Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations.

ABSTRACT:

Objective

To empirically explore how pragmatic clinical trials (PCTs) that used real-world data (RWD) assessed study-specific fitness-for-use.

Methods

We conducted interviews and surveys with PCT teams who used electronic health record (EHR) data to ascertain endpoints. The survey cataloged key concerns about RWD, activities used to assess data fitness-for-use, and related barriers encountered by study teams. Patterns and commonalities across trials were used to develop recommendations for study-specific fitness-for-use assessments.

Results

Of 15 invited trial teams, 7 interviews were conducted. Of 31 invited trials, 15 responded to the survey. Most respondents had prior experience using RWD (93%). Major concerns about EHR data were data reliability, missingness or in

SUBMITTER: Raman SR 

PROVIDER: S-EPMC9006695 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature