Screening for participants in the ISCHEMIA trial: Implications for clinical research.
Fatima RodriguezJudith S HochmanYifan XuHarmony R ReynoldsJeffrey S BergerStavroula MavromichalisJonathan D NewmanSripal BangaloreDavid J MaronPublished in: Journal of clinical and translational science (2022)
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.
Keyphrases
- cardiovascular events
- healthcare
- randomized controlled trial
- primary care
- emergency department
- end stage renal disease
- study protocol
- clinical trial
- public health
- ejection fraction
- physical activity
- systematic review
- chronic kidney disease
- newly diagnosed
- mental health
- risk assessment
- early onset
- human health
- double blind