Armstrong Melissa J, Bloom Joshua A
Department of Neurology, University of Florida College of Medicine, Gainesville, FL USA.
University of Florida College of Medicine, Gainesville, FL 32610 USA.
Res Involv Engagem. 2017 Oct 2;3:19. doi: 10.1186/s40900-017-0070-2. eCollection 2017.
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.
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.
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.
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.
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.
美国医学研究所发布的2011年医疗保健指南可信开发标准建议，指南制定者应让患者和公众代表参与开发过程。这些标准建议：（1）患者和公众应作为指南制定小组的成员积极参与；（2）指南制定者在审查指南草案时征求患者和公众的意见。在本研究中，研究人员通过查看网站和指南制定实践，审查了美国指南制定者的患者和公众参与策略。在审查的101个组织中，只有8%要求患者和公众参与指南制定小组；15%有时要求或表示这是可选的。只有24%的指南制定者总是发布指南草案以供公众评论。13%的指南制定者至少有时会要求患者或患者组织审查指南草案。只有20%的指南制定者制作针对患者的指南产品（如指南的患者摘要）。这些低比例表明，在患者和公众参与指南制定的标准与实际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的优先事项、引入新主题、确定重要人群和结果、表明研究结果是否有意义、促使采取整体护理方法、评估建议与患者价值观的相互作用，以及编写通俗易懂的指南版本。指南制定者必须致力于将患者和公众参与作为可信指南开发的一部分进行优先考虑。
美国医学研究所2011年可信临床实践指南开发标准建议，通过患者和公众代表参与指南制定小组以及外部审查和公众评论策略，让患者和公众参与指南开发。尚未评估指南制定者对这些标准的遵守情况。本研究旨在确定美国指南制定者采用参与、咨询和沟通患者及公众参与策略的频率。
两名评审员独立提取独立指南制定者当前的患者和公众参与策略，这些制定者要么是（1）北美指南国际网络的组织成员，和/或（2）在2011年3月至2015年11月期间在国家指南交换中心有≥2份指南。2015年11月至2016年12月期间，从指南制定者的网站、方法手册和指南中提取公开可用信息。通过讨论解决分歧。
在符合纳入标准的101个组织中，只有8%要求患者/公众参与指南制定小组；15%有时要求或表示这是可选的。只有24%总是对指南草案进行公众评论；13%至少有时让患者/公众参与外部审查。20%的制定者制作针对患者的指南产品。
即使在美国医学研究所标准发布5年后，指南开发中患者/公众参与的标准与实践之间仍存在很大差距。这是一个错失的机会，因为患者和公众对指南开发的贡献包括评估指南的优先事项、引入新主题、确定关键人群和结果、告知研究结果是否有意义、促使采取整体护理方法、评估建议与患者价值观的相互作用，以及编写通俗易懂的指南版本。指南制定者必须致力于将患者和公众参与作为可信指南开发的一个要素进行优先考虑。
