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Squire2.0.pdf
Critical Care Research
SQUIRE 2.0 (STANDARDS FOR QUALITY
IMPROVEMENT REPORTING EXCELLENCE): REVISED PUBLICATION GUIDELINES FROM A DETAILED CONSENSUS PROCESS By Greg Ogrinc, MD, MS, Louise Davies, MD, MS, Daisy Goodman, DNP, MPH, Paul Batalden, MD, Frank Davidoff, MD, and David Stevens, MD
©2015 American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ajcc2015455
Since the publication of Standards for Quality Improve- ment Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistruc- tured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of 3 key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, imple- menting, and evaluating improvement work; the con- text in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recog- nizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). (American Journal of Critical Care. 2015;24:466-473)
466 AJCC AMERICAN JOURNAL OF CRITICAL CARE, November 2015, Volume 24, No. 6 www.ajcconline.org
I n 2005, draft publication guidelines for quality improvement reporting debuted in Quality
and Safety in Health Care.1 At that time, publications of scholarly work about health care
improvement were often confusing and of limited value. Leaders in the field were work-
ing to consolidate the evidence for a science of improvement2,3 and without guidance
on how to write their findings, authors struggled to report their improvement work in a
reliable and consistent way.4,5 These factors influenced the initial publication in 2008 of the
Standards for Quality Improvement Reporting Excellence (SQUIRE),6 which we will refer to
as SQUIRE 1.0. The guidelines were developeyd in an effort to reduce uncertainty about the
information deemed to be important in scholarly reports of health care improvement, and to
increase the completeness, precision, and transparency of those reports.
In the intervening years, the reach of systematic
efforts to improve the quality, safety, and value of
health care has grown. Health professions education worldwide now includes improvement as a standard competency.7-11 The science of the field also continues to advance through guidance on applying formal and informal theory in the development and interpreta- tion of improvement programs12; stronger ways to identify, assess, and describe context13-16; recommen- dations for clearer, more complete descriptions of interventions,17 and development of initial guidance on how to study an intervention.18
In this setting, we have undertaken a revision of SQUIRE 1.0. When we began, it rapidly became
apparent that a wide variety of approaches had
developed for improving health care, ranging from
formative to experimental to evaluative. Rather than limit the revised guidelines to only a few of these, we fashioned them to be applicable across the many methods that are used. We aimed to reflect the dynamic nature of the field, and support its fur- ther development. This article describes the devel- opment and content of SQUIRE 2.0 (Table 1).
SQUIRE 2.0 Developmental Path We developed SQUIRE 2.0 between 2012 and
2015 in 3 overlapping phases: (1) evaluation of the initial SQUIRE guidelines, (2) early revisions, and (3) pilot testing with late revisions.
We began the evaluation of SQUIRE 1.0 by collecting data to assess its clarity and usability.19 Semistructured interviews and focus groups with 29 end-users of SQUIRE 1.0 revealed that many found SQUIRE 1.0 helpful in planning and doing improvement work, but less so in the writing pro- cess. This issue was especially apparent in efforts to write about the cyclic, iterative process that often occurs with improvement interventions. SQUIRE 1.0 was seen by many as unnecessarily complex
with too much redundancy and lacking a clear
distinction between “doing improvement” and “studying the improvement.” A recent independent study and editorial also documented and addressed
some of these challenges.20,21
In the second phase, we convened an interna- tional advisory group of 18 experts that included
editors, authors, researchers, and improvement
professionals. This group met through 3 conference calls, reviewed SQUIRE 1.0 and the results of the end-user evaluation, and provided detailed feed-
back on successive revisions. This advisory group
and additional participants attended 2 consensus conferences in 2013 and 2014 where they engaged
in intensive analysis and made recommendations that further guided the revision process.
About the Authors Greg Ogrinc is senior associate dean for medical education, Geisel School of Medicine at Dartmouth, associate chief of staff for education, White River Junction VA, and associate professor of community and family medicine, medicine, and The Dartmouth Institute for Health Policy and Clinical Practice at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. Louise Davies is senior scholar, Quality Scholars Program, Department of Veterans Affairs Medical Center, White River Junction, Vermont, and asso- ciate professor of surgery, Geisel School of Medicine and The Dartmouth Institute for Health Policy & Clinical Prac- tice, Hanover, New Hampshire. Daisy Goodman is fellow, VA Quality Scholars Fellowship Program and instructor of obstetrics and gynecology and community and family medicine at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. Paul Batalden is active emer- itus professor, pediatrics and community and family medicine, Geisel School of Medicine and The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, New Hampshire. Frank Davidoff is editor emeritus, Annals of Internal Medicine, and adjunct professor at The Dartmouth Institute for Health Policy and Clinical Prac- tice, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. David Stevens is adjunct professor, The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, New Hampshire; editor emeritus, BMJ Quality and Safety, London, England; and senior fellow, Institute for Healthcare Improvement, Cambridge, Massachusetts.
Corresponding author: Greg Ogrinc, MD, MS, White River Junction VA, 215 North main St (111), White River Junction, VT 05009 (e-mail: [email protected]).
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Text section and item name Section or item description
Table 1 Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) Publication Guidelines
Notes to authors
Title and abstract
1. Title
2. Abstract
Introduction
3. Problem description
4. Available knowledge
5. Rationale
6. Specific aims
Methods
7. Context
8. Intervention(s)
9. Study of the intervention(s)
10. Measures
11. Analysis
12. Ethical considerations
Results
13. Results
Discussion
14. Summary
• The SQUIRE guidelines provide a framework for reporting new knowledge about how to improve health care
• The SQUIRE guidelines are intended for reports that describe system level work to improve the quality, safety, and value of health care, and used methods to establish that observed outcomes were due to the intervention(s).
• A range of approaches exists for improving health care. SQUIRE may be adapted for reporting any of these.
• Authors should consider every SQUIRE item, but it may be inappropriate or unnecessary to include every SQUIRE element in a particular manuscript.
• The SQUIRE Glossary contains definitions of many of the key words in SQUIRE. • The Explanation and Elaboration document provides specific examples of well-written SQUIRE items,
and an in-depth explanation of each item. • Please cite SQUIRE when it is used to write a manuscript.
Indicate that the manuscript concerns an initiative to improve health care (broadly defined to include the quality, safety, effectiveness, patient-centeredness, timeliness, cost, efficiency, and equity of health care)
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
Why did you start?
Nature and significance of the local problem
Summary of what is currently known about the problem, including relevant previous studies
Informal or formal frameworks, models, concepts, and/or theories used to explain the problem, any rea- sons or assumptions that were used to develop the intervention(s), and reasons why the interven- tion(s) was expected to work
Purpose of the project and of this report
What did you do?
Contextual elements considered important at the outset of introducing the 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
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)
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
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
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
What did you find?
a. Initial steps of the intervention(s) and their evolution over time (eg, 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
What does it mean?
a. Key findings, including relevance to the rationale and specific aims b. Particular strengths of the project
Continued
In the third phase, 44 authors used an interim draft version of the updated SQUIRE guidelines to write sections of a manuscript. Each author then provided comments on the utility and understand- ability of the draft guidelines, and in their submit- ted section, identified the portions of their writing sample that fulfilled the items of that section.22 We also obtained detailed feedback about this draft version through semistructured interviews with 11 biomedical journal editors. The data from this phase revealed areas needing further clarification and which specific items were prone to misinterpre- tation. Finally, a penultimate draft was e-mailed to over 450 individuals around the world, including the advisory group, consensus meeting participants, authors, reviewers, editors, faculty in fellowship pro- grams, and trainees. This version was also posted on the SQUIRE website with an invitation for pub- lic feedback. We used the information from this
process to write SQUIRE 2.0 (Table 1).
SQUIRE 2.0 Many publication guidelines, including
CONSORT (randomized trials), STROBE (observa-
tional studies), and PRISMA (systematic reviews) focus on a particular study methodology (www
.equator-network.org). In contrast, SQUIRE 2.0 is designed to apply across the many approaches used
for systematically improving the quality, safety, and value of health care. Methods range from iter-
ative changes using Plan-Do-Study-Act (PDSA)
cycles in single settings to retrospective analyses of large-scale programs to multisite randomized trials.
We encourage authors to apply other publication
guidelines—particularly those that focus on specific study methods—along with SQUIRE, as appropri- ate. Authors should carefully consider the relevance of each SQUIRE item but recognize that it is some- times not necessary, nor even possible, to include each item in a particular manuscript.
SQUIRE 2.0 retains the IMRaD (Introduc- tion, Methods, Results, and Discussion) structure.23 Although used primarily for reporting research within a spectrum of study designs, this structure expresses the underlying logic of most systematic investigations and is familiar to authors, editors, reviewers, and readers. We continue to use A. Brad- ford Hill’s 4 fundamental questions for writing: Why did you start? What did you do? What did you find? What does it mean?24 In our evaluation of SQUIRE 1.0, novice authors found these questions to be straightforward, clear, and useful.
SQUIRE 2.0 contains 18 items, but omits the multiple subitems that were a source of confusion for SQUIRE 1.0 users.19 A range of approaches exists for improving health care and SQUIRE may be
adapted for reporting any of these. As stated earlier,
authors should consider every SQUIRE item, but it may be inappropriate or unnecessary to include every SQUIRE item in a particular manuscript. In addition,
authors need not use items in the order in which they
appear. Major changes between SQUIRE 1.0 and 2.0 are concentrated in 4 areas: (1) terminology, (2) the-
ory, (3) context, and (4) studying the intervention(s).
Terminology The elaborate detail in SQUIRE 1.0 was seen
by users as both a blessing and a curse19: helpful
Text section and item name Section or item description
Table 1 Continued
Discussion
15. Interpretation
16. Limitations
17. Conclusions
Other information
18. Funding
What does it mean?
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
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
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
Sources of funding that supported this work. Role, if any, of the funding organization in the design, implementation, interpretation, and reporting
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in designing and executing quality improvement
work but less useful in the writing process. The level
of detail sometimes led to confusion about what
to include or not include in a manuscript. Conse-
quently, we made the items in SQUIRE 2.0 shorter
and more direct.
A major challenge in the reporting of system-
atic efforts to improve health care is the multiplic-
ity of terms used to describe the work, which is
challenging for novices and experts alike. Improve-
ment work draws on the epistemology of a variety
of fields, and depending on one’s field of study,
the same words can carry different connotations, a
particularly undesirable state of affairs. Terms such
as “quality improvement,” “implementation science,”
and “improvement science” refer to approaches
that have many similarities but can also connote important (and often-debated) differences. Other terms such as “health care delivery science,” “patient safety,” and even simply “improvement” are also subject to surprising variation in interpretation. To address this problem in semantics, we created a glossary of terms used in SQUIRE 2.0 (Table 2). The glossary provides the intended meaning of certain key terms as we have used them in SQUIRE 2.0 (Table 1). These definitions may be helpful in other endeavors, but are not necessarily intended to be adopted for use in other contexts. Overall, we sought terms and definitions that would be useful to the largest possible audience. For example, we chose “intervention(s)” to refer to the changes that are made. We decided not to use the word “improve- ment” in the individual items (although it remains in the SQUIRE acronym) to encourage authors to report efforts that did not lead to changes for the better. Reporting well-done, negative studies is vital for the learning in this discipline.
Theory SQUIRE 2.0 includes a new item titled “Ratio-
nale.” Biomedical and clinical research is driven by
iterative cycles of theory building and hypothesis testing. Health care improvement work has not con- sistently based the planning, design, and execution
of its programs solidly in theory, to the detriment
of the work. For this reason, SQUIRE 2.0 explicitly includes an item devoted to theory, although we chose to use the broader and less technical label
“Rationale,” to encourage authors to be explicit in
reporting formal and informal theories, models, concepts, or even hunches as to why they expected
a particular intervention to work in a particular con- text. A plain language interpretation of “Rationale”
might be, “Why did you think this would work?”
A recent narrative review of the nature of theory and its use in improvement describes the many
types and applications of theory, and considers pit-
falls in using, and not using, theory.12
The addition of the “Rationale” item is
intended to encourage clarity around assumptions
about the nature of the intervention, the context,
and the expected outcomes. The presence of a well-
thought-out rationale will align with appropriate
measures and with the study of the intervention; it
may also be the starting point for the next round
of work. The “Summary” item in the Discussion
section encourages authors to revisit the original
rationale in the light of its findings and in the larger
context of similar projects.
Context SQUIRE 2.0 accepts “context” as the key features
of the environment in which the work is immersed and which are interpreted as meaningful to the suc- cess, failure, and unexpected consequences of the intervention(s), as well as the relationship of these to the stakeholders (eg, improvement team, clinicians, patients, families).13-16 Systematic efforts to improve health care should contain clear descriptions and acknowledgement of context, rather than efforts to control it or explain it away. SQUIRE 1.0 included context with items in all sections of the manuscript, but context did not rise to the level of a distinct item itself. SQUIRE 2.0 recognizes context as a fundamen- tal item in the Methods section, but its relevance is not limited to this section. In addition to affect- ing the development of the rationale and subsequent design of the intervention(s), context plays a key role in the iterations of intervention(s) and the outcomes. While it is often not simple to capture or describe context, understanding its impact on the design, implementation, measurement, and results make it a vital contributor in identifying and reporting the factors and mechanisms responsible for the success
or failure of the intervention(s).
Studying the Intervention(s) The study of the intervention is, perhaps, the
most challenging item in SQUIRE. In the evaluation
of SQUIRE 1.019 and in the pilot testing,22 many were perplexed by this item and its subelements.
This item was intended to encourage a more formal
assessment of the intervention and its associated outcomes. In SQUIRE 2.0, this section is called, “Study of the Intervention(s)” (Table 1).
“Doing” an improvement project is fundamen-
tally different from “studying” it. The primary pur- pose of “doing” improvement is to produce better
local processes and outcomes, rather than contrib- ute to new generalizable knowledge. In contrast,
the reason for “studying” the intervention is mainly
to contribute to the body of knowledge about the
470 AJCC AMERICAN JOURNAL OF CRITICAL CARE, November 2015, Volume 24, No. 6 www.ajcconline.org
Table 2 Glossary of key terms used in SQUIRE 2.0. This glossary provides the intended meaning of selected words and phrases as they are used in the SQUIRE 2.0 guidelines. They may, and often do, have different meanings in other disciplines, situations, and settings.
Assumptions Reasons for choosing the activities and tools used to bring about changes in health care services at the system level.
Context Physical and sociocultural makeup of the local environment (for example, external environmental factors, organizational dynamics,
collaboration, resources, leadership, and the like), and the interpretation of these factors (“sense-making”) by the health care delivery professionals, patients, and caregivers that can affect the effectiveness and generalizability of intervention(s).
Ethical aspects The value of system-level initiatives relative to their potential for harm, burden, and cost to the stakeholders. Potential harms particularly
associated with efforts to improve the quality, safety, and value of health care services include opportunity costs, invasion of privacy, and staff distress resulting from disclosure of poor performance.25
Generalizability The likelihood that the intervention(s) in a particular report would produce similar results in other settings, situations, or environments
(also referred to as external validity).
Health care improvement Any systematic effort intended to raise the quality, safety, and value of health care services, usually done at the system level. We encour-
age the use of this phrase rather than “quality improvement,” which often refers to more narrowly defined approaches.
Inferences The meaning of findings or data, as interpreted by the stakeholders in health care services—improvers, health care delivery professionals,
and/or patients and families.
Initiative A broad term that can refer to organization-wide programs, narrowly focused projects, or the details of specific interventions (for example,
planning, execution, and assessment).
Internal validity Demonstrable, credible evidence for efficacy (meaningful impact or change) resulting from introduction of a specific intervention into a
particular health care system.
Intervention(s) The specific activities and tools introduced into a health care system with the aim of changing its performance for the better. Complete
description of an intervention includes its inputs, internal activities, and outputs (in the form of a logic model, for example), and the mechanism(s) by which these components are expected to produce changes in a system’s performance.17
Opportunity costs Loss of the ability to perform other tasks or meet other responsibilities resulting from the diversion of resources needed to introduce, test,
or sustain a particular improvement initiative.
Problem Meaningful disruption, failure, inadequacy, distress, confusion or other dysfunction in a health care service delivery system that
adversely affects patients, staff, or the system as a whole, or that prevents care from reaching its full potential.
Process The routines and other activities through which health care services are delivered.
Rationale Explanation of why particular intervention(s) was chosen and why it was expected to work, be sustainable, and be replicable elsewhere.
Systems The interrelated structures, people, processes, and activities that together create health care services for and with individual patients and
populations. For example, systems exist from the personal self-care system of a patient, to the individual provider-patient dyad system, to the microsystem, to the macrosystem, and all the way to the market/social/insurance system. These levels are nested within each other.
Theory or theories Any “reason-giving” account that asserts causal relationships between variables (causal theory) or that makes sense of an other-
wise obscure process or situation (explanatory theory). Theories come in many forms, and serve different purposes in the phases of improvement work. It is important to be explicit and well-founded about any informal and formal theory (or theories) that are used.
efficacy and generalizability of efforts for improv-
ing health care. Both “doing” and “studying” are
required for a deep understanding of the nature and impact of the intervention(s) as well as the
possible underlying mechanisms. “Study of the
Intervention(s)” focuses mainly on whether and why
an intervention “works.” It should align with the rationale and may include, but is not limited to, pre-
planned formal testing of the proposed theory that
the intervention(s) actually produced the observed
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changes, as well as the impact of the intervention(s)
on the context in which the work was done.
SQUIRE 2.0 asks authors to be as transparent,
complete, and as accurate as possible about report-
ing “doing” and “studying” improvement work as
both aspects of the work are key to scholarly report-
ing. The “Summary” and “Interpretation” items
in the Discussion encourage authors to explain
potential mechanisms by which the intervention(s)
resulted (or failed to result) in change, thereby
developing explanatory theories that can be sub-
sequently tested.
Conclusions The development of SQUIRE 2.0 consisted
of a detailed analysis of SQUIRE 1.0, input from
experts in the field, and thorough pilot testing. Many methods and philosophical approaches to improve the quality, safety, and value of health care are available. The systematic efforts to improve health care are often complex and multidimen- sional, and their effectiveness is inherently context dependent. SQUIRE 2.0 provides common ground on which the discoveries contributed by the var- ious approaches can advance the field by sharing them in the published literature.
At the same time, we recognize that simply publishing SQUIRE 2.0 will not effect this change; additional efforts and resources are required. For example, we have created an explanation and elab- oration (E&E) document (Goodman D, Ogrinc G, Davies L; personal communication, 2015) to accompany this article. For each item in SQUIRE 2.0, the E&E provides one or more examples from the published literature and a commentary on how the example(s) meets or does notmeet the item’s standards; this information brings the con- tent of each item to life. The SQUIRE website (www.squire-statement.org) contains a number of resources in addition to the guidelines themselves,
including interactive E&E pages and video com-
mentaries. The website supports an emerging online community for the continuous use, conversation about, and evaluation of the guidelines.
Writing about improvement can be challeng-
ing. Sharing successes, failures, and developments through scholarly literature is an essential com- ponent of the complex work required in order to
improve health care services for patients, profes-
sionals, and the public.
ACKNOWLEDGMENTS This article was originally published in the September 2015 issue of BMJ Quality and Safety, and has been reprinted here, with permission, as a service to our readers.
FINANCIAL DISCLOSURES This material is based upon work supported by the Health Foundation and the Robert Wood Johnson Foundation and included the use of facilities and material at the White River Junction VA in White River Junction, Vermont.
APPENDIX Name and affiliation of members of the SQUIRE 2.0 advisory group: Davina Allen, Cardiff University, United Kingdom (UK); Ross Baker, University of Toronto, Can- ada; Helen Crisp, Health Foundation, UK; Mary Dixon- Woods, University of Leicester, UK; Don Goldmann, Institute for Healthcare Improvement, USA; Steve Goodman, Stanford University, USA; Leora Horwitz, New York University, USA; Pam Ironside, Indiana Uni- versity, USA; Peter Margolis, University of Cincinnati, USA; Paul Miles, American Board of Pediatrics, USA; Shirley Moore, Case Western Reserve University, USA; Peter Pronovost, Johns Hopkins University, USA; Lisa Rubenstein, University of California Los Angeles, USA; Gwen Sherwood, University of North Carolina, USA; Kaveh Shojania, University of Toronto, Canada; Richard Thomson, Newcastle University, UK; Charles Vincent, Imperial College London, UK; Hub Wollersheim, Rad- boud University Medical Center, the Netherlands.
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