Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide
Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author: Agency for Health Care Research and Quality (U.S.)

Publisher: Government Printing Office

Published: 2013-02-21

Total Pages: 236

ISBN-13: 1587634236

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This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Federal Statistics, Multiple Data Sources, and Privacy Protection
Federal Statistics, Multiple Data Sources, and Privacy Protection

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-01-27

Total Pages: 195

ISBN-13: 0309465370

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The environment for obtaining information and providing statistical data for policy makers and the public has changed significantly in the past decade, raising questions about the fundamental survey paradigm that underlies federal statistics. New data sources provide opportunities to develop a new paradigm that can improve timeliness, geographic or subpopulation detail, and statistical efficiency. It also has the potential to reduce the costs of producing federal statistics. The panel's first report described federal statistical agencies' current paradigm, which relies heavily on sample surveys for producing national statistics, and challenges agencies are facing; the legal frameworks and mechanisms for protecting the privacy and confidentiality of statistical data and for providing researchers access to data, and challenges to those frameworks and mechanisms; and statistical agencies access to alternative sources of data. The panel recommended a new approach for federal statistical programs that would combine diverse data sources from government and private sector sources and the creation of a new entity that would provide the foundational elements needed for this new approach, including legal authority to access data and protect privacy. This second of the panel's two reports builds on the analysis, conclusions, and recommendations in the first one. This report assesses alternative methods for implementing a new approach that would combine diverse data sources from government and private sector sources, including describing statistical models for combining data from multiple sources; examining statistical and computer science approaches that foster privacy protections; evaluating frameworks for assessing the quality and utility of alternative data sources; and various models for implementing the recommended new entity. Together, the two reports offer ideas and recommendations to help federal statistical agencies examine and evaluate data from alternative sources and then combine them as appropriate to provide the country with more timely, actionable, and useful information for policy makers, businesses, and individuals.