PLAIN ENGLISH SUMMARY The 2011 standards for trustworthy development of healthcare guidelines published by the United States-based Institute of Medicine recommend that guideline developers involve patients and public representatives in the development process. The standards recommend that (1) patients and the public be actively involved as members on guideline development panels and (2) guideline developers seek patient and public input during review of the draft guideline. In this study, researchers reviewed the patient and public involvement strategies of guideline developers in the United States by looking at websites and guideline development practices. Of 101 organizations reviewed, only 8% require patient and public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% of guideline developers always post draft guidelines for public comment. Thirteen percent of guideline developers ask patients or patient organizations to review draft guidelines at least some of the time. Only 20% of guideline developers create patient-targeted guideline products (e.g. patient summaries of guidelines). These low numbers show that there is a substantial gap between standards for patient and public involvement in guideline development and what is actually happening. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying important populations and outcomes, suggesting whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one part of trustworthy guideline development. ABSTRACT BACKGROUND The United States-based Institute of Medicine 2011 standards for trustworthy clinical practice guideline development recommended patient and public involvement in guideline development via participation by patients and public representatives on guideline development groups and via external review and public comment strategies. Guideline developer compliance with these standards has not been assessed. This study aimed to identify the frequency with which United States guideline developers are employing participation, consultation, and communication patient and public involvement strategies. METHODS Two reviewers independently extracted current patient and public involvement strategies of independent guideline developers, either (1) an organizational member of the Guidelines-International-Network North America and/or (2) having ≥2 guidelines in the National Guideline Clearinghouse between March 2011 and November 2015. Publicly available information was extracted from guideline developers' websites, methodology manuals, and guidelines between November 2015 and December 2016. Disagreements were resolved by discussion. RESULTS Of 101 organizations meeting inclusion criteria, only 8% require patient/public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% always utilize public comment on draft guidelines; 13% engage patients/public in external review at least some of the time. Twenty percent of developers create patient-targeted guideline products. CONCLUSIONS There remains a substantial gap between patient/public involvement standards for guideline development and practice in the United States, even 5 years after publication of Institute of Medicine standards. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying key populations and outcomes, informing whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one element of trustworthy guideline development.

中文翻译：

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制定医学标准五年后，患者对指南的参与度很差：审查指南方法。

普通英语摘要由总部位于美国的医学研究所发布的2011年值得信赖的医疗保健准则开发标准建议，准则制定者应让患者和公众代表参与制定过程。该标准建议（1）患者和公众积极参与准则制定小组的活动，以及（2）准则制定者在审查准则草案期间寻求患者和公众的意见。在这项研究中，研究人员通过查看网站和指南制定实践，回顾了美国指南制定者的患者和公众参与策略。在接受审查的101个组织中，只有8％要求患者和公众参与指南制定小组；15％的人有时需要它或将其描述为可选的。只有24％的准则开发人员总是发布准则草案以征询公众意见。百分之十三的准则制定者要求患者或患者组织至少在某些时候审查准则草案。只有20％的指南开发人员会创建针对患者的指南产品（例如，患者指南摘要）。这些低数字表明，患者和公众参与指南制定的标准与实际发生的情况之间存在很大差距。这是一个错失的机会，因为患者和公众对指南制定的贡献包括评估指南优先级，引入新主题，确定重要的人群和结果，建议研究结果是否有意义，促进整体护理方法，评估建议如何与患者价值互动，并编写通俗易懂的指南版本。指南制定者必须承诺将患者和公众的参与列为优先事项，这是值得信赖的指南制定的一部分。背景技术基于美国医学协会2011年的可信赖的临床实践指南制定标准建议患者和公众通过患者和公众代表参与指南制定小组并通过外部评审和公众意见策略参与指南制定。尚未评估开发人员是否符合这些标准。这项研究旨在确定美国指南制定者采用参与，咨询和交流患者与公众参与策略的频率。方法两名审稿人独立地提取了独立指南制定者的当前患者和公众参与策略，或者是（1）北美指南网络的组织成员和/或（2）2011年3月之间在国家指南信息交换所中拥有≥2条指南2015年11月和2015年11月。从指南开发者的网站，方法论手册和指南中提取了公开可用的信息，时间范围为2015年11月至2016年12月。结果在满足纳入标准的101个组织中，只有8％的患者/公众需要参与指南制定小组；15％的人有时需要它或将其描述为可选的。只有24％的人总是利用公众对准则草案的评论；13％的患者/公众至少在某些时候参与了外部审查。20％的开发人员创建了针对患者的指南产品。结论在美国，即使是在医学研究所标准发布后的5年中，患者/公众参与标准在指南制定和实践方面仍然存在很大差距。这是一个错失的机会，因为患者和公众对指南制定的贡献包括评估指南重点，引入新主题，确定关键人群和结果，告知调查结果是否有意义，促进整体护理方法，评估建议如何与患者价值互动以及编写普通语言准则版本。指南制定者必须承诺将患者和公众的参与列为优先事项，这是值得信赖的指南制定的要素之一。