Standards for QUality Improvement Reporting Excellence 2.0: revised publication guidelines from a detailed consensus process.

Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured 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 three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context 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, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org).

Music lessons: what musicians can teach doctors (and other health professionals).

Medicine is a learned profession, but clinical practice is above all a matter of performance, in the best and deepest sense of the word. Because music is, at its core, a pure distillate of real-time performance, musicians are in an excellent position to teach us about better ways to become and remain expert performers in health care and ways for our teachers and mentors to help us do that. Ten features of the professionalization of musicians offer us lessons on how the clinical practice of medicine might be learned, taught, and performed more effectively.

Publication guidelines for improvement studies in health care: evolution of the SQUIRE Project.

In 2005, draft guidelines were published for reporting studies of quality improvement as the initial step in a consensus process for development of a more definitive version. The current article contains the revised version, which we refer to as Standards for QUality Improvement Reporting Excellence (SQUIRE). This narrative progress report summarizes the special features of improvement that are reflected in SQUIRE and describes major differences between SQUIRE and the initial draft guidelines. It also explains the development process, which included formulation of responses to informal feedback, written commentaries, and input from publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programs; and a meeting of stakeholders for critical review of the guidelines' content and wording, followed by commentary on sequential versions from an expert consultant group. Finally, the report discusses limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions under development; and plans for dissemination, testing, and further development of SQUIRE.

Heterogeneity is not always noise: lessons from improvement.

Rigorous experimental methods suppress differences among study participants (noise) to detect true intervention effects (signals). But suppressing participants' heterogeneity obscures an essential dimension of biological and clinical knowledge. Medicine is therefore ambivalent about the influence of heterogeneity on outcomes and struggles to find ways to take it properly into account in both clinical practice and research. This analysis explores the roots of that ambivalence. Drawing on the evaluation of 2 health care improvement initiatives, this article examines the unique features of improvement that help to understand heterogeneity's influence on study methods, and suggests a variety of ways to assess the effect of heterogeneity on study outcome measures.

Understanding contexts: how explanatory theories can help.

OBJECTIVE: To rethink the nature and roles of context in ways that help improvers implement effective, sustained improvement interventions in healthcare quality and safety. DESIGN: Critical analysis of existing concepts of context; synthesis of those concepts into a framework for the construction of explanatory theories of human environments, including healthcare systems. DATA SOURCES: Published literature in improvement science, as well as in social, organization, and management sciences. Relevant content was sought by iteratively building searches from reference lists in relevant documents. RESULTS: Scientific thought is represented in both causal and explanatory theories. Explanatory theories are multi-variable constructs used to make sense of complex events and situations; they include basic operating principles of explanation, most importantly: transferring new meaning to complex and confusing phenomena; separating out individual components of an event or situation; unifying the components into a coherent construct (model); and adapting that construct to fit its intended uses. Contexts of human activities can be usefully represented as explanatory theories of peoples' environments; they are valuable to the extent they can be translated into practical changes in behaviors. Healthcare systems are among the most complex human environments known. Although no single explanatory theory adequately represents those environments, multiple mature theories of human action, taken together, can usually make sense of them. Current mature theories of context include static models, universal-plus-variable models, activity theory and related models, and the FITT framework (Fit between Individuals, Tasks, and Technologies). Explanatory theories represent contexts most effectively when they include basic explanatory principles. CONCLUSIONS: Healthcare systems can usefully be represented in explanatory theories. Improvement interventions in healthcare quality and safety are most likely to bring about intended and sustained changes when improvers use explanatory theories to align interventions with the host systems into which they are being introduced.

Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project.

In 2005 we published draft guidelines for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. The current article contains the revised version, which we refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). We describe the consensus process, which included informal feedback, formal written commentaries, input from publication guideline developers, review of the literature on the epistemology of improvement and on methods for evaluating complex social programs, and a meeting of stakeholders for critical review of the guidelines' content and wording, followed by commentary on sequential versions from an expert consultant group. Finally, we examine major differences between SQUIRE and the initial draft, and consider limitations of and unresolved questions about SQUIRE; we also describe ancillary supporting documents and alternative versions under development, and plans for dissemination, testing, and further development of SQUIRE.

Development of the SQUIRE Publication Guidelines: evolution of the SQUIRE project.

These guidelines address the development and testing of interventions to improve the quality and safety of health care.

The ethics of using quality improvement methods in health care.

Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. Most QI activities are not human subjects research and should not undergo review by an institutional review board; rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice.

Implementation and de-implementation: two sides of the same coin?

Avoiding low value care received increasing attention in many countries, as with the Choosing Wisely campaign and other initiatives to abandon care that wastes resources or delivers no benefit to patients. While an extensive literature characterises approaches to implementing evidence-based care, we have limited understanding of the process of de-implementation, such as abandoning existing low value practices. To learn more about the differences between implementation and de-implementation, we explored the literature and analysed data from two published studies (one implementation and one de-implementation) by the same orthopaedic surgeons. We defined 'leaders' as those orthopaedic surgeons who implemented, or de-implemented, the target processes of care and laggards as those who did not. Our findings suggest that leaders in implementation share some characteristics with leaders in de-implementation when comparing them with laggards, such as more open to new evidence, younger and less time in clinical practice. However, leaders in de-implementation and implementation differed in some other characteristics and were not the same persons. Thus, leading in implementation or de-implementation may depend to some degree on the type of intervention rather than entirely reflecting personal characteristics. De-implementation seemed to be hampered by motivational factors such as department priorities, and economic and political factors such as cost-benefit considerations in care delivery, whereas organisational factors were associated only with implementation. The only barrier or facilitator common to both implementation and de-implementation consisted of outcome expectancy (ie, the perceived net benefit to patients). Future studies need to test the hypotheses generated from this study and improve our understanding of differences between the processes of implementation and de-implementation in the people who are most likely to lead (or resist) these efforts.

A physicians' agenda for partnering with employers and insurers: fresh ideas.

We report the results of the second phase of a multiphase qualitative investigation of the ways physicians, employers, and insurers can work together more effectively to provide better ambulatory care to employees and their dependents. This article focuses on ways physicians can develop more useful relationships among these groups. We used a grounded theory approach to conduct 71 interviews from August 12, 2004, to December 27, 2005, with 25 practicing physicians in large and small groups, urban and rural areas, private and academic settings, and primary care and specialty practices; 33 hospital administrators, medical association executives, health insurance medical officers, and health policy analysts; and 13 senior executives of large and small companies. The study identifies 2 approaches to the structuring of ambulatory care that can lead to improved health care outcomes and value. In the first approach, direct contracting between physicians and employers transfers tasks previously performed by insurers to employers or other intermediaries who may be able to provide better service or lower cost. In the second approach, insurer-mediated relationships between physicians and employers are restructured, particularly in ways that improve information flow. Such relationships may strengthen physicians' ability to provide quality services while enabling patients to make more informed decisions about physician selection, treatments, and spending. We believe that broader use of these approaches may improve the quality and efficiency of ambulatory care for the large proportion of the population that has work-related health insurance. Although the findings are promising, our intent is not to claim broad external validity but rather to encourage greater experience with these approaches and more formal studies of their effectiveness.

Women in Academic Medicine Leadership: Has Anything Changed in 25 Years?

Over the past 25 years, the number of women graduating from medical schools in the United States and Canada has increased dramatically to the point where roughly equal numbers of men and women are graduating each year. Despite this growth, women continue to face challenges in moving into academic leadership positions. In this Commentary, the authors share lessons learned from their own careers relevant to women's careers in academic medicine, including aspects of leadership, recruitment, editorship, promotion, and work-life balance. They provide brief synopses of current literature on the personal and social forces that affect women's participation in academic leadership roles. They are persuaded that a deeper understanding of these realities can help create an environment in academic medicine that is generally more supportive of women's participation, and that specifically encourages women in medicine to take on academic leadership positions.