Clinical comparison between trial participants and potentially eligible patients using electronic health record data: A generalizability assessment method.

ABSTRACT:

Objective

To present a generalizability assessment method that compares baseline clinical characteristics of trial participants (TP) to potentially eligible (PE) patients as presented in their electronic health record (EHR) data while controlling for clinical setting and recruitment period.

Methods

For each clinical trial, a clinical event was defined to identify patients of interest using available EHR data from one clinical setting during the trial's recruitment timeframe. The trial's eligibility criteria were then applied and patients were separated into two mutually exclusive groups: (1) TP, which were patients that participated in the trial per trial enrollment data; (2) PE, the remaining patients. The primary outcome was standardized differences in clinical characteris

SUBMITTER: Rogers JR 

PROVIDER: S-EPMC8260457 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature