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Observational Studies in a Learning Health System - Workshop Summary (Paperback)
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Observational Studies in a Learning Health System - Workshop Summary (Paperback)
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Clinical research strains to keep up with the rapid and iterative
evolution of medical interventions, clinical practice innovation,
and the increasing demand for information on the clinical
effectiveness of these advancements. In response to the growing
availability of archived and real-time digital health data and the
opportunities this data provides for research, as well as the
increasing number of studies using prospectively collected clinical
data, the Institute of Medicine\'s Roundtable on Value &
Science-Driven Health Care convened a workshop on Observational
Studies in a Learning Health System. Participants, including
experts from a wide range of disciplines - clinical researchers,
statisticians, biostatisticians, epidemiologists, health care
informaticians, health care analytics, research funders, health
products industry, clinicians, payers, and regulators - explored
leading edge approaches to observational studies, charted a course
for the use of the growing health data utility, and identified
opportunities to advance progress. Workshop speakers and individual
participants strove to identify stakeholder needs and barriers to
the broader application of observational studies. Observational
Studies in a Learning Health Systemis the summary of the workshop.
This report explores the role of observational studies in the
generation of evidence to guide clinical and health policy
decisions. The report discusses concepts of rigorous observational
study design and analysis, emerging statistical methods, and
opportunities and challenges of observational studies to complement
evidence from experimental methods, treatment heterogeneity, and
effectiveness estimates tailored toward individual patients. Table
of Contents Front Matter 1 Introduction 2 Issues Overview for
Observational Studies in Clinical Research 3 Engaging the Issue of
Bias 4 Generalizing Randomized Clinical Trial Results to Broader
Populations 5 Detecting Treatment-Effect Heterogeneity 6 Predicting
Individual Responses 7 Strategies Going Forward 8 Common Themes for
Progress Appendix A: Biographies of Workshop Speakers Appendix B:
Workshop Agenda Appendix C: Workshop Participants
General
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