Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials.
J Am Med Inform Assoc
; 28(1): 14-22, 2021 01 15.
Article
in English
| MEDLINE | ID: covidwho-1066364
ABSTRACT
OBJECTIVE:
This research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data. MATERIALS ANDMETHODS:
On June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020-June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.RESULTS:
There were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4-28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event.DISCUSSION:
By adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.CONCLUSIONS:
This research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Eligibility Determination
/
Electronic Health Records
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
/
Pregnancy
/
Young adult
Language:
English
Journal:
J Am Med Inform Assoc
Journal subject:
Medical Informatics
Year:
2021
Document Type:
Article
Affiliation country:
Jamia
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