Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.
Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.
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DOI：
10.1186/s13063-021-05276-8
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发表时间：
2021-05-10
期刊：
影响因子：
2.5
通讯作者：
Witham MD
中科院分区：
文献类型：
--
作者：
Treweek S;Banister K;Bower P;Cotton S;Devane D;Gardner HR;Isaacs T;Nestor G;Oshisanya A;Parker A;Rochester L;Soulsby I;Williams H;Witham MD
确保试验的设计使其参与者反映出那些可能从结果中受益或免受伤害的人，这是使试验的潜在利益达到他们应该达到的所有利益的关键。本文描述了由Trial Forge推动的过程，该过程在2019年7月至2020年10月期间用于制定INCLUDE种族框架，这是国家卫生研究所更广泛的INCLUDE倡议的一部分，旨在改善临床研究中服务不足群体的包容性。该框架的制定分七个阶段进行：（1）大纲，（2）初稿，（3）利益攸关方会议，（4）修改草案，（5）利益攸关方反馈，（6）应用框架和（7）包装。第二阶段和第三阶段是面对面会议。与利益攸关方的协商是反复进行的，特别是第4至第6阶段。一旦所有或大多数利益攸关方对当前阶段的结果感到满意，就进入下一阶段。当该框架的版本可以被视为最终版本时，该框架将被应用于六项试验以创建一组示例（第6阶段）。最后，框架、指南和实例已打包，可供分发（第7阶段）。我的试验应该适用于谁？所确定的群体是否可能以不同的方式作出反应？我的研究干预会使一些团体更难参与吗？我设计的研究方式是否会使某些群体更难参与？来自利益相关者群体的40人，包括患者和公共合作伙伴、临床医生、资助者、与各种族群体合作的学者、试验管理者和方法学家，为七个开发阶段做出了贡献。该框架包括两个部分。第一部分是四个关键问题的列表：第二部分是一套帮助审判团队解决这些问题的方法。该框架可用于任何试验阶段，用于任何疾病领域的医疗干预。该框架于2020年10月1日推出，并可在Trial Forge网站上开放访问：https://www.trialforge.org/trial-forge-centre/include/。仅仅考虑我们试验中的人数是不够的：我们需要开始更仔细地考虑我们的参与者是谁。在线版本包含补充材料，可通过10.1186/s13063-021-05276-8获得。
Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies. Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7). Who should my trial apply to? Are the groups identified likely to respond in different ways? Will my study intervention make it harder for some groups to engage? Will the way I have designed the study make it harder for some groups to engage? A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/. Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are. The online version contains supplementary material available at 10.1186/s13063-021-05276-8.
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影响因子：
5.1
作者：
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