Critical Analysis of Intervention Studies: Methodological Problems and Pitfalls

Abstract

“Double-blind, randomized control trials have become the hallmark of therapeutic respectability” (1). From small beginnings some thirty years ago, clinical trials have come to take an increasingly large place in medical research and, indeed, the research budget. In their heyday, in the early 1970s, it was fashionable to suggest that all new methods of management should be submitted to this discipline and those who were reluctant to do so were castigated fiercely by statisticians and community physicians. Cardiologists, in particular, have been the butt of these complaints, notwithstanding the fact that many of the leaders of the subspeciality were early in the field in studies of anticoagulant therapy. Perhaps it was the disillusionment occasioned by this experience that made their colleagues too reluctant for a time to embark on further experiments of the same kind.