使用标准化、自动化的现场评估调查工具(SASI)选择试验中心。

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-05-29 DOI:10.1016/j.cct.2024.107583
Karen Lane , Shannon Hillery , Ryan Majkowski , Bradley J. Barney , Daniel Amirault , Sarah J. Nelson , Mary Bailey , Eun Hea Unsicker , Mary Stroud , Lindsay M. Eyzaguirre , Amy Gawad , Angeline Nanni , Gwendolyn Mirzoyan , Theodora Cohen , Salina P. Waddy , Ken Wiley , Paul A. Harris , Daniel E. Ford , Daniel Hanley , For the Trial Innovation Network
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引用次数: 0

摘要

背景:为了改进临床试验的选点流程,我们扩大了选点调查的范围,纳入了对选点承诺时间、团队经验、紧迫时间表的可行性以及当地医学界的平衡性等因素的标准化评估,以更好地预测试验结果。目的:作为第一步,我们希望确认扩大调查范围是否可行并具有普遍性--要求试验机构团队预先提供更多细节是可以接受的,而且尽管评估时间较长,调查也可以在合理的时间内完成:使用可公开访问的仪表板开发了一个标准化的、由两部分组成的 "现场评估调查工具"(SASI),其中包括定性部分和多个联系名单部分,随后将其转移到 REDCap 平台上。经过多轮内部测试后,SASI 在多中心试验中部署了 11 次。我们向研究机构团队发送了后续调查问卷,以确认研究机构可以接受扩展后的调查工具,并且可以在短暂的工作时间内完成调查:结果:受访者认为 SASI 收集了有关研究机构的有用和相关信息(100%)。研究机构 "乐于"(90%)在选址初期提供详细信息,57%的研究机构在一到两个小时内完成了 SASI:结论:协调中心和研究机构认为,SASI 工具在收集数据以考虑多中心试验选址时是可接受的,而且很有帮助。"令人瞩目的是,我们对试验最基本的方面之一,即试验场地选择的科学理解是如此之少"。-麦克默里 2016 [1]。
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Selecting trial centers using a standardized, automated site assessment survey instrument (SASI)

Background

To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.

Aim

As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable—that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.

Methods

A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.

Results

Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were “comfortable” (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.

Conclusions

Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.

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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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