Aid to the evaluation of therapeutic studies.

Physicians are often faced with conflicting recommendations from therapeutic studies. An evaluation form is proposed to facilitate the evaluation of the quality of therapeutic studies and the resulting treatment or management recommendations in any area of medicine. Twelve major topics for evaluation include sample size determination, randomization, selection of control group(s), "blinding," and support for treatment recommendations. Emphasis is placed on study design and performance rather than data analysis. Thirty-four primary criteria based on accepted research standards are designated as most important, and examples from the literature are provided to illustrate their use. The form provides a comprehensive set of well-accepted standards of research in a format that encourages detailed, consistent, and thoughtful evaluation of therapeutic studies. The evaluation form is recommended as a tool for physicians who wish to develop and exercise skill in evaluating therapeutic studies.