PLAIN ENGLISH SUMMARY This commentary article describes three interactive workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials across the world. Outcomes like quality of life, side-effects and pain are used in trials to measure whether a treatment is effective. Here, we outline how research groups are increasingly coming together to develop 'core outcomes sets' for particular conditions. Core outcome sets are lists of agreed outcomes. Their use will help in identifying which treatments are effective by enabling people to compare the findings of different clinical trials in the same condition. Currently, it is often very difficult to make these comparisons because different studies often measure different outcomes. Delegates attending the workshops included patients, clinicians and researchers. They discussed ways of making core outcome set development more meaningful and accessible for patients, and ensuring that they have a genuine say in the development process. This article summarises these discussions and concludes by identifying three distinctive challenges in securing patient input to core outcome set development: the process and objectives can seem far removed from the immediate concerns of patients, difficulties can arise in securing patient input on an international scale, and difficulties can also arise in bringing multiple stakeholder groups together to achieve consensus. While patient participation, involvement and engagement in core outcome set development can draw on lessons from other research areas, these distinctive challenges point to the need for distinctive solutions to enable meaningful patient input to core outcome set development. ABSTRACT Background This article describes three workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials. People need evidence about what treatments are best for particular health conditions. The strongest evidence comes from systematic reviews comparing outcomes across different studies of treatments for a particular condition. However, it is often difficult to do these comparisons because the different studies-even though they have all investigated the same condition-often measure different outcomes. To tackle this problem, research teams are increasingly coming together to develop core outcome sets (COS) for particular conditions or treatments. The goal is that across the world, all the research teams working on the same condition or treatment will then use the COS in their research.Main body We report on three interactive workshops that explored how patients and the public can contribute to decision making about what outcomes should be included in a COS. About 100 international delegates, including researchers, clinicians and patients, attended the workshops. The workshops were held in the United Kingdom, Italy and Canada as part of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative annual meetings. Patients who had some experience as research advisors, collaborators, partners or co-ordinators facilitated the workshops together with a researcher. Notes made during each workshop informed the preparation of this article. Workshop discussion focussed on ways of making core outcome set development more meaningful and accessible for patients. Delegates wanted patients to have a genuine say, alongside other stakeholders, in what outcomes are included in COS. Delegates felt that key to ensuring this is recognising that patient participation in COS development alone is not enough, and that patients will also need to be involved in the design of COS development studies.Conclusion We conclude by pointing to some distinctive challenges in including patients in COS development. While the COS development community can draw on the lessons learnt from other research areas about patient participation, involvement and engagement, the distinctive challenges that arise in COS development point to the need for some distinctive solutions too.

中文翻译：

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将患者纳入核心结果集开发：基于与约 100 名国际代表的三个研讨会要考虑的问题。

简明英文摘要 这篇评论文章描述了三个互动研讨会，探讨了患者如何为决定在世界各地的临床试验中测量哪些结果做出贡献。在试验中使用生活质量、副作用和疼痛等结果来衡量治疗是否有效。在这里，我们概述了研究小组如何越来越多地聚集在一起为特定条件开发“核心结果集”。核心成果集是商定成果的列表。通过使人们能够比较相同条件下不同临床试验的结果，它们的使用将有助于确定哪些治疗方法是有效的。目前，进行这些比较通常非常困难，因为不同的研究经常测量不同的结果。参加研讨会的代表包括患者，临床医生和研究人员。他们讨论了使核心结果集开发对患者更有意义和更容易获得的方法，并确保他们在开发过程中拥有真正的发言权。本文总结了这些讨论，并通过确定确保患者对核心结果集开发的投入的三个独特挑战得出结论：过程和目标似乎与患者的直接关注相去甚远，在国际范围内确保患者投入可能会出现困难，以及将多个利益攸关方群体聚集在一起以达成共识也会出现困难。虽然患者参与、参与和参与核心结果集开发可以借鉴其他研究领域的经验，这些独特的挑战表明需要独特的解决方案，以使患者能够为核心结果集开发提供有意义的输入。抽象背景 本文描述了三个研讨会，探讨了患者如何为临床试验中测量结果的决策做出贡献。人们需要关于哪些治疗最适合特定健康状况的证据。最有力的证据来自系统评价，比较了针对特定疾病的不同治疗研究的结果。然而，通常很难进行这些比较，因为不同的研究——即使他们都调查了相同的条件——经常测量不同的结果。为了解决这个问题，研究团队越来越多地聚集在一起，为特定条件或治疗开发核心结果集 (COS)。目标是，在世界范围内，所有从事相同疾病或治疗的研究团队都将在他们的研究中使用 COS。主体 我们报告了三个互动研讨会，探讨了患者和公众如何为决策做出贡献结果应包含在 COS 中。包括研究人员、临床医生和患者在内的大约 100 名国际代表参加了研讨会。作为 COMET（有效性试验的核心结果措施）倡议年度会议的一部分，这些研讨会在英国、意大利和加拿大举行。具有研究顾问、合作者、合作伙伴或协调员经验的患者与研究人员一起促进了研讨会。每次研讨会期间所做的笔记为本文的准备工作提供了依据。研讨会讨论的重点是使核心结果集开发对患者更有意义和更容易获得的方法。代表们希望患者与其他利益相关者一起对 COS 中包含的结果有真正的发言权。代表们认为，确保这一点的关键是认识到仅让患者参与 COS 开发是不够的，患者还需要参与在 COS 发展研究的设计中。结论 我们最后指出了将患者纳入 COS 发展的一些独特挑战。虽然 COS 开发社区可以借鉴其他研究领域关于患者参与、参与和参与的经验教训，但 COS 开发中出现的独特挑战也表明需要一些独特的解决方案。