推出《临床和公共卫生指南》:指南领域的独特期刊

Ivan D. Florez
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Clinical practice guidelines gradually started implementing this approach and shifted from the expert-based approach to a process based on systematic reviews to answer clinically relevant questions.<span><sup>2</sup></span> As a result, ‘systematic review’ was incorporated in the definition by, formerly, the United States Institute of Medicine (currently, the National Academy of Health) in 2011: guidelines are ‘statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’.<span><sup>3</sup></span> This newer generation of evidence-based guidelines quickly became the ideal methodological approach to develop more transparent recommendations. However, the evolution of guidelines was far from ending.</p><p>Additional factors were also identified as key to informing the development of recommendations. The consideration of patients' values and preferences, costs and use of resources, the impact on health equity and the feasibility and applicability of the recommended actions have been identified as critical in the recommendation process. In short, guidelines need to provide recommendations supported by evidence but also feasible, affordable, usable and acceptable to users and patients. Therefore, guidelines evolved from consensus-based statements to recommendations that use evidence-based methods to work with research evidence and, later, to systematically consider patients' values and preferences, costs and resources used and the feasibility of the recommendations.<span><sup>4</sup></span></p><p>This exciting evolution of guidelines has been possible thanks to the work of many guidelines developers, researchers and users who have contributed for decades to improve guidelines in different ways. 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引用次数: 0

摘要

文献中最早可追溯的指南是由专业协会根据与会者的经验和意见制定的共识声明(即在美国专科会议期间制定的建议)。这种方法被称为 GOBSAT(Good Old Boys Sat Around the Table),即主要由自我选择的专家讨论他们的意见(通常是主观的)并提供建议的过程。2 因此,"系统回顾 "于 2011 年被纳入前美国医学研究所(现为美国国家健康研究院)的定义中:"指南是'包含旨在优化患者护理的建议的声明,这些建议是通过对证据的系统回顾和对替代护理方案的利弊评估得出的'3。然而,指南的发展远未结束。其他因素也被认为是制定建议的关键。考虑患者的价值观和偏好、成本和资源使用情况、对健康公平的影响以及建议行动的可行性和适用性被认为是建议过程中的关键。简而言之,指南需要提供有证据支持的建议,同时也要可行、负担得起、可用并为用户和患者所接受。因此,指南从以共识为基础的声明发展为以证据为基础的建议,利用研究证据,后来又系统地考虑患者的价值观和偏好、成本和所用资源以及建议的可行性。要列出所有做出贡献的关键人物是不可能的,但这一历程中最重要的里程碑可能是 EBM 运动的兴起、系统回顾方法的发展和扩展、AGREE 工具的开发5 、国际指南网络(GIN)的建立6 以及建议分级、评估、发展和评价工作组的成立7。7 作为儿科医生,我是指南的使用者。不过,我与指南的关系更为密切,也更令人欣慰。我曾担任过指南主席、方法论专家、实施者、专家小组成员以及指南和证据综合研究员。我花了 15 年时间制定指南、领导指南计划、开展指南培训或教学,或研究指南方法。在许多层面和背景下,我见证了指南是如何成为缩小科学与临床实践或政策制定之间差距的非凡工具。令人惊讶的是,指南领域还没有一本专门的期刊供用户、研究人员和开发人员发表他们的产品、开展有关指南的学术讨论并促进建议的传播。临床与公共卫生指南》是一本开放性期刊,因此所有文章均可在网上查阅。我们的期刊考虑两种类型的稿件:与指南科学相关的稿件和指南相关的稿件。所谓与指南科学相关的稿件,我们指的是旨在了解和改进指南制定和使用的任何方面的一级和二级研究、这类文章的协议以及讨论指南制定挑战或方法工具的开发和应用的方法论稿件。关于指南的稿件,我们考虑的是临床或公共卫生循证指南或卫生系统指南。其中包括完整版、改编版、全新或更新版指南,指南的公开版本以及活指南。最后,我们还考虑指南协议。作为提高透明度和加强合作的重要一步,指南注册的建立应有助于制定更多的指南规程。我们期待《临床与公共卫生指南》将成为其中许多指南的发源地。在接下来的数月、数年甚至数十年中,这些网页将报道亟待解决的主题,并将帮助塑造指南领域。 其中包括人工智能和真实世界证据在指南中的作用、快速和活生生的建议制定与实施、指南注册、患者和公民版指南、证据综合和指南层面的研究完整性、中低收入国家的指南制定、指南调整、建议实施、指南在法律问题中的作用、指南培训与认证等。特别感谢 GIN 董事会给我这次机会,感谢扎卡里-蒙恩(Zachary Munn),他是该期刊诞生的幕后策划者,并为本创刊号撰写了一篇社论。我非常感谢这群同事和朋友,尽管他们工作繁忙,但还是接受了我们的邀请,加入了这一旅程。我希望我们的团队合作能在未来几年为期刊带来成功。现在,我们应该把《临床与公共卫生指南》也列入其中。毫无疑问,我们拥有自己的期刊是向承认指南在医疗保健和公共卫生中的重要性迈出的又一步。因此,我相信《临床与公共卫生指南》的创刊将成为我们向所有用户、开发者和研究人员传播指南科学的一个转折点,这反过来将有助于缩小知识与行动之间的差距,改善医疗保健和政策决策/制定过程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Launching Clinical and Public Health Guidelines: A unique journal for the guidelines field

The first traceable guidelines in the literature were consensus statements (i.e., recommendations formulated during specialties conferences in the United States) developed by professional associations and based on the participants' experience and opinions. This methodology has been called GOBSAT (Good Old Boys Sat Around the Table), namely, the process by which mainly self-selected experts discuss their (often subjective) opinions and provide recommendations.1 During the early 1990s, the evidence-based medicine (EBM) movement was born. Clinical practice guidelines gradually started implementing this approach and shifted from the expert-based approach to a process based on systematic reviews to answer clinically relevant questions.2 As a result, ‘systematic review’ was incorporated in the definition by, formerly, the United States Institute of Medicine (currently, the National Academy of Health) in 2011: guidelines are ‘statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’.3 This newer generation of evidence-based guidelines quickly became the ideal methodological approach to develop more transparent recommendations. However, the evolution of guidelines was far from ending.

Additional factors were also identified as key to informing the development of recommendations. The consideration of patients' values and preferences, costs and use of resources, the impact on health equity and the feasibility and applicability of the recommended actions have been identified as critical in the recommendation process. In short, guidelines need to provide recommendations supported by evidence but also feasible, affordable, usable and acceptable to users and patients. Therefore, guidelines evolved from consensus-based statements to recommendations that use evidence-based methods to work with research evidence and, later, to systematically consider patients' values and preferences, costs and resources used and the feasibility of the recommendations.4

This exciting evolution of guidelines has been possible thanks to the work of many guidelines developers, researchers and users who have contributed for decades to improve guidelines in different ways. It is impossible to list all the key actors that have contributed, but perhaps the most significant milestones in this journey are the emergence of the EBM movement, the development and expansion of systematic review methods, the development of the AGREE tool,5 the establishment of the Guidelines International Network (GIN)6 and the constitution of the Grading of Recommendations, Assessment, Development and Evaluations working group.7

As a paediatrician, I am a guidelines user. However, my relationship with guidelines is much closer and gratifying. I have been a guidelines chair, methodologist, implementer, panellist and guideline and evidence synthesis researcher. I have spent 15 years developing guidelines, leading a guideline programme, training or teaching about guidelines or researching on guidelines methods. At many levels and contexts, I have witnessed how guidelines are an extraordinary tool to reduce the gap between science and clinical practice or policy making. Surprisingly, the guidelines field did not have a specific journal where users, researchers and developers could put their products, start an academic discussion about guidelines and facilitate recommendations dissemination.

In response to this gap, we are launching Clinical and Public Health Guidelines, the first scientific journal exclusively focused on guidelines. Clinical and Public Health Guidelines is open-access, and as such, all its articles are universally accessible online. Our journal considers two types of manuscripts: those related to the science of guidelines, and guidelines. By manuscripts related to the science of guidelines, we mean primary and secondary research aiming to understand and improve any aspect of guidelines development and use, the protocols of those types of articles and methodological manuscripts discussing guidelines development challenges or the development and application of methodological tools.

Regarding the guidelines' manuscripts, we are considering clinical or public health evidence-based guidelines or health systems guidance. These include full, adapted, de novo or updated guidelines, public versions of guidelines and living guidelines. Lastly, we are also considering guidelines protocols. The establishment of guidelines registration as a major step towards more transparency and collaboration should facilitate the development of more guidelines protocols. We expect Clinical and Public Health Guidelines will be the home of many of them.

There are many challenges ahead of us. Urgent topics will be covered in these pages in the following months, years and decades, and will help shape the field of guidelines field. Some of them are the role of artificial intelligence and real-world evidence in guidelines, rapid and living recommendations development and implementation, guidelines registration, patients and citizen versions of guidelines, research integrity at the evidence synthesis and guideline levels, guidelines development in low- and middle-income countries, guidelines adaptation, implementation of recommendations, the guidelines roles in legal issues, guidelines training and certification, and many more.

I feel privileged, humbled and grateful to take the leadership of this journal. Special thanks to the GIN Board of Trustees for this opportunity and to Zachary Munn, who was the architect behind the birth of the journal, and who wrote an editorial for this inaugural issue.7 We have gathered an unparalleled team of global guidelines experts to support the journal as Editorial Board members or Associate Editors. I am very grateful to this group of colleagues and friends who, despite their busy schedules, accepted our invitation to join this journey. I hope our teamwork will translate into success for the Journal in the next few years.

Previously, I mentioned some milestones in the guidelines world. We should now add Clinical and Public Health Guidelines to that list. Having our own journal is, without doubt, another step towards recognizing the importance of guidelines in health care and public health. Therefore, I am confident that the launching of Clinical and Public Health Guidelines will be an inflection point in our aim to disseminate the science of guidelines among all the users, developers and researchers, which in turn will help to reduce the gap between the knowledge and action and improve the health care and policy decision/making process.

The author is the current lead of the AGREE collaboration and is a member of the GRADE working group.

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