Screening for participants in the ISCHEMIA trial: Implications for clinical research
Fatima Rodriguez1,2, Judith S Hochman3, Yifan Xu3
1Division of Cardiovascular Medicine and the Cardiovascular Institute, Stanford University, Stanford, CA, USA.
Insights
The ISCHEMIA trial found no difference in cardiovascular events between invasive and conservative strategies for heart ischemia. Physician or patient refusal was a major barrier to enrollment in this important clinical trial.
Area of Science:
- Cardiology
- Clinical Trials
- Health Services Research
Background:
- The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial investigated optimal treatment strategies for patients with moderate to severe ischemia.
- Previous findings indicated no significant difference in cardiovascular events between initial invasive and conservative management approaches.
Purpose of the Study:
- To analyze the reasons why potentially eligible patients did not enroll in the ISCHEMIA trial.
- To identify barriers to participation in large-scale cardiovascular clinical trials.
Main Methods:
- Review of screening logs for patients meeting preliminary inclusion criteria for the ISCHEMIA trial.
- Analysis of reasons for non-enrollment, including physician refusal and patient refusal.
Main Results:
- Over half of potentially eligible patients did not enroll in the ISCHEMIA trial.
- Physician and patient refusal were the primary reasons for non-participation, representing a potentially modifiable barrier.
Conclusions:
- Physician equipoise is crucial when discussing randomized controlled trial participation with patients.
- Addressing physician and patient refusal may improve enrollment in future cardiovascular trials.
Abstract:
The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) found that there was no statistical difference in cardiovascular events with an initial invasive strategy as compared with an initial conservative strategy of guideline-directed medical therapy for patients with moderate to severe ischemia on noninvasive testing. In this study, we describe the reasons that potentially eligible patients who were screened for participation in the ISCHEMIA trial did not advance to enrollment, the step prior to randomization. Of those who preliminarily met clinical inclusion criteria on screening logs submitted during the enrollment period, over half did not participate due to physician or patient refusal, a potentially modifiable barrier. This analysis highlights the importance of physician equipoise when advising patients about participation in randomized controlled trials.
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