Standards for Quality Improvement Reporting Excellence (SQUIRE)

1. Standards for Quality Improvement Reporting Excellence (SQUIRE) Frank Davidoff Susan Kirsh Greg Ogrinc VA Cyberseminar December 2, 2008

2. Objectives • Understand the origin and development of the SQUIRE publication guidelines • Identify how one author has used the guidelines to publish her work • Review the SQUIRE guideline website • Start on your homework for Dec 16

3. Why publication guidelines?The SQUIRE story Frank Davidoff VA Cyberseminar December 2, 2008

4. The Problem:Failure to publish QI work • Why is it a problem? • Why isn’t it published more often? • Why is it so hard to write about QI? • What are the SQUIRE publication guidelines? • How can they help?

5. Failure to publish QI work:1. Why is it a problem? • Fails to advance the science • Limits transparency, public accountability • Slows dissemination of proven interventions • Less stimulation of new ideas, innovation • Permits unnecessary/redundant work • Limits learning from mistakes

6. Failure to publish QI work:2. Why isn’t it published more often? • Done by busy “front line” professionals • More concerned with local change than discovering generalizable truths • Lack of training, experience in research, publishing • Academic incentives often not relevant • Editors, peer-reviewers unfamiliar, skeptical • Writing about QI is hard

7. Failure to publish QI work:3. Why is writing about QI so hard? • The heart of the matter: • QI is NOT the same as drugs, tests, clinical procedures • QI is performance change, driven by experiential learning • Context-dependent • Interventions are complex, multi-component • Problems occur at various organizational levels, type varies • Interventions adapted, evolve in response to feedback (reflexive) • Change is fragile, results unstable • Result: uncertainty about what evidence is needed • Little guidance available on how to study, hence on how to write in this area

8. Failure to publish QI work:4. What are the SQUIRE guidelines? • Checklist: 19 items, information to consider in QI reports • Models: Other guidelines (e.g., CONSORT, STROBE, etc.) • Focus: Content, rather than study design • Development: Several years, iterative process, multiple endorsers • Immediate purpose: To increase completeness, precision, transparency • Ultimate purpose: To encourage more and better reports • Target audience(s): Mainly authors, but also reviewers, editors, users of QI reports; funders • Dissemination: website (squire-statement.org), articles (6)

9. Failure to publish QI work:5. How can SQUIRE help? • SQUIRE does: • Offer guidance on: • Content: e.g., context-dependence, complexity, reflexiveness • Organization: IMRaD format, • Methods: evaluation of impact, and explanation of mechanisms • SQUIRE doesn’t: • Apply to reviews, commentary • Demand rigid or mechanical use • Prescribe specific study designs • Define intended audience, readership, journal • Clean up a messy room; just turns on the light so you can see what needs to be cleaned up

10. Failure to publish QI work:Summing up • People often don’t publish solid, important QI work • Failure to publish is a problem • Lots of reasons for this failure • QI is not the same as most clinical interventions • Writing is hard • Little guidance on studying, writing, publishing • SQUIRE guidelines encourage publication of complete, accurate, transparent reports • Use them, share that experience with us!

11. Rigor, Relevance, and Reality: WorldA Tale of Two Papers Using SQUIRE GuidelinesSusan Kirsh, MD Louis Stokes Cleveland VAMC October 24, 2008 HPEC QI is hard; publishing QI is very hard.

12. Continuum of Quality Improvement and Research:Rigor vs. Relevance Operations “Relevant” Context-Dependent Problem Solving Quantitative >, <, or = Qualitative Pre-test post-test or quasiexperimental designs Tends to be NON-LINEAR Research “Rigorous” Identify generalizable knowledge, i.e., Eliminate Context Publishable Quantitative>Qualitative RCTs Rule Tends to be LINEAR Potential Synergy • Continuum not a dichotomy • Goal is relevance moving as close to rigor as one can

13. A P S D D S P A A P S D A P S D *** Danger *** Linear Fallacy of Research and QI: Widely-held assumption that social and biological systems can be largely understood by dissecting out micro-components and analyzing them in isolation. DATA Complexity The journey up the ramp of complexity is NOT linear. Time

14. P A P P P A S S S S D D D Revised Conceptual Model of Rapid Cycle Change Tomolo, Lawrence, and Aron, QSHC, in press. Complexity Challenges P D D P D P S A A S P D Opportunities Time Legend: P=Plan D= Do = Barrier = Direct flow of impact S=Study A=Act = Lingering background impact Arrowhead = Feedback or feedforward Different Sizes of letters and cycles and bolding of letters = denotes differences in importance/impact

15. Why? In short, the issue is CONTEXT Research • Target of the interventions – the context - cannot as easily be controlled, randomized or matched in the same way as can patients • Quality programs usually cannot be controlled or standardized • The context of the intervention is constantly changing Project is fixed Context must adapt Context is fixed Project must adapt T. Greenhalgh Practice

16. Initial design: pre-test post-test with 44 patients • Reviewer comments - 3 times • Lack of recognition that this was a quality improvement project • Put ‘QI’ in the title • Organization/Format issues • Inserted SQUIRE as signposts and follow a familiar format

17. Reviewer #2 comments re: first version • “The major problem is the lack of a control group. The participants were selected based on high levels of particular measures.” • “The second problem is that the people are treated in clusters, and that therefore the independence assumption of the statistical tests is violated” • “An appropriate method of analysis should be used– such as multilevel models, generalised estimating equations or Huber-White sandwich estimators.” • (Note that subsequent reviews from this reviewer were even worse!

18. Response • Changed design to quasi-experimental: Added a control group – matched, concurrent, but not randomized. • Use as much rigor as possible: Consider sources of bias and address wherever possible eg., regression to the mean • Required 3 revisions overall • Persistence pays off • It was a much better paper as a result of the reviewers’ comments. Leave your ego out of it.

19. Qualitative work adds another dimension that makes quantitative data more meaningful • Used framework of Grol model to add structure and rigor • Triangulation

20. Reviewer comments • “The majority of the paper is placed in a section entitled ‘Methods and Conceptual Framework’. It is easy to get lost in this section, and difficult to find key information. It would be worth attempting switching the structure to the more common Introduction, Methods, Findings, Discussion/conclusion format. For example, the methods were unclear.” • More signposts needed

21. Changes based on reviews • Use of SOME signposts of SQUIRE, but not all applicable • Less than previous paper • This paper also required several revisions, but it is a much better paper as a result. • If you can choose a reviewer, choose one who will be critical and thoughtful, but unbiased.

22. Final lessons • Begin with the end in mind • Squire guidelines can help more at the beginning than at the end. • Make conceptual model explicit and specify context as much as you can. • Plan for that (choose a comprehensive framework, e.g., CFIR, PARIHS, Greenhalgh, Grol) • You cannot document too much • Recognize the rigor/relevance balance and consider the reviewers’ background.

23. www.squire-statement.org

35. Charge to Participants Between now and Dec 16, review the SQUIRE website www.squire-statement.org • What works well about the guidelines? • How does the website help understand and use the guidelines? • What questions remain for you about the SQUIRE guidelines? • How can the website be improved?

36. Summary • Thanks to the SQUIRE web team: Leslie Walker, Susan Mooney, Scott Chesnutt, Scott Hepler • SQUIRE guidelines offer guidance • not intended as “must haves” • guidance to write about your improvement efforts • share important findings with others • Several tools available • SQUIRE articles (QSHC supplement, online) • www.squire-statement.org