1. Daisy Goodman, Greg Ogrinc, Louise Davies, Paul Batalden, Frank Davidoff, David Stevens

2. Disclosures No financial conflicts The SQUIRE evaluation and revision process were supported by generous contributions from the Health Foundation and the Robert Wood Johnson Foundation.

3. Objectives Describe the importance of sharing your improvement work through the published literature Describe the process through which the SQUIRE guidelines were developed and revised Identify key components of the Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) that distinguish academic, scholarly QI writing Walk through the process of preparing a manuscript for publication

4. Why publication guidelines? What’s different about SQUIRE?

5. Evolution of SQUIRE: an improvement journey 1 st iteration of SQUIRE was produced by experts Both the evaluation and revision process included end-users in evaluating and pilot testing through an iterative process

6. SQUIRE 2.0 Development 1.Evaluation of the initial SQUIRE guidelines (SQUIRE 1.0, 2008) – Assess usability and clarity – Semi-structured interviews / focus groups with 29 end users – Input from 18 experts (editors, researchers, improvers) 2.Early revisions of versions 1.2 and 1.4 – Two consensus conferences (Nov 2013 & Nov 2014) 3.Pilot testing of version 1.6 with late revisions – 44 authors used interim draft to write sections of a manuscript Provided feedback on utility and understandability of the draft guidelines – Semi-structured interviews with 11 journal editors – Version 1.8 sent to over 450 individuals around the world Davies, Louise, et al. "The SQUIRE Guidelines: an evaluation from the field, 5 years post release." BMJ quality & safety (2015): bmjqs-2015. Davies, Louise, et al. "Findings from a novel approach to publication guideline revision: user road testing of a draft version of SQUIRE 2.0." BMJ quality & safety (2015): bmjqs-2015.

7. SQUIRE 2.0 Publications

8. Standards for QUality Improvement Reporting Excellence v 2.0 Provides a framework for writing and thinking about improvement work – Familiar IMRAD format – Describes the essential elements to include in a report – Frequently used in planning improvement work- although not the intended purpose of a publication guideline – The companion E&E explores the meaning of each guideline item in more depth www.squire-statement.org

9. Components of SQUIRE 2.0: Title and Abstract Title and Abstract 1.Title Indicate that the manuscript concerns an initiative to improve healthcare (broadly defined to include the quality, safety, effectiveness, patient-centeredness, timeliness, cost, efficiency, and equity of healthcare) 1.Abstract a.Provide adequate information to aid in searching and indexing b.Summarize all key information from various sections of the text using the abstract format of the intended publication or a structured summary such as: background, local problem, methods, interventions, results, conclusions

10. Introduction Why did you start? 3. Problem DescriptionNature and significance of the local problem 4. Available knowledge Summary of what is currently known about the problem, including relevant previous studies 5. Rationale Informal or formal frameworks, models, concepts, and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s), and reasons why the intervention(s) was expected to work 6. Specific aimsPurpose of the project and of this report

11. Methods…. MethodsWhat did you do? 7. Context Contextual elements considered important at the outset of introducing the intervention(s) 8. Intervention(s) a.Description of the intervention(s) in sufficient detail that others could reproduce it b.Specifics of the team involved in the work 9. Study of the Intervention(s) a.Approach chosen for assessing the impact of the intervention(s) b.Approach used to establish whether the observed outcomes were due to the intervention(s)

12. …More about Methods 10. Measures a.Measures chosen for studying processes and outcomes of the intervention(s), including rationale for choosing them, their operational definitions, and their validity and reliability b.Description of the approach to the ongoing assessment of contextual elements that contributed to the success, failure, efficiency, and cost c.Methods employed for assessing completeness and accuracy of data 11. Analysis a.Qualitative and quantitative methods used to draw inferences from the data b.Methods for understanding variation within the data, including the effects of time as a variable 12. Ethical Considerations Ethical aspects of implementing and studying the intervention(s) and how they were addressed, including, but not limited to, formal ethics review and potential conflict(s) of interest MethodsWhat did you do?

13. Results What did you find? 13. Results a.Initial steps of the intervention(s) and their evolution over time (e.g., time-line diagram, flow chart, or table), including modifications made to the intervention during the project b.Details of the process measures and outcome c.Contextual elements that interacted with the intervention(s) d.Observed associations between outcomes, interventions, and relevant contextual elements e.Unintended consequences such as unexpected benefits, problems, failures, or costs associated with the intervention(s). f.Details about missing data

14. Discussion What does it mean? 14. Summary a.Key findings, including relevance to the rationale and specific aims b.Particular strengths of the project 15. Interpretation a.Nature of the association between the intervention(s) and the outcomes b.Comparison of results with findings from other publications c.Impact of the project on people and systems d.Reasons for any differences between observed and anticipated outcomes, including the influence of context e.Costs and strategic trade-offs, including opportunity costs

15. Limitations and Conclusions 16. Limitations a.Limits to the generalizability of the work b.Factors that might have limited internal validity such as confounding, bias, or imprecision in the design, methods, measurement, or analysis c.Efforts made to minimize and adjust for limitations 17. Conclusions a.Usefulness of the work b.Sustainability c.Potential for spread to other contexts d.Implications for practice and for further study in the field e.Suggested next steps Other information 18. Funding Sources of funding that supported this work. Role, if any, of the funding organization in the design, implementation, interpretation, and reporting

16. Key concepts introduced in SQUIRE 2.0 Rationale Informal or formal frameworks, models, concepts, and/or theories used to – explain the problem – reasons or assumptions that were used to develop the intervention(s) – reasons why the intervention(s) was expected to work Not the method used for the work (e.g., lean or six sigma) Context “All the things that are not your intervention” Everything that affects your work Study of the intervention(s) Reflecting upon and evaluating the work done Approach chosen for assessing the impact of the intervention(s) Approach used to establish whether the observed outcomes were due to the intervention(s): – Did things get better for the reasons you thought? – Were there unintended consequences?

17. The Evolution of “Context” “Nothing exists, and therefore can be understood, in isolation from its context” -Paul Bate Although previously described as the “setting” for an intervention We now see context more ecologically As intervention and context interact, both change and adapt

18. Examples of Contextual Factors: Systems Level External environment – External motivators – Sponsorship Organization – Improvement leadership – Senior leader as sponsor – Supportive culture – Maturity of organizational improvement – Physician payment structure Is the Problem /Project seen as strategically important to the organization? Improvement support and capacity – Data infrastructure – Resource availability – Workforce focused on improvement Microsystem – Improvement leadership – Culture supportive of improvement – Staff training in improvement – Motivation for change Kaplan, et al, 2012

19. Improvement team – Team diversity – Physician involvement – Subject matter expert – Team tenure – Prior improvement work – Team leadership – Team decision making process – Team improvement skills What about patient level factors? Kaplan, et al, 2012 Examples of Contextual Factors: Intervention Level

20. MethodsWhat did you do? 7. Context Contextual elements considered important at the outset of introducing the intervention(s) 10. Measures a.Description of the approach to the ongoing assessment of contextual elements that contributed to the success, failure, efficiency, and cost ResultsWhat did you find? 13. Results a.Contextual elements that interacted with the intervention(s) 17. Conclusions a.Usefulness of the work b.Sustainability c.Potential for spread to other contexts d.Implications for practice and for further study in the field e.Suggested next steps Context is present throughout SQUIRE 2.0

21. Why is it important to describe context in writing about improvement? Sometimes improvement efforts work and sometimes they don’t – Context is likely to be part of the reason your work succeeded or failed – If you can describe it, you can learn from it- and help others be successful – What we discover from studying and reporting about context may be broadly relevant, even if a specific intervention cannot be transplanted from one context to another

22. Writing about Context Ask yourself- Why did this happen the way it did? Why didn’t it happen the way I thought it would? Direct Observation – Attitudes and behaviors- what are they telling us? – Day to day workflow – Minutes of meetings – Field notes – Safety culture survey, Staff engagement survey – Semi-structured interviews/focus groups Reflect on and document the process of your improvement work – Victories and failures – Adjustments made along the way (and why) – Memorable events and conversations – Concurrent organizational events

23. Field notes: improvement process Courtesy of Grey Ogrinc, MD

24. Writing about Context When describing your results: – Describe the contextual factors that interacted with your intervention(s) in an important way When interpreting your results: – Consider reasons for the difference between the outcomes that occurred, and what you initially thought would happen – How did contextual factors influence this? It’s too much to report everything… report the unexpected, and what’s crucial to telling the story

25. Take Home Points about Context Context can make or break an improvement program Consider contextual factors carefully from the beginning – Over time, the impact of contextual factors became clear – Interventions are often re-designed as a result of interacting with context Share what you learn – Provide specific information about important features of your context – Describe how contextual factors interacted with your intervention(s) – Describe how intervention(s) and context changed as a result Read with an eye for how other writers communicate about context effectively

26. Table work: The influence of context Review the methods and results section of this paper. Discuss with your neighbor: What do the authors tell you about context of their interventions? How did contextual factors impact the results of their interventions? How did contextual factors change the interventions? J. Pediatrics 2015; 135(1)

27. The setting for the intervention… Teaching hospital Suburban setting Dedicated pediatric ED Specifics about the physician team that provided ER coverage What could be added to this description? – More about context! METHODS Setting “UNC Hospitals is a large, suburban, academic medical center … Tertiary pediatric care, including pediatric and neonatal level IV intensive care, level I trauma care, and emergency care, are provided. Pediatric emergency medicine physicians provide care in the pediatric ED between 8:00 AM and 2:00 AM. During the remaining hours, board-certified emergency medicine physicians in the general ED care for pediatric cases.”

28. Changes made as a result of contextual factors RESULTS In phase II, strategies focused on improving performance by providing data and other information for learning… A key intervention implemented during phase II as the result of this engagement was to develop placards to address access and language barriers… CONTEXTUAL FACTORS Factors that interacted with the intervention(s) Multi-lingual community Lack of staff knowledge about the problem Staff engagement was also addressed through incentives

29. Phase 1 interventions were not effective RESULTS “During phase I, the existing processes for identifying and managing febrile patients with central lines were mapped and analyzed. Key interventions [were] tested and implemented … Phase I interventions alone had little effect on timeliness.” Why was there a difference between observed and anticipated outcomes?

30. The influence of context on the intervention(s) RESULTS “In phase III…. A new patient identification and initial management process was designed based on the steps, weaknesses, and challenges identified... This process benefited from feedback from frontline ED staff and the results of multiple PDSA cycles during phases I and II” The intervention changed as a result of interaction with contextual factors Feedback from frontline staff was essential to understand PDSA cycles were used to adapt

31. Rationale “Informal or formal frameworks, models, concepts, and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s), and reasons why the intervention(s) was expected to work” Always present, whether acknowledged or not Important to make this explicit, to facilitate understanding about the mechanism of action of the intervention, and how it might vary across contexts May be a formal model…. Michie, et al., 2014

32. Rationale: Example …or an informal theory or assumption Brady, 2015

33. Table work: Rationale Review the background and methods section of the paper in front of you: What were the informal or formal frameworks, models, concepts, and/or theories used to explain the problem? What were the reasons or assumptions used to develop the intervention? Why did the authors think the intervention would work?

34. Study of the Intervention Approach chosen for assessing the impact of the intervention(s) – Including its unintended consequences – May be qualitative or quantitative Approach used to establish whether the observed outcomes were due to the intervention(s) – Informed by the rationale for the intervention – Should include assessment of the internal and external validity of the intervention

35. Table work: Study of the Intervention How did the authors assess the impact of their interventions? How did the authors show that the observed outcomes were due to the interventions?

36. Using Statistical Process Control to Assess the impact of the intervention(s) Jobson, et al 2014

37. SQUIRE Summary Provide a framework for reporting new knowledge about how to improve healthcare Intended for reports that describe system level work to improve the quality, safety, and value of healthcare, and used methods to establish that observed outcomes were due to the intervention(s) May be adapted for reporting a range of approaches for improving healthcare Authors should consider every SQUIRE item, but it may be inappropriate to include every one in a particular manuscript. The Explanation and Elaboration document provides specific examples of well-written SQUIRE items with an explanation. Please cite SQUIRE when it is used to write a manuscript.

38. Getting published…..

39. Why is it important to write about improvement work? Personal Incentives Publicity administrative support for your project Builds credibility for “QI” Getting and renewing funding Building morale for your team Networking/career building “Publish or perish” Benefits to the field Report new approaches Increase transparency Share lessons learned – What worked – What didn’t work – Interactions with context Contribute to general knowledge about improving health care A few reasons (among many)…

40. Why is writing about improvement work so hard? Improvement work is more complex to write about than biomedical research – Boundaries may be ill defined – Intervention protocols may have multiple iterations – Context changes interventions – Reporting about methods and context may be more important than the results achieved – There is much to learn from an “unsuccessful” project Frontline clinicians rarely have protected time – Especially true for nurses – Writing about improvement work requires changing perspectives, from “doing” to observing and reflecting Editors may not understand quality improvement or want to publish it

41. Table work: 5 minutes of reflection about your writing process (borrowed from David Stevens) Do you find writing fun? – Which aspects of writing do you find to be fun? – What keeps you from writing? – Why do you want to write? How frequently do you actually sit down and write for scholarly purposes? – How often do you wish you sat down to write? – What prevents you from writing as often as you would like? What is one thing you think might help you increase the amount of time you spend writing? http://www.ihi.org/education/IHIOpenSchool/resources/Pages/Publications/Guid edReflectionOnYourWriting.aspx

42. Debrief How did it feel to talk to someone about this? What are the best things about writing? The worst? What is the biggest barrier? Lack of time for writing is generally the most difficult barrier to overcome Writing is a process which requires focused attention- a systematic approach is necessary! SQUIRE can be used as a blueprint for both planning and writing

43. Process map for journal submission Idea Is it worth writing? Which audience? Literature review Which Journal? Which format? Can I use SQUIRE? Outline & feedback 1st draft More Feedback 2 nd draft More Feedback Recheck style guide Final draft Cover letter, disclosure etc. Submit Paper

44. Getting started Questions to answer before starting writing What do I have to say? Is this paper worth writing? Has it been written already? (The “so-what?” test) Who do I want to write it with? What is the right format? What is the right audience for the message? (The “who-cares?” test) What journal should I target? Huth, E. Writing and Publishing in Medicine (3 rd ed). 1999

45. The “so-what?” test Description of the problem (Introduction: problem description/available knowledge) What you did about it (Methods: context/intervention) Description of what happened (Results: interaction between context and intervention) Why it is important (Discussion) SQUIRE elements can help structure your thinking at this stage

46. Co-authorship Co-authors must meet 4 criteria (ICMJE) “Make substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published; AND Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.” http://www.icmje.org/recommendations/browse/roles-and- responsibilities/defining-the-role-of-authors-and-contributors.html

47. The “who cares?” test Who needs to know about your work? To whom is it relevant? Choose a journal that speaks to that audience…AND publishes quality improvement work Journal selection Does the journal publish improvement work? What has this journal published on your topic in the past? What type of papers does this journal accept? – Review the “Instructions for Authors” – Do they offer pre-submission review? – Which is the right format for your message? Should I use SQUIRE?

48. Choosing wisely Journals publishing SQUIRE 2.0 Am. J. Critical Care Permanente Journal J. Surgical Research J. Continuing Education in Nursing Am. J. Medical Quality Canadian J. Diabetes J. Nursing Care Quality Joint Commission Journal J. American College of Surgeons BMJ Quality and Safety Journals publishing QI reports Health Affairs Health care: J. of Delivery Science Implementation Science International J. for Quality in Health Care J. for Healthcare Quality J. of Clinical Outcomes Mgmt J. of Healthcare Risk Mgmt PLoS One Quality Mgmt in Health Care J. Nursing Care Mgmt NEJM JAMA

49. Process map for journal submission idea Is it worth writing? Which audience? Literature review Which Journal? Which format? Can I use SQUIRE? Outline & feedback 1st draft More Feedback 2 nd draft More feedback Recheck style guide Final draft Cover letter, disclosures (etc.) Submit

50. Process map for journal submission idea Is it worth writing? Which audience? Literature review Which Journal? Which format? Can I use SQUIRE? Outline & feedback 1st draft More Feedback 2 nd draft More feedback Recheck style guide Final draft Cover letter, disclosures (etc.) Submit

51. Help from others The purpose of writing is to communicate about your work- so don’t wait until after the paper is written Take advantage of opportunities for posters or oral presentations Get feedback early and often! Seek out peers and mentors to review sections of your paper Peer review – Keeps your writing moving – Improves quality of communication – Learn by providing the same assistance to others Mentorship – Involve mentors from the planning stage on – Allows you to pilot test your message – Expert advice – A “friendly enemy”

52. Final Steps idea Is it worth writing? Which audience? Literature review Which Journal? What format? Can I use SQUIRE? Outline 1st draft More feedback 2 nd draft More feedback Recheck style guide Final draft Cover letter, disclosures (etc.) Submit

53. What happens next? Accepted with revisions Revise and resubmit Not accepted

54. Clarity and brevity require self-discipline “Je n’ai fait celle-ci plus longue que parce que je n’ai pas eu le loisir de la faire plus courte. “ “I have made this longer than usual because I have not had time to make it shorter.” Blaise Pascal (1657)

55. Summary Publishing quality improvement work is essential – For transparency – To share new approaches – To build general knowledge Writing about quality improvement is different than writing about research – Frontline clinicians are most likely to write during nights and weekends SQUIRE is designed to guide and facilitate the writing process Writing is about communicating your work to others: don’t do it alone!

56. Breaking news! SQUIRE website: www.squire-statement.orgwww.squire-statement.org Upcoming writing conference in US and UK: fall, 2016

57. November 15 - 16, 2016 Hanover Inn at Dartmouth Hanover, NH. LEARN HOW TO PUBLISH YOUR QUALITY IMPROVEMENT WORK SECOND ANNUAL SQUIRE WRITING CONFERENCE www.squire-statement.org

58. Bamberger Re. Perspectives on context. The health foundation, 2014 Brady PW, Zix J, Brilli R, et al. Developing and evaluating the success of a family activated medical emergency team: a quality improvement report. BMJ Qual Saf 2015;24:203–11 Kaplan, et al, 2012 The Model for Understanding Success in Quality (MUSIQ) BMJ Qual Safety 2012 21:13-20 Michie S, Atkins L, West R. The behaviour change wheel—a guide to designing interventions. London: Silverback Publishing, 2014