通过系统性审查,确定并整理影响患者临床试验之旅的因素。

JRSM Open Pub Date : 2023-06-07 eCollection Date: 2023-06-01 DOI:10.1177/20542704231166621
Rebecca Dobra, Gemma Wilson, Jessie Matthews, Marco Boeri, Stuart Elborn, Frank Kee, Jane C Davies, Susan Madge
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引用次数: 0

摘要

以患者为中心的试验设计和实施;改善招募和保留情况;提高参与者的满意度;鼓励更具代表性的群体参与;并使研究人员能够更好地满足参与者的需求。该领域的研究大多集中在试验参与的狭义方面。我们的目标是系统地识别影响参与试验的以患者为中心的广泛因素,并将其整理成一个框架。我们希望借此帮助研究人员找出可以改善以患者为中心的试验设计和实施的因素。在健康研究中,稳健的定性和混合方法系统性综述越来越常见。本综述的方案已在 PROSPERO 上进行了前瞻性注册,注册号为 CRD42020184886。我们使用 SPIDER(样本、感兴趣现象、设计、评价、研究类型)框架作为标准化的系统性检索策略工具。我们检索了 3 个数据库并查阅了参考文献,然后进行了专题综合。由两名独立研究人员进行筛选,并进行代码和主题检查。数据来自 285 篇经同行评审的文章。确定了 300 个离散因素,并将其分类为 13 个主题和次主题。全部因素目录见补充材料。文章正文中包含了一个总结框架。本文重点概述了各主题的共同点,突出了关键特征,并探讨了数据中的有趣之处。我们希望来自多个专业的研究人员能借此更好地满足患者的需求,保护患者的社会心理健康,优化试验招募和保留,从而对研究时间和成本效率产生直接的积极影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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A systematic review to identify and collate factors influencing patient journeys through clinical trials.

Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.

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来源期刊
自引率
0.00%
发文量
16
审稿时长
12 weeks
期刊介绍: JRSM Open is a peer reviewed online-only journal that follows the open-access publishing model. It is a companion journal to the Journal of the Royal Society of Medicine. The journal publishes research papers, research letters, clinical and methodological reviews, and case reports. Our aim is to inform practice and policy making in clinical medicine. The journal has an international and multispecialty readership that includes primary care and public health professionals.
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