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Randomized Controlled Trials for Evaluating Surgical Questions
Eric K. Fung, MD;
John M. Loré, Jr, MD
Arch Otolaryngol Head Neck Surg. 2002;128:631-634.
Objective To discuss some of the obstacles inherent in the design of the randomized
controlled trial (RCT) that the surgeon must confront and options to minimize
these obstacles.
Data Sources The literature was searched for articles discussing RCTs using MEDLINE
from 1966 to 1998.
Study Selection Studies relevant to the general use of RCTs for evaluating surgical
questions were selected.
Synthesis Several problems inherent in RCTs were noted: (1) ethical considerations,
(2) difficulties in patient accrual, (3) patient preferences, and (4) variability
in surgical proficiency/technique. Some means of minimizing these problems
are (1) the concept of clinical equipoise, (2) multicenter trials, and (3)
stratified sampling of patients. Alternatives to the classic RCT are discussed,
namely, the randomized consent design and the patient preference design.
Conclusions The nature of the RCTs is that they are difficult to use to evaluate
surgical techniques. Some options are available to minimize these difficulties.
Designing and conducting RCTs to evaluate surgical interventions require careful
planning and some compromises. Unless the previously mentioned criteria are
applied, the validity of the RCT can be considered no greater than that of
other trials.
From the Department of Otolaryngology and Communication Sciences, The
State University of New York, Upstate Medical University Hospital, Syracuse
(Dr Fung), and the Head and Neck Center, Sisters of Charity Hospital, Buffalo,
NY (Dr Loré).
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