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提高手术临床试验保留率的干预措施:一种实用的、利益攸关方驱动的方法。

Interventions to improve retention in a surgical, clinical trial: A pragmatic, stakeholder-driven approach.

机构信息

School of Medicine, University of Nottingham, Nottingham, UK.

York Trials Unit, Department of Health Sciences, University of York, York, UK.

出版信息

J Evid Based Med. 2018 Feb;11(1):12-19. doi: 10.1111/jebm.12271. Epub 2018 Jan 22.

Abstract

OBJECTIVE

To explore stakeholder perspectives upon participant retention in clinical trials, and to generate strategies to support retention in a surgical, clinical trial.

STUDY DESIGN AND SETTING

The SWIFFT trial is a multicenter study comparing treatments for the fracture of the waist of the scaphoid bone in adults. Here we report upon a multistage, iterative consultative process with SWIFFT stakeholders, these include workshops with members of the public, with nurses involved in data collection, and with consultant clinicians. Structured discussions were digitally recorded and transcribed, data were handled and analyzed following a framework approach to qualitative data analysis.

RESULTS

Removing practical barriers were identified as important factors in supporting retention. Stakeholders also identified that (i) how well a study is understood and (ii) how much it is valued are important factors in an individual's willingness to maintain their involvement. A number of strategies resulted from this consultation, these include: in-clinic data collection, co-ordinated clinical and research appointments, a SWIFFT website, and newsletter.

CONCLUSION

A participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of specific and contextually relevant solutions to the challenge of participant retention.

摘要

目的

探索利益相关者对临床试验中参与者保留的看法,并制定支持手术临床试验中保留的策略。

研究设计与设置

SWIFFT 试验是一项多中心研究,比较了成人舟状骨腰部骨折的治疗方法。在这里,我们报告了与 SWIFFT 利益相关者的多阶段、迭代协商过程,这些利益相关者包括与公众成员、参与数据收集的护士以及顾问临床医生的研讨会。结构化讨论被数字记录和转录,数据按照定性数据分析的框架方法进行处理和分析。

结果

消除实际障碍被确定为支持保留的重要因素。利益相关者还确定,(i)对研究的理解程度和(ii)对研究的重视程度是个人愿意继续参与的重要因素。这次咨询产生了一些策略,包括:在诊所进行数据收集、协调临床和研究预约、SWIFFT 网站和时事通讯。

结论

参与式的试验保留方法可以使所有相关利益相关者都参与到临床试验的实施中,也可以支持针对参与者保留这一挑战生成具体和相关的解决方案。

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