Reference: Carlson, R. W.; Tu, S. W.; Lane, N. M.; Lai, T. L.; Kemper, C. A.; Musen, M. A.; & Shortliffe, E. H. Potential Accrual of Patients to Prospective Clinical Trials. Knowledge Systems Laboratory, June, 1993.
Abstract: The identification of eligible patients is a major barrier to the completion of clinical trials. Our research group is developing a computer-based system called T-HELPER that is designed to assist health-care providers in the enrollment of patients with HIV disease in clinical trials. To assess the potential effect of T-HELPER on accrual to clinical trials, we have developed a computer- based methodology to retrospectively and prospectively identify patients who are eligible or potentially eligible for protocols. This methodology was tested retrospectively over a 7-month period on a randomly selected group of 60 patients who were HIV- infected, 30 of whom had an AIDS-defining diagnosis, and receiving care at a county-operated clinic. For each clinic visit and hospitalization, patients were categorized as eligible, potentially eligible, or ineligible for each of the 17 protocols active during the 7-month period. None of the patients was enrolled on a clinical trial during the 7-month period. Thirteen patients were identified as eligible for protocol; three of the patients were eligible for two different protocols and one was eligible for the same protocol during two different time intervals. An additional 54 patients were identified as potentially eligible for a total of 165 potential accrual opportunities, but important information, such as the result of a required laboratory test, was missing, so that eligibility could not be unequivocally determined. Ineligibility for protocol was determined in 414 (35%) clinic visits and hospitalizations based only on conditions which were potentially amenable to modification, such as the use of concurrent medications; 194 (17%) failed only laboratory tests or subjective determinations not routinely performed; and 346 (29%) failed only routine laboratory tests. Our results document that there are substantial numbers of eligible and potentially eligible patients who are not enrolled or evaluated for enrollment in prospective clinical trials. Computer-based eligibility screening when coupled with a computerized- medical record offers the potential to assist in the selection of protocol eligibility criteria and to make accrual estimates.