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Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable.

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Date
2020-02-06
Authors
Rockhold, Frank W
Tenenbaum, Jessica D
Richesson, Rachel
Marsolo, Keith A
O'Brien, Emily C
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Abstract
Pragmatic clinical trials often entail the use of electronic health record (EHR) and claims data, but bias and quality issues associated with these data can limit their fitness for research purposes particularly for study end points. Patient-reported health (PRH) data can be used to confirm or supplement EHR and claims data in pragmatic trials, but these data can bring their own biases. Moreover, PRH data can complicate analyses if they are discordant with other sources. Using experience in the design and conduct of multi-site pragmatic trials, we itemize the strengths and limitations of PRH data and identify situational criteria for determining when PRH data are appropriate or ideal to fill gaps in the evidence collected from EHRs. To provide guidance for the scientific rationale and appropriate use of patient-reported data in pragmatic clinical trials, we describe approaches for ascertaining and classifying study end points and addressing issues of incomplete data, data alignment, and concordance. We conclude by identifying areas that require more research.
Type
Journal article
Subject
electronic health records
patient reported outcome measures
pragmatic clinical trials as topic
randomized controlled trials as topic, patient-generated health data
Permalink
https://hdl.handle.net/10161/20274
Published Version (Please cite this version)
10.1093/jamia/ocz226
Publication Info
Rockhold, Frank W; Tenenbaum, Jessica D; Richesson, Rachel; Marsolo, Keith A; & O'Brien, Emily C (2020). Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable. Journal of the American Medical Informatics Association : JAMIA, 27(4). pp. 634-638. 10.1093/jamia/ocz226. Retrieved from https://hdl.handle.net/10161/20274.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Marsolo

Keith Allen Marsolo

Associate Professor in Population Health Sciences
Dr. Marsolo is a faculty member in the Department of Population Health Sciences (DPHS) and a member of the Duke Clinical Research Institute (DCRI).  His current research focuses on infrastructure to support the use of electronic health records (EHRs) and other real-world data sources in observational and comparative effectiveness research and public health surveillance, as well as standards and architectures for multi-center learning health systems
O'Brien

Emily O'Brien

Associate Professor in Population Health Sciences
I am an epidemiologist and health services researcher at the Duke Clinical Research Institute. My research focuses on comparative effectiveness, patient-centered outcomes, and pragmatic health services research in cardiovascular and pulmonary disease.Areas of expertise: Epidemiology, Health Services Research, and Clinical Decision Sciences
Richesson

Rachel L Richesson

Associate Professor in the School of Nursing
Rachel Richesson, PhD, MPH, a noted informaticist, joined the DUSON faculty in December 2011. Dr. Richesson earned her BS (Biology) at the University of Massachusetts in 1991, and holds graduate degrees in Community Health (MPH, 1995) and Health Informatics (MS, 2000 and PhD, 2003) from the University of Texas Health Sciences Center in Houston. Her dissertation involved the integration of heterogeneous data from multiple emergency departments. Dr. Richesson spent 7 years as at the University
Rockhold

Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics
Frank is a fulltime Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at HunterRockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has
Tenenbaum

Jessica Dale Tenenbaum

Assistant Professor of Biostatistics & Bioinformatics
Dr. Tenenbaum is a faculty member in the Division of Translational Biomedical Informatics in the Department of Biostatistics and Bioinformatics. Her primary research interests are  1. Informatics to enable precision medicine; 2. Mental health informatics; 3. Infrastructure and standards to enable research collaboration and integrative data analysis; and 4. Ethical, legal, and social issues that arise in translational research, direct to consumer genetic testing, and data sharing. Cu
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