PDF(Pubmed)
Abstract：
BACKGROUND: Interventional clinical trials in recurrent miscarriage use varying expected effect sizes to inform their sample size calculations. Often these are not informed by what stakeholders consider a meaningful treatment effect. Adaptive trial designs may integrate stakeholder views on trial success and futility but the criteria to inform this is lacking. This study aims to understand relevant stakeholder views of what is considered a worthwhile treatment effect for miscarriage prevention interventions and what is acceptable stopping criteria in miscarriage clinical trials.
METHODS: The study is designed as a cross-sectional online anonymous survey. The survey presents different scenarios to respondents relating to varying target differences and probability thresholds and explores success and futility criteria for clinical trials. The survey was developed with personal and public involvement (PPI) through focus groups and a PPI partner. Eligible participants will be those with a personal history of miscarriage, including partners, and healthcare professionals who manage patients who experience a miscarriage. Convenience, snowball and purposive sampling techniques will be employed to invite eligible participants to complete the survey. The survey will be accepting responses for an initial 2-week pilot to check validity, prior to being open for a further 12 weeks. Descriptive analyses and linear regression analyses will synthesise the survey results.
BACKGROUND: Ethical approval was obtained from the NHS Research Ethics Committee North West-Greater Manchester East (23/NW/0322) on 30 January 2024. Informed consent will be obtained prior to survey completion. No personal identifying information will be collected. The results will be published in a relevant scientific journal and communicated through our institutional website.
METHODS: The study is designed as a cross-sectional online anonymous survey. The survey presents different scenarios to respondents relating to varying target differences and probability thresholds and explores success and futility criteria for clinical trials. The survey was developed with personal and public involvement (PPI) through focus groups and a PPI partner. Eligible participants will be those with a personal history of miscarriage, including partners, and healthcare professionals who manage patients who experience a miscarriage. Convenience, snowball and purposive sampling techniques will be employed to invite eligible participants to complete the survey. The survey will be accepting responses for an initial 2-week pilot to check validity, prior to being open for a further 12 weeks. Descriptive analyses and linear regression analyses will synthesise the survey results.
BACKGROUND: Ethical approval was obtained from the NHS Research Ethics Committee North West-Greater Manchester East (23/NW/0322) on 30 January 2024. Informed consent will be obtained prior to survey completion. No personal identifying information will be collected. The results will be published in a relevant scientific journal and communicated through our institutional website.
摘要：
背景：复发性流产的介入临床试验使用不同的预期效应大小来计算样本量。通常，这些信息并没有被利益相关者认为有意义的治疗效果所告知。适应性试验设计可能会整合利益相关者对试验成功和徒劳的看法，但缺乏告知这一点的标准。本研究旨在了解相关利益相关者的观点，即什么被认为是流产预防干预措施的有价值的治疗效果，以及什么是流产临床试验中可接受的停止标准。
方法：该研究设计为横断面在线匿名调查。该调查向受访者提出了与不同的目标差异和概率阈值有关的不同情景，并探讨了临床试验的成功和无效标准。该调查是通过焦点小组和PPI合作伙伴在个人和公众参与（PPI）的情况下进行的。符合条件的参与者将是那些有个人流产史的人，包括合伙人,以及管理流产患者的医疗保健专业人员。方便,将采用滚雪球和目的性抽样技术邀请符合条件的参与者完成调查。该调查将接受最初为期2周的试点的回应，以检查有效性，在进一步开放12周之前。描述性分析和线性回归分析将综合调查结果。
背景：在2024年1月30日获得了NHS研究伦理委员会西北-大曼彻斯特东部（23/NW/0322）的伦理批准。调查完成前将获得知情同意。不会收集个人识别信息。研究结果将发表在相关科学杂志上，并通过我们的机构网站进行交流。
方法：该研究设计为横断面在线匿名调查。该调查向受访者提出了与不同的目标差异和概率阈值有关的不同情景，并探讨了临床试验的成功和无效标准。该调查是通过焦点小组和PPI合作伙伴在个人和公众参与（PPI）的情况下进行的。符合条件的参与者将是那些有个人流产史的人，包括合伙人,以及管理流产患者的医疗保健专业人员。方便,将采用滚雪球和目的性抽样技术邀请符合条件的参与者完成调查。该调查将接受最初为期2周的试点的回应，以检查有效性，在进一步开放12周之前。描述性分析和线性回归分析将综合调查结果。
背景：在2024年1月30日获得了NHS研究伦理委员会西北-大曼彻斯特东部（23/NW/0322）的伦理批准。调查完成前将获得知情同意。不会收集个人识别信息。研究结果将发表在相关科学杂志上，并通过我们的机构网站进行交流。
