Patient Comprehension and Reaction to Participating in a Double-blind Randomized Clinical Trial (ISIS-4) in Acute Myocardial Infarction

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Abstract
RANDOMIZED clinical trials are the criterion standard for evaluating new treatment modalities and are ethically justified.1 These trials expose the patient to state-of-the-art therapeutic strategies, but most trials dictate management decisions at randomization centers far from the patient and the attending physician, with an inevitable compromise in the traditional physician-patient relationship. Little attention has been paid to the perspective of the patients recruited to a trial,2 and particularly so in the circumstances of acute myocardial infarction.3,4