Linda Brubaker1, Charles W Nager2, Holly E Richter3, Alison C Weidner4, Yvonne Hsu5, Clifford Y Wai6, Marie Paraiso7, Tracy L Nolen8, Dennis Wallace8, Susan Meikle9. 1. Departments of Obstetrics and Gynecology and Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, IL. Electronic address: LBrubaker@lumc.edu. 2. Department of Reproductive Medicine, University of California, San Diego, School of Medicine, San Diego, CA. 3. Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL. 4. Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC. 5. Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, UT. 6. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, TX. 7. Ob/Gyn and Women's Health Institute, Cleveland Clinic, Cleveland, OH. 8. RTI International, Research Triangle Park, NC. 9. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.
Abstract
OBJECTIVE: This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception. STUDY DESIGN:Sham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed. RESULTS: Prior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42). CONCLUSION: Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.
RCT Entities:
OBJECTIVE: This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception. STUDY DESIGN: Sham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed. RESULTS: Prior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42). CONCLUSION: Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.
Authors: T B Freeman; D E Vawter; P E Leaverton; J H Godbold; R A Hauser; C G Goetz; C W Olanow Journal: N Engl J Med Date: 1999-09-23 Impact factor: 91.245
Authors: John T Wei; Ingrid Nygaard; Holly E Richter; Charles W Nager; Matthew D Barber; Kim Kenton; Cindy L Amundsen; Joseph Schaffer; Susan F Meikle; Cathie Spino Journal: N Engl J Med Date: 2012-06-21 Impact factor: 91.245
Authors: John Wei; Ingrid Nygaard; Holly Richter; Morton Brown; Matthew Barber; Kimberly Kenton; Charles Nager; Joseph Schaffer; Anthony Visco; Anne Weber Journal: Clin Trials Date: 2009-04 Impact factor: 2.486
Authors: Brook L McFadden; Melissa L Constantine; Sarah L Hammil; Megan E Tarr; Husam T Abed; Kimberly S Kenton; Vivian W Sung; Rebecca G Rogers Journal: Int Urogynecol J Date: 2013-07-02 Impact factor: 2.894