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Many patients do not want to be in randomized trials
Study shows randomized trials have 50% fewer potential patients than nonrandomized trials.
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VANCOUVER, British Columbia — A retrospective study of patients who had operative treatment for ankle arthritis shows that many would not be willing to participate in a randomized surgical trial.
“For treatment of end-stage ankle arthritis, recruitment into a randomized clinical trial may yield 50% fewer patients than recruitment into a nonrandomized surgical trial,” Jacynda L. Wheeler, BS, said during her presentation at the American Orthopaedic Foot and Ankle Society annual meeting. “Even after treatment is completed, patients may hold on to their initial bias. This study shows that it may be difficult to obtain the number of patients needed for a large, randomized clinical trial.”
However, she underscored the value of comparison studies to determine the efficacy of surgical procedures.
Alternatives
“It may be worthwhile to consider alternative study designs that include nonrandomized arms, such as the comprehensive cohort design,” she said. “Observational trials may be an effective compliment to randomized clinical trials (RCTs) for treatments in which patients have preconceived preferences.”
Michael S. Pinzur, MD, a moderator for the session, asked, “Should we continue to put randomized controlled clinical trials on the pedestal as the only thing to consider as a gold standard?”
Wheeler responded, “Randomized trials should be something to strive for, if possible, but there are some obstacles that we meet.”
Retrospective study
In the study, Wheeler and colleagues retrospectively surveyed 100 patients who had already undergone ankle arthrodesis or arthroplasty as part of a nonrandomized prospective trial evaluating treatment outcomes for end-stage ankle arthritis. The investigators questioned the patients regarding their willingness to enroll in a surgical RCT and asked whether the treatment they received was based on their own preference, their surgeon’s preference or a combination of the two preferences.
Of the 78 respondents, 50% of the patients noted that they would have enrolled in a surgical RCT.
The investigators also discovered that more patients in the ankle arthrodesis group reported that the treatment was based on the surgeon’s preference, while patients in the arthroplasty group were more likely to respond that treatment was based on their preference.
For more information:Jacynda L. Wheeler, BS, can be reached at VA Puget Sound Health Care System, VA RR&D Center, MS 151, 1660 S. Columbian Way, Seattle, WA 98108; 206-277-1079; e-mail: jacynda@u.washington.edu. The study was supported by the Department of Veterans Affairs, Rehabilitation Research and Development Service.
Michael S. Pinzur, MD, can be reached at Loyola University Medical Center, 2160 S. First Ave., Maywood, IL 60153; 708-216-4993; e-mail: mpinzu1@lumc.edu. He is a paid consultant and does presentations for SBI and Smith & Nephew, and receives research support from BioMimetic and Synthes.
- Reference:
Wheeler JL, Segal AD, Ledoux WR, et al. Patient willingness to enroll in a randomized surgical trial. Presented at the 25th Annual Summer Meeting of the American Orthopaedic Foot and Ankle Society. July 15-18, 2009. Vancouver, British Columbia.