Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable.
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 [...]
Author(s): Rockhold, Frank W, Tenenbaum, Jessica D, Richesson, Rachel, Marsolo, Keith A, O'Brien, Emily C
DOI: 10.1093/jamia/ocz226