A critique of the VA cooperative study

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Publication of the preliminary results of the VA cooperative study of medical versus surgical treatment of chronic stable angina pectoris1 has added fuel to the raging debate over this issue, but has not resolved the question regarding survival. Emotionalism has carried the issue beyond the scientific realm into the lay press, even into the halls of Congress. The study has shown no superiority of one form of treatment over the other and leaves us with the unsettling conclusion that both forms of treatment may be equally good or equally bad. However, a critical analysis of the study raises serious questions whether a prospective randomized multicenter study of a surgical procedure can be carried out effectively in a free society.

Prospective randomized clinical trials of pharmacologic agents have been carried out with notable success, establishing the randomized study as a valuable clinical method for studying the results of drug therapy. Inherent in these studies have been certain key ingredients: (1) carefully designed protocol assuring identical populations for study groups; (2) therapeutic intervention of high quality and reliability; (3) fully informed consent from participating subjects; (4) careful and continuous monitoring of the data; and (5) provision for early termination of all or any part of the study upon demonstration of clear benefits or excessive risk.

The VA cooperative study raises serious questions in many of these areas.

The carefully designed protocol

Of 2804 patients who fulfilled the initial clinical criteria for inclusion in the VA study, 564 were rejected as unwilling, unreliable, . . .



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