Core Working Groups
Biostatistics and Study Design
Creates guidance and technical documents regarding study design and biostatistical issues; develops case studies; and allies with collaborators, NIH Collaboratory Trials investigators, and academic institutions to gather input into key methodological issues.
Community Health Improvement
Develops guidance for researchers on how to conduct pragmatic trials across a variety of health systems and communities, including in rural areas. Documents methods to ensure pragmatic research can improve the health of all populations.
Electronic Health Records
Created the NIH Collaboratory Distributed Research Network to enable distributed remote analysis of research datasets across health systems and currently acts as the key repository for the tools and infrastructure created to leverage electronic health records to support clinical research across multiple health systems.
Ethics and Regulatory
Develops policies and practices to provide a framework for the conduct of health systems research in an ethical manner and in compliance with federal and state regulations. Identifies areas of uncertainty and aids the NIH Pragmatic Trials Collaboratory and its network in resolving uncertainty through dialogue or empirical research when needed.
Health Care Systems Interactions
Engages those involved in healthcare delivery systems to participate in research; facilitate the design and conduct of research protocols attractive to practitioners; lower administrative barriers; and communicate results to all parties.
Implementation Science
Supports NIH Collaboratory Trials in achieving their implementation-related research aims. Promotes the uptake and sustainability of NIH Collaboratory Trial interventions that have proven effective in routine practice. Provides guidance on de-implementation of interventions when necessary. Produces guidance and best practices for conducting implementation research as part of embedded pragmatic clinical trials.
Patient-Centered Outcomes
Creates guidelines and defines best practices with respect to selecting, compiling, and curating the most appropriate patient-reported outcome (PRO) measures (and stimulating the development of new instruments when new solutions are needed); the creation of efficient, high-quality PRO data collection systems compatible with EHRs and registries; and conducting statistical analyses of PRO endpoints.