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1 Introduction
Pages 1-8

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From page 1...
... All research methods have advantages and disadvantages; therefore, the role of specific methods in contributing to a learning health system varies according to the framing of the questions being asked and the context in which the research is being carried out. Although RCTs have strong internal validity, their use of well-defined test and control populations limits their applicability to patients in the real world, who often have characteristics 1  The planning committee's role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.
From page 2...
... The Role of OBSERVATIONAL STUDIES IN a Learning Health System An effective and efficient health care system requires a continually evolving evidence base to guide clinical decisions at the patient level and policy decisions at the level of the population. To meet this need, the methods used must be rigorous and the evidence must be valid and generalizable.
From page 3...
... Although attempts to obtain an understanding of this heterogeneity were made through the analysis of subgroups of individuals participating in RCTs, the size of observational studies provides a greater power to detect and understand heterogeneity among subsets of a larger study population. Finally, data collected in the context of routine care or for observational studies can be used to develop predictive models to, for example, help clinicians and patients make health care decisions on the basis of data from patients who are the most like the patients being treated.
From page 4...
... . To achieve this ambitious managed used captured goal, the Roundtable convenes meetings of key leaders in health care, holds public workshops, stewards collaborative projects that advance a learning Missed Opportunities, Waste, and Harm system, and authors reports and related publications.
From page 5...
... These Collaboratives foster information sharing and cooperation across the health and health care system, explore emerging issues facing particular sectors of the health system, and harness the talent and expertise of the participants in practical efforts to advance the field. Workshop scope and Objectives The workshop described in this publication was designed to initiate a comprehensive evaluation of the role of observational studies in contributing to the body of evidence for decision making in a learning health system (see Box 1-1)
From page 6...
... The final workshop session elicited perspectives from speakers with a variety of backgrounds and workshop participants on what the strategies going forward should be. Organization of the Summary This publication summarizes the discussions that occurred throughout the workshop, highlighting the key lessons presented, practical strategies, and the needs and opportunities for the use of observational studies in conjunction with RCTs in the context of a learning health care system.
From page 7...
... 2012. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.


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