Surgical procedures and devices should be evaluated in the same way as medical therapy

Control Clin Trials. 1997 Dec;18(6):478-87. doi: 10.1016/s0197-2456(96)00114-6.


This paper is a personal essay that starts and ends with the message that surgical procedures and devices should be evaluated in the same way as medical therapies, namely, by randomized clinical trials (RCTs). I discuss, with particular attention to surgical procedures and devices, the objections raised against RCTs in medical decision-making, a schema for utilizing the traditional phases of RCTs in the evaluation of surgical procedures and devices, the importance of RCTs to FDA approval, financial compensation, and health care costs, the impact of RCTs on clinical practice, the role of RCTs in academia, teaching, and research, and the surgeon's obligation to participate in a leadership role in RCTs. The belief is expressed that national funding of health care should mandate allocations for RCTs and that such expenditures, as well as the spending of health care dollars on the basis of the outcomes of such trials, will not only improve patient management in the shortest time but will eventually reduce health care costs. The RCT, by selecting effective and safe surgical procedures and devices, as well as diets and drugs, is the best means science has to assess the validity of patient management.

MeSH terms

  • Attitude of Health Personnel
  • Device Approval
  • Equipment and Supplies*
  • Evaluation Studies as Topic
  • General Surgery / methods*
  • Humans
  • Randomized Controlled Trials as Topic*
  • United States
  • United States Food and Drug Administration