Patient and public involvement in guidelines is important because it recognizes patients as experts, empowers consumers in making well-informed healthcare decisions, and respects the rights of citizens and consumers in health care policy.

Healthcare guidelines are not rules for clinicians and patients to follow, but rather guidance on what steps are most likely to lead to the best outcomes for most patients. This guidance is part of the foundation for shared decision making. Also called “clinical practice guidelines” or “evidence-based guidelines,” healthcare guidelines are documents that include two parts: (1) a thorough review of the available research for a specific question with an assessment of how well the research was done and (2) recommendations for the best medical care based on the reviewed evidence.

While international standards for guideline development differ in some nuances, there is agreement on many of the core elements of quality clinical practice guidelines. For example, the Guidelines-International-Network standards, the U.S.-based Institute of Medicine (IOM) standards, and the Appraisal of Guidelines Research & Evaluation (AGREE) Enterprise tool all emphasize the importance of a transparent development process, inclusion of relevant stakeholders, use of a systematic evidence review, and recommendation development based on evidence and elements such as anticipated benefits and harms.

The IOM (Institute of Medicine) published its eight standards for developing trustworthy clinical practice guidelines in 2011. In addition to highlighting the practices outlined above, the IOM included two standards specifically identifying the importance of involving patient and/or consumer stakeholders throughout guideline development.

It is believed that patient and public involvement in guidelines will make guidelines more patient-centered and trustworthy.

Standard 3 states that guideline development groups should include patient and public involvement when developing guideline questions and reviewing the draft guideline, at a minimum. Standard 7 states that patients and the public should have the chance to review guidelines through external review and public comment processes prior to guideline finalization. Patient and consumer engagement is also emphasized by the Guidelines-International-Network, which published a toolkit on approaches to patient engagement in guidelines.

Patient and public involvement in guidelines is important because it recognizes patients as experts, empowers consumers in making well-informed healthcare decisions, and respects the rights of citizens and consumers in health care policy. It is also believed that patient and public involvement in guidelines will make guidelines more patient-centered and trustworthy.

There are examples of guideline developers partnering with patients and consumers when writing guidelines. For example, the National Institute for Health and Care Excellence (NICE) in the United Kingdom involves patients and the public in guideline development in various ways including participation in guideline development groups and public hearings.

The only research investigating the frequency with which guideline developers involve patients or consumers, though, is an international survey from 2008. In that study, only 29% of 31 responding guideline developers always involved consumers; 39% reported involving consumers “only if necessary.”

Are guideline developers actually involving patients?

Given the increasing emphasis on patient and public involvement in research, guidelines, and health policy, and given that five years have elapsed since the publication of the IOM standards for trustworthy clinical practice guideline development, my coauthor and I aimed to investigate whether U.S. guideline developers are engaging patients and the public in guideline development as recommended. The results of this study are published in the October issue of Research Involvement and Engagement.

We investigated the guideline development approaches of 101 U.S.-based guideline developers who had more than one guideline included in the National Guideline Clearinghouse since 2011 or who were members of the Guidelines-International-Network North America chapter when the research started in 2015.

Only 8% of included guideline developers require patient and public involvement on guideline development groups.

The results were sobering. Only 8% of included guideline developers require patient and public involvement on guideline development groups; an additional 15% sometimes require it or describe it as optional. Only 13% of included developers involve patients or the public in external review at least some of the time and only 24% routinely use public comment. Additionally, only 20% of included developers prepare guideline summaries for patients or the public.

These results demonstrate a substantial gap between standards and practice. Increasing national and international standards, conferences, and public discussions highlight the importance and value of patient and public engagement in guidelines (and other aspects of policy development and research), but the frequency with which this is practiced is low. This has implications for the trustworthiness of published guidelines and also reflects a missed opportunity.

Research suggests that 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.

Saying that patient and public involvement in guidelines is important is clearly not enough to change practice. It is likely that guideline developers require continued assistance in how to engage patients and the public well, but developers will need to prioritize patient and public involvement and commit the necessary resources. If practice does not change, guideline repositories like the National Guideline Clearinghouse may need to require evidence of patient and public involvement for inclusion alongside other standards for trustworthy guideline development.