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Rigorous evaluations of evolving interventions: can we have our cake and eat it too?
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  1. Robert E Burke1,
  2. Kaveh G Shojania2
  1. 1 Research and Hospital Medicine Sections, Denver VA Medical Center, Denver, Colorado, USA
  2. 2 Department of Medicine, Sunnybrook Health Sciences Centre and the University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Robert E Burke, Research and Hospital Medicine Sections, Denver VA Medical Center, Denver, CO 80220, USA; Robert.Burke5{at}va.gov

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The years immediately following the widespread interest in patient safety1 and then healthcare quality2 saw considerable debate between pragmatically oriented improvers and research-oriented evaluators3–6 —or between ‘evangelists’ and ‘snails’ as one longtime observer characterised the two groups.7 Too often, enthusiastic improvers (‘evangelists’) relied on simple pre-post designs within a single context leading to erroneous claims of efficacy.8 In contrast, research-oriented investigators (‘snails’) and journals pushed for ever more rigorous designs including randomised trials, potentially at the cost of discouraging many improvers without this training and leading to slower development and deployment of effective interventions.9 10 Many clinicians, quality improvement (QI) experts and researchers are thus caught in a quandary: how best to evaluate a candidate QI intervention? How can we best balance the pragmatic needs of improvement—including the frequent need to refine the intervention or its implementation—with the requirement of most traditional evaluative designs, which typically require a static intervention?

We believe this question is one of the most important issues to consider when developing a QI intervention and is often not considered carefully enough—either by snails or evangelists. Decisions about when and how to evaluate potentially promising interventions can have crucial implications for the future of the intervention and the patients it could affect.

Two recent examples of improvement interventions evaluated using traditional designs

In this issue of BMJ Quality and Safety, Swaminathan and colleagues11 present a rigorous evaluation of the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) QI intervention, intended to reduce adverse events stemming from the insertion of peripherally inserted venous central catheters (PICC). PICCs have become ubiquitous as a substitution for a central intravenous line when patients need longer term central intravenous access, but clinicians often order them unnecessarily or order inappropriate types—for example, a double-lumen PICC when a single-lumen PICC would work just as well and carry a lower risk of complications. …

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