关于在《高级护理杂志》上报道公众和患者参与和参与研究的思考

2022
11/24

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NursingResearch护理研究前沿
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从历史上看,患者利益相关者(患者、家属和护理人员)一直是研究的对象,仅仅是研究企业中的数据点。

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Historically, patient stakeholders (patients, families and caregivers) have been the subject of research, mere datapoints in the research enterprise. Researchers used participants' data and rarely considered other contributions they could offer. Over the last 15 years, this perspective has changed, as researchers and funding agencies now acknowledge that patients and the public have capacity to design, implement and share relevant and meaningful research (Manafo et al., 2018). This fundamental paradigm shift from paternalism, towards democratic partnership, provides a new and exciting opportunity for patients and the public where they work alongside researchers as team members.

Ultimately, involving patients and the public throughout the lifecycle of research is simply seen as the ‘right thing to do’ as research must be relevant to the lives of the people affected by its outcomes. Patients and the public can influence patient-and family-centred care principles by mobilizing and legitimizing the experiential knowledge of patients and ensuring research focuses on patient concerns (Manafo et al., 2018). Public and Patient Engagement and Involvement in Research (PPEI) overlaps with the Triple Aim mandate of healthcare by addressing more effective care, a better patient experience and improved per capita costs. Accordingly, ethical review boards and funding organizations increasingly require researchers to actively involve patients and the public in their research.

Recently, the Journal of Advanced Nursing (JAN) made PPEI a requirement for reporting. This includes: a paragraph at the end of the abstract titled “Patient or Public Contribution” containing details of how patients, service users, caregivers or members of the public were involved in the study; or a paragraph at the end of the abstract titled “No Patient or Public Contribution”, if these details are not necessary or do not apply to the work, with a statement of why. This timely initiative increases awareness of this orientation towards research.

In 2014, the BMJ introduced PPEI reporting mandates. In response, there was a 10-fold increase in the proportion of papers reporting PPEI (Price et al., 2018). However, it should be noted that only a small proportion (n = 16 out of 125 articles; 11%) included PPEI activity; substantial variation in the clarity of reporting was observed (Price et al., 2018). Thus, PPEI reporting guidelines are not the magic bullet; there are deeper issues with uptake and structured reporting of PPEI practices. However, JAN's new reporting guideline is a critical step towards making PPEI more widespread and transparent through emphasizing the importance of integrating meaningful PPEI into the dissemination phase.

JAN's new guidelines support that there is no one-fit-all approach to PPEI; it can occur at different levels. At lower levels, patients and the public are ‘consulted’, where they provide advice and feedback on specific research activities, which may or may not be, incorporated. PPEI at this level is common. For example, in a study of 200 projects conducted in primary care, about half had evidence of patients reviewing patient information leaflets (i.e. ‘consulted’) (Blackburn et al., 2018). Greater opportunities exist for patients and the public to build alliances and move beyond this level of engagement. At higher levels of engagement patients and the public are co-researchers and ‘collaborate’ whereby they are on equal footing with researchers on all aspects of the project, actively contributing to decisions about research design, acceptability, relevance, conduct and governance from the study conception to dissemination (Hoddinott et al., 2019). Occasionally, patients lead or do the research (Hoddinott et al., 2019). Participation at this level is rarer; in a study of PCORI projects, patients were collaborators on 53% of projects, or co-leaders on 6% of projects (Forsythe et al., 2016). There is no right level of PPEI, and each author is encouraged to reflect on and plan for appropriate levels of PPEI for their study.

By the same token, authors may report that PPEI did not occur at all. Having no PPEI should never result in immediate rejection from a journal; as this may perpetuate tokenistic PPEI practices by researchers who try to ‘tick a box’ to meet journal guidelines. Instead, PPEI reporting guidelines should encourage a research culture of reporting meaningful PPEI at a level appropriate for each study. It is important to plan PPEI early, well before the dissemination phase. This helps to guarantee that PPEI is genuine, has been a part of the project's development from the beginning, and is not just an addition after all the decisions have been made.

There are other considerations that could enhance your reporting of PPEI. GRIPP2 is an evidence-based reporting checklist that lists PPEI concepts that should be reported to enhance the quality and transparency of PPEI (Staniszewska et al., 2017). The GRIPP2 is not only useful for retrospective reporting but can be used at the outset of the study to plan PPEI in the study. Ultimately, by using GRIPP2 to share lessons learnt (i.e. what worked well and what did not work well), we can bridge gaps and enhance understanding, allowing other researchers to understand how to do PPEI (Staniszewska et al., 2017). Further, by improving PPEI reporting, we can improve the synthesis of PPEI in systemic reviews and the evidence base for this approach (Staniszewska et al., 2017).

JAN's new guideline also raises another important reporting consideration: acknowledging patient and public contribution when they author or co-author publications. The BMJ instructs authors to thank patients and the public involved in the acknowledgement section. However, patient authorship is expected to increase because patients, the public and funders support this practice. Oliver et al. (2022) suggest that for authorship patients should meet the following criteria: “A person who lives with or is affected by a disease or condition (i.e. a broad definition of patient that includes those with lived conditions or receiving health or social care, caregivers, family members and members of patient advocacy groups who represent them); A person who provides unique and valuable input from the patient perspective to the publication; A person who meets all the criteria required for authorship (e.g. criteria from the International Committee of Medical Journal Editors [ICMJE])” (Oliver et al., 2022, pp.2). This highlights the importance of authorship conversations early in partnerships; patients and the public should be informed of ICMJE conditions and what this means for their involvement. Most Editor-in-Chiefs (69.2% [N = 74]) support patients being co-authors on publications (Cobey et al., 2021). However, they hold mixed views about whether ICMJE criteria should be revised to be more inclusive of patient co-authors (Cobey et al., 2021).

As this practice increases, the field may benefit from a way to track and report this practice. A research group suggests that using the term “Patient Author” for the patient's or member of the public's author affiliations would facilitate PubMed searching to easily identify patient author and co-author practices (Oliver et al., 2022). These researchers report that using the term “Patient Author” in affiliations has increased 9-fold (Oliver et al., 2022) and there are calls for this requirement to be added to the GRIPP2 checklist (Jones et al., 2021).

We are pleased that JAN is proactive in taking a meaningful approach to PPEI. Such an approach builds on JAN's other initiatives such as involving community members in the peer review process when submissions are received about minoritized groups (Jackson & Moorley, 2022). JAN provides a service that includes a range of voices/perspectives and the new reporting guidelines ensure JAN's published discourse reflects its position on PPEI. Researchers are encouraged to reflect on what meaningful PPEI looks like in their study; research projects have a range of methodologies and the activities in which patients and the public engage in (i.e. reviewing materials, collecting data, disseminating findings), the phases of the research they engage in (i.e. start-up, active and close-out phase) and their level of engagement (i.e. consulted, collaborate or co-leaders), will differ. The JAN PPEI reporting guidelines are a pertinent shift in the cultural expectations around reporting, that we hope will change the visible presence of patients and the public in the generation of disciplinary knowledge.

全文翻译(仅供参考)

从历史上看,患者利益相关者(患者、家属和护理人员)一直是研究的对象,仅仅是研究企业中的数据点。研究人员使用了参与者的数据,很少考虑他们可以提供的其他贡献。在过去 15 年中,这种观点发生了变化,因为研究人员和资助机构现在承认患者和公众有能力设计、实施和分享相关且有意义的研究(Manafo 等人,  2018 年)。这种从家长式作风向民主伙伴关系的根本范式转变,为患者和公众提供了一个新的令人兴奋的机会,他们与研究人员作为团队成员一起工作。

最终,让患者和公众参与整个研究生命周期被简单地视为“正确的做法”,因为研究必须与受其结果影响的人们的生活相关。患者和公众可以通过动员和合法化患者的经验知识并确保研究关注患者问题来影响以患者和家庭为中心的护理原则(Manafo 等人,  2018 年)。公众和患者参与和参与研究 (PPEI) 通过解决更有效的护理、更好的患者体验和降低的人均成本,与医疗保健的三重目标任务重叠。因此,伦理审查委员会和资助组织越来越要求研究人员积极让患者和公众参与他们的研究。

最近,《高级护理杂志》(JAN)将 PPEI 列为报告要求。这包括:摘要末尾标题为“患者或公众贡献”的段落,其中包含患者、服务使用者、护理人员或公众如何参与研究的详细信息;或标题为“没有患者或公共贡献”的摘要末尾的段落,如果这些细节不是必需的或不适用于工作,并说明原因。这一及时的举措提高了人们对这种研究方向的认识。

2014 年,BMJ 引入了 PPEI 报告授权。作为回应,报告 PPEI 的论文比例增加了 10 倍(Price 等人,  2018 年)。然而,应该注意的是,只有一小部分(n  = 16 篇文章中的 125 篇;11%)包括了 PPEI 活动;观察到报告的清晰度存在很大差异(Price 等人,  2018 年)。因此,PPEI 报告指南并不是灵丹妙药;PPEI 实践的采用和结构化报告存在更深层次的问题。然而,JAN 的新报告指南是通过强调将有意义的 PPEI 纳入传播阶段的重要性,从而使 PPEI 更加广泛和透明的关键一步。

JAN 的新指南支持 PPEI 没有万能的方法;它可以发生在不同的层面。在较低级别,患者和公众被“咨询”,他们就特定的研究活动提供建议和反馈,这些活动可能会或可能不会被纳入。此级别的 PPEI 很常见。例如,在一项针对 200 个初级保健项目的研究中,大约一半的患者有证据表明患者查看了患者信息传单(即“咨询过”)(Blackburn 等人,  2018 年))。患者和公众有更多机会建立联盟并超越这种参与水平。在参与度较高的情况下,患者和公众是共同研究人员和“合作者”,因此他们在项目的各个方面与研究人员处于平等地位,积极参与有关研究设计、可接受性、相关性、实施和治理的决策从概念到传播(Hoddinott 等人,  2019 年)。有时,患者会领导或进行研究(Hoddinott 等人,  2019 年)。这个级别的参与比较少;在一项 PCORI 项目研究中,患者是 53% 项目的合作者,或 6% 项目的共同领导者(Forsythe 等,  2016)。没有正确的 PPEI 水平,鼓励每位作者思考和计划适当的 PPEI 水平以供其研究。

出于同样的原因,作者可能会报告根本没有发生 PPEI。没有 PPEI 绝不会导致期刊立即拒稿;因为这可能会使试图“打勾”以满足期刊指南的研究人员进行象征性的 PPEI 实践。相反,PPEI 报告指南应鼓励在适合每项研究的水平上报告有意义的 PPEI 的研究文化。在传播阶段之前尽早规划 PPEI 很重要。这有助于确保 PPEI 是真实的,从一开始就是项目开发的一部分,而不仅仅是做出所有决定后的补充。

还有其他考虑因素可以增强您对 PPEI 的报告。GRIPP2 是一份基于证据的报告清单,列出了应报告的 PPEI 概念,以提高 PPEI 的质量和透明度(Staniszewska 等人,  2017 年)。GRIPP2 不仅对回顾性报告有用,而且可以在研究开始时用于计划研究中的 PPEI。最终,通过使用 GRIPP2 分享经验教训(即,哪些工作做得好,哪些做得不好),我们可以弥合差距并增进理解,让其他研究人员了解如何进行 PPEI(Staniszewska 等人,  2017 年)。此外,通过改进 PPEI 报告,我们可以改进系统评价中 PPEI 的综合以及这种方法的证据基础(Staniszewska et al.,  2017)。

JAN 的新指南还提出了另一个重要的报告考虑因素:在作者或共同作者出版物时承认患者和公众的贡献。BMJ 指示作者感谢参与致谢部分的患者和公众。然而,由于患者、公众和资助者支持这种做法,预计患者作者身份将会增加。奥利弗等人。( 2022) 建议对于作者身份,患者应符合以下标准:“患有疾病或状况或受疾病或状况影响的人(即患者的广义定义,包括患有生活状况或接受健康或社会护理的人、护理人员、家庭成员以及代表他们的患者权益团体的成员);从患者的角度为出版物提供独特且有价值的意见的人;符合作者身份所需的所有标准(例如国际医学期刊编辑委员会 [ICMJE] 的标准)的人”(Oliver 等人,  2022 年),第 2 页)。这凸显了合作伙伴关系早期作者身份对话的重要性;应告知患者和公众 ICMJE 的情况以及这对他们的参与意味着什么。大多数主编 (69.2% [ N  = 74]) 支持患者作为出版物的合著者 (Cobey et al.,  2021 )。然而,他们对是否应该修订 ICMJE 标准以更加包容患者合著者持有不同的看法(Cobey 等人,  2021 年)。

随着这种做法的增加,该领域可能会受益于跟踪和报告这种做法的方式。一个研究小组建议,将“患者作者”一词用于患者或公众作者的隶属关系将有助于 PubMed 搜索,从而轻松识别患者作者和共同作者的做法(Oliver 等人,  2022 年)。这些研究人员报告说,在附属机构中使用“患者作者”一词增加了 9 倍(Oliver 等人,  2022 年),并且有人呼吁将此要求添加到 GRIPP2 清单中(Jones 等人,  2021 年)。

我们很高兴 JAN 积极主动地对 PPEI 采取有意义的方法。这种方法建立在 JAN 的其他举措的基础上,例如在收到有关少数群体的提交时让社区成员参与同行评审过程(Jackson & Moorley,  2022)。JAN 提供的服务包括一系列声音/观点,新的报告指南确保 JAN 发表的言论反映了其在 PPEI 上的立场。鼓励研究人员思考在他们的研究中有意义的 PPEI 是什么样的;研究项目有一系列方法和患者和公众参与的活动(即审查材料、收集数据、传播结果)、他们参与的研究阶段(即启动、活动和结束阶段) 和他们的参与程度(即咨询、合作或共同领导)将有所不同。JAN PPEI 报告指南是围绕报告的文化期望的相关转变,我们希望这将改变患者和公众在学科知识生成中的可见存在。

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关键词:
患者,公众,参与,研究,报告

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