What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.
What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.
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DOI：
10.1136/bmjopen-2021-057019
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发表时间：
2022-03-25
期刊：
影响因子：
2.9
通讯作者：
Gillies K
中科院分区：
文献类型：
--
作者：
Bruhn H;Campbell M;Entwistle V;Humphreys R;Jayacodi S;Knapp P;Tizzard J;Gillies K
生成利益相关者知情的证据，以支持试验人员向参与者传播结果摘要的建议。涉及q方法学、内容分析、焦点小组和联合制作研讨会（向参与者适当报告临床试验结果项目）的多阶段混合方法三角测量设计。III期有效性试验。一系列参与者包括正在进行和最近完成的试验、公共捐助者、试验者、赞助商、研究资助者、监管机构、伦理委员会成员。在现有的试验结果摘要中，只有不到一半包含了研究结果的临床意义的信息，而在q -方法学研究中，这一项被认为对参与者非常重要。包含感谢信息的优先级取决于是否考虑个人或群体的结果。会议强调，必须建立个人响应模式，分享试验结果摘要。理想情况下，参与者应该第一个知道分享结果摘要的时间，但考虑到这可能具有挑战性，因此管理期望很重要。除患者外，在制定试验结果摘要时，与一系列利益相关者进行接触也很重要。试验参与者的结果总结应涵盖四个核心问题：(1)试验旨在回答什么问题？(2)庭审发现了什么？(3)试验结果产生了什么影响，将如何改变国民保健服务/治疗？(4)如何了解更多信息？试验团队应制定适当的资源计划，并就如何“最好”地分享有关内容、模式和时间的关键信息咨询患者合作伙伴和试验参与者。研究结果为试验团队提供了关于分享结果摘要的“什么、如何、何时和谁”等核心考虑因素的明确指导。
To generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants. A multiphase mixed-methods triangulation design involving Q-methodology, content analysis, focus groups and a coproduction workshop (the REporting Clinical trial results Appropriately to Participants project). Phase III effectiveness trials. A range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members. Fewer than half of the existing trial result summaries contained information on the clinical implications of the study results, an item deemed to be of high importance to participants in the Q-methodology study. Priority of inclusion of a thank you message varied depending on whether considering results for individuals or populations. The need for personally responsive modes of sharing trial result summaries was highlighted as important. Ideally, participants should be the first to know of the results with regard to the timing of sharing results summaries but given this can be challenging it is therefore important to manage expectations. In addition to patients, it was identified that it is important to engage with a range of stakeholders when developing trial results summaries. Results summaries for trial participants should cover four core questions: (1) What question the trial set out to answer?; (2) What did the trial find?; (3) What effect have the trial results had and how will they change National Health Service/treatment?; and (4) How can I find out more? Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how ‘best’ to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the ‘what, how, when and who’ with regard to sharing results summaries.
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影响因子：
1.6
作者：
Cairns, Rose C.
通讯作者：
Cairns, Rose C.
影响因子：
2.9
作者：
Raza, M. Zulfiqar;Bruhn, Hanne;Gillies, Katie
通讯作者：
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DOI：
10.1111/hex.13402
发表时间：
2022-03
期刊：
Health expectations : an international journal of public participation in health care and health policy
影响因子：
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作者：
Wood J;Cotton SC;Gillies K
通讯作者：
Gillies K
影响因子：
2.9
作者：
Schroter, Sara;Price, Amy;Clarke, Mike
通讯作者：
Clarke, Mike
影响因子：
2.5
作者：
Bruhn H;Cowan EJ;Campbell MK;Constable L;Cotton S;Entwistle V;Humphreys R;Innes K;Jayacodi S;Knapp P;South A;Gillies K
通讯作者：
Gillies K