04628nam 2200649 450 991078936040332120230803034635.00-309-29084-80-309-29082-1(CKB)3710000000103418(EBL)3379284(SSID)ssj0001219048(PQKBManifestationID)11702770(PQKBTitleCode)TC0001219048(PQKBWorkID)11212634(PQKB)10765834(MiAaPQ)EBC3379284(Au-PeEL)EBL3379284(CaPaEBR)ebr10863942(OCoLC)881805343(EXLCZ)99371000000010341820140505h20132013 uy| 0engurcnu||||||||txtccrObservational studies in a learning health system workshop summary /Claudia Grossmann and Joe Alper, rapporteurs ; A Learning Health System Activity, Roundtable on Value & Science-Driven Health Care, Institute of Medicine of the National AcademiesWashington, District of Columbia :National Academies Press,[2013]©20131 online resource (135 p.)Description based upon print version of record.0-309-29081-3 Includes bibliographical references and index.""Front Matter""; ""Institute of Medicine Roundtable on Value & Science-Driven Health Care *Charter and Vision Statement*""; ""Reviewers""; ""Foreword""; ""Contents""; ""Acronyms and Abbreviations""; ""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"""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.Clinical medicineResearchCongressesMedical careCongressesEvidence-based medicineCongressesExperimental designCongressesClinical medicineResearchMedical careEvidence-based medicineExperimental design616Grossman ClaudiaAlper JoeInstitute of Medicine (U.S.).A Learning Health System Activity,Institute of Medicine (U.S.).Roundtable on Value & Science-Driven Health Care,MiAaPQMiAaPQMiAaPQBOOK9910789360403321Observational studies in a learning health system3788866UNINA