Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com BMJ Quality & Safety Online First, published on RESEARCH14 May 2013 AND as REPORTING10.1136/bmjqs-2012-001603 Organising a manuscript reporting quality improvement or

Christine G Holzmueller,1,2 Peter J Pronovost1,3,4,5

1Armstrong Institute for Patient While a useful manual, it does not discuss Safety and Quality, Johns Background Peer-reviewed publication plays the nuances of reporting quality improve- Hopkins Medicine, Baltimore, Maryland, USA important roles in disseminating research ment and patient safety research. 2Department of Anesthesiology findings, developing generalisable knowledge Published guidelines are available to & Critical Care Medicine, The and garnering recognition for authors and improve the reporting of quality improve- Johns Hopkins University School institutions. Nonetheless, many bemoan the ment and other health services–related of Medicine, Baltimore, 5 Maryland, USA whole manuscript writing process, intimidated by research. The Standards for QUality 3Departments of Anesthesiology the arbitrary and somewhat opaque conventions. Improvement Reporting Excellence & Critical Care Medicine, and Methods This paper offers practical advice about (SQUIRE) guidelines offer an informative Surgery, Johns Hopkins organising and writing a manuscript reporting University School of Medicine, checklist when describing quality improve- Baltimore, Maryland, USA quality improvement or patient safety research for ment studies, which often have interven- 4Department of Health Policy & submission to a peer-reviewed journal. tions that evolve over time and are Management, Johns Hopkins Results Each section of the paper discusses a context-dependent.6 Bloomberg School of Public — Health, Baltimore, Maryland, specific manuscript component from title, Whether clinical or quality improve- USA abstract and each section of the manuscript body, ment, research is conducted to observe or 5Johns Hopkins University School through to reference list and tables and figures— explain something unknown or to evaluate of Nursing, Baltimore, Maryland, explaining key principles, offering content an intervention’simpactonanoutcome.7 USA organisation tips and providing an example of Observational studies ask questions and Correspondence to how this section may read. The paper also offers a generate hypotheses, while evaluation Christine G Holzmueller, checklist of common mistakes to avoid in a studies test hypotheses. Randomised clin- Armstrong Institute for Patient manuscript. ical trials generally evaluate one therapy’s Safety and Quality, Johns Hopkins Medicine, 1909 Thames impact on one outcome, sometimes com- Street, 2nd floor, Baltimore, MD Peer-reviewed publication plays important paring to a placebo or an alternative 21231, USA; roles in disseminating research findings, therapy, most often controlling all other [email protected] producing generalisable knowledge and care. Quality improvement is messier Received 17 October 2012 garnering recognition for authors and because it involves changing human behav- Revised 20 March 2013 institutions. Yet, writing is rarely taught iour in practice, testing and evolving inter- Accepted 2 April 2013 in . In a 1985 survey, only ventions over time, developing theories 11 of 100 American medical schools that explain how the intervention relates to offered some type of composition course improved outcomes, incorporating how for biomedical research papers.1 Pierson2 local context influences implementation studied manuscript rejections and found and, often, evaluating performance. that one of the major reasons was poor The SQUIRE guidelines help authors preparation (eg, over interpretation of untangle the mess of quality improve- results, text difficult to follow). ment work. Nonetheless, we repeatedly Many healthcare professionals have hear colleagues and mentees bemoaning trouble organising and writing a research the whole manuscript writing process. manuscript. One editor-in-chief described They have trouble determining what to it this way: ‘Their scholarly and creative include and how to frame their paper, ideas and insightful data interpretation seeking practical guidance and heuristics. To cite: Holzmueller CG, often seem to get lost in the translation This paper offers practical advice about Pronovost PJ. BMJ Qual Saf ’3 Published Online First: [please from brain to page. This quote begins the organising and writing a manuscript include Day Month Year] foreword for the AMA Manual of Style, reporting quality improvement or patient doi:10.1136/bmjqs-2012- which is a comprehensive guide to writing safety research for submission to a peer- 001603 and publishing biomedical research.4 reviewed journal.

Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 1 Copyright Article author (or their employer) 2013. Produced by BMJ Publishing Group Ltd under licence. Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology

PLANNING A MANUSCRIPT We have organised our manuscript into six distinct The four phases of a manuscript include planning, parts: title, abstract, body, reference list, tables and writing, submitting and revising. We cover the first two figures, and acknowledgements. phases. A recent article nicely lays out the last phase, revising your manuscript following peer-review com- TITLE AND ABSTRACT ments.8 This section is important, please read it carefully. The title and abstract are prominent parts of a manu- In the planning phase, define your audience and script. Both sections are the first, and in some cases, choose an appropriate journal. Understanding your the only content the editor and journal readers will audience will guide the level of detail you provide (eg, peruse. Your title should grab the readers’ attention, definitions for terminology). Look at the journal’s like a news headline, while providing an informative scope and article categories to ensure your research description of the study. Try to mention the interven- fits. Once you have chosen a journal, read the author tion, setting, patient population, outcome measure instructions for the word limit, specific formatting and study design. For example, ‘Patient information instructions, and required content and forms (eg, dis- sheet improves inpatient care during Radiology closing competing interests). Also, draft the order of testing.’ Notice that this title is concise and is not a authorship, complete a literature search related to wordy sentence. your research topic, assemble tables and figures of The abstract is a snapshot of your study and should your data and outline your paper. inform and persuade the editor and audience to read Outlining can help organise your thoughts and the full manuscript. Content that will clearly illustrate manuscript content, offering a double check for com- your study includes the objective, study design, popula- plete and consistent information. For instance, if you tion, setting, intervention, primary outcome measure describe a survey of laboratory technicians and nurses and the method of analysis, important findings and in the methods, report the response rates by job cat- brief conclusion. Before you draft the abstract, read the egory and the survey data in the results. Head your author instructions and follow their structure and word outline with a thesis statement to avoid scope creep length. Avoid abbreviations unless it is a unit of measure and remain focused on the paper’s main message. (eg, mg for milligram) and exclude references. Your abstract must make sense and not read as WRITING A MANUSCRIPT random content grabbed from your manuscript and Writing the first draft of your manuscript is different plunked into subheadings. For example, if you report from writing a novel, in which you start at the begin- that ‘92% of radiology technicians perceived the ning and proceed to the end. A research paper has dis- patient information sheet was useful’ in the results, tinct sections (abstract, introduction, methods, results, then describe the mechanism of data collection (eg, discussion) that fit together like a jigsaw puzzle to tell survey, interviews) and sample size in the methods. your story. Write each section separately. Read some published abstracts to guide your writing. We can recommend several strategies to make the Whether you write the abstract before or after the writing process less onerous. You can write the sec- main body of your manuscript is a matter of prefer- tions in the following order: methods, results, intro- ence. If you write it first, remember to revise it when duction, discussion and finish with the abstract. the manuscript is complete to ensure consistency of Alternatively, write the abstract and create the tables content. As a general composition rule, write in the and figures first, write the methods and results past tense when discussing what you did or found and together next, then write the discussion and finish in the present tense when describing what is known with the introduction. You could also write the (eg, the evidence). methods during the planning and implementing phases of the study. Writing your paper concurrently MANUSCRIPT BODY with the work is invaluable because it helps produce a Your manuscript body is a nonfiction story, with a more accurate account of what occurred and clarifies beginning (Introduction), a middle (Methods and what needs to be done. This strategy may also help Results) and an ending (Discussion); in the biomedical you catch omissions or limitations early in the imple- publishing world this is called the IMRaD structure. mentation phase when they are more easily remedi- All of the pieces of your story should connect and the able. Another strategy is to write your results information must be consistent. The introduction concurrently with the assembly of each table and describes why your research was undertaken and what figure, or write the methods, results and important question you wanted to answer. The methods explain conclusions with each table or figure. You should how your results were achieved; whatever you select a strategy that works for you. Several books on promise in the methods needs corresponding data in – may also be helpful references.9 12 the results section, tables or figures. The discussion When writing your paper, think of your main message answers your , summarises where in terms of a newspaper headline and use the manu- your findings fit in the existing body of evidence and script to narrate that message. discusses what this means moving forward.

2 Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology

Our manuscript body follows the IMRaD structure your study is needed, clarifying the limitations or gaps and includes information recommended in the SQUIRE in the current knowledge and making the connection to guidelines in each section.13 Within each section, we your study. In the next paragraph, summarise what you describe its purpose, offer tips to organise the content intended to improve; include the study aim and the and end with an example of how this section may read. tipping point that prompted the change. This point may have been a series of adverse events in your workplace, Introduction high complication rates across the USA or a national The introduction provides the context regarding why patient safety goal. If you are testing a hypothesis (evalu- your research is needed and important. Limit this ation study), consider including it here rather than (or in section to one double-spaced page (about 300 words, addition to) in your methods section. End this section generally two or three paragraphs) and cite the most with your main research question or questions. recent and relevant evidence to support your statements. While you want to exhibit a thorough literature search, Methods avoid describing and citing every article you read. You The methods section describes what you did. The can elaborate on important details from your literature editor and reviewers will carefully scrutinise this search in the discussion section. In general, comment on section to determine whether your study represents studies in the aggregate rather than as individual studies. good science. Provide sufficient detail to show how Your introduction should funnel down from the the study can be replicated, to evaluate how bias may broader problem to your specific action to resolve the influence your study results, and to consider how problem. Define the problem in the leading sentence another organisation may implement the intervention. and back this up with current evidence. Justify why Think of the methods as a historical documentation of your study in which more is better. Organise your methods in a logical or chronological order that Introduction Example a makes sense to the reader. For instance, it is more Define problem (lead sentence): ‘Communication pro- logical to describe the intervention (intended to have blems are common during patient handoffs and linked to an effect on an outcome) before the outcome variable. preventable harm.’ Describe your research framework first, including the Current evidence (remainder of paragraph 1): {Include the study design, study period, population of interest (if evidence delineating how common communication pro- there is one), setting, ethical issues and institutional blems are during handoffs. Reference [R] your statement review board (IRB) approval. Also, introduce the reader and read the author instructions to determine if the in-text to your project by mentioning the intervention and main citation goes before or after the punctuation mark. Provide outcome. Whether an improvement or safety project the summary estimates linking patient handoffs to prevent- requires IRB review remains unclear, causing review pro- able harm.[R] If available, also include any evidence linking cesses to vary widely by hospital.14 Anewethicalframe- poor communication to preventable harm.[R]} work highlights the moral imperative to learn and Make a connection (next paragraph): ‘Checklists have improve and may provide guidance.15 16 Given the local improved the exchange of important information between variation in oversight for quality improvement work, caregivers when transferring patients to another team or consult your hospital IRB when planning a project and unit.[R] Nonetheless, information sharing remains a sub- describe the criteria that decided whether your project stantial problem during temporary hand-offs for inpatient required IRB review in your methods. Explain why or testing.’ how the setting and the population (if appropriate) were Intended improvement (same or new paragraph): ‘The spe- chosen and justify exclusions (eg, children). cific aim of this study was to send a sheet that communicated Under the subheading, Intervention, or a more the medical information Radiology technicians needed to descriptive title, explain your programme theory (how safely perform an imaging study on inpatients. We chose radi- the intervention related to the improved outcome and ology because the complication rate among inpatients under- why you chose them). The theory will offer a way to going imaging studies was high and missing patient understand and predict the effects of your quality information (eg, allergies) was a common cause of these improvement or patient safety project.17 Also describe complications.’ how the intervention was implemented in the setting, Research question (end of introduction): ‘We sought to how you assessed its effectiveness and how you evalu- assess whether the sheet was an effective and efficient ated its impact on your outcome. Describe whether or way to communicate pertinent patient information during how your intervention evolved over time. If multiple temporary handoffs, and whether complication rates sites participated, mention whether they modified the decreased among inpatients undergoing Radiology implementation phase to fit the local context. In some imaging studies.’ instances, iterative changes in an improvement inter- aQuotation marks set off an example of content, and itali- vention will generate qualitative data that should be cised text within brackets offers recommendations for reported in your results section. If your intervention is content. substantially refined during the implementation phase

Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 3 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology based on what you have learned, this new knowledge Reporting the science of quality or safety improve- should go in your results.6 Thus, provide the context ment in healthcare requires a fair amount of explan- for the intervention’s evolution in the methods so the ation. Your methods will likely be the longest section reader will understand the basis for your results. It of your manuscript. Table 1 shows how the methods may help to supply an online supplement with add- connect to the data reported in the results. itional details about your evaluation of the interven- tion overtime and the learning that occurred. Methods Example with Subheadings If you have multiple interventions, use different sub- ‘Study design and setting headings. Use appropriate subheadings (eg, Data This prospective cross-sectional study tested the patient Collection and Variables) to describe your data collec- information sheet on the adult inpatient medicine service tion methods, variables, and defining information from September 2009 to March 2010. We chose this about the variables. If you administered a survey, for service because of the high frequency of temporary hand- example, describe how it was developed, pilot tested offs for inpatient testing. Paediatric inpatients were and administered, and define the respondent categor- excluded to increase the homogeneity of our sample ies (eg, bedside nurse, radiology laboratory techni- population. A survey was administered at the end of the cian). Describe your primary outcome measure, any 6-month pilot study to assess the efficacy of the sheet. secondary outcomes and hypothesis if it was not Patient information sheet stated in your introduction (some journals want all of The sheet intended to communicate pertinent patient this information under a new subheading). End the information that the radiology technician needed to methods with an Analysis subsection, describing the safely perform the imaging study, and to reduce the risk statistical analyses and the software product used. of complications. The sheet was developed by two Quality improvement researchers typically collect data patient safety leaders (one nurse, one physician) and dis- at multiple time periods (called time series measure- tributed to three bedside nurses and three physicians on ments) to evaluate variations in performance over time. the medicine service in August 2009 to determine face The intervention often varies over time. If you are validity. Figure X illustrates the final sheet that was pilot evaluating the impact of an intervention, collect baseline tested. The bedside nurse printed out the patient infor- data for comparison to your postimplementation data. mation sheet from the electronic medical record (EMR) If your study includes a single site, statistical process and gave it to the transporter. Patient transporters were control methods are often helpful. If your study includes instructed, at the time of patient pick up, to give the multiple sites, time series regression analysis, which sheet to the radiology technician performing the test. allows for time-dependent covariates, for adjustment of The pilot study was introduced to radiology technicians and historical trends and for confounding, will help reduce patient registrars in a staff meeting. Radiology technicians potential biases when reporting your findings. These were instructed to record the unique identification number methods, which are well developed for observational (assigned when the sheet was generated from the EMR) on clinical studies, also help the authors communicate their a log to document receipt of the sheet and answer two results by providing a point estimate for the degree of questions: Was the medical information useful? Was it improvement, usually in the form of a risk ratio. necessary to call the unit for more information about the Researchers should avoid single time period pre/post patient? Radiology technicians or the registrar used the studies because the post-time period is often defined same log to keep a count of inpatients arriving without a after the results are available (encouraging authors to sheet (stratified by unit or floor). Patient-specific information pick the time period that shows the greatest improve- was not collected to maintain anonymity. The study project ment) and have the most risk for bias. Fan and collea- coordinator collected the log at the end of each week. gues offer guidance to interpret robust study methods Survey and data collection for quality improvement.18 A three-item survey was administered to bedside nurses on the medical inpatient units and to radiology techni- cians between April and June, 2010. The survey elicited Table 1 Common subheadings for methods section mapped to opinions regarding the usefulness of the patient informa- structure of results tion sheet. The items included the following:’ {include ver- Location in Location in batim wording of each question or assemble a table with Type of data methods results the questions as row headings and corresponding data in Characteristics of study Study design, setting, Presented first; columns and point the reader to the table}. ‘The response sample participants (described table 1 category was dichotomous. The project coordinator dis- first) tributed the survey during staff meetings and collected it Unadjusted estimates (eg, Variables Presented after the meeting. Survey respondents were instructed to outcome variables, exposure Primary and/or second; (tables variables) secondary outcomes or figures) refrain from putting their name on the survey to maintain anonymity. The project coordinator returned for a second Adjusted estimates (eg, Statistical analysis Presented third: logistic regression analysis) (tables or figures) staff meeting to capture additional respondents.

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Primary and secondary outcome variables and have a substantial amount of qualitative data, report it hypothesis in bullet format in a table or box and provide the The primary outcome measure was efficacy of informa- main points in the text. As a quality check, any data tion sharing, calculated as the number of inpatient reported in your results must be defined in the sheets wherein the technician did not call the unit for methods. For example, if you report complications additional information, divided by the total number of rates by type of surgery, the methods section should inpatients with a documented sheet delivery. The second- describe how you categorised types of surgery and ary outcome measure was the complication rate after complications. 6 months of exposure to the patient information sheet. We hypothesised that use of the sheet would decrease Results Example the frequency of radiologic imaging-related complications Framework of study: ‘Ninety of 92 (98%) inpatients among adult inpatients. We obtained complication rates from the medicine service had a patient information (baseline and postimplementation) from the radiology sheet on presentation to radiology for diagnostic imaging quality assurance officer; rates were calculated per 100 (table 1).’ diagnostic imaging studies. What you found: {The length of your results section Analysis may determine whether subheadings are needed. If sub- Survey data were summarised as proportions. We com- headings will make the connection to the methods, use pared complication rates at baseline to rates 6 months them; the editorial office can always delete subheadings after the sheet was implemented; mean±SD were if they feel they are unnecessary.} reported. Paired t tests were performed and statistical ‘Efficacy of sheet: Eighty-five of 90 (85%) patient infor- ’ significance defined as p<0.05. mation sheets shared pertinent medical information. Eight-nine of 100 (89%) survey respondents felt the Results sheet was an effective communication tool (Table X). The results section should highlight pertinent findings Complication rates in Radiology: The complication from your study in an objective manner. This section rate was 11.5 per 100 diagnostic imaging studies at is not meant to convince the reader why your findings baseline compared to 1.3 per 100 diagnostic imaging are important; save adjectives for your discussion. studies 6-months after the intervention was implemented ’ ‘Significant’ only applies if you can provide support- (Figure X). ing confidence intervals or p values below your threshold for statistical significance, usually <0.05. Discussion Pay close attention to parallel construction within sen- The discussion should make sense of your findings. tences and across sentences. Parallel construction You want to interpret and discuss your findings, not establishes a rhythm and an expectation of content regurgitate data. Tell the reader what is important and that easily walks the reader through your findings. what they should do with this information. In the first The following example highlights nonparallel and par- paragraph, answer your research question and sum- allel construction of the same sentence. marise important findings. For example, ‘our inter- ▸ Nonparallel: The baseline complication rate was 11.5 per vention was associated with a 66% reduction in 100 diagnostic imaging studies compared to 1.3/100 infections over 18 months.’ Unless your study was a diagnostic imaging studies 6 months after the interven- randomised controlled design, use words that imply tion was implemented. an association (as described in the previous example) ▸ Parallel: The complication rate was 11.5 per 100 diag- rather than declare or infer causality (eg, the interven- nostic imaging studies at baseline compared to 1.3 per tion reduced infections).18 Explain why your findings 100 diagnostic imaging studies 6 months after the inter- are new and important knowledge; even negative find- vention was implemented. ings will offer useful information. The results section should follow the same logical In the next paragraph or two put your findings in order presented in the methods (table 1). If you the context of other relevant studies, expanding on compare predata and postdata, the logical order will similarities and differences. Discuss how your study always report the predata (baseline) first in a sentence builds on prior studies and what knowledge your (as done in both examples above), giving the reader a study adds. Talk about your intervention and any con- reference point to compare the postintervention textual factors that helped or hindered your interven- results. Report the demographics/characteristics of tion (did any other study encounter the same issues?). your population or setting first (usually the first table) Reiterate your hypothesis and explore any differences to illustrate the framework of your study. Next, report in what you observed and expected. Discuss whether what you found, starting with unadjusted estimates the intervention would work in other hospitals in the followed by any adjusted estimates (other tables/ same setting or even translate to different clinical set- figures). Again, only highlight important results and tings (is it generalisable?). This is a question broached use your tables and figures to show all the data. If you by many, particularly anyone working with limited

Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 5 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology resources in quality improvement and patient safety. If the inferences you made and your efforts to mitigate your study is translatable, simple or inexpensive, or eliminate the effects of these limitations. Conclude mention these strengths. with a strong take-away message about the importance In the next paragraph, discuss the implications of of your findings. Your conclusion should be brief your research for stakeholders, whether they are clini- (four sentences or less) to ensure your message is not cians, patients or policymakers. What does this mean missed by the reader. As a last bit of advice, keep the for them and what should they do? In the next para- discussion as short as possible and tightly connected graph, or even earlier in your discussion, disclose your to your results and research question. study limitations in a subsection, titled Limitations. Disclose all the limitations, any expected impact on REFERENCES The reference list follows the manuscript body and begins on a new page. Each journal has specific for- matting requirements for the in-text citations and the Discussion example list of references (read author instructions). The Answer research question: ‘We found that the patient in-text citation is the call out (number, or author last information sheet was a practical and effective mode of name and date) in your manuscript body, tables, and communication between bedside nurses and radiology figures that points to the corresponding full reference technicians.’ in the list. Use a software program to automate the Summarise important findings: ‘The majority of nurses management and manipulation of your references. and technicians reported that the sheet saved time and Proof the reference list carefully to ensure the infor- relayed pertinent patient information. Moreover, use of mation is complete, accurate, and formatted according the sheet was associated with decreased complication to the journal specifications. Check links to web rates among inpatients undergoing diagnostic imaging in content to ensure they are active. Radiology.’ As a general rule, include anything accessible to the Put findings in context of existing body of literature: public in the reference list, such as journal articles, ‘No known studies have addressed poor communication books, book chapters and websites. A more detailed during temporary hand-offs for inpatient testing.’ list of reference types is available from the {Discuss any published studies describing interventions International Committee of Medical Journal Editors that focused on exchange of information during transi- Uniform Requirements for Manuscripts Submitted to tions of care (eg, between units, between care teams). Biomedical Journals.19 If you make a statement based As you do this, walk the reader through what is known, on a personal communication or unpublished data, where your findings fit, and what this means.} note this in parentheses at the end of the statement Discuss if generalisable: ‘Although we only tested the (eg, personal communication, Jane Smith, MD, 17, sheet with medicine patients undergoing radiology July 2011) and obtain written permission from the imaging, it would generalise to other patient populations individual to include this information and grant publi- and clinical testing areas. The sheet could be easily cation rights if the manuscript is accepted. adapted to print any patient information from the EMR for any medical test.’ TABLES AND FIGURES Explore implications: ‘This study has important implica- The tables follow your reference list (or figure legend tions for clinical practice. The sheet was easily generated page) and precede your figures. Present each table and from the patient’s EMR and was an effective way to com- figure on a separate page in chronological order. Your municate patient information to an inpatient testing unit. tables and figures must stand alone without referring It was an inexpensive solution to a problem that was to the manuscript. Therefore, use footnotes to define causing costly complications.’ abbreviations and describe statistical methods for esti- Consider limitations: ‘The study has several limitations. mates reported in a table, and provide a legend page First, the sample size was small and only one clinical that clearly explains each figure. Use concise short area was studied. Second, we did not collect confounders titles and standardise the format and presentation of that may have influenced complications rates and cannot data in your tables. We have provided a (figure 1) that make inferences about the impact of the sheet.’ {In this dissects the components of a table and offers some section it is good to offer brief counterarguments for a common formatting requirements, and a (figure 2) limitation.} that illustrates how to present data in a table. It may Conclusion: The patient information sheet was a quickly help to annotate a graph of your performance data generated tool that effectively communicated medical over time, labelling when interventions were imple- information during temporary handoff of inpatients to mented or pertinent times when it evolved. If you Radiology. Moreover, there was an associated decrease include any tables or figures previously published, you in complication rates in the diagnostic imaging area. This must obtain permission from the publisher for copy- tool should be tested in other clinical areas of the right privileges; this process can be found on the pub- hospital.’ lisher’s website.

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Figure 1 Shows the five parts of a table: title, column headings, row headings, body and footnotes. Each part is labelled and the general formatting rules described and set off by brackets and italic font. An example of each part is enclosed in quotation marks.

ACKNOWLEDGEMENT SECTION the three criteria for authorship. For example, an indi- This section follows your manuscript body and describes vidual who collected data, but did not work on the anyone who contributed to your study but did not meet manuscript, only meets one criterion.19 Provide their

Figure 2 Focuses on the consistent presentation of data in a table. The reference format in row one provides an example of how data should be presented compared to row 2 in which inconsistent formatting and missing data are illustrated.

Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 7 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology

Table 2 Checklist to avoid common mistakes Contributors CGH provided the concept and design, drafted the article and revised it for critical Task Achieved intellectual content, and provided final approval for Introduction 2–3 paragraphs (one double-spaced page) submission of the manuscript. PJP contributed to Introduction moves from broad to specific critical revisions of the article, offered supervision and Methods written in past tense gave final approval of the version submitted. Methods describe what was done when (more is better) Competing interests Ms Holzmueller received honoraria Methods define all variables present in Results from MCIC Vermont, Inc. to conduct a workshop on Results written in past tense organising and writing a manuscript describing quality Results written using parallel structure improvement and patient safety research. Dr Pronovost Results written in objective manner (just the dry facts) reports receiving grant or contract support from the Discussion starts with statement of major finding (answer Moore Foundation, the Agency for Healthcare Research research question) and Quality, the National Institutes of Health, RAND Limitations section is complete (answer the questions peer reviewers will ask) and The Commonwealth Fund for research related to measuring and improving patient safety; honoraria from Discussion of policy implications various hospitals and healthcare systems and the Leigh Paper as a whole—tells a cohesive story (What is your newspaper headline?) Bureau to speak on quality and safety; consultancy with Tables and figures are understandable without looking at the the Association for Professionals in Infection Control manuscript body and , Inc.; and book royalties for Reference list—is formatted in journal style, and includes authoring ‘Safe Patients, Smart Hospitals: How One accurate information that allows the reader to find it in the Doctor’s Checklist Can Help Us Change Health Care public domain (recheck just before paper submission) from the Inside Out.’ Provenance and Not commissioned; externally peer reviewed. name, degrees, professional affiliation, and description of contribution (again, obtain written permission to publish their name). Other content in this section or else- ’ REFERENCES where (such as the title page) includes the authors con- 1 Yanoff KL, Burg FD. Types of medical writing and teaching of flicts of interest relevant to the research being writing in U.S. medical schools. J Med Educ 1988;63:30–7. 20 reported, a statement expanding on author contribu- 2 Pierson DJ. The top 10 reasons why manuscripts are not tions, and any financial support for the research and the accepted for publication. Respir Care 2004;49:1246–52. manuscript production. Many journals supply a conflict 3 DeAngelis CD. Foreward. In: Iverson C, Christiansen S, of interest form that outlines types of financial and non- Flanagin A, et al. AMA manual of style. 10th edn. New York, financial information that should be disclosed, be trans- NY: Oxford University Press, 2007. parent when reporting and follow the instructions. It 4 Iverson C, Christiansen S, Flanagin A, et al. AMA manual of takes time to gather this information and, in many cases, style. A Guide for Authors and Editors. New York, NY: Oxford the form(s) required by a journal. Try to collect this University Press, Inc., 2007. 5 EQUATOR (Enhancing the QUality and Transparency Of information and any forms (including a copyright form) health Research) Network Web site. http://www. when the authors are reviewing the manuscript rather equator-network.org/home/ (accessed Mar 20 2013). than when the paper is ready for submission. 6 Davidoff F, Batalden P,Stevens D, et al. Publication guidelines for quality improvement in health care: evolution of the SQUIRE project. Qual Saf Health Care 2008;17:i3–9. CONCLUSION 7 Vandenbroucke JP.Observational research, randomised In summary, organising and writing a manuscript trials, and two views of medical science. PLoS Med 2008; reporting quality improvement or patient safety 5:e67. research is not as intimidating as it may seem. Think 8 Vintzileos AM, Ananth CV.How to write and publish an original about your target audience, choose an appropriate research article. Am J Obstet Gynecol 2010;202:344. e1–e6. journal, read the author instructions and several pub- 9 Hall GM. How to Write a Paper. Oxford, UK: John Wiley & lished articles, and use this article and checklist of Sons, Ltd., 2013. common mistakes (table 2) to help you along the way. 10 Lang TA. How to write, publish, and present in the health Your study is a nonfiction story in which it is best to sciences: a guide for physicians and laboratory researchers. write the sections separately. One approach is to write Philadelphia: American College of Physicians, 2010. 11 Huth EJ. Writing and publishing in medicine. Philadelphia: the middle (methods then results) first, followed by Lippincott Williams & Wilkins, 1999. your ending (discussion), and then your introduction. 12 Bolker J. Writing your dissertation in fifteen minutes a day. While we have not mentioned this previously, it is an New York: Owl Books, Henry Holt and Company, LLC, appropriate ending: there is better writing through 1998. rewriting. A good, quick reference book to help you is 13 Ogrinc G, Mooney SE, Estrada C, et al. The SQUIRE 21 Strunk and White’s The Elements of Style. (Standards for QUality Improvement Reporting Excellence)

8 Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com Research and reporting methodology

guidelines for quality improvement reporting: explanation and 17 Foy R, Ovretveit J, Shekelle PG, et al. The role of theory in elaboration. Qual Saf Health Care 2008;17:i13–32. research to develop and evaluate the implementation of patient 14 Thompson DA, Kass N, Holzmueller CG, et al. Variation in safety practices. Qual Saf Health Care 2011;20:453–9. local institutional review board evaluations of a multicenter 18 Fan E, Laupacis A, Pronovost PJ, et al. How to use an article patient safety study. J Healthcare Qual 2012;34:33–9. about quality improvement. JAMA 2010;304:2279–87. 15 Faden RR, Kass NE, Goodman SN, et al. An ethics framework 19 International Committee of Medical Journal Editors Web site. for a learning health care system: a departure from traditional Uniform Requirements for Manuscripts Submitted to Biomedical research ethics and clinical ethics. Hastings Cent Rep 2013; Journals: Manuscript Preparation and Submission, 2013. http:// Spec No:S16-27. www.icmje.org/manuscript_1prepare.html (accessed 20 Mar 2013). 16 Kass NE, Faden RR, Goodman SN, et al. The 20 Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research-treatment distinction: a problematic approach for research groups. JAMA 2002;288:3166–8. determining which activities should have ethical oversight. 21 Strunk W,White EB. The elements of style. New York, NY: Hastings Cent Rep 2013;Spec No:S4-S15. Longman Publishing Group, 1999.

Holzmueller CG, et al. BMJ Qual Saf 2013;00:1–9. doi:10.1136/bmjqs-2012-001603 9 Downloaded from qualitysafety.bmj.com on January 31, 2014 - Published by group.bmj.com

Organising a manuscript reporting quality improvement or patient safety research

Christine G Holzmueller and Peter J Pronovost

BMJ Qual Saf published online May 14, 2013 doi: 10.1136/bmjqs-2012-001603

Updated information and services can be found at: http://qualitysafety.bmj.com/content/early/2013/05/13/bmjqs-2012-001603.full.html

These include: References This article cites 10 articles, 4 of which can be accessed free at: http://qualitysafety.bmj.com/content/early/2013/05/13/bmjqs-2012-001603.full.html#ref-list-1 P

Notes

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