Involving service users in trials: developing a standard operating procedure
Involving service users in trials: developing a standard operating procedure
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DOI：
10.1186/1745-6215-14-219
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发表时间：
2013-07-17
期刊：
影响因子：
2.5
通讯作者：
Russell, Ian
中科院分区：
文献类型：
--
作者：
Evans, Bridie Angela;Bedson, Emma;Russell, Ian
背景：许多资助机构要求研究人员积极参与服务用户的研究，以提高相关性，问责制和质量。目前对研究人员的指导主要讨论一般原则。关于如何让服务用户在业务上参与审判的进行，缺乏正式的指导。我们的目的是制定一个标准的操作程序（SOP），以支持研究人员参与服务用户在试验和严格的studies.Methods：研究人员的经验，涉及服务用户和服务用户谁是有助于试验与西威尔士组织严格的健康试验，注册的临床试验单位，制定SOP。草案在一个任务和完成小组，审查所有的共同作者和修订made.Results：我们阐明了核心原则，其中定义了平等的服务用户与所有其他研究团队成员和协作过程的基础上的SOP，再加上如何实现这些指导。我们开发了一个框架，让服务用户参与研究，定义了最低水平的合作，以及额外的咨询和决策机会。我们建议服务用户参与整个试验过程，包括计划和开发、数据收集、分析和传播，以及列出的协作任务。我们列出了负责让服务用户参与研究和促进包容性文化的人员。我们提倡服务使用者尽早积极参与研究过程，所有正式的试验组和委员会中至少有两名使用者。我们建议，研究人员保护至少1%的总研究预算作为最低资源，涉及服务用户，并允许足够的时间，以促进积极participation.Conclusions：本SOP提供指导研究人员参与服务用户成功地在开发和开展临床试验，并创造一种文化，积极参与服务用户在研究的各个阶段。英国临床研究协作组织应鼓励临床试验单位积极参与服务用户，研究资助者应在研究赠款中为此提供足够的资金和时间。
Background: Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies.Methods: Researchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made.Results: We articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement.Conclusions: This SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants.