Observational Studies in a Learning Health System Workshop Summary (2013) / Chapter Skim
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8 Common Themes for Progress
8 Common Themes for Progress
Pages 79-84
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From page 79... ...
(Ryan) • The right question must be asked, and the right analytic meth ods applied, in order to validly compare observational studies and randomized controlled trials (RCTs)
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From page 80... ...
These themes both touched on the role of observational studies as contributors to clinical evidence and identified priorities for innovation in the methods of conduct of clinical trials on the basis of current gaps and shortfalls. Participants and speakers shared their thoughts on changes in policies, particularly those of funders and journal editors, that can move research toward producing practical evidence useful to health care decision making.
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From page 81... ...
Several workshop participants called for the need to move beyond discussions of whether treatment effect heterogeneity is real to better understanding of the fundamental biologic differences which are likely the main source of heterogeneity. Kent highlighted the limitations of current approaches, including analytical approaches that cannot contend with studies that are under-powered to detect sub-group effects and the one-variableat-a-time approach to subgroup analysis.
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From page 82... ...
The development of a framework to organize the evidence and evaluate when the evidence is good enough to inform decision making, depending on the methods used and the data source, was suggested to be a practical approach to address this. STAKEHOLDER ENGAGEMENT Greater stakeholder engagement around observational studies and their role in supporting health care decisions was a theme of many of the discussions throughout the workshop.
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From page 83... ...
Several workshop participants who spoke highlighted similar issues around challenges communicating uncertainty to individual patients, clinicians, and the population. In addition to the use of targeted communication strategies, the incorporation of uncertainty into robust tools for decision making was suggested.
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