Clinical trials : journal of the Society for Clinical Trials
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Randomized Controlled Trial Multicenter Study
A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial.
Since the late 1960s, coronary artery bypass graft (CABG-only) procedures were traditionally performed using a heart-lung machine on an arrested heart (on-pump). Over the past decade, an increasing number CABG-only procedures were performed on a beating heart (off-pump). Advocates of the off-pump approach expect to reduce many of the adverse side effects related to using the heart-lung machine, while advocates for the on-pump procedure raise concerns related to graft patency rates and long-term event-free survival for the off-pump technique. ⋯ The study design presented allows for a balanced and fair assessment of the on-pump and off-pump CABG procedures across a diversity of clinical outcomes and resource use metrics. Its results have the potential to influence clinical cardiac surgical practice in the future.
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Randomized Controlled Trial
Quality assurance questionnaire for professionals fails to improve the quality of informed consent.
The informed consent process for research warrants improvement but approaches designed to enhance informed consent need testing in the context of actual clinical research. ⋯ Despite prior beliefs, a standardized quality assurance tool do not enhance informed consent in actual clinical trials. Future research is needed to rigorously evaluate proposed methods to enhance informed consent prior to widespread introduction.