Patient involvement in guidelines is poor five years after institute of medicine standards: review of guideline methodologies

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40900-017-0070-2) contains supplementary material, which is available to authorized users.