Review and special article
A Proposal to Speed Translation of Healthcare Research Into Practice: Dramatic Change Is Needed

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Abstract

Efficacy trials have generated interventions to improve health behaviors and biomarkers. However, these efforts have had limited impact on practice and policy. It is suggested that key methodologic and contextual issues have contributed to this state of affairs. Current research paradigms generally have not provided the answers needed for more probable and more rapid translation. A major shift is proposed to produce research with more rapid clinical, public health, and policy impact.

Section snippets

A Bold Proposal

Sometimes a problem reaches a point of acuity where there are just two choices left: bold action or permanent crisis.

David Rothkopf

We propose a 10-year moratorium on efficacy RCTs in health and health services research. This would provide the necessary time for researchers, practitioners, policymakers, and citizens to collaboratively identify and evaluate innovations that have real potential for translation. With funding available for such efforts, investigators could design and conduct

Why Such a Change?

Uncritically accepting designs that isolate, decontextualize, and simplify issues has dramatically decreased the applicability of the current results. The key problems of today are “wicked” problems18 that are multilevel, multiply determined, complex, and interacting. Physicists employing mechanistic and decontextualizing, isolation design approaches learned the limitations of such approaches at reductionism decades ago and have since moved to chaos and complexity theory, and more contextual

No More Cookbook Randomized Controlled Trials

Efficacy-focused, RCT designs achieved prominence, at least in part, as a method for pharmaceuticals seeking FDA approval, where it can be argued that biological responses are standard (though even this assumption is inconsistent with personalized or genomic medicine). But this type of highly prescribed science has often been applied uncritically to all intervention problems and questions. These efforts have produced important outcomes24 but even when a definitive result is produced, this

What Could Be Learned During a Moratorium

The types of research more likely to be applicable to real-world problems would be thoughtful alternative designs that fit the question—not projects that automatically use RCT designs for every question.27 This emerging evidence would be practical, contextual, and transparent so others more easily could understand and build on its limitations.28, 29

Such a shift would help us to consider multiple principles of causation.30, 31 In particular, greater attention would be paid to replication32 and

Other Issues and Consequences

The types of important, practical questions that decision makers need answered are of the form: What does it cost; how many and what types of people will participate and how do I know this will work in our setting? If these questions cannot be answered to the satisfaction of the questioner, further consideration of the program or policy is extremely unlikely regardless of the amount, strength, or quality of data on its efficacy.

Cost questions are important and complex, and cost data must be a

Larger Impacts on Research

Here are likely consequences of a moratorium, using the NIH funding process as a jumping off point. Although only one-way research is funded, NIH accounts for a considerable amount of research funding, and the issues below generalize to other funding sectors. With an increased focus on research that rapidly responds to “messy and wicked, complex questions,” funding priorities, and announcements would change, especially those related to comparative effectiveness research.58, 59 As complex

Anticipated Reactance

We have focused attention and identified the consequences of a moratorium on efficacy-style RCTs. This is good science and responds to a set of issues that has been severely limiting the impact, relevance, and timely application of the present science. Admittedly the ideas propose changes to the currently dominant philosophy of science held by many medical researchers—and proposing science that moves away from a mechanistic, reductionist view to a contextualist63 or realist perspective.35

This

Conclusion

The current model of mechanistic simplification and isolation of key factors in “efficacy-style RCT” intervention research clearly has not produced the results needed—and there is no indication that faster, more applicable results from this paradigm are on the horizon. The difficult issues to which answers are now needed—and quickly—can be summarized as complex problems of complex patients embedded in complex healthcare systems in complex and changing communities that require complex

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