| Other author/creator | Grossmann, Claudia, 1978- |
| Other author/creator | Alper, Joe. |
| Other author/creator | Institute of Medicine (U.S.). Roundtable on Value & Science-Driven Health Care. |
| Other author/creator | Patient-Centered Outcomes Research Institute (U.S.) |
| Contents |
Introduction -- Issues overview for observational studies in clinical research -- Engaging the issue of bias -- Generalizing randomized clinical trial results to broader populations -- Detecting treatment-effect heterogeneity -- Predicting individual responses -- Strategies going forward -- Common themes for progress. |
| Abstract |
"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 System is 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"--Publisher's description. |
| General note | "Observational Studies in a Learning Health System: an Institute of Medicine workshop, sponsored by the Patient-Centered Outcomes Research Institute; a Learning Health System Activity, IOM Roundtable on Value & Science-Driven Health Care, April 25-26, 2013, National Academy of Sciences"--Page 101. |
| Bibliography note | Includes bibliographical references. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2014397702 |
| ISBN | 9780309290814 |
| ISBN | 0309290813 |
