lewin, 2007; T. N. Nguyen & Wilson, 2016). However, according to a survey of 234 nurses working at two central hospitals in Vietnam, Vietnamese nurses were not prepared to undertake research and implement research findings into practice (T. N. Nguyen & Wilson, 2016). Nearly half expressed a lack of knowledge and skills when conducting evidence-based practice, such as searching for literature, basic principles of nursing/health science research, and English to be able to understand scientific articles and reports (T. N. Nguyen & Wilson, 2016).
Considering all of this evidence, Vietnamese nurses face many challenges when caring for patients with surgical wounds, including: (1) inadequate knowledge and skills about wound care assessment and management; (2) high pressure of workloads in clinical settings; (3) lack of opportunities for retraining after graduation; (4) limited knowledge and skills in searching for and understanding nursing science research to apply evidence into clinical practice; and (5) absence of holistic approach for individual patients. Consequently, a standard wound assessment tool would be a useful solution to assist nurses to provide holistic wound assessment and improve patient outcomes. This project therefore aims to develop and validate a surgical wound assessment tool for use in Vietnam.
1.3 AIMS AND RESEARCH QUESTIONS
This project aimed to:
Determine the current practice of surgical wound assessment and documentation in Vietnam.
Develop a surgical wound assessment tool for use in Vietnam.
Evaluate the validity and reliability of the new surgical wound assessment tool relevant to the Vietnamese context.
8 Chapter 1: Introduction Three studies were conducted to achieve these three aims. The following specific objectives and research questions were developed for each study.
1.3.1 Specific objectives The research aimed to:
Identify the key components of surgical wound assessment that nurses collect when conducting a surgical wound assessment (Study 1). Explore nurses’ perceptions of current practices in surgical wound assessment and their requirements from a surgical wound assessment tool (Study 1). Determine the extent to which surgical wound assessment documentation in Vietnam meets international guidelines (Study 1). Develop a surgical wound assessment tool for use in Vietnam (Study 2). Evaluate the inter-rater reliability of the surgical wound assessment tool (Study 3). Validate the construct validity of the surgical wound assessment tool (Study 3). Identify the risk factors in the surgical wound assessment tool predicting surgical wound complications on postoperative day five (Study 3).
1.3.2 Research questions The research questions addressed in this research were:
Study 1
1. What data do nurses collect while the undertaking the process of assessing surgical wounds?
2. What are nurses’ perceptions of the current practices for surgical wound assessment?
3. What do nurses require from a surgical wound assessment tool?
4. How does the current state of surgical wound assessment documentation in Vietnam compare to international evidence-based guidelines?
Study Two
Chapter 1: Introduction 9 1. Which components/factors identified from a review of the literature and experience from the research team could be incorporated into a surgical wound assessment tool that is practical and could be easily used by Vietnamese nurses?
2. What is the level of content validity of the newly developed surgical wound assessment tool, as evaluated by Vietnamese surgeons and surgical nurse wound care experts?
3. What additional elements would Vietnamese surgeons and surgical nurse wound care experts recommend for inclusion in a surgical wound assessment tool?
Study Three
1. What is the inter-rater reliability for the new surgical wound assessment tool?
2. What is the construct validity for the new surgical wound assessment tool?
3. What risk factors identified in the surgical wound assessment tool predict surgical wound complications at day five post-operative?
1.4 OVERVIEW OF METHDOLOGY
The concept of using both qualitative and quantitative methods has stimulated much interest and debate (Andrew & Halcomb, 2009). Researchers increasingly have used a combination of the qualitative and quantitative approach to expand the scope and deepen insights from their studies. As advocates of mixed qualitative and quantitative method research have argued, the complexity of human phenomena mandates more complex research designs to capture them (Sandelowski, 2000). Based upon the overall purpose of the study and the research questions identified, the researcher used a combination of qualitative and quantitative approaches including the collection, analyses, and mixing of qualitative and quantitative data in a single study. The approach was deemed appropriate because, when used in combination, qualitative and quantitative methods complement each other. They also provide a more comprehensive understanding of the research problem and generate detailed evidence (Andrew & Halcomb, 2009; Sandelowski, 2000). In this study, the qualitative approach was used as an exploratory study to provide rich
10 Chapter 1: Introduction descriptive and documentary information about the topic in relation to the relatively unexplored area of surgical wound assessment and nurses’ expectation of a surgical wound assessment tool to facilitate nursing practice in Vietnamese hospitals. The identified research problem and concepts derived were then examined with a quantitative approach to develop a surgical wound assessment tool and to psychometrically test the newly developed surgical wound assessment tool to identify whether this newly developed tool was suitable to use in Vietnam.
To achieve the three aims, three studies were conducted. Study 1 was a qualitative descriptive study that explored current surgical wound assessment and documentation, as well as nurses’ requirements of a surgical wound assessment tool. Then Study 2 used a quantitative approach involving the use of the Delphi method. This method was used to gain consensus among experts to develop items for a surgical wound assessment tool. Finally, Study 3 was a psychometric study to evaluate the validity and reliability of the newly developed surgical wound assessment tool.
1.5 SIGNIFICANCE OF THE STUDY
This research provided a comprehensive description of the current practice of surgical wound assessment and documentation in Vietnam. This was the first time that this type of research had been conducted in Vietnam. Thus, it was expected that the results will contribute significantly to both local knowledge and to the global perspective. In addition, through understanding routine wound care practices and what nurses require from a surgical wound assessment tool, this project proposes an intervention strategy to improve the current practice of surgical wound assessment and documentation through the development of a surgical wound assessment tool. The surgical wound assessment tool was designed based on international standard guidelines, then evaluated and modified through a different process to fit with current surgical wound assessment in Vietnam.
This research is significant because the surgical wound assessment tool developed in this project will provide significant benefits for nurses in clinical practice to improve patient outcomes. Thus, it is hypothesised that by using a surgical assessment tool to guide nurses in holistic and comprehensive wound assessment, nurses will be guided to provide improved postoperative wound management, which will result in improved healing rates, reduced surgical wound complications, and
Chapter 1: Introduction 11 enhanced quality of the systematic recording of patient information. With education and training, this research project also provides Vietnamese nurses with standardized documentation and communication about wounds. This will enable them to be consistent when communicating with other health care professionals. In addition to contributing to improving patients’ wound care outcomes in Vietnam, this research also reduces the gap in current surgical wound assessment tools worldwide.
1.6 THESIS OUTLINE
This thesis is organised into nine chapters. This introductory chapter has provided the background, Vietnamese context regarding where the studies were undertaken, and the significance of this thesis project. Chapter 2 follows with a literature review about surgical wounds and the risk factors associated with surgical wound complications. Chapter 3 describes the current existing wound assessment tools and provides a literature review of wound assessment and documentation. Chapter 4 includes the conceptual framework used to guide the development of the surgical wound assessment tool. The current practices for surgical wound assessment and documentation in Vietnam, including the methods, findings, and discussion, are described in Chapter 5. Chapters 6 and 7 provide details about the development of the surgical wound assessment tool. The outcomes of the evaluation of the validity and reliability of the surgical wound assessment tool are presented in Chapter 8. Finally, Chapter 9 summarises the study, and highlights the key interpretations, contribution, recommendations, and limitations. The research outline is presented diagrammatically in Figure 1.1.
12 Chapter 1: Introduction
Figure 1.1: Study Flow Diagram
Chapter 1: Introduction 13 Chapter 2: Literature Review of Surgical Wounds
2.1 INTRODUCTION
This chapter provides an overview of surgical wounds and the risk factors associated with delayed surgical wound healing and surgical wound complications. The literature review for this section was compiled from literature from the early 1990s to 2018, after an extensive search of the databases: EBSCOhost (Medline, PsycINFO and CinaHl), ProQuest (Nursing and Allied Health for journals, dissertations, and theses), the Cochrane Library databases, PubMed, Wiley On-Line library, as well as Google Scholar. Professional associations for wound management websites were also searched for relevant information, including: European Wound Management Association, Australian Wound Management Association, Wound Healing Society, the Canadian Association of Wound Care, and World Union of Wound Healing Societies.
These searches were undertaken using the keywords “surgical” OR “postoperative” OR “post-surgical” AND “wound*” OR “incision”, “delayed healing” OR “poor healing” OR “impaired healing”, and “risk factor*”.
2.2 PREVALENCE OF SURGICAL WOUNDS
Surgery has become an integral part of global healthcare, and has now been acknowledged as an essential element of health care, contributing to overall social and economic growth (Meara et al., 2015). Worldwide, at least 312.9 million surgical procedures were indicated as being performed yearly by Weiser et al. (2015), while Rose et al. (2015) estimated that approximately 64.2 million operations were required for communicable, maternal, perinatal, and nutritional conditions, 208.8 million for non-communicable diseases, and 48.8 million for injuries. In addition, surgical services are a requirement for the full accomplishment of local and global health goals in areas as diverse as cancer, injuries, cardiovascular disease, infection, reproductive, maternal, neonatal, and child health (Meara et al., 2015). Breaking these figures down for specific countries, this is higher in high-income countries. For example, 22.5
14 Chapter 2: Literature Review of Surgical Wounds million surgeries were performed in Australia during 2016-2017 (Australian Institute of Health and Welfare, 2018), and this was estimated to increase by an average of around 4% each year (Gillespie, Chaboyer, Allen, et al., 2014). In the United States, in 2010, 10 million major in-patient operations were performed (Rose, Chang, Weiser, Kassebaum, & Bickler, 2014). The need for surgical services will continue to increase considerably from now until 2030, and it is projected that approximately 143 million additional surgical procedures are needed in low-income and middle-income communities, equating to one procedure per 21 people alive (Meara et al., 2015; Rose et al., 2015).
The term surgical wound is defined “as a wound caused by external trauma to the human body and follows a systematic process of repair, progressing through vascular, inflammatory, proliferation and maturation stages of healing” (Wound Care Canada, 2010, p. 25-26) . There are many varied surgical techniques that can result in the development of a wound, including incision or excision, investigative or corrective, open or keyhole (Cooper, Russell, & Stringfellow, 2004). Surgical wounds can be further classified into clean, clean-contaminated, contaminated, or dirty-infected. The classification of a surgical wound provides an indication about whether the wound will heal through primary or secondary intention (National Institute for Clinical Excellence, 2008). Surgical wounds with minimal tissue loss that are closed surgically heal by primary intention. Surgical wounds that remain open for several days to remove all sources of contamination before final closure are defined as dirty-infected wounds and heal best by secondary intention (Mahon, 2010).
Although there has been a recent emphasis on chronic wounds and strategies to improve hard to heal wounds, there are more acute surgical wounds than chronic wounds (Franz et al., 2007). This can be illustrated by numerous studies published in the literature. For example, in a study conducted at 85 public hospitals in Western Australia in 2008 with 5,800 inpatients, the prevalence of wounds in the surveyed population was 49%, while the largest proportion of wounds were acute surgical wounds, accounting for 31%, followed by chronic wounds, such as pressure ulcers (9%), skin tears (8%), and leg ulcers (3%) (Santamaria, 2009). This view was supported by Srinivasaiah, Dugdall, Barrett, and Drew (2007) who conducted a survey at five health trusts in north-east England with a total population of approximately 590,000 and concluded that surgical wounds were still the most common type of
Chapter 2: Literature Review of Surgical Wounds 15 wound (41.5%) in this population. The evidence of higher prevalence of surgical wounds than chronic wounds has also been clearly identified in other studies conducted in the UK (Vowden & Vowden, 2009; Vowden, Vowden, & Posnett, 2009), Australia (J. Walker et al., 2014), North America (Pieper, Templin, Dobal, & Jacox, 2002), and France (Mahé et al., 2006). However, to date, little research has analysed the incidence of acute surgical wound types. Further research should therefore be undertaken to provide a more detailed account of the incidence of surgical wounds.
2.3 SURGICAL WOUND HEALING
The healing of surgical wounds can be categorised into three main types: primary or first intention, secondary intention, and tertiary intention or delayed primary closure (Irion, 2010). The majority of surgical procedures result in wounds that heal by primary intention, which means that wounds are brought together (approximated) using sutures, staples, clips, or glue, and this is described as ideal for wound healing (Bates-Jensen & Woolfolk, 2012). This type of primary closure is applied for clean wounds, with smooth edges and minimal tissue loss (Irion, 2010). The advantages of wound healing by primary intention are that it results in wounds healing faster, there is minimal scar formation, no separation of the wound edges, and good cosmetic effect (Dunn, 2007; Irion, 2010; Kumar & Leaper, 2007). Ideally, the primary closure should be performed within six to eight hours after the trauma (Kumar & Leaper, 2007).
The second type of surgical wound healing is wounds that heal by secondary intention. Such wounds are left open and close themselves through the construction of granulation tissues and reduction (Kumar & Leaper, 2007). Wounds healed by secondary intention include those with significant tissue loss, excessive trauma, severe burns, irregular edges, infection, or the presence of other debris (Dunn, 2007; Irion, 2010; Kumar & Leaper, 2007). The process of this wound healing is much slower than primary intention and often heals with a contracted scar (Dunn, 2007). Currently, there is very little data available regarding the incidence and prevalence of surgical wound healing by secondary intension, but according two published studies, it estimated that surgical wound healing by secondary intension constitutes approximately 28% of all prevalent acute (mainly surgical/traumatic) wounds (Srinivasaiah et al., 2007; Vowden & Vowden, 2009). However, a more recent UK study that evaluated the prevalence of surgical wound healing by secondary intension over a two-week period in community,
16 Chapter 2: Literature Review of Surgical Wounds primary and secondary care settings found a prevalence of 0.41 per 1000 population (Chetter, Oswald, Fletcher, Dumville, & Cullum, 2017).
Tertiary closure or delayed primary intention is a third method of surgical wound healing. In general, this method of closure is applied to wounds contaminated by soil or manure, that were caused by animal bites or projectiles, or that have a high risk of infection, but do not have substantial skin damage (Kumar & Leaper, 2007). Such wounds are left open for a short period of time (three to four days) to be cleaned or debrided to prevent infection before the wound is closed (Bates-Jensen & Woolfolk, 2012). To date, there is limited evidence about the prevalence of surgical wound healing through delayed primary intension.
2.3.1 Phases of wound healing The healing of acute wounds involves a complex biological process that results in restoring the structure and function of damaged or injured tissue (Hunt, Hopf, & Hussain, 2000). Surgical wound healing occurs as a series of overlapping processes. These processes involve four continuous phases of haemostasis, inflammation, proliferation, and remodelling (Bates-Jensen & Woolfolk, 2012; Dunn, 2010; Irion, 2010), as described below.
2.3.1.1 Haemostasis phase Haemostasis is the first stage in the wound healing process, beginning as soon as the surgical incision or injury occurs (Dunn, 2010). The key aim of this stage is to prevent additional haemorrhage of the damaged blood vessels (Yao, Bae, & Yew, 2013). The development of a fibrin clot is the key to this step, which first stops the bleeding by plugging the injured vessels via platelet aggregation, and the clot and surrounding wound tissue then release pro-inflammatory cytokines and growth factors that continue to regulate the healing cascade (Dunn, 2010).
2.3.1.2 Inflammatory phase The key aim of the inflammatory phase is to prevent infection (A. Young & McNaught, 2011). During this stage, neutrophils and macrophages migrate into the wound site. Neutrophils are the most common leukocytes, and they constitute 40% to 75% of circulating white cells (Enoch & Leaper, 2008; Wysocki, 1989). They appear at the wound site within 24-48 hours after injury and stay in the wound up to five days (Enoch & Leaper, 2008; Wysocki, 1989). Neutrophils have three main mechanisms
Chapter 2: Literature Review of Surgical Wounds 17 for destroying debris and bacteria: directly ingesting and destroying foreign particles, as well as degranulation and releasing a variety of toxic substances that will destroy bacteria and dead host tissue (A. Young & McNaught, 2011). Together with neutrophils, macrophages are the largest white cells (Irion, 2010). They actively perform phagocytosis by immersing and digesting bacteria and dead tissue, in both aerobic and anerobic conditions (Irion, 2010). Macrophages also undergo a phenotypic transition to a reparative transition to stimulate tissue regeneration. In this way, they promote the changeover to the proliferative phase of healing (A, Young & McNaught, 2011). This phase of wound healing is responsible for the classical signs of inflammation that arise in reaction to an injury, including erythema, heat, oedema, pain, and decreased function (Yao et al., 2013).
2.3.1.3 Proliferation phase The proliferative phase starts at about day three and lasts for two to four weeks after wounding (Enoch & Leaper, 2008). Granulation tissue, neovascularisation, and collagen synthesis occur during this phase to fill the wound defect (Irion, 2010). As the wound defect fills, the wound progressively contracts and epithelial tissue starts to formulate at the wound edges. Finally, complete epithelialisation occurs, with epithelial cells fully reappearing in the wound (Yao et al., 2013).
2.3.1.4 Remodelling phase Remodelling, the final phase of wound healing, takes place once the wound is closed and can take up to two years, resulting in the development of normal epithelium and maturation of the scar tissue (A. Young & McNaught, 2011). In this phase, the wound recovers its tensile strength because the collagen fibres within the wound remodel and reorganise themselves. It is also during this phase that the wound devascularises and proceeds to its original state of blood supply. They eventually regain a structure similar to that seen in unwounded tissue (Yao et al., 2013). However, the wounds may not achieve the same level of tissue strength as normal tissue, with only 80% of tensile strength in the long term (A. Young & McNaught, 2011).
2.3.2 Factors affecting surgical wound healing Identification of the factors associated with healing can help to minimise the factors that result in delayed healing in surgical wounds. The literature has identified several risk factors that influence the wound healing process. This literature review
18 Chapter 2: Literature Review of Surgical Wounds focuses on studies that have examined the risk factors impacting surgical wound healing and surgical wound complications, such as surgical site infection, wound dehiscence, and haematoma/seroma.
A narrative literature review was undertaken, as a meta-analysis could not be conducted due to differences in research designs, measures, sample inclusion, and exclusion. The literature search revealed 129 articles exploring a diversity of risk factors for surgical wound healing and surgical wound complications conducted from the early 1990s to September 2017. These studies ranged from having 85 to 164,297 participants and examined single or multiple risk factors for surgical wounds.
The studies were mostly conducted in the United States of America and Europe, with some studies conducted in Australia, Africa, Canada, Mexico, Columbia, and few studies undertaken in Asian countries, such as Vietnam, Thailand, China, Korea, and India. These studies focused on a variety of surgical procedures, such as cardiac, abdominal, orthopaedic, and general surgeries. Each study presented in this review has been categorised according to the level of evidence classified by the Joanna Briggs Institute levels of evidence in 2013 (See Appendix A). Most of the studies found had a low level of evidence (level 3 or 4). Few risk factors were investigated through randomised controlled trials or systematic reviews (level 1 or 2). The factors influencing surgical wound healing have been divided into three categories: 1) patient, 2) diseases and treatments, and 3) surgical procedure related risk factors, according to the conceptual framework presented in Chapter 4. All risk factors identified are discussed, beginning with those found to have strong significance, to those with little evidence.
2.3.2.1 Patient related risk factors The literature review identified several patient risk factors that impact on surgical wound healing and are predictive of surgical wound complications, including smoking, obesity, malnutrition, advanced age, stress, and pain.
2.3.2.1.1 Smoking Level 1 evidence from systematic reviews and meta-analyses indicated that smoking is a substantial independent risk factor for the increase of surgical complications and delayed surgical wound healing (Mills et al., 2011; Nelson et al., 2015; Sørensen, 2012; Sørensen & Jørgensen, 2003; Cavichio, Pompeo, de Oller, &
Chapter 2: Literature Review of Surgical Wounds 19 Rossi, 2014; Wong, Lam, Abrishami, Chan, & Chung, 2012) [Level 1]. The odds ratios for the development of impaired surgical wound healing are ranked differently from study to study, but they are significantly higher in smokers than non-smokers (Cavichio et al., 2014) [Level 1b], (Bettin et al., 2015; Jung et al., 2015; K. Wu, Wang, Wang, & Li, 2014) [Level 3c]. For example, a systematic review and meta-analysis of 13 studies involving 7,265 patients across different types of surgery reported that the risk of wound healing complications in smokers continuing smoking at the time of surgery was twice as high as those of non-smokers (relative risk 2.08; 95% CI: 1.60 - 2.71; I2 = 8%; p<0.001), and the risk remained greater in ex-smokers who quit smoking within three to four weeks before surgery and non-smokers (RR 1.64; 95% CI 1.04 to 1.92; I2 =0%; p<0.001) (Wong et al., 2012) [Level 1b]. Another example is the report by Sørensen (2012), who conducted a systematic review and meta-analysis of 140 cohort studies and four randomised controlled trials and also indicated that compared to non-smokers, smokers had significantly increased odds of impaired wound healing (OR 2.07, 95% CI 1.53 to 2.81) and increased of surgical wound complications (OR 1.79, 95% CI 1.57-2.04) [Level 1b] . Smoking is not only related to impaired wound healing, but is also associated with other postoperative complications, which were examined in 11 studies. Among the 11 studies, smoking was identified as an independent risk factor predicting surgical wound infection in six multivariate models, with odds ratios ranging from 1.56 to 13.78 (Dahl et al., 2014; Decker et al., 2012; Durand, Berthelot, Cazorla, Farizon, & Lucht, 2013; Kamath, Sinha, Shaari, Young, & Campbell, 2005; Mawalla, Mshana, Chalya, Imirzalioglu, & Mahalu, 2011; C. L. Wu et al., 2014). However, these studies were predominately level 3 and 4 evidence, with some limitations associated with single institution, retrospective data records, and not well-defined smoking status.
Preoperative smoking cessation at least four weeks before surgery has been demonstrated to have benefits for patients because it significantly reduces delays in healing (Cavichio et al., 2014; Wong et al., 2012) [Level 1b]. The results pooled from six randomised trials demonstrated a relative risk decrease of 41% for the prevention of postoperative complications, and each week of cessation increased the magnitude of effect by 19% (Mills et al., 2011) [Level 1a]. This view was supported by another systematic review in which the relative risk was 0.07 (95% CI0.56-0.98; I2 = 34%;p=0.04); that is, the risk was considerably lower in ex-smokers who stopped
20 Chapter 2: Literature Review of Surgical Wounds smoking more than three to four weeks prior to the operation compared to those who stopped smoking later than that (Wong et al., 2012) [Level 1b].
Although there is high-quality evidence from systematic reviews and randomised controlled trials indicating that smoking leads to adverse surgical outcomes, particularly the development of impaired wound healing in smokers compared to non-smokers, the definition of smokers is not consistent between studies. Bettin et al. (2015) pointed out that active smokers who smoked an average of 18 cigarettes per day were associated with complications, whereas those without complications smoked an average of 14 cigarettes per day [Level 3c]. Sørensen, Hørby, Friis, Pilsgaard, and Jørgensen (2002) defined smokers by how many grams of cigarettes they consumed per day. Light smoking was defined as consuming 1- 14grams per day; heavy smoking was consuming ≥ 15 grams per day (Sørensen et al., 2002) [Level 1d]. Kuri, Nakagawa, Tanaka, Hasuo, and Kishi (2005) defined smokers as those who had smoked within seven days before surgery [Level 3c]. The differences in defining smokers may have had an impact on the outcomes; therefore, more studies should be carried out to investigate how many cigarettes per day are considered to impact at a particular rate on surgical wound healing compared to non-smokers.
2.3.2.1.2 Obesity Obesity has also been considered a potential risk factor for poor postoperative outcomes from a variety of surgical procedures. These include orthopaedic (Griffin, Werner, Gwathmey, & Chhabra, 2015; London et al., 2014; Werner, Rawles, Jobe, Chhabra, & Freilich, 2015) [Level 3c, 3d], cardiac (Fu et al., 2015) [Level 3c], and gastrointestinal surgery (Anannamcharoen, Vachirasrisirikul, & Boonya-Assadorn, 2012; Manilich et al., 2013; Moghadamyeghaneh et al., 2015) [Level 3c]. Obesity status has been examined in the form of body mass index (BMI) in a variety of studies (Amri, Bordeianou, Sylla, & Berger, 2014; Fu et al., 2015; Manrique, Chen, Gomez, Maltenfort, & Hozack, 2017) [Level 3c]. Most studies have used BMI cut off points based on the WHO (1995), with four groups: less than 18.5 (underweight), 18.5-24.9 (normal range), 25-29.9 (overweight), and over 30 (obese).
Although there is limited evidence regarding the impact of obesity on impaired wound healing, numerous studies have shown that obesity is a significant independent risk factor for surgical wound complications, such as wound dehiscence and surgical site infection. A systematic review of 20 studies among patients who underwent
Chapter 2: Literature Review of Surgical Wounds 21 orthopaedic surgeries indicated that obesity (BMI ≥ 30) was a risk factor of surgical wound complications and the pooled relative risk of infection rate among obesity (BMI ≥ 30) was 1.915 (95% CI 1.530-2.396; p< 0.001) compared to those who were not obese (Yuan & Chen, 2013) [Level 3b]. Another systematic review conducted by Korol et al. (2013) in May 2012 with 57 studies (31 cohort studies, the rest of lower research designs) among patients who underwent general surgeries also demonstrated that increasing BMI was associated with increased risk of surgical site infection. More specifically, BMI was analysed in 20 regression models, in which 17 models had statistical significance, with estimates of OR ranging 1.0-7.1 [Level 3b]. There was consistency with other eight studies (two prospective and six retrospective cohort studies) (Anannamcharoen et al., 2012; Fu et al., 2015; Gili-Ortiz, González-Guerrero, Béjar-Prado, Ramírez-Ramírez, & López-Méndez, 2015; Hibbert, Abduljabbar, Alhomoud, Ashari, & Alsanea, 2015; Lieber et al., 2016; Manilich et al., 2013; Meyer et al., 2016; Moghadamyeghaneh et al., 2015) [Level 3c, 3e]. The strength of these studies is the large sample of participants, ranging from 229 to 164,297 with multicenter. However, the limitation of these studies is mainly the retrospective designs and selection bias.
Different BMI categories have also demonstrated their impact on surgical wound healing. Firstly, some studies looked at BMI cut-offs < 25 and ≥ 25. Compared to BMI < 25, three studies were found in which two retrospective cohort studies demonstrated BMI ≥ 25 was associated with increased risk of surgical wound complications, with odds ratios ranging from 1.78 to 2.1 (Davis et al., 2017; Meyer et al., 2016) [Level 3c]. However, the findings of a recent study did not support the previous research (Park et al., 2017) [Level 1c]. This inconsistency may be due to a low incidence rate of SSI in each BMI group, and the difference in methodology. Secondly, BMI categories were investigated to compare people who were underweight (BMI <18.5) and at a normal weight (BMI 18.5-24.9) (Manrique et al., 2017). The research indicated that underweight patients had an increased risk of SSI (OR 23.3; 95% CI 1.2-466.5, p=0.05) compared with normal weight patients (Manrique et al., 2017) [level 3d]. However, these findings must be interpreted with caution due to the limitations of this study, including retrospective data collection, low incidence of underweight patients, and small sample size (109 participants).
22 Chapter 2: Literature Review of Surgical Wounds 2.3.2.1.3 Malnutrition Delayed wound healing is also a consequence of inadequate nutritional status (Myers, Leong, & Phillips, 2007). Numerous studies have shown that malnourished patients have an increased incidence of postoperative complications, such as impaired wound healing, increased risk of the development of surgical wound infections, wound dehiscence, and increased rate of mortality and length of hospital stay (Bozzetti, Gianotti, Braga, Di Carlo, & Mariani, 2007; Gourin, Couch, & Johnson, 2014; Hiesmayr et al., 2009; Isabel, Correia, & Waitzberg, 2003) [Level 3c, 3e]. Although the role of nutrition in surgical patients is well described in the literature, only two studies were found to directly examine the effect of malnutrition on impaired surgical wound healing (Marin, Salido, López, & Silva, 2002; Rai, Gill, & Satish Kumar, 2002) [Level 3c].
Both early studies investigating the impact of nutrition on surgical wound healing used serum albumin, serum transferrin level, and total lymphocyte count to measure the preoperative nutritional status and its effect on wound healing; however, the findings were inconsistent between the two studies. Marin et al. (2002) conducted a prospective cohort study of 170 patients with primary hip or knee joint prosthesis surgery and found a statistically significant correlation between the preoperative lymphocyte count delay in wound healing (OR 2.2, 95% 1.2-3.9, p=0.007), while serum albumin and transferrin levels were not associated with impaired wound healing [Level 3c]. However, Rai et al. (2002) examined 40 patients who underwent an arthroplasty and did not find any statistically significant different association between those variables and delayed wound healing or wound infection [Level 3e]. The different results between the two studies could be explained by the small sample sizes and different methodologies, which may have led to an impact on the significance of the outcomes. Further research with a larger sample size is therefore required to clarify these findings.
In regards to indirectly examining the impact of nutrition on wound healing, five studies were found in the literature that reviewed the impact of preoperative nutritional status and surgical wound complications (Anannamcharoen et al., 2012; Bozzetti et al., 2007; Gourin et al., 2014; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007) [Level 3c]. Serum albumin level was used to measure nutritional status affecting postoperative wound complications in three studies (one prospective cohort
Chapter 2: Literature Review of Surgical Wounds 23 and two retrospective cohort studies), with total participants ranging from 229 to 164,297. The findings indicated that a lower serum albumin level (≤ 3.5g/dL) was a significant predictor for surgical wound disruption, with odds ratios ranging from 1.13 to 2.8 (Anannamcharoen et al., 2012; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007) [Level 3c]. In addition, by using serum albumin level, two other studies used weight loss to define nutritional status. An example of this is a study by Gourin et al. (2014) who reported that weight loss was associated with an increased risk of postoperative wound healing complications (relative risk 2.04; 95% CI 1.15-2.74; p < 0.001), and surgical site infection (relative rate 1.97; 95% CI 1.39-2.79, p<0.001) [Level 4b]. In contrast to Gourin et al. (2014), Moghadamyeghaneh et al. (2015) argued that weight loss greater than 10% in body weight in the six months before surgery increased the risk of wound disruption (OR 1.12, 95% CI 0.89-1.42, p= 0.32), but was not statistically significant [Level 3c]. A possible explanation for these different findings compared with the previous studies may be due to the low rate of weight loss incidence (less than 10%) in this study, and different methods being used to measure nutritional status and outcomes.
However, to improve patient outcomes after surgery, evidence from two Cochrane systematic review and meta-analyses showed that nutritional support before or after surgery improves postoperative outcomes (Andersen, Lewis, & Thomas, 2006; Burden, Todd, Hill, & Lal, 2012). For instance, a Cochrane systematic review to identify the effect of preoperative nutritional support in patients undergoing gastrointestinal surgery indicated that preoperative nutritional support might result in a significantly reduced level of infection complications, and a shorter length of stay (Burden et al., 2012) [Level 1a]. This view was supported by another Cochrane systematic review conducted by Andersen et al. (2006), who reviewed 14 randomised controlled trials representing a total of 1,224 patients. This study indicated that earlier feeding might reduce the risk of post-surgical complications, such as wound infection, wound dehiscence, mortality, and length of hospital stay compared to a control group (Andersen et al., 2006) [Level 1a]. It has also been recommended that among patients undergoing gastric cancer surgery, enteral nutrition formula supplemented with arginine and omega three fatty acids in the early postoperative period has considerably promoted surgical wound healing, reduced general morbidity, and the number of postoperative infections (Farreras et al., 2005) [Level 1c]. Considering all of this
24 Chapter 2: Literature Review of Surgical Wounds evidence, it is clear that malnutrition is associated with adverse outcomes of surgical wound complications, and that nutrition support may improve patients’ surgical outcomes.
2.3.2.1.4 Advanced age The effect of ageing on wound healing has been widely investigated over the last few decades and research has demonstrated that advanced age is a significant risk factor for delayed wound healing (Khalil, Cullen, Chambers, Carroll, & Walker, 2015; Tada et al., 2016) [Level 3c]. It is commonly recognised that advanced age affects all phases of the wound healing process, such as increased platelet degranulation, impaired macrophage function, delayed collagen deposition, delayed re- epithelialisation, reduced collagen turnover and remodelling, and decreased wound strength (Snäll et al., 2013) [Level 1d]; (Lenhardt et al., 2000) [Level 2c]; (Thomas & Burkemper, 2013) [Level 5a]. In the late 1990s and early 2000s, clinical studies also showed a significant impact of ageing on wound healing. Holt et al. (1992) examined the rate of re-epithelialisation for 2 x 2cm split-thickness wounds in subjects aged 18– 55 years and 65 years and over and found a 1.9-day delay in re-epithelialisation in the older group [Level 3d]. Similarly, Ashcroft, Horan, and Ferguson (1998) examined the acute inflammatory response of subjects in three age groups (19–39 years, 40–59 years, and over 60 years old) and the findings showed delayed monocyte, macrophage and lymphocyte appearance in subjects aged over 60 years [Level 3d]. Another study investigated collagen deposits among men and women after undergoing surgery and indicated that men older than 45 years had significantly decreased collagen deposits compared to those younger than 45 years (Lenhardt et al., 2000) [Level 2c].
However, in recent years, one prospective cohort study from 2,350 patients with 3,726 wounds in which 56% of wounds were surgical, crush, and trauma wounds also indicated that advanced age (≥ 65) was a significant predictor of healing time (β:15.86, 95% CI 8.68-23.36, p=0.001) (Khalil et al., 2015) [Level 3c]. These results seem to be consistent with other research of 332 patients who underwent elective orthopaedic surgical procedures that found that increasing age was a risk factor for delayed wound healing (OR 1.16, 95% CI 1.07-1.27, p=0.001) (Tada et al., 2016) [Level 3c].
Although limited evidence was found regarding the effect of different age groups on the healing of surgical wounds, to date, 13 reports, including two systematic reviews and 11 studies, were found to examine the association between age and
Chapter 2: Literature Review of Surgical Wounds 25 surgical wound complications across different types of surgery. Out of 13 reports, age was a significant risk factor for predicting surgical wound complications in two systematic reviews (Korol et al., 2013; Xue, Qian, Yang, & Wang, 2012) [Level 3b]; and six studies (Dubory et al., 2015; Kaye et al., 2005; Knight et al., 2007; Neumayer et al., 2007; Ridgeway et al., 2005) [Level 3c] (Park et al., 2017) [Level 2c]. More specifically, according to a systematic review of 57 articles, which included 31 cohort studies among patients who underwent general surgery, increasing age was associated with an increased risk of all surgical site infections in the adjusted analyses (Korol et al., 2013) [Level 3b]. Among the 15 regression models reported, 10 (66.7%) models were statistically significant, with estimates of odds ratios ranging from 1.0-14 (Korol et al., 2013). These results are consistent with data obtained in another systematic review of eight studies of patients who underwent breast surgery, where the findings also demonstrated that increasing age was a significant risk factor for breast surgical site infection (OR 1.73, 95% CI 1.41-2.12) (Xue et al., 2012) [Level 3b].
However, the definition of age cut-off points has varied between reviewed studies. Age ≥ 40 or age < 40 was found to be a significant predictor for surgical wound infection in two studies among patients who underwent vascular and renal transplant surgery, with odds ratios ranging from 1.24 to 2.54 (Knight et al., 2007; Neumayer et al., 2007) [Level 3c]. One retrospective and one prospective cohort study demonstrated that age ≥ 65 was a significant risk factor of surgical site infections, with odds ratios ranging from 1.6-3.59 (Dubory et al., 2015; Kaye et al., 2005) [Level 3c]. In addition, one study used a cut-off point of age ≥ 60 or < 60 (Park et al., 2017) [Level 2c], and other study used an age cut-off of ≥ 70 or < 70 (Nicolle, Huchcroft, & Cruse, 1992) [Level 3d]; however, all found statistically significant relationships between these groups and surgical wound complications. Even though all of the studies reviewed here support the hypothesis that advanced age is a significant factor affecting the recovery of surgical wounds, future studies with well-designed research are required to further investigate how and which age groups have a stronger impact on surgical wound healing.
2.3.2.1.5 Stress Stress can be physical or psychological, acute or chronic (Lucas, 2011). Studies have demonstrated that mental stress has a negative impact on patients’ health, including alterations in immune system functioning (Miller & Cohen, 2001) [Level
26 Chapter 2: Literature Review of Surgical Wounds 3b], poor surgical outcomes (Rosenberger et al., 2009) [Leval 3c], increased risk of obesity (Pelletier, Lytle, & Laska, 2015; Torres & Nowson, 2007) [Level 3c], and increased risk of developing cardiovascular disease (Rosengren et al., 2004) [Level 3c]. The speed of wound healing also decreases as a result of psychological stress, which has been demonstrated through previous laboratory work with both animal and human subjects. A systematic review and meta-analysis of 22 studies (17 observational studies and five experimental or quasi-experimental designs) across a variety of wound types in different contexts indicated that psychological stress was associated with delayed wound healing, and the relationship estimated by the meta-analysis was r= - 0.42 (95%, CI = -0.51 to -0.32) (Walburn, Vedhara, Hankins, Rixon, & Weinman, 2009) [Level 2b]. A number of experimental laboratory studies using a variety of animal species also indicated that stress was associated with poorer wound healing, such as in male tree lizards (French, Matt, & Moore, 2006), and mice (Padgett, Marucha, & Sheridan, 1998; Sheridan, Padgett, Avitsur, & Marucha, 2004).
The link between psychological stress and healing is well established, yet few studies have evaluated the effects of psychological stress on the healing of surgical wounds. It has been suggested that stress is a significant factor in poor surgical wound healing (Broadbent, Petrie, Alley, & Booth, 2003; Doering, Moser, Lemankiewicz, Luper, & Khan, 2005) [Level 3e]; Yang et al. (2002) [Level 3c]; (Solowiej, Mason, & Upton, 2009) [Level 4a]. However, with a small sample size, caution must be applied, as the findings of these studies might not be representative of this target population. Further research with more focus on stress and surgical wound healing is therefore suggested.
Even though stress is less investigated in surgical wound healing, it is also recognised that stressed individuals are more likely to have unhealthy habits, such as inadequate nutrition (Pelletier et al., 2015; Torres & Nowson, 2007) [Level 3c], reduced sleep patterns, (Ohayon, 2009) [Level 4a], less exercise, and a higher propensity for the abuse of alcohol, cigarettes, and other drugs (Guo & DiPietro, 2010; Pelletier et al., 2015) [Level 3c, 4a]. All of these factors in turn negatively affect the speed of wound healing (Guo & DiPietro, 2010) [Level 4a]. Psychological stress should therefore be considered an important symptom to manage during the wound healing process in clinical practice.
Chapter 2: Literature Review of Surgical Wounds 27 2.3.2.1.6 Pain Acute postoperative pain is one of the most disturbing complaints in patients after surgery (Koranyi, Barth, Trelle, Strauss, & Rosendahl, 2014) [Level 1b]; (Francis & Fitzpatrick, 2013) [Level 4b]. According to a random sample of 250 adults who underwent surgical procedures in the United States, approximately 80% of the patients reported acute pain after their operation. Of these patients, 86% rated moderate, severe, or extreme pain levels (Apfelbaum, Chen, Mehta, & Gan, 2003) [Level 4b]. Wound pain can be caused by the wound itself and can also be caused by some wound treatments (Solowiej et al., 2009) [Level 4a]. It has been suggested that acute postoperative pain has a negative impact on postoperative outcomes, such as a 3.5 times increased risk of suffering from chronic pain after cardiac surgery (Cogan, 2010) [Level 4a], detrimental effects on the quality of recovery (Wu et al., 2005) [Level 3c], and reductions in both the physical and mental well-being domains of health-related quality of life (Taylor et al., 2013) [Level 3e].
However, little evidence is available about the influence of postoperative pain on the recovery of surgical wounds. Only one prospective study of 17 women who underwent elective gastric bypass surgery was found in the literature examining the relationship between postoperative pain and subsequent healing of a standard 2.0-mm punch biopsy wound (McGuire et al., 2006) [Level 3c]. The post-surgery pain was assessed using a 10-point numerical rating scale from 1 (no pain) to 10 (intense pain) and the average of patients’ pain ratings for the first two days post-surgery was used to create two groups as ≤ 8 or >8. The findings showed that patients who rated their pain for the first two days post-surgery as ≤ 8 experienced faster healing compared with patients who reported more acute pain post-surgery (McGuire et al., 2006). However, the small sample size (n=17) of this study may have resulted in low statistical power and may have precluded significant results for analysis. Therefore, further research on this topic needs to be undertaken before the association between post-surgical pain and wound healing is more clearly understood.
Even though there is little evidence regarding the link between acute postoperative pain and the healing of surgical wounds, stress is known to be a significant independent factor for impaired postoperative wound healing (Broadbent et al., 2012; Broadbent et al., 2003; Doering et al., 2005; Walburn et al., 2009) and evidence shows that pain can contribute to stress and other negative emotional states,
28 Chapter 2: Literature Review of Surgical Wounds such as anxiety, fear, and depression (Woo et al., 2008) [Level 4a]. This in turn results in poorer wound healing processes. Thus, appropriate assessment and management of postoperative pain may assist to minimise stress and provide faster recovery of postoperative wounds for patients after surgery.
2.3.2.2 Disease and treatment related risk factors Several diseases and treatments associated with poorer postoperative wound healing and increased risk of wound complications were identified. Diabetes was found to have a significant impact on surgical wound outcomes; however, other factors such as steroid use, immune deficiency, traumatic injury present, and chemotherapy require further investigation.
2.3.2.2.1 Diabetes Diabetes has been shown to be a strong independent factor for surgical wound complications. According to a systematic review of 57 studies with 31 cohort studies, diabetes was associated with increased risk of surgical site infection and reported in 11 out of 12 regression models, with estimates of odds ratios ranging 1.5 to 24.3 (Korol et al., 2013) [Level 3b]. These results are consistent with another systematic review of 681 patients who underwent breast surgery and found that diabetes mellitus was a significant risk factor for surgical site infections (OR 1.88, 95% CI 1.47-2.39) (Xue et al., 2012) [Level 3b]. From 2012 to September 2017, seven more studies were identified. Out of the seven studies, four studies (two prospective and two retrospective cohort studies) indicated that patients with diabetes were at higher risk of surgical wound complications compared to those without diabetes, with the estimate of odds ratios ranging from 1.57 to 3.42 (Decker et al., 2012; Dubory et al., 2015; Fu et al., 2015; Hijas-Gómez et al., 2017) [Level 3c]. However, three studies did not find statistical significance between the two groups (Park et al., 2017) [Level 2c]; (Aga et al., 2015; Moghadamyeghaneh et al., 2015) [Level 3c]. A possible explanation for these different results may be the lack of consistency in defining diabetic conditions between these studies.
In fact, there are different ways to define patients with diabetes. One of the common methods often mentioned in the literature is using Haemoglobin A1c (HbA1c) levels. An example of this is the systematic review carried out by Rollins, Varadhan, Dhatariya, and Lobo (2016). The authors indicated that out of 15 studies
Chapter 2: Literature Review of Surgical Wounds 29 that had specifically examined the relationship between HbA1c and surgical wound infections, five studies provided evidence of a significantly increased risk of wound complications, and 10 studies suggested no relationship (Rollins et al., 2016) [Level 3b]. A possible explanation for this might be that different cut-off point of HbA1c was used, which may have led to the different results between those 15 studies. For example, one study used the HbA1C cut off ≥ 7% or < 7%, and demonstrated that HbA1C ≥ 7% increased the risk of postoperative wound complications, with odd ratios of 1.22, 95% CI 1.01-1.47 (A. H. Harris, Bowe, Gupta, Ellerbe, & Giori, 2013) [Level 3c]. A further study using a cut-off of 6.5% showed that HbA1C ≥ 6.5% was an independent risk factor for sternal dehiscence (OR 2.161, 95% CI 0.008-4.63, p=0.04) (Narayan et al., 2017) [Level 3c]. Another study used the HbA1c cut-off at < 6% and ≥ 6% (Gustafsson, Thorell, Soop, Ljungqvist, & Nygren, 2009; Walid et al., 2010) [Level 3c]. However, according to the American Diabetes Association (2013) guidelines, the target HbA1c for people with diabetes should be < 7% (53mml/mol). Overall, there appears to be some evidence to indicate that diabetes is a strong factor associated with surgical wound outcomes. Good glucose control before surgery should therefore be included in nursing plans to avoid adverse post-operation complications.
2.3.2.2.2 Steroid use Chronic steroid use is one of the factors associated with surgical wound complications. According to the definition of the American College of Surgeons National Surgical Quality Improvement Program databases, prolonged steroid users are defined as “patients who required regular administration of oral or parenteral corticosteroid medications in the 30 days before surgery for a chronic medical condition” (Turan et al., 2010, p. 286). Six retrospective cohort studies demonstrated a significant association between chronic steroid use and surgical wound complications, with an OR ranging from 1.38-1.86 (Ismael et al., 2011; Lieber et al., 2016; Merkler, Saini, Kamel, & Stieg, 2014; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007; Sullivan, Roman, & Sosa, 2012) [Level 3c]. There are some strengths and limitations between these six studies. On the one hand, the strengths of these six studies are the large number of participants, ranging from 1,912 to 635,265 multiple centres and using the same data from the American College of Surgeons National Surgical Quality Improvement Program database. On the other hand, there
30 Chapter 2: Literature Review of Surgical Wounds are limitations of these studies associated with retrospective data, in which the quality of the collected data depended on the accuracy of documentation.
However, in contrast to the six studies above, Kenig, Richter, Zurawska, Lasek, and Zbierska (2012) reported no significant difference in surgical wound complications between patients who use steroids prior to surgery and those did not [Level 3c]. The possible explanation for these results may be the lack of consistency in defining chronic steroid use. Kenig et al’s (2012) study defined steroid use as chronic steroid treatment in the last 12 months. Another possible explanation for this is that all of these reviews used retrospective data collection. Therefore, the collected data were affected by documentation accuracy. Considering this evidence, it seems that chronic steroid use is associated with postoperative wound complications. However, future studies should use randomised controlled trials or prospective cohort studies to confirm the findings.
2.3.2.2.3 Immune deficiency Immune deficiency is one of the contributors to surgical wound infection. Immune deficiency can be found in patients with conditions such as being HIV positive (Kigera et al., 2012) [Level 3a]. Several studies have investigated the relationship between HIV positive or HIV negative and postoperative surgical site infection. A systematic review of 18 cohort studies (four studies conducted in Africa and the rest in Europe and North America) among patients undergoing orthopaedic surgery reported that the pooled risk ratio of surgical wound infection was 1.4 (95% CI 0.5-3.8) in HIV patients when compared to non-HIV patients (Kigera et al., 2012) [Level 3a]. These results correspond with those from a recent study indicating that patients with higher immunity had a lower odds of surgical site infection compared to patients who had low immunity (OR: 0.09; 95% CI 0.05-0.18; p<0.001) (Akhter, Verma, Madhukar, Vaishampayan, & Unadkat, 2016) [Level 3c]. However, a study carried out by Howard, Phaff, Aird, Wicks, and Rollinson (2013) did not support the hypothesis that patients with HIV undergoing surgical fixation had significantly increased the rates of postoperative wound infections compared to those who did not [Level 3c]. It is difficult to explain the inconsistency in these results; however, it might be related to small sample sizes (Akhter, Verma, Madhukar, Vaishampayan, & Unadkat, 2016) and different methodologies.
Chapter 2: Literature Review of Surgical Wounds 31 2.3.2.2.4 Traumatic injury present Trauma may increase the risk of poor postoperative wound healing. Several studies have been conducted to investigate the relationship between patients with trauma and surgical wound complications. For example, one cross-sectional study including 120 hospitals in England with 24,808 patients undergoing hip arthroplasty operations indicated that trauma was an independent risk factor for surgical site infection (OR 1.87; 95% CI 1.50-2.34; p<0.001) (Ridgeway et al., 2005) [Level 4b]. These results are consistent with data obtained in a study conducted by Sohn et al. (2002) in Vietnam, where the authors reported that compared to patients with no trauma, the odds of postoperative wound infection among patients with traumatic injuries was 2.73 more likely (95% CI 1.04-5.44) [Level 4b]. Recently, Li et al. (2015) investigated how different types of trauma affected surgical wound complications and indicated that abdominal trauma was the only independent risk factor for surgical wound infection (OR 28.867; 95% CI 3.893-214.075, p=0.001) [Level 3c]. However, these data must be interpreted with caution because the data were analysed based on only 10 cases of abdominal trauma and 38 without trauma. Regarding the duration of injury to surgery, it seems that the duration of injury to surgery is not associated with the development of surgical site infection. This is exemplified in the work undertaken by Morales, Escobar, Villegas, Castaño, and Trujillo (2011) who conducted a prospective cohort study among 614 patients undergoing exploratory laparotomy. The authors used a cut-off time of 6h and reported that there was no significant association between the time from injury to surgery and surgical wound infection (Morales et al., 2011) [Level 3c]. Even though there is some evidence regarding the relationship between traumatic injuries and postoperative wound disruption; these studies were at Level 4b evidence. Therefore, studies with stronger research designs should be conducted to confirm these findings.
2.3.2.2.5 Chemotherapy/radiotherapy In recent years, some authors have investigated the relationship between chemotherapy and surgical wound outcomes. Three retrospective cohort studies across different surgical operations demonstrated that chemotherapy was not a predictor of postoperative wound disruptions at the multivariate level of analysis (Decker et al., 2012; Scilletta et al., 2014; Sullivan et al., 2012) [Level 3c]. Similarly, in a prospective cohort study of 320 patients undergoing abdominal surgeries conducted by Aga et al.
32 Chapter 2: Literature Review of Surgical Wounds (2015) [Level 3c], it was shown that chemotherapy was not significantly associated with an increase of surgical site infection (OR 10.084, 95% CI 0.775-131.213, p=0.078). However, these findings are not consistent with other studies in which patients receiving preoperative chemotherapy before surgery were at higher risk of wound complications, with an OR ranging from 2.44 to 6.03 (Lieber et al., 2016; Liu et al., 2015; Pellini et al., 2013) [Level 3c]. It is difficult to explain the inconsistent findings between these studies; however, the retrospective data collection and single sites were limitations of these studies. Further research is therefore required to confirm these findings.
In regards to radiotherapy, studies have also demonstrated that there was no difference in surgical wound complications between patients who received radiotherapy within 90 days before the operation and those that did not (Holubar, Brickman, Greaves, & Ivatury, 2016; Lieber et al., 2016) [Level 3c]. The reviewed studies appear to provide unclear findings about the relationship between chemotherapy or radiotherapy and postoperative wound complications. Further research on this topic therefore needs to be undertaken before the association between chemotherapy or radiotherapy and surgical wound outcomes can be more clearly understood.
2.3.2.3 Surgery procedural related risk factors There are several risk factors associated with the procedure of surgery that influence surgical wound healing. These factors are discussed below and include surgical wound classification, emergency surgery, the duration of surgery, and the method of wound closure.
2.3.2.3.1 Surgical wound classification According to the Centres for Disease Control and Prevention (2016), surgical wounds are divided into four categories including:
Clean: an uninfected operative wound in which no inflammation is encountered, and the respiratory, alimentary, genital, or uninfected urinary tracts are not entered. Also, clean wounds are primarily closed, and if necessary, drained with closed drainage. Operative incisional wounds that follow non-penetrating (blunt) trauma should be included in this category if they meet the criteria.
Chapter 2: Literature Review of Surgical Wounds 33 Clean-Contaminated: Operative wounds in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of infection or major break in technique is encountered. Contaminated: Open, fresh, accidental wounds. Also, operations with major breaks in sterile technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered including necrotic tissue without evidence of purulent drainage (e.g., dry gangrene) are included in this category Dirty or Infected: Includes traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera. This definition suggests that the organisms causing postoperative infection were present in the operative field before the operation (pp. 6-7).
Research has demonstrated that contaminated or dirty/infected surgical wounds are independent risk factors for surgical wound infection. This was illustrated by a systematic review of 57 studies published from 2002 to 2012, where the findings indicated that among 10 regression models, eight models were statistically significant and the OR ranged from 1.7 to 10.7 (Korol et al., 2013) [Level 3b]. These findings were supported by a large study of 7,035 patients undergoing vascular and general surgery at 14 academic and 128 Department of Veteran Affairs medical centres, which reported that higher odds of surgical wound infection were found in patients with clean-contaminated (OR 1.404; 95% CI 1.265-1.559), contaminated (OR 1.706; 95% CI 1.454-2.002), and infected/dirty wounds (OR 1.584; 95% CI 1.287-1.948) when compared to clean wounds (Neumayer et al., 2007) [Level 3c]. In addition, four recent prospective cohort studies (Aga et al., 2015; Hijas-Gómez et al., 2017; Pathak et al., 2014) [Level 3c], one retrospective cohort study (Lieber et al., 2016) [Level 3c], and one prospective observational study [Level 3e] found similar findings. Overall, these findings indicate that the surgical wound classes of contaminated, infected, or dirty arepredictors of postoperative wound complications.
2.3.2.3.2 Emergency surgery Emergency surgery has been identified as a risk factor contributing to surgical wound complications. Numerous studies have attempted to examine the relationship between urgent surgery and postoperative wound infections. To date, emergency
34 Chapter 2: Literature Review of Surgical Wounds surgery has been analysed in 11 multivariate analyses and eight models demonstrated statistical significance (Ramos et al., 2008; Thu, Dibley, Ewald, Tien, & Lam, 2005; van Ramshorst et al., 2010; Watanabe et al., 2008; Webster et al., 2003) [Level 3c], (Akhter et al., 2016; Moghadamyeghaneh et al., 2015) [Level 3c], (Gili-Ortiz et al., 2015) [Level 4b]. However, emergency surgery was not associated with surgical wound disruption within three models (Hijas-Gómez et al., 2017) [Level 3c], (Pathak et al., 2014) [Level 3c], (Fiorio, Marvaso, Viganò, & Marchetti, 2006) [Level 4b]. The odds of the risk of surgical wound complications varied from study to study. For instance, the odds were from 1.8-3.38 with regards to abdominal surgery (Gili-Ortiz et al., 2015; Moghadamyeghaneh et al., 2015; van Ramshorst et al., 2010; Watanabe et al., 2008) [Level 3c], 1.4-2.63 with all type of surgeries (Akhter et al., 2016; Fiorio et al., 2006; Ramos et al., 2008) [Level 3c], 2.1 for orthopaedic (Thu et al., 2005) [Level 3c], and 2.54 for obstetric and gynaecological surgeries (Pathak et al., 2017) [Level 3c]. Together, these studies indicate that patients who undergo emergency surgery may be more at risk of postoperative wound infection.
2.3.2.3.3 Duration of surgery The relationship between the length of surgery and surgical wound healing has also been investigated, and there is evidence to suggest that increased length of surgery is a risk factor for poor postoperative wound healing. For instance, longer operative time (over 89 minutes) was found to be a risk factor associated with delayed wound healing, where for every additional 10 minutes of operative time, patients were 1.19 times more likely to have delayed wound healing (Yano et al., 2016) [Level 3c]. This view was supported by another study indicating that a surgical duration longer than three hours significantly increased the risk of impaired wound healing (odds ratio: 3.00, 95%CI;1.54-5.86) compared to operations of less than three hours (Hardy et al., 2014) [Level 3c].
Length of surgery was also shown to be a risk factor for increased rates of surgical wound complications, with estimates of OR ranging 1.2 to 3.8 (Korol et al., 2013) [Level 3b]. These findings were supported by 10 recent studies published to 2017 (Akhter et al., 2016; Broadbent et al., 2012; Davis et al., 2017; Dubory et al., 2015; Hijas-Gómez et al., 2017; Moghadamyeghaneh et al., 2015; Pathak et al., 2014; Rollins et al., 2016; Tada et al., 2016) [Level 3c], (Manilich et al., 2013) [Level 3e], (Ren, Ding, Xue, He, & Xiao, 2015) [Level 4b].
Chapter 2: Literature Review of Surgical Wounds 35 The surgical duration varied between surgical procedures; however it was found that the length of procedure greater than the 75th percentile of predicted operation time increased the risk of surgical site infection (Canadian Association of Wound Care, 2017; Culver et al., 1991). Although the definition of cut-off point values for surgical duration varied between studies, taken together, these findings suggest that postoperative wound complications begin from one to three hours, with the risk of surgical wound disruption ranking from 1.06-2.55 (Moghadamyeghaneh et al., 2015; Pathak et al., 2014; Ren et al., 2015) [Level 3c], and a significantly increased risk beginning at three hours, with an OR ranging from 2.11 to 4.02 (Akhter et al., 2016; Davis et al., 2017; Dubory et al., 2015; Manilich et al., 2013; Moghadamyeghaneh et al., 2015) [Level 3c]. Overall, the studies reviewed here support the hypothesis that increasing the duration of surgery results in a higher risk of wound complications.
2.3.2.3.4 Methods of wound closure Sutures (stitches), staples, and adhesive tapes have been used as methods for wound closure (Whitney, 2012). Current evidence suggests that skin closure techniques may impact on surgical wound healing. Liang and colleagues (2015) conducted a randomised controlled trial among 180 patients after laparotomy with a lower midline incision and showed that poor healing risk for patients without subcutaneous sutures was 0.323 times lower than that of those with subcutaneous sutures [Level 1c].
Numerous studies have also been carried out to compare the effect of closure techniques on wound complications and have demonstrated that using subcuticular sutures for skin closure is associated with a significantly lower incidence of wound complications. For example, a meta-analysis including six papers with 332 patients who underwent suture closure and 351 staple closures was analysed to compare the clinical outcomes of staples and versus sutures in wound closure (T. O. Smith, Sexton, Mann, & Donell, 2010) [Level 1a]. The results showed that there was a three times greater risk of developing a superficial wound infection using staple closure than suture closure among patients who underwent orthopaedic surgery. This study also pointed out that the risk of developing a wound infection in hip surgery was four times greater after using staple closure than suture closure (T. O. Smith et al., 2010). The finding regarding the use of subcuticular sutures was associated with lower incidence of wound complication and was confirmed in other clinical trials, such as after
36 Chapter 2: Literature Review of Surgical Wounds orthopaedic surgery (Shetty et al., 2004) [Level 2c], cardiovascular surgery (Sanni & Dunning, 2007) [Level 1b], and caesarean section (Tuuli et al., 2011) [Level1b].
However, there have been some inconsistent findings in other studies, where using either suture or staple methods did not reveal a significant difference in wound complications. A Cochrane systematic review of randomised controlled trials of 148 leg wounds closed with staples and 175 wounds closed with sutures after vein graft harvesting in patients undergoing coronary artery bypass surgery suggested that there was no evidence of a difference in the risk of SSI and wound dehiscence when using staples and sutures (Biancari & Tiozzo, 2010) [Level 1a]. This view was supported by other studies (Tsujinaka et al., 2013) [Level 1c] (Kobayashi et al., 2015) [Level 1c]. However, the risk of bias of the reviewed studies is high regarding randomisation methods, allocation concealment, and assessment of the outcome end-point. Therefore, further research with strong designs is needed to confirm these findings.
2.4 SURGICAL WOUND COMPLICATIONS
2.4.1 Haematoma/seromas Haematomas and seromas are undesirable consequences of surgery that result from the pooling of blood and serum, respectively, in the operated area (Kilpadi & Cunningham, 2011). The incidence of haematoma or seroma has been reported as varying in studies depending on the type of surgery; for example, ranging from 10 to 45% of patients undergoing abdominoplasty procedures (Bullocks, Basu, Hsu, & Singer, 2006), and between 2.5% and 51% after breast surgery (Barwell, Campbell, Watkins, & Teasdale, 1997; Woodworth, McBoyle, Helmer, & Beamer, 2000). Acute wound haematomas or seromas can impair and delay acute wound healing (Bullocks et al., 2006; Franz et al., 2008). Delayed wound healing caused by haematomas or seromas may be explained by mechanisms such as acute wound fluid collections, which can mechanically disrupt wound healing due to pressure exceeding capillary perfusion resulting in wound ischaemia, or cause increased dead space (Franz et al., 2008). Even though haematoma and seroma formation in surgical wounds may have negative effects on wound healing, the degree to which haematomas and seromas result in poor surgical wound healing is still unknown. Further research should therefore be carried out to obtain a better understanding of the relationship between haematomas/seromas and healing of surgical wounds.
Chapter 2: Literature Review of Surgical Wounds 37 2.4.2 Surgical site infection Surgical site infection (SSI) is the leading infection in hospitals and is one of the most common complications of surgical wounds (Allegranzi et al., 2011; European Wound Management Association [EWMA], 2005). The incidence of SSI has varied between different studies. Numerous studies have been carried out to identify the incidence of SSI, and it has been suggested that SSI occurs at significantly higher rates in developing countries compared to developed countries. For example, according to a report by the WHO (2016a), the SSI incidence was 11.2 per 100 surgical patients in low- and middle-income countries, which was higher than the rate of SSI in developed nations, such as European countries, where the rate ranged from 0.6% to 9.6% per 100 surgical procedures (European Centre for Disease Prevention and Control, 2017), approximately 2-5% in the UK (National Institute for Clinical Excellence, 2008), and 2.8 per 100 procedures in Australia (Worth, Bull, Spelman, Brett, & Richards, 2015). Economic status factors may influence the different rates between low-income nations and higher income countries.
Similar to global trends, in Vietnam, the incidence of SSI ranges from 8.3% to 27.5%, and is predicted to increase from 2% in clean wounds to 44.6% in dirty wounds (Thu et al., 2005; Thu et al., 2011). One current study of seven different cities in Vietnam indicated that the highest SSI rates were found in three types of surgery: colon surgery (33%), limb amputation (25%), and small bowel surgery (21%) (Viet Hung et al., 2016). The reasons for the high SSI incidence in recent studies conducted in Vietnam could be explained by a number of factors including: small numbers of healthcare workers being trained in principles of infection control; lack of official training materials related to wound healing, deficient hospital facilities, and limited surgical instruments (Pham, Payne, & Michel, 2013; Thu et al., 2007; Viet Hung et al., 2016). In addition, limited preventative measures, such as the lack of adequate supplies for wound care, poor personal hygiene, uncontrolled use of antibiotics, and poor compliance with routine SSI control and prevention practices in Vietnamese hospitals are likely to lead to high SSI incidence (Pham, Payne, & Michel, 2013; Thu et al., 2007; Viet Hung et al., 2016). The impact of SSI is a significant economic burden in terms of the extra postoperative length of stay in hospital and increased costs of treatment (de Lissovoy et al., 2009; Weber et al., 2008; WHO, 2009). According to a report by the World
38 Chapter 2: Literature Review of Surgical Wounds Health Organisation in 2009, at least 780,000 surgical site infections occur each year in the United States, which results in 3.7 million excess hospital days and cost increases of US $1.6-3 billion per year. In Australia, hospital-acquired infections add approximately 17.3% to treatment costs, and an estimated AU$38.5 billion is spent on hospital services in Australia every year (Australian Institute of Health and Welfare, 2011). Similarly, in European nations, SSI contributes greatly to costing health care systems, between €1.47 billion to €19.1 billion (Leaper et al., 2004). In the United Kingdom, additional costs related to the development of an SSI range from £954 to £6,103, with extra time in hospital ranging from 3.3 days to 21.0 days (Coello et al., 2005). Wound infection is not only a costly burden, it can significantly impact a patient’s quality of life, causing pain, psychological stress, social isolation (Jidéus, Liss, & Ståhle, 2009; Tovar & Badia, 2014; White, 2009), and higher mortality rates compared to patients without an SSI (Andersson et al., 2010; Coello et al., 2005). Even though, to date, there is limited evidence about the economic burden and other impacts of SSI in Vietnam, it is obvious that Vietnamese healthcare providers are facing similar financial burdens and other consequences resulting from SSI. Hence, SSI problems need to be taken into consideration to improve the situation.
To successfully prevent SSI, nurses need to understand the intrinsic and extrinsic risk factors associated with SSI, which have been identified in several studies. Risk factors have been independently associated with SSI and reported in many studies, such as the duration of the operation (Harder et al., 2013; Haridas & Malangoni, 2008; Morikane, Honda, Yamagishi, & Suzuki, 2015; Shiba et al., 2009), pre-operative stay (González-Vélez, Díaz-Agero Pérez, Robustillo-Rodela, & Monge-Jodrá, 2011; Harder et al., 2013), surgical wound classifications, multiple procedures, emergency operation (Korol et al., 2013; Morikane et al., 2015; Thu et al., 2005), morbidity (Harder et al., 2013; Nanashima et al., 2014), obesity, malnutrition, steroid use, smoking, and diabetes (Leavitt, 2007; Lewin et al., 2014; Wound Care Canada, 2010). Other factors also found to be correlated with SSI include blood loss and transfusion, low albumin, and chronic obstructive pulmonary disease (Alexander, Solomkin, & Edwards, 2011; Nanashima et al., 2014; Shiba et al., 2009); however, those factors were only found in a few studies. Further research should therefore be conducted to verify these findings.
Chapter 2: Literature Review of Surgical Wounds 39 2.4.3 Wound dehiscence Another common surgical wound complication is wound dehiscence. Wound dehiscence is characterised by the opening up of a surgically closed wound and can be classified as either superficial or deep (McDonagh, 2010). It has been suggested that wound dehiscence contributes to longer hospital stays, a delay in wound healing, reduced quality of life, increasing financial burden, and high rate of mortality (Corrêa, de Brito, & de Carvalho Resende, 2016; Sandy-Hodgetts, Carville, & Leslie, 2015; Slater, Bleichrodt, & van Goor, 2012; van Ramshorst, Eker, van der Voet, Jeekel, & Lange, 2013). Wound dehiscence occurs following any surgical procedure; however, abdominal wound dehiscence is the most widely reported dehiscence in the literature (Sandy-Hodgetts et al., 2015; van Ramshorst et al., 2010). The incidence of wound dehiscence has been shown to range from 0.4-2.97% of patients after elective laparotomy, and increasing rates of up to 12% have been observed after emergency procedures (Shanmugam et al., 2015; Slater et al., 2012). It has been reported that wound dehiscence is more often observed nine days after surgery (Schweinberger & Roukis, 2009; Slater et al., 2012). However, according to Dealey (2005), if infection is present, wound dehiscence is more likely to occur after 5-8 postoperative days. Even though several studies have been carried out to identify the incidence of abdominal wound dehiscence (Shanmugam et al., 2015; Slater et al., 2012), limited evidence has been reported in the general surgical population.
Factors contributing to surgical wound dehiscence have been widely reported in the literature. Some risk factors of wound dehiscence are avoidable (Johnson, 2009). The most frequently reported common factors include age, gender, chronic pulmonary disease, emergency surgery, postoperative coughing, and wound infection, smoking, obesity, and steroid use (Bartlett & Kingsnorth, 2009; Sandy-Hodgetts et al., 2015; van Ramshorst et al., 2010). Even though there are many risk factors related to wound dehiscence, it is apparent that more work needs to be carried out to identify which is the most important group of risk factors contributing to the occurrence of wound dehiscence and to specify whether the occurrence of wound dehiscence results from surgical site infection.
40 Chapter 2: Literature Review of Surgical Wounds 2.5 SUMMARY OF LITERATURE ON SURGICAL WOUNDS
The healing of surgical wounds is a complicated process, including four different phases that overlap. The healing of surgical wounds is divided into three different types of wound healing, including primary intention, secondary intention, and delayed primary intention. To optimise surgical wound healing and improve the quality of recovery after surgery, it is essential to identify the risk factors for impaired postoperative wound healing to provide an appropriate intervention to facilitate wound healing. This chapter has reviewed the risk factors related to slow postoperative wound healing and categorised the risk factors into three groups based on the conceptual framework, including patient-related factors, disease and treatment factors, and surgical procedure related factors. Some research on risk factors is dated; however, there is consistent evidence for the following risk factors: smoking, diabetes, obesity, stress, and ageing; surgical wound classification; duration of surgery; and emergency surgery. Other factors require further research, such as chemotherapy, immune deficiency, steroid use, method of wound closure, whether trauma is present, and pain. These factors were considered for the development of a new practical surgical wound assessment tool for use in Vietnam, as described in the next chapter.
Chapter 2: Literature Review of Surgical Wounds 41 Chapter 3: Literature Review: Wound Assessment Tools and Documentation
3.1 INTRODUCTION
The best way to evaluate the status of the wound is to conduct a comprehensive wound assessment to determine whether the wound is progressing or deteriorating (Wounds Australia, 2016). Research indicates that using a wound assessment tool to guide wound assessment and make a plan of wound care results in significantly improved accuracy of wound staging, and enhanced overall patient wound care (D. L. Young, Shen, Estocado, & Landers, 2012). This chapter provides an overview of existing wound assessment tools that measure changes in wound healing and predict healing for both acute and chronic wounds, as well as a review of current wound assessment documentation.
A search of the literature was conducted from the 1990s to 2017 using the keyword search terms of “wound assessment tool*” OR “wound assessment instrument*”; OR “wound assessment” and (tool* or measure* or scale* or instrument*); OR “surgical wound*” OR “post-operative wound*” and (tool* or measure* or scale* or instrument*); OR “wound healing” and (tool* or measure* or scale* or instrument*); OR “wound healing” and (valid* or reliable or reliability or sensitive* or response*); OR “ wound assessment documentation”.
3.2 THE ROLE OF WOUND ASSESSMENT TOOLS
In the literature, the term “assessment” is used to refer to information gathered by observation, questioning, physical, and clinical examination to begin planned care (Eagle, 2009). Effective wound management must start with an accurate and holistic assessment of the patient’s ability to heal, the likelihood of complications, the wound factors affecting healing, and the environmental factors that impact on optimum wound management (Burton, 2006; Cooper et al., 2010). This holistic assessment provides baseline data and beneficial information that can support nurses to identify short and long-term goals of care, and determine priorities for management planning at each stage (Cooper et al., 2010; Keast et al., 2004). Research has indicated that using a
42 Chapter 3: Literature Review: Wound Assessment Tools and Documentation wound assessment tool significantly increases the accuracy of correctly identifying a wounds’ stage, from 35% without the tool to 71% when using a tool, resulting in improved patient wound care (D. L. Young et al., 2012). A wound assessment tool not only helps to monitor wound progress but also collects data to justify nurses’ actions (Dowsett, 2009; Pillen et al., 2009).
However, inappropriate wound assessment can result in inadequate wound care management, with patients failing to heal. As a consequence, the wound is present for longer than necessary, with increased risk of complications (Eagle, 2009; Fletcher, 2010). The process of wound assessment therefore requires a range of clinical skills and knowledge of the physiology of the skin; the ability to determine relevant risk factors and potential hindrance to wound healing; the capability to distinguish between significant and non-significant data, both subjective and objective; and the ability to evaluate and elucidate results from the assessment (Benbow, 2011). Many studies investigating nurses’ knowledge and skills have been carried out on wound management and have suggested that nurses are not always able to provide an appropriate assessment of wounds and the optimal care to promote wound healing. This results in delayed wound healing, discomfort for the patient, increased risk of infection, and reduced patient quality of life (Ashton & Price, 2006; Dowsett, 2009; J. Edwards, Mitchell, Bayat, & Dunn, 2005; McIntosh, 2008).
Wound assessment is essential for wound management; however, it is an area of practice that is often performed poorly or infrequently (Dowsett, 2009). An early study conducted by Kennedy and Arundel (1998) reported that among 20 district nurses who participated in the study, 30% of nurses used a combination of observation and experience to assess wounds. Very few nurses (5%) used a standardised wound assessment tool to evaluate wounds. Similar to these findings, Cook (2011) found that even when a wound assessment tool was available, nurses still preferred their own way of assessment, with 63% of practitioners not regularly using a wound assessment tool. Another study of 120 acute care nurses working in a large urban hospital in Queensland Australia, revealed that acute care nurses had knowledge of wound assessment and wound healing; however, more than half (50.4%) stated they were unaware of the national standards regarding wound care management (Gillespie, Chaboyer, Allen, et al., 2014). Together, the evidence presented in this section highlights the importance of undertaking further research to identify specific barriers and enablers to guideline
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 43 adherence. The factors associated with nurses’ wound care decision-making requires further exploration, as this would enhance understanding of this practice area.
3.3 WOUND ASSESSMENT TOOLS
3.3.1 Elements of wound assessment The best approach to define the status of the wound is to conduct a comprehensive wound assessment (Wounds Australia, 2016). However, Ding et al. (2016) undertook an integrative literature review about surgical wound assessment and documentation from January 1990 until November 2013 and reported that in the evaluation of clinical characteristics of surgical wounds, the frequency of wound assessment and wound documentation is insufficient and lacks standardisation in wound assessment and documentation practices worldwide. The authors also indicated that and there is lack of agreement about which tools to use to assess surgical wounds (Ding et al., 2016). The literature has identified several criteria for inclusion in an optimal wound assessment tool, which include systematic factors affecting healing, and assessment of wound status. The following section introduces the criteria for inclusion in the wound assessment tool.
Comprehensive wound management must consider assessment of a patient’s overall health to determine the risk factors that may affect surgical wound healing in the pre-operative, intra-operative, and post-operative phases (Canadian Association of Wound Care, 2017). Assessment of the person with a surgical wound begins immediately post operation (Canadian Association of Wound Care, 2017), and reassessment needs to occur during the entire post-operative phase or a change in wounds, such as odour and purulent exudate (Doughty, 2004). However, most surgical incisions are usually not assessed until 48 hours after surgery (Canadian Association of Wound Care, 2017). The following areas have been identified as important for wound assessment.
Wound location: even though the wound location does not have any significant effect on the prevalence of SSI (Osakwe, Nnaji, Osakwe, Agu, & Chineke, 2014), identifying the location of the wound can provide baseline information to assist nurses in understanding the wound before beginning to formulate a plan of care (Greatrex-White & Moxey, 2013).
44 Chapter 3: Literature Review: Wound Assessment Tools and Documentation Wound measurement: the normal wound healing process involves wounds filling with healthy tissue, and a decrease in wound depth and volume (Cornforth, 2013). Basic wound measurement can identify whether a wound is progressing or deteriorating (Greatrex-White & Moxey, 2013). The use of centimetres as a unit of measure for a wound is typically recommended (Oldfield, 2010). The length, width and depth should be measured and recorded for a wound (Oldfield, 2010). According to the Association for the Advancement of Wound Care (2012), the length of the wound is defined as the longest dimension of the wound (geometric length) or along the vertical axis (head to toe is from 12 to 6 o’clock) of the body. The width of the wound is either the longest perpendicular to geometric wound length or a horizontal axis (side to side is 3 to 9 o’clock) of the body. Depth is the deepest part of a wound (Association for the Advancement of Wound Care, 2012).
Tissue type: the specific characteristics of the tissue within a wound bed play a critical role in the wound healing continuum (WUWHS, 2016b). The inclusion of tissue type in a wound assessment assists nurses to determine the phase of wound healing to decide on treatment or intervention (Greatrex-White & Moxey, 2013). There are four common types of wound bed description, including epithelialisation, granulation, slough, and necrosis, in which the existence of slough or necrotic tissue in wounds has been identified as a barrier to wound healing and a potential source of wound infection (WUWHS, 2016b).
Wound edge: the wound edge needs to be moist, intact, attached to and flush with the base of the wound to enable migration of epithelial cell (WUWHS, 2016b). In the surgical context, Bates-Jensen and Woolfolk (2012) describe the colour and wound edges outcomes and expected time frames for positive and negative results of surgical wound healing (see Table 3.1).
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 45 Table 3.1: Surgical wound healing outcomes (Bates-Jensen and Woolfolk, 2012)
Postoperative days Positive outcomes Negative outcomes Days 1-4 Colour of the incision is Colours of the incision (Inflammatory phase) red with well- may be red but tension approximated edges. on the incision line. Days 5-9 Progression from red to The incision may no (Proliferative phase) bright pink, edges are longer well- approximated. approximated, and the tension remains. Days 10-14 Bright pink The colour may remain (Proliferative phase) red or progress to bright pink. Days 15-1 year Pale pink and progressing Prolonged epithelial (Proliferative/remodelling to darker than normal skin resurfacing, or phase) colour in the darkly hypertrophic scar pigmented skin. formation.
Peri-wound skin: the evaluation of the skin surrounding a wound is a fundamental part of wound assessment to monitor the process of wound healing (Greatrex-White & Moxey, 2013). The peri-wound skin refers to “the area of skin extending to 4 cm beyond the wound edges” (WUWHS, 2016b, pp. 9). A wound should be assessed regularly to identify any signs of maceration, excoriation, dry skin, oedema, and allergic reactions. These are indicators of ineffective wound care management and adverse wound healing outcomes (Oldfield, 2010).
Exudate: the occurrence of exudate in a wound is a part of normal wound healing (Greatrex-White & Moxey, 2013). The assessment of exudate is an essential component of any wound assessment. The characteristics of exudate should be observed in the wound bed, including colour, consistency, and amount of exudate (WUWHS, 2007).
Consistency and colour are also essential descriptors of wound healing and a change in colour or consistency may be predictors of infection (Wounds UK, 2013). Normal exudate should be a serous (clear, amber, thin, and watery) (Wounds UK, 2013). In surgical wounds, the exudate can be blood-stained and would be called haemoserous (Oldfield, 2010). However, purulence (cloudy, milky, or creamy; green;
46 Chapter 3: Literature Review: Wound Assessment Tools and Documentation yellow or brown) may indicate bacterial infection (WUWHS, 2007; Wounds UK, 2013).
In addition to the colour and consistency, the volume of exudate can indicate the improvement or deterioration of the healing of a wound (Oldfield, 2010). An increase in exudate volume may indicate infection or impending dehiscence (Greatrex-White & Moxey, 2013). Exudate can be measured as “low”, “moderate”, and “heavy”, but it is subjective. However, the World Union of Wound Healing Societies (2007) recommended evaluating the volume of exudate by evaluation of the dressing. This includes five categories: (1) dry (no visible moisture on the primary dressing), (2) moist (the primary dressing may be lightly noticeable with small amount of exudate), (3) wet (the primary dressing is expansively noticeable with amounts of fluid), (4) saturated (primary dressing is wet, peri-wound skin may be macerated), and (5) leaking (dressing is saturated, to secondary dressing and onto clothes).
Odour: an unpleasant odour can indicate bacterial progression (WUWHS, 2007). It is difficult to quantify odour, as it can be subjective (Wounds UK, 2013). However, wound care experts in the UK recommended a guide to facilitate the assessment of odour, which includes: (1) low (wound odour present when removing primary dressing), (2) moderate (odour present when removing secondary dressing), and (3) high (odour present prior to dressing change and patient aware) (Wounds UK, 2013).
In the following section of this chapter, an overview of existing wound assessment tools is provided to identify the current gaps in the literature. This section reviewed wound assessment tools for both acute wounds and chronic wounds to provide a whole picture of current existing wound assessment tools. The result of this comprehensive review provide evidence on which tools are reliable to use in a clinical setting in regard to acute and chronic wounds. The review of wound assessment tools therefore is divided into three categories. This includes a review of existing wound assessment tools to measure and predict healing in all types of wounds, followed by tools measuring surgical wounds and general tools measuring chronic wounds.
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 47 3.3.2 Tools to measure healing in all types of wounds Three different tools were identified to measure the healing of general wounds: the Wound Healing Scale (Krasner, 1997), Barber Measuring Tool (Barber, 2008), and the Photographic Wound Assessment Tool (Houghton, Kincaid, Campbell, Woodbury, & Keast, 2000). This section describes the purpose, strengths, and limitations of each tool.
The Wound Healing Scale was designed by Krasner (1997) as a descriptive scale for assessing healing in all types of wounds. The scale is based upon the existing National Pressure Ulcer Advisory staging system; however, eight alphabetic modifiers can be combined with an initial assessment of wound scores to describe significant changes in wound healing status (Krasner, 1997). To date, no studies were found that that have validated this tool.
The Barber Measuring Tool is utilised to track changes of wound healing over time and across different wound types, including both chronic and acute wounds (Barber, 2008). At the time of this review, the use of this tool had only been found in one study. The Barber Measuring Tool was used to track the progress of more than 400 wounds, containing surgical and burn wounds, and indicated that the tool appropriately represented healing progression (Barber, 2008). However, the validity and reliability of this tool have not been statistically analysed.
The Photographic Wound Assessment Tool (PWAT) was first introduced in 2000 (Houghton et al., 2000) and was developed based on a modified version of the Pressure Sore Status Tool (PSST) (Bates-Jensen, Vredevoe, & Brecht, 1992). This tool was developed to accurately measure the status of all types of wounds based on a 2 – dimensional visual image (Houghton et al., 2000). The tool consists of six domains. The total PWAT score ranges between 0 and 24, with zero representing totally healed ulcers heal (Houghton et al., 2000). The PWAT has been reported as having good intra- rater reliability (ICC =0.96), inter-rater reliability (ICC=0.73), good concurrent validity (r=0.70), and demonstrated sensitivity to change in wound appearance of healing (Houghton et al., 2000). However, in 2013, the PWAT was revised by Thompson, Gordey, Bowles, Parslow, & Houghton, (2013). The new version of the PWAT currently contains eight domains including size, depth, necrotic tissue type, amount of necrotic tissue, edges, and periulcer skin viability with scores ranging from 0 to 32. A score of 0 represents a fully healed wound. The revPWAT has shown
48 Chapter 3: Literature Review: Wound Assessment Tools and Documentation moderate to excellent intra-rater, and inter-rater reliability, as well as test-retest reliability (Thompson et al., 2013).
3.3.3 Tools to measure surgical wound healing It has been suggested that there is no single, standard, widely accepted method for assessing the healing of surgical wounds (Whitney, 2012). To date, the National Nosocomial Infection Surveillance System risk index (Culver et al., 1991), and the ASEPSIS tool (Wilson, Treasure, Sturridge, & Gruneberg, 1986) were found in the literature as often being used to assess for surgical wound complications.
The National Nosocomial Infection Surveillance System (NNIS) risk index was developed to predict surgical wound infection, and includes three parameters: an American Society of Anaesthesiologists preoperative assessment score of 3, 4, or 5; a surgical wound classed as contaminated or dirty-infected; and duration of surgery longer than 75% of similar cases (Culver et al., 1991). The NNIS risk index ranges from 1 to 3. A score of 0 is interpreted as a low risk for SSI, 1 means an intermediate risk, and an index of 2 or 3 equates to a high risk. The NNIS risk index has been shown to be more accurate than the simple preoperative wound classification of “clean”, “clean-contaminated”, “contaminated”, and “dirty” described by the Centers for Disease Control and Prevention in the United States (Culver et al., 1991). The NNIS risk index has been applied to benchmarked surgical site infection rates using indirect standardisation. Therefore, it can be a useful tool for comparing surgical site infection rates between institutions (WHO, 2009).
The ASEPSIS tool (Wilson, Treasure, et al., 1986) is the most frequently used tool to evaluate acute surgical wound complications (Whitney, 2012). The ASEPSIS tool has been applied in numerous studies in the assessment of wound infection rates among patients undergoing cardiac surgery (Hassan Al-Wahsh & Wahsheh, 2011; Malhotra et al., 2014), coronary artery bypass grafting (Akowuah et al., 2006), and general surgery (Topaloglu et al., 2008). The ASEPSIS tool was initially developed for sternal surgical patients by Wilson, Treasure, et al. (1986) to evaluate the characteristics of surgical incisions related to wound infection. ASEPSIS is an acronym for seven wound assessment parameters, including: Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days, and each category of infection is determined as a score:
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 49 0-10 satisfactory healing
11-20 disturbance of healing
21-30 minor wound infection
31-40 moderate wound infection
> 40 severe wound infection (Wilson, Treasure, et al., 1986).
Several studies have been carried out to determine the validity, reliability, and sensitivity of the ASEPSIS scoring system. The validity of the ASEPSIS was assessed by comparing the ASEPSIS scoring system against the criteria of the Centers for Disease Control (CDC) (Wilson, Helder, Theminimulle, & Scott, 1998). From a total of 559 surgical site infections detected by the CDC criteria, under half were detected by the ASEPSIS scoring system within the first seven days postoperatively (Wilson et al., 1998). The authors also compared the ASEPSIS scoring system with the Wells, Newsom, and Rowland criteria, in which wounds are defined as grade 1 for normal wound, grade 2 for inflammation and some exudating wounds, and grade 3 for purulent exudate and breakdown of wounds. The study revealed that only wound scores of > 40 in the ASEPSIS tool were consistent with wounds graded as 3 in the Wells, Newsom, and Rowlands grading system (Wilson, Treasure et al., 1986). Therefore, it can be concluded that the concurrent validity of the ASEPSIS tool may be inadequate for identifying surgical wound infection.
However, the ASEPSIS scale has been found to have excellent reliability for assessment of sternal SSI. The inter-rater reliability of the ASEPSIS by two independent observers on 51 patients undergoing cardiac surgery and 34 patients, who had leg wounds was 4.2 and 3.2, respectively (Wilson, Webster, Gruneberg, Treasure, & Sturridge, 1986). Similarly, Byrne and colleagues (1988) also evaluated interrater reliability on 100 general and vascular wounds and reported an observed coefficient of repeatability of 3.4, and that the correlation coefficient for two observers was 0.96 (Byrne, Napier, & Cuschieri, 1988).
Even though the ASEPSIS had excellent reliability, it was developed based on sternal surgical sites. Therefore, its validity to identify SSI for general surgical wounds might not apply to non-sternal surgical sites because the sites and the length and depth of incisions on sternal surgical sites are different to others. This tool also primarily aims to detect infection, rather than progress in surgical wound healing (Siah & Childs,
50 Chapter 3: Literature Review: Wound Assessment Tools and Documentation 2012). Considering this evidence, it appears that there are gaps in the literature with regards to validation of existing surgical wound assessment tools. Future work therefore needs to be undertaken to establish the best assessment instruments to measure the healing of surgical wounds.
3.3.4 Tools to measure chronic wound healing A search of the literature revealed 10 different types of tools to measure the status of pressure ulcers, diabetic foot ulcers, and all types of chronic leg ulcers. This included the Pressure Ulcer Scale for Healing (Thomas et al., 1997); Pressure Sore Status Tool, with a new name of the Bates-Jensen Wound Assessment Tool (Bates- Jensen et al., 1992; C. Harris et al., 2010); the Sussman Wound Healing Tool (Sussman & Swanson, 1997); the Sessing Scale (Ferrell, Artinian, & Sessing, 1995); DESIGN (Sanada et al., 2004); CODED (Emparanza, Aranegui, Ruiz, & Perez, 2000); the Leg Ulcer Measurement Tool (Woodbury, Houghton, Campbell, & Keast, 2004); the NE1 Wound Assessment Tool (D. L. Young, Estocado, Landers, & Black, 2011); the RESVECH V1.0. (Carlos & Soriano, 2012); and the new Diabetic Foot Ulcer Assessment Scale (Flegal, Graubard, Williamson, & Gail, 2005).
The Pressure Ulcer Scale for Healing (PUSH) was developed and validated in 1996 by the National Pressure Ulcer Advisory Panel in the United States. The PUSH tool is used to measure the healing of pressure ulcers by checking wound parameters for length, times width, amount of exudate, and tissue type (Thomas et al., 1997). The total score of the PUSH ranges from 0 to 17. Higher scores indicate worse ulcers and lower scores show improvement in the wound healing process (Thomas et al., 1997). The PUSH tool has been evaluated for validity and reliability in several studies. The concurrent validity of the PUSH was evaluated by comparing scores with the PSST scores and ulcer surface over a period of five weeks, with total PUSH scores strongly associated with these concurrent measures (p<0.01) (Gardner, Frantz, Bergquist, & Shin, 2005). Predictive validity and sensitivity to changes in the process of healing of the PUSH tool have also been consistently noted in various studies (Gardner et al., 2005; Stotts et al., 2001; Thomas et al., 1997). In terms of reliability, agreement between raters was reported as greater than 95% (Stotts et al., 2001); however, no information was reported regarding how this value was obtained.
The Pressure Sore Status Tool (PSST) was developed to measure the healing of pressure ulcers (Bates-Jensen et al., 1992). The PSST involves 15 items (Bates-Jensen
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 51 et al., 1992). Content validity, concurrent validity, intra-rater reliability, and inter-rater reliability of the PSST have been explored in different studies (Bates-Jensen, 1997; Bates-Jensen & McNees, 1995; Bates-Jensen et al., 1992). Even though the findings of those studies indicated the PSST had content validity and acceptable reliability, concurrent validity was uncertain, and the predictive validity or sensitivity of the PSST was not reported in those studies.
However, in 2001, the PSST was reviewed, and the name was altered to the Bates-Jensen Wound Assessment Tool (BWAT) (C. Harris et al., 2010). The BWAT was designed for use in a variety of wounds other than pressure ulcers (C. Harris et al., 2010). Item revision comprised the addition of a “none present” choice, which is a score of “1”, and was added to the elements measuring exudate type and amount, induration, and oedema (C. Harris et al., 2010). The BWAT is an increasingly common tool for measuring wound healing (National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, 2014). Currently, the validation and reliability of the BWAT has been evaluated in a Turkish Language Version, showing that the Turkish version of BWAT had high content validity, interrater reliability, and internal consistency (Karahan et al., 2014).
The Sussman Wound Healing Tool (SWHT) was introduced by Sussman and Swanson (1997) as a diagnostic tool to predict and measure the progress of the healing of pressure wounds over time. The SWHT was developed according to an acute model of wound healing including 21 items (Sussman & Swanson, 1997). However, since being introduced in 1997, a scoring system has not yet been established for the tool. To date, only one study has been conducted to check the predictive validity. The findings indicate that while the SWHT tool may be able to predict whether a pressure ulcer is progressing or deteriorating, it may not have a role in measuring wound healing (Sussman & Swanson, 1997). Therefore, it has been suggested that the SWHT may not be an appropriate tool to measure the healing of wounds until a scoring system is established, and until validity, reliability, and sensitivity has been confirmed (Pillen et al., 2009)
The Sessing Scale was developed through a series of interviews with a clinical nurse specialist in wound care and a qualitative nurse researcher for the purpose of promoting a descriptive scale for measuring the progression of pressure ulcer healing (Ferrell et al., 1995). Although the content, concurrent, and predictive validity, and
52 Chapter 3: Literature Review: Wound Assessment Tools and Documentation intra-rater reliability, as well as inter-rater reliability of the Sessing Scale have been established, and indicated that it is a valid and reliable tool to monitor the progression of pressure healing in two studies (Ferrell, 1997; Ferrell et al., 1995), the tool’s validity and reliability were only evaluated using a small sample size, and assessment was performed by two nurses assessing a small number of pressure ulcers. Further research with a larger sample size should therefore be undertaken to confirm these findings.
DESIGN is an abbreviation resulting from the six components (depth, exudate, size, infection, granulation, and necrosis), and was established in 2002 by the Scientific Education Committee of the Japanese Society of Pressure Ulcers (Sanada et al., 2004). This tool is used to categorise the severity of pressure ulcers and monitor the progression of wound healing (Sanada et al., 2004). DESIGN was found to have both high inter-rater reliability and high concurrent validity in evaluating the wound healing progress of the pressure ulcers in one study (Sanada et al., 2004). However, the results from this study should be interpreted with caution due to using only eight photos to test concurrent validity, and six actual pressure ulcers to evaluate inter-rater reliability. Content, construct validity, and intra-rater reliability were also described in that study.
The DESIGN tool is considered useful to monitor each pressure ulcer; however, it fails to compare the process of wound healing in various patients (Matsui et al., 2011). Therefore, in 2011, the Scientific Education Committee of the Japanese Society of Pressure Ulcers reviewed DESIGN, and DESIGN-R (rating) was introduced to overcome this limitation (Matsui et al., 2011). DESIGN-R has been shown to be a valuable tool to forecast pressure ulcer healing for a varied range of patients, healthcare providers and wounds sites (Matsui et al., 2011). Currently, DESIGN-R has been translated into Chinese, and the Chinese version of DESIGN-R has demonstrated that it is a valid and reliable tool with acceptable accuracy in monitoring pressure ulcer status in Chinese populations (Zhong et al., 2013).
The CODED tool is an acronym of colour (CO) in the wound base, depth (DE) of the ulcer, and mean diameter (D) of the wound. This tool was designed and tested as a pressure ulcer severity score based on evaluation by knowledgeable clinicians (Emparanza et al., 2000). The validity of the CODED tool was tested by using a set of 50 ulcers, and the resulting CODED score showed good correlation (r=0.92), with the severity stage as assessed by the experts (Emparanza et al., 2000). However, content, concurrent, and construct validity were not reported. Thus, until the validity and
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 53 reliability of the CODED have been established, CODED should only be used with caution.
The NE1 Wound Assessment Tool (NE1 WAT) previously named the N.E. One Can Stage tool (NEOCS) [Nancy Estocado Solution, LLC, Las Vegas, Nevada], was developed by experts in wound care with 22 years of clinical experience (Lilly, Estocado, Spencer-Smith, & Englebright, 2014). This tool was designed to improve the correct staging of pressure ulcers (D. L. Young et al., 2011). The test-retest reliability of NE1 WAT was found to be strong (ICC =0.892; 95CI: 0.840-0.927) for different types of healthcare providers (Lilly et al., 2014). Criterion validity for the tool was evaluated by comparing scores between Test 1 and 2 and between Tests 1 and 3. Out of a possible 90 points, NE1 WAT scores increased by 12.3 points between tests 1 and 2, and 14.1 points between tests 1 and 3 (Lilly et al., 2014). However, the NE1 WAT was not compared to existing wound healing tools. Thus, additional work is required to determine concurrent validity, and evaluate the reliability of the NE1 WAT tool to identify whether this tool can be used by a variety of healthcare professionals.
The Leg Ulcer Measurement Tool (LUMT) was designed to detect changes in the appearance of leg ulcers, including diabetic, venous, and arterial ulcers (Woodbury et al., 2004). The LUMT consists of two domains, a clinician and patient-rated domain (Woodbury et al., 2004). The total scores range between 0 and 56. A score of 0 indicates that the wound has completely healed. Construct and concurrent validity, inter-and intra-rater reliability, and sensitivity to change of the LUMT have only been evaluated in one study (Woodbury et al., 2004). The findings indicated that concurrent criterion validity was r=0.82, intra-rater and inter-rater reliability (ICC>0.75), and the LUMT detected changes in the status of the wound over time. However, the validity and reliability of this tool must be interpreted with caution, because no information was provided about how the agreement was achieved and how bias was diminished when evaluating construct validity. Moreover, to assess the responsiveness of the LUMT, wounds were evaluated only once a month, which may not be regularly enough to use in measuring outcomes in research or clinical settings (Pillen et al., 2009). Therefore, future studies should be conducted to verify these findings.
The provisional RESVECH V1.0 was developed to assess the healing progression of all types of chronic wounds that can be applied from the time in which the chronic wound is identified until the wound is healed (Carlos & Soriano, 2012).
54 Chapter 3: Literature Review: Wound Assessment Tools and Documentation The scale includes nine items, and the scale scores range from 0 to 40 points, with a high score indicating the worst possible lesion. The overall content validity index of RESVECH V1.0 was 0.98 (Carlos & Soriano, 2012). However, further work needs to be undertaken to evaluate whether this tool is valid and reliable to use.
The new Diabetic Foot Ulcer Assessment Scale was developed to measure the healing of diabetic foot ulcers among Indonesian patients (Arisandi et al., 2016). This tool includes 11 domain items, and the total score ranges from 0 to 98, with higher scores indicating more severe wounds. Only one study was found that validated this scale. The concurrent validity, construct validity, and predictive validity of the Diabetic Foot Ulcer Assessment Scale was evaluated, and it was reported as a valid tool for measuring diabetic foot ulcers (Arisandi et al., 2016). However, the reliability of this scale was not reported due to a small convenience sample size, and it was conducted in only one site setting. Thus, future studies with large sample size and multicentre settings should be carried out to verify the validation of this scale.
3.3.5 Summary of literature on wound assessment tools In conclusion, the status of a wound can be evaluated by conducting a comprehensive wound assessment. Research indicates that using a wound assessment tool significantly improves the accuracy of wound staging, resulting in enhanced overall patient wound care. From a review of the literature, there are 14 existing wound assessment tools that measure changes in wound healing and predict healing for both chronic and acute wounds. Among these tools, the PUSH (National Pressure Ulcer Advisory Panel, 1996) and PSST (now renamed the BWAT) (C. Harris et al., 2010) appear to show acceptable validity in the monitoring of pressure ulcer healing, while the LUMT (Woodbury et al., 2004) demonstrates a capacity for assessing healing of leg ulcers. However, out of 14 tools that have been validated, only one is specific for evaluating surgical wound complications, and specifically infection, the ASEPSIS tool (Wilson, Treasure, et al., 1986). Wound assessment tools not only assist nurses to conduct a comprehensive and holistic wound assessment but also aid nurses to record information about their assessment. The following sections provide a discussion of assessment documentation.
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 55 3.4 WOUND DOCUMENTATION
3.4.1 Nursing documentation Nursing documentation is referred to as the record of nursing care that is planned and given to individual patients and clients by qualified nurses or by other caregivers (Urquhart, Currell, Grant, & Hardiker, 2009). Adequate records enhance the continuity and individuality of care by providing effective communication between healthcare professionals, demonstrating the quality of the care delivered and providing evidence of a nurse’s involvement with a patient (Griffith, 2016; Inan & Dinç, 2013; Wang, Hailey, & Yu, 2011). In contrast, inadequate records may have an adverse impact on the quality of care delivery and clinical decision-making (Inan & Dinç, 2013). To achieve good records, nursing documentation must include valid and reliable information and provide sufficient detail to show that a nurse has discharged their duty of care (Griffith, 2016; Urquhart et al., 2009). It has therefore been suggested that when making an entry in a patient’s record, the elements of a good record must contain FACTS. FACTS is an acronym for five elements of nursing record, including F-factual (record is truthful and based on fact), A-accurate (what is recorded is clear, unambiguous, dated, timed and signed), C-consistent (the record is reliable and dependable), T-timely (the record has been contemporaneously written), and S-shared (the record entry has been shared with others involved in the care of the patient) (Griffith & Tengnah, 2013).
Wound documentation is an essential component of wound assessment. Wounds should be documented upon the patients’ admission, with each dressing change, and upon any significant change in the wound and discharge (Baranoski, Ayello, & Langemo, 2012). The documented initial and ongoing wound assessment should consider and incorporate clinical features of wounds, such as: type of wound, wound location, wound dimension, wound edge appearance, the clinical characteristics of the wound bed, peri-wound appearance, amount of exudate and odour, and patient and healing environmental factors that may delay wound healing (Vuolo, 2006; Wounds Australia, 2016). However, these recommendations only provide broad guidance about wound assessment. There has been little discussion regarding how the clinical features of surgical wounds should be assessed and documented in the literature.
56 Chapter 3: Literature Review: Wound Assessment Tools and Documentation 3.4.2 Current wound documentation Appropriate nursing documentation is able to provide sufficient communication between nurses and other healthcare professionals (Wang et al., 2011). However, the accuracy of nursing records in comparison with the reality of practice requires attention. Wang et al. (2011) conducted a systematic review of 77 quantitative and qualitative studies published between 2000 and 2010 with the purpose of examining the quality status of nursing documents. The review revealed three major issues with nursing records: (1) insufficiency of documentation about psychological, social, cultural, and spiritual features of care, and deficient recording of the assessment of patients’ preferences, health perceptions, and quality of life; (2) insufficient recording of the five steps of the nursing procedure, such as insufficient records of assessment, patient’s vital signs, and the rare application of an assessment tool for pain and cognitive impairment; and (3) inconsistency in terminology and timing for documentation, such as inappropriate phrasing of statements and inadequate concordance between record content and results from patient evaluation. All of the studies reviewed here support the hypothesis that nursing care is not adequately conveyed in the documentation and there is inadequate written communication between distinctive healthcare staff about patients (Wang et al., 2011).
Nine studies were found in the literature that focussed on research specific to wound assessment and documentation. Of the nine studies, three studies surveyed wound assessment (Cook, 2011; Gillespie, Chaboyer, Allen et al., 2014; Kennedy & Arundel, 1998), five studies investigated documentation of wound assessment and management plan (Carville & Smith, 2004; Danielsson-Ojala, Salanterä, & Lundgren- Laine, 2010; Gartlan et al., 2010; Gillespie et al., 2014; L. N. Smith & Lait, 1996), and one study examined both wound assessment and documentation (Oseni & Adejumo, 2014). In an early study, a total of 119 case notes were reviewed, and it was found that over 80% of records did not contain wound assessment sheets on the following criteria: colour, inflammation, swelling, discharge, and pain (L. N. Smith & Lait, 1996). The majority of wound assessment documentation (89.7 %) was poorly recorded (L. N. Smith & Lait, 1996). This view was supported by Carville and Smith (2004), who found that documentation was documented incompletely and inconsistencies existed between the lengths of documentation times.
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 57 A further study examined the wound care documentation of intensive care unit nurses (Danielsson-Ojala et al., 2010) and another examined acute wound care documentation by doctors and nurses in a regional Australian hospital (Gartlan et al., 2010). Both studies concluded that wound care documentation did not meet the standards of wound care management and patients’ safety (Danielsson-Ojala et al., 2010; Gartlan et al., 2010). Similarly, Gartlan et al. (2010) reported that less than 5% of wound dimensions, wound bed, surrounding skin, and skin sensation were documented during dressing changes, and less than 20% of documentation contained information about exudate and wound edges. However, wound pain and dressing type were frequently recorded, which accounted for 43% and 47%, respectively. This view was supported by another current study conducted in Queensland, Australia (Gillespie, Chaboyer, Kang, et al., 2014), where the findings indicated that nearly 60% of wound assessments were not adequately documented and almost 20% of postoperative wound assessments were documented in progress notes rather than with a specific tool. Over half (61.8%) of the patients in this sample also had no documented assessment of a change in patient conditions (Gillespie, Chaboyer, Kang, et al., 2014). Considering this evidence, it appears that the documentation of wound assessment is carried out poorly and there is ineffective communication about wound care among caregivers in a setting where multiple staff are looking after patients.
3.5 CHAPTER SUMMARY
In conclusion, two main issues were discussed in this chapter associated with the gap of lack of surgical wound assessment tools and inadequate surgical wound assessment documentation. Out of all 14 existing tools, only the ASEPSIS tool (Wilson, Treasure, et al., 1986) was found to measure surgical wound infection. Even though ASEPSIS has been used to evaluate surgical site infection, there are number of reasons to justify the need for a new surgical wound assessment tool. First, the existing ASEPSIS tool focusses only on predicting surgical wound infection. Thus, it fails to provide a comprehensive surgical wound assessment. Second, in clinical practice, when assessing surgical wounds, a holistic and comprehensive assessment of the risk factors associated with an increased likelihood of surgical wound complications is not addressed by the existing tools (ASEPSIS). Finally, some characteristics considered to be important in monitoring healing or deterioration (i.e., wound dimension, wound edge, wound bed tissue, exudate volume, and odour) are not assessed by the existing
58 Chapter 3: Literature Review: Wound Assessment Tools and Documentation ASEPSIS tool. These characteristics are critical components to be considered when monitoring the status of surgical wound healing, and for recognition of healing or deterioration requiring further intervention. Thus, it is essential to develop a valid and clinician-friendly surgical wound assessment tool as an evaluative tool explicitly designed to assess surgical wound healing status, detect potential factors that increase the risk of surgical wound complication, and enhance the quality of surgical wound assessment documentation. This tool will be beneficial for wound care nurses in Vietnam to evaluate the effectiveness of their interventions. The conceptual framework used to guide this research project is presented in the following chapter.
Chapter 3: Literature Review: Wound Assessment Tools and Documentation 59 Chapter 4: Conceptual Framework
4.1 INTRODUCTION
The selection of an appropriate conceptual or theoretical framework is a crucial stage in the development of the research process due to the provision of reasoning to guide the research (Mock et al., 2007). The selection of such frameworks requires a deep and thoughtful understanding of the problem, purpose, significance, and research question (Grant & Osanloo, 2014). In order to select an appropriate theoretical or conceptual framework, Glanz, Rimer, and Viswanath (2008) suggested three criteria. First, the theory or model must meet certain fundamental standards for research and practice, thereby having the promise of effective utilisation by healthcare professionals and educators. Second, there must be evidence that it has been used in contemporary health research. The last criterion is that there must be some evidence supporting the theory’s validity. However, different frameworks best suit different sections of practice, such as individuals, groups, and organisations. The selection of a suitable theory or model should therefore commence with recognising the difficulty, goals, and units of practice (Sussman & Sussman, 2001).
It has been suggested that theoretical or conceptual frameworks are used in all stages of the research process (Polit & Beck, 2014). Therefore, the first step of using a conceptual or theoretical framework is to choose a theory or model that is suited to the research question. It is essential to examine the relationship between the question asked and the theoretical framework and to make sure the question and the methodology, including the data analysis, are congruent with the theory or model. The conceptual framework can define the concepts and variables, which can be used as keywords to retrieve and organise the literature. As a result, this assists with the selection of appropriate literature and the exclusion of inappropriate literature. Finally, the theory or framework can be used as a guide to interpreting the findings and judging their significance (Richardson-Tench, Taylor, Kermode, & Roberts, 2014).
In regards to the wound care field, there have been a small number of conceptual frameworks published to guide the assessment of wounds. Some of these frameworks have been designed for chronic wound assessment and management, including the
60 Chapter 4: Conceptual Framework MEASURE framework (Keast et al., 2004), the TIME framework (Schultz et al., 2003), the holistic framework for chronic wound management (Popoola, 2003), and the framework of factors that may affect complex and hard to heal wounds (European Wound Management Association, 2008). On the other hand, others have been created for specific wound types, such as surgical wounds (Han & Choi-Kwon, 2011). This chapter describes the frameworks most frequently used to guide wound assessment and concludes with an evaluation of the relevant aspects, which were incorporated into the design of the final framework used to guide this study.
4.2 CONCEPTUAL FRAMEWORKS
4.2.1 The MEASURE framework The MEASURE framework is recognised as a straightforward conceptual framework for the development of a consistent wound assessment approach (Sibbald, Orsted, Coutts, & Keast, 2007). This wound assessment framework was developed by Keast et al. (2004) and is presented in a table with seven parameters. MEASURE provides basic wound assessment parameters that should be focused on in routine chronic wound assessment and management. MEASURE is an acronym for seven wound assessment parameters including Measure (length, width, depth, and area), Exudate (quantity and quality), Appearance (wound bed, including tissue type and amount), Suffering (pain type and level), Undermining (presence or absence), Re- evaluate (monitoring of all parameters regularly), and Edge (condition of edge and surrounding skin) (Keast et al., 2004). The MEASURE framework provides the clinician with valuable decision-making information and allows them to develop a comprehensive wound assessment (Sibbald et al., 2007).
Although the MEASURE mnemonic is a useful tool to assist clinicians in assessing the wound, the limitation of this framework is that it focuses only on the wound itself, rather than other factors that may impact wound healing. However, it has been suggested that effective wound healing depends on the management of the whole patient, not just the wound (Popoola, 2003). Therefore, the assessment of the wound must be integrated into the context of the holistic assessment of patients and the environment that may affect wound healing, because only by understanding the interaction of these factors and their impact on wound healing can clinicians develop
Chapter 4: Conceptual Framework 61 effective and appropriate strategies to promote the healing of the wound (European Wound Management Association, 2008; Sibbald et al., 2007).
4.2.2 TIME framework The TIME framework was developed for wound bed preparation by a group of experts in wound care to provide a framework for a structured approach to wound bed preparation, and it was first presented at the 2003 annual meeting of the European Wound Management Association (Schultz, Barillo, Mozingo, & Chin, 2004; Schultz et al., 2003). This framework is based on the observable characteristics of chronic wound healing by secondary intention (Schultz et al., 2003). TIME is an acronym from four parameters that need to be addressed at each wound assessment including: “Tissue (assessment and debridement of non-viable or foreign material on the surface of the wound), Infection/inflammation (assessment of the aetiology of each wound, control infection and management of inappropriate inflammation unrelated to infection), Moisture imbalance (assessment of the aetiology and management of wound exudate), and Edge of wound (assessment state of the surrounding skin)” (Schultz et al., 2003).
The TIME framework has been widely recognised and frequently cited in the literature, such as wound management papers, guidelines, protocols, and consensus documents. It is also suggested as a valuable practical assessment tool to identify obstacles to wound healing, and implement strategies to eliminate these obstacles and promote healing (Dowsett & Newton, 2005; Leaper et al., 2012). However, as the healing of wounds depends on many other factors, it has therefore been suggested that the holistic and systematic evaluation of patients and their healing environment should be considered in the TIME principle (Cornforth, 2013). In response to these developments and recent evidence found in the literature, the TIME acronym was re- examined by a group of experts of the International Wound Infection Institute to identify its validity for current best practice (Leaper et al., 2012). Thus, in 2012, a new version of the TIME framework was produced with an emphasis on addressing patient- centred concerns and promoting a holistic approach to patients with wounds (Leaper et al., 2012). The TIME framework is widely recognised in the reviewed literature as a vital tool for both acute and chronic wound assessment and management (Cornforth, 2013; Schultz, Mozingo, Romanelli, & Claxton, 2005). It has also been used as a guideline for developing a wound assessment tool (Fletcher, 2007), a care programme (Dowsett & Newton, 2005), and burn care protocols (Schultz et al., 2005). As a result
62 Chapter 4: Conceptual Framework of its clarity, logic, and suitability to the purpose of the current study, the principle of the TIME framework (Leaper et al., 2012) was incorporated into other frameworks to design the final framework used to guide this study.
4.2.3 Surgical Wound Care Algorithms Framework It has been recognised that evidence-based clinical practice guidelines may not only provide health professionals with useful tools to communicate effectively but also assist them to make decisions. Evidence-based clinical practice guidelines in wound care can be provided in a variety of formats, including clinical pathways, algorithms, decision trees, protocols, procedures, or frameworks (Courtney, 2005). However, to date, only one framework has been found in the literature that focuses on surgical wound care management. The Surgical Wound Care Algorithm was developed by a group of 10 experts in wound care based on the “ADAPTE process” (ADAPTE Collaboration, 2007) and an international clinical practice guideline development method (Han & Choi-Kwon, 2011). The components of the Surgical Wound Care Algorithm were adapted from the Bonnie Sue local wound care algorithm (Bryant, 2007), and include nine content areas: wound assessment by the Bates-Jensen Wound Assessment Tool (BWAT), infection control, management of necrotic tissue, wound classification, dressing selections, systemic factors, expected outcomes, re-evaluation, and other treatment options for impaired healing wounds (Han & Choi-Kwon, 2011).
These components of the Surgical Wound Care Algorithm were integrated into the Surgical Wound Care Algorithm framework (Han & Choi-Kwon, 2011) (see Figure 4.1) to allow for an overview of surgical wound assessment and management. The whole framework in Figure 4.1 presents the relationship between wound characteristics, patient characteristics, disease attributes, and treatment factors. Central to this framework is the recovery of surgical wounds. According to this framework, in order to recover from surgical wounds, the wounds are not only affected by host factors that influence wound status, but also patients and their healing environmental factors that impact on the healing of the wound (Han & Choi-Kwon, 2011). The four important elements displayed in the surgical framework include disease, treatment, patient factors and wound characteristics.
Chapter 4: Conceptual Framework 63
Figure 4.1: The Surgical Wound Care Algorithm Framework
BMI = Body mass index; WBC = White blood cell; CRP = C-reactive protein; APACHE score = Initial Acute Physiologic and Chronic Health Reprinted from position document: Adaptation of Evidence-based Surgical Wound Care Algorithm, (Han & Choi-Kwon 2011, p.771), with permission from the Journal of Korean Academy of Nursing
The first component of the Surgical Wound Care Algorithm framework is “wound characteristics”, including the assessment of depth, exudate, necrotic tissue, infection, and type of wound (Han & Choi-Kwon, 2011). The remaining three elements of the Surgical Wound Care Algorithm framework, which include disease, treatment, and patient factors, consider the systemic factors that can impact on the recovery of surgical wounds. However, these three elements are particularly important for critically ill patients. The first element considered in this framework is “patient factors”, including gender, BMI, age, and past history. The second element is “disease attributes”, which considers the degree of infection and immune function (white blood cell, C-reactive protein), disease progress, and type of disease treatment. The final component of the surgical wound care framework is “treatment factors”, which are systemic treatments, such as drugs, oxygen, perfusion, nutrition, temperature, glucose, and infection control; and local treatments (dressing, debridement) (Han & Choi- Kwon, 2011).
64 Chapter 4: Conceptual Framework Considering all of the evidence, the Surgical Wound Care Algorithm framework (Han & Choi-Kwon, 2011) and the TIME framework (Leaper et al., 2012) were considered the most appropriate frameworks to guide the development of a surgical wound assessment tool for the current study. The following reasons support the choice of the Surgical Wound Care Algorithm framework: (1) to date, the Surgical Wound Care Algorithm framework is the only framework that has been located for surgical wound care assessment and management, (2) compared with existing frameworks, the Surgical Wound Care Algorithm framework takes patients with wounds into consideration for a systemic and holistic assessment and does not focus only on the wound itself, while existing wound care frameworks, such as the MEASURE framework do not consider other factors, which may affect wound healing (Han & Choi-Kwon, 2011), and (3) the framework is clear, logical, and suitable for the current study.
Regarding the choice of the TIME framework, as mentioned above, wound characteristics according to the Surgical Wound Care Algorithm framework include only the assessment of depth, exudate, necrotic tissue, infection, and type of wound (Han & Choi-Kwon, 2011). Therefore, in order to ensure that important clinical aspects of surgical wound characteristics are assessed, the four principle elements of the TIME framework (Leaper et al., 2012) were adapted and incorporated into the Surgical Wound Care Algorithm framework to guide the assessment of clinical features of surgical wounds (Figure 4. 2) in this study. The rationale for this decision is; first, it is generally agreed that the use of regular wound assessment carried out consistently and with the same techniques, such as using the same four elements of the TIME framework each time, is significantly better than no guideline for wound assessment (Schultz et al., 2005). Second, research shows that using the TIME framework can make significant improvements to wound care practice (Dowsett, 2009) and improve acute wound care management (Schultz et al., 2005). Finally, it is widely recognised as a useful practice tool for wound assessment, and it also results in significant improvements in wound care (Cornforth, 2013; Dowsett, 2009). As a result, TIME was incorporated into the Surgical Wound Care Algorithm Framework to design a final framework to guide the selection of which elements would be included in the surgical wound assessment tool.
Chapter 4: Conceptual Framework 65 Therefore, in order to achieve the purpose of this study, a modified version of the Surgical Wound Care Algorithm framework combined with the TIME framework was developed to provide the final framework used to guide this study in the development of a surgical wound assessment tool (see Figure 4.2).
In the modified version of the Surgical Wound Care Algorithm framework, some aspects not relevant to the purpose of this research were omitted, such as disease progress, critical patients, or the degree of infection and immune function (white blood cell, and C-reactive protein), because the purpose of this study was to focus on general patients who had undergone surgery, rather than critically ill patients. In addition, due to the study’s focus on the development of a surgical wound assessment tool, only those factors that have shown a significant impact on the healing of surgical wounds were included in the modified version. Risk factors found to be associated with impaired surgical wound healing were added into the modified Surgical Wound Care Algorithm framework, including the type of surgical wound classification (clean, clean-contaminated, contaminated and infected wounds), operative time, smoking, stress/depression, nutrition, dressing types, and cleaning agents.
The final modified version of the Surgical Wound Care Algorithm and the TIME framework contains four major elements that should be taken into consideration for assessment of acute surgical wounds, including:
Surgical wound characteristics (Bates-Jensen & Woolfolk, 2012; Schultz et al., 2003)
Tissue: assessing surrounding tissue and colour of the incision.
Infection/inflammation: assessing pain, odour, pus.
Moisture balance: assessing exudate amount and type.
Edge/epithelial resurfacing of the incision.
Patient factors: age, gender, BMI, smoking, stress/depression, and nutrition.
Disease factors: Diabetes mellitus, infectious disease (HIV/AIDS), and drug use (steroids chemotherapeutic drugs).
Surgical factors: operative time, surgical wound classification, dressing type, and cleaning agents.
66 Chapter 4: Conceptual Framework
Figure 4.2: Modified version of Surgical Wound Care Algorithm Framework (Han & Choi-Kwon, 2011) combined with the TIME framework (Leaper et al., 2012) for surgical wound assessment
Chapter 4: Conceptual Framework 67 4.3 CHAPTER SUMMARY
This chapter provided a review of the common concepts related to wound assessment cited in the literature. Further, the three most common frameworks that were considered to be close to the purpose of this study were outlined to identify the most appropriate elements for the current study. These were the MEASURE framework (Sibbald et al., 2007), the TIME framework (Leaper et al., 2012), and the Surgical Wound Care Algorithm Framework (Han & Choi-Kwon, 2011).
There are strengths and limitations of each framework. The MEASURE and TIME frameworks are considered practical tools for basic wound assessment, while the limitation of these frameworks is that they focus only on the wound itself and do not include the holistic and systematic evaluation of patients and their healing environments. However, the new version of the TIME framework addresses this drawback and includes patient-centered concerns and promotes a holistic approach to patients with chronic wounds (Leaper et al., 2012). Regarding the Surgical Wound Care Algorithms framework, this is the only framework that has been identified for surgical wound care assessment and management. The strength of this framework is in the description of the relationships between the wound characteristics, patient factors, disease, treatment factors, and the recovery of surgical wounds.
Therefore, the modified Surgical Wound Care Algorithm framework and the TIME framework were combined and adapted to form a framework that guided the development of the surgical assessment tool for this study. In the new modified version of the framework, only the factors identified as having a significant impact on the healing of post-operative wounds were included.
Before describing the process of developing the surgical wound assessment tool for use in Vietnam in the following chapters, the research approach and current practices of surgical wound assessment and documentation in Vietnam are explored in the next chapter.
68 Chapter 4: Conceptual Framework Chapter 5: Study One - Exploratory Study
5.1 INTRODUCTION
The review of the literature discussed in Chapter 2 and Chapter 3 indicated a significant gap in the tools available to assess surgical wounds and highlighted a need for a tool to guide surgical wound assessment. Even though there is some evidence of surgical wound assessment and documentation in current practice in some countries (Cook, 2011; Gillespie, Chaboyer, Allen et al., 2014; Kennedy & Arundel, 1998), no evidence was found about current surgical wound assessment and documentation in Vietnam. Therefore, prior to developing a practical surgical wound assessment tool for use in Vietnam, this exploratory study was undertaken to identify the current practices in surgical wound assessment and documentation in Vietnam.
The objectives were to:
Identify the key components of surgical wound assessment that nurses could collect when conducting a surgical wound assessment (Study 1A).
Explore Vietnamese nurses’ perceptions of current practice in surgical wound assessment and their requirements from a surgical wound assessment tool (Study 1A).
Determine the extent to which surgical wound assessment documentation in Vietnam meets international guidelines (Study 1B).
In order to achieve these objectives, the following questions guided the research:
1. What data do nurses collect while undertaking the process of assessing surgical wounds? (Study 1A)
2. What are nurses’ perceptions of current practices for surgical wound assessment? (Study 1A)
3. What do nurses require from a surgical wound assessment tool? (Study 1A)
4. How does the current surgical wound assessment documentation in Vietnam compare to international evidence-based guidelines? (Study 1B)
Chapter 5: Study One - Exploratory Study 69 This chapter is divided into two sections. The first section (Study 1A) discusses the method and results of the study on current practices of surgical wound assessment, and the following section (Study 1B) presents the method and results of the study on current surgical wound assessment documentation.
5.2 STUDY 1A: SURGICAL WOUND ASSESSMENT
To understand the current practices of surgical wound assessment in Vietnam, this study sought to gain an insight to identify the components of wound assessment that nurses collect while undertaking surgical wound assessment and to then explore nurses’ perceptions of current practice for surgical wound assessment and their requirements from a surgical wound assessment tool. By understanding the current practice of surgical wound assessment in Vietnam and the requirements for a surgical wound assessment tool, the aim was to develop a surgical wound assessment tool to meet nurses’ needs and enhance patient care.
5.2.1 Research design The research design for Study 1A was a qualitative descriptive design to explore current surgical wound assessment among Vietnamese nurses.
5.2.2 Method An exploratory study using a combination of the think aloud technique (Newell & Simon, 1972) and semi-structured interviews was undertaken to gain a deep understanding of the phenomenon. Qualitative methods are often used to obtain factual information, to learn the respondent’s definition of a given situation, or for the evaluation of a healthcare encounter (Gill, Stewart, Treasure, & Chadwick, 2008; Waltz, Strickland, & Lenz, 2010a).
The think aloud technique was applied to identify what information nurses collect while engaged in the process of surgical wound assessment. This technique involves asking people to verbalise their thinking while performing tasks or solving problems (Lundgren-Laine & Salantera, 2010). It is considered a straightforward method to gain insights into the knowledge of human decision making, and problem- solving (Van Someren, Barnard, & Sandberg, 1994). In nursing practice, patient assessment has been described as the first step of the nursing process, which includes gathering and organising patient data or information into categories that are linked
70 Chapter 5: Study One - Exploratory Study together through clinical reasoning to determine the patient’s status and needs (Levett- Jones et al., 2010). It has been advised that the think aloud method is an efficient way to access the cognitive processes used in clinical reasoning and indicate what information is being concentrated on at the time (Simmons, Lanuza, Fonteyn, Hicks, & Holm, 2003). Consequently, the think aloud technique was used to describe the cognitive process used by surgical nurses during the assessment of surgical wounds with the purpose of determining what information nurses collect while assessing surgical wounds.
Regarding exploring nurses’ views of surgical wound assessment and their needs for a surgical wound assessment tool, an interview was deemed an appropriate methodology. There are three basic types of research interviews: structured, semi- structured, and unstructured. On the one hand, structured interviews are a set of specific questions with little or no variation, and limited interviewer responses, and therefore, of little use if “depth” is required (Gill et al., 2008; Tappen, 2011). Unstructured interviews yield “in-depth” information, but are often time-consuming and can be difficult to manage, especially with a new researcher. Thus, this approach is only considered when significant “in-depth” information is required (Gill et al., 2008). On the other hand, the semi-structured interviews approach is used most frequently in healthcare (Gill et al., 2008). This method consists of several key questions that help to define the area to be explored, allows free responses from the participant, and provides the interviewer with more opportunities to explore for clarification or ask for a more in-depth response (Gill et al., 2008; Tappen, 2011). It is also used when the researcher cannot predict all possible responses but wants to keep responses focused on a specific topic (Tappen, 2011). As a result, the semi-structured format was considered the most appropriate approach to guide the interview, with the purpose of obtaining an understanding of nurses’ perceptions of current practices of surgical wound assessment and their requirements from a surgical wound assessment tool.
5.2.3 Setting The research was conducted at Haiduong General Hospital. This hospital is known as the largest government hospital in the Haiduong Province, with 23 wards and 1,000 beds, integrating medical treatment, healthcare service, training, and research. Within the hospital, there are four different surgical wards, with a total 300
Chapter 5: Study One - Exploratory Study 71 beds for inpatients and approximately 600-800 emergency and elective operations are undertaken per month. As such, this site provided the researcher with an extensive sample. Resource limitations, regarding time and budget, were also taken into account when selecting the study setting; it was not within the scope of this PhD study to conduct the study across the whole country. An attempt was made to achieve a diverse sample. A convenience sample of a provincial hospital, where prior relationships had been established, was therefore chosen as the setting for this study.
5.2.4 Sample Qualitative approaches guide researchers to consider several factors when selecting participants. One of the first considerations is the number of participants who will be interviewed. The number of participants should be sufficient in variation to be able to gather a wide range of experiences to understand how and why people perceive, reflect, interpret, and interact (Bowden & Green, 2005). However, the sample must not be too large that it might lead to difficulties in data management. Thus, one of the best strategies is to gather data until empirical saturation is reached (Baker & Edwards, 2012; Bowden & Green, 2005; Polit & Beck, 2006b). Therefore, nurses who met the inclusion criteria at each surgical ward were recruited, and the PhD student used the principle of saturation, which means discontinuing interviewing when no new information was raised.
Another consideration in determining the selection of participants is participant characteristics. They should have experience with the phenomenon being studied and be able to articulate their experience (Bowden & Green, 2005). Participants in this study were therefore selected using the following criteria: (a) those who worked in surgical wards; (b) graduated from 2, 3, and 4 year nursing programs; (c) had at least 12 months experience in surgical nursing; and (d) were able to communicate in Vietnamese.
5.2.5 Procedure and data management 5.2.5.1 Instrument A scenario with a photograph of a patient with a surgical wound and the semi- structured questions for the interviews were developed based on the Standards of Wound Management guideline (Wounds Australia, 2016), and the literature review. It has been recommended that several aspects should be taken into consideration during
72 Chapter 5: Study One - Exploratory Study the development of interview questions, which include: being sure the wording accurately conveys the meaning intended; keeping the sentences, phrases, or questions short; using simple terms that can be understood by the least educated respondent; avoiding questions with multiple ideas; and not asking questions in ways that suggest an answer (Waltz et al., 2010a). Therefore, a scenario and semi-structured questions were reviewed several times by experts in the research team to ensure the right meaning for each question, and minor revisions were made. Three main areas were targeted through the interview: surgical wound assessment, risk factors related to delayed wound healing, and surgical wound assessment tools (see Appendix B).
Once the central questions were designed, appropriate follow-up questions and clarification questions were determined to encourage the participants to expand their experience. Tappen (2011) suggested that these questions should be neutral questions, such as "Can you tell me more about that?", or, “Can you give me some example…?”. The interviewer may need to clarify what the participants have already mentioned by asking "What did you mean when you said…?”.
Before beginning the data collection, pilot-testing of the interview was carried out. According to Waltz et al. (2010a), several issues should be considered when undertaking pilot-test interviews, which include: selecting individuals with characteristics and experiences like those for whom the interview is designed, and conducting the pilot interview in a setting similar to that in which the interview will ultimately be carried out to assess the barriers and facilitators that might be inherent in the setting. Therefore, two nurse teachers who worked part-time at the surgical ward in Haiduong General Hospital were invited for a pilot interview, with the purpose of detecting problems with the wording of instructions and questions, as well as determining the time involved.
5.2.5.2 Procedures Nurses at each of the four wards were recruited using the following procedures. First, the head nurse of each ward introduced the researcher to their staff during the morning shift meeting, and the researcher then gave a 10-minute presentation about the rationale, aims, and procedures of the study to the nursing staff. Nurses who met the inclusion criteria were then given the information sheet and given time to read it and make a decision about whether or not to participate. After two days, the researcher returned to the ward to answer questions and approach potential participants. People
Chapter 5: Study One - Exploratory Study 73 who consented were provided with the researcher’s contact details and negotiated a date, time, and location for the interview.
The individual interviews between nurses and the PhD student were then held privately in the head nurse’s room to be as convenient as possible for participants. At the beginning of the interview, the researcher provided a brief orientation explaining the purpose of the study, subject of the interview, recording the interview, and the right to decline to answer questions. Participants were invited to sign consent forms after an opportunity to ask further questions.
Each interview took about 40-60 minutes, and included two sections: the think aloud technique and the semi-structured interview. The first section was the think aloud technique, when the participant was asked to talk aloud about what they would assess for a patient with surgical wounds based on the scenario (See Appendix B). While participants were working on the task, the researcher was only listening. Interference only occurred when the subject stopped talking. The researcher only prompted the subject by saying: “Keep on talking” (Van Someren et al., 1994). After finishing the think aloud section, in the second section, nurses were then asked questions using a semi-structured interview to promote a discussion about general surgical wound assessment, the risk factors associated with surgical wound healing, and the surgical wound assessment tool (See Appendix B). The think aloud and interview sections were recorded, and notes were made by the PhD student for each interview.
5.2.6 Data analysis Data from the think aloud section and semi-structured taped interviews were transcribed verbatim by the PhD student. Transcription was carried out progressively as each interview was completed. The advantage of this was that having conducted the interviews, the researcher was able to contextualise discussions that were unclear on the recordings and deduce the correct words. This also provided the researcher with the opportunity to become very familiar with the data to assist in the analysis, as recommended by Huberman and Miles (2002).
There are various methods for qualitative data analysis, such as qualitative content analysis, thematic analysis, and discourse analysis (J. Green & Thorogood, 2009; Polit & Beck, 2006b). Verbal protocol analysis is the most frequently used
74 Chapter 5: Study One - Exploratory Study method to explore the decision-making process for the data from think aloud techniques (Fonteyn, Kuipers, & Grobe, 1993; Van Someren et al., 1994). However, as analysis progressed, it became clear that verbal protocol analysis was not the best approach to answer the research question because the aim of this study was focused on key components of wound assessment that nurses collected rather than identifying the nurses’ decision-making process. The complexity of the concepts and their linkages was deemed to be better examined through qualitative content analysis. Therefore, in accordance with Elo and Kyngäs (2008), a qualitative content analysis was considered an appropriate method for the analysis of the qualitative data from the think aloud technique and the semi-structured interviews for the following reasons: (1) content analysis was well-suited to analyse the multifaceted, important, and content- sensitive phenomena of nursing, as well as offering flexibility in terms of research design (Elo & Kyngäs, 2008; Schreier, 2012); and (2) it has been suggested that if one is conducting an exploratory study in an area where not much information is known, qualitative content analysis may be suitable for the simple reporting of common issues mentioned in the data or describing meaning in the context (J. Green & Thorogood, 2009; Schreier, 2012). In this study, both data from the think aloud section and the interview were the content of interest. Therefore, qualitative content analysis was considered an appropriate method for analysing the interview. The process of the content analysis presented by Elo and Kyngäs (2008) allowed precise, logical steps, and it therefore suited the unstudied phenomenon.
Elo and Kyngäs (2008) proposed a step by step approach for guiding analysis. There are two approaches for data analysis: deductive and inductive content analysis. On the one hand, deductive content analysis is applied when the structure of analysis is operationalised by previous knowledge, and the purpose of the study is testing categories, concepts, models, or hypotheses (Elo & Kyngäs, 2008). On the other hand, if there is not enough previous knowledge about the phenomenon, or if this knowledge is fragmented, the inductive approach is recommended, and the categories are derived from the data in the inductive content analysis (Elo & Kyngäs, 2008). Thus, for this study, the data from think aloud section and the interview were analysed by using inductive qualitative content analysis.
According to Elo and Kyngäs (2008), there are three phases when conducting an inductive content analysis: preparation, organising, and reporting. Regarding the
Chapter 5: Study One - Exploratory Study 75 preparation phase, data were read and reread several times to catch the meaning of the interviews, and the statements of participants were then divided into meaning units. This included all words, nouns, phrases, sentences, or even the portion of pages related to surgical wound assessment. Each of the responses was read with the aim of highlighting exact words, phrases, or ideas that captured units of information phenomena.
The process of the organising phase included open coding, creating categories, and abstraction. Open coding means that notes and headings are written in the text while reading it (Elo & Kyngäs, 2008). In open coding, analysts immerse themselves in the data through line-by-line analysis and coding the data in as many ways as possible (D. Walker & Myrick, 2006). In this study, each data segment was reread through, coded, and the code entered on the left-hand margin opposite the transcribed interview to describe all aspects of the content. The headings were collected from the margins onto coding sheets, and sub-categories were freely generated at this stage, as shown in Table 5.1.
Table 5.1: Line-by-line coding example
Transcription Open coding “On the patient with an incision, we need to assess whether a wound has swelling and erythema or Swelling, erythema not and there is any tension surrounding sutures or Tension surrounding sutures not?” (Participant 06) “Besides looking after the incision, we need to Stress reduce stress for the patient.” (Participant 08) “Stress is a factor leading to the debilitation of the Stress is factor body.” (Participant 08) “This results in slower wound healing” Slower wound healing (Participant 08)
After open coding, the lists of sub-categories were grouped under higher order headings. Grouping data aimed to reduce the number of sub-categories. Sub-categories with similar events and incidents were then grouped into categories to provide a means of describing the phenomenon. An example below is provided in Figure 5.1 below:
76 Chapter 5: Study One - Exploratory Study Open coding Sub-categories Categories Swelling, erythema Peri-wound skin Tension surrounding sutures Purulent exudate Type of exudate Characteristics of surgical wounds Heavy exudate Volume of exudate Stress Diabetes Patient factors Risk factors
Figure 5.1: Coding example
Each category was named using content-characteristics words. Finally, abstraction formulated a general description of the research topic by generating categories (Elo & Kyngäs, 2008). To increase the rigour of the data analysis, the identified categories and sub-categories in the two transcripts were discussed with the two other researchers in the research team and further refined. Once the two researchers had agreed with the categories and subcategories, the PhD student analysed the remaining transcripts according to the categories and subcategories identified, and if what arose, these were then discussed until agreement was reached.
5.2.7 Ethical considerations Ethical approval was obtained from the Queensland University of Technology Human Research Ethics committee (N0 1600000367), and the acceptance letter for data collection from Haiduong General Hospital before the data collection (see Appendices C and D).
The main ethical issue was maintaining the anonymity of the interviewed participants and ensuring that each participant was fully aware of their rights and the purpose and implication of the study. Before conducting the interviews, participants received a written and verbal explanation. Participants were informed that their consent could be withdrawn at any time during the study. The researcher removed names and other identifying information to prevent (as far as possible) identification of study participants.
5.2.8 Results This section presents the findings of the think aloud section and semi-structured interviews. First, the demographics and clinical characteristics of the participants are described. The findings are then presented to address the following objectives of this
Chapter 5: Study One - Exploratory Study 77 study: 1) the components of surgical wound assessment nurses collect while undertaking the process of surgical wound assessment; 2) nurses’ perceptions of current practices of surgical wound assessment and their requirements from a surgical wound assessment tool.
5.2.8.1 Demographic characteristics Thirteen participants (nine female, four male), who ranged in age from 25-59 years (median =31 years) were recruited for the study. Over half of the participants had graduated from a 4-year nursing program (bachelor degree), while nurses who completed 2-year and 3-year nursing programs accounted for nearly 25% respectively. The median of years’ experience in nursing was nine (range from 2-35), and the median of surgical experience was eight years (range from 2-35) (Table 5.2).
Table 5.2: Surgical nurses’ demographic characteristics (n=13)
Demographic Values Frequency (%) characteristics Gender Male 4 (30.8) Female 9 (69.2) 2-year nursing program 3 (23.1) Qualification 3-year nursing program 3 (23.1) 4-year nursing program 7 (53.8) Median Range Age (years) 31 25-59 Years’ experience in nursing(years) 9 2-35 Surgical experience (years) 8 2-35
5.2.8.2 Components of surgical wound assessment nurses collect while undertaking surgical wound assessment There were two separate data sources: the think aloud data and semi-structured interview data. The purpose of presenting separate findings from the think aloud and semi-structured interview data is to compare similar and different information about the key components of surgical wound assessment that nurses considered while undertaking wound assessment.
Two categories emerged from the think aloud data and the interview data: “clinical surgical wound characteristics”, which related to the clinical characteristics of the surgical wound itself, and “risk factors associated with delayed surgical wound
78 Chapter 5: Study One - Exploratory Study healing”, which related to factors influencing the healing process. The categories and sub-categories are presented below and summarised in Table 5.3.
Table 5.3: Categories resulting from the think aloud technique and the interviews on surgical wound assessment (n=13 nurses)
The number of
statements Categories
Sub- Think Interview Description/keywords Categories aloud (n=105) (n=119) Clinical surgical wound characteristics Wound site The location of the wound 1 5
Wound Wound surface area including length by 1 4 measurement width by depth Wound edge The external margin or rim of the wound. 8 7
Peri-wound The skin surrounding the incision. 9 9 skin Wound bed Visible tissue at the base of the wound 4 3
Colour or type The fluid that is excreted from the wound 5 2 of exudate bed Volume of Amount of fluid 13 11 exudate Signs of Areas of bogginess upon palpation 0 1 haematoma Odour Unpleasant smell 0 2
Wound pain The unpleasant physical sensation caused 2 3 by a wound Signs of Purulent exudate, odour, erythema, 12 10 infection warmth, tenderness
Risk factors associated delayed surgical wound healing Patient and Advanced age 5 3 treatment Drinking alcohol 10 1 factors Smoking 8 1
Mental wellbeing: physical, social, 9 2 psychological, and spiritual factors.
Chapter 5: Study One - Exploratory Study 79 The number of
statements Categories
Sub- Think Interview Description/keywords Categories aloud (n=105) (n=119) Nutrition: the intake of food that the body 10 11 needs Co-morbidity (e.g., diabetes, 12 9 hypertension): have one or more other diseases or conditions. Medication history: using drugs for 1 2 treating a chronic condition Immune deficiency: Failure of the 1 2 immune system to protect the body adequately from infection Surgical Surgical duration: the length of time for 1 0 procedures surgical operation factors Causes for undertaking surgery 3 5 The surgical wound on site of the old scar 1 0 Suture materials: absorbable and non- 1 0 absorbable materials The wound Surrounding environment: wound-related 1 4 healing equipment, facilities, temperature environment The individual’s lifestyle and hygiene 0 4 factors Individual Healthcare professional knowledge and 1 3 knowledge and skills skills factors Patient’s knowledge: the understanding of 0 1 their health condition
5.2.8.2.1 Clinical surgical wound characteristics The first category was formed by 11 subcategories associated with the characteristics of surgical wounds, as shown in Table 5.3. There were some similar findings between the think aloud data based on the scenario and the interview data. The first similarity was the common wound components that nurses collected during their assessment. Out of 11 subcategories associated with clinical characteristics of the surgical wound, the assessment of wound edge, peri-wound skin, the volume of
80 Chapter 5: Study One - Exploratory Study exudate, and signs of infection were frequently mentioned during nurses’ assessments. However, measuring the volume of exudate was most frequently repeated by nurses. Nurses emphasised wounds with heavy exudate, and immediately proposed interventions, “in this case of heavy exudate, we should cut alternate sutures to eliminate [the] exudate, which is kept inside the incision” (Participant 10).
Another nurse suggested, “the incision still has heavy exudate and has not reduced the amount of exudate…. this patient should have a culture and sensitivity test to find which type of antibiotics suits the patient” (Participant 02).
“Signs of surgical site infection” is another aspect that the nurses assessed during their assessment. Classic symptoms such as swelling, erythema, and increased exudate were assessed to identify signs of infection. For instance, one nurse stated the following:
by looking at the photo, we can see [a] patient with the (sic) poor condition. There is erythema, [and] swelling in the surrounding tissue and suture line. It is also necrotic and exudates in the wound bed. It can be concluded that it is [an] infected surgical wound. (Participant 08)
Another made a similar comment:
[we] need to monitor whether a patient is having any signs of infection, such as swelling, erythema, or sometimes we need to inspect gently under [the] incision line to examine for any purulent exudate to report to [the] doctors (Participant 05)
Other surgical wound characteristics nurses assessed were “peri-wound skin”, and “wound edges”. Skin conditions were mentioned in assessing surrounding tissue such as erythema, swelling and tension at sutures line. One nurse indicated that, “looking at the wound, I can see swelling, erythema, and tension surrounding [the] incision and sutures”. (Participant 12)
By observing photos in the scenario, nurses also directly stated that the wound edges could predict wound healing, “I guess that the incision edges were not approximated. This may result in a big scar” (Participant 03).
On the other hand, the second similar finding between the think aloud section and the interview was that the remaining seven subcategories of clinical surgical wound characteristics were infrequently or rarely collected by nurses during their
Chapter 5: Study One - Exploratory Study 81 assessment. These included wound site, wound dimension, wound bed, colour or type of exudate, signs of haematoma, odour, and wound pain.
Data from this analysis demonstrated that nurses were aware of the clinical characteristics of the surgical wound, but did not frequently assess all aspects of the wound during their assessment. This may lead to vital omission of information required to provide appropriate wound care management.
5.2.8.2.2 Risk factors associated with surgical wound healing The second category from the think aloud section and interview data was risk factors associated with surgical wound healing. This category comprised four sub- categories: patient and treatment factors, surgical procedure factors, wound healing environment factors, and individual knowledge and skills factors. The findings are presented in Table 5.3.
Patient and treatment factors were more likely to be the focus of a nurse’s assessment. Notably, nutritional status and co-morbidities (specifically diabetes) were frequently mentioned while undertaking wound assessment. Nurses emphasised the role of nutrition in wound healing “even though I just graduated from the two-year nursing program, I understood (sic) that the wound would (sic) heal faster if patients are provided with enough protein and rich nutritional foods”. (Participant 12)
In addition to concern about nutrition, nearly all nurses identified co-morbidities as a risk factor for delayed wound healing “[a] patient with [a] co-morbidity condition, such as diabetes or heart diseases, will affect the healing of the wound” (Participant 10).
However, there were significantly different findings between the results from the think aloud section and the interviews regarding the patient and treatment factors sub- category. On the one hand, in the think aloud based scenario, around 10 out of 13 nurses described drinking alcohol, smoking, and mental wellbeing as factors that were highly likely to delay surgical wound healing, as follows, “[the] possibility of wound healing in this patient will be slow due to current smoking and drinking alcohol” (Participant 03).
Another nurse also underlined the impact of mental wellbeing on the process of surgical wound healing:
82 Chapter 5: Study One - Exploratory Study besides looking after the incision, we need to reduce stress and sleep disorder for the patient. A patient suffering from stress and sleep disturbance is a factor leading to the debilitation of the body. This results in slower wound healing (Participant 08).
On the other hand, these three factors (drinking, smoking, and mental wellbeing) were not frequently identified during the interviews. Only a few nurses (n=2) described these three factors as affecting wound healing. This implies that nurses are more likely to evaluate risk factors if these factors are highlighted in the scenario, because without the topic being mentioned, nurses were more likely to forget to assess them.
Regarding the remaining three subcategories: surgical procedure factors, environmental factors, and individual knowledge and skills factors, only a few nurses described those components as risk factors associated with delayed surgical wound healing in both the think aloud section and interview data. One of the nurses explained the importance of evaluating the cause of surgery:
Of course, we must consider other factors related to wound healing, such as [the] causes of undertaking surgery to predict the process of wound healing. For example, a burn will heal faster if it is resulting (sic) from hot water compared to being generated by chemicals… a patient with an open fracture will have a high risk of infection leading [them to] heal poorly compared to those with a closed fracture (Participant 02).
Another nurse, concerned about the wound healing environment in the Vietnamese hospital, identified these environmental risk factors for spreading infection and impacting wound healing “due to the hospital environment, patients with infected wounds share a room with patients without infection. This may lead to [a] high risk of cross contaminates, or antibiotic resistance” (Participant 04).
Few nurses (n=3) described individual knowledge and skills as factors that should be assessed during wound assessment. One nurse said that the nurse’s knowledge and skills influence wound healing, “[it] depends on [the] nurse’s skills and knowledge [in] undertaking a wound assessment, we can know whether the nurses make decisions on [the] dressing process correctly or not” (Participant 08).
By using two different methods (think aloud scenario and semi-structured interviews) to identify the key components of surgical wound assessment that nurses
Chapter 5: Study One - Exploratory Study 83 collect during their wound assessment, the findings from think aloud scenario and the semi-interview confirmed that there are limited wound assessment components that nurses collect during their assessments. These four components associated with clinical characteristics of the wound, such as wound edge, peri-wound skin, the volume of exudate, and signs of infection, as well as two risk factors including nutrition and co-morbidity were the most frequent assessed by nurses. Other wound characteristics and factors associated with delayed wound healing were focussed on less while nurses were undertaking their assessment. However, while smoking, drinking, and mental wellbeing were frequently described as factors associated with wound healing by nearly 77% of nurses during the think aloud section, only a few nurses (15%) said that those factors affected wound healing when asked about surgical wound assessment in the interview. This difference may be due to smoking, drinking, and mental wellbeing factors being highlighted in the scenario. If these factors are not mentioned on the assessment form, nurses are more likely to forget to assess them. Using structured wound assessment approaches may therefore be essential to reduce the omission of important information and guide nurses to a comprehensive wound assessment.
5.2.8.3 Nurses’ perceptions of current practices for surgical wound assessment In the context of nurses’ perceptions of current practices for surgical wound assessment, three main categories emerged: an inadequate systematic approach to wound assessment, lack of standard guidelines, and the need for the implementation of a more structured wound assessment approach. In the first category, eight nurses described their methods of undertaking surgical wound assessment, which were based on previous knowledge, observation, and their own clinical experience. One nurse emphasised their assessment method during their time working at surgical unit:
Over 10 years of working at the surgical ward, evaluation of wounds is only based on the theory that I learned from my medical school, there is not any tool to guide us as to what and how to assess a wound. (Participant 08).
Other nurses expressed the basis of their wound assessment method undertaken during their wound care routine, “now everyone assessing an incision is only basing it on observation, without using any standard guideline” (Participant 02).
Another nurse made a similar comment, “We assess a surgical wound almost based on our experiences” (Participant 04).
84 Chapter 5: Study One - Exploratory Study The second category was linked to statements about the lack of standard guidelines to guide nurses during their wound assessment. One of the nurses identified insufficient resources supporting their wound assessment “we only have the checklist of wound dressing procedures, we do not have any guidelines for wound assessment” (Participant 3).
Another nurse also said that they lacked a standard guideline, even at the national hospital level during their continued training after graduation:
I was training at Bach Mai Hospital (the largest national hospital in the north of Vietnam), and the hospital also has only documentation for sterile procedures and they have not had (sic) wound assessment procedures yet, so assessment of a wound is just based on nurses’ skills and experiences (Participant 10).
However, nurses expressed that the implementation of a more structured approach in their clinical setting would be positive. Nearly all of the nurses in the interviews (n=12) expressed the possibility of the implementation of a surgical wound assessment tool. There were some benefits that nurses described if they were to use a standard tool to guide their assessment.
One of the nurses linked the appropriate wound assessment and wound care plan in the following statement:
by using the same standard tool, everyone will know precisely what he or she needs to assess. Even someone who does not (sic) know about wound assessment before; now they will know the minimal criteria according to the tool that they need for assessing a surgical wound, and through doing assessment, we can provide an appropriate wound care intervention (Participant 02).
Other nurses expressed the possibility of the implementation of an assessment tool compared to traditional wound care management “I think it would not take too much time. Following the tool, it will be quicker than traditional assessment and records” (Participant 03).
Whereas, one nurse did not think that using the more structured wound assessment approach was suitable in the current clinical setting. The nurses commented, “In my opinion, it is hard to use the tool for all patients, because each
Chapter 5: Study One - Exploratory Study 85 patient will have a different condition; for example, [an] incision in the abdomen is different from an incision in [the] legs” (Participant 04).
The findings from these interviews suggest that there is an inadequate approach to wound assessment and a lack of standard guidelines, resulting in the requirement for a more appropriate wound assessment approach to assist nurses in their wound assessment. The following section presents nurses’ identified requirements from a surgical wound assessment tool that would be suitable within their current working situation.
5.2.8.4 Nurses’ requirements from a surgical wound assessment tool Four categories emerged from the interviews describing nurses’ requirements from a surgical wound assessment tool: meeting international and national standards, comprehensive but concise, understandable, and user-friendly, and a scoring system.
In the first category, it is important to note that the process of developing a surgical wound assessment tool is not only ensuring the validity and reliability of a tool, but also meeting international standards. However, only one nurse considered this criterion to be essential for developing a tool, and said, “it would be better if the tool can meet international standards and national standards” (Participant 01).
However, in the second category of “comprehensive and concise”, over half of the nurses (n=8) emphasised the requirement for the concise and logical structure of a tool. One of the nurses described their needs associated with essential information on tool items as follows, “items in the tool need to contain all-important information” (Participant 01).
Other nurses were concerned about the structure of the tool, “I want to have a tool with short and logical content assessment” (Participant 02).
Another made a similar comment:
the structure of the tool needs to be logical, convenient for the evaluation process; for example, items should be designed based on examination skills from observation, palpation, percussion, to auscultation, otherwise an illogical structure may lead to difficulties to fill out information during wound assessment (Participant 08).
The third category was “understandable and user-friendly”, and nearly half the nurses stated that they wanted a tool that was easy to use. One of the nurses said:
86 Chapter 5: Study One - Exploratory Study I do not have any specific criteria for a standard tool, but [if] you are a person who develops a tool, you need to build a tool [that is] easy to use and [where it is] easy to identify items in the tool to avoid missing or leave out information (Participant 03).
The last category was linked to statements about the scoring system. Eight nurses indicated using a scoring system was a convenience for their assessment, as well as being easy to indicate the status of the surgical wound. For example, one nurse stated that the benefit of using a scoring system was not only easy for themselves, but also made it easy to cooperate with other healthcare professionals “it would be better if the tool has a scoring system, because when reporting [the] score even [the] doctors [will] also know the condition of the incision” (Participant 02).
Similarly, another nurse linked the score with the wound care intervention plan:
I think it is better if the tool is designed with a score such as 5, 10, or 15 and the score can [be] use[d] as an indicator of the wound status. Also, for example, if the score ranges from 1-5, what is the wound care intervention plan? (Participant 12).
However, two nurses expressed their preference for using colour instead of using a scoring system. One of the nurses stated:
I think that using a colour system is more precise than a scoring system. For example, darker colour for severe swelling, and a lighter colour for less swelling …. The score is complicated, and I like colour more” (Participant 06).
The results from the nurses’ perspectives on wound assessment tool provided information about important criteria when developing a tool for practical use in the Vietnamese healthcare setting. In the following section, the main findings of this section are discussed within the context of current literature.
5.2.9 Study 1A Discussion This section presents a discussion of the findings following each of the three research questions, which address: (1) the components of surgical wound assessment nurses collect when conducting a surgical wound assessment; (2) nurse’s perceptions of current practice in surgical wound assessment, and (3) their requirements from a surgical wound assessment tool.
Chapter 5: Study One - Exploratory Study 87 5.2.9.1 Components of surgical wound assessment nurses collect when conducting a surgical wound assessment. This study identified two primary wound components that nurses mentioned during their assessment, including surgical wound characteristics and the risk factors associated with delayed surgical wound healing. The first category was associated with the clinical surgical wound characteristics and revealed that the volume of exudate, signs of infection, peri-wound skin, and wound edge were most frequency assessed by nurses while undertaking an assessment. These components may be essential to note when looking for changes in a surgical wound. This corresponds with Bates-Jensen and Woolfolk (2012), who also described some of these wound components, such as incision edge, surrounding tissue, and type and amount of exudate as expected outcomes to measure the process of surgical wound healing.
The findings are also somewhat consistent with the recommendations from evidence-based practice guidelines (WUWHS, 2016b; Wounds Australia, 2016). However, this study also indicated that less information regarding baseline wound status was obtained during wound assessment, such as wound site, wound dimension, wound bed, colour or type of exudate, signs of haematoma, odour, and wound pain. This is inconsistent with findings from Pokorná and Leaper (2015), who conducted an extensive study of 77 inpatient medical facilities with chronic wounds in the Czech Republic. The authors demonstrated that the evaluation of basic/fundamental parameters of a wound, such as size and location, peri-wound skin, and wound bed were the most commonly evaluated compared with the evaluation of more specific parameters (e.g., exudate or signs of infection) (Pokorná & Leaper, 2015). The possible explanation for these differing results may be due to the different focus between chronic and acute wounds, research design (qualitative and quantitative research designs), and instruments (survey and think aloud scenario) used to measure nurses’ practices about wound assessment.
The second category was the risk factors associated with surgical wound healing. Even when nurses were aware of these risk factors, they were not frequently assessed, with the exception of the assessment of nutritional status and co-morbidities. Interestingly, while smoking is a substantial risk factor associated with postoperative wound complications (see Section 2.3.2), only one nurse in the interview discussion identified it as an essential factor they needed to assess. The reason for not considering
88 Chapter 5: Study One - Exploratory Study smoking as a risk factor for wound healing may be due to the high prevalence of smoking in health professionals themselves (Dao, Nguyen, & Dao, 2008); thus, there may be familiarity with the habit of smoking in patients. In addition, findings from the think aloud process and interviews highlighted that nurses were more likely to assess risk factors and characteristics of surgical wounds if they were presented in an assessment form. These findings correlate to other current research, which showed that the application of a standard assessment form, such as a chart, tool, or checklist was associated with increased detection of potential safety hazards, decreased surgical complications, and improved communication among operating staff (Rodella et al., 2018; Treadwell, Lucas, & Tsou, 2014). Therefore, using a structured wound assessment approach may be beneficial for Vietnamese nurses to overcome the omission of essential information about wounds.
Inadequate surgical wound assessment among Vietnamese nurses may reflect a lack of knowledge and skill about wound assessment due to insufficient preparation in their nursing program (see Section 3.4), a lack of nurses with higher qualifications (e.g., wound care specialists) (WHO, 2013), and/or nurses’ lack of knowledge and skills in implementing evidence-based practice (T. N. Nguyen & Wilson, 2016). This is consistent with data obtained in a recent worldwide systematic review on nurses’ knowledge and skills on wound management, which suggested that nurses do not always have sufficient knowledge to provide an appropriate assessment of wounds and optimal care to promote wound healing (Welsh, 2018). Even in a situation where a nurse’s knowledge was sufficient, the application of knowledge in the clinical setting was still poor. For example, Gillespie, Chaboyer, Allen et al. (2014) found that despite having good theoretical knowledge of wound assessment, Australian nurses working in the acute sector demonstrated similar poor links between knowledge and practice and an inadequate application of clinical guidelines. Similarly, it has been suggested that a higher level of wound care education is a positive attitude to evidence-based practice, which subsequently results in better wound care practice (Dugdall & Watson, 2009). Therefore, improving knowledge and attitudes about evidence-based wound care practice may be closely linked to behavioural practice change.
Chapter 5: Study One - Exploratory Study 89 5.2.9.2 Nurse’s perceptions of the current practice of surgical wound assessment and their requirements from a surgical wound assessment tool This is the first qualitative study to explore nurse’s perceptions of current practices for surgical wound assessment in Vietnam. This study found several issues in relation to surgical wound assessment in Vietnam, including the inadequate approach to surgical wound assessment and a lack of standard guidelines. The most commonly reported method of assessing surgical wounds was a combination of observation and clinical experience. These results match the observations in an earlier study conducted among 20 district nurses in one healthcare trust that indicated that there are no standard guidelines or tools to assist nurses in undertaking their wound assessment (Kennedy & Arundel, 1998). This view corresponds to findings from de Faria et al. (2016), who found that 70.9% of interviewed nurses reported that there were no wound care guidelines or standards in their areas of practice, and 18.2% said they did not know they existed. The assessment of wounds without using a standard wound assessment guideline is likely to be subjective, inaccurate, and inconsistent, resulting in making it difficult to maintain continuity of care in a hospital setting when one patient is looked after by many different health care professionals (Dowsett, 2009).
However, in some cases, even when standards or guidelines are available, research shows a low rate of wound assessment completion. For instance, 73% of delegates who responded to a survey during the wound assessment zone at Wound Expo 2011 indicated that they did not regularly use a tool for assessment (Cook, 2011), only 41.4% of a wound assessment tool was fully completed when examining 200 patient records in one Australian hospital (Gillespie, Chaboyer, Kang et al., 2014), and 50.4% of nurses reported they were unaware of national guidelines in another study conducted in Australia (Gillespie, Chaboyer, Allen et al., 2014). However, most of these studies used a quantitative research design. Therefore, qualitative research should be undertaken to gain an understanding of the barriers to implementing a wound assessment tool in clinical practice.
Even though the current practice of surgical wound assessment was inadequate in this study in Vietnam, in the interview, 12 nurses expressed that a positive outcome would result from the implementation of a standardised wound assessment tool that could enhance nurses’ assessment ability and improve patient outcomes. These results are in accord with an earlier study, indicating that 80% of nurses agreed that the
90 Chapter 5: Study One - Exploratory Study implementation of a standard wound assessment chart could enhance practice (Kennedy & Arundel, 1998).
As a result, nurses’ expectations about a surgical wound assessment tool (SWAT) were taken into consideration when developing the SWAT to facilitate the implementation of the SWAT into the Vietnamese health care system in the future. Nurses’ expectations included: meeting the international and national standards, being comprehensive but concise, user-friendly, and containing a scoring system. These findings are somewhat consistent with a study conducted by Greatrex-White and Moxey (2013). The authors reviewed the international nursing literature to determine what nurses required in a wound assessment tool and which components of an optimal wound assessment tool it should contain. The findings indicated that nurses’ needs for optimal wound assessment included detailed characteristics of the wound (e.g., wound location, wound size, tissue type, exudate, peri-skin, pain, and signs of infection), patients’ details, documentation, communication and continuity of care, ease of use, planning care, monitoring of the healing process, and guiding practice. However, in the context of Vietnam, overcrowding in central and specialised hospitals is a considerable issue (World Health Organization and the Ministry of Health, 2012). A small number of nursing staff are a responsible for a large number of patients (P. S. Jones et al., 2000), resulting in less time spent with each patient. As such, a surgical wound assessment tool that is comprehensive but concise, easy to use, and has a scoring system is a critical aspect of the successful implementation of the tool into clinical practice.
In conclusion, data from nurses in this study suggested incomplete surgical wound assessment. If a nurse was able to recognise the primary symptoms of delayed healing, early intervention could be undertaken. In current practice, nurses were not using any standard tools for the evaluation status of a surgical wound and one of the main reasons for this was the lack of unified guidelines for the evaluation of surgical wounds in clinical practice at the national level. The outcomes of this study found that the development of a surgical wound assessment tool with comprehensive content, precise terms that are user-friendly, and with an easy to calculate score to determine the status of a surgical wound may be practical for use in Vietnam to improve care outcomes for all patients with surgical wounds. The following section discusses the
Chapter 5: Study One - Exploratory Study 91 research methods and results for Study 1B, which was undertaken to determine the current level of surgical wound assessment documentation in Vietnam.
5.3 STUDY 1B: SURGICAL WOUND ASSESSMENT DOCUMENTATION
5.3.1 Research design The study was a retrospective, cross-sectional descriptive study of current surgical wound assessment documentation practice.
5.3.2 Method A retrospective chart audit was undertaken to identify the current level of surgical wound documentation in Vietnam. A clinical audit is a process that aims to improve patient care and outcomes through a systematic review of care against explicit criteria, and the implementation of change (Copeland, 2005). It can also be used to confirm that current practice meets the expected level of performance (Quality and Patient Safety Directorate, 2013). There are concurrent and retrospective audits. A concurrent audit is carried out while treatment/care is being provided. However, the downside of this approach is that time is required for collecting the data, and there is a potential for bias through awareness that an audit is ongoing (Copeland, 2005). On the other hand, a retrospective audit is undertaken after the completion of treatment/care to service users. Thus, the data may be gathered quickly, as it already exists, and the possibility of identifying all service users meeting the inclusion criteria may be increased (Potter, Fuller, & Ferris, 2010). As a result, a retrospective chart audit was used in this study. By reviewing patients’ documentation through a chart audit, the findings of this study provided valuable information about how surgical wound assessment in Vietnam was recorded prior to implementing a systematic method for recording surgical wound assessment in the Vietnamese context. Haiduong General Hospital was also selected as the site for this data collection.
5.3.3 Sample size A clinical audit is not research. It is about evaluating compliance with standards rather than generating new knowledge. Thus, the sample sizes are often a compromise between the statistical validity of the results and pragmatic issues around data collection (Quality and Patient Safety Directorate, 2013). It has been recommended that approximately 40 sets of notes can provide a view of the care within a healthcare setting, but ideally, the sample should be more (Potter et al., 2010). However, it is
92 Chapter 5: Study One - Exploratory Study essential to gain a balance at the numbers required to provide an unbiased picture of care (Potter et al., 2010). It has also been proposed that a time frame of one to three months should be adequate for the majority of audits (Copeland, 2005). As a result, the audit for this study was undertaken for three months, from the 1st of February to the 30th of April, 2016, and a total of 200 charts from four different surgical wards at Haiduong General Hospital were randomly selected following criteria to provide a perspective of surgical wound documentation in the hospital in Vietnam.
Inclusion criteria:
All patients who underwent elective or emergency surgery from the 1st February to the 30th April, 2016.
Exclusion criteria:
Patients who had endoscopic procedures not involving a surgical incision.
Patients who had wounds related to donor sites, skin grafts, and pin sites.
Patients admitted with chronic wounds (a chronic wound refers to a wound that has not healed within a four to six week period) (Mekkes, Loots, Van Der Wal, & Bos, 2003).
5.3.4 Procedure and data management 5.3.4.1 Instrument A clinical audit tool was developed based on a literature review and best practice guidelines for wound assessment and management. According to a practical guide to clinical audits developed by the Quality and Patient Safety Directorate published in 2013, identifying the standards and audit criteria against which the audit will be conducted is an essential process of a clinical audit. It has been suggested that standards that are being selected should be “robust” and evidence-based (Potter et al., 2010). The recommendation of choosing valuable sources for standards include evidence-based guidelines, national clinical guidelines, standards and clinical guidelines from relevant quality and safety programmes, or clinical guideline development organisations, such as NICE and SIGN (Quality and Patient Safety Directorate, 2013). Therefore, the Standards for Wound Management developed by Wounds Australia (2016) was specifically selected for this audit, as it was collected from the best evidence, a consensus of opinions sought from expert wound clinicians,
Chapter 5: Study One - Exploratory Study 93 and transparent criteria for achieving standards. During the development of the chart audit instrument, the two researchers in the research team reviewed and provided feedback, and minor revisions were made.
The final version of the audit instrument contained four parts, with 30 questions related to general data, patient clinical details, patient-related factors to wound healing, and surgical wound assessment (see Appendix E). The first part included general data, such as the admission date, discharge date, and type of admission. The second part contained patient clinical details, including age, gender, type of surgery performed, duration of surgery, and the date of operation. Section three contained patient-related factors about wound healing, including the evidence-based assessment of current co- morbidities, wound history, nutrition status, psychosocial factors, medication use, and allergy assessment. The last part was the surgical wound assessment, which included incision location, wound dimensions, the clinical characteristics of the wound bed, wound edge appearance, exudate, odour, pain, signs and symptoms of a surgical site infection, and wound drainage. In this study, the signs and symptoms of the surgical site infection were defined based on criteria developed by the Centers for Disease Control and Prevention (2016).
5.3.4.2 Procedures A random sample of 200 medical records of patients who underwent elective and emergency surgery was undertaken over a three-month period from the 1st of February to the 30th of April, 2016. The process for the selection of the 200 charts is described below:
Step 1: All charts meeting the inclusion criteria were selected (see Section 5.3.2)
Step 2: A stratified sampling technique was used to allocate the number of charts for each ward. The number of charts for each ward was selected based on the average number of patients undergoing surgery in each ward:
Surgical 1 (orthopaedics): 40% of 200 charts.
Surgical 2 (abdominal surgery focusing on the liver, stomach.): 30% of 200 charts.
Surgical 3 (urology surgery): 15% of 200 charts.
94 Chapter 5: Study One - Exploratory Study Surgical 4 (cardiothoracic surgery): 15% of 200 charts.
Step 3: A simple random sampling technique was used to select charts for each surgical ward by assigning a sequential number to each surgical ward, and then using a random number table technique to select the sample for each surgical ward. The total number of charts meeting the inclusion criteria of each ward determined through the simple random selection was 80 charts for Surgical 1, 60 charts for Surgical 2, and 30 charts for Surgical 3 and Surgical 4.
Patients’ names and date of birth were not recorded. The audit tool included an audit ID using a unique identifier, and a separate piece of paper, or “code sheet” was then kept that linked each unique identifier to the patient’s hospital number. Without this list, data collection forms could not be linked to specific patients.
5.3.5 Data analysis The purpose of data analysis in a chart audit is to compare actual practice and performance against the agreed standards to identify whether or not performance levels have been reached, and as a result, simple, clear, and concise analyses are required for an audit (Quality and Patient Safety Directorate, 2013). Descriptive statistics were therefore analysed using IBM SPSS version 23.0 (IBM Corp. Armonk, NY) for all variables to describe the demographics and clinical data. Where appropriate, bar graphs are used to present the results.
5.3.6 Results This section presents the findings of the chart audit. First, the demographics and clinical characteristics of the participants are described. The findings are then introduced to address the following objective of this study: To what extent does surgical wound assessment documentation in Vietnam meet standard guidelines?
5.3.6.1 Demographic characteristics A total of 576 operations were undertaken during the three months of the audit, in which 329 charts met the inclusion criteria. Two-hundred medical records were randomly selected to review. The median age of the audited inpatients was 48 years, and 66.5% were male. Most participants underwent elective surgery, accounting for 62.5%. The median hospital stay was 11 days, with a pre-operative period of two days.
Chapter 5: Study One - Exploratory Study 95 The median number of different nurses undertaking preoperative assessment was three (Table 5.4).
Table 5.4: Demographic characteristics of patients (n=200)
Demographic Values Frequency n (%) characteristics Gender Male 133 (66.5) Female 67 (33.5) Type of surgery performed Orthopaedics 87 (43.5) Abdominal 57 (28.5) Urology 30 (15.0) Cardiothoracic 26 (13.0) Surgery performed Elective 125 (62.5) Emergency 75 (37.5) Median (Range) Age (years) 48 (2-89) Hospital length of stay 11 (2-49) Preoperative period 2 (0-23) Number of different nurses do preoperative assessment 3 (1-14)
5.3.6.2 Audit of preoperative wound documentation Before the operation, charts were reviewed to identify the documented patient risk factors associated with a delay in surgical wound healing after surgery. Figure 5.2 shows the frequency of patient factors documented before the operation by nurses upon patient admission to the surgical units. Even though the median of pre-operative hospital stay was two days and the median of different nurses recording patient’s assessment was three nurses, less than 10% of pre-operative factors (such as co- morbidities, smoking, and nutrition status) related to the risk of delayed surgical wound healing were documented, with the exception of allergy assessments, which were recorded in over 87.5% of charts.
96 Chapter 5: Study One - Exploratory Study 100 87.5% 90 80 70 60 Documented 50
40 Percentage 30 20 8% 7% 10 6% 1% 3% 0% 0
Figure 5.2: Documentation of patient factors related to surgical wound healing recorded before an operation
5.3.6.3 Audit of surgical wound assessment documented during the first five days post-operation. Table 5.5 (below) shows the frequency of surgical wound characteristics documented by nurses on the first five postoperative days. As shown in Table 5.5, incision location, wound dimension, wound bed (in wounds healing by secondary intention), or odour were not documented in any charts. Similarly, less than 10% of information about type or colour of exudate was documented during the five days after surgery. The highest percentage of surgical wound aspects documented were swelling (peri-skin) and pain documentation during the first five postoperative days, which accounted for 30% and 41.5%, respectively. However, interestingly, while the type or colour of exudate was less frequently documented, the volume of exudate was frequently documented in around 90% of charts. Similarly, with the volume of exudate, signs of infection (particularly temperature) were recorded on all charts.
Chapter 5: Study One - Exploratory Study 97 Table 5.5: Surgical wound characteristics documentation during first five post- operative days
Day of operation Day 1 Day 2 Day 3 Day 4 Day 5 (n=200) (n=191) (n=173) (n=155) (n=141) Surgical wound n(%) n(%) n(%) n(%) n(%) characteristics Location 0 0 0 0 0
Dimension 0 0 0 0 0
Wound bed (in wounds with 0 0 0 0 0 secondary intention)
Peri-wound skin (swelling) 29 (14.5) 47 (24.6) 49 (28.3) 35 (22.7) 30 (21.3)
Volume of exudate 187 175 152 145 128 (93.5) (91.6) (87.9) (93.5) (90.8) Type or colour of exudate 18(9) 12(6.3) 3(1.7) 5(3.2) 3(2.1)
Odour 0 0 0 0 0
Pain 83 (41.5) 57 (29.8) 36 (20.8) 21 (13.5) 18 (12.8)
Temperature 100 (100) 100 (100) 100 (100) 100 (100) 100 (100)
5.3.7 Study 1B Discussion The objective of this study was to describe the current practice of surgical wound assessment documentation by nurses, using a chart audit of an acute hospital in Vietnam. To the best of the researcher’s knowledge, this study is the first to examine surgical wound assessment documentation; thus, providing a baseline for further research in this area. Documentation is an important communication strategy for all health professionals to record and monitor the wound’s healing progress (Ding, Lin, Marshall, & Gillespie, 2017). However, the results of this study suggest that surgical wound assessment documentation in Vietnam does not meet the Standards for Wound Management (Wounds Australia, 2016). There was a significant shortfall in surgical wound assessment documentation in patients’ charts, specifically wound edge, wound bed, peri-wound skin, or signs of infection. Some documentation included the volume
98 Chapter 5: Study One - Exploratory Study of exudate, but failed to mention the risk factors, wound healing process, or signs of wound infection. This is somewhat concerning given that signs of surgical wound infection, such as pain or tenderness, redness, swelling, wound incision, and healing status are important indicators for diagnosing SSI (Centers for Disease Control and Prevention, 2016). It appears that in this acute hospital, documentation in patients’ charts lacked specificity and standardisation in terms of what information is important to document in medical records. The justification for surgical wound management decisions is therefore unclear.
The findings are similar to previous studies where incomplete or omitted documentation has also been described. For example, in 2014, a cross-sectional prospective study conducted in an acute tertiary hospital in Australia found that less than a quarter (23.3%) of wound care events were recorded on both wound assessment charts and patient’s progress notes (Ding et al., 2017). Inadequate surgical wound assessment documentation has also been demonstrated in other studies (Danielsson- Ojala et al., 2010; Gartlan et al., 2010; Gillespie, Chaboyer, Kang, et al., 2014; L. N. Smith & Lait, 1996). It is acknowledged that documentation is the foundation for protecting nurses’ legal status, reflecting the tasks that have been completed, and the patient care performed. It is also necessary for the nursing profession to confirm their contribution to patient care, and nursing documentation can be used as evidence to show the outcomes of nursing care (Sondergaard, Lorentzen, Sorensen, & Frederiksen, 2017). A nursing contribution that has not been documented remains invisible (Tiusanen, Junttila, Leinonen, & Salantera, 2010). Therefore, the findings of this surgical wound assessment documentation study raise doubts about the validity of a wound care management plan without a complete and well-documented assessment to justify them.
There is research supporting the use of a wound healing assessment chart or tool that allows wound care documentation to be more efficient and easier to use (Saunders & Rowley, 2006; Shepard & Nixon, 2013). For example, using a tool has improved record-keeping, especially in some wound assessment areas that are often poorly recorded, such as wound location, type of wound, and the factors delaying healing (Shepard & Nixon, 2013). Charts/tools also support the professional reflection of nurses’ tasks and provide for more consistent documentation and influence the overall results of the surgical pathway (Yontz, Zinn, & Schumacher, 2015), as well as
Chapter 5: Study One - Exploratory Study 99 providing other benefits, such as acting as a teaching tool (Saunders & Rowley, 2006). However, a lack of time and insufficient knowledge about how and what to record are significant factors that constrain adequate documentation (Ehrenberg, 2001). Therefore, the design of any documentation tool must be adapted to specific clinical practice, cover several aspects, be easy to enter the crucial data, and possibly, allow for simultaneous documentation (Sondergaard et al., 2017). If the tool does not meet the expectations and requirements, or is not adapted to current practice, this will lead to a reduced focus on documentation, resulting in incomplete and inaccurate documentation (Sondergaard et al., 2017). Emphasising the importance of comprehensive and complete assessment and documentation may be essential to enhance the quality of patient care.
5.4 STRENGTHS AND LIMITATIONS OF STUDY ONE
There are some strengths and limitations of Study One that must be acknowledged. Regarding the strengths, first, to the best of the researcher’s knowledge, this is the first study undertaken in Vietnam to provide a unique insight into current wound assessment practices. This research utilised a combination of the think aloud technique, semi-structured interviews, and a chart audit to gain insights into the current practices for wound assessment and documentation in Vietnam. The findings from this study contribute to a comprehensive description of wound care practice in Vietnam, as well as providing a solid foundation for the development of the SWAT. Second, the findings of this study also create new priority research areas in Vietnam: contemporary nursing practice and nursing care in Vietnam, research on implementing evidence-based practice guidelines into practice, and research on the context of developing countries adopting evidence-based guidelines.
However, Study One also has some limitations that should be noted when interpreting the study findings. First, the method used in the qualitative study may have some limitations. All transcripts were transcribed and coded by the PhD candidate. However, care was taken to ensure the reliability and validity by involving two other researchers from the research team to check the process of analysis. Second, this study may contain some limitations that may affect the generalisability of the results because participants were recruited from one of the biggest provincial hospitals in the north of Vietnam. Generalisation to other parts of Vietnam therefore needs to be made with caution due to cultural and geographic differences. Finally, barriers of conducting
100 Chapter 5: Study One - Exploratory Study surgical wound assessment and factors constraining adequate nursing documentations were not explored in this study to provide a comprehensive picture of current wound assessment and documentation in Vietnam. Future investigations of these areas are therefore recommended.
5.5 CHAPTER SUMMARY
In conclusion, the findings from Study One indicate that surgical wound assessment and documentation in this sample in Vietnam was inadequate. There is currently no standard wound assessment guideline to guide nurses in an accurate and holistic assessment, and there is no systematic recording of wound assessment information. This suggested that a more structured wound assessment tool should be developed to assist nurses to perform comprehensive wound assessment and to enhance the quality of systematically recorded wound assessment information. However, the development of a practical surgical wound assessment tool suitable for the Vietnamese context required the consideration of several aspects to meet nurses’ expectations, including meeting international standards that it is comprehensive yet concise, understandable and easy to use, and contains a scoring system. The process of development of a surgical wound assessment tool for use in Vietnam is presented in the following chapters.
Chapter 5: Study One - Exploratory Study 101 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool
6.1 INTRODUCTION
As reported in the previous chapters, surgical wound assessment and documentation in Vietnam were explored and no standard guidelines were found to guide nurses for assessment. Nurses used a combination of observation and experience to evaluate wound status, leading to inadequate performance of wound assessment and documentation. Thus, it was determined that a structured surgical wound assessment approach is required to improve nurses’ assessment ability resulting in appropriate wound care management. The process of developing the surgical wound assessment tool to use in Vietnam involved two phases (see Figure 6.1). This chapter presents Phase One of the surgical wound assessment tool development process, which includes the preparation of the initial surgical wound assessment tool (SWAT) and consultation with Vietnamese surgeons on content validity of the SWAT.
6.2 OBJECTIVES AND RESEARCH QUESTIONS
The objective of Study Two (Phase One) was to develop a surgical wound assessment tool for use in Vietnam. In order to achieve the objective, the following questions guided the phases of the research, including:
1. Which components/factors identified from a review of the literature could be incorporated into a surgical wound assessment tool that is practical and easily used by Vietnamese nurses?
2. What is the content validity of the new developed surgical wound assessment tool as evaluated by Vietnamese surgeons? 3. What additional elements would Vietnamese surgeons recommend for inclusion in a surgical wound assessment tool?
102 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool
Figure 6.1: The process for the development of the surgical wound assessment tool for Study Two
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 103 6.3 PHASE ONE: DEVELOPMENT OF INITIAL SURGICAL WOUND ASSESSMENT TOOL
6.3.1 Development of SWAT items The initial surgical wound assessment tool was developed based on different resources. These included the most current evidence-based practice guidelines: the Best Practice Recommendations for the Prevention and Management of Surgical Wound Complications (Canadian Association of Wound Care, 2017) and the standards set by the Australian Standards for Wound Management (Wounds Australia, 2016). These two evidence-based practice guidelines were specifically selected for the development of SWAT because they were collected from best evidence, feature a consensus from expert wound clinicians, and provide clear criteria for wound assessment. The second resource was a comprehensive literature review. This included the modified version of the Surgical Wound Care Algorithm framework (Han & Choi- Kwon, 2011) combined with the TIME framework (Leaper et al., 2012) to guide the development of items and domains of the SWAT (see Section 4.2.3), and a literature review of the risk factors related to surgical wound complications and delayed surgical wounds (see Section 2.3.2). The final resource was advice from wound experts in the research team.
According to the modified Surgical Wound Care algorithm combined with the TIME framework (see Section 4.2.3), the SWAT was divided into three domains, including patient and disease factors influencing surgical healing, surgical procedure factors associated with surgical wound healing, and surgical wound characteristics. After developing the three domains, the main items in each domain were developed based on the Best Practice Recommendations for the Prevention and Management of Surgical Wound Complication (Canadian Association of Wound Care, 2017), and the standards set in the Australian Standards for Wound Management (Wounds Australia, 2016). In the patient and disease risk factors domain, seven items were included: age, body mass index, diabetes, smoking, steroid use, chemotherapy, and nutritional status. The second domain was surgical procedure risk factors and this included three items: surgical wound classification, emergency surgery, and duration of surgery. The last domain was clinical surgical wound assessment, which included 12 items associated with clinical surgical wound characteristics (Wounds Australia, 2016). Due to the need for a practical SWAT to facilitate nurses’ duties in a clinical setting, risk factors such
104 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool as hygiene of the surrounding environment and wound related equipment, level of oxygenation of the tissues, size, and virulence of the microbial inoculums, that did not demonstrate a strong impact on surgical wound healing in the literature and were not feasible to measure were excluded from inclusion in the initial SWAT. The details about the items included in each domain are presented in Table 6.1.
Table 6.1: Items of the initial SWAT
Items Patient and disease factors for delayed wound healing2 Item #1: Age1,2 Item #2: BMI1,2 Item #3: Diabetes (any type of diabetes)1,2 Item #4: Smoking status1,2 Item #5: Steroids (current use)2 Item #6: Chemotherapy (current, use)2 Item #7: Nutritional status1,2,3 Surgical procedure factors for delayed wound healing2 Item #8: Surgical wound contamination classification1,2 Item #9: Emergency surgery1 Item #10: Duration of surgery1,2 Clinical surgical wound assessment items2 Item #11: Wound location1: ………. Item #12: Wound dimensions1 Item #13: Incision edges1,2 Item #14: Wound bed1,2 Item #15: Swelling1,2 Item #16: Erythema1,2 Item #17: Haematoma formation3 Item #18: Maceration1 Item #19: Colour and type of exudate1,2 Item #20: Volume of exudate1,2 Item #21: Odour 1 Item #22: Wound pain (numeric scale 0-10)1 1: Evidence-based practice guidelines (Canadian Association of Wound Care, 2017; Wounds Australia, 2016); 2: The modified version of Surgical Wound Care Algorithm framework (Han & Choi-Kwon, 2011) combined with the TIME framework (Leaper et al., 2012); 3: Wound experts’ advice
After the main items for each domain were identified, the response options for each item were then developed based on the current literature review and the advice
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 105 of wound experts in the research team. The following section presents the justification for the selected cut-off points for the response options for each item.
6.3.2 Development of item response options The response options for each item were then developed according to the current literature review (see Section 2.3.2 and Section 3.3.1) and the advice from wound experts in the research team. A total of 22 items were included in the initial SWAT, and the following section provides justification for the selected cut-off points for these 12 items. The remainder of the items (10 items) had “Yes” or “No” as their response options.
Regarding age, advanced age is one of the key risk factors for delayed wound healing (Khalil et al., 2015; Tada et al., 2016). However, different studies have used different cut-off points for age to measure the effect of age on surgical wound healing. Following the literature review (Section 2.3.2), age was presented as three groups: 18- 39 years, 40-59 years, and over 60 years. Participants under 18 years were excluded because the SWAT focuses only on adults.
With respect to body mass index (BMI), it was divided into four categories based on the standards recommended by the WHO (1995): less than 18.5 (underweight), 18.5-24.9 (normal range), 25-29.9 (overweight), and over 30 (obese).
In terms of surgical wound classification, this item was classified according to the Centres for Disease Control and Prevention (2016) classification, which includes clean, clean-contaminated, contaminated and dirty, or infected wounds. However, the title was changed to “surgical wound contamination classification” for clearer classification due to comments from wound care experts in the research team.
An additional item that was indicated from the literature and included in the SWAT was wound dimension. If the wound was healing by primary intention, the length of the wound was required to be measured. If the surgical wound was healing by secondary intention, the widest point and the length were to be measured (Association for the Advancement of Wound Care, 2012).
With regard to wound edges, the wounds were divided into different groups from positive to negative outcome measures for incisional wound healing progress according to the description provided by Bates-Jensen and Woolfolk (2012) and wound care experts in the research team. Edges were classified as either well
106 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool approximated, approximated but tension at incision line, not approximated and tension in incision line, and edges not together.
The tissue type of the wound bed was defined as visible tissue at the base of the wound, and used options provided by the World Union of Wound Healing Societies (2016): epithelialising, granulating, sloughy, and necrotic. However, it would be not applicable to assess wound bed on surgical wounds healing by primary intention. Therefore, for this surgical wound assessment tool, wound bed response options were classified with five options instead of four options: incision edges closed, mostly epithelialising, mostly granulating, mostly sloughy, and mostly necrotic.
Regarding swelling and erythema, the response options for these two items were divided into present at the suture line, the surrounding tissue, and both according to the suggestions from wound care experts in the research team.
Colour and type of exudate were also considered necessary to be included in the tool. In accordance with the World Union of Wound Healing Societies (2007), exudate was defined by four categories: (1) none or mostly clear, amber (considered a normal type of exudate), (2) bloodstained (due to the presence of red blood cells and indicating capillary damage), (3) cloudy, milky (may indicate the presence of fibrin strands or infection), and (4) green or yellow (may be indicative of bacterial infection or maybe due to the presence of wound slough or material from an enteric or urinary fistula). Therefore, these four categories of exudate were also used for assessing the colour and type of exudate. They were also used as indicators for determining wound healing from normal to abnormal, as symptoms of wound infection.
In terms of the volume of exudate, response options were described using the amount of exudate on wound dressings as either as dry, moist, wet, and saturated according to the recommendation set by Wounds UK (2013) in their Best Practice Statement. Effective Exudate Management. However, to make it easier for nurses to measure the amount of exudate, it was decided to refine these options slightly as dry (no moisture), moist (less than 50% exudate in primary dressing), wet (50-75% exudate in primary dressing), and saturated (more than 75% exudate in primary dressing and/or leakage to secondary dressing).
With regards to odour, this item was defined as either low (wound odour present after removal of primary dressing), moderate (odour present when removing
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 107 secondary dressing), or high (odour present prior to dressing change and patient aware) according to recommendations set out in the Best Practice Statement. Effective Exudate Management (Wounds UK, 2013).
The final item was wound pain, and the numeric rating scale for pain was chosen to measure wound pain (K. R. Jones, Vojir, Hutt, & Fink, 2007). The reason for choosing the numeric rating scale for pain is that this tool is validated, user-friendly, takes less than one minute to complete and is easy to administer and score (Hawker, Mian, Kendzerska, & French, 2011). Scores range from 0 to 10 with higher scores indicating greater pain intensity; scores were divided into 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain) (K. R. Jones et al., 2007).
After all of the items and their response options were developed, the initial SWAT (Version 1), which is presented in Table 6.2, was sent to groups of surgeons in Vietnam to ask for their feedback about the surgical wound assessment tool. The reason for consultation only with surgeons in this phase included: (1) the need to gather surgeons’ theoretical and practical experiences in Vietnam about a surgical wound assessment tool; and (2) surgeons’ involvement was deemed more likely to aid acceptance of the tool throughout the hospitals in the future because they are the primary decision-makers in Vietnamese healthcare culture (Ng'ang'a et al., 2014). However, surgeons were invited to only provide feedback on the initial SWAT because it was not feasible for surgeons to participate in several Delphi rounds of SWAT development process due to their busy schedules in clinical settings. Moreover, in this phase, nurses were not invited because they were subsequently involved in the Delphi process (Phase Two), which gave them the opportunity for provide input in developing and refining the final version of SWAT. However, before sending the tool to surgeons for feedback, the tool was translated into Vietnamese and back translated.
108 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool Table 6.2: The initial SWAT (Version 1)
Items Response options Item #1: Age (years) - 18-39 - 40-59 - Over 60 - Less than 18 (underweight) Item #2: BMI (kg/m2) - 18.5-24.9 (normal weight) - 25-29.9 (overweight) - Over 30 (Obese) Item #3: Diabetes - No (any type of diabetes) - Yes Item #4: Smoking (currently) - No - Yes Item #5: Steroids (currently use) - No - Yes Item #6: Chemotherapy - No (currently, prescribed) - Yes Item #7: Nutritional status - No (current weight loss or eating - Yes poorly) Item #8: Surgical wound - Clean contamination classification - Clean-contaminated - Contaminated - Dirty/infected Item #9: Emergency surgery - No - Yes Item #10: Duration of surgery - No (greater than 75th percentile of - Yes predicted operating time) Item #11: Wound location …………….. Item #12: Wound measurement Primary Intention - Wound length……cm Secondary Intention - The widest point:…..cm - The wound length:…..cm Item #13: Incision edges - Well approximated - Approximated but tension at incision line - Not approximated - Not approximated, and tension in incision line
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 109 Items Response options - Edges are not together Item #14: Wound bed - Incision edges closed - Mostly epithelialising - Mostly granulating - Mostly sloughy - Mostly necrotic Item #15: Swelling - Suture line - Surrounding tissue - Both Item #16: Erythema - Suture line - Surrounding tissue - Both Item #17: Haematoma formation - No - Yes Item #18: Maceration - No - Yes - None or mostly clear, amber Item #19: Colour of exudate - Mostly bloodstained - Mostly cloudy, milky - Mostly green or yellow Item #20: Volume of exudate - Dry - Moist - Wet - Saturated Item #21: Odour - Low - Moderate - High Item #22: Wound pain - 0 (no pain) (numeric scale 0-10) - 1-3(mild) - 4-6 (moderate) - 7-10(severe) The following section introduces the translation process, and then presents the methods and results from the surgeons’ feedback about the first version of SWAT.
6.3.3 Translation process There are a number of recognised methods for cross-cultural research in the literature, such as the Brislin (1970) model, an adaptation of Brislin’s translation model (P. S. Jones, Lee, Phillips, Zhang, & Jaceldo, 2001), and Guidelines for the Process of Cross-Cultural Adaptation of Self-Report Measures (Beaton, Bombardier, Guillemin,
110 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool & Ferraz, 2000). However, the choice of method was impacted by two factors in particular; the limited time and resources available in the scope of undertaking research for a PhD, and the challenge of finding translators who met the requirements (e.g., a Vietnamese bilingual who was not only excellent in English and Vietnamese languages but also had specific knowledge and familiarity with wound care terminology). Therefore, the process of translation was modified based on an adaptation of Brislin’s translation model developed by P. S. Jones et al. (2001).
First, the PhD candidate translated the initial English SWAT version 1 (SWAT- E-V1) into the Vietnamese language (SWAT-V1). Following this, the SWAT-V1 and the SWAT-E-V1 were sent to a surgeon and a surgical nurse in Vietnam, who were not only excellent in English but also familiar with wound care terminology, to double check the SWAT-V1 by comparing the translated Vietnamese version with the SWAT- E-V1 version. After receiving the surgeon and surgical nurse’s feedback about the SWAT-V1, it was revised and SWAT-V2 was then sent back to the surgeon and nurse. SWAT-V3 was finalised after obtaining agreement between the PhD candidate, nurse, and surgeon. Upon completion of the translation, the SWAT-V3 was then used to rate the importance of the item and item response options of the tool by Vietnamese surgeons.
Due to the SWAT being revised through the process development, only the final SWAT Vietnamese vision was independently back-translated by two bilingual experts who had not seen the original English version. A meeting between the PhD candidate and bilingual experts was organised to compare the original and back-translated versions of the tool. The final version of the Vietnamese surgical wound assessment tool was required to be accepted by all of the people in the meeting.
6.4 PHASE ONE: CONSULTATION WITH SURGEONS
6.4.1 Method Fifteen surgeons across public hospitals in Vietnam were recruited. The panel of surgeons was nominated by president of the Wound Care Management Association in Vietnam, the head nurses of the surgical hospital, and convenience sampling, following the criteria below:
willingness to contribute to the study;
sufficient time to participate in the study;
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 111 a minimum of 5 years practical experience working in the surgical area;
graduated from a postgraduate level in surgery;
able to communicate in either Vietnamese or English.
After potential surgeons were identified, the researcher sent an email to the targeted surgeons, including a link to the consent form and the survey. Before beginning the survey, surgeons were asked to read the participant information sheet and consent form carefully. When surgeons confirmed consent via the online consent form, they then completed the survey. In the survey, they were asked to evaluate the first version of SWAT via Key Survey online. This questionnaire consisted of four sections.
Section (1) involved the evaluation of each surgical wound assessment tool item individually using a 5-point Likert scale (1 = very unimportant, 2 = not important, 3 = neither important nor unimportant, 4 = important, and 5 = very important). Section (2) involved an open-ended question: “In addition to items included in the initial surgical wound assessment tool, what other components do you believe should be included?”. Section (3) included evaluation of each item’s response options by using “agree” or “not agree”. The comment section for each item’s response option was also provided in case they wanted to leave their comments. Section (4) consisted of demographic information such as age, gender, years of surgical experiences, qualifications, professional occupation, and area of work.
Two weeks were given to complete the survey. At the end of the process, data received from each surgeon who completed the online survey was automatically compiled by the Key Survey online system and emailed to the PhD candidate. The research team then revised the tool based on the evaluations from the panel of surgeons about the first version of SWAT.
6.4.2 Data analysis All data from surgeons’ evaluations were entered into SPSS version 23.0 (IBM Corp., Armonk, NY) for analysis. Summary statistics (frequencies, descriptive) were run on the described data.
112 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool The level of content validity of the initial surgical wound assessment tool evaluated by Vietnamese surgeons was examined by calculating the content validity for items (I-CVI) and content validity of the overall scale (S-CVI).
To calculate each item, the CVI was computed using the number of experts giving a rating of 4 or 5 divided by the total number of experts who evaluated the items (Polit & Beck, 2006a). Once a CVI had been determined for each item, an overall CVI was calculated. According to Polit and Beck (2006a), the content validity of the overall scale can be divided into a scale-level content validity index, using a universal agreement calculation method (S-CVI/UA), and scale-level content validity index, using an averaging calculation method (S-CVI/Ave) (Polit & Beck, 2006a).
S-CVI/UA was calculated as the proportion of items on a scale that achieved a rating of 4 or 5 by all the experts, and S-CVI/Ave was calculated as the average of the I-CVIs for all items on the scale. As suggested, a minimum I-CVI of 0.78 for 6 to 10 experts and an SCVI/Ave of 0.90 or higher would be required to achieve excellent content validity (Polit, Beck, & Owen, 2007).
Regarding open-ended questions, the content analysis described by Elo and Kyngäs (2008) was applied to group statements generated by the surgeons and put into similar categories. These qualitative comments were then divided into three main reporting categories. First, any additional comments or suggestions regarding new items that should be included in the tool. Second, all comments or suggestions related to items already listed in the SWAT, and the third group was for other comments that did not fit into the two above categories. Once all the qualitative responses from surgeons were categorised, the quantitative responses were analysed in preparation for the development of the survey instrument for the following phase.
6.4.3 Ethical consideration Study Two was approved by the QUT Human Research Ethics Committee (approval number 1700000125), and the Haiduong Medical Technical University Research Ethics Committee (approval number 01-2017/QD-DHKTYTHD).
6.4.4 Results 6.4.4.1 Surgeon panel characteristics Fifteen surgeons were approached, of whom 10 (71.4%) agreed and completed the survey. The 10 surgeons were recruited from different hospitals across Vietnam,
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 113 including Viet Duc hospital (n=3), Ho Chi Minh Pharmacy Hospital (n=2), Haiduong General Hospital (n=2), 108 Hospital (n=2), and Bach Mai Hospital (n=1). The demographic characteristics of the 10 surgeons are shown in Table 6.3. They were all male, and their ages ranged from 25 to 65 years. Five surgeons (50%) had a doctoral degree in the surgical field, and five surgeons had Masters degree or equivalent. Nearly 40% (4 out of 10) of doctors had more than 25 years’ experience in the surgical area, only three out of 10 surgeons had less than 10 years’ experience in the surgical field. They were all currently working in public hospitals.
Table 6.3: The demographic characteristics of surgeons
Demographic characteristics Values Frequency (n=10) n(%) Gender Male 10 (100) Female 0 Age (years) 25-34 3 (30) 34-44 3 (30) 55-65 4 (40) Doctoral degree or equivalent 5 (50) Highest qualification Masters degree or equivalent 5 (50) Medical doctor degree 0 Surgical experience (years) 5-9 Years 3 (30) 10-14 Years 2 (20) 15-19 Years 1 (10) 20-25 Years 0 More than 25 Years 4 (40) Working place Public hospital 9 (100) Viet Duc hospital 3 (30) Ho Chi Minh Pharmacy 2 (20) Name of hospitals HaiduongHospital General Hospital 2 (20) 108 Hospital 2 (20) Bach Mai Hospital 1 (10) 6.4.4.2 Items rated by surgeons As can be seen in Table 6.4, almost all items were ranked as important or very important, with the exception of six items (smoking, steroid, emergency surgery, wound location, wound dimension and wound pain), which were rated as neutral. No items were ranked as unimportant or very unimportant.
The level of content validity of the initial SWAT was determined as the content validity for items and content validity of the overall scale. First, the content validity for items was calculated. All 22 items on the initial SWAT were considered important to include in the tool (I-CVI >0.78). More specifically, as can be seen in Table 6.4, 17
114 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool out of the 22 items in the initial SWAT had I-CVI scores of 1.00. The other five items had an I-CVI ranging from 0.8 to 0.9 including smoking, steroid use, wound location, wound dimensions, and wound pain.
The overall scale-content validity index was calculated by using the averaging method (S-CVI/Ave), which achieved 0.97, showing excellent content validity, meaning that there was an average of 97% agreement across items. The S-CVI/UA was 0.77. This meant that 17 out of 22 items were rated as important or very important by all 10 surgeons.
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 115 Table 6.4: Importance as items rated by each surgeon (: Important or very important; -: Neutral)
Items Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Experts in Item- 1 2 3 4 5 6 7 8 9 10 Agreement CVI Item # 1: Age Item # 2: BMI Item # 3: Diabetes Item # 4: Smoking Status Item # 5: Steroid use for a chronic disease Item # 6: Chemotherapy Item # 7: Nutritional status Item # 8: Type of surgical wounds Item # 9: Emergency surgery Item # 10: Duration of surgery Item # 11: wound location Item # 12: Wound dimensions Item # 13: incision edges Item # 14: Wound bed Item # 15: Swelling Item # 16: Erythema Item # 17: Hematoma formation Item # 18: Maceration Item # 19: Colour and type of exudate
116 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool Items Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Surgeon Experts in Item- 1 2 3 4 5 6 7 8 9 10 Agreement CVI Item # 20: Volume of exudate Item # 21: Odour Item # 22: Wound pain Proportion S-CVI/UA=0.77 important 1.00 1.00 1.00 1.00 0.91 1.00 0.86 0.95 1.00 1.00 S-CVI/Ave=0.97 Note: : Important or very important; -: Neutral I-CVI: Item-level content validity index S-CVI/UA: Scale-level content validity index using universal agreement calculation method S-CVI/Ave: Scale-level content validity index using averaging calculation method
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 117 6.4.4.3 Additional items recommended by surgeons In the second section of the survey, surgeons were asked an open-ended question “In addition to the items included in the initial surgical wound assessment tool, what other components do you believe should be included?”
Out of 10 experts, nine recommended that additional items should be included in the tool. From these nine surgeons’ recommendations, 23 statements were generated and sorted to identify similar responses. These similar responses were combined, resulting in 20 statements. Of the 20 statements, 11 statements were excluded, including: (1) recommendations that were associated with repeating items already included in the tool (n=4), (2) recommendations that were not written clearly enough to capture the meaning of the statements (n=2), (3) recommendations that were not related to answering the question (n=2), and (4) recommendations that were not practical measures in the tool (n=3). The remaining statements were used to develop an additional eight items:
patient’s temperature;
immune deficiency (e.g., HIV, kidney failure, or infection disease);
surgery on site of old scar (the same site from previous surgery or injury);
pre-operative antibiotic use (for clean-contaminated, contaminated, or infected wounds);
the duration from injury to surgery (hours);
the length of preoperative stay;
type of surgery;
surgical wound cleaning agents.
6.4.4.4 Item response options rated by surgeons In the third part of the survey, the surgeons were asked to agree or not agree with the provided response options for each item in the initial SWAT. A comment section was also provided for each item response option, in case they wanted to make comments. Of the 22 items, 21 item response options were evaluated (the exception was item wound location with free responses). Among these 21 item response options, 100% of surgeons agreed with the response options for three items associated with
118 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool BMI, emergency surgery, and the volume of exudate, without any comments on those item response options. Five items: age, diabetes, wound bed, and the colour and type of exudate, also achieved 100% level of agreement, but there were some comments for refining those item response options. Other item response options that also received high agreement (90%) were smoking, steroid use, chemotherapy, nutritional status, surgical wound contamination classification, swelling, erythema, haematoma formation, odour, and wound pain; however, comments were also provided for revision of those items. Wound dimension and maceration reached 80% of agreement from surgeons. However, interestingly, only three out of 10 experts (30%) agreed with the response options for the surgical duration.
Based on feedback from the surgeons, the initial SWAT was refined and modified. Out of 21 item response options, 12 response options items were revised based on the surgeons ’suggestions, and are presented below.
Regarding the smoking item, the original option for assessment of smoking status was “Yes” or “No”. However, according to surgeons’ suggestions and the literature review (see Section 2.3.2) on the impact of current smoking, past smoking, and no smoking on surgical wound healing and complications, current smoking status was revised into three groups: non-smoker, previously smoked but gave up four weeks before surgery, and current smoker: continued to smoke in the preoperative period.
With regards to steroid use, three surgeons provided comments on this item and recommended that it be made clearer. The literature was reviewed again to define the status of using steroids. According to the definition of the American College of Surgeons National Surgical Quality Improvement Program databases, prolonged steroid users are defined as “patients who required regular administration of oral or parenteral corticosteroid medications in the 30 days before surgery for a chronic medical condition” (Turan et al., 2010, pp. 286). Therefore, current steroid use was revised as regular use of steroids for long-term treatment, in which regular use for long-term treatment was defined as using steroids at least 30 days before surgery. “Yes” or “No” response options remained for this item.
In terms of the chemotherapy use item, two surgeons suggested providing more details regarding the type of chemotherapy use and its duration. However, this was complicated if looking at details of chemical formulae or duration time. Therefore, the item title “chemotherapy currently used” was modified slightly to be currently
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 119 receiving chemotherapy before surgery, because research has shown that receiving chemotherapy before surgery is associated with an increased risk for surgical complications (Gerber et al., 2014). However, the “Yes” or “No” response option remained the same for this item.
As far as nutrition status was concerned, this item also received comments from surgeons. One surgeon recommended assessing nutritional status by measuring the percentage of weight loss, such as reduced weight by 10%, 20% or 30%. Others suggested calculating the total kilocal intake per day. Therefore, to make this item achievable to assess in clinical practice, the nutrition status was defined based on the following questions set in the Mini Nutritional Assessment short-form (Kaiser et al., 2009) as currently has decreased food intake and/or unintentional weight loss over the last three months.
With regards to emergency surgery, the “Yes” or “No” response option was indicated. However, according to surgeons’ recommendation, this item’s response options were revised slightly into three groups: non-emergency, emergency for a pathological condition, and emergency surgery for trauma.
With respect to surgical duration, there was the biggest disagreement (70%) on the response option of this item. All comments from experts were related to the cut- off point time for the surgical duration. Therefore, the response options of the duration of surgery were defined as less than 1 hour, 1 to 3 hours, and over 3 hours according to the surgeons’ suggestions and the literature review (see Section 2.3.2).
According to the recommendation from the surgeons, the items wound dimension, incision edges and wound bed, and surgical wounds were divided into two groups: surgical wound healing by primary intention, and open surgical wounds. The open surgical wound group involved surgical wounds healing by secondary intention and delayed primary intention. The wound dimension and wound bed response options remained the same as the first version; however, there were slight changes in the response option of wound edges for the open surgical wound. It was classified as edges sloping or flat, edges raised or rolled, and undermining present according to the recommendations set in document title Advances in Wound Care: The Triangle of Wound Assessment (WUWHS, 2016b).
120 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool Regarding haematoma formation, only one comment was given about this item. However, this item was still revised to make it easier to measure (based on the comments from experts in the research team). The title of haematoma formation was changed to sign of haematoma formation along with examples for easy identification such as the focused area of swelling, hardness, or bogginess upon palpation, or bruising and painful. However, the response option for this item remained “Yes” or “No”.
With regards to maceration, two surgeons commented and gave suggestions on this item. However, it seems that there was a misunderstanding between maceration and exudate, because two comments referred to assessing the volume of exudate. Therefore, this item was revised, and the definition of maceration was provided to avoid misunderstandings about this item (maceration is defined as the softening and breakdown of the skin resulting from pronged exposure to moisture) (WUWHS, 2016b).
In the case of odour, this item was revised and defined as none, present after removing dress, present before dressing removal, and patient aware based on recommendations from the surgeons and research team members.
The rest of the nine-item response options of the tool remained the same as the first version of SWAT. Regarding the eight additional items recommended by surgeons, the response options for those eight were developed based on a review of the literature to select the cut-off points, which are presented below.
Regarding the item related to patient’s temperature (axillary measure), research shows that a temperature of 37.5°C is associated with a worse outcome and becomes significant at temperatures greater than 38.5 °C (Lee et al., 2012; Ogoina, 2011). Therefore, temperature (measured at the axillary) was classified into three groups: less than 37.5 °C, 37.50c – 38.50c, and greater than 38.5 °C.
In terms of the length of preoperative hospital stay, in its document Global Guidelines for the Prevention of Surgical Site Infection, the WHO (2016b) demonstrated that a preoperative hospital stay of at least two days is a factor associated with an increased risk of surgical site infection. Therefore, the length of preoperative hospital stay was measured as less than two days and greater than two days.
Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool 121 The duration from injury to surgery was another item recommended by the surgeons, and its response option was classified as less than 10 hours, and greater than 10 hours (Nicks, Ayello, Woo, Nitzki-George, & Sibbald, 2010).
In terms of the surgical wound cleaning agent item, surgical wound cleaning agents’ response options were defined as sodium chloride 0.9%, Povidone, Hydrogen peroxide, and other based on the suggestion from a surgeon.
Regarding items related to immune deficiency, surgery on the site of an old scar, and preoperative antibiotic use, “Yes” or “No” options were defined for these items. However, there was a free response for the type of surgery and wound location due to no proposed response options being provided by the respondents.
6.5 CHAPTER SUMMARY
In Phase One of the development of a surgical wound assessment tool for Vietnamese use, 22 items and response options in an initial wound assessment tool were developed based on different primary sources (Version 1). These were evidence- based practice guidelines (Canadian Association of Wound Care, 2017; Wounds Australia, 2016), a literature review associated with the risk factors for delayed surgical wound healing, and advice from wound care experts in the research team. These 22 items and their response options were then sent to groups of surgeons in Vietnam for their evaluation and feedback. The initial surgical wound assessment tool had item-content validity index scores of 1.00 in 17 out of 22 items, and the other five items had an item-content validity index ranging from 0.8 to 0.9. In addition, the overall scale-content validity index was calculated using the averaging method (S- CVI/Ave), which achieved 0.97, showing excellent content validity. In regards to additional items to be included in the tool: eight more items were suggested by surgeons and added into the initial tool. This increased the total items of the tool to 30 items (Version 2). These 30 items and their response options were then sent to surgical nurse wound care experts in Vietnam for their evaluation through the Delphi process. The following chapter (Phase Two) presents the method and results of the Delphi process.
122 Chapter 6: Study Two - Phase One: Development of a Surgical Wound Assessment Tool Chapter 7: Study Two - Phase Two: The Delphi Study
7.1 INTRODUCTION
Conducting a comprehensive wound assessment is the best way to evaluate the status of a wound to ascertain whether the wound is progressing and achieving the desired goal (Wounds Australia, 2016). Several wound assessment tools exist; however, no standard wound assessment tool is used in Vietnam to guide nurses in a holistic wound assessment. In the previous chapter, the initial surgical wound assessment tool was developed based on different sources and through consultation with Vietnamese surgeons. A total of 30 items and their response options were further developed and improved in the second phase. In this chapter, the second phase of Study Two is reported. The study was conducted to invite surgical nurse wound care experts in Vietnam to provide feedback and evaluate the tool through the Delphi process. This chapter describes the study process, its findings, and discusses the main study findings.
7.2 OBJECTIVES AND RESEARCH QUESTIONS
The aim of this second phase was to continue to develop and revise the tool to ensure relevancy to the Vietnamese context through the Delphi process. The elicitation study addressed the following research questions:
1. What is the content validity of the new developed surgical wound assessment tool, as evaluated by Vietnamese surgical nurse wound care experts?
2. What additional elements would Vietnamese surgical nurse wound care experts recommend for inclusion in the surgical wound assessment tool?
7.3 METHOD
7.3.1 Research design This study was undertaken by applying the Delphi method. This method was used to gain consensus among experts to develop items for the surgical wound assessment tool.
Chapter 7: Study Two - Phase Two: The Delphi Study 123
7.3.2 Delphi methods The Delphi method was originally developed by Dalkey and Helmer (1963) and defined as “a method used to obtain the most reliable consensus of a group of experts by a series of intensive questionnaires interspersed with controlled feedback” (p.458). It is a widely applied and recognised method for obtaining convergence of opinion concerning real-world knowledge from experts. It is most beneficial when empirical evidence is lacking (Hsu & Sandford, 2007b). This approach has been widely applied in various fields, such as business, education (R. A. Green, 2014), health research (Cowman et al., 2012; Jorm, 2015; Keeney, Hasson, McKenna, & Wiley, 2011; C. A. Smith et al., 2011), and particularly, in nursing research, as well as in the development of instrument research (Biondo, Nekolaichuk, Stiles, Fainsinger, & Hagen, 2008; Chang, Gardner, Duffield, & Ramis, 2010; Cucolo & Perroca, 2015).
Several different types of Delphi techniques have been recognised, such as “classical Delphi”, “modified Delphi”, “decision Delphi”, and “real time Delphi”, and “e-Delphi” (Keeney et al., 2011). However, depending on the purpose of the study, each type of Delphi technique focuses on different aspects. An example of this is “decision Delphi”, which concentrates on constructing decisions rather than coming to a consensus. Another example is “argument Delphi” in which the process is concentrated on the making of relevant factual arguments, and “real time Delphi”, which requires experts to sit in the same room and reach consensus in real-time rather than by post (Keeney et al., 2011).
However, traditionally, the first round of the Delphi process often commences with an open-ended exploratory questionnaire aimed at eliciting opinions and ideas from the contributors (Day & Bobeva, 2005; Hsu & Sandford, 2007a). Similar, in nature to a “brainstorming” session, this approach is particularly appropriate when a lack of empirical evidence exists to be able to form a conclusive questionnaire. For this reason, it is known as an “exploratory approach” (Day & Bobeva, 2005). After receiving participants’ responses, the researcher needs to transform the collected data into a well-structured questionnaire. This form is then utilised as the survey tool for the round two data collection (Hsu & Sandford, 2007b). From the second round, each Delphi panel member is given the second questionnaire and is requested to evaluate the items summarised by the researchers based on the information provided in the first
124 Chapter 7: Study Two - Phase Two: The Delphi Study rounds, often using a Likert scale (Hsu & Sandford, 2007b; Keeney et al., 2011). The results of round two are then formulated, and the means and standard deviations are calculated for each survey item. A summary of this information and any comments given by panel members is provided as a part of round three, where the members are again asked to rank or rate items on the questionnaire. This process of tabulating, providing comments, and re-rating continues until consensus is achieved or until there is sufficient convergence to justify using the results without complete agreement (Keeney et al., 2011).
In contrast to the traditional Delphi, which employs open-ended questions to gather data in the first round, a modified Delphi method can be applied to manage a structured questionnaire to commence the Delphi method and as the platform for upcoming survey development employed in following iterations (Hsu & Sandford, 2007a). Although there is no comprehensive answer to this issue, it has been suggested that the use of a modified Delphi is an appropriate option if topic information exists (Hsu & Sandford, 2007a). However, others have argued that providing questionnaires to panellists is inappropriate and can possibly lead to bias at the outset (Shields, Silcock, Donegan, & Bell, 1987). In reality, the use of a close-ended, pre-established questionnaire in the first round allows researchers to at least confirm the face and content validity of the instrument before distribution of the first-round package to panel experts. That is, the ability to establish face and content validity in Round One can be considered an essential and necessary methodological improvement for a Delphi study (Hsu & Sandford, 2007a). In support of using the pre-established statements in the first round, a modified Delphi has demonstrated several advantages. First, it saves time when gathering and managing the qualitative statements from the first round responses to develop the survey for the second round. Second, it assures that the researcher includes critical statements that otherwise may have been omitted. Finally, panel members appreciate a completed instrument to which to respond (McCampbell & Stewart, 1992). From the participant’s point of view, if the questions are also easy to respond to and less time-consuming, he/she is more likely to complete and return the survey (Hsu & Sandford, 2007a)
Due to these advantages, for the current study, the modified Delphi method (close-ended) was deemed appropriate. The list of the surgical wound assessment tool items pooled from an extensive review of the literature and consultation with
Chapter 7: Study Two - Phase Two: The Delphi Study 125 Vietnamese surgeons was sent to Vietnamese wound care experts to rank each item. Moreover, in Round One, an open-ended question was also provided to ask the panel to list any additional items that they believed should be included in the tool. The details of the Delphi method are described in the following sections.
7.3.3 The Delphi rounds The number of rounds in a Delphi study is flexible. Theoretically, the Delphi process can be continuously repeated until a consensus is determined to have been reached (Hsu & Sandford, 2007b). This could be two to 10 rounds (Day & Bobeva, 2005). However, it has been suggested that three rounds are often enough to gather the required information and to achieve consensus in most cases (Custer, Scarcella, & Stewart, 1999; Hsu & Sandford, 2007b). As a result, three rounds of the Delphi were applied for this current study.
7.3.4 The panel of experts Expert identification is a primary consideration in using the “Delphi” since deciding on a group of the panel of experts is the first stage in the Delphi process (Keeney et al., 2011). The composition of the panel can affect the results obtained, as well as whether the information achieved reflects current knowledge or perceptions (Goodman, 1987; Keeney et al., 2011). There are different ways to define “experts”. Goodman (1987) described experts as “specialists in their field”, whereas, B. Green, Jones, Hughes, and Williams (1999) used the term “expert” to refer to someone who has knowledge about a particular subject. Due to the principles that experts must have knowledge of the subject area, the fact that Delphi experts cannot be selected randomly must be considered by the researcher (Keeney, Hasson, & McKenna, 2006). Most Delphi studies recruit individuals who have expertise in the subject under investigation (Cowman et al., 2012; Jorm, 2015; C. A. Smith et al., 2011). However, Keeney et al. (2011) argued that individuals who have knowledge of a particular topic are not necessarily experts. In fact, those who are willing to engage are more likely to be directly affected by the outcome of the process and are also more likely to remain involved in the Delphi process. This is because the commitment of participants is related to their interest and their involvement with the issue being addressed (Novakowski & Wellar, 2008). Therefore, a researcher must decide on the criteria for selecting experts before the study commences.
126 Chapter 7: Study Two - Phase Two: The Delphi Study Although there remains no formal criteria or guidance for the selection of experts, some authors have suggested inclusion criteria for selecting experts. For instance, Keeney et al. (2011) and Biondo et al. (2008) suggested a number of criteria such as specific qualifications, the number of publications for an area of expertise, geographical location, years of experience in a particular field, and willingness to contribute to the study. It also recommended that heterogeneous groups from diverse backgrounds would possibly produce more reliable results (Powell, 2003). There are many different sampling techniques to identify expert panels, such as convenience, snowballing, and through literature searches (Skulmoski, Hartman, & Krahn, 2007). Therefore, for this study, panel members (Vietnamese nurse wound care experts across Vietnam) were identified through convenience sampling and recommendations from other recognised experts in the surgical field, such as the president of Vietnamese Wound Care Association, and the head nurse and former head nurse of national surgical hospitals, using the following criteria:
willingness to contribute to the study: sufficient time to participate in the study; a minimum of five years’ practical experience working in the surgical area; graduated from at least a Bachelor’s Degree in Nursing; able to communicate in either Vietnamese or English. 7.3.5 Expert panel size There is no definite recommendation regarding the minimum or a maximum number of experts on a panel required to constitute a representative sample of the Delphi method (Keeney et al., 2006). The size of Delphi panels varies significantly between studies and could be from under 15 (Cucolo & Perroca, 2015; Strasser, London, & Kortenbout, 2005), from 15 to hundreds (Back-Pettersson, Hermansson, Sernert, & Bjorkelund, 2008; Chang et al., 2010; Cowman et al., 2012; C. A. Smith et al., 2011), and thousands of participants (Grundy & Ghazi, 2009). It has been suggested that if the expert panel size of the Delphi study is too small, these participants may be unable to provide a representative pooling of judgments on the targeted issue (Hsu & Sandford, 2007b). In contrast, if the sample size is too large, the downside of the Delphi method is potentially low response rates and the commitment of large blocks of time by the respondents (Hsu & Sandford, 2007b). A number of authors have recommended that the numbers in an expert panel should be between 15-
Chapter 7: Study Two - Phase Two: The Delphi Study 127 30 members from the same discipline (homogeneous population) and 10 to 15 participants if the background of the Delphi is a heterogeneous group of experts (Back- Pettersson et al., 2008; Hsu & Sandford, 2007b; Powell, 2003). However, research shows that there is a high rate of withdrawal from experts through several rounds due to fatigue or distractions between rounds, and the authors believed that withdrawal is most likely to occur after the third round (Donohoe & Needham, 2009). For example, Shelton (2010) illustrated this in her study, where she invited 76 experts to participate in a Delphi study. Among the 76 participants, 44 accepted, and 43 officially commenced the study. However, out of 43, only 26 completed all rounds. This example demonstrates that even though the study started with a high number of participants, the resulting number of experts was within the 15 to 30 range recommended by the literature. Therefore, to reach a minimum number of expert panellists, a minimum of 35 nursing experts in surgical wound care were invited to participate in developing a Vietnamese surgical wound assessment tool.
7.3.6 Level of consensus According to de Villiers, de Villiers, and Kent (2005), achieving consensus “is crucial for the Delphi technique” (pp.639). However, to reach agreement, the classification of consensus must first be understood, and a standard of when consensus has been achieved must be established (Powell, 2003). Unfortunately, it seems that the classification of consensus is somewhat uncertain (Williams & Webb, 1994). In an effort at clarity, several authors have endeavoured to define the concept of consensus. For instance, von der Gracht (2008) determined that consensus is a reflection of the panel’s agreement or disagreement with a statement. However, de Villiers et al. (2005) defined consensus as “a gathering around median response with minimal divergence” (p.639). Other authors have described consensus as a “percentage higher than the average proportion of majority opinion, where majority represents more than 50% of the responses” (von der Gracht, 2012, p. 1530).
The method to decide on the level of agreement varies in the literature, and there are no clear guidelines to establish the consensus (von der Gracht, 2012). Some researchers use a percentage of panel agreement, which ranges from 50% to 80% to determine consensus (Ahmed, McCaffery, & Aslani, 2016; Schulz et al., 2009; Smith et al., 2011). For example, on the one hand, some researchers have indicated that consensus was achieved when 80% of the expert members agreed or disagreed with a
128 Chapter 7: Study Two - Phase Two: The Delphi Study statement (Ahmed et al., 2016; C. A. Smith et al., 2011). On the other hand, other researchers sought 100% expert panel agreement for consensus to be achieved (Williams & Webb, 1994).
In addition to using the percentage of panel agreement, other researchers have determined consensus by dividing responses according to different levels of agreement. For instance, Meskell, Murphy, Shaw, and Casey (2014) established the level of consensus by the categorisation of the panel members’ total responses into a high, moderate, low, or no level of consensus for each statement. The level of consensus was high when the level of agreement among the members achieved 70% or higher, moderate when the agreement reached 60% or higher, and low when the agreement was 50% or greater. When the percentage of responses was less than 50%, no level of consensus occurred (Meskell et al., 2014).
However, other authors have suggested using a combination of different methods to define agreement. Another example was demonstrated by Giannarou and Zervas (2014), who recommended using three measures to assess consensus: (i) interquartile range, (ii) standard deviation, and (iii) 51% percentage of respondents lying in the “highly important” or “strongly agreeing” category (Giannarou & Zervas, 2014). The authors also demonstrated the inadequacy of using one method to determine the level of consensus. In addition, other research has defined consensus regarding descriptive statistics (mean, mode, standard deviation, interquartile range) in conjunction with the percentage of expert panel responses. Shelton (2010) and Burgin (2012) is a typical example of using the combination of the percentage of agreement and descriptive statistical method. They indicated that consensus was achieved when there was a minimum mean score of 4 or above on a Likert scale of 5 and a panel member agreement of 70% or more.
For the current study, consensus was determined as a combination of a mean 3.5 or higher (using a 4-point Likert scale) and panel agreement of at least 70%. This means that this agreement was documented in one of three ways. First, the items and each item response option were accepted into the tool if those items and response options achieved a minimum of 70% of the expert panel agreement and a minimum mean score of 3.5 or above on a 4-point Likert scale. Second, 70% of the expert panel in agreement and a mean score of 2.5 or below on a 4-point Likert scale was used as indicated on the item or item response options that were excluded in the tool. Finally,
Chapter 7: Study Two - Phase Two: The Delphi Study 129 if the items and the item response options achieved less than a 70% agreement, and a mean between 2.5 to 3.5 (on a 4-point Likert scale), those items and those response options were sent back to the expert panel for a re-rank.
7.3.7 Procedure and data management In the present study, three Delphi rounds were conducted. Each round consisted of formulating questions and statements, sending these questionnaires to the experts, performing an analysis of the data received, and writing a feedback report. In each round, Delphi panellists were given two weeks to respond, because it has been suggested that response times of less than one week may not allow participants enough time to complete the round, whereas over two weeks may result in it becoming a low priority and never being completed (Keeney et al., 2011). The following section presents the Delphi process.
7.3.7.1 Invitation to participants At the beginning of the Delphi process, 10 nurses from 10 hospitals across Vietnam, who were identified and recruited through convenience sampling and recommendations from other recognised experts in the surgical area, were asked to recommend their colleagues from different surgical wards at their hospital to participate in the study. A list of 35 nurses was identified. Once a prospective panellist was identified, initial contact was made via email. All nurse experts received an invitation email describing the study (see Appendix F), a participant information sheet, and a formal invitation for the individual to become a member of the panel. In the initial contact, they were also told how they were identified and why they were being approached. Of the 35 nurses, 28 nurses replied and agreed to participate in the Delphi round.
7.3.7.2 Round One To begin Round One, each nurse received the invitation email link to Key Survey that allowed the panellists to access the Round One questionnaire (see Appendix G). Before beginning Round One of the survey process, nurses were asked to read the Delphi participant information sheet and consent form carefully. When nurses confirmed consent via the online consent form, they completed the Round One questionnaire.
130 Chapter 7: Study Two - Phase Two: The Delphi Study There were four sections in the Round One questionnaires (Appendix H). Section (A) involved evaluation of each surgical wound assessment tool item individually by using a 4-point Likert scale (1 = very unimportant, 2 = not important, 3 = important, and 4 = very important). Section (B) included evaluation of each item response by using a 4-point Likert scale (1 = not appropriate, 2 = somewhat appropriate, 3 = quite appropriate, and 4 = highly appropriate). The comment section for each item’s response option was also provided in case they wanted to leave comments. Section (C) involved an open-ended question: “What other components in addition to items included in the initial surgical wound assessment tool do you believe should be included?”. Section (D) consisted of demographic information, such as age, gender, years of surgical experience, qualifications, professional occupation, and area of work. Data received from each participant’s completed online survey was automatically emailed to the researcher.
Reminders are critical between Delphi rounds (Keeney et al., 2011). One week following the first email, a reminder email was sent to any of the experts who had not completed the survey instrument. This email reminded them of the importance of their contribution to the Delphi study and reminded them of the closing date for Round One (Appendix I).
A few days before closing the survey for Round One, an additional reminder email was sent to all of the expert members who had not completed the survey, reminding them of the date that the Round One survey instrument was closing.
After the deadline, it was suggested that the use of telephone or e-mail contacts, in conjunction with a short interval of time between deadlines to directly and promptly communicate with non-respondents would expedite the process of data collection and would ultimately result in a high response rate (Hsu & Sandford, 2007a). Therefore, after the deadline, another email was sent to all participants who had not completed the survey to give them two more days to return their questionnaires (see Appendix J). If there was no response, the survey was officially closed.
7.3.7.3 Round Two and Round Three Round Two was initiated by the distribution of an email to all of the experts who had completed Round One. This email contained a Key Survey hyperlink that allowed
Chapter 7: Study Two - Phase Two: The Delphi Study 131 the expert panellists to access the Round Two survey. This email also reminded each expert panel of the time frame for completing the survey.
The experts were asked to re-evaluate each item on which consensus had not been reached in the previous round by using the same 4-point scale, ranging from 1 (very unimportant) to 4 (very important). Each expert member was also asked to re- rate item response options that did not reach consensus in the previous round. The evidence for developing an item response option and overall group rating was also provided for expert consideration before re-ranking these item response options.
Using the same process as in Round One, two reminder emails were also sent to participants who had not completed the survey after one week of launching the investigation and a few days before the deadline for the survey. After the deadline, another email was sent to the expert members who had not started the survey to extend the date and encourage them to complete the survey.
Round Three was carried out following the same pattern as Round Two. After finishing Round Three (the final round), a thank you letter was sent to each member of the expert panel.
7.3.8 Data analysis Data returned from each round were entered into SPSS version 23.0 (IBM Corp., Armonk, NY) for analysis. Summary statistics (frequencies, descriptive) were run on the data to describe the expert panel and their demographics, as well as also to determine the number of items that had reached consensus at this stage. The items and item response options that achieved consensus were accepted; those that did not reach consensus were added back into the questionnaire to be re-rated for the following rounds.
Regarding the open-ended question in Round One, the content analysis described by Elo and Kyngäs (2008) was applied to group statements generated by the expert panel and put into similar categories. These qualitative comments were then divided into two reporting categories: first, any new additional comments or suggestions regarding new items that should be included in the tool; second, an exclusion category, which included all comments or suggestions related to items that were already listed in the Round One questionnaire, items not feasible to measure, items in the exclusion criteria, and items that did not meet the purpose of the tool. Once
132 Chapter 7: Study Two - Phase Two: The Delphi Study all of the qualitative response statements from the expert panel in Round One were categorised, the quantitative responses for each category were used in preparation for the development and distribution of the survey for Round Two.
7.3.9 Ethical considerations Study Two was approved by the QUT Human Research Ethics Committee (approval number 1700000125), and the Haiduong Medical Technical University Research Ethics Committee (approval number 01-2017/QD-DHKTYTHD) (see Appendices K and L).
7.4 DELPHI RESULTS
7.4.1 Timeline and response rate for the three Delphi rounds The Delphi study officially began on May 9th, 2017. Thirty-five consent email invitations were distributed to the panel members, and 28 responded with agreement to participate in the study. However, only 23 out of 28 experts returned their responses in the first round (82.1% response rate). In Round Two, 21 nurse experts answered the survey questionnaire with a 91.3% completion rate. Regarding the last round, the 21 expert members who completed Round Two also finished the final round of the Delphi, with a 100% response rate. The two experts who discontinued their involvement did not indicate their intentions to drop out of the study and did not disclose their reasons for ending their participation. Table 7.1 shows the numbers in the panels and response rates throughout each round.
Table 7.1: Percentage of expert panel participation
Total number of Delphi rounds Experts who Total experts who received the completed the Response rate survey survey Delphi round 1 28 23 82.1% Delphi round 2 23 21 91.3% Delphi round 3 21 21 100%
7.4.2 Demographic characteristics of nurse wound care expert panel members completing all three rounds
The characteristics of this group of experts are essential to understanding the results of this Delphi study. Although Round One of this study initially invited 28
Chapter 7: Study Two - Phase Two: The Delphi Study 133 experts in surgical wound care, only 23 experts completed the first round; followed by 21 expert panel members completing Round Two and Round Three. Therefore, the demographics of the nurse wound care panel are presented based on the data from 21 experts. Among the 21 experts who completed all three rounds, 16 nurses (76.2%) came from six different hospitals in the north of Vietnam, and five nurses (23.8%) were working at three hospitals in the south of Vietnam. Nearly two-thirds of nurse experts (71.4%) were currently in positions as the head nurses of surgical wards. Fifty- seven percent (12 out of 21 experts) were female, and their age ranged from 25-65 years. All of the expert panel (n=21) met the selection criteria, which were set prior to the beginning of the study, including having a minimum of five years working in the surgical field, and having at least a Bachelor of Nursing degree. More specifically, the median of years of experience in the surgical area was 15 years (min-max: 6-36). Nearly 70% (14 out of 21) of experts had a Bachelor of Nursing degree, 28.6% (6 out of 21) had a Masters degree, and 4.8% had a Doctoral degree. The details of panel’s demographic information are shown in Table 7.2.
Table 7.2: Demographic characteristics of nursing wound care expert panel
Demographic Values Frequency characteristics (%) (n=21) Gender Male 9 (42.9) Female 12 (57.1) 25-34 7 (33.3) Age (years) 34-44 10 (47.6) 45-54 3 (14.3) 55-65 1 (4.8) Doctoral degree or equivalent 1 (4.3) Highest qualification Masters degree or equivalent 6 (28.6) Bachelor of nursing degree 14 (66.7) National surgical (Viet Duc) hospital 8 (38.1) Cho Ray 3 (14.3) Name of hospitals Haiduong General Hospital 3 (14.3) Uong Bi hospital 2 (9.5) Ho Chi Minh Pharmacy Hospital 1 (4.8) Bach Mai Hospital 1 (4.8) Thai Nguyen 1 (4.8) E hospital 1 (4.8) Khanh Hoa Hospital 1 (4.8) Former head nurse of the surgical hospital 1 (4.8) Current nursing position Head nurse of the hospital 2 (9.5) Head nurse of the surgical ward 15 (71.4) Nursing staff 3 (14.3) Median Range Year of surgical experience 14 6-36 (years)
134 Chapter 7: Study Two - Phase Two: The Delphi Study
7.4.3 Round One 7.4.3.1 Round one timeline The Delphi Round One officially began on May 9th, 2017. It ran from 9th May to 26th May 2017. Twenty-eight emails were distributed to the expert panel. After the first week of starting the survey, eight experts completed Round One. Following this, on the 15th May 2017, the first reminder emails were sent to the 20 experts who had not yet completed the Round One survey instrument. After the first reminder email, seven more experts completed the questionnaire, bringing the total number of experts who completed the Round One to 15. On the 22nd May 2017, the second reminder emails were distributed to 13 experts who had not yet completed the survey to remind them about the deadline for the survey. After the second reminder email, six more experts completed the survey, raising the total number of experts who completed Round One to 21. On the closing date of the survey (25th May 2017), the third reminder email was sent to all participants who had not responded to extend the deadline. Two experts responded to the email and expressed difficulty in accessing the survey due to the poor internet connection at their homes. Therefore, the survey deadline was extended for one more day. On May 26th, 2017, Round One officially closed, with 23 experts having completed the Round One survey.
7.4.3.2 Item rating and consensus When the expert panel formally ranked the 30 SWAT items in Round One, three results emerged. Thirteen out of 30 items achieved full consensus , as shown in Table 7.3. The experts’ panel agreement ranged from 73.9% to 91.3%, and their mean scores ranged from 3.74 to 3.91 out of 4 points on the Likert scale. As a result, these items were accepted into the tool. However, even though maceration did achieve consensus, this item was excluded from the tool due to confusion for experts between maceration and volume of exudate.
Chapter 7: Study Two - Phase Two: The Delphi Study 135 Table 7.3: Items that reached full consensus in Round One
Panel agreement important/ Items Mean SD very Resulting important action n=23 n(%) Diabetes: 3.87 0.34 20 (87) Accepted
Nutritional status 3.87 0.34 20 (87) Accepted
Immune deficiency 3.91 0.29 21 (91.3) Accepted
Surgical wound contamination 3.91 0.29 21 (91.3) Accepted classification Preoperative antibiotic use 3.83 0.39 19 (82.6) Accepted
Surgical wound cleaning agents 3.78 0.42 18 (78.3) Accepted
Wound location 3.74 0.45 17 (73.9) Accepted
Wound bed 3.87 0.34 20 (87) Accepted
Swelling 3.83 0.39 19 (82.6) Accepted
Erythema 3.78 0.42 18 (78.3) Accepted
Maceration 3.78 0.42 18 (78.3) Excluded
Colour and type of exudate 3.87 0.34 20 (87) Accepted
Volume of exudate 3.87 0.34 20 (87) Accepted
SD: standard deviation
Twelve of the 30 SWAT items achieved partial consensus, as shown in Table 7.4. These 12 items reached a minimum mean of 3.5; however, these items did not reach a minimum of 70% agreement of the panel. More specifically, the expert panel’s consensus on these 12 items ranged from 56.5% to 69.7%, and their mean scores ranged from 3.56 to 3.70. These 12 items achieved only partial consensus, they were therefore fed back to the expert panel in Round Two to re-rate their importance.
136 Chapter 7: Study Two - Phase Two: The Delphi Study Table 7.4: Items that reached partial consensus in Round One
Panel agreement important/very important Items Mean SD n=23 Resulting action n(%) Age (years) 3.65 0.49 15 (65.2) Continue to Round 2 Regular use of steroids for 3.56 0.51 13 (56.5) Continue to Round 2 long-term treatment
Chemotherapy 3.61 0.50 14 (60.9) Continue to Round 2 Temperature 3.70 0.47 16 (69.6) Continue to Round 2 (measure the axillary)
Emergency surgery 3.70 0.47 16 (69.6) Continue to Round 2
The duration from injury to 3.70 0.47 15 (69.6) Continue to Round 2 surgery (hour)
Type of surgery 3.65 0.57 16 (69.6) Continue to Round 2 Wound dimensions 3.70 0.47 16 (69.6) Continue to Round 2 Wound edges 3.70 0.47 16 (69.6) Continue to Round 2 Signs of haematoma 3.70 0.47 16 (69.6) Continue to Round 2 formation Odour 3.61 0.50 14 (60.9) Continue to Round 2 Wound pain 3.61 0.50 14 (60.9) Continue to Round 2 (numeric rating scale 0-10) SD: standard deviation
Finally, five items did not achieve consensus in Round One, (Table 7.5). Panel agreement ranged from 56.5% to 60.9% and mean scores ranged from 3.09 to 3.45. As a result, those items were returned to the panel of experts for re-rating in Round Two.
Chapter 7: Study Two - Phase Two: The Delphi Study 137 Table 7.5: Items that did not reach consensus in Round One
Panel agreement important/ very important Items Mean SD n=23 Resulting action n(%) BMI 3.39 0.50 14 (60.9) Continue to Round 2 Smoking status 3.09 0.67 13 (56.5) Continue to Round 2 Surgery on site of old scar 3.13 0.69 12 (52.2) Continue to Round 2 Duration of surgery (hours) 3.49 0.73 14 (60.9) Continue to Round 2 The length of preoperative 3.35 0.65 11 (47.8) Continue to Round 2 hospital stay (day)
SD: standard deviation
7.4.3.3 Additional items suggested by nurse wound care experts In the second part of the survey questionnaire, the experts were asked to list any additional items, outside of the 30 items in the SWAT, that they thought would be appropriate to be included in the SWAT. Among the 23 expert members, only 12 experts provided suggestions. Similar suggestions were combined and grouped as subcategories, and subcategories were then grouped as categories (Appendix M). When considering the suggestions, not all suggested items could be included in the tool because the purpose of the surgical wound assessment tool was to provide a simple, quick measure of the progress in wound healing, and early detection of factors associated with delayed wound healing. Therefore, only factors with evidence of a substantial impact on wound healing were included in the tool.
As a result, suggestions were excluded for the following reasons: (1) the suggested items were already included in the SWAT (n=12); (2) suggested items were not feasible to measure in routine practice in Vietnamese healthcare settings (n=2); (3) suggestions were associated with exclusion criteria for the SWAT, such as laparoscopic surgery (n=2); and (4) suggestions were not fit for the purpose of the tool, which was to measure surgical wound healing and early detection of factors associated with delayed surgical wound healing (n=5). The following four additional items were suggested:
depth of wounds;
138 Chapter 7: Study Two - Phase Two: The Delphi Study exudate from surgical drainage system;
patient’s mobility;
type of dressing.
However, based on the findings from two systematic reviews, patient’s mobility and type of dressing were not included in Round Two for rating, because these factors were not found to have a significant impact on surgical wound healing and surgical wound complications in the systematic review (Korol et al., 2013; Vermeulen et al., 2004). Consequently, only two new items: the depth of wounds and exudate from the surgical drain system, were sent to the panel in Round Two to rate using the same 4- point Likert scale from Round One.
7.4.3.4 Items with response options rating and consensus Among the 30 tool items, 28 item response options were sent to the expert panel for rating, (less than 30 due to the open-ended responses for the type of surgery and incision location). Overall, out of the 28 item response options, only two item response options (surgical wound contamination classification, and surgical wound on the site of old scar) achieved full consensus. Five-item response options (BMI, chemotherapy, emergency surgery, pre-operative antibiotic use, and odour) reached partial consensus, and the rest (21 items) did not reach agreement. The detailed results are presented in Appendix N. The following section presents the detailed rating for each item response option, as well as their revision to prepare for the Round Two survey.
7.4.3.4.1 Items with response options that achieved full consensus Two item response options: surgical wound on the site of old scar, and surgical wound contamination classification reached consensus, with the expert panel’s agreement ranging from 73.7% to 78.3% and their mean scores ranging from 3.63 to 3.78. Therefore, these two item response options were not re-rated in Round Two.
7.4.3.4.2 Items with response options that achieved partial consensus Five item response options (BMI, chemotherapy, emergency surgery, pre- operative antibiotic use, and odour) reached a partial consensus, with a minimum mean score of 3.5 and a panel agreement ranking from 52.2% to 60.9% (Appendix N). However, all five of these item response options also received expert comments for
Chapter 7: Study Two - Phase Two: The Delphi Study 139 revision. Therefore, these five item response options were revised and resent to the expert panel to re-rate. The revision of these five items is described below.
As mentioned in Section 6.3.2, the original response option for the BMI item was divided into four groups based on the WHO’s (1995) classification. However, experts have suggested using different cut-off points for the Asian population. Therefore, the cut-off points for BMI were revised according to the WHO recommendations for an Asian population, which includes four groups: less than 18.5 (underweight), 18.5-22.9 (normal weight), 23-27.5 (overweight), and over 27.5 (Shiwaku, Anuurad, Enkhmaa, Kitajima, & Yamane, 2004).
Regarding chemotherapy (received before surgery), the original response option for this item was “Yes” or “No”. However, an expert suggested choosing either “currently receiving” or “received chemotherapy”. To make it more transparent, this item’s response option was revised according to the impact of chemotherapy on surgical complications (Gerber et al., 2014; Sullivan et al., 2012). The new response option for this item was revised to: received either currently or in the 30 days before surgery, or not received at all.
In terms of the emergency item, the original response option for this item included non-emergency, emergency surgery for pathological condition, and emergency surgery for trauma. Three-panel members gave comments on this choice, including deleting the option (non-emergency surgery), and others suggested using the “Yes” or “No” option, and if “Yes” option was chosen, then selecting what type of emergency surgery had been performed. Taking the experts’ recommendation into consideration, this item response option remained as “Yes” or “No”, but “What type of emergency surgery?” was asked if the “Yes” option was chosen.
As regards pre-operative antibiotic use, the original response option for this item was “Yes” or “No”. However, three-panel members suggested providing more detail about the duration of preoperative surgical antibiotic prophylaxis and clarifying this item’s response option. Taking into consideration the experts’ comments and according to the recommendation from the WHO set out in Global Guidelines for the Prevention of Surgical Site Infection published in 2016, the preoperative surgical antibiotic prophylaxis should be administered within 120 minutes before incision to reduce the surgical site infection As a result, the response option was kept the same, with a “Yes” or “No” option; however, the title of the item was changed to
140 Chapter 7: Study Two - Phase Two: The Delphi Study Preoperative surgical antibiotic prophylaxis within 120 minutes pre-incision for more precise measurement.
In the case of odour, the original response options to measure odour included three options, which were none, present after removing the dressing, and present before dressing removal and patient aware. As mentioned in Section 6.3.2, the three response options above were classified based on the recommendation from Wounds UK, set out in Best Practice Statement. Effective exudate management.. (Wounds UK, 2013), and suggestions from surgeons in Vietnam. However, one expert suggested changing patient aware to nurses aware. Therefore, this item’s response options remained the same, however the last option was revised slightly to present before dressing removal and nurses aware.
7.4.3.4.3 Items with response options that did not achieve consensus Twenty-one item response options did not achieve consensus, with a panel agreement ranging from 39.1% to 65.2%, and a mean score ranging from 2.65 to 3.48. Rating details are presented in Appendix N. Although these 21 items response options did not achieve the required level of agreement, recommendations to revise the response options were provided for each item by expert members. Therefore, these 21 items were revised again based on the expert recommendations and the current review of the literature. The revision of these response options is presented below.
Concerning age, the original response option of this item was divided into three groups including 18-39, 40-59, and over 60. The evidence for these cut-off points was explained in Section 6.3.2. However, an expert member suggested using the cut-off point at 65 instead of 60. Considering the expert’s suggestions and reviewing other evidence in the literature on the impact of age on surgical wound healing and complications, the cut-off point of age over 65 was found to be a strong factor associated with surgical wound complications in a number of studies (Khalil et al., 2015; Knight et al., 2007; National Collaborating Centre for Women's and Children's Health (UK), 2008; Roine, Bjork, & Oyen, 2010). Therefore, the response option of this item was slightly changed to three groups of 18-40, 41-65, and over 65.
As regards diabetes, the original response option for the diabetes item was “Yes”/“No”. Three expert members suggested adding a prediabetes option in the tool; others recommended considering the duration of diabetes, complications, or the level
Chapter 7: Study Two - Phase Two: The Delphi Study 141 of blood sugar before and after surgery. Considering the experts’ comments, the literature was reviewed again to identify the best response option for this item.
Evidence indicated that level of Hemoglobin A1c (HbA1C) is a significant independent factor associated with delayed surgical wound healing and increased surgical complications (Humphers, Shibuya, Fluhman, & Jupiter, 2014; Shibuya, Humphers,
Fluhman, & Jupiter, 2013; Younger, Awwad, Kalla, & de Vries, 2009). The cut-off point of HgbA1C varied from study to study. However, according to the American Diabetes Association guidelines, the target HbA1c for people with diabetes should be < 7% (53mml/mol) (American Diabetes Association, 2013). As a result, the response option for measuring diabetes was revised as “Yes”/“No”, but the level of HbA1C (<7% or > 7%) before surgery was asked if the “Yes” option was chosen.
Regarding the item on smoking, two experts gave feedback about this item; however, they did not comment on the response options. Therefore, the response options remained the same as the original and were included in Round Two for re- rating.
With regards to the steroids use item, the original response option was “Yes”/“No”. However, there were four comments from members in the panel who suggested changing the response option of this item to improve the preciseness of the measure. Taking the panel comments into consideration, the research team defined this item more precisely in the response options as used for less than 30 days before surgery, used for more than 30 days before surgery, and not used at all.
In terms of the nutrition status item, the original response option for this item was “Yes”/“No”. Five expert members suggested defining a clearer response option for this item. As the purpose of this tool is for early detection of factors associated with delayed surgical wound healing, the nutrition status of interest is to identify patients at risk of malnutrition. Therefore, this response option was refined by using two questions from the Mini Nutrition Assessment-short form tool in the surgical assessment tool as an indicator of risk of malnutrition (Kaiser et al., 2009). If a patient was identified as being at risk of malnutrition, the full version of the nutrition assessment form was recommended to assess the nutrition status. As a result, taking expert comments into consideration, and the current literature review (see Section 2.3.2), the response option remained the same, with two options “Yes”/“No”; however, the title of this item was revised to be more specific to Risk of
142 Chapter 7: Study Two - Phase Two: The Delphi Study malnutrition (e.g., decreased food intake and/or unintentional weight loss over the last 3 months).
In the case of duration of surgery, the response option for this was divided into three groups: less than 1h; from 1 to 3 h, and greater than 3h. However, three expert members suggested including one more group of over 6h. Therefore, considering expert recommendations, the response option for this question was revised as less than 1h, 1 to 3h, between 3 to 6h, and over 6h.
With respect to the item “duration from injury to surgery”, less than 10 hours and greater than 10 hours were the response options allocated to this item. However, eight expert members gave feedback on this question, with most comments suggesting a cut-off point of six hours. It was suggested that in general, 6-10h is an appropriate period for extremity and laceration repair, with 10-12h for the more vascular face and scalp. However, this time suggestion requires integration with clinical judgment and infection potential (Nicks et al., 2010). Considering most experts suggested using the cut-off point for six hours and the review of the literature, the title of this item was changed to trauma wound, and its response options were revised as “No” and “Yes”, but the duration from injury to surgery (less than 6h or greater than 6h) was classified if the “Yes” option was chosen.
In terms of surgical wound cleaning agents, the original response option for this item, based on the suggestions from surgeons, included sodium chloride 0.9%; Povidone, Hydrogen peroxide, and other. However, two expert members suggested removing the hydrogen peroxide option because it is no longer used in Vietnam. As a result, the response option of this item remained the same as the original option, except the choice of hydrogen peroxide was removed.
Regarding the item types of surgery, this was an open-ended response option and was not rated in Round One. However, wound care experts in the research team suggested including some kinds of operations that have a higher risk of surgical wound complications to determine whether patients were in this high-risk group. Therefore, the literature was reviewed on this topic. According to a cohort prospective multinational multicentre surveillance study of 83 hospitals from 30 countries with total 260,973 patients who undergoing surgical procedures, the top surgical operation having a higher risk of infection compared to others included exploratory abdominal surgery, hip prosthesis, colon surgery, coronary bypass, and open reduction of fracture;
Chapter 7: Study Two - Phase Two: The Delphi Study 143 with relative risk ranging from 1.44-2.44 (Rosenthal et al., 2013). As a result, these types of surgery were allocated as examples, and “Yes” or “No” was indicated as the response option for this item.
As far as the wound edges item was concerned, three expert members found a lack of clarity in the response options of the item. Therefore, the response options were revised again according to the recommendations from the Canadian Association of Wound Care (2017) for closed surgical wounds, and the World Union of Wound Healing Societies (2016b) for open surgical wounds. The recommendations are shown in Table 7.6, below.
Table 7.6: The response options of wound edges item
Closed surgical wounds Open surgical wound
- Red, edges well approximated (days 1- - Edges sloping or flat 4) - Edges raised or rolled - Red, edges well approximated and - Undermining present progressing to bright pink (days 5-14) - Red, edges approximated but tension at incision line (days 1-4) - Red, edges are not approximated and tension at incision line (days 5-14)
With regards to the wound bed item, one expert suggested using the percentage of the wound surface, such as 10%, 20%, 50%, 75%, and 100% to assess the amount of tissue type in the wound bed. However, it was decided that it was not practical to determine the accurate percentage of the tissue kinds in the wound bed. The response option for assessment of the wound bed of open surgical wounds therefore remained the same according to guidelines from the World Union of Wound Healing Societies (2016b).
In the case of the swelling item, the original response option was “Yes” or “No”. One panel member suggested assessing the level of swelling. However, it is not practical to determine the degree of swelling because there is no objective instrument to measure the degree of swelling. Therefore, the response option for this item remained the same with a “Yes” or “No” choice, but the title of this item was defined more accurately as swelling of the incision and surrounding tissues.
144 Chapter 7: Study Two - Phase Two: The Delphi Study With respect to erythema, five expert members provided comments for the response options of the item. All of these comments were related to providing details about measuring the level of erythema. Considering experts’ suggestions and after reviewing the literature, erythema was more explicitly defined as present within 4 cm of the wound edges according to the World Union of Wound Healing Societies’ criteria (2016b). As a result, the “Yes” or “No” option for this item remained the same as the original, but the title of erythema was revised to be more precise and specific as localised erythema either at the incision or within 4 cm of the wound edges.
Regarding signs of haematoma formation, a “Yes” or “No” option was designed for this item; however, a panel member left a comment for clarification. Therefore, experts in the research team suggested revising the response option to be more specific: at least one sign of haematoma formation or no signs of haematoma formation.
Even though the definition of maceration was provided, it seemed that the comments from the expert panel referred to the volume of exudate. It would be hard to assess this item if there was a misunderstanding about this concept, because it was assumed that if the surgical wound care expert panel did not understand the items that it is likely most nurses would not understand it either. Therefore, this item was excluded from the tool by the research team due to the misconception about maceration condition and the volume of exudate.
Another item’s response options that received comments from the expert panel was colour and type of exudate, in which one suggestion was to leave space for the nurse to take photos of the wounds and stick them on the colour of the exudate section to provide a more accurate record of the colour of exudate. However, although photography would be ideal to measure wound healing, it was not suitable in the Vietnamese context, where there is not enough equipment provided to assist nurses to take photos. Therefore, to be more practical, this item’s response option remained the same as the original: none; mostly clear, amber; mostly bloodstained; mostly cloudy, milky; and mostly green or yellow”.
With respect to wound pain, it was asked to be measured by a numeric score from 0-10; however, two experts suggested dividing the score range 7-10 into 7-8 for severe and 9-10 for extremely severe. However, the four group response option for this item remained the same as the original due to validated cut-off points for the numeric pain scale (K. R. Jones et al., 2007).
Chapter 7: Study Two - Phase Two: The Delphi Study 145 The rest of the item response options, including immune deficiency, temperature, the length of preoperative hospital stay, incision dimension, and exudate volume were revised slightly for re-rating in Round Two. The summary of Round One results is presented in Figure 7.1.
Figure 7.1: Summary of the actions and results of Round One
146 Chapter 7: Study Two - Phase Two: The Delphi Study 7.4.4 Round Two 7.4.4.1 Round Two timeline The Delphi Round Two commenced on July 3rd, 2017. Email invitations for the web-based survey were sent to 23 nursing wound-care experts who agreed to be panel members for the study and had completed the survey in Delphi Round One (see Appendices O and P). After the first week, seven experts had finished Round Two. Following this, the first reminder was sent on July 10th, and six more members completed the survey, which increased the number of survey completion to 13. Three days before the deadline, the second email reminder was sent to the rest of the participants who had not started the survey. After the second reminder email about the deadline of Round Two, seven more experts completed the questionnaire. This raised the total number of participants who completed Round Two to 20. However, in an effort to increase the response rate, another email was sent to the three participants who had not started the survey to extend the deadline by one more day for them to complete. One more expert completed the Round Two, but the two other members did not respond. On 17th July, Round Two officially closed with a total of 21 out of 23 (91.3%) experts.
7.4.4.2 Items re-rating and consensus Among the 17 items that were revised from Round One and re-rated in Round Two, six items (regular use of steroids for long-term treatment, chemotherapy, trauma wound, type of surgery, signs of haematoma formation, and odour) achieved full consensus, with panel agreement ranging from 71.4% to 81% and mean scores ranging from 3.71 to 3.81. As a result, those six items were accepted into the tool (see Table 7.7).
Chapter 7: Study Two - Phase Two: The Delphi Study 147 Table 7.7: Items that reached full consensus in Round Two (n=21)
Panel agreement important/ Achieve Item Mean SD very consensus Result action important n (%) Regular use of 3.71 0.46 15 (71.4) Yes Accepted into steroids for long- the tool term treatment Chemotherapy 3.71 0.46 15 (71.4) Yes Accepted into the tool Trauma wound 3.76 0.44 16 (76.2) Yes Accepted into the tool Type of surgery 3.71 0.46 15 (71.4) Yes Accepted into the tool Sign of haematoma 3.71 0.46 15 (71.4) Yes Accepted into formation the tool
Odour 3.81 0.40 17 (81) Yes Accepted into the tool SD: Standard deviation
Five items, including age, BMI, emergency surgery, wound dimensions, and wound edges achieved only partial consensus, with a minimum mean of 3.52 and higher; however, the level of agreement was less than 70%. Thus, these five items were sent to be re-rated in Round Three (see Table 7.8)
148 Chapter 7: Study Two - Phase Two: The Delphi Study Table 7.8: Items that reached partial consensus in Round Two
Panel agreement important/very Item Mean Standard important Result deviation n=21 action n(%) Age 3.62 0.50 13 (61.9) Continue to round 3 BMI 3.52 0.51 11 (52.4) Continue to round 3 Emergency surgery 3.57 0.60 13 (61.9) Continue to round 3 Wound dimensions 3.62 0.49 13 (61.9) Continue to round 3 Wound edges 3.67 0.48 14 (66.7) Continue to round 3
The rest of the six items (smoking, temperature, surgical wound on site of an old scar, duration of surgery, the length of preoperative stay if elective surgery, and wound pain) did not reach consensus. The panel agreement ranged from 47.6% to 66.7%, and mean scores ranged from 3.14 to 3.43 (Table 7.9). As a result, the six items that did not reach an agreement, and five items that reached only partial consensus were re- rated in Round Three.
Regarding two new items suggested by an expert member in Round One: the depth of the wound and the exudate from surgical drain system, the depth of open surgical wound achieved consensus, with a mean of 3.81 and panel agreement was 81%; while the other new item (exudate from surgical drain system) did not reach consensus. However, these two suggestions were not used to develop new items, instead the depth of wound was added as one of response options of items for wound dimensions when measuring an open surgical wound, and exudate from surgical drain systems was added as one of the response options for the item volume of exudate.
Chapter 7: Study Two - Phase Two: The Delphi Study 149
Table 7.9: Items that did not reach consensus in Round Two
Panel agreement important/very Item Mean Standard important Result deviation n=21 action n(%) Smoking status 3.19 0.68 11 (52.4) Continue to round 3 Temperature 3.14 0.57 14 (66.7) Continue (measure the axillary) to round 3 Surgical wound on site 3.42 0.59 10 (47.6) Continue of old scar to round 3 Duration of surgery 3.43 0.51 12 (57.1) Continue (hours) to round 3 Length of preoperative 3.14 0.73 10 (47.6) Continue hospital stay if elective to round 3 surgery Wound pain (numeric 3.48 0.68 12 (57.1) Continue rating scale 0-10) to round 3
7.4.4.3 Item response options re-rating and consensus Twenty-six item response options were re-rated in Round Two. After Round Two re-rating, 17 item response options reached full consensus with and without comments from the panel. Five item response options reached partial consensus, and four item response options did not reach agreement among panel members. The following sections present the details of the item response options re-rating results in Round Two.
7.4.4.3.1 Items with response options that reached full consensus Among the 26 item response options sent to the panel to re-rate in Round Two, 17 items response options achieved a full level of consensus with and without comment for revision. Among 17 items with full consensus, 12 items reached full consensus without any comments. Panel agreement ranged from 71.4% to 81%, and the mean scores ranged from 3.62 to 3.81. These items included BMI, smoking status, regular use of steroids, the risk of malnutrition, immune deficiency, trauma wound, wound dimension, swelling, signs of haematoma formation, colour and type of
150 Chapter 7: Study Two - Phase Two: The Delphi Study exudate, the volume of exudate, and wound pain. Thus, these 12 items’ response options were accepted into the tool (see Appendix Q).
Regarding the five items’ response options that reached full consensus with some comments, the expert panel’s agreement on these five item response options ranged from 71.4% to 81%, and their mean scores ranged from 3.52 to 3.76 (see Appendix R). These five items involved chemotherapy, duration of surgery, preoperative surgical antibiotic prophylaxis within 120 minutes pre-incision, wound bed, and odour. Among these five item response options, four items were accepted into the tool after slight revision based on expert suggestions and research team member comments; however, for item pre-operative surgical antibiotic prophylaxis within 120 minutes pre-incision, it was commented that in Vietnam, the use of antibiotics is very different from doctor to the doctor due to different guidelines. Therefore, this item’s response option was revised slightly to make it clearer: clean wound that does not need preoperative antibiotic use, received within 120 minutes pre-incision, received but more than 120 minutes pre-incision, or not received at all. This response option was sent back to the panel to re-rate in Round Three.
7.4.4.3.2 Items with response options that reached partial consensus Five items’ response options (diabetes, temperature, emergency surgery, surgical wound cleaning agents, and wound edges) reached a partial consensus with and without comments for revision. These item response options achieved a minimum mean of 3.52 or higher but did not achieve a 70% level of agreement. Even though comments were provided for some items, these comments were expressions of agreement about the impact of those factors on wound healing. Therefore, these five response options remained the same and were returned to the expert panel for re- ranking in Round Three (see Appendix S).
7.4.4.3.3 Items with response options that did not reach consensus Four items’ response options (age, the length of preoperative hospital stay if elective surgery, type of surgery, and erythema) did not achieve consensus. The level of agreement ranged from 52.4 % to 61.9%, and means ranged from 3.24 to 3.48. Again, these four item response options received comments from the panel; however, these comments were related to emphasising the agreement on the impact of risk
Chapter 7: Study Two - Phase Two: The Delphi Study 151 factors on wound healing. Therefore, these item response options remained the same and continued to be re-rated in Round Three (see Appendix T).
In conclusion, Round Two results can be summarised into three parts. First, regarding item re-rating, among the 17 items re-rated in Round Two, six items reached full consensus and were accepted into the tool; five items reached partial consensus, and six items did not reach consensus. Those 11 items were sent back to the panel to re-rate in Round Three. Second, in terms of two new items recommended by the panel, one item reached consensus and one did not; however, those two items were able to be incorporated into altered response options for the items about exudate volume and wound dimension. Finally, with regards to item response options, among the 26 item response options that were re-rated 17 item response options reached full consensus with and without revision, and nine item response options did not reach consensus. They were then re-rated in Round Three. Round Two results are summarised in Figure 7.2.
152 Chapter 7: Study Two - Phase Two: The Delphi Study
Figure 7.2: Summary of the actions and results of Round Two
Chapter 7: Study Two - Phase Two: The Delphi Study 153 7.4.5 Round Three 7.4.5.1 Round Three timeline Round Three opened on 25th July, when emails were distributed via Key survey to the 21 participants who completed Round Two (see Appendix U). This email contained a hyperlink allowing the members of the expert panel to gain access to the Round Three questionnaire (see Appendix V). After the first week, nine members had completed Round Three. On the 1st August, the first reminder email was distributed to the 13 members of the expert panel who had not yet responded. Five more members responded to the survey after the first reminder. A few days before the deadline of Round Three, another reminder email was distributed to the rest of panel members who had not started the survey. On the 8th August, Round Three officially closed with 20 out of 21 members of the expert panel completed the survey resulting in a 95% response rate. However, consistent with previous rounds, a final email was sent to a member who had not yet responded to the Round Three-survey in an attempt to garner further responses from the expert panel. Consequently, on the 9th August, the last panel member completed Round Three, resulting in a 100% response rate.
7.4.5.2 Item re-rating and consensus Eleven items were sent to the panel members to re-rate in Round Three. Six out of 11 items: age, BMI, emergency surgery, wound dimensions, wound edges, and wound pain, reached full consensus in Round Three, with panel agreement ranging from 76.2 % to 90.5%, and mean scores ranging from 3.76 to 3.90. Consequently, those six items were accepted into the tool (Table 7.10).
154 Chapter 7: Study Two - Phase Two: The Delphi Study Table 7.10: Items that achieved full consensus in Round Three (n=21)
Panel agreement Item Mean Standard important/very Achieve Result action deviation important consensus n(%) Age 3.76 0.44 16 (76.2) Yes Accepted into the tool BMI 3.81 0.40 17 (81) Yes Accepted into the tool Emergency 3.76 0.44 16 (76.2) Yes Accepted into surgery the tool Wound 3.86 0.36 18 (85.7) Yes Accepted into dimensions the tool Wound 3.86 0.36 18 (85.7) Yes Accepted into edges the tool Wound pain 3.90 0.30 19 (90.5) Yes Accepted into the tool
Five out of 11 items (smoking, monitoring temperature, surgical wound on site of an old scar, duration of surgery, and length of preoperative hospital stay for elective surgery) did not achieve consensus in the last round. The panel agreement ranged from 52.4% to 61.9% and mean scores ranged from 3.28 to 3.51. However, after three rounds, even though the items smoking status and the duration of surgery did not achieve consensus, they were identified in the literature as strong factors associated with delayed wound healing. As a result, those items were retained in the tool to evaluate the construct validity of the tool. Another three items were excluded from the tool (Table 7.11).
Chapter 7: Study Two - Phase Two: The Delphi Study 155 Table 7.11: Items that did not reach consensus in Round Three (n=21)
Panel agreement Item Mean Standard important/very Achieve Result Deviation important consensus action n(%) Smoking status 3.47 0.51 11 (52.4) No Remain to further test Monitoring 3.38 0.50 13 (61.9) No Excluded temperature Surgical wound 3.42 0.51 12 (57.1) No Excluded on site of old scar Duration of 3.51 0.51 11 (52.4) No Remain to surgery (hours) further test The length of 3.28 0.56 13 (61.9) No Excluded preoperative hospital stay if elective surgery
7.4.5.3 Items with response options re-rating and consensus Among the 9 items’ response options re-rated in Round Three, eight item response options achieved full consensus, with panel agreement from 71.4% to 90.5%, and means ranging from 3.71 to 3.90. These items included diabetes, monitoring axillary temperature measurement, emergency surgery, preoperative surgical antibiotic prophylaxis, length of preoperative hospital stay if elective surgery, surgical wound cleaning agents, type of surgery, wound edge, and erythema. However, the other two item’s response options: age and the length of preoperative hospital stay for elective surgery, did not reach consensus. The panel agreement ranged from 61.6% to 66.7% and mean scores ranged from 3.57 to 3.67 (Appendix W).
Even though age response options did not reach consensus in Round Three, age was rated as important item and reached consensus to include in the tool after the last round (see Section 7.4.5.2). Therefore, the title of measuring age was revised slightly as age (over 65 years), and the response option was changed to “Yes” or “No”.
In conclusion, Round Three resulted in six out of 11 items achieving full consensus, and five items not reaching consensus. Regarding items’ response options
156 Chapter 7: Study Two - Phase Two: The Delphi Study rerating in Round Three, eight out of 10 item response options reached full consensus. Round Three results are summarised in Figure 7.3.
Chapter 7: Study Two - Phase Two: The Delphi Study 157
Figure 7.3: Summary of the actions and results of Round Three
158 Chapter 7: Study Two - Phase Two: The Delphi Study 7.5 SCORING SYSTEM FOR THE SURGICAL WOUND ASSESSMENT TOOL
Regression coefficients (β) and odds ratios are a commonly used method of developing a scoring system for risk models (Kassaian et al., 2015; Neumayer et al., 2007; van Ramshorst et al., 2010). Although the use of odds ratios has more drawbacks when assigning a relative score to each predictor compared to the use of regression coefficients (Moons, Harrell, & Steyerberg, 2002), for this SWAT, the odds ratios were used to allocate the score of item response options for the following reasons. First, the assessment items and their response options for the SWAT were developed based on a review of different studies in the literature (see Section 2.3.2), and most of those studies reported odd ratios rather than regression coefficients. Second, the odds ratio method has been successfully used to estimate risk scoring models in previous studies (Kassaian et al., 2015; Neumayer et al., 2007; Solomon et al., 2002).
There are three domains in the SWAT. The scores for each item response option in the first two domains of SWAT were assigned based on odds ratios (OR), and rounding to whole numbers for ease of use; that is, one point for an OR from 1.0 to 1.5; 1.5 points for an OR from 1.51-2; two points for an OR from 2.1-2.5; 2.5 points for an OR from 2.51-3; and 3 points for an OR from 3.1-3.5. From the review of literature in Section 2.3.2, risk factors in the SWAT were summarised with a value of OR range across different studies and the selected OR to estimate the score for SWAT. Previous research was selected to estimate scores for this SWAT based on criteria, including well-designed research (cohort studies, a systematic review of cohort and other studies, randomised controlled trials, and the target population focusing on general surgery). Appendix X presents the summary of the estimated score for the first two domains of SWAT. Once the score of each item was established, the total score of the first two domains was calculated to measure the risk of wound healing deterioration. A higher score indicated increased risk of poor wound healing.
Regarding the last domain (clinical surgical wound characteristics) in the SWAT, variables were presented in a way such that a sign of healthy progress in wound healing was allocated zero points, and one point was added for each variable showing deterioration. This was done due to lack of evidence on clinical surgical wound characteristics on wound healing. However, a different approach was used for the incision dimensions item. If the wound was healing by primary intention, the length
Chapter 7: Study Two - Phase Two: The Delphi Study 159 of the wound was allocated as zero points, and the total score from the last domain (clinical surgical wound characteristics) was calculated to measure the actual deterioration in healing. In the case of open surgical wounds, due to the limited discussion on the size of this type of surgical wound in the literature, the actual length and width were collected in the evaluation study (Chapter 8) to estimate size and score for open surgical wounds. The surgical wound assessment tool with scores is presented in Table 7.12.
160 Chapter 7: Study Two - Phase Two: The Delphi Study Table 7.12: The surgical wound assessment tool with scoring
SURGICAL WOUND ASSESSMENT TOOL Patient code No: ………… (SWAT) Date of admission…………. Date of operation………….. After operation at first assessment A. Patient, disease factors Score 1.Age (equal or greater than 65 years) No = 0 Yes = 1.5 2. BMI (Kg/m2) Less than 18.5 18.5-22.9 23-27.5 Over 27.5 (underweight) (normal) (overweight) (obese) = 1 = 0 = 0.5 = 1.5
3.Diabetes: Yes, the level of HbA1C before surgery? (currently diagnosed with diabetes) No = 0 Unknown = 1 Less than or equal to 7% = 1 Greater than 7% = 2 4. Smoking Non-smoking Previously smoked but gave up at least 4 Currently smoking weeks before surgery = 2 = 0 = 1.5 5. Use of steroids Not used at all or used for less than 30 Used regularly for more than 30 days before surgery days before surgery = 1 = 0 6. Chemotherapy Not received at all Received either currently or in the 30 days before surgery = 0 = 1 7. Immune deficiency (e.g. HIV, kidney failure, infectious disease) No = 0 Yes = 1 8. Risk of malnutrition (e.g. decreased food intake and/or unintentional No = 0 Yes = 1 weight loss over the last three months). 9. Trauma wound Yes, the duration from injury to surgery? No = 0 Less than 6 hours = 1 Greater than 6 hours = 2
Sub TOTAL A
Chapter 7: Study Two - Phase Two: The Delphi Study 161 B. Surgical procedure factors 10 . Surgical wound contamination classification Clean Clean-contaminated Contaminated Dirty/infected = 0 = 1 = 1.5 = 2 11 . Emergency surgery Yes, what type of emergency surgery? No = 0 Pathological condition = 1.5 Trauma = 2 12. Duration of surgery (hours) Less than 1h 1 - 3h Between 3-6h Over 6 h = 0 = 1 = 2 = 3 13. Preoperative surgical antibiotic prophylaxis Clean wounds Received within 120 Received but more than Not received at all do not need minutes pre-incision 120 minutes pre-incision preoperative antibiotic use =0 = 0 = 1 = 2 14. Type of surgery (Is this type of surgery exploratory abdominal surgery, hip prosthesis, colon surgery, coronary bypass and open reduction of No = 0 Yes = 1 fracture?)
Sub TOTAL B Sub TOTAL (A+B) C. Surgical wound characteristics Date post-operative: …………. 15. Wound location: …………………………………. = 0 Closed surgical wound Open surgical wounds (Please fill out information for item 16,18,19 on Please fill out information for item 16,18,19 on column below) column below) Length…….cm 16. Wound dimension Length……….cm = 0 Widest width:…….cm
Deepest part of wound:…..cm Edges well approximated Edges sloping or flat = 0 = 0 Edges approximated but tension at incision line Edges raised or rolled = 1 = 1 Edges are not approximated and tension at incision Tunnelling or undermining 17. Wound edges line = 2 = 2
162 Chapter 7: Study Two - Phase Two: The Delphi Study Incision edges closed Mostly epithelialising = 0 = 0 Mostly epithelialising Mostly granulating = 0 = 1 Mostly granulating Mostly sloughy 18. Wound bed = 1 = 2 Mostly sloughy = 2 Mostly necrotic Mostly necrotic = 3 = 3 19. Swelling at incision and/or No = 0 Yes = 1 surrounding tissue 20. Erythema at incision or within 4cm of No = 0 Yes = 1 wound edges 21. Signs of haematoma (e.g. focused area of swelling, hardness or No signs of haematoma One or more signs of haematoma bogginess, painful) = 0 = 1 Mostly clear, amber Mostly bloodstained Mostly cloudy, milky Mostly green or 22. Exudate: colour and type = 0 = 1 = 2 yellow = 3 Dry Moist Wet Saturated (no visible exudate) (less than 50% exudate (50-75% exudate on (over 75% on dressing, on dressing) dressing) leakage to secondary 23. Exudate volume dressing, or increased = 0 =0 = 1 volume in drain tube) = 2 24. Odour None Present after removing Present before dressing removal =0 dressing =2 = 1 25. Surgical wound cleaning agents Iodine Sodium chloride 0.9% Both = 0 = 1 = 0 26. Wound pain on a numeric rating 0 1 - 3 4 - 6 7 - 10 scale 0 -10 (no pain) (mild) (moderate) (severe) = 0 = 0 = 0 = 1 Sub TOTAL C TOTAL SWAT SCORE (A+B+C)
Chapter 7: Study Two - Phase Two: The Delphi Study 163
7.6 DISCUSSION
Twenty-one panellists contributed to all three rounds, demonstrating their engagement in the process of developing a surgical wound assessment tool. In order to maintain a high response rate in this Delphi study, different strategies recommended by Hsu & Sandford (2007a) were applied such as mixture of different type of question formats, setting deadlines for all participants, using follow up and email as a reminder for non- respondents, and the use of incentives. Their high level of education and years of experience in the surgical nursing field further confirmed their expertise. Experts were located across Vietnam, which reflected varied expertise. The panellists identified the content validity of surgical wound assessment tool items and achieved consensus on 24 items, with eight items associated with the patient and disease risk factors domain, four items related to the surgical procedure risk factors domain, and 12 items in the surgical wound characteristics domain. A comprehensive and holistic assessment of the individual, their wound, and the wound healing environment is an integral component of wound prevention and management (Wounds Australia, 2016). To recover from surgical wounds, the wounds are not only affected by host factors that influence wound status, but also by patients and their environmental healing factors (Han & Choi-Kwon, 2011). Therefore, an important strategy to prevent surgical wound complications is the completion of a detailed pre-operative assessment to identify potential factors that may impact healing and increase the risk for surgical wound complications (Canadian Association of Wound Care, 2017).
In this study, eight out of 10 pre-operative risk factors associated with patient and disease condition reached full consensus after three rounds; two factors (smoking and monitoring temperature) failed to reach consensus. The eight risk factors, identified at the pre-operative phase of surgery coincided with the recommendations from the publication of international guidelines; the Best Practice Recommendations for the Prevention and Management of Surgical Wound Complications (Canadian Association of Wound Care, 2017), the Standards for Wound Prevention and Management (Wounds Australia, 2016), and Global Guidelines for the Prevention of Surgical Site Infection (WHO, 2016a). Although smoking was identified as a substantial factor affecting surgical wound healing from the literature (see Section
164 Chapter 7: Study Two - Phase Two: The Delphi Study 2.3.2), it did not achieve agreement from this study’s expert panel. It is hard to explain the lack of awareness by surgical nurses about the impact of smoking on the recovery of surgical wounds; however, the high prevalence of smoking in adults in Vietnam (Van Minh et al., 2017), no strict enforcement of the ban on tobacco advertising and promotion in Vietnam (Huong et al., 2017), and slow progress in implementing policies and systems to access smoking cessation therapies and services (Tran et al., 2015) may lead to challenges to reduce the prevalence of smoking in patients. In addition, a high prevalence of health professionals also smoke (Dao et al., 2008), and this may therefore lead to a familiarity with the habit of smoking in patients amongst health professionals. Regarding the monitoring of temperature by axillary measure item recommended by Vietnamese surgeons, this item did not achieve consensus in the Delphi rounds. Therefore, this item was excluded from the tool due to lack of evidence about the impact of body temperature on surgical wound complications.
In 2016, the WHO reported that surgical wound infection was the leading healthcare-associated infection reported hospital-wide in low-middle incomes countries (WHO, 2016a). Important determinants of a high burden of healthcare- associated infection in these countries may include inadequate environmental equipment, paucity of knowledge and application of basic infection-control measures, scarcity of local and national guidelines and policies (Allegranzi et al., 2011), as well as overcrowding in tertiary hospitals (some exceed capacity by 200-300%) (Meara et al., 2015). It has been shown that hospitals with high levels of acute surgical volume result in losing the ability to offer more complex planned surgery (Meara et al., 2015). However, there are several positive patients and economic outcomes that can be achieved by having a structured pre-operative nursing care plan to identify high-risk patients and resolve complex medical problem before surgery (Turunen, Miettinen, Setala, & Vehvilainen-Julkunen, 2017). Some determinants are obviously not modifiable, such as age. However, other potential factors can be improved to increase the likelihood of a positive surgical outcome, such as nutritional status, tobacco use cessation, correct use of antibiotics, and steroids (WHO, 2016a). Thus, implementation of a more structured wound assessment approach may improve nurses’ assessment ability, which can then result in the provision of an appropriate pre-operative nursing care plan for the patient. This may result in improved postoperative patient outcomes.
Chapter 7: Study Two - Phase Two: The Delphi Study 165 The risk of developing surgical wound complications can be affected by the nature of the intended surgical procedure. Four risk factors associated with surgical procedures achieved full consensus after three rounds for inclusion in the tool. These were surgical wound contamination classification, emergency surgery, preoperative surgical antibiotic prophylaxis, and type of surgery. These results are in agreement with the recommendation from Wounds Canada guidelines for the prevention and management of surgical wound complications (Canadian Association of Wound Care, 2017). However, three other factors did not achieve panel agreement, including duration of surgery, the length of perioperative hospital stay, and surgical wound site of an old scar. This finding was inconsistent with the recommendations from evidence- based guidelines, in which a longer duration of surgery or pre-surgery hospital stay of at least two days was identified as a factor associated with an increased risk of surgical site infection (Canadian Association of Wound Care, 2017; WHO, 2016a). The impact of longer surgical duration on postoperative wound infection is also supported by other research (Akhter et al., 2016; Broadbent et al., 2012; Davis et al., 2017; Dubory et al., 2015; Hijas-Gómez et al., 2017; Moghadamyeghaneh et al., 2015; Pathak et al., 2014; Rollins et al., 2016; Tada et al., 2016). It is difficult to explain the reason why Vietnamese wound care experts did not include the duration of the operative procedure in the tool, however the reason may be related to the perception of their inability to control the duration of the operation, which is dependent on surgeons and patient conditions. Therefore, nurse experts may be aware of it, yet may not consider it an important factor for them to assess. Regarding item length of preoperative hospital stay and surgical wound site of an old scar recommended by Vietnamese surgeons, these two items also did not reach panel agreement after three rounds and were excluded from the tool due to limited evidence about the impact of these two factors on surgical wound complications (Lieber et al., 2016).
Regarding the characteristics of surgical wounds, 13 items were sent to the panel for rating, and all 13 items achieved consensus after three rounds. However, only 12 items were included in the final surgical wound assessment tool, with the exception being maceration, because nurses’ comments indicated that there were different understanding of the term. This item was therefore excluded. The rest of the items that achieved agreement to be included in the tool indicated the importance of the assessment of characteristics of the surgical wound to monitor the status of wound
166 Chapter 7: Study Two - Phase Two: The Delphi Study healing. These 12 items measuring surgical wound characteristics from this study are consistent with a recommendation from evidence-based guidelines (Canadian Association of Wound Care, 2017; Wounds Australia, 2016); other wound assessment tools, such as the Leg Ulcer Measurement Tool (Woodbury et al., 2004), Photographic Wound Assessment Tool (Thompson et al., 2013); and also include all of the essential indicators of surgical wound infection, presented in the ASEPSIS tool, such as serous discharge, erythema, and purulent exudate (Wilson, Treasure et al., 1986).
7.7 STRENGTHS AND LIMITATIONS
There are some strengths and limitations of this current study. Selecting an appropriate methodology was an aspect that strengthened the outcomes of the study. The process of seeking Vietnamese surgeons’ consultation and applying the Delphi method were appropriate approaches to obtain convergence of opinion from experts to adapt the content of international practice guidelines into the Vietnamese context. Using an anonymity approach with panel members to promote open discussion made it possible to obtain information and advice from some of the most influential and experienced surgical nurses in Vietnam to contribute to the development of the detailed items of the tool to suit current wound care practice in Vietnam. Therefore, the SWAT is suitable for use in the Vietnamese context. Another strength of this study was the characteristics of participants. Both surgeons and nurses who participated in this study had high qualifications and many years of clinical experience in the surgical field. This confirmed their expertise in contributing to the content validity of the SWAT.
However, several limitations of this study need to be acknowledged. The first limitation is related to the selection of items to be included in the SWAT. Due to the purpose of developing a practical tool to use in a clinical setting rather than testing the relationship between risk factors and surgical wound complications, not all criteria in the two evidence-based practice guidelines were included in the SWAT for evaluation. Hence, only the factors that had a substantial impact on postoperative wound complications and were feasible to measure were selected in the initial SWAT. Another limitation was that selection bias may have occurred since a convenience sample was used. Only nurses and surgeons working in 10 tertiary hospitals were recruited to participate in the process to develop the SWAT. Therefore, the results may not necessarily reflect practices of health professionals regarding surgical wound care at other hospitals in Vietnam. Moreover, the concept of “expert” has not yet been
Chapter 7: Study Two - Phase Two: The Delphi Study 167 clearly defined in the literature, and those with expertise and specialist knowledge may not always have the time or willingness to participate in a study. Therefore, these experts were selected for a specific purpose, not randomly, resulting in the representative nature of the sample not able to be ensured. In addition, the level of consensus was chosen arbitrarily, because no clear guidelines could be used to establish consensus (von der Gracht, 2012). If a high consensus level was chosen (e.g., 80%), fewer items would be considered to include in the tool. This may have provided a more compact, easier-to-use, but less comprehensive list of tool items. To overcome this limitation, the level of consensus was designed using a combination of a percentage of agreement (panel agreement of at least 70%), combined with a mean 3.5 or higher (4-point Likert scale) as the standard to determine the level of consensus for all three rounds of this Delphi study, and there was evidence to support this as reasonable (Burgin, 2012; Keeney et al., 2011; Shelton, 2010). Finally, surgeons were not invited to participate in the Delphi study due it not being feasible for surgeons to participate in all three rounds. However, their input was taken into consideration as a foundation for the Delphi process.
7.8 CHAPTER SUMMARY
In conclusion, this chapter presented a process for developing a surgical wound assessment tool for use in Vietnam through three rounds of the Delphi process. Twenty-four items were recommended for inclusion in the SWAT to monitor surgical wound healing and detect early potential risk factors that affect wound healing. Even though smoking and duration of operation did not reach enough consensus to be included in the tool, these two factors have demonstrated their impact on surgical wound complications in previous studies. Therefore, these two items were still included in the tool to evaluate their impact in surgical wound complications. As a result, the final version of the SWAT consisted of 26 items and was divided into three sections. The first two sections included patient and surgical risk factors for poor healing (14 items). These sections are only for the first pre-operative assessment to determine potential factors increasing the risk of surgical wound complications, and will only be assessed once before surgery. However, the third section is the assessment of surgical wound characteristics (12 items) which will be used to monitor the progress of wound healing. This section will be usedto assess the surgical wound every day in the postoperative period until the patient is discharge from hospital. The following
168 Chapter 7: Study Two - Phase Two: The Delphi Study chapter presents the method and results of the evaluation of the validity and reliability of the SWAT.
Chapter 7: Study Two - Phase Two: The Delphi Study 169 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool
8.1 INTRODUCTION
The surgical wound assessment tool developed as described in Chapters 6 and 7 was designed to be easy and straightforward to use to monitor surgical wound healing and early detection of risk factors that could delay the healing of a surgical wound. A total of 26 items were included in the tool covering patient and disease factors, surgical procedural factors, and the characteristics of the surgical wound. The 26 items were developed based on evidence-based practice guidelines, consultation with Vietnamese surgeons, and an interactive Delphi process with Vietnamese wound care nurse experts to refine and develop a final version of the SWAT. The findings of Vietnamese nurses’ requirements for the surgical wound assessment tool (see Chapter 5) were also taken into consideration to format the structure and design the score system for the tool.
However, to conduct evidence-based practice, clinical data must be collected using reliable and valid tools. It was essential to evaluate the reliability and validity of the surgical wound assessment tool to identify to what extent the tool measures what it was designed to measure and to provide evidence to update the tool to suit the Vietnamese clinical setting. As a result, Study Three (evaluation study) was carried out to estimate the inter-rater reliability, construct validity, and validate which factors in the SWAT predicted surgical wound complications at post-operative day five to refine the tool to suit the clinical setting in Vietnam.
8.2 OBJECTIVES AND RESEARCH QUESTIONS
The objectives of Study Three were to:
Evaluate the inter-rater reliability of the surgical wound assessment tool.
Validate the construct validity of the surgical wound assessment tool.
Validate the risk factor items in the new surgical wound assessment tool that predict surgical wound complications at post-operative day five.
170 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool Study Three addressed the following research questions:
1. What is the inter-rater reliability of the new surgical wound assessment tool?
2. What is construct validity evaluation of the new surgical wound assessment tool?
3. Which risk factors in the new surgical wound assessment tool predict surgical wound complications at day five post-operative?
8.3 METHOD
8.3.1 Research design This study was a psychometric study to evaluate validity and reliability of the newly developed surgical wound assessment tool
8.3.2 Validity The research design was a prospective study to evaluate the validity and reliability of a new surgical wound assessment tool for use in Vietnam. In the literature, the term “validity of a scale” can be used to refer to the degree to which it measures what it is supposed to measure (Pallant, 2013). According to Soeken (2010), the three most basic types of validity are content validity, criterion validity, and construct validity. In this study, the validity of the surgical wound assessment tool was evaluated through construct validity.
Construct validity refers to the extent to which a scale measures the “construct” that it was designed to measure (Soeken, 2010). If a tool lacks construct validity, findings gained by the measure will be hard to interpret. Therefore, construct validity should be considered as the centre of any study in which researchers develop an instrument to assess a construct that is not directly observable (Cronbach & Meehl, 1955). There are some sub-dimensions of construct validity: convergent validity, discriminant validity, trait validity, and substantive validity (Streiner, Norman, & Cairney, 2015). They are usually evaluated by using: (1) the contrasted group approach, (2) hypothesis testing approach, (3) the multitrait-multimethod approach, and (4) factor analysis (Soeken, 2010).
The current study aimed to examine the construct validity of the SWAT by employing exploratory factor analysis (EFA). EFA is a normally useful method for the investigation of construct validity in cases where the relationships amongst variables
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 171 are unknown or ambiguous (Brown, 2015). If the instrument has high construct validity, the factors, dimensions, loading, and measurements from the EFA should all be appropriate for the original scale domains (Soeken, 2010).
8.3.3 Reliability The reliability of a scale means how free it is from random error (Pallant, 2013). There are four different types of reliability: test-retest, inter-rater reliability, intra-rater reliability, and internal consistency reliability (Waltz, Strickland, & Lenz, 2010b). However, for the current study, the reliability of the SWAT was evaluated through inter-rater reliability. Inter-rater reliability analysis “the degree of concordance or the consistency of the performance of two or more raters in recording the same responses at the same time” (Santos, Sellmer, & Massulo, 2007, p. 393).
8.3.4 Risk factors at postoperative day 5 Risk factors in the SWAT were included based on current evidence from the literature review. It was therefore essential to test which factors in the SWAT were statistically significant to predict surgical wound complications at day 5 postoperative for the Vietnamese populations. There were some reasons for using post-operative day 5 as a cut-off point for detecting surgical wound complications. First, according to the process of acute surgical wound healing, the first four postoperative days covers the inflammation phase and signs of inflammation are expected and normal. However, after day 4, continued signs of inflammation at the incision site and any increase in the amount of wound exudate are considered a negative outcome and signs of probable wound infection (Bates-Jensen & Woolfolk, 2012). Second, research also shows that surgical wound complications are more likely to occur from five postoperative days onwards (Dealey, 2005; Gillespie, Chaboyer, Kang et al., 2014).Unfortunately, it was not feasible to follow patients for 30 days after operation according to the Centres for Disease Control and Prevention guidelines for detecting surgical site infection due to the time limit and budget of a PhD. This would be an interesting area in which to conduct a prospective study in the future, with follow up to 30 days after operation. Finally, in Vietnam, patients remain in hospital much longer than they do in Western countries and are thus still likely to be in hospital at Day 5 post-operatively. Therefore, postoperative day 5 was considered a reasonable cut off for detecting early signs of surgical site infection.
172 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 8.3.5 Settings Haiduong General Hospital was again chosen to evaluate the reliability and validity of SWAT for the following reasons: (1) many emergency and elective operations are undertaken per month (400-600 operations per month), and it could therefore provide a wide sample for data collection; and (2) there were limited resources and time within the scope of undertaking this PhD study. A convenience sample setting was therefore used for this study.
8.3.6 Sample Construct validity was evaluated using EFA. To conduct EFA, it has been recommended that larger samples are better than smaller samples, because larger samples tend to minimise the probability of errors, maximise the accuracy of population estimates, and increase the generalisability of the results (Osborne & Costello, 2004). There are many different recommendations in terms of sample size for running EFA. For example, according to Comrey and Lee (1992), the following EFA findings present generalisability levels: 50 – very poor, 100 – poor, 200 – fair, 300 – good, 500 – very good, and 1,000 or more – excellent. Other authors have recommended using a subject to item ratio to estimate the sample size for EFA, such as a minimum subject to item ratio being 5:1, 10:1, or 20:1(Costello & Osborne, 2005). However, there is a widely cited rule of thumb recommended by Nunnally and Bernstein (1994) that the subject to item ratio for EFA should be at least 10:1. Therefore, for this current study, the sample size for EFA analysis was calculated based on subject to item ratio of 10:1. As such, for this SWAT with 26 items, the sample size to evaluate construct validity was 260 patients.
To test inter-rater reliability, the sample size was computed using the method described by Walter, Eliasziw, and Donner (1998), which estimates the sample size based on the intraclass correlation coefficient (ICC). It has been suggested that three raters are sufficient to meet the power requirement of 30 subjects, or two raters for at least 42 subjects (Walter et al., 1998). The use of two raters was supported by Sok, Palethorpe & Rodger, (2012). However, in this study, two nurses rating the same 60 patients were selected instead of using three raters due to the difficulty in gathering three nurses together at the same time to assess the same patient in a clinical setting. Therefore, a convenience sample of 60 patients with surgical wounds and two nurses were recruited for this study.
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 173 A convenience sample of nurses and patients who were admitted to Haiduong General Hospital from 1st November 2017 to 1st February 2018 was invited to participate in the study to test validity and inter-rater reliability of SWAT according to the following criteria:
Nurses
Inclusion for nurses:
currently worked in surgical wards;
graduated from 2, 3, or 4 year nursing programs;
a minimum of 12 months experience in surgical nursing;
willing to contribute to the study;
sufficient time to participate the study.
Patients
Inclusion criteria for patients
patients who had undergone elective or emergency surgery.
Exclusion criteria
patients undergoing endoscopic procedures not involving a surgical incision;
patients with chronic wounds;
patients who had wounds related to donor sites, skin grafts, pin sites;
patients diagnosed with cognitive impairment by the clinician;
patients unable to communicate in Vietnamese.
8.3.7 Procedure and data management After obtaining QUT Human Research Ethics Committee approval, and the letter of acceptance for conducting the evaluation study at Haiduong General Hospital, potential participants, including nurses and patients, were approached and the process of data collection began, as described below.
174 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 8.3.7.1 Nurse participants To evaluate the construct validity of the SWAT, a convenience sample of two nurses from each surgical ward was recruited using the following procedures. First, the head nurse of the surgical ward introduced the PhD student to their staff during the morning shift meeting, and the PhD student then gave a 10 minute presentation about the rationale, aims, and procedures of the study to nursing staff. Following this, nurses who met the inclusion criteria were given the information sheet to explain more about the study and their involvement in the study. Nurses were also given time to think about and decide whether to take part in the study. In the afternoon of the same day, the PhD student came back to the surgical wards to approach potential participants. Nurses who signed a consent form provided the researcher with contact details and negotiated a date, time, and location to further discuss how to use the surgical wound assessment tool in their normal routine of dressing change.
However, before starting the training section of how to use the surgical wound assessment tool, nurses received an explanation about their involvement, which included undertaking surgical wound assessment at the first dressing change after surgery, and at post-operative day 5 using the following process: (1) questioning patients regarding their medical history and life style, (2) removing the dressing, (3) using the surgical wound assessment tool to complete the information required in the SWAT, (4) treating and redressing the wound as per usual practice; and (5) returning the surgical wound assessment sheet to PhD student.
To increase the consistency and reliability of the data collection, training sessions were organised for eight nurses from four surgical wards and the training involved three sections: (1) providing instructions on how to use the SWAT and clarification of the terminology included in the tool, (2) applying the SWAT to practice evaluation of a photo of surgical wound, and finally, (3) using the SWAT to evaluate a real patient with a surgical wound. The outcomes of assessment between the eight nurses were compared and discussed until agreement was achieved between all nurses and the PhD student.
To evaluate inter-rater reliability, two nurses from the same surgical ward were asked to both do wound assessments on the same 60 patients. The process of wound assessment was carried out using the same process of data collection to evaluate construct validity as described above. However, in this phase, one patient was assessed
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 175 twice by two nurses. The same two nurses were asked to use the surgical wound assessment tool to perform the wound assessment in their routine daily dressing change. During their routine of dressing change, the first nurse performed a wound assessment after removing the dressing, and the second nurse undertook a wound assessment right after the first nurse finished the wound assessment and then treated and redressed the wound as per usual practice. The two nurses were asked not to exchange information about any information on the surgical wound assessment tool to ensure they remained blind to the ratings of the other nurse.
8.3.7.2 Patient participants In regards to recruiting patients, a convenience sample of 260 patients who met the inclusion criteria were recruited as follows:
The PhD student contacted the head nurses of each surgical ward each day to identify patients who met the inclusion criteria to invite them to participate in the study.
For identified patients with elective surgery, patients were contacted in the morning the day before their surgery to explain the rationale and aims of the study and to be given the patient information sheet. They were given around one hour to read the information and decide whether to participate in the study. Emergency patients were contacted on the day after their surgery to invite them to participate in the study.
Once patients verbally confirmed their consent to be involved in the study, patients were asked to sign the consent form to permit their wound assessment information to be used in this research project. The surgical wounds were assessed during the first dressing change after surgery and on day five post-operatively.
The PhD student knew which patients had agreed to participate in the study and let nurses know which patients were to be assessed in the first dressing change after surgery and who was in postoperative day five.
8.3.8 Data analysis Descriptive analysis using IBM SPSS version 25.0 (IBM Corp., Armonk, NY) was undertaken for all variables to describe the demographics and clinical data, and to
176 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool check variables for any violation of the assumptions underlying the statistical techniques used to address the research questions (Pallant, 2013). Frequencies and histograms were produced to obtain descriptive statistics for categorical variables, whereas means, medians, and standard deviations (SD) were checked to determine the normal distribution for all continuous variables. Normality was checked for all continuous variables, including subscale scores and overall scale according to the following rules: the median was within 10% of the mean; mean ± 3SD approximately represented the real minimum and maximum for symmetrical distribution; the skewness and Kurtosis coefficients were between ±2; and the histogram looked approximately symmetrical and bell-shaped (Kirkwood & Sterne, 2003). For this study, data were mostly normally distributed except for one variable, which was the length of the wound.
Inter-rater reliability was then examined based on the ICC because it has been suggested as the standard statistical method for assessing the agreement between two or more raters, and ICC also provides a measure of reliability to indicate whether the assessment tool could be used effectively by a variety of healthcare providers (Shrout & Fleiss, 1979). Therefore, ICC was applied to compare the ratings between two nurses on the score of three subscales and the score of overall scale in the SWAT. ICC coefficients are categorised between 0 and 1, the ICC values between 0.75 and 1.0 are considered excellent, the values of 0.40 to 0.75 show good agreement, and those with less than 0.4 showed poor agreement (Bower & Hobbs, 2009; Santos et al., 2007; Shrout, 1998). The acceptance level of ICC for this study was from 0.75 or higher. However, regarding the individual items of the SWAT, Cohen’s kappa was recommended to apply to the measurement of observer agreement for categorical data (Landis & Koch, 1977). A kappa value of 0.00-0.20 is considered slight; 0.21-0.04 fair; 0.41-0.60 moderate; 0.61-0.80 substantial, and 0.81 and over as almost perfect (Landis & Koch, 1977).
To identify the validity of SWAT, EFA using Mplus version 8 (Muthén & Muthén) was undertaken on items of the tool that included both categorical and continuous variables. EFA was chosen as it is a widely used technique for testing the construct validity of an instrument (Streiner et al., 2015) and enables a determination of whether the variables that are measured can be explained by a smaller number of factors (Norman, 2003). In this study, EFA was undertaken separately, with 14 items
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 177 associated with the first two domains, and 12 items in the last domain. There were two main reasons for conducting separate EFAs. First, items to measure risk factors in the first two domains and items measuring characteristic of surgical wounds in the last domain in the SWAT were obviously measuring different aspects, it was therefore not suitable to undertake EFA with all the items to identify the latent construct of the SWAT. Second, this analysis method was advised by consultant statisticians working at Queensland University of Technology, who suggested separate EFA. Subsequently, out of 14 items in the first two domains, EFA was only applied for 11 items, therefore excluding the use of steroids, chemotherapy, and immune deficiency due to the low incidence of these events. Another EFA was also carried out separately for 12 items of the third domain in the SWAT according to clinical surgical wound characteristics at post-operative day 1 and 5. The best EFA model was determined according to clinical adjustment and the statistic, which included the model’s fit with data for a non- significant χ2, and the chi-square to degrees of freedom ratio (χ2/df) of less than 3 (Kim, McGuire, Tulman, & Barsevick, 2005). A comparative fit index (CFI) and Tucker- Lewis Index (TLI) were used for values above 0.95 (Hu & Bentler, 1999); however, CFI and TLI values above 0.90 indicate as adequate fit (Hu & Bentler, 1999; Marsh, Hau, & Wen, 2004). The root mean square error of approximation and the standardised root mean – square residual values less than 0.05 suggest a good fit, but values up to 0.08 indicate as reasonable errors of approximation in the population (Marsh et al., 2004). Items were retained if they had a factor loading ≥ 0.3 on any of the factors. The domains of the SWAT were renamed according to the reflection of the core items within each factor.
To identify which factors in the SWAT had a significant relationship with surgical wound complications at post-operative day five, a general linear model (GLM) was applied. Surgical wound complications were measured by Day 5 SWAT scores, in which the high score shows the signs and symptoms of surgical wound complications. However, before running the GLM, the assumptions of GLM were checked to ensure there were no violations. Multicollinearity is detected using correlation matrix as results of EFA when examining the latent construct of the first two domains in the SWAT. If the correlation coefficient of two variables was larger than 0.6, one variable was deemed redundant to prevent two separate variables measuring the same aspect (Leech, Barrett, & Morgan, 2005). After checking all
178 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool correlations between items, GLM was run by initial simultaneous entry of all variables, then using the backward stepwise method to obtain a parsimonious model, taking the items out one by one (with the highest p-value) and checking there was no loss of model strength until the final model obtained.
8.3.9 Ethics consideration Study Three was approved by the QUT Human Research Ethics Committee (approval number 1700000125), the Haiduong Medical Technical University Research Ethics Committee (approval number 01-2017/QD-DHKTYTHD), and the acceptance letter for data collection from Haiduong General Hospital.
8.4 RESULTS
8.4.1 Demographic characteristics During the period of data collection from 6th November 2017 to 10 January 2018, a total of 940 operations were undertaken in the hospital. However, only 263 cases met inclusion criteria and were recruited for this study. Among the 263 patients, only three patients had open surgical wounds, and the rest were closed surgical wounds (surgical wounds heal by primary intention). This reflected the high prevalence of closed surgical wounds rather than open surgical wounds in this population. Therefore, this study focused only on reporting the outcome of validity and reliability of the SWAT for closed surgical wounds. Among 260 patients with a closed surgical wound, their ages ranged from 18 to 92 years, with a mean of 49 (sd: 18.63) years. There were 176 males (67.7%), and 74 females (32.3%). A total of 131 (50.4%) patients underwent orthopaedic surgery, and 89 patients (34.2%) experienced abdominal surgery. Urology and cardiothoracic surgery accounted for 7.7% each. The characteristics of the SWAT samples associated with patient disease factors, surgical procedure factors, and surgical wound characteristics at postoperative day 1 and 5 are shown in Table 8.1, Table 8.2, and Table 8.3.
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 179 Table 8.1: SWAT patient and disease factors: sample characteristics
Items (Part A) (n=260) Frequency n (%) Age (over 65 years) - No 201 (77.3) - Yes 59 (22.7) BMI - Less than 18.5 (underweight) 47 (18.1) - 18.5-22.9 (normal weight) 172 (66.2) - 23-27.5 (overweight) 36 (13.8) - Over 27.5 (Obese) 5 (1.9) Diabetes - No 224 (86.2) - Yes, HbA1C unknown 33 (12.7) - Yes, HbA1C ≤7% 3 (1.2) - Yes, HbA1C >7% 0 Smoking - Non-smoker 171 (65.8) - Previously smoked but gave up at least 4 weeks before 18 (6.9) surgery - Current smoker 71 (27.3) Use of steroids - Not used at all or used for less than 30 days before surgery 257 (98.8) - Used regularly for more than 30 days before surgery 3 (1.2) Chemotherapy - Not received at all 260 (100) - Received either currently or in the 30 days before surgery 0 Immune deficiency - No 259 (99.6) - Yes 1 (0.4) Risk of malnutrition - No 206 (79.2) - Yes 54 (20.8) Trauma wound - No 202 (77.7) - Yes, the duration from injury to surgery ≤ 6h 17 (6.5) - Yes, the duration from injury to surgery > 6 hours 41 (15.8) Mean(SD) Subtotal A score 2.04 (1.47)
180 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool Table 8.2: SWAT surgical procedural factors: sample characteristics
Items (Part B) Frequency (n=260) n (%) Surgical wound contamination classification - Clean 94 (36.2) - Clean-contaminated 85 (32.7) - Contaminated 65 (25) - Dirty/infected 16 (6.2) Emergency surgery - No 144 (54.5) - Yes, pathological condition 57 (21.9) - Yes, trauma 59 (22.7) Duration of surgery (hours) - Less than 1h 26 (10) - 1 - 3h 220 (84.6) - Between 3-6h 14 (5.4) - Over 6h 0 Preoperative surgical antibiotic prophylaxis - Clean wounds do not need antibiotic prophylaxis 18 (6.9) - Received within 120 minutes pre-incision 31 (11.9) - Received but more than 120 minutes pre-incision 149 (57.3) - Not received at all 62 (23.8) Type of surgery: (is this surgery exploratory abdominal surgery, hip prosthesis, colon surgery, coronary bypass or open reduction of fracture?) - No 46 (17.7) - Yes 214 (82.3) Mean(sd) Subtotal B score 4.44 (1.89)
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 181 Table 8.3: SWAT surgical wound characteristics: sample characteristics
Items Variable Post-operative Post- (Part C) day 1 operative (n=260) day 5 (258) n (%) n (%) Head 2 (0.8) Wound location Chest and abdomen 141 (54.2) Arm and leg 117 (45) Edges well approximated 80 (30.8) 126 (48.8) Wound edges Edges approximated but tension at 165 (63.5) 114 (44.2) the incision line Edges are not approximated and 15 (5.8) 18 (7.0) tension at the incision line Incision edges closed 246 (94.6) 174 (67.4) Wound bed Mostly epithelializing 0 64 (24.8) Mostly granulating 14 (5.4) 5 (1.9) Mostly sloughy 0 13 (5.0) Mostly necrotic 0 2 (0.8) Swelling No 7 (2.7) 75 (29.1) Yes 253 (97.3) 183 (70.9) Erythema No 150 (57.7) 150 (58.1) Yes 110 (42.3) 108 (41.9) Signs of No signs of haematoma 223 (85.8) 234 (90.7) haematoma One or more signs of haematoma 37 (14.2) 24 (9.3)
Mostly clear, amber 39 (15) 209 (81) Exudate: colour Mostly bloodstained 221 (85) 17 (6.6) and type Mostly cloudy, milky 0 32 (12.4) Mostly green or yellow 0 0 Dry 8 (3.1) 167 (64.7) Moist 160 (61.5) 75 (29.1) Exudate volume Wet 66 (25.4) 9(3.5) Saturated 26 (10) 7 (2.7) None 0 256 (99.2) Odour Present after removing the 0 2 (0.8) dressing Present before dressing removal 0 0 Surgical wound Iodine 241 (92.7) 238 (92.2) cleaning agents Sodium chloride 0.9% 0 1 (0.4) Both 19 (7.3) 19 (7.4) Wound pain on a 0 (no pain) 2 (0.8) 14 (5.4) numeric rating 1 - 3(mild) 15 (5.8) 153 (59.3) scale 0 -10 4 – 6 (moderate) 195 (75) 86 (33.3) 7 – 10 (severe) 48 (18.5) 5 (1.9)
Median (range) Incision length 13 (4-42) Subtotal C score 4 (0-10) 2 (0-13)
182 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 8.4.2 Inter-rater reliability The inter-rater reliability of the SWAT between two nurses was evaluated in 60 patients with a closed surgical wound. Patients’ ages ranged from 22 to 92 years, with a mean (SD) of 61.9 (17.1) years, and 37 (61.7%) were male patients. ICC estimates and their 95% confidence internals were calculated based on a mean-rating (k=2), absolute-agreement, 2-way mixed effects model for three subscales, and the overall scale. For subscales, the value of ICC was 0.77 (95% CI 0.62-0.86, p< 0.001) for the surgical wound characteristics domain, 0.94 (95 % CI 0.90-0.96) for the surgical procedure domain, and 0.95 (95 % CI 0.91-0.97, p< 0.001) for the patient and disease domain.
The values of ICC demonstrated good to excellent levels of inter-rater reliability for each domain. In regards to the overall scale, the average total score of the SWAT of the two nurses was 12.31 (SD = 1.63), and 12.53 (SD= 1.94), with an ICC value of 0.81 (95% CI 0.68-0.89, p< 0.001), confirming a very good level of inter-rater reliability for the overall SWAT scale.
With regards to individual items, the Cohen’s kappa measure of agreement between the two nurses was substantial to almost perfect for most items, with a k value ranging from 0.66 to 1 (p<0.001). Only five items (smoking, risk of malnutrition, wound bed, erythema, and exudate volume) showed a moderate level of inter-rater reliability between two nurses. However, one item (wound pain) had a kappa value of 0.06, confirming no agreement between the two nurses about this item. These results are presented in detail in Table 8.4.
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 183 Table 8.4: Inter-rater reliability results of the surgical wound assessment tool
Cohen’s Variable description ICC kappa Strength of (n=60) (95%CI) coefficient agreement Domain 1. Patient and disease factors - Age 0.97** Almost perfect - BMI 0.82** Almost perfect - Diabetes 0.53** Moderate - Smoking 1** Perfect - Use of steroids All agreement - Chemotherapy All agreement - Immune deficiency All agreement - Risk of malnutrition 0.60** Moderate - Trauma wound 0.82** Almost perfect Total subscore domain 1 0.95 (0.91-0.97)** Very good Domain 2. Surgical procedure factors - Surgical wound contamination 0.74** Substantial classification - Emergency surgery 0.84** Almost perfect - Duration of surgery 0.95** Almost perfect - Preoperative surgical antibiotic 0.91** Almost perfect prophylaxis - Type of surgery All agreement Total subscore domain 2 0.94 (0.90-0.96)** Very good Domain 3. Surgical wound characteristics - Wound location All agreement - Wound length 0.96** Almost perfect - Wound edges 0.66** Substantial - Wound bed 0.48** Moderate - Swelling All agreement - Erythema 0.57** Moderate - Signs of haematoma 1** Perfect - Exudate: colour and type 0.61** Substantial - Exudate volume 0.51** Moderate - Odour All agreement - Surgical wound cleaning All agreement agents - Wound pain 0.06* No agreement Total subscore domain 3 0.77 (0.62-0.86)** Good Total score 0.81 (0.68-0.89)** Very good ** p<0.001; *p>0.5
184 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 8.4.3 Construct validity Separate EFA with 1, 2, and 3 factors were carried out to determine the construct of the first two domains (patient disease factors and surgical procedure factors domains) in the SWAT. Eleven items out of a total of 14 risk factors in the SWAT were tested using EFA, except for three items: the use of steroids, chemotherapy, and immune deficiency, due to the low prevalence of these events. The result of the EFA indicated that a two-factor solution was the most acceptable. The two-factor model had a good fit, with χ2/df = 2.00, p=0.005, CFI=0.98, TLI=0.97, and RMSEA= 0.06. The correlation between the two factors was 0.123. As shown in Table 8.5, six items loaded on the first factor, and three items loaded on the second factor.
The first factor was related to a patients’ health condition and was named “patient health-related factors”, which consisted of age, diabetes, smoking, the risk of malnutrition, preoperative surgical antibiotic prophylaxis, and type of surgery. The second factor was associated with the nature of the surgical procedure “intra-operative related factors”, including whether the wound was traumatic, surgical wound contamination classification, and emergency surgery. Trauma wounds were associated with both factors, while BMI and duration of surgery did not load on either factor.
Table 8.5: Factor structure of the first two domains associated with risk factors in the surgical wound assessment tool
Patient health-related factors SC Intra-operative related SC factors Age 0.59 Diabetes 0.81 Smoking -0.34 Risk of malnutrition 0.40 Preoperative surgical 0.47 antibiotic prophylaxis Type of surgery 0.48 Trauma wound -0.76 Trauma wound 0.94 Surgical wound 0.91 contamination classification Emergency surgery 0.95 SC: Structure coefficient
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 185 Separate EFA with one or two factors were applied to determine the construct validity of the surgical wound characteristics domain in the SWAT. However, due to some characteristics of the surgical wound not being assessed at post-operative day 1, EFA was only applied for the assessment on the 5th postoperative day. All 12 items associated with the clinical surgical wound characteristics domain in the SWAT at post-operation day 5 were tested to determine the latent constructs. One construct was found to be the most acceptable (Table 8.6). As can be seen in Table 8.6, structure coefficients indicated how well each item loaded onto its latent construct at post- operative day 5. However, wound location, wound dimension, and surgical wound cleaning agents loaded weakly in this factor.
Table 8.6: Factor structure of the surgical wound characteristics domain in the surgical wound assessment tool
Clinical surgical wound characteristics at Structure coefficient postoperative day 5 Wound location 0.06 Wound length 0.03 Wound edges 0.94 Wound bed 0.30 Swelling 0.90 Erythema 0.74 Signs of haematoma 0.58 Exudate: colour and type 0.97 Exudate volume 0.84 Odour 0.63 Wound pain 0.62 Surgical wound cleaning agents 0.03
8.4.4 Risk factors predicting surgical wound complications at post- operative day five To further explore which factors in the SWAT increased the risk of surgical wound complications at post-operative day 5, a GLM was carried out, as described below.
186 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool First, to prevent two items measuring the same aspect, multicollinearity was examined using the correlation matrix from results of the EFA presented above. The correlation matrix in EFA detected a strong correlation between some items including:
Surgical wound contamination classification and emergency surgery: r = 0.86.
Surgical wound contamination classification and trauma wound: r = 0.82.
Emergency surgery and trauma wound: r = 0.89.
These three items (surgical wound contamination classification, trauma wound, and emergency surgery) were then checked for their correlation with surgical wound characteristic scores from postoperative day 5 by running nonparametric correlations. The results were:
Surgical wound contamination classification: r = 0.57, n= 258, p < 0.001.
Trauma wound: r = 0.32, n= 258, p < 0.001.
Emergency surgery: r = 0.46, n= 258, p <0.001.
As a result, out of these items, only surgical wound contamination classification was selected for the GLM for analysis due to surgical wound contamination classification having the stronger correlation with the outcome variable (surgical wound characteristics at post-operative day 5). Trauma wound and emergency surgery were then excluded from the GLM model.
The second step was to determine which items were able to be entered into the GLM. Out of 14 items in the first two domains (patient and disease factors and surgical procedure factors) in the SWAT, 10 items were entered simultaneously into the GLM to explore which of these items were independently associated with surgical wound complications at post-operative day 5. The chemotherapy and immune deficiency items were not included in the model due to the low prevalence of patients with immune deficiency and who had received chemotherapy in this sample. The trauma wound and emergency surgery items were also excluded in the GLM model due to the risk of multicollinearity and their strong correlation with surgical wound contamination classification. The remaining 10 items were entered into the GLM model.
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 187 The initial GLM contained 10 items entered simultaneously, including age, BMI, diabetes, smoking, use of steroids, the risk of malnutrition, surgical wound contamination classification, duration of surgery, preoperative surgical antibiotics prophylaxis, and type of surgery. To obtain a parsimonious model, a backward stepwise process was followed, removing items one by one with the highest p-value, and checking that the removal made no or minimal difference to the model R square value. The final model contained five independent variables that were statistically significant, model value F = 16.46, p<0.001. This indicated that those five variables were independently significantly associated with surgical wound complication at post- operative day 5 score. The model as a whole explained 37.6% (adjusted R square) of the variance in the postoperative day 5 score. As shown in Table 8.7, five independent items made a unique and statistically significant contribution to surgical wound complications at post-operative day 5.
Table 8.7: General linear model analysis of predictors of surgical wound complications at post-operative day 5 (complications as measured by Day 5 SWAT scores)
Items B P 95% CI BMI 0.04value - BMI = 18.5 - 22.9 (normal weight) Ref - BMI < 18.5 (underweight) 0.21 0.53 - 2.30 - 1.20 - BMI = 23 - 27.5 (overweight) 1.01 0.006 0.29 - 1.70 - BMI > 27.5 (obese) 0.56 0.53 - 2.3 - 1.19 Diabetes 0.04 - No Ref - Yes 0.75 0.04 0.03 - 1.47 Surgical duration 0.002 - Less than 1h Ref - 1 - 3h 1.01 0.01 0.21 - 1.82 - Over 3h 2.43 < 0.001 1.10 - 3.77 Surgical wound contamination classification < 0.001 - Clean Ref - Clean-contaminated 1.27 < 0.001 0.66 - 1.89 - Contaminated 2.54 < 0.001 1.90 - 3.18 - Dirty/infected 4.23 < 0.001 3.22 - 5.36 Type of surgery (Is this surgery exploratory 0.02 -abdominal No surgery, hip prosthesis, colon surgery, Ref -coronary Yes bypass, or open reduction of fracture?) 0.76 0.02 0.10 - 1.41
188 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool The first independent factor was BMI. Compared to patients with normal weight, overweight patients had a 1.01 (95% CI 0.29 -1.70, p = 0.006,) mean increase in risk for postoperative wound complications. However, there was no difference in the mean of risk postoperative wound complications between participants with normal weight and those who were underweight.
In regards to diabetes, as can be seen in Table 8.7, patients diagnosed with diabetes had higher mean of postoperative wound complications at day 5 compared to those who did not have diabetes (B = 0.75, 95% CI 0.03-1.47, p=0.04).
Regarding the duration of surgery, increased length of operation was associated with increased risk of surgical wound complications. Compared to operations lasting less than one hour, the risk of wound complication was 1.01 units higher (95% CI 0.21 - 1.82, p=0.01) for durations from 1-3 hours, and this risk of complication increased to 2.43 units (95 % CI 1.10 - 3.77, p < 0.001) when the operation lasted longer than three hours.
Surgical wound contamination classification was a strong independent factor of surgical wound complications. The mean score of surgical wound complications increased from 1.27 (95% CI 0.65 -1.89, p<0.001) to 4.23 (95%CI 3.22 - 5.36, p<0.001) units for patients who had clean-contaminated to dirty/infection wounds, respectively, when compared to those who had a clean wound.
Finally, patients who had high-risk types of surgery had a 0.76 (95% CI 0.10 – 1.42 p = 0.02) unit increase in risk for postoperative wound complications at day 5 compared to those did not have high-risk types of surgery.
8.5 DISCUSSION
This chapter presented the evaluation study outcomes of the SWAT, which was tested in the Vietnamese population. The SWAT was tested for inter-rater reliability and construct validity. Two nurses independently assessed the same 60 patients with a closed surgical wound to evaluate the reliability of the SWAT. A sample of 260 patients was analysed by using exploratory factor analysis to determine the construct validity of the SWAT. This section discusses the findings of this study to answer the three research questions associated with reliability, validity, and risk factors predicting postoperative wound complication at day 5 post operation.
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 189 Reliability is the consistency between independent measurements of the concept by following the same procedure. Using the same measurement methods and obtaining the same results means that the measurement is free from random errors (Streiner et al., 2015). Low inter-rater reliability would cause adverse disadvantage, because in clinical practice, the assessment tools are used by many different healthcare professionals at different points of time. Therefore, high degrees of error would mean these tools may be useless (Kottner, Dassen, & Tannen, 2009). For this study, the SWAT total scale and subscales demonstrated good to the excellent levels of inter- rater reliability. The ICC was 0.81 for the total scale and 0.95 for patient and disease factors domain, 0.94 for surgical procedure factors domain, and 0.77 for surgical wound characteristics domain, respectively.
In regards to individual items, the SWAT also demonstrated moderate to excellent levels of agreement between raters for 25 out of the 26 items of the tool, with the one exception being the pain item. Pain assessment had a Cohen’s kappa value of 0.06, demonstrating no agreement between the two nurses on this item. Compared to other wound assessment tools, among the 14 wound assessment tools reviewed in Chapter 3, only the Leg Ulcer Measurement Tool (LUMT) included measuring wound pain in the tool (Woodbury et al., 2004). In the LUMT, pain was measured as pain amount using a numerical rating scale, and pain frequency. Even though inter-rater reliability was established for individual items in the LUMT, the author only evaluated and reported the result of ICC on the wound characteristics domain; however, no rating result on wound pain was reported in the LUMT (Woodbury et al., 2004). Therefore, the level of agreement on measuring wound pain in the LUMT was unclear. In the current study, it is hard to explain the no agreement rating results on wound pain; however, through the PhD student’s observation during the data collection, it appeared that some nurses used their estimation about patient’s pain rather than recording the patient’s reported pain level. The different perspectives of pain levels between nurses may have resulted in no agreement in the assessment of this item. Therefore, clear instruction about how to assess pain is required in the SWAT instruction manual to avoid inconsistencies when measuring pain.
In terms of validity, this study evaluated the construct validity of the SWAT to refine the number of items and to improve the validity and reliability of the scale. EFA is often used to validate the constructs of a tool because it is the ability to summarise
190 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool and group items into meaningful groups according to the relationships within the items (Chang, Gardner, Duffield, & Ramis, 2012). The construct validity of the 26 items were examined separately using EFA. The results from the EFA with 11 items associated with risk factors indicated that two subscales were most acceptable, confirming two subscales was appropriate for measuring risk factors in the SWAT.
Factor 1, which included six items: age, diabetes, smoking, the risk of malnutrition, preoperative surgical antibiotic use, and type of surgery had a factor loading range from 0.34 to 0.81 and no cross loading. Within this subscale, the most important risk factors were related to individuals and their health conditions. These findings were consistent with recommendations set in the Standards for Wound Prevention and Management (Wounds Australia, 2016), in which comprehensive and ongoing assessment of the individual’s health and wellbeing risk of wound healing is recommended to be conducted and documented. However, this subscale, renamed slightly, was compared to the original SWAT based on the core items in this factor “patient health-related factors”. When compared to other wound assessment tools, there are some factors that are consistently included in the risk assessment tools to predict wound healing in chronic leg ulcers, such as ulcer area, duration of ulcers, age, lives alone, uses an aid to mobilise, and wound bed characteristics (Falanga, Saap, & Ozonoff, 2006; Parker, Finlayson, & Edwards, 2017; Skene, Smith, Doré, Charlett, & Lewis, 1992). However, in the case of pressure ulcers, mobility, nutrition, moisture, and sensory impairment were identified and included in the risk assessment tool to predict the healing of pressure ulcers (Braden & Bergstrom, 1987; Waterlow, 1985). This example demonstrates that even though both leg ulcers and pressure ulcers are classified under the same category of chronic wounds, risk factors predicting wound healing on two type of wounds are different due to the different pathologies that cause wounds. Therefore, making the comparison between “patients health-related factors” in the SWAT and other risk assessment tools is difficult, because acute and chronic are different types of wounds. However, numerous studies have demonstrated that the six factors in the SWAT are factors known to increase the risk of surgical wound complications (Dubory et al., 2015; Hijas-Gómez et al., 2017; Neumayer et al., 2007; Rosenthal et al., 2013; Wong et al., 2012; WHO, 2016a).
Factor 2 included three items (trauma wounds, surgical wound contamination classification, and emergency surgery). Trauma wounds cross-loaded in both factor 1
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 191 and 2, with factor loadings of 0.76 and 0.94 respectively. However, the results showed that this item loaded more strongly on the second factor. Thus, this item was retained in the second factor. Within the second factor, these three items were associated with the surgical procedure “intra-operative related factors”. This subscale of the SWAT was supported by the Best Practice Recommendation for the Prevention and Management of Surgical Wound Complications (Canadian Association of Wound Care, 2017). In that document, these factors are categorised as intra-operative risks of postoperative wound complications. When comparing with the ASEPSIS tool, none of the risk factors associated with surgical procedures in the current study were included in the ASEPSIS tool because the ASEPSIS tool uses only clinical characteristics of surgical wounds to predict wound infection, such as erythema, purulent exudate, separation of deep tissues, and isolation of bacteria (Wilson, Treasure et al., 1986). However, surgical wound contamination classification, emergency surgery, and trauma wounds were consistently found to be independent risk factors of postoperative wound complications in the literature (Korol et al., 2013; Ridgeway et al., 2005; van Ramshorst et al., 2010)
Two items (BMI and duration of surgery) in the SWAT did not load on either factor. However, the two items were identified as independent predictors of surgical wound complications at post-operative day in 5 in this sample. Thus, these two items remained in the tool. Including BMI under “patient health-related risk factors” was deemed most appropriate, while the duration of surgery was included under “intra- operative related risk factors” for future testing.
In regards to the 12 items associated with surgical wound characteristics of the SWAT, the results of EFA showed that one factor with 12 items was the most appropriate. Out of 12 items, only nine items loaded strongly on one factor, with a factor loading range from 0.3 to 0.97. The remaining three items: wound location, wound dimension, and surgical wound cleaning agents, loaded weakly on this factor. However, wound location and wound dimension were retained in the tool because these two items are basic characteristics of a surgical wound. Surgical wound cleaning agents was removed from the SWAT, resulting in a total of 11 items being maintained in the surgical wound characteristics domain.
The 11 items included wound location, wound dimension, wound edge, wound bed, swelling, erythema, signs of haematoma, type of exudate, the volume of exudate,
192 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool odour, and wound pain. These items being under one construct covering the basis of surgical wound characteristics and surgical wound complications was supported by clinical practice guidelines (Canadian Association of Wound Care, 2017; Wounds Australia, 2016), frameworks such as TIME framework (Leaper et al., 2012; Schultz et al., 2003), and the Surgical Wound Care Algorithm framework (Han & Choi-Kwon, 2011). When comparing with other wound assessment tools, almost all of the main items to measure the characteristics of surgical wounds in the SWAT were consistently included in other wound assessment tools such as LUMT (Woodbury et al., 2004), PWAT (Thompson et al., 2013), and the ASEPSIS tool(Wilson, Treasure et al., 1986). This confirmed the content and construct validity of the SWAT.
Although EFA is commonly used in instrument-development research (Brown, 2015), it is claimed that the EFA method does not prove sufficient information to confirm the theoretical and statistical model of an instrument (Streiner et al., 2015). Therefore, further evaluation of the SWAT is recommended through confirmation of a factor analysis in a new sample to test and confirm the factor structure obtained from this study.
Regarding items in the SWAT predicting post-operative wound complication at day 5, 10 out of the total 14 items in the first two domains (the patient and disease factor domain and surgical procedure domain) were evaluated for their impact on surgical wound complications at postoperative day 5. Five out of 10 items in the SWAT made a unique statistically significant prediction of surgical wound complications at day five post operation: BMI, diabetes, surgical wound contamination classification, duration of surgery, and type of surgery.
These five items have previously been identified as risk factors of surgical wound complications in studies conducted in Vietnam (D. Nguyen et al., 2001; Sohn et al., 2002; Thu et al., 2005) and other overseas research, such as for surgical wound contamination classification, duration of surgery, type of surgery (Aga et al., 2015; Akhter et al., 2016; Hijas-Gómez et al., 2017; Rosenthal et al., 2013; Yano et al., 2016), BMI (Davis et al., 2017; Meyer et al., 2016), and diabetes (Korol et al., 2013). These findings indicate that even in the different context of Western or Vietnamese cultures, these five factors are consistently identified as independent factors contributing to the poorer recovery of surgical wounds. Therefore, targeting patients
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 193 with these risk factors is particularly important because they are at high risk of developing postoperative surgical wound complications.
Contrary to expectation, the remaining five items in the first two domains in the SWAT did not reach statistical significance in predicting surgical wound complications at day 5 in this sample: smoking, age over 65 years, use of steroids, the risk of malnutrition, and the use of preoperative antibiotics. Smoking was found to be a significant contributor to increased risk of surgical wound complication in various studies (Durand et al., 2013; Mawalla et al., 2011); however, the relationship between smoking and surgical wound complications was not confirmed in the current study. Interestingly, even though there were three studies undertaken in the Vietnamese population to examine the risk factors of surgical site infection, none of these studies included smoking in their study to evaluate the impact of smoking on postoperative wound complications (D. Nguyen et al., 2001; Sohn et al., 2002; Thu et al., 2005). This may explain why Vietnamese health care professionals also did not consider smoking to be a risk factor for surgical wound healing, resulting in smoking not reaching consensus after three rounds of the Delphi process (see Chapter 7). The possible explanation for smoking not reaching statistical significance in the present study might be explained by the short follow up period after surgery (5 days), which may have led to inadequate power to detect smoking as a risk factor for surgical wound complications for this population. Other studies found smoking to be a risk factor of postoperative wound complications when following up 30 days postoperatively (Mawalla et al., 2011) to one year (Durand et al., 2013).
Similarly, in contrast with some studies conducted in the Western population (Khalil et al., 2015; Tada et al., 2016), in this current study, advanced age was not related to surgical wound complications and this finding was consistent with other studies undertaken in the Vietnamese population (D. Nguyen et al., 2001; Sohn et al., 2002; Thu et al., 2005). This inconsistency of findings when compared to other studies conducted in Western populations may be due to the low prevalence of people over 65 years old (22.7%) in the current study resulting in inadequate information to detect an increased risk of wound complications, while other studies had high prevalence of patients being 65 years or more in their target population (Khalil et al., 2015; Tada et al., 2016).
194 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool In regards to the risk of malnutrition, the present findings contrast with previous studies (Anannamcharoen et al., 2012; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007). A possible explanation for these different results may be the use of different methods to measure the risk of malnutrition. In the current study, the risk of malnutrition was measured based on the two questions from the Mini Nutritional Short-form Assessment, which relied on patient self-reporting (Kaiser et al., 2009), while other studies have used more objective measurement to measure malnutrition, such as using serum albumin level (Anannamcharoen et al., 2012; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007) or weight loss > 10% (Gourin et al., 2014).
With regard to use of steroids, it has been established as a significant predictor of the postoperative surgical site infection in a number of studies (Ismael et al., 2011; Lieber et al., 2016; Merkler et al., 2014; Moghadamyeghaneh et al., 2015; Neumayer et al., 2007; Sullivan et al., 2012); however, in this current study, this factor did not reach statistical significance. This result may be explained by the fact that only a few patients reported the use of steroids in this sample, resulting in inadequate power to detect wound complications.
However, there are other possible explanations for the different findings of this current study compared to previous studies. First, a different measurement was used for wound complications in the current study compared to other studies. In the present study, adverse event (outcome variable) was measured based on surgical wound score in the SWAT at post-operative day 5, in which a high score indicated a higher risk of surgical wound complications. Whereas, other studies have measured an adverse outcome as surgical site infection or surgical wound dehiscence up to 30 days after the operation or up to one year following up (Durand et al., 2013; Mawalla et al., 2011). Second, in this study, some items, such as the risk of malnutrition, use of steroids, and smoking relied on self-reporting, which may have led to inaccurate reporting, while other studies have used more objective measurement to measure risk factors. Finally, the low prevalence of adverse events for some factors in the present study, including the use of steroids, the risk of malnutrition, and age, may reflect inadequate power to detect an increased risk of surgical wound complications at day 5 after the operation. Even though these items did not reach statistical significance, this does not exclude the possibility that a clinically significant difference may exist. Therefore, prospective
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 195 studies with larger sample sizes and across multiple centres are recommended to verify these findings.
8.6 STRENGTHS AND LIMITATIONS
Some limitations of this study should be noted. Although the sample was reasonably large, the SWAT was tested on a convenience sample (one single setting) and with a homogeneous group of patients who underwent general surgeries. Therefore, generalisation of the findings to the wider population cannot be assumed. Additionally, the SWAT was originally developed to measure wound healing for both closed and open surgical wounds, but was tested only in surgical wound healing by primary intention. Patients with open surgical wounds (wounds healing by secondary intention, and delayed primary intention), which often experience higher risk of postoperative wound complications, were not included in this study due to an insufficient number of patients with open surgical wounds during the data collection period. The validity and reliability of the SWAT can therefore not be generalised to both closed and open surgical wounds. Moreover, due to restrictions of time while undertaking this PhD, patients were only followed up to post-operative day 5, which may have resulted in limited capacity in detecting all type of wound complications. Therefore, a prospective study with a longer follow up (up to 30 days according to the Centres for Disease Control and Prevention [2016]) is required to confirm the findings of this study. Regarding inter-ratter reliability, some limitations should be acknowledged. Firstly, asking nurses to “not confer” when they are using the tool immediately after each other could be a limitation of the study. In addition, as the inter- rater reliability test results related to wound characteristics was (at kappa =0.77) was not high, developing some educational resources that discuss wound bed, exudate and erythema assessment are recommended as a focus for nurse education and for future pedagogical research. Finally, only two experienced nurses evaluated the inter-rater reliability of the SWAT; thus, the inter-rater reliability of the SWAT should be further tested with other health professional disciplines, such as surgeons, nurses, educators, and nursing students to confirm these findings.
8.7 CHAPTER SUMMARY
In conclusion, a good tool or scale can take years to develop. It is vital to continue testing, modifying, and improving the tool. This study has taken the first step by
196 Chapter 8: Study Three - Evaluation of the reliability and validity of the tool examining the inter-rater reliability and construct validity of the tool. These findings demonstrated a very good level of inter-rater reliability of the SWAT. The construct validity of the tool was tested using EFA, and the results indicated that the two subscales for risk factors in the SWAT and one subscale for clinical characteristics of the surgical wound were adequate to monitor wound healing and detect early factors impacting the healing of a surgical wound. Even though three items; that is, use of steroids, chemotherapy, and immune deficiency, were not included in the EFA to test due to the low prevalence of these events, these three items were retained under the “patient health-related factor” subscale for further testing. As a result, the first domain in the SWAT (patient health related factors), included 10 items, and the second domain (intra-operative related factors) contained four items. The final domain was clinical surgical wound characteristics, which included 11 items rather than the 12 items in the original SWAT due to surgical wound cleaning agents being excluded according to the results of the EFA. In the future, confirmatory factor analysis should be conducted to confirm the factor structure, and a prospective study is also recommended to test the predictive accuracy of the tool by evaluating the area under the receiver operating characteristic curve and calibration (Hosmer-Lemeshow statistic).
Chapter 8: Study Three - Evaluation of the reliability and validity of the tool 197 Chapter 9: Discussion and Conclusion
9.1 INTRODUCTION
This research project had three main aims and included three studies. The first study was conducted to examine the current practice of surgical wound assessment and documentation in Vietnam. The second study presented the process of developing a surgical wound assessment tool. The final study was used to evaluate the validity and reliability of the surgical wound assessment tool (SWAT), which was developed based on the results of Study Two.
This chapter is divided into four main sections. First, the key findings of the three main aims of the three studies are discussed, along with their contribution to global knowledge, followed by the strengths and limitations of this research project. Recommendations are then provided for the use of the surgical wound assessment tool in clinical practice, education, and research. Finally, strategies to implement the SWAT into clinical practice in Vietnam are also proposed for a further step of implementation.
9.2 SUMMARY OF KEY FINDINGS
9.2.1 Study One aim: To identify and describe surgical wound assessment and documentation practices in Vietnam
An excellent standard structure of care is required to assess, diagnose, and manage wounds, and that assessment is fundamental to planning care (Wounds UK, 2008). Study One, reported in Chapter 5, examined the current practice of surgical wound assessment and documentation in Vietnam and indicated several issues related to surgical wound assessment. First, that Vietnamese nurses do not use a structured approach to guide their wound assessment. The most commonly reported method of assessing surgical wounds was a combination of observation and clinical experience, and no standard guidelines were used for surgical wound assessment. Not using a structured wound assessment approach may result in subjective assessment, and the omission of critical information. This was demonstrated by nurses assessing a clinical scenario using the think aloud technique. The findings showed that only a few wound
198 Chapter 9: Discussion and Conclusion components, such as wound edge, peri-wound skin, the volume of exudate, and signs of infection were focused on during nurses’ assessment. Other wound characteristics and risk factors associated with wound healing were less frequently collected. These results are in agreement with previous studies (Cook, 2011; Gillespie, Chaboyer, Allen et al., 2014). Inadequate performance of wound assessment in Vietnam may be explained by a lack of knowledge and skills about wound assessment due to insufficient preparation in their nursing program (see Section 3.4), a lack of nurses with higher qualifications (WHO, 2013), and lack of knowledge and skills for conducting evidence-based practice (T. N. Nguyen & Wilson, 2016). In a recent systematic review conducted up to 2017 on nurses’ knowledge and skills on wound management, Welsh (2018) indicated that nurses do not always have sufficient knowledge to provide an appropriate assessment of wounds and optimal care to promote wound healing. Even in a situation where a nurse’s knowledge is sufficient, the application of knowledge in the clinical setting is still poor (Gillespie, Chaboyer, Allen et al., 2014). It has been suggested that knowledge, attitudes, and behaviour are associated with each other. Knowledge influences attitudes, and then attitudes affect behaviour (Cabana et al., 1999). Therefore, improving Vietnamese nurses’ knowledge, and attitude about evidence-based wound care practice may be closely linked to behavioural practice change.
Second, Study One also showed that surgical wound assessment documentation in Vietnam does not meet the Standards for Wound Management (Wounds Australia, 2016). In this study, surgical wound characteristics and the risk factors associated with increased surgical wound complications were documented as insufficient and imprecise, in which significant aspects of surgical wound healing status such as wound bed, peri-wound skin, type of exudate, and wound dimension were missing. These findings about surgical wound assessments associated with inadequate documentation have been supported in overseas research (Danielsson-Ojala et al., 2010; Gartlan et al., 2010; Gillespie, Chaboyer, Kang et al., 2014; L. N. Smith & Lait, 1996). It is acknowledged that nursing documentation is the foundation for protecting nurses’ legal status, confirming their contribution to patient care and that it can also be used as the evidence to demonstrate patient outcomes (Sondergaard et al., 2017). Therefore, these findings about surgical wound assessment documentation raise doubts to justify the validity of wound care intervention without complete and well-documented
Chapter 9: Discussion and Conclusion 199 assessment. Even though wound care practices was one area researched in this study, the findings were found to be similar to findings in other nursing practice areas in Vietnam. For example, Vietnamese nurses’ knowledge and skills in palliative care were identified as low and requiring more education to develop their knowledge and skill in nursing care (Nguyen, Yates, & Osborne, 2014). Therefore, more formal and informal wound care education programs are required in Vietnam to enhance nurses’ knowledge and skills in the management of patient care.
9.2.2 Study Two aim: To develop a surgical wound assessment tool Based on a review of the literature (see Section 3.2) associated with existing wound assessment tools, out of 14 existing wound assessment tools, only one tool was designed for surgical wounds, the ASEPSIS tool (Wilson, Treasure, et al., 1986). However, this tool primarily focusses on evaluating surgical wound infection rather than providing a comprehensive surgical wound assessment. This integrative review found considerable gaps in the literature regarding the validation of surgical wound assessment tools.
Thus, this gap led to the development of a surgical wound assessment tool for use in Vietnam (Study Two), which was reported in Chapters 6 and 7. The surgical wound assessment tool was developed in two phases. Phase One was reported in Chapter 6, with the initial SWAT developed based on international evidence-based guidelines and a comprehensive literature review along with advice from wound care experts in the research team. Following this, 10 Vietnamese surgeons evaluated the initial SWAT by rating the importance of items. Phase Two was reported in Chapter 7 and included Vietnamese wound care nurse experts in an interactive Delphi process to refine and develop the final version of the SWAT.
In Phase One of Study Two, the initial SWAT was developed based on the standards and principles presented in two international evidence-based guidelines for wound management and preventing surgical wound complications (Canadian Association of Wound Care, 2017; Wounds Australia, 2016). The comprehensive literature review provided up to date evidence in developing response options for each item. Consequently, 22 items were identified for the assessment of surgical wound healing and early detection of risk factors for surgical wound complications. The 22 items in the initial SWAT contained three subscales corresponding to items identified by the modified version of Surgical Wound Care Algorithm framework (Han & Choi-
200 Chapter 9: Discussion and Conclusion Kwon, 2011) combined with the TIME framework (Leaper et al., 2012) for surgical wound assessment (see Chapter 4). The three domains of the SWAT included patient and disease risk factors (7 items), surgical procedure factors (3 items), and surgical wound characteristics (12 items).
Even though the initial SWAT was developed based on international evidence- based guidelines, the SWAT was further developed and improved through a number of processes in order to be suitable for the Vietnamese context. First, the initial SWAT was sent to a panel of 10 surgeons from different hospitals across Vietnam for their feedback. Ten Vietnamese surgeons evaluated the initial SWAT by rating the importance of the items, and the level of content validity of the initial SWAT was determined as the content validity for items and content validity of the overall scale. The initial surgical wound assessment tool had item-content validity index scores of 1.00 in 17 out of 22 items, confirming surgeons’ agreement on essential items to be included in the tool. The overall scale content validity index also achieved 0.97, showing an average of 98% agreement across items. Eight more items were suggested by surgeons and were added to the initial tool. This increased the total items of the tool to 30. The second phase of development of the SWAT was the Delphi process.
Thirty items and their response options were evaluated through three interactive rounds of the Delphi process. The high response rate across all three rounds demonstrated the nurse experts’ commitment to identifying appropriate components for measuring surgical wound healing and detecting risk factors for surgical wound complications. In addition, a panel with a high level of educational qualifications and years of experience in the nursing field (median of 15 years’ experience) also confirmed their expertise and ability to contribute to the knowledge generated in this study. After the end of the third round of the Delphi process, consensus had been achieved for 24 items out of 30 items seen as being important in measuring surgical wound healing and early detection of risk factors of surgical wound complications. Twenty-four items were organised into three subscales, in which eight items were associated with patients and disease risk factors, four items related to intra-operative risk factors, and 12 items were related to the surgical wound characteristics. Even though smoking and duration of surgery did not reach consensus after three rounds, these two factors were identified as strong risk factors of surgical wound complications, and were therefore included in the tool for further evaluation.
Chapter 9: Discussion and Conclusion 201 Accurate measurement of the surgical wound is essential because it plays a vital role in providing appropriate intervention (Canadian Association of Wound Care, 2017). It is therefore necessary to complete a detailed pre- and intra-operative assessment to identify potential factors that may impact healing and the risk for postoperative wound complications. Conducting holistic and comprehensive assessment results in an appropriate plan of care for preventing surgical wound complications (Canadian Association of Wound Care, 2017). The SWAT was developed after three rounds of the Delphi process, providing a clear guideline for wound assessment, a list of all potential pre- and intra-operative risk factors, as well as details of surgical wound characteristics to monitor the status of surgical wound healing. Consequently, the SWAT overcomes the omission of crucial information by directly identifying patients at risk of wound complications. The SWAT addresses the limitation of previous tools by considering the assessment of not only the status of the surgical wound itself, but also the potential risk factors that contribute to the delayed healing of surgical wounds. Whereas other tools, such as ASEPSIS (Wilson, Treasure et al., 1986), only focus on detecting surgical site infection rather than providing a comprehensive surgical wound assessment. The SWAT was also designed to systematically record information about wound assessment to demonstrate nursing contribution to patient care. According to the criteria for an optimal wound assessment tool conducted by Greatrex-White and Moxey (2013), from an international nurses’ point of view, the SWAT covers almost all essential areas of an optimal wound assessment tool. The findings of Study Two were the first step in confirming the content validity of the SWAT for use in Vietnam. There is no doubt that the SWAT can be expanded and adapted to international use.
9.2.3 Study Three aim: To evaluate validity and reliability of the SWAT In addition to confirming the content validity of the SWAT, this tool was tested to evaluate the reliability and validity in Study Three, as reported in Chapter 8. The results of Study Three indicated that the SWAT met the first step of satisfactory validity and reliability for evaluating surgical wound healing and early detection of risk factors of delayed closed surgical wound healing. Indeed, the SWAT has established construct validity and inter-rater reliability. Regarding construct validity, exploratory factor analysis (EFA) confirmed that two subscales associated with risk factors and one subscale measuring clinical characteristics of the surgical wound were
202 Chapter 9: Discussion and Conclusion most acceptable. These findings reflect the conceptual framework that guided the development of the SWAT, as presented in Chapter 4. Based on the conceptual framework, the results from Study 3 confirmed that three categories might be appropriate for a holistic surgical wound assessment. Some of the conceptual framework variables in the patient and disease factors loaded under the same construct. Intra-operative factors and surgical wound characteristics loaded on the two separate constructs. However, other items in the framework will require further investigation. The results of the EFA in this Study Three led to the adaption and modification of the framework, as presented in Chapter 4, into the triangle of surgical wound assessment (Figure 9.1). In the new adapted conceptual framework, the recovery of the surgical wound is the centre of the framework and is being influenced by other factors that should be considered when assessing a surgical wound including patient health-related factors, intra-operation related factors, and surgical wound characteristics. This framework will be a useful for further research into the area of surgical wound assessment and its relationship between factors and the healing of surgical wounds. However, further confirmatory factor analysis is required to confirm the latent construct.
Regarding reliability, inter-rater reliability was calculated for the overall scale and individual items. The level of inter-rater reliability for the overall SWAT scale was estimated using ICC. ICC is a reliability index that reflects both degrees of correlation and agreement between measurements and is widely used to evaluate inter- rater reliability of numerical or continuous measurement (Koo & Li, 2016). A low ICC can not only indicate a low degree of agreement, but also relate to the small number of subjects, and/or a small number of raters (Koo & Li, 2016). In this current study, the SWAT demonstrated a very good level of inter-rater reliability for the overall SWAT scale, with an ICC value of 0.81. The 95% confidence interval of the ICC estimate was 0.68-0.89, confirming that the level of reliability can be regarded as “good” to “excellent”.
Chapter 9: Discussion and Conclusion 203
Wound location Wound dimension Wound edge Wound bed tissue Surrounding tissue: swelling, erythema Signs of haematoma Exudate: type and volume Infection: Pain, odour,
pus Surgical wound
Characteristics
Recovery of Surgical Wound
Patient health Intra- related operative factors related factors
Age BMI Operative time Smoking Surgical wound Nutrition contamination Diabetes Mellitus classification (clean, Infection disease clean-contaminated , (HIV/AIDS) contaminated Drugs: steroids, infected wound) chemotherapeutic Emergency surgery drugs Trauma wound Preoperative antibiotic use Type of surgery
Figure 9.1: The triangle of surgical wound assessment for surgical wounds healing by primary intension
204 Chapter 9: Discussion and Conclusion Several inter-rater reliability tests have been performed on wound assessment tools, such as surgical wound complications (ASEPSIS tool) (Byrne et al., 1988), and chronic wounds (Bates-Jensen et al., 1992; Emparanza et al., 2000; Houghton et al., 2000; Sanada et al., 2004; Woodbury et al., 2004). However, among six wound assessment tools found to measure inter-rater reliability, only two studies examined inter-rater reliability using ICC (Houghton et al., 2000; Woodbury et al., 2004). The ICC of the SWAT in this current study was slightly higher than the LUMT (ICC=0.77) (Woodbury et al., 2004), and PWAT (ICC=0.75) (Houghton et al., 2000). Nevertheless, when compared to the ASEPSIS tool, which was specially designed to measure surgical wound infection, the ICC value of the SWAT was lower than the correlation coefficients of ASEPSIS tool (0.96) (Byrne et al., 1988). Making the comparison associated with reliability scores of the SWAT and ASEPSIS difficult, since methods for calculating inter-rater reliability in the two studies were different. However, the use of an ICC to assess inter-rater reliability is considered a more rigorous statistical method than calculating a coefficient, as it takes into account any systematic bias between the two determinations (Koo & Li, 2016). A good level of inter-rater reliability of the overall SWAT score was high enough to suggest that the SWAT is reliable to use by different healthcare professionals.
Regarding individual items, there are few items that need to be clarified and improved due to receiving a moderate level of agreement between two nurses, such as smoking, the risk of malnutrition, wound bed, erythema, and exudate volume. The wording of the questions may be a reason for misinterpretation. Therefore, these items will be adapted and clarified in a further version of the SWAT. The development of a training manual may assist in the use of the surgical wound assessment tool. Each item of the SWAT needs to be clearly defined by using definitions that reflect widespread use. A training manual would improve consistency and interpretation of the questions and provide confidence to the assessor. The item measuring pain in the SWAT also needs to be clarified due to no agreement obtained for this item. The reason for not having agreement in the assessment of pain may be due to nurses’ estimation about patients’ pain rather than recording patients’ evaluation of their pain. Therefore, emphasising how to assess pain in the instruction manual for the tool training section will be a crucial strategy to obtain constancy of pain assessment.
Chapter 9: Discussion and Conclusion 205 9.3 STRENGTHS AND LIMITATIONS
There were several strengths and limitations of each study, as reported in Chapters 5, 7, and 8. However, this section presents the overall strengths and limitations of this PhD project. The present research project has several strengths. First, to the best of the researcher’s knowledge, this is the first study conducted in Vietnam with the aim of developing a new surgical wound assessment tool to assist nurses in conducting a comprehensive surgical wound assessment and to guide nurses to detect early risk factors that may increase the risk of surgical wound complications. According to DeVon et al. (2007), the claims of content validity of published tools have been criticised as having inadequate information relating to a specified method. In this thesis, to maximise the validity and reliability, all study procedures of developing, testing, and validating the tool have been provided in detail to clearly explain every step of decision making in designing and validating the SWAT. The SWAT was developed through comprehensive procedures including: implementation of a qualitative study to explore current gaps in surgical wound assessment in Vietnam, conducting comprehensive literature reviews and careful review of implementation guidelines to develop items for the SWAT to meet international standards, a consultation phase with Vietnamese surgeons to obtain their theoretical and clinical experience to refine the tool to fit with Vietnamese context, continued modification and improvement of the SWAT in Vietnamese context through an interactive Delphi process by inviting a Vietnamese wound care expert panel to evaluate the tool, evaluation of inter-rater reliability of the SWAT between two nurses and 60 patients, and the evaluation of construct validity among 260 patient with closed surgical wounds. Translation and back translation procedures were also carefully performed during the steps of the instrument’s development. Therefore, with international and national expert’s contributions to the development of the tool, the SWAT was found to be appropriate for achieving the goals of this research project.
In addition to the several limitations reported in each study, there are also a number of overall limitations that should be recognised in this thesis. First, since the instrument was newly developed, other validity tests (such as criterion and concurrent validity), and other reliability tests (such as intra-rater reliability) are necessary to strength the tool. Another weakness is that the context of policy and regulation in the implementation of a new instrument into practice in Vietnam has not yet been
206 Chapter 9: Discussion and Conclusion researched due to the limitation of time and restricted budget of this PhD research. Therefore, strategies to implement the SWAT into clinical practice in Vietnam may require further investigation. Finally, due to constraints of time and resources, the PhD student placed priority on the main scope of the research such as collection data, and analysis. This is recognised as a limitation of the study, as construct equivalence was not completely confirmed.
9.4 RECOMMENDATIONS
These are the recommendations proposed in the areas of clinical practice, education, and research arising from the results and outcomes of this research programme.
9.4.1 Clinical practice The results from these studies indicate inadequate surgical wound assessment in Vietnam, as Vietnamese nurses in these studies did not use any standard guidelines or protocols to guide their wound assessment. Without using a structured wound assessment approach, surgical wound assessment is performed with inconsistency and does not collect all essential information. The SWAT not only provides baseline data and beneficial information that can assist nurses to identify short- and long-term goals of care, but also acts as an educational tool to assist inexperienced wound care nurses to complete an accurate assessment. Therefore, application of the SWAT would not only improve the assessment of surgical wounds in daily nursing practice in Vietnam, it could also offer an opportunity for all clinicians to measure the effectiveness of wound care treatments. In addition, due to offering a comprehensive wound assessment, the SWAT can be used to examine nurses’ knowledge about the risk factors of surgical wound complications and the characteristics of surgical wounds to design educational programmes to improve nurses’ knowledge and skills when conducting a holistic surgical wound assessment.
The findings of these studies also demonstrate that surgical wound assessment was not recorded adequately, with essential information about surgical wound assessment missing. Inadequate nursing records may lead to ineffective communication between nurses and other healthcare professionals where one patient is looked after by a variety of clinical staff. Thus, the use of the SWAT would not only assist both experienced and less experienced nurses to improve the accuracy of their
Chapter 9: Discussion and Conclusion 207 surgical wound assessment documentation in a systematic way by using a standardised tool, but also help them to demonstrate the quality of care delivered and provide evidence of their contribution to patient care. It is acknowledged that a nursing contribution that has not been documented remains invisible (Tiusanen et al., 2010).
9.4.2 Education Professional development education for healthcare workers should include increased awareness of the availability of the SWAT for use in a clinical setting. Education for nurses and other health professionals should include information about the significant predictors of surgical wound complications. Training in the implementation of the SWAT should also be incorporated into orientation programmes for nurses and other healthcare professionals to ensure the accuracy of using the tool. Refresher courses should be offered to existing staff to maintain competence.
Surgical patients and families or their caregivers require education to understand their condition and the factors that increase the risk of postoperative wound complications. They should be provided with resources and advice about how to recover quickly after the operation and how to detect early signs of wound complications after discharge from the hospital. Close follow-up post hospitalisation care is therefore vital to reinforce the education given to the patients, adjust treatment, and clarify any misconceptions.
Knowledge and professional skills regarding surgical wound assessment should be included in academic education and training. In addition to medical and nursing students, training in surgical wound assessment should also be incorporated into the curriculum for students to enhance their knowledge of postoperative management. Strategies for making an impact on the implementation of the SWAT should be aimed at multiple levels, including individual, family, organisation, community, and national levels.
9.4.3 Future research and ongoing development of the tool The results of this research program uncovered several issues that promise interesting directions for future research. In response to the validity and reliability of the surgical wound assessment tool, further work is required to refine the surgical wound assessment tool. First, a confirmatory factor analysis should be performed in future studies with a new sample to confirm the latent constructs identified in the
208 Chapter 9: Discussion and Conclusion exploratory factor analysis. Second, determining the cut-off points for low risk to high- risk scores of surgical wound complications for patients with a surgical wound is another area recommended for further improvement. This may facilitate the possibility of applying the SWAT into clinical practice and defining a protocol for subsequent action. Further prospective studies therefore need to be carried out to evaluate the predictive accuracy of the tool by evaluating the area under the receiver operating characteristic curve and calibration (Hosmer-Lemeshow statistic).
Further efforts are required to establish the validity of the SWAT. A prospective study with a larger sample size, multiple settings, and longer follow up (up to one month) is required to confirm which risk factors in the SWAT are independent predictors of surgical wound complications. Identifying the specific factors for high risk of surgical wound complications would not only reduce the number of items in the SWAT to be more practical in a clinical setting, but also target those patients at high risk of surgical complications, as these patients may be most vulnerable to adverse outcomes.
In relation to reliability, although the surgical wound assessment demonstrated an excellent level of inter-rater reliability among two nurses, inter-rater reliability of the tool would benefit from further testing with other health professional disciplines, such as experienced nurses, nurse educators, and nursing students, as well as at other hospitals in Vietnam. Intra-rater reliability is also recommended to strengthen the tool.
To confirm the impact of the use of SWAT for further implementation, randomised controlled trials could be carried out to compare the effectiveness of using the SWAT regarding nurses’ knowledge and skills in relation to surgical wound assessment and management.
9.4.4 Proposed strategies to implement the surgical wound assessment tool in clinical practice in Vietnam
It is important to note that guidelines do not implement themselves; thus, implementation strategies are required (Grol, 1997). The adaptation of guideline recommendations into everyday practice requires changes in the attitudes and behaviour of health professionals, as well as specific adaptation for the organisational environment (Fischer, Lange, Klose, Greiner, & Kraemer, 2016). According to the Knowledge-Attitude-Behaviour Framework, physicians have to be aware of a
Chapter 9: Discussion and Conclusion 209 guideline and need to have some knowledge of its content (Cabana et al., 1999). Subsequently, knowledge influences attitudes, and attitudes affect practice behaviour (Cabana et al., 1999). Guideline implementation is a complex process that is restricted by numerous obstacles. According to a systematic review of 69 articles published up until the end of 2015, the most significant barriers to guideline implementation were categorised into three main factors: personal factors, guideline-related factors, and external factors (Fischer et al., 2016). Personal factors are associated with health professional knowledge (e.g., lack of awareness and lack of familiarity with the guideline and its recommendation), and attitude (e.g., lack of agreement, self-efficacy, skills, outcome expectation, and motivation). Regarding guideline-related factors, they are linked to the complexity, layout, accessibility, and applicability of the guideline. External factors are associated with organisational constraints, such as lack of resources, time restrictions, and heavy workload (Fischer et al., 2016).
However, it has been suggested that the success of any implementation depends on consideration of a variety of barriers and the use of adequate strategies to overcome any challenges (Fischer et al., 2016). Multifaceted interventions have been shown to be more efficient than single interventions (H. E. Edwards et al., 2017; Fischer et al., 2016; Registered Nurses' Association of Ontario, 2012). According to two current systematic reviews, successful strategies for guideline implementation include dissemination (e.g., supplying educational materials), education and training (e.g., educational meetings, educational outreach visits, audit and feedback, workshops and small-group integrative postgraduate training sessions), social interaction (e.g., local opinion leaders, champions), decision support systems, and standing orders (Fischer et al., 2016; Watkins, Wood, Schneider, & Clifford, 2015).
Along with the ongoing modification and improvement of the SWAT, strategies to implement the SWAT into clinical practice are also proposed. Based on the successful “Champions for Skin Integrity” model developed by wound care experts in Australia for implementing evidence-based wound management in aged care (H. E. Edwards et al., 2017), the process of implementing the SWAT into a Vietnamese healthcare setting could be achieved through adaptation of the process used for the Champions for Skin Integrity model. However, only two hospitals: Haiduong General Hospital and Haiduong Medical Technical University Hospital, will be chosen to pilot the SWAT implementation due to the PhD student having a previous relationship with
210 Chapter 9: Discussion and Conclusion these two settings. If the pilot of the implementation is successful, the successful model of implementation of the SWAT into Vietnam will then be integrated into other hospitals. The effect of the implementation of the SWAT will be measured by: (1) reduced prevalence of surgical wound complications, (2) improvement in nurses’ knowledge about surgical wound assessment and management, (3) enhanced patient documentation in relation to surgical wound assessment and management, and (4) increased awareness of patients, families, and all levels of staff about evidence-based wound management and prevention strategies for surgical wound complications. The proposed implementation of the SWAT into clinical practice is outlined in Figure 9.2.
Chapter 9: Discussion and Conclusion 211
Preparatory phase Setting for recruitment: one hospital and one university hospital Identify and develop champions and an advisory group Commence a communication campaign to raise awareness of project activities
Develop an audit tool and knowledge survey associated with surgical wound assessment and management for staff in consultation with all experts who were involved in developing the SWAT Develop an education program for training and assessing the competency of audit data collectors
Pre-implementation phase Conduct interviews and focus groups with all levels of staff, patients, and families to obtain contextual information Distribute surgical wound care assessment and management knowledge surveys to all staff working at surgical wards at two hospitals Conduct a chart audit to identify surgical wound assessment and management documentation over a period of three months at the two hospitals Analyse the data from the surveys, interviews, and chart audits and disseminate the results to each hospital for feedback Develop education programs, workshops, and educational materials
Implementation phase Deliver intensive evidence-based education and specialised training in surgical wound assessment and management for preventing surgical wound complications during the implementation phase Use the SWAT in daily routine practice Ongoing staff education, group education, and hands on skill development Continue communication campaigns to raise awareness Multidisciplinary and link clinician network development Ongoing audit and feedback
Post-Implementation phase Interview staff, patients, and families to obtain feedback Conduct surgical wound assessments and management knowledge surveys for all staff
Conduct a chart audit of surgical wound assessment and management documentation
Analyse pre- and post-data and produce summary reports for each hospital
Set goals for the future sustainability of the project
Figure 9.2: The adapted CSI model implementation process
212 Chapter 9: Discussion and Conclusion 9.5 CONCLUSION
This research programme has addressed a range of gaps in the current literature associated with surgical wound assessment tools, and has made a significant contribution to the body of knowledge in this area, especially in Vietnam. Surgical wound complications lead to a significant economic burden for patients and healthcare providers. Effective wound management must therefore begin with an accurate and holistic assessment of the patient’s ability to heal, the likelihood of complications, and the factors that affect wound healing. The surgical wound assessment tool not only provides baseline data and beneficial information that can assist nurses to develop an appropriate surgical wound care management plan, the tool can also assist with determining priorities for management planning at each stage of wound healing where standard care may be insufficient to achieve healing. Moreover, this assessment tool also assists nurses with the recording of wound progress to enhance inter-disciplinary communication and patient care. Even though this is the first step to confirm the inter- rater reliability, content, and construct validity of the tool for assessment of surgical wounds that could be used across Vietnam, further modification and testing are recommended to strengthen the tool.
Chapter 9: Discussion and Conclusion 213 References
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References 251 Appendices
Appendix A: JBI levels of Evidence 2013
Level I Experimental designs
Level 1.a Systematic review of Randomised Controlled Trials (RCTs)
Level 1.b Systematic review of RCTs and other study designs
Level 1.c RCT
Level 1.d Pseudo-RCTs
Level 2 Quasi-experimental designs
Level 2.a Systematic review of quasi-experimental studies
Level 2.b Systematic review of quasi-experimental and other lower study design
Level 2.c Quasi-experimental prospectively controlled study
Level 2.d Pre-test, Post-test or historic/retrospective control group study
Level 3 Observational –analytic designs
Level 3.a Systematic review of comparable cohort studies
Level 3.b Systematic review of comparable cohort and other lower study design
Level 3.c Cohort study with control group
Level 3.d Case-controlled study
Level 3.e Observational study without a control group
Level 4 Observational – Descriptive Studies
252 Appendices
Level 4.a Systematic review of descriptive studies
Level 4.b Cross-sectional study
Level 4.c Case series
Level 4.d Case study
Level 5 Expert Opinion and Bench Research
Level 5.a Systematic review of expert opinion
Level 5.b Expert consensus
Level 5.c Bench research/single expert opinion
Appendices 253 Appendix B: Think Aloud Scenario and Semi-structured Interview Questions
THINK ALOUD SCENARIO A patient named Nguyen Van A, Male, 65 years old (high 170cm, weight 65kg) had a fall at home. He was brought to the hospital by ambulance, X-rays show fractured patella and ultrasound scan shows torn tendon to left leg, requiring surgery immediately. He states his pain is extremely high and has limited mobility in the joint. He was sent to the theatre for surgery. The duration of operation was 1hour and 25 minutes and vital signs were stable after surgery. Past medical history includes diagnosis of diabetes three years ago controlled by tablets, currently smoker for the last 20 years and drinks alcohol on a daily basis. Social background: He currently lives alone. His wife died five years ago, and all his children live far away. Therefore, he is still moving and adjusting to an independent life of housework, cooking and shopping which he had always heavily relied on his wife to do. This has caused increased stress and sleeps disturbance.
Photos of incision day five post-operation.
Ocampo, M. (2008). Treatment of Wound Infection on Knee Following Surgery [image]. Retrieved from http://www.eakin.eu/treatment-of-wound-infection-on-knee-following-surgery Please talk about what you would do for this patient?
254 Appendices SEMI-STRUCTURED INTERVIEW 1. Surgical wound assessment Main questions Additional questions Clarifying questions Please tell me when and how often you assess a surgical wound? Do you use any specific tools or Can you expand a little charts? bit more…? What information do How do you do to assess a surgical Can you tell me more you collect when you wound? specific…? assess a surgical What do you do if you see unusual Can you give me some wound? or concerning signs and symptoms example…? of surgical wounds? Do you mean…? What do you do if patients complain about symptoms of a wound that bothered them? How do you record the information that you collect and observe?
2. Patients’ factors related to delayed wound healing
Main questions Additional questions Clarifying questions Please tell me the How do you identify wound’ wound’ factors you factors related to delay wound believe are associated healing? with delayed surgical What wound factors may delay wound healing? wound healing but you maybe Can you expand a little cannot address? bit more…? Please tell me the How do you identify a patient’s Can you tell me more patients’ factors you factors related to delay wound specific…? believe are associated healing?
Appendices 255 Main questions Additional questions Clarifying questions with delayed surgical What patient factors may delay Can you give me some wound healing? wound healing but you maybe example…? cannot assess? Do you mean…? When those factors are identified, do you make any intervention plan? (If Yes, what do you do? If No, explain the reason?) Do you document all those identified factors in patient’s record? (If No, Why?) If yes, how? 3. Surgical wound assessment tool Main questions Additional questions Clarifying questions In your opinion, what does If you have a tool, would a surgical wound you use it? Please give assessment tool mean to explanation for your Can you expand a little bit you? choice? more…? Can you tell me more Which subjective and specific…? objective wound factors do Can you give me some you think should be example…? included in a tool? Do you mean…? What subjective and objective of patient factors should be included in a tool? Are there any other considerations for a surgical assessment tool that we have not discussed and you want to add?
256 Appendices Appendix C: QUT ethics approval
Appendices 257 Appendix D: Letter of acceptance from hospital
QUT Verified Signature
258 Appendices Appendix E: Chart Audit instrument
Appendices 259
260 Appendices
Appendices 261 Appendix F: Invitation Email
Dear Sir/Madam, Re: Development and validation of a surgical wound assessment tool for Vietnamese patients
My name is Do Thi Thu Hien from the School of Nursing, Queensland University of Technology, Brisbane, Australia. I am undertaking a PhD into surgical wound assessment and management. In Vietnam, wound assessment is often carried out based on nurses’ experiences and observation, and there is currently no standard tool to assist nurses in assessing surgical wounds and recording wound information. Therefore, we would like to invite you to participate in the process of a surgical wound assessment tool development because you have been identified as an expert in this area. This study aims to achieve consensus from you and other expert panel members in relation to relevant items for the tool. The study has inclusion criteria that we think you might meet, as follows:
willingness to contribute to the study; sufficient time to participate to the study; a minimum of 5 years’ practical experience working in the surgical area; graduated from at least a Bachelor Degree; able to communicate either Vietnamese or English.
This research will be carried out using the Delphi technique consisting of 3 questionnaires (known as rounds) aiming to achieve consensus related to assessment tool items. The amount of time necessary for completion of each questionnaire (or round) will vary with each panelist, but should range from approximately 20-30 minutes for Round 1, 10-15 minutes for Round 2, and 5-10 minutes for Round 3. There are no right or wrong answers to the questions. This study is seeking your expert opinion. We think you will find the process interesting and the results will be made available at you at the conclusion of this study.
Please note that this study has been approved by QUT Human Research Ethics Committee (approval number 1700000125), and Haiduong Medical Technical University Research Ethics Committee (approval number 01-2017/QD- DHKTYTHD).
262 Appendices Please view the attached Participant Information Sheet for further details on the study.
We sincerely hope that you will agree to participate. If you have any questions, pleases contact me via email [email protected] or call +61 7 3138 6108.
Thank you for your time and any help you may be able to offer to this study.
Yours sincerely
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108 Email: [email protected]
Supervisors
Prof Helen Edwards Phone: +61 7 3138 4523 Email: [email protected]
Dr Kathleen Finlayson Phone: +61 7 3138 6105 Email: [email protected]
Faculty of Health, Queensland University of Technology (QUT)
Appendices 263 Appendix G: Round One – Initiating Email
Dear:< participant name> Re: Development and validation of a surgical wound assessment tool for Vietnamese patients
I want to express my appreciation to you for your agreement to be part of the panel for this Delphi. I believe that this process will be a rewarding experience, and your contribution will make a difference for many years to come This Delphi study will use an expert panel in an effort to reach consensus regarding the items and their response options about the surgical wound assessment tool. This process will contain three rounds of electronic mail surveys. Each survey may be completed within a two week time frame. You can leave the survey and return to complete it at a more convenient time. It is tracked by your computer, so you will need to return to it using the computer you used to start the survey. Your responses will be anonymous, so we encourage you to respond sincerely. Your responses will be collected, and together with the rest of the expert panel will make up the following round survey. For this study to be reliable and valid, it is crucial that you complete all three rounds. The first round survey will be open from 9th May to 26th May. However, if all panel members have completed before then, the survey will close and we will move to the second round. To start the survey, please click on the link below to access the Round One survey instrument. https://survey.qut.edu.au/f/189334/119f/
If you have any questions pleases contact me via email [email protected] or call +61 7 3138 6108.
Please do not forward this email to other because this link is uniquely tied to your email address.
Yours sincerely
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108 Email: [email protected]
264 Appendices Appendix H: Round One Instrument
Appendices 265
266 Appendices
Appendices 267
268 Appendices
Appendices 269
270 Appendices Appendices 271
272 Appendices
Appendices 273
274 Appendices
Appendices 275
276 Appendices Appendix I: Round One_ First reminder email
Subject Title: REMIDER to complete Round One: Develop and evaluate a surgical wound assessment tool for Vietnamese patients
Dear <
Thank you for agreeing to participate in the study to develop and evaluate a surgical wound assessment tool for Vietnamese patients.
Further to our email of 9th May survey sent. We would like to remind you that the survey link expires on 26th May. Therefore, we would appreciate it if you would complete the survey before then.
You may access the Round One by clicking on the following link: https://survey.qut.edu.au/f/189334/119f/
If you have any difficulty accessing the link or have any questions, please contact me via email [email protected] or call +61 7 3138 6108.
Thank you in advance for your time and cooperation.
Yours sincerely
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108 Email: [email protected]
Appendices 277 Appendix J: Round One_ Third reminder email
(for those who partially or not responded)
Subject Title: REMIDER to complete Round One: Develop and evaluate a surgical wound assessment tool for Vietnamese patients
Dear <
I understand that you are extremely busy with your current duties, but I do hope that you will spend some of your time to participate in this study. I also hope that the survey is not too long and does not take too much time from you. Your contribution would be helpful for improving patient care in Vietnam in the future. Therefore, I would certainly love to have your expertise as part of my research. I can extend the deadline for another day for you to complete the survey. If not, I certainly understand.
The link for the Round One questionnaires can be found in here:
https://survey.qut.edu.au/f/189334/119f/
I look forward to receiving feedback from you.
Yours sincerely
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108 Email: [email protected]
278 Appendices Appendix K: QUT ethics approval for Study 2 and Study 3
Appendices 279 Appendix L: Ethic approval from Vietnam for Study 2 and Study 3
QUT Verified QUT Verified Signature Signature
280 Appendices Appendix M: Round One Content analysis result from open-ended questions
Categories Keywords Expert’s suggestion Number Sub- of categories comments Items excluded from the tool Surrounding The skin surrounding should be assessed 1 incision for: dryness, moisture, or inflammation The colour of surrounding incision: pink 1 or normal, bright red, grey, maroon or Items already purple, black mentioned in Wound bed If open wound: the percentage of tissue 1 the initial (necrotic or granulation tissue) surgical Volume of The volume of exudate: 1 wound exudate Little: no need to do dressing assessment changes each day tool Moderate: Need to change dressing each day Heavy: need to change dressing more than twice per day Wound A location, such as abdominal line, lower 1 location abdominal Immune The status of infection before admission, 1 deficiency the status of infection before surgery Incision Incision location 1 location Incision edges Colour of incision should compare with 1 patient’s skin colour in the same area to have a more reliable result Nutrition Assess more about nutritional status 1 status Surgical Should develop criteria for two different 1 wound surgical wound classification classification Emergency Emergency surgery 1 surgery The sign of Should include a question related to the 1 haematoma status of tissue under incision (because sometimes the incision seems healed when observed via surface but there is bogginess under the incision; therefore, another operation is required to clean all of the tissues under incision)
Appendices 281 Categories Keywords Expert’s suggestion Number Sub- of categories comments Not practical Patient The tool should include patients living 1 to measure lifestyle, and habits, and the wound healing wound healing environment to be able to achieve better environment assessment Temperature Temperature at incision should be 1 at incision considered Excluded Exclusion Procedure of surgery: Laparoscopic 1 criteria for criteria surgery applying the Number The number of wounds in one patient 1 tool wound in one patient Allergies Allergies with cleaning agents and 2 Not fit for the dressings also need to be considered purpose of the Patient history Patient’s history of surgery 2 tool of surgery Scar factors Scar factors 1 Patient I think it should be included in the 1 mobility assessment of patient’s mobility Risk factors Type of Type of dressing 1 dressing New tool items recommended Depth The depth of the wound should be 1 measured. Exudate from The volume of fluid in 2 surgical drain drainage: little, moderate, or system heavy The colour of fluid in drainage: red, amber, The characteristics of fluid (depending on the type of surgery)
282 Appendices Appendix N: Round One: Items’ response options rating
Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) Age (years) 18-39 2.91 0.79 65.2% 3 No Continue 40-59 to Round Over 60 2 BMI Less than 18.5 3.57 0.51 56.5% 0 Partial Continue (underweight) consensus to Round 18.5-22.9 (normal weight) 2 23-27.5 (overweight) Over 27.5 (Obese) Diabetes: No 3.48 0.67 56.5% 3 No Continue (currently diagnosed with Yes to Round diabetes) 2 Smoking status Non-smoker 3.16 0.76 57.9% 1 No Continue Previous smoked but gave to Round up four weeks before 2 surgery Current smoker: continued to smoke in the preoperative period Regular use of steroids for 3.34 0.83 52.2% 4 No Continue long-term treatment No to Round Yes 2
Appendices 283 Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) (regular use defined as used steroid at least 30 days before surgery) Chemotherapy No 3.57 0.59 60.9% 1 Partial Continue (currently receiving before Yes consensus to Round surgery) 2 Nutritional status No 3.21 0.67 52.2% 5 No Continue Currently has decreased food Yes to Round intake. 2 And/or Unintentional weight loss over the last 3 months Immune deficiency No 3.34 0.79 60.9% 1 No Continue (e.g., HIV, kidney failure, Yes to Round skin infection) 2 Temperature Less than 37.50C 3.43 0.73 52.5% 2 No Continue (measure the 37.50c – 38.50C to Round axillary) Greater than 38.50C 2 Surgical wound on No 3.63 0.76 73.7% 1 Yes Accepted site of old scar Yes in to the tool Surgical wound Clean 3.78 0.42 78.3% Yes Accepted contamination classification Clean-contaminated in to the Contaminated tool Dirty/infected
284 Appendices Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) Emergency surgery Non-emergency 3.52 0.67 60.9% 2 Partial Continue Emergency for pathological consensus to Round condition 2 Emergency surgery for trauma Duration of surgery Less than 1h 3.30 0.92 50% 3 No Continue (hours) 1 to 3h to Round Greater than 3h 2 Pre-operative No 3.52 0.67 60.9% 3 Partial Continue antibiotic use Yes consensus to Round 2 The duration from Less than 10h 2.65 1.02 39.1% 9 No Continue injury to surgery Greater than 10h to Round 2 The length of preoperative Less than 2 days 2.7 1.06 42.9% 3 No Continue hospital stay if elective Greater than 2 days to Round surgery (day) 2 Surgical wound cleaning Sodium chloride 0.9% 3.39 0.78 52.2% 2 No Continue agents Povidone to Round Hydrogen peroxide 2 Other Closed surgical Open surgical wounds wounds
Appendices 285 Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) Wound dimensions Wound length…cm Wound length: 3.39 0.84 56.6% 2 No Continue cm to Round The widest point: 2 cm Wound edges Edges well Edges sloping or 3.21 0.95 47.8% 3 No Continue approximated flat to Round Edges Edges raised or 2 approximated but rolled tension at incision Undermining line present Edges not approximated tension in incision line Edges are not together Wound bed Incision edges Mostly 3.13 1.10 52.2% 3 No Continue closed granulating to Round Mostly 2 epithelializing Mostly sloughy Mostly necrotic Swelling Yes 3.43 0.73 56.5% 1 No Continue No to Round 2
286 Appendices Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) Erythema Yes 3.35 0.71 47.8% 5 No Continue No to Round 2 Sign of No 3.48 0.67 56.5% 2 No Continue haematoma Yes to Round formation 2 (e.g., focused area of swelling, hardness, or bogginess upon palpation, painful) Maceration No 3.04 0.88 73.9% 4 No Continue (Is the softening and Yes to Round breakdown of the skin a 2 result of prolonged exposure to moisture?) Colour and type of None 3.39 0.78 56.5% 3 No Continue exudate Mostly clear, amber to Round Mostly bloodstained 2 Mostly cloudy, milky Mostly green or yellow Volume of exudate Dry (no visible) 3.30 0.87 52.2% 4 No Continue Moist (less than 80% exudate in to Round primary dressing) 2 Wet (50-70% exudate in primary dressing)
Appendices 287 Panel agreement
quite
appropriate/
highly Comment Achieved Resulting appropriate for Items Response option Mean Sd consensus action n=23 revision n(%) Saturated (more than 75% primary dressing and leakage to secondary dressing) Odour None 3.52 0.51 52.2% 1 Partial Continue Present after removing dress consensus to Round Present prior to dressing removal 2 and patient aware Wound pain 0 (no pain) 3.26 0.81 43.5% 2 No Continue (numeric rating scale 0- 1-3 (mild) to Round 10) 4-6 (moderate) 2 7-10 (severe)
288 Appendices Appendix O: Round Two_ EMAIL
Dear expert panel member,
Re: Development and validation of a surgical wound assessment tool for Vietnamese patients
Thank you for your participation in this Delphi panel for the development of a surgical wound assessment tool. We gathered a tremendous amount of data in the first round, and I have included the Round 2 survey here for your additional feedback. Your responses will again be collected, and the overall results will make up the next round of the survey. Please remember that the ultimate goal of this project is to develop a surgical wound assessment tool to measure the progress of surgical wound healing, and to also detect early factors related to delayed wound healing.
You will have two weeks to complete this second round. The second survey is now open until the 16th of July. However, as before, if all of you have responded before then, the survey will close, and we will move to the next round.
To start the survey, please click the link at:
http://survey.qut.edu.au/f/189608/1191/
Should you have any questions or comments regarding this process, please feel free to contact me at [email protected] or call +61 7 3138 6108. This link is uniquely tied to this survey and your email address. Please do not forward this message.
Thank you for your participation.
Yours sincerely,
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108 Email: [email protected]
Appendices 289 Appendix P: Round Two Instrument
PART I. Re-rating the surgical wound assessment tool's items that did not achieve consensus from the expert panel (n=23).
Among the 30 items that were sent to you in Round 1 to rate how important it is that those items should be included in the surgical wound assessment tool, 13 items reached consensus for inclusion from over 70% of the expert panel (n=23), who rated those items as 3 or 4 on a Likert scale (1 = Very unimportant – 4 = Very important) to be included in the surgical wound assessment tool.
However, 17 items did not achieve agreement in Round 1. Therefore, these 17 items are being sent to you again to consider for re-rating. The mean of group responses in Round 1 is provided for your reference to re-rate the items that did not reach consensus in Round 1.
Please use the same 4-point-likert scale used in Round 1 to re-rate items. These numbers correspond to a response as below:
1. Very unimportant
2. Unimportant
3. Important
4. Very important
How important is it that the patient risk factors associated with delayed wound healing listed below should be included in the surgical wound assessment tool?
1. Very 2. 3. 4. Very
Unimportant Unimportant Important important
Age (previous response mean 3.65)
BMI (previous response mean 3.39)
Smoking status (previous response mean 3.09)
290 Appendices Regular use of steroids for at least 30 days before surgery (previous response mean 3.56)
Monitoring temperature axillary measure (previous
response mean 3.61)
Chemotherapy (received either currently or in the 30 days before
surgery) (previous response mean 3.70)
Surgery on the site of an old scar (same site as previous surgery or
injury) (previous response mean 3.13)
How important is it that the surgical procedure factors associated with delayed wound healing listed below should be included in the surgical wound assessment tool?
1. Very 2. 3. 4. Very
Unimportant Unimportant Important important
Type of surgery: limb amputation, colon surgery, vascular surgery and bowel surgery (previous response mean 3.65)
If the wound is caused from a traumatic injury, (the duration from injury
to surgery) (previous response mean 3.70)
Appendices 291 Emergency surgery (previous response
mean 3.70)
If the wound is from elective surgery, the
length of preoperative hospital stay (days) (previous response mean 3.70)
Duration of surgery (previous
response mean 3.49)
How important is it that the surgical wound characteristics listed below should be included in the surgical wound assessment tool?
1. Very 2. 3. 4. Very
Unimportant Unimportant Important important
Wound dimensions (previous
response mean 3.70)
Incision/wound edge characteristics (previous
response mean 3.70)
Signs of hematoma formation (previous
response mean 3.70)
Odour (previous response mean 3.70)
Wound pain (numeric rating scale 0- 10) (previous response mean 3.61)
292 Appendices Part II. Additional items suggested to add into the surgical wound assessment tool
From analysis of responses to the open-ended question (In addition to the items included in the initial surgical wound assessment tool, what other components do you believe should be included?) that was sent to you in Round 1, there are a number of additional items suggested to be included in the surgical wound assessment tool. Three additional items have been included for your consideration in Round 2 for rating. When considering the suggestions, not all suggested items could be included because the purpose of the surgical wound assessment tool is to provide a simple, quick measure of the progress in wound healing and early detection of factors associated with delayed wound healing. Therefore, only factors with evidence of a strong impact on wound healing can be included in the tool.
Please check the box that you feel best describes how important it is to include these additional items in the tool.
1. Very 2. 3. 4. Very
Unimportant Unimportant Important important
The depth of open surgical wound
The exudate from the surgical drain system
PART III. Re-rating the response options for the surgical wound assessment tool items that did achieve partial consensus.
A minimum mean of 3.5 and 70% panel agreement is required for this revision to be included in the tool
Age Original response option: 18-39 40-59 Over 60
In round 1, this item response option did not achieve the level of agreement, with a
Appendices 293 mean = 2.91, and panel agreement = 65.2%. Three experts provided comments for this question, including adding a group for age less than 18, asking a direct question "How old are you?", and others suggested dividing the groups into 18-40, 41-65 and over 65.
However, this tool is designed for adults only, so the option of an age less than 18 was not considered. In addition, due to the goal of this tool for early detection of risk factors for delayed wound healing, a known risk cut-off point on the impact of age on the wound healing is essential.
Taking experts’ suggestions into consideration and reviewing the evidence in the literature (Knight et al., 2007; Roine et al., 2010; Khalil et al., 2015), this item's response option was revised as below.
Reference: Knight, R. J. et al. (2007). Risk factors for impaired wound healing in sirolimus-treated renal transplant recipients. Clin Transplant, 21(4), 460-465. doi:10.1111/j.1399-0012.2007.00668.x Roine, E., Bjork, I. T., & Oyen, O. (2010). Targeting risk factors for impaired wound healing and wound complications after kidney transplantation. Transplant Proc, 42(7), 2542-2546. doi:10.1016/j.transproceed.2010.05.162 Khalil, H., Cullen, M., Chambers, H., Carroll, M., & Walker, J. (2015). Elements affecting wound healing time: An evidence-based analysis. Wound Repair and Regeneration, 23(4), 550-556. doi:10.1111/wrr.12307
Age New response option: 18-40 41-65 Over 65
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Revise the response option Somewhat appropriate appropriate appropriate (please give suggestions below) appropriate
BMI (Body Max Index) Response options: Less than 18.5 (underweight) 18.5-22.9 (normal weight) 23-27.5 (overweight) Over 27.5 (Obese)
This item response options received partial consensus, with mean = 3.57, and panel agreement = 56.6%. The four options were defined based on the recommendation from the World Health Organization for Asian populations (Shiwaku, Anuurad, Enkhmaa, Kitajima, & Yamane, 2004).
294 Appendices
Referencence Shiwaku, K., Anuurad, E., Enkhmaa, B., Kitajima, K., & Yamane, Y. (2004). WHO expert consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet, 363 North American Edition (9414), 1077-1077.
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Revise the response option Somewhat appropriate appropriate appropriate (please give suggestions below) appropriate
Diabetes (currently diagnosed with any type of diabetes) Original response options: Yes No
In Round 1, this item's response reached partial consensus, with mean = 3.57, and panel agreement = 56.5%.
However, three expert members provided comments for this response options that included adding a prediabetes option in the tool, and considering the duration of diabetes, complications, or the level of blood sugar before and after surgery.
Taking the experts' comments into consideration and reviewing the literature (Shibuya. et.al, 2013; Halkos et al., 2008) this item's response option was revised as below.
Reference: Shibuya, N., Humphers, J. M., Fluhman, B. L., & Jupiter, D. C. (2013). Factors Associated with Nonunion, Delayed Union, and Malunion in Foot and Ankle Surgery in Diabetic Patients. The Journal of Foot and Ankle Surgery, 52(2), 207-211. doi:https://doi.org/10.1053/j.jfas.2012.11.012 Halkos, M. E. et al. (2008). Elevated Preoperative Hemoglobin A1c Level is Associated With Reduced Long-Term Survival After Coronary Artery Bypass Surgery. The Annals of Thoracic Surgery, 86(5), 1431-1437. doi:http://dx.doi.org/10.1016/j.athoracsur.2008.06.078
Diabetes (currently diagnosed with any type of diabetes) New response options: No Yes, the level of HbA1C? Less than 7% Greater than 7%
Appendices 295 Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (Please give suggestions below) appropriate appropriate appropriate appropriate
Smoking status Response options: Non-smoker Previously smoked but gave up four weeks before surgery Current smoker: continued to smoke in the preoperative period
This item's response options did not receive consensus in Round 1, with mean = 3.16 and panel agreement = 57.9%. Therefore, these response options are being sent to you again for your consideration.
The three options for these items were classified based on the extensive review of the literature. Evidence shows that smoking is a strong independent factor in delayed wound healing and the risk of wound healing complications in smokers continuing to smoke at the time of surgery was twice as high as those of non- smokers (Wong et al., 2012).
However, preoperative smoking cessation at least 4 weeks before surgery has been demonstrated to have significantly reduced delays in would healing (Mills et al., 2011). As a result of reviewing the literature, three response options were designed for assessment of smoking status.
Reference Wong, J., Lam, D. P., Abrishami, A., Chan, M. T. V., & Chung, F. (2012). Short-term preoperative smoking cessation and postoperative complications: a systematic review and meta-analysis. Canadian Journal Of Anaesthesia = Journal Canadien D'anesthésie, 59(3), 268-279. doi:10.1007/s12630-011-9652-x Mills, E. et al. (2011). Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. The American Journal of Medicine, 124(2), 144-154.e148. doi:10.1016/j.amjmed.2010.09.013 Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
296 Appendices Regular use of Steroids for long term treatment Original response options: Yes No
In Round 1, this item's response options did not reach the consensus, with mean = 3.34, and panel agreement = 52.2%.
There were four comments from panel members for this question. Taking the panel’s comments and evidence from the literature review into consideration, a new response option was designed for this question according to the American College of Surgeons National Surgical Quality Improvement program databases (Turan et al., 2010).
Reference Turan, A. (2010). Preoperative prolonged steroid use is not associated with intraoperative blood transfusion in noncardiac surgical patients. Anesthesiology, 113(2), 285-291. doi:10.1097/ALN.0b013e3181e6a195
Regular use of Steroids for long term treatment New response options: Used for less than 30 days before surgery Used for more than 30 days before surgery Not used at all Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (Please give suggestions below) appropriate appropriate appropriate appropriate
Chemotherapy (currently receiving chemotherapy) Original response options: Yes No This item's response options received partial consensus, with mean a 3.57, and panel agreement = 60.9%.
Evidence shows that patients who receive chemotherapy before surgery may have an increased risk of surgical complications (Gerber.et.al. 2014). Therefore, the response options were revised according to the impact of chemotherapy on surgical complications for your consideration.
Appendices 297
Reference Gerber, B. et al. (2014). Surgical outcome after neoadjuvant chemotherapy and bevacizumab: results from the GeparQuinto study (GBG 44). Ann Surg Oncol, 21(8), 2517-2524. doi:10.1245/s10434-014-3606-9
Chemotherapy New response options: Either currently receiving or received in the 30 days before surgery Not received at all Please re-rate the response option. A minimum of a 3.5 mean and a 70% panel agreement is needed for this revision to be included in the tool
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Immune deficiency (e.g. HIV, kidney failure, disease infection) Response options: Yes No
In Round 1, this items' response options did not reach consensus with a mean = 3.34, and a panel agreement = 60.9%.
A group of doctors in Vietnam revised this item and we would like you to re-rate this item's response options. Please re-rate the response option
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Nutritional status (currently measured as decreased food intake and/or unintentional weight loss over the last 3 months) Original response options: Yes No
In Round 1, this item's response options did not reach a consensus, with a mean = 3.21 and panel agreement = 52.2%.
298 Appendices It has been suggested that malnutrition status is a strong risk factor for impaired wound healing. Five panel members provided comments for this response option.
As mentioned before, the purpose of this tool is for early detection of factors associated with delayed surgical wound healing. To screen patients at risk of malnutrition, two questions from the Mini Nutrition Assessment-short form tool in the surgical assessment tool have been used as an indicator of risk of malnutrition (Kaiser et al., 2009). If a patient was identified to be at risk of malnutrition, we would recommend using the full version of the nutrition assessment form to assess the nutrition status.
Reference Kaiser, M. J. et al. (2009). Validation of the Mini Nutritional Assessment short-form (MNA®-SF): A practical tool for identification of nutritional status. JNHA – The Journal of Nutrition, Health and Aging, 13(9), 782. Doi:10.1007/s12603-009-0214-7
Revised item: Screening for risk of malnutrition (e.g., decreased food intake and/or unintentional weight loss over the last 3 months). Response options: Yes No Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Monitoring temperature axillary measure Response options: Less than 37.50C 37.5-38.50C Greater than 38.50C In Round 1, this item's response option did not reach the consensus, with a mean = 3.43, a panel agreement = 52.5%.
Research shows that a temperature of 37.5°C is associated with worse outcomes and becomes significant at temperatures greater than 38.5 °C (Lee et al., 2012; Ogoina, 2011). Therefore, the three groups of temperature were maintained, as above.
Appendices 299 References: Lee, B. H. et al. (2012). Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study. Critical Care, 16(1), R33. doi:10.1186/cc11211 Ogoina, D. (2011). Fever, fever patterns and diseases called ‘fever’ – A review. Journal of Infection and Public Health, 4(3), 108-124. doi:https://doi.org/10.1016/j.jiph.2011.05.002 Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Emergency surgery Original response options: Non-emergency surgery Emergency surgery for a pathological condition Emergency surgery for trauma
In Round 1, this item's response options reached partial consensus with a mean = 3.52, and panel agreement = 60.9%.
Two-panel members provided comments for this response option, including deleting option 1 (non-emergency surgery), and others suggested using a Yes or No option and if Yes was chosen, then choose option 2 or 3.
Taking expert recommendation into consideration, we revised the response options as below:
Emergency surgery New response options: No Yes, what type of emergency surgery? Pathological condition Trauma
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (Please give suggestions below) appropriate appropriate appropriate appropriate
Duration of surgery Original response options:
300 Appendices Less than 1 hours 1-3 hours Greater than 3 hours
In Round 1, this item's response option did not reach the consensus, with a mean = 3.30, and panel agreement = 50%.
Three panel members suggested changes to this question, in which two advised including the group from 3-6 hours and over 6 hours, another member suggested using direct hours for measuring the duration of surgery.
Taking the expert comments into consideration and reviewing the literature on the impact of the length of operation on surgical wound complications, the response options for this item were revised as below:
Duration of surgery New response options: Less than 1 hours 1-3 hours Between 3 hours to 6 hours Over 6 hours
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
If a traumatic injury is present, the duration from injury to surgery (hours) Original response options: Less than 10 hours Greater than 10 hours
In round 1, this item's response options did not reach the consensus, with a mean = 2.65, and panel agreement = 39.1%.
Nine expert members provided comments for this question, in which the majority of comments were associated with a cut-off point of 6 hours. Taking experts’ suggestions into consideration, the response option was revised as below
Traumatic injury present New response options:
Appendices 301 No Yes, the duration from injury to surgery? Less than 6 hours Greater than 6 hours
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
If it is a non-emergency surgery, what is the length of preoperative hospital stay? Original response options: Less than 2 days Greater than 2 days
In round 1, this item's response option did not reach the consensus with a mean = 2.65, and panel agreement = 42.9%. Three experts provided comments for this question. All of the comments were associated with providing a classification for this question.
Research indicated that a pre-surgery hospital stay of at least 2 days is a factor associated with an increased risk of surgical site infection (World Health Organization. 2016). As a result, this item's response option was revised as below References World Health Organization. (2016). Global Guidelines for the Prevention of Surgical Site Infection. Retrieved from http://apps.who.int/iris/bitstream/10665/250680/1/9789241549882- eng.pdf?ua=1 Elective surgery? New response options: No Yes, the length of preoperative hospital stay? Less than 2 days Greater than 2 days Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
302 Appendices Surgical cleaning agents Original response options: Sodium chloride 0.9% Povidone Hydrogen peroxide Other
In round 1, this item's response option did not reach the consensus with mean = 3.39, a panel agreement = 52.2%.
Two experts suggested that Hydrogen peroxide is no longer required for surgical cleaning. Taking suggestions from the expert panel, this response option was revised as below:
Surgical cleaning agents used at site of surgery New response options: Sodium chloride 0.9% Povidone Other Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Type of surgery: exploratory abdominal surgery, hip prosthesis, colon surgery, coronary bypass, and open reduction of fracture Response options: Yes No Some types of surgery are associated with an increased surgical site infection. An example of four types of surgery associated with increasing the risk of surgical site infection was selected to determine whether patients are in the high risk group of surgical infection.
The four types of surgery were determined according to the findings of surgical site infection rate in Vietnam (Viet Hung.et al, 2016), and the recommendation the top types of surgery associated with surgical site infection, set out in the Best Practice Recommendations for the Prevention and Management of Surgical Wound Complications (Canadian Association of Wound care, 2017).
References: Viet Hung, N. et al. (2016). Surgical Site Infection Rates in Seven Cities in Vietnam: Findings of
Appendices 303 the International Nosocomial Infection Control Consortium. Surg Infect (Larchmt), 17(2), 243-249. doi:10.1089/sur.2015.073 The Canadian Association of Wound Care. (2017). Best Practice Recommendations for the Prevention and Management of Surgical Wound Complications. Retrieved from https://www.woundscanada.ca/docman/public/554-bpr-prevention-and-management-of-surgical- wound-complications/file
Please consider and chose the option you feel is most appropriate for this response options.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option(please give suggestions below) appropriate appropriate appropriate appropriate
Incision dimension Original response options: If surgical wound healing by primary intention If open surgical wounds The wound length:...... cm The wound length:...... cm The widest point:...... cm
In round 1, this item's response option did not reach the consensus with a mean=3.39, and panel agreement = 56.6%.
Two expert members recommended including the measurement of the depth of the wound for open surgical wounds. Therefore, this item's response option was revised as below:
Incision/wound dimension New response options: If surgical wound healing by primary intention If open surgical wounds The wound length:...... cm The wound length:...... cm The widest point:...... cm The deepest point:.....cm Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Revise the response option (please give Somewhat appropriate appropriate appropriate appropriate suggestions below)
Incision edges Original response options:
304 Appendices If surgical wound healing by primary If open surgical wounds intention Edges well approximated Edges approximated but tension at Edges sloping or flat incision line Edges raised or rolled Edges are not all approximated and undermining present tension at incision line Edges are not together
In round 1, this item's response option did not reach consensus with a mean = 3.21, and panel agreement= 47.8%.
Two experts provided comments for this question, in which one expert recommended moving from the last 3 options in surgical wound healing by primary intention to the column of open surgical wounds.
However, the purpose of assessment of incision/wound edges is to predict the progress of wound healing. Therefore, this response option was revised according to the recommendation from the Canadian Association of Wound care for surgical wound healing by primary intention(The Canadian Association of Wound Care, 2017), and World Union of Wound Healing Societies for open wounds (WUWHS, 2016). The items were revised as below.
References: The Canadian Association of Wound Care. (2017). Best Practice Recommendations for the Prevention and Management of Surgical Wound Complications. Retrieved from https://www.woundscanada.ca/docman/public/554-bpr-prevention-and-management-of-surgical- wound-complications/file World Union of Wound Healing Societies (WUWHS). (2016). Florence Congress, Position Document. Advances in wound care: The Triangle of Wound Assessment. Wounds International. Retrieved from http://www.wuwhs2016.com/files/WUWHS_TWA_FINAL_web.pdf
Incision colour within 4 cm of wound edge New response options: If surgical wound healing by primary If open surgical wounds intention Red, edges well approximated (days 1-4) Edges sloping or flat Red, edges well approximated Edges raised or rolled and progressing to bright pink undermining present (days 5-14)
Appendices 305 Red, edges approximated but tension at incision line (days 1-4) Red, edges are not approximated and tension at incision line (days 5-14)
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Wound bed tissue type Response options: If surgical wound healing by primary If open surgical wounds intention Mostly epithelializing Mostly granulating Incision edges closed Mostly sloughy Mostly necrotic
In round 1, this item's response option did not reach the consensus, with a mean = 3.13, and panel agreement 52.2%.
Two expert members provided comments for this question and one expert suggested to use the percentage of the wound surface, such as 10%, 20%, 50%, 75%, 100% to assess the amount of tissue type in the wound bed.
However, taking expert comments into consideration and reviewing the literature, the wound bed tissue type options for open surgical wounds was based on guidelines from World Union of Wound Healing Societies (2016) as above.
References World Union of Wound Healing Societies (WUWHS). (2016). Florence Congress, Position Document. Advances in wound care: The Triangle of Wound Assessment. Wounds International. Retrieved from http://www.wuwhs2016.com/files/WUWHS_TWA_FINAL_web.pdf Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
306 Appendices
Swelling Original response options Yes No In round 1, this items’ response option did not reach the consensus, with a mean=3.43, and panel agreement =56.5.
One expert panel member suggested assessing the level of swelling. This item's response option was revised slightly as below.
Swelling at incision and surrounding tissues Response options: Yes No Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Erythema Response options: Yes No
In round 1, this item's response option did not reach the consensus with a mean = 3.35, and panel agreement = 47.8%
There were five comments and suggestions for this question. Taking experts’ suggestions into consideration and reviewing the literature, erythema was more specifically defined as present within 4cm of the wound edges (World Union of Wound Healing Societies, 2016). Therefore, this item’s response option was revised as below. Reference World Union of Wound Healing Societies (WUWHS). (2016). Florence Congress, Position Document. Advances in wound care: The Triangle of Wound Assessment. Wounds International.
Appendices 307 Retrieved from http://www.wuwhs2016.com/files/WUWHS_TWA_FINAL_web.pdf
Localised erythema either at incision or within 4 cm of the wound edges Response options: Yes No Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Signs of haematoma formation (e.g., focus area of swelling, hardness or bogginess upon palpation, painful) Response options: Yes No In round 1, this item's response option did not reach the consensus, with a mean = 3.48, and panel agreement = 56.5%. Two comments from experts were provided for this question. This question was revised as below: Signs of haematoma formation (e.g., focus area of swelling, hardness or bogginess upon palpation, painful) Response options: At least one sign of hematoma formation No signs of hematoma formation Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Color and type of exudate Response options: None Mostly clear, amber Mostly bloodstained Mostly cloudy, milky Mostly green or yellow
In round 1, this item's response option did not reach the consensus with a mean = 3.39, and panel agreement = 56.5%.
308 Appendices According to World Union of Wound Healing Societies, (2007), the characteristic of the color of exudate can be used as an indicator for components, contaminants, or underlying cause of the wounds, for example: None or mostly clear, amber (it is often considered the normal type of exudate) Bloodstained (due to the presence of red blood cells and indicating capillary damage) Cloudy, milky (may indicate the presence of fibrin strands or infection) Green or yellow (may be indicative of bacterial infection or maybe due to the presence of wound slough or material from an enteric or urinary fistula).
Therefore, the item's response option was defined according to the recommendation from the World Union of Wound Healing Societies.
Reference: World Union of Wound Healing Societies (WUWHS). (2007). Principles of best practice: wound exudate and the role of dressings. A consensus document. London: MEP Ltd. Retrieved from http://www.woundsinternational.com/media/issues/82/files/content_42.pdf
Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Exudate volume Response options: Dry (no visible exudate) Moist (less than 50% exudate in primary dressing) Wet (50-70% exudate in primary dressing Saturated (more than 75% primary dressing and leakage to secondary dressing)
In Round 1, this items' response option did not reach the consensus, with a mean = 3.30, and panel member = 52.2%.
Two experts recommended dividing exudate volume into none, little, and heavy.
However, response options for measuring exudate volume based on the observations above were defined according to the recommendation from Wounds UK, which is based on Best Practice Statement. Effective Exudate
Appendices 309 Management. (Wounds UK, 2013), and experts’ recommendations in the research team.
Reference: Wounds UK. (2013). Best Practice Statement. Effective exudate management. Retrieved from http://www.wounds-uk.com/pdf/content_10816.pdf. Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Odour Response options: None Present after removing dressing Present prior to dressing removal and patient aware of it In round 1, this item's response options reached partial consensus with a mean =3.52, and panel agreement 52.2%.
The three response options above were classified based on the recommendations from Wounds UK which are set out in Best Practice Statement. Effective Eexudate Management. (Wounds UK, 2013), and suggestions from doctors in Vietnam.
However, in Round 1, one expert suggested changing "patient aware" to "nurses aware". Therefore, this items' response was revised as below. Reference: Wounds UK. (2013). Best Practice Statement. Effective exudate management. Retrieved from http://www.wounds-uk.com/pdf/content_10816.pdf.
Odour Response options: None Present after removing dressing Present prior to dressing removal and nurse aware Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
310 Appendices Wound pain Response options: 0 (no pain) 1-3 (mild) 4-6 (moderate) 7-10 (severe) In round 1, this item's response option did not reach consensus, with a mean = 3.26, and panel agreement = 43.5%.
Two experts suggested dividing the score range 7-10 into 7-8 for severe and 9-10 for extremely severe. However, the numeric rating scale for pain is a validated, user-friendly tool. The scores range from 0 to 10 and the scores are divided into 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain) and 7-10 (severe pain) (Jones, K. R., Vojir, Hutt, & Fink, 2007). As the result of reviewing the literature, this item's response options have remained the same as above. Reference Jones, K. R., Vojir, C. P., Hutt, E., & Fink, R. (2007). Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents. Journal of rehabilitation research and development, 44(2), 305. Please re-rate the response option.
2. 1. Not 3. Quite 4. Highly Somewhat Revise the response option (please give suggestions below) appropriate appropriate appropriate appropriate
Appendices 311 Appendix Q: Round Two items’ response options which achieved full consensus without comments (n-21)
Mean (m), Standard Deviation (SD), and % Reach Resulting Items Response option of panel agreement (PA) consensus action BMI - Less than 18.5 (underweight) m =3.71 Yes Accepted into - 18.5-22.9 (normal weight) SD= 0.46 the tool - 23-27.5 (overweight) PA=71.4% - Over 27.5 (Obese) Smoking status - Non-smoker m =3.71 Yes Accepted into - Previously smoked but gave up four SD=0.46 the tool weeks before surgery PA=71.4% - Current smoker: continued to smoke in the preoperative period Regular use of steroids for long term - Used for less than 30 days before m =3.67 Yes Accepted into treatment surgery SD=0.46 the tool - Used for more than 30 days before PA=71.4% surgery - Not used at all Risk of malnutrition - No m =3.67 Yes Accepted into - Yes SD=0.58 the tool PA=71.4% Immune deficiency - No m =3.81 Yes Accepted into - Yes SD=0.40 the tool PA=81% Trauma wound - No m =3.81 Yes Accepted into - Yes, the duration from injury to surgery? SD=0.40 the tool Less than 6 hours PA=81% Greater than 6 hours
312 Appendices Mean (m), Standard Deviation (SD), and % Reach Resulting Items Response option of panel agreement (PA) consensus action Closed surgical Open surgical wounds wounds Wound dimension - Length…cm - Length…cm m =3.67 Yes Accepted into - The widest point:…cm SD=0.73 the tool - The most depth point:.....cm PA=76.2% Swelling at incision and surrounding - No m =3.81 Yes Accepted into tissues - Yes SD=0.40 the tool PA=81% Signs of haematoma formation - At least one signs of haematoma m =3.62 Yes Accepted into formation SD=0.74 the tool - No signs of haematoma formation PA=71.4% Colour and type of exudate - None m =3.81 Yes Accepted into - Mostly clear, amber SD=0.40 the tool - Mostly blood-stained PA=81% - Mostly cloudy, milky - Mostly green or yellow
Volume of exudate - Dry m =3.81 Yes Accepted into - Moist SD=0.40 the tool - Wet PA=81% - Saturated
Wound pain - 0 (no pain) m =3.76 Yes Accepted into (numeric rating scale 0-10) - 1-3 (mild) SD=0.44 the tool - 4-6 (moderate) PA=76.2% - 7-10 (severe)
Appendices 313 Appendix R: Round Two items’ response options which reached full consensus with expert comments
Mean (SD), and % of panel Achieved Resulting Items Response option agreement consensus Comments for revision action (n-21) Chemotherapy - Received either currently or m =3.62 Yes Patients receiving chemotherapy Accepted in the 30 days before surgery SD=0.74 before surgery have [a] higher risk into the - Not received at all PA=71.4% [of] post-operative complications tool (n=1) In my option, this response option should be divided into in more detail as patients just receiving chemotherapy treatment will be different to patients who have received it in the [last] 30 days (n=1) Duration of surgery - Less than 1 hours m =3.52 Yes Provide another response option Accepted (hours) - 1-3 hours SD=0.93 (n=1) into the - Between 3 hours to 6 hours PA=71.4% Depending on the type of surgery, tool - Over 6 hours details of operation time should be used to compare… (n=1) Preoperative surgical - No m =3.81 Yes In fact, in Vietnam, as doctors give the Continue in antibiotic prophylaxis - Yes SD=0.40 order to use antibiotic prophylaxis do round 3 within 120 minutes pre- PA=81% not follow the same guidelines, the use incision of antibiotic prophylaxis within Vietnam is very different between physicians. Therefore, if patients [are] receiving antibiotics more than 120
314 Appendices Mean (SD), and % of panel Achieved Resulting Items Response option agreement consensus Comments for revision action (n-21) minutes before surgery is considered to be not appropriate, so…. Closed surgical Open surgical wounds wounds Wound bed - Incision edges - Mostly m =3.62 Yes Not clear granulating 10%, 20%? Or Accepted closed epithelializing SD=0.74 necrotic 10% or 20%?(n=1) into the - Mostly - Mostly PA=71.4% In my option, the percentage should be tool epithelializing granulating provided to give more details of the - Mostly - Mostly sloughy wound bed (n=1) granulating - Mostly necrotic - Mostly sloughy - Mostly necrotic
Odour - None m =3.76 Yes Should delete the option “nurse Accepted - Present after removing dress SD=0.54 aware” since it may be both nurse and into the - Present prior to dressing removal and PA=81% patient [are] aware [of] odour(n=1) tool nurse aware M = mean; SD = Standard Deviation; PA = % of Panel agreement
Appendices 315 Appendix S: Round two items’ response options which reached partial consensus
Mean (SD), % Items Response option of panel Achieved Comments for Resulting agreement consensus revision action (n=21) Diabetes: - No m =3.67 Partial Level of HbA1C Continue - Yes, the level of HbA1C before surgery? SD=0.48 consensus > 7%, in round 3 Unknown PA=66.7% complications, Less than 7% level of glucose Greater than 7% before and after surgery(n=1) Temperature - Less than 37.50C m =3.52 Partial Continue - 37.50c – 38.50C SD=0.75 consensus in round 3 - Greater than 38.50C PA=61.9% Emergency surgery - No m =3.52 Partial Yes (emergency Continue - Yes, what type of emergency surgery? SD=0.75 consensus surgery for in round 3 Pathological condition PA=61.9% pathological Trauma condition and trauma)(n=1) Surgical wound cleaning - Sodium chloride 0.9% m =3.57 Partial Continue agents - Povidone SD=0.75 consensus in round 3 - Other PA=66.7%
316 Appendices Mean (SD), % Items Response option of panel Achieved Comments for Resulting agreement consensus revision action (n=21) Closed surgical Open surgical wounds wounds Wound edges - Red, edges well - Edges sloping m =3.67 Partial Continue approximated or flat SD=0.48 consensus in round 3 (days 1-4) - Edges raised or PA=66.7% - Red, edges well rolled approximated and - Undermining progressing to present bright pink (days 5-14) - Red, edges approximated but tension at incision line (days 1-4) - Red, edges are not approximated and tension at incision line (days 5-14) Note: m = Mean; SD = Standard deviation; PA = % of panel agreement
Appendices 317 Appendix T: Round Two items’ response options which did not reach consensus
Mean (SD), and % of panel Achieve Results Items Response option agreement consensus Comments for revision action (n=21) Age - 18-40 m =3.43 No Aging is one small Continue in - 41-65 SD=0.68 factor impacting on round 3 - Over 65 PA=52.4% wound healing; there are many factors that impact on wound healing (n=1) The length of - No m =3.24 No In Vietduc hospital, Continue in preoperative - Yes, the length of SD=0.99 patients with elective round 3 hospital stay if preoperative hospital PA=52.4% surgery are admitted to elective surgery stay? the hospital only one Less than two day before surgery. days Therefore, this question Greater than two is not appropriate for days elective surgery (n=1) Types of surgery - No m =3.48 No Higher risk of infection Continue in - Yes SD=0.81 compared to another round 3 PA=61.9% type of operation(n=1) Localised - No m =3.48 No Swelling and erythema Continue in erythema - Yes SD=0.81 (n=1) round 3 PA=61.9% Note: m = Mean; SD = Standard deviation; PA = % of panel agreement
318 Appendices Appendix U: Round Three Email
Dear expert panel member,
Re: Development and validation of a surgical wound assessment tool for Vietnamese patients
Welcome to Round Three, the final round of the survey: Development of a surgical wound assessment tool for Vietnamese patients. The comments and ratings you provided in Round One and Two were insightful and interesting. The energy and thoughtfulness with which you completed the questions were valuable and have greatly enhanced this study. After finishing Round Two, 21 nurse wound care experts completed the survey, there are only 11 items and 10 item response options that did not reach consensus in Round Two; thus, we are sending these to you for re-rating.
You will have two weeks to complete this third round. The third survey is now open until 8/8/2017. Therefore, it would be greatly appreciated if you could fill out this survey by 8th of August.
To start the survey, please click the link at http://survey.qut.edu.au/f/189903/128a/
Should you have any questions or comments regarding this process, please feel free to contact me at [email protected] or call +61 7 3138 6108. This link is uniquely tied to this survey and your email address. Please do not forward this message.
Thank you for your participation
Yours sincerely,
Do Thi Thu Hien PhD candidate Queensland University of Technology Phone: +61 7 3138 6108
Email: [email protected]
Appendices 319 Appendix V: Round Three_ Questionnaire
PART I: RE-RATE ITEMS IN THE SURGICAL WOUND ASSESSMENT TOOL
Please review overall group rating by 21 nurse wound care experts for each question in Round 2.
After you have reviewed the group rating, please reconsider your response in the context of the feedback provided and then re-rate the items. You may choose to make the same answer you gave previously, or change your rating
A minimum mean of 3.5 and 70% panel agreement is needed for an item to be included in the tool
How important is it that the following items should be included in the surgical wound assessment tool?
Item 1. Not 2. 3. Quite 4. Highly appropr Somewhat appropriat appropriate iate appropriat e e Age
Overall groups rating (median):4 Panel agreement:61.9% BMI
Overall groups rating(median):4 Panel agreement:52.4% Smoking statues
Overall groups rating (median):3 Panel agreement: 52.4% Monitoring temperature
Overall groups rating (median): 3 Panel agreement: 66.7% Surgery on site of old scare
Overall groups rating (median):3 Panel agreement:47.6%
Emergency surgery
Overall groups rating(median): 4
320 Appendices
Panel agreement: 61.9% Duration of surgery
Overall groups rating(median):3 Panel agreement: 57.1% Length of preoperative hospital stay for elective surgery Overall groups rating(median):3 Panel agreement: 47.6% Wound dimensions
Overall groups rating:4 Panel agreement: 61.9% Incision/wound edges
Overall group ratings:4 Panel agreement: 66.7% Wound pain on a numeric rating scale 0 - 10 Overall groups rating(median):4 Panel agreement:57.1%
PART II: RE-RATE ITEM'S RESPONSE OPTIONS IN THE SURGICAL WOUND ASSESSMENT TOOL
A minimum mean of 3.5 and 70% panel agreement is needed for this items' response options to be included in the tool
Age Response option
18-40 41-65 Over 65
Overall group response: 4 Panel agreement: 52.4%
Please re-rate this item response option
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Appendices 321
Diabetes (currently diagnosed with any type of diabetes) No Yes, the level of HbA1C? Less than 7% Greater than 7%
Round 2: Overall group rating (median): 4 Panel agreement: 66.7% Please re-rate this item response option
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
2. 3. 4.
Monitoring temperature axillary measure Response option
Less than 37.50C 37.50C – 38.50C Greater than 38.50C
Round 2:
Overall group rating (median): 4 Panel agreement: 61.9%
Please re-rate this item response option
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Emergency surgery Response option
No Yes, what type of emergency surgery?
322 Appendices Pathological condition Trauma
Round 2:
Overall group rating (median): 4 Panel agreement: 61.9%
Please re-rate the response option.
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Preoperative surgical antibiotic prophylaxis Response option
Clean wounds do not need preoperative antibiotic use Received within 120 minutes pre-incision Received but more than 120 minutes pre-incision Not received at all
Round 2:
Overall group rating (median): 4 Panel agreement: 52.4%
Please re-rate the response option.
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Length of preoperative hospital study for elective surgery Response option
No Yes, the length of preoperative hospital stay? o Less than 2 days o Greater than 2 days
Round 2:
Appendices 323 Overall group rating (median): 4 Panel agreement: 52.4%
Please re-rate the response option.
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Surgical cleaning agents used at site of surgery Response option
Sodium chloride 0.9% Povidone Other
Round 2:
Overall group rating (median): 4 Panel agreement: 66.7%
Please re-rate the response option.
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Type of surgery: exploratory abdominal surgery, hip prosthesis, colon surgery, coronary bypass and open reduction of fracture? Response option:
No Yes
Round 2:
Overall group rating (median): 4 Panel agreement: 61.9%
Please re-rate the response option.
324 Appendices 2. Somewhat 4. Highly
1. Not appropriate appropriate 3. Quite appropriate appropriate
Incision edges response options:
If surgical wound healing by primary intention If open surgical wounds
Red, edges well approximated Red, edges approximated but tension at Edges sloping or flat incision line Edges raised or rolled Red, edges are not approximated and tension at undermining present incision line
Round 2:
Overall group rating (median): 4 Panel agreement: 66.7%
Please re-rate the response option.
2. Somewhat 3. Quite 4. Highly
1. Not appropriate appropriate appropriate appropriate
Localised erythema either at incision or within 4cm of the wound edges) Response option
No Yes
Round 2:
Overall group rating (median): 4 Panel agreement: 61.9%
Please re-rate the response option.
Appendices 325 2. Somewhat 4. Highly
1. Not appropriate appropriate 3. Quite appropriate appropriate
326 Appendices Appendix W: Round Three items’ response options and resulting action (n=21)
Panel agreement quite appropriate / Items Response option Mean SD highly appropriate Achieved Resulting action n(%) consensus Age - 18-40 3.67 0.48 14(66.7) No Response options - 41-65 accepted, as this item - Over 65 reached consensus in item rating section Diabetes: - No 3.90 0.30 19(90.5) Yes Accepted - Yes, the level of HbA1C before surgery? Unknown Less than 7% Greater than 7% Monitoring - Less than 37.50C 3.71 0.46 15(71.4) Yes Excluded, as this temperature axillary - 37.50c – 38.50C item did not reach measure - Greater than 38.50C consensus in item rating section Emergency surgery - No 3.90 0.30 19(90.5) Yes Accepted - Yes, what type of emergency surgery? Pathological condition Trauma
Appendices 327 Panel agreement quite appropriate / Items Response option Mean SD highly appropriate Achieved Resulting action n(%) consensus Preoperative - Clean wounds do not need 3.90 0.30 19(90.5) Yes Accepted surgical antibiotic preoperative antibiotic use prophylaxis - Received within 120 minutes pre-incision - Received but more than 120 minutes pre-incision - Not received at all Length of - No 3.57 0.60 13(61.9) No Excluded preoperative hospital - Yes, the length of stay if elective preoperative hospital stay? surgery Less than 2 days Greater than 2 days Surgical wound - Sodium chloride 0.9% 3.76 0.44 16(76.2) Yes Accepted agents - Povidone - Other Type of surgery: (is - No 3.76 0.44 16(76.2) Yes Accepted this surgery? - Yes exploratory abdominal surgery, hip prosthesis, open reduction of fracture
328 Appendices Panel agreement quite appropriate / Items Response option Mean SD highly appropriate Achieved Resulting action n(%) consensus
Closed surgical Open surgical wounds wounds Wound - Edges well - Edges sloping 3.76 0.44 16(76.2) Yes Accepted edges approximated or flat - Edges - Edges raised approximated but or rolled tension at incision - Undermining line present - Edges are not approximated and tension at incision line Localised - No 3.81 0.40 17(81) Yes Accepted erythema - Yes either at incision or within 4cm of the wound edges SD: Standard deviation
Appendices 329 Appendix X: The score for the surgical wound assessment tool.
Factors OR range from Estimate score for Selected OR Original research Notification literature SWAT Age 1.6-3.59 1.5 (over 65 years) 1.6, 95% IC (Kaye et al., 2005) 1.5-1.8 BMI 1.0-7.1 1.5 (BMI >27.5) 1.78, 95% CI (Davis et al., 2017) No studies were found 1.23-2.57 specifically using the cut off 1 (BMI < 18.5) 1.126, 95% CI (Neumayer et al., 2007) points for Asian BMI. 1.039-1.221 Therefore, subcategories of BMI were estimated based on the closest study with the smallest range of 95% CI Diabetes 1.5 to 24.3 1 (HbA1c =7% or less) 1.22, 95% CI (Harris et al., 2013) 2 (HbA1C >7%) 1.01-1.47 Smoking 1.56 - 13.78 2 (Currently smoking) RR 2.08, 95% (Wong et al., 2012) RR (relative risk) was CI 1.60 to 2.71 reported instead of OR 1.5 (Ex-smokers who quit RR 1.64, 95% less than three to four CI 1.04 to 1.92 weeks before surgery) Use of steroids 1.38-1.86 1 1.387, 95% CI (Neumayer et al., 2007) 1.179-1.346 Chemotherapy 1 There is limited evidence about receiving chemotherapy having higher risk of surgical wound
330 Appendices Factors OR range from Estimate score for Selected OR Original research Notification literature SWAT complications. Therefore, the score for this item was allocated as 1 point. Immune deficiency 1.4 1 1.4 95% CI 0.5- (Kigera et al., 2012) 3.8 Risk of malnutrition 1.13 - 2.8 1 1.126, 95% CI (Neumayer et al., 2007) 1.039-1.221 Trauma wound 1.87-2.73 2 1.87, 95% CI (Ridgeway et al., 2005) 1.50-2.34 Surgical wound 1.4 to 10.7 1 (clean-contaminated) 1.404; 95% CI (Neumayer et al., 2007) contamination 1.265-1.559 classification 1.5 (contaminated) 1.706; 95% CI 1.454-2.002 2 (infected/dirty) 1.584; 95% CI 1.287-1.948 Emergency surgery 1.4-2.63 2 2.2 , 95% 1.21- (Ramos et al., 2008) 3.80 Duration of surgery 0.1-3.2 1 (1-3h) The cut of point of operation 2 (Between 3-6h) duration varied from study to 3 (Over 6) study. The score for each response option was allocated based on a review of the literature, which presented in Section 2.3.2
Appendices 331 Factors OR range from Estimate score for Selected OR Original research Notification literature SWAT Preoperative surgical 1 (received more than 120 (World Health The cut-off point of 120 antibiotic prophylaxis minutes pre-incision) Organization, 2016a) minutes of preoperative 2 (not received at all) surgical antibiotics associated with preventing SSI was based on a recommendation from WHO, (2016a). However, no substantial evidence was found on OR associated with risk of surgical site infection. Therefore, a score for this item was allocated as 1 for received more than 120 minutes and 2 points for not received at all Type of surgery 1 (Rosenthal et al., 2013) There is some evidence for some surgeries, such as abdominal, hip prosthesis, colon, coronary bypass, and open reduction of fractures having a higher risk of surgical complications compared to others. Therefore, 1 point was allocated for patients who
332 Appendices Factors OR range from Estimate score for Selected OR Original research Notification literature SWAT underwent this group of surgeries. Surgical cleaning agents 1 (Sodium chloride 0.9%) (Dumville et al., 2015; There is some evidence about using topical antibiotic or Heal, Banks, Lepper, antiseptics associated with Kontopantelis, & van reducing the incidence of Driel, 2016) surgical wound infection. Therefore 0 was indicated for
using any antiseptic agents, and 1 point was allocated for using normal cleaning agents.
Appendices 333