Richesson Publishes Article in JAMIA

Richesson Publishes Article in JAMIA

Rachel RichessonRachel Richesson, associate professor, published article entitled "Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable" in the Journal of the American Medical Informatics Association. Co-authors include F.W. Rockhold, Duke Clinical Research Institute; J.D. Tenenbaum, K.A. Marsolo, and E.C. O'Brien, Duke University School of Medicine.

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.

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