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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2017-020147 on 14 March 2018. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 25, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020147 on 14 March 2018. Downloaded from The impact of violence against women on severe acute maternal morbidity in the intensive care unit: a case-control study protocol ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020147 Article Type: Protocol Date Submitted by the Author: 16-Oct-2017 Complete List of Authors: Ayala Quintanilla, Beatriz; La Trobe University College of Science Health and Engineering, Judith Lumley Centre; Peruvian National Institute of Health, Lima Taft, Angela; La Trobe University, Mother and Child Health Research McDonald, SJ; Midwifery Professorial Unit, La Trobe University/Mercy Hospital for Women Pollock, Wendy; La Trobe University, The Judith Lumley Centre; Mercy Hospital for Women Severe acute maternal morbidity, violence against women, intimate Keywords: partner violence, intensive care unit, social determinants, near miss http://bmjopen.bmj.com/ on September 25, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 34 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020147 on 14 March 2018. Downloaded from 1 2 3 4 Title Page 5 6 Study Protocol 7 8 9 The impact of violence against women on severe acute maternal 10 11 morbidity in the intensive care unit: a case-control study protocol 12 13 14 Corresponding autor: 15 16 Dr. Beatriz Paulina ForAyala Quintanilla. peer review only 17 18 Address: 215 Franklin Street, Melbourne, Vic 3000, Victoria, Australia. 19 20 Telephone: +61 3 9479 8800. Fax: +61 3 9479 8811. 21 22 Email: [email protected] 23 24 Authors: Beatriz Paulina Ayala Quintanilla1, 2, 4, Angela Taft1, Susan McDonald1, 2, Wendy 25 26 1, 2, 3 27 Pollock 28 29 30 Author affiliations 31 32 1 The Judith Lumley Centre, La Trobe University, Melbourne, Australia http://bmjopen.bmj.com/ 33 34 2 Mercy Hospital for Women, Melbourne, Australia 35 36 3 37 University of Melbourne, Melbourne, Australia 38 4 39 Peruvian National Institute of Health, Lima, Peru 40 on September 25, 2021 by guest. Protected copyright. 41 42 Keywords: Severe acute maternal morbidity, violence against women, intimate partner violence, 43 44 intensive care unit, social determinants, near miss. 45 46 47 Words in the abstract: 299 words. 48 49 Words in article: 3,276 words, excluding title page, abstract and references. 50 51 52 53 54 55 56 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 34 BMJ Open: first published as 10.1136/bmjopen-2017-020147 on 14 March 2018. Downloaded from 1 2 3 4 ABSTRACT 5 6 Introduction: Preventing and reducing violence against women (VAW) and maternal mortality 7 are Sustainable Development Goals. Worldwide, the maternal mortality ratio has fallen about 8 9 44% in the last 25 years; however, the majority of maternal deaths (99%) continue to occur in 10 developing countries. In addition, for one maternal death there are many women affected by 11 severe acute maternal morbidity (SAMM) requiring management in the intensive care unit 12 (ICU). These women represent the most critically ill obstetric patients of the maternal morbidity 13 spectrum and should be studied to complement the review of maternal mortality. Furthermore, 14 many women (30%) endure violence usually exerted by their intimate partners and VAW is 15 thought to be a contributory factor to maternal mortality; but, the impact on SAMM is unknown. 16 For peer review only 17 Thus, this study aims to investigate the impact of VAW on SAMM in the ICU. 18 19 Methods and analysis: This will be a prospective case-control study undertaken in a tertiary 20 healthcare facility in Lima-Peru. We calculated the sample size of 218 participants, 109 cases 21 (maternal ICU admissions) and 109 controls (non-maternal ICU admissions), considering a 22 confidence interval (CI) of 95% and a power of 80%. After obtaining individual written 23 24 informed consent, data on social determinants, medical and obstetric characteristics, VAW, 25 pregnancy and neonatal outcome will be collected through interviews and medical records. 26 VAW will be assessed by using the World Health Organization (WHO) instrument. Binary 27 logistic regression models will be developed to assess any association between VAW and 28 SAMM. 29 30 Ethics and dissemination: Ethical approval has been granted by the La Trobe University 31 32 Human Ethics committee, Melbourne, Australia and the tertiary healthcare facility in Lima-Peru. http://bmjopen.bmj.com/ 33 This research follows the WHO ethical and safety recommendations for research on VAW to 34 ensure the safety of the participants and interviewer. Findings will be presented at conferences, 35 and published in peer-reviewed journals. 36 37 38 39 40 Strengths and limitations of this study on September 25, 2021 by guest. Protected copyright. 41 42 • This prospective study will examine for the first time worldwide the influence of violence 43 against women (VAW) on severe acute maternal morbidity (SAMM). 44 • Studying the stage before maternal death (SAMM) can be considered as a complement to 45 46 maternal death review, and may provide evidence that gives useful insight into factors that 47 may prevent maternal deaths and improve the mother-baby dyad health. 48 • Assessing VAW can be challenging, because it is a sensitive issue and can be underestimated 49 due to recall and cultural bias. The sensitivity may have an impact on willingness to 50 participate in the study. This study will follow the ethical and safety recommendations for 51 research on VAW, and use standardised and pre-tested questions for the assessment of VAW 52 53 and other variables of interest to maximize participation. 54 • This study is within one very large tertiary hospital and further multi-centre studies are 55 needed, based on these replicable methods. 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 34 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020147 on 14 March 2018. Downloaded from 1 2 3 4 5 INTRODUCTION 6 Preventing and reducing violence against women (VAW) and maternal mortality are Sustainable 7 Development Goals (SDG).1 Worldwide, the maternal mortality ratio (MMR) has declined by 8 44% with a reduction from 385 to 216 maternal deaths per 100,000 live births between 1990 9 (532,000 maternal deaths) and 2015 (303,000 maternal deaths). This equates to approximately 10 2 11 830 women dying daily, of which 99% of maternal deaths occurred in developing countries. 12 However, maternal mortality is only a small proportion of the global burden of the maternal 3-5 13 morbidity spectrum. This is because for one maternal death there are many women affected by 14 severe acute maternal morbidity (SAMM) during pregnancy, childbirth and the postpartum 15 period5-11 including those obstetric patients who require multidisciplinary management in the 16 intensive care unit (ICU).For11-19 peer review only 17 18 13 15 20-25 19 ICU admission can be an alternative marker for defining SAMM, and SAMM can be 20 named as near miss; either term has been widely used to study this population of obstetric 15 17 21 25-28 21 patients. Although the World Health Organization (WHO) has developed a set of 22 (clinical, laboratory and management) criteria to facilitate the identification of near miss, taking 23 into account organ system dysfunction parameters;26 29 many researchers have argued the 24 applicability of using these criteria in both low-income and high-income countries.13 30-34 As a 25 result, in some studies, researchers have used an adapted version of the WHO criteria according 26 27 to the local context and characteristics of healthcare system resources, including the availability 31 32 35-38 28 of advanced laboratory measures and well-trained healthcare professionals. 29 30 Accordingly, there are no internationally accepted criteria for defining SAMM and its definition 31 could differ across studies.13 15 20 25 27 39-44 The use of ICU admission to identify severe maternal 32 22 morbidity has high sensitivity (86.4%), specificity (87.8%) and positive predicted value (0.85). http://bmjopen.bmj.com/ 33 27 45-48 34 This may not identify the wide range of severe obstetric complications because ICU 35 admission criteria may vary across setting and countries according to guidelines established by 26 49-51 36 the healthcare facility, hospital resources availability, among other factors.
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