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
|2 Issues Overview for Observational Studies in Clinical Research||9-16|
|3 Engaging the Issue of Bias||17-30|
|4 Generalizing Randomized Clinical Trial Results to Broader Populations||31-44|
|5 Detecting Treatment-Effect Heterogeneity||45-56|
|6 Predicting Individual Responses||57-68|
|7 Strategies Going Forward||69-78|
|8 Common Themes for Progress||79-84|
|Appendix A: Biographies of Workshop Speakers||85-100|
|Appendix B: Workshop Agenda||101-110|
|Appendix C: Workshop Participants||111-114|
Find relevant information like your own rough draft from among the thousands of reports available for free at NAP.edu. Copy and paste up to 8 pages of content—whether from your own draft or an outside article—and Reference Finder will recommend NAP publications related to your text.
View Reference Finder
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, please click here to view more information.
Loading stats for Observational Studies in a Learning Health System: Workshop Summary...