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EHR-based cohort assessment for multicenter RCTs: a fast and flexible model for identifying potential study sites
Sarah J Nelson1, Bethany Drury1, Daniel Hood2
1Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
The Recruitment Innovation Center developed an efficient electronic health record method to estimate patient populations for clinical trial site selection. This approach aids multicenter trials in meeting enrollment goals by identifying suitable study sites.
Area of Science:
- Clinical Research
- Health Informatics
- Translational Science
Background:
- Identifying suitable enrollment sites is crucial for multicenter clinical trial success.
- Electronic Health Records (EHR) offer a rich data source for estimating patient populations.
- Existing methods for EHR-based cohort assessment can be burdensome.
Purpose of the Study:
- To develop and test a low-burden, high-yield service line for retrieving study population estimates from EHRs.
- To aid in selecting enrollment sites for multicenter clinical trials.
- To complement existing cohort assessment tools within the Clinical and Translational Science Awards (CTSA) network.
Main Methods:
- Developed a computable phenotype algorithm to target desired patient populations.
- Collaborated with investigators and CTSA hubs to refine the algorithm and query process.
- Standardized the return of results via surveys and provided comprehensive reports for site selection.
Main Results:
- Between 2017 and 2020, 36 phenotype-dependent cohort requests were processed.
- Achieved an average response rate of 73% for these requests.
- Demonstrated a method for querying EHRs using generalizable phenotype algorithms.
Conclusions:
- The RIC's EHR cohort assessment process is efficient and effective for multicenter trial site evaluation.
- The developed method provides reliable participant counts to facilitate enrollment.
- The model is replicable for use by other research programs.
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