Accepted for/Published in: JMIR Formative Research
Date Submitted: May 25, 2023
Date Accepted: Nov 22, 2023
Evaluation of eligibility criteria relevance for the purpose of IT-supported trial recruitment: A descriptive quantitative analysis
ABSTRACT
Background:
To address the difficulties in identifying potential participants for clinical trials, clinical trial recruitment support systems (CTRSS) can search data from patient care for eligible patients. Eligibility criteria for clinical trials are often extensive, and not all of them are necessary or appropriate for an automated search.
Objective:
We aimed to identify which sets of eligibility criteria are relevant for an automated clinical trial participant search.
Methods:
We asked trial experts and CTRSS developers to first categorize the eligibility criteria of their clinical trials according to data element groups and then to classify them into one of three categories: necessary, complementary, and irrelevant. In addition, the experts had to assess whether a criterion was documented (on paper or electronically) or whether it was information known only to the treating physicians or patient.
Results:
We reviewed 82 clinical trials with 1157 criteria. Of these, 30.9% were considered "necessary", 19.8% "complementary" and 30.0% "irrelevant". 19.2% were not documented. We found that diagnoses, age, and current medications were used to search for subjects in more than 20% of trials. In addition, examination results, laboratory results, medication history and the date of a diagnosis appear in the eligibility criteria of more than 10% of the studies.
Conclusions:
The distribution of data element groups in clinical trials has been heterogeneously described in previous works. Therefore, we recommend identifying the percentage of trials in which data element groups can be found as a more reliable way to determine the relevance of eligibility criteria. Only necessary and complementary criteria should be included in this data element relevance index (DERI).
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