A distribution-based method for assessing the differences between clinical trial target populations and patient populations in electronic health records.

ABSTRACT:

Objective

To improve the transparency of clinical trial generalizability and to illustrate the method using Type 2 diabetes as an example.

Methods

Our data included 1,761 diabetes clinical trials and the electronic health records (EHR) of 26,120 patients with Type 2 diabetes who visited Columbia University Medical Center of New-York Presbyterian Hospital. The two populations were compared using the Generalizability Index for Study Traits (GIST) on the earliest diagnosis age and the mean hemoglobin A1c (HbA1c) values.

Results

Greater than 70% of Type 2 diabetes studies allow patients with HbA1c measures between 7 and 10.5, but less than 40% of studies allow HbA1c<7 and fewer than 45% of studies allow HbA1c>10.5. In the real-world population, only 38% of patients had Hb

SUBMITTER: Weng C 

PROVIDER: S-EPMC4081748 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature