Brubaker Linda, Nager Charles W, Richter Holly E, Weidner Alison C, Hsu Yvonne, Wai Clifford Y, Paraiso Marie, Nolen Tracy L, Wallace Dennis, Meikle Susan
Departments of Obstetrics and Gynecology and Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, IL.
Department of Reproductive Medicine, University of California, San Diego, School of Medicine, San Diego, CA.
Am J Obstet Gynecol. 2014 Nov;211(5):554.e1-7. doi: 10.1016/j.ajog.2014.07.009. Epub 2014 Jul 11.
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.
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.
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).
Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.
本项对阴道脱垂修复和经阴道无张力尿道中段吊带术试验结果进行的计划中的二次分析，评估了随机分组在12个月时治疗知识是否存在差异，以及治疗认知是否会影响治疗成功率。
在阴道脱垂修复和经阴道无张力尿道中段吊带术试验中，对随机分配至不接受经阴道无张力尿道中段吊带术（TVT）的参与者进行假耻骨上无张力阴道吊带切口。在12个月时评估主要手术结果和盲法维持情况。比较各组之间对治疗分配的知晓情况，并评估其与治疗成功率的关系。
在术后12个月随访前，仅4%接受治疗的参与者（336例中的13例）正式报告已被揭盲。在12个月时，94%的随机分组参与者（336例中的315例）提供了治疗知识数据。16例接受TVT的参与者（10%）报告了治疗知识；大多数（n = 15，94%）正确；17例假手术参与者（11%）报告了治疗知识；一半（n = 8，47%）正确。报告无治疗知识的未揭盲参与者中，正确猜测/感知治疗分配的比例相似（假手术组为46例[33%]，TVT组为44例[33%]）。我们未发现基于所接受治疗组内及组间认知的治疗成功率存在显著差异（总体感知假手术组与TVT组比较[P = 0.76]）。在接受TVT的参与者中，感知接受TVT的参与者治疗成功的比例高于感知接受假手术的参与者（84%对74%；P = 0.29）。在假手术参与者中，感知接受假手术的参与者成功的比例高于感知接受TVT的参与者（65%对56%；P = 0.42）。
假手术切口有效地掩盖了TVT随机分组情况。这些发现可能有助于为未来的手术试验设计提供参考。
