Brubaker Linda, Jelovsek J Eric, Lukacz Emily S, Balgobin Sunil, Ballard Alicia, Weidner Alison C, Gantz Marie G, Whitworth Ryan, Mazloomdoost Donna
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, San Diego, CA, USA.
Department of Obstetrics and Gynecology, Duke University, Durham, NC, USA.
Clin Trials. 2019 Oct;16(5):481-489. doi: 10.1177/1740774519865541. Epub 2019 Jul 26.
BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.
Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05.
Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group.
The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
背景/目的：在本研究中，我们比较了两种研究同意技术：标准化视频加常规同意和单纯常规同意。
邀请在“顶端支持丧失管理中的手术与盆底肌训练”研究中完成24个月结局评估的个体（完成者）参与一项延长的纵向随访研究（“顶端支持丧失管理中的延长手术与盆底肌训练”）。符合条件的潜在参与者（1）能够提供同意书且（2）不在长期护理机构中，按1:1随机分为两组，一组观看详细介绍盆底疾病长期随访研究重要性的标准化视频，然后进行常规机构同意程序，另一组仅进行常规同意程序。随机分组按地点分层，采用随机排列的区组。主要结局是在手术后5年参与延长研究并完成数据收集事件的参与者比例。次要结局包括参与延长研究的比例、每个研究年度随访的完成情况、数据收集点的完成情况、亲自访视的完成情况以及生活质量电话随访的完成情况。在招募进入“顶端支持丧失管理中的延长手术与盆底肌训练”研究之前，通过问卷测量参与研究的动机和障碍（研究层面和个人层面）以及对研究同意程序的满意度。采用意向性分析原则，使用未调整的学生t检验（连续变量）和卡方检验或Fisher精确检验（分类变量）对两组进行比较。估计样本量为340（每组170例），以检测两组在参与率和研究完成率上15%的差异，p<0.05。
在327例“顶端支持丧失管理中的手术与盆底肌训练”完成者中，305例被随机分配至同意程序研究（153例观看视频组 vs 152例未观看视频组）。两组在人口统计学、手术治疗和结局方面相似。延长研究的总体参与率较高，两组之间无显著差异（观看视频组92.8% vs 未观看视频组94.1%，p = 0.65）。主要结局（观看视频组79.1% vs 未观看视频组75.7%，p = 0.47）或任何次要结局均无显著差异。在对研究信息总体“非常满意”方面（97.7% vs 88.5%，p = 0.01）；在对了解研究情况“强烈同意”方面（81.3% vs 70.8%，p = 0.06）、理解研究目的方面（83.6% vs 71.0%，p = 0.02）、研究性质和范围方面（82.8% vs 70.2%，p = 0.02）以及潜在社会效益方面（82.8% vs 67.9%，p = 0.01）；在认为研究协调员/研究护士关系“非常重要”方面（72.7% vs 63.4%，p = 0.03），观看视频组均优于未观看视频同意组。
延长研究的参与率较高；大多数参与者在3年的观察性延长期内完成了大部分研究任务，无论是否使用视频来加强研究同意程序。视频与更高比例的参与者报告对研究的理解有所改善以及与研究人员的关系更好相关。
