Potential Accrual of Patients to Prospective Clinical Trials

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Citation: R. Carlson and Samson W. Tu and Nancy M. Lane and Tse L. Lai and Carol A. Kemper and Mark A. Musen and Edward H. Shortliffe. (1993) Potential Accrual of Patients to Prospective Clinical Trials. In KSL-93-28, June,1993.

Publication techreport ( Edit )
type Technical Report
bibtype techreport
Bibtex basics
author R. Carlson and Samson W. Tu and Nancy M. Lane and Tse L. Lai and Carol A. Kemper and Mark A. Musen and Edward H. Shortliffe
title Potential Accrual of Patients to Prospective Clinical Trials
number KSL-93-28
institution Knowledge Systems, AI Laboratory
address Stanford, CA, USA
year 1993
month June
Bibtex more
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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.

KSL Technical Report ID: KSL-93-28
Facts about Potential Accrual of Patients to Prospective Clinical TrialsRDF feed
Abstract The identification of eligible patients is … 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. ty criteria and to make accrual estimates.
Address Stanford, CA, USA  +
Author R. Carlson and Samson W. Tu and Nancy M. Lane and Tse L. Lai and Carol A. Kemper and Mark A. Musen and Edward H. Shortliffe  +
Bibtype techreport  +
Has author R. Carlson and Samson W. Tu and Nancy M. Lane and Tse L. Lai and Carol A. Kemper and Mark A. Musen and Edward H. Shortliffe  +
Has identifier KSL-93-28  +
Has publishing details June,1993  +
Has title Potential Accrual of Patients to Prospective Clinical Trials  +
Has where published KSL-93-28  +
Has year 1993  +
Institution Knowledge Systems, AI Laboratory  +
Ksl tr id KSL-93-28  +
Month June  +
Number KSL-93-28  +
Process note NO  +
Title Potential Accrual of Patients to Prospective Clinical Trials  +
Year 1993  +
Retrieved from "http://tw.rpi.edu/wiki/Potential_Accrual_of_Patients_to_Prospective_Clinical_Trials"
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