Strength of evidence, theory and context

Critical analysis of what actually has happened in an author's healthcare improvement initiative—and, more importantly, why and how—inevitably draws on scholarly fields beyond biomedical science including the wide range of social sciences and organisation research.8 ,18 Moreover, boundaries are increasingly permeable among the epistemologies of healthcare improvement, health services research and the social sciences.2 ,3 ,8

At least three elements of a healthcare improvement report have emerged in greater focus since the original SQUIRE publication. As healthcare improvement scholars and practitioners become increasingly unambiguous about the underpinning discipline of healthcare improvement, strength of evidence,2 ,19 the theories that underlie improvement efforts20 and empirical evidence for the role of context,21–23 appear to be fundamental for such a report.

Strength of evidence

SQUIRE's emphasis on the clear statement of a report's critical study question with supporting evidence1—appearing simple on its face—in fact in 2008 constituted a radical pivot to the critical study of the improvement itself and its outcomes. The SQUIRE elements that explored the study question invited the author to go beyond the description of the improvement initiative per se to define the research question that offered evidence for the effect of the initiative on patient care or a health system. It asked for critical measurement of the improvement and its associated outcomes, which in turn required supporting statistical methodology.2 ,19

Theory that underlies the improvement

There were early calls for description of the theory on which an improvement initiative was based.24 This evolved increasingly into an explicit expectation for hypotheses that underlie an improvement intervention in its commitment to improving patient care or a health system—what some authors have called ‘reason-giving’.20 Such analysis demands deeper exploration of the social components of context that provide the drivers and barriers to implementation. Dixon-Woods et al25 provide the most salient example of the complexity of post hoc theory development in their analysis of the successful Michigan Intensive Care Unit central line initiative by Pronovost et al26 Critical analysis of what was intended, or supposed to happen, inevitably draws on scholarly fields beyond biomedical science, including the wide range of social sciences.25

Context

The interaction between an improvement initiative and the context in which it occurs lies at the very heart of healthcare improvement.27 Context is a mutable part of the social process that is healthcare improvement in contrast to biologically active clinical interventions where context must be rigidly controlled.28 To this end, Kaplan et al21 and others22 ,23 have emphasised the importance of an author's empirical evidence for the critical contribution of context to an improvement initiative. These reports underscored that few scholarly improvement reports have heretofore contained such evidence.

This critical focus offers a fresh challenge for improvement authors. It goes well beyond broad description of the physical and organisational attributes of a clinical setting to address context's wider scope—leadership, external regulations, hierarchy and other issues that influence the social context of improvement.21 ,22

Broadening dissemination of SQUIRE

There is currently a consensus-based revision process underway which will produce SQUIRE 2.0.29 The aim is to capture the promise of SQUIRE to address the emerging science of healthcare improvement including elements such as strength of evidence, theory and context. It will be particularly important to make SQUIRE continually more useful for authors, editors and reviewers. It should include dissemination to wider specialties and more diverse journals.

A new version should also call for avoidance of the straitjacket against which the original SQUIRE authors cautioned.1 Improvement reports increasingly are emerging from diverse healthcare fields that embrace diverse methodologies, and the risk of overly rigorous implementation could inadvertently lead SQUIRE to limit innovation. This requires a balance of the strengths of traditional quality improvement methodologies with those of sensibly crafted innovative improvement initiatives—perhaps methodologies that are not even currently apparent. One practical strategy will be wider employment of SQUIRE as an anchor for formal teaching and coaching about writing, which offers a pragmatic test bed for how and where SQUIRE fits in the design of improvement initiatives and the preparation of useful manuscripts.11 ,30 Ultimately, the many stakeholders in healthcare improvement including clinicians, improvement specialists, methodologists, statisticians, editors, reviewers and readers will be the arbiters of the essential elements of a scholarly improvement report.