Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool.
Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool.
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临床试验旨在得出关于治疗效果的结论，但试验可以解决许多不同的潜在问题。例如，这种治疗对按处方服用的患者有效吗？还是不管病人是否完全按照处方服用都有效？由于不同的问题可能导致不同的治疗获益结论，因此清楚地了解试验旨在研究的治疗效果是很重要的，这被称为“被估量”。使用被估量有助于确保试验的设计和分析能够回答不同利益相关者（包括患者和公众）感兴趣的问题。然而，患者和公众是否愿意参与被估量的定义以及如何参与还存在不确定性。公共合作伙伴是患者和/或公众成员，他们是研究团队的一部分或建议。我们的目标是（i）与公共合作伙伴共同开发一种工具，帮助解释被估量是什么，（ii）探索公共合作伙伴对试验设计期间讨论被估量重要性的看法。与来自联合王国不同地区的5个不同年龄、性别和种族的公共伙伴举行了一次在线咨询会议。收集了公共伙伴的意见，并开发了一个描述被估量的实用工具，该工具由研究小组在会议之前起草。之后，对该工具进行了改进，并通过电子邮件寻求更多反馈。公共合作伙伴希望参与评估讨论。他们发现了一个介绍性的工具，由研究人员向他们介绍和描述，有助于在试验设计背景下开始讨论被估量。他们建议在工具中使用讲故事、类比和视觉辅助。确定了与公共合作伙伴参与定义被估量有关的四个主题：（i）在试验中解决与患者和公众相关的问题的重要性，（ii）让公共合作伙伴尽早参与，（iii）需要对所有利益相关者进行教育和沟通，以及（iv）公共合作伙伴和研究人员共同努力。我们共同开发了一个工具，供研究人员和公共合作伙伴使用，以促进公共合作伙伴参与估计数讨论。在线版本包含补充材料，可通过10.1186/s13063-023-07469-9获得。
Clinical trials aim to draw conclusions about the effects of treatments, but a trial can address many different potential questions. For example, does the treatment work well for patients who take it as prescribed? Or does it work regardless of whether patients take it exactly as prescribed? Since different questions can lead to different conclusions on treatment benefit, it is important to clearly understand what treatment effect a trial aims to investigate—this is called the ‘estimand’. Using estimands helps to ensure trials are designed and analysed to answer the questions of interest to different stakeholders, including patients and public. However, there is uncertainty about whether patients and public would like to be involved in defining estimands and how to do so. Public partners are patients and/or members of the public who are part of, or advise, the research team. We aimed to (i) co-develop a tool with public partners that helps explain what an estimand is and (ii) explore public partner’s perspectives on the importance of discussing estimands during trial design. An online consultation meeting was held with 5 public partners of mixed age, gender and ethnicities, from various regions of the UK. Public partner opinions were collected and a practical tool describing estimands, drafted before the meeting by the research team, was developed. Afterwards, the tool was refined, and additional feedback sought via email. Public partners want to be involved in estimand discussions. They found an introductory tool, to be presented and described to them by a researcher, helpful for starting a discussion about estimands in a trial design context. They recommended storytelling, analogies and visual aids within the tool. Four topics related to public partners’ involvement in defining estimands were identified: (i) the importance of addressing questions that are relevant to patients and public in trials, (ii) involving public partners early on, (iii) a need for education and communication for all stakeholders and (iv) public partners and researchers working together. We co-developed a tool for researchers and public partners to use to facilitate the involvement of public partners in estimand discussions. The online version contains supplementary material available at 10.1186/s13063-023-07469-9.
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影响因子：
7.2
作者：
Murray, Eleanor J.;Caniglia, Ellen C.;Hernan, Miguel A.
通讯作者：
Hernan, Miguel A.
影响因子：
2.5
作者：
Goulao B;Bruhn H;Campbell M;Ramsay C;Gillies K
通讯作者：
Gillies K
影响因子：
--
作者：
McConnell T;Best P;Davidson G;McEneaney T;Cantrell C;Tully M
通讯作者：
Tully M
影响因子：
2.9
作者：
Goulao B;Poisson C;Gillies K
通讯作者：
Gillies K
影响因子：
--
作者：
Minogue, Virginia;Cooke, Mary;Wells, Bill
通讯作者：
Wells, Bill