Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains.
Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains.
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DOI：
10.1186/s40900-018-0091-5
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发表时间：
2018
影响因子：
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通讯作者：
Core Outcome Measures in Tinnitus (COMiT) initiative
中科院分区：
文献类型：
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作者：
Smith H;Horobin A;Fackrell K;Colley V;Thacker B;Hall DA;Core Outcome Measures in Tinnitus (COMiT) initiative
结果域是对患者和临床医生重要的病情方面，可以测量以评估治疗效果。对于耳鸣，例子包括“耳鸣响度”和“集中注意力的能力”。本研究的重点是同意在耳鸣的所有临床试验中应该测量哪些结果域的第一阶段。至关重要的是，它涉及到在投票过程之前确定结果域。本文描述了我们如何有效地将患者纳入研究设计过程，并反映了他们的投入的影响。这项研究首先编制了一份长长的清单，列出了所有可能的结果领域，然后让包括患者在内的利益相关方投票决定包括哪些领域。确保患者充分参与这一过程具有独特的挑战，因为它可能是漫长的，重复的，其目的与他们的需求相去甚远。这些挑战可以通过让患者参与设计研究来解决。有证据表明，其他研究团队也在这样做，但其报告不够详细，无法指导其他研究团队。我们的论文试图解决这个问题。我们描述了我们如何让患者（耳鸣患者）参与到我们的研究中，创建了一长串的结果域。我们也反思了这带来的好处。两位病人与我们合作设计了这项调查。我们还咨询了一个独立的患者审查小组。涉及患者减少了调查中包含的域名列表，并使域名和相关描述更清晰。我们的调查结果在招募和留住患者作为参与者方面表现良好。耳鸣是一种复杂的听力学疾病，影响着日常生活的许多不同领域。耳鸣干预的临床试验测量和报告的结果域不一致，这阻碍了研究结果之间的直接比较。为了解决这个问题，一个正在进行的项目正在制定一个核心成果集；一份在未来所有试验中要测量和报告的结果域的商定清单。该项目的一部分使用共识方法（“德尔菲”调查），所有相关利益相关者从一长串候选列表中确定重要和关键的结果领域。本文通过描述和反思我们对患者的参与来创建一个有意义的候选结果域的长列表，从而解决了患者参与文献中的空白。方法两位有耳鸣生活经验的公共研究伙伴在两次面对面的研讨会上回顾了124个结果域的初步列表。与研究管理团队一起，他们解释了每个候选结果域，并生成了一个简单的语言描述。随后，14名患者和5名临床专家通过在线调查平台对域名和描述进行了额外的外行审查。从研讨会和调查反馈中获得的见解促使对长长的清单进行了实质性的、不可预见的修改。其中包括通过排除广义概念和巩固等效领域或研究范围之外的领域来减少结果领域的数量（从124个减少到66个）。审稿人还运用他们耳鸣的生活经验，为域名和简单的语言描述带来清晰和相关性。在德尔菲调查中观察到四个影响：招聘超过目标171%，患者和专业参与者人数相当（n = 358和n = 312），反馈大多是积极的，保留率高（87%）。结论：患者参与是研究设计过程中不可或缺的、具有变革性的一步。患者参与是有影响的，因为在线德尔菲调查成功地招募和留住了参与者，并且有许多关于积极参与体验的评论。七个一般的方法特点是突出符合良好的病人参与的一般原则。这可以让其他核心结果集开发者受益。本文的在线版本（10.1186/s40900-018-0091-5）包含补充材料，仅供授权用户使用。
Outcome domains are aspects of a condition that matter to patients and clinicians and can be measured to assess treatment effects. For tinnitus, examples include ‘tinnitus loudness’ and ‘ability to concentrate’. This study focuses on the first stage of agreeing which outcome domains should be measured in all clinical trials of tinnitus. Crucially, it involves identifying outcome domains, prior to a voting process. This article describes how we effectively involved patients in that study design process, and reflects on the impact of their input. The study first compiled a long list of all possible outcome domains before asking interested parties, including patients, to vote which ones to include. Ensuring patients fully participate in this process holds unique challenges as it can be long, repetitive and its purpose far removed from their needs. These challenges may be addressed by involving patients in designing the research. There is evidence that other research teams are doing this, but its reporting is not detailed enough to guide others. Our paper seeks to address this. We describe how we involved patients (people living with tinnitus) in creating a long list of outcome domains that we included in our study. We also reflect on the benefits this brought. Two patients partnered with us in designing the survey. We also consulted an independent patient review panel. Involving patients reduced the list of domains included in the survey and made domain names and associated descriptions clearer. Our resulting survey performed well in recruiting and retaining patients as participants. Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology (‘Delphi’ survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains. Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform. Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants (n = 358 and n = 312, respectively), feedback was mostly positive, and retention was high (87%). Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers. The online version of this article (10.1186/s40900-018-0091-5) contains supplementary material, which is available to authorized users.