Clinicians' Views on the Feasibility of Surgical Randomized Trials in Urogynecology: Results of a Questionnaire Survey
Clinicians' Views on the Feasibility of Surgical Randomized Trials in Urogynecology: Results of a Questionnaire Survey
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DOI：
10.1002/nau.20943
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发表时间：
2011-01-01
影响因子：
2
通讯作者：
Taylor, David
中科院分区：
文献类型：
--
作者：
Bakali, Evangelia;Pitchforth, Emma;Taylor, David
目的：调查临床医生（泌尿科医生和妇科医生）对一项比较两种方法治疗女性尿失禁和阴道脱垂的随机手术试验的看法。研究方法：一项问卷调查嵌套在一项关于阴道悬吊术与前路修补术加TVT（CARPET 1）治疗失禁和阴道前壁脱垂女性的初步随机对照试验中。英国尿失禁协会、英国泌尿妇科学会和国际尿失禁协会的成员通过电子邮件收到了半结构化问卷，其中包含封闭式和开放式问题以及自由文本回复框。自由文本的反应进行了分析，使用专题定性分析。结果：从400名来自英国和1,700名国际受访者中，共收回了157份问卷。58%的人认为试验符合伦理，44%的人认为可取，47%的人认为可行。33%的人会参加完整的研究，22%的人会参加自己或伴侣的研究。对自由文本回复的分析确定了影响参与的三个主题：患者选择和同意的问题;临床医生对两组感知获益和并发症的看法;以及所选试验设计的问题。结论：这项研究强调了集体和个人平衡之间的差异及其对手术试验的影响。临床医生持有强烈的观点，阻止他们对这项研究持积极态度。难以放弃对程序选择的控制似乎是核心问题。这些发现支持了越来越多的证据，有利于详细的定性试点工作的手术试验。基于专业知识的随机化的作用值得进一步考虑。Neurorol。优强30：69-74，2011. (C)2010 Wiley-Liss，Inc.
Aims: To survey the views of clinicians (urologists and gynecologists) about a proposed randomized surgical trial comparing two approaches for the treatment of women with urinary incontinence and vaginal prolapse. Methods: A questionnaire survey nested within a pilot randomized controlled trial of colposuspension versus anterior repair plus TVT (CARPET1) for women with incontinence and anterior vaginal prolapse. Members of the UK Continence Society, British Society of Urogynaecology, and International Continence Society were sent a single electronic mailing of semi-structured questionnaires containing closed and open questions and free text response boxes. Free text responses were analyzed using a thematic qualitative analysis. Results: One hundred fifty-seven questionnaires were returned, from a potential total of 400 from UK and 1,700 international respondents. Fifty-eight percent thought the trial ethical, 44% desirable, and 47% feasible. Thirty-three percent would recruit to the full study, and 22% would enroll themselves or their partner. Analysis of free text responses identified three themes impacting participation: issues of patient choice and consent; clinicians' views of perceived benefit and complications of the two arms; and issues about the chosen trial design. Conclusions: This study highlights the difference between collective and individual equipoise and their impact upon surgical trials. Clinicians held strong views preventing them from regarding the study favorably. Difficulty with relinquishing control over choice of procedure appeared central. These findings support the growing evidence in favor of detailed qualitative pilot work for surgical trials. The role of expertise-based randomization deserves further consideration. Neurourol. Urodyn. 30: 69-74, 2011. (C) 2010 Wiley-Liss, Inc.