Consultation strategies are particularly useful to gather the views of a lot of individuals regarding their needs, values, preferences and experiences. Consultation can also be targeted to seldom heard or unrepresented groups who may be less likely to join a guideline group with health and social care professionals. Consultation can identify topics that appear most important for patients and the public and is therefore useful in determining the need for new or updated guidelines. It can also inform the scope of a guideline, its research questions and health or care outcomes of importance to patients. Consultation using research techniques can add to the evidence base being considered to inform the process of guideline development. It can also help assess the public acceptability of draft guideline recommendations. However, a drawback of using consultation strategies only is that they do not recognise the unique expertise of patients and the public and their value as development partners. Several major bodies recommend using public and targeted consultation to inform the development of guidelines. The National Health and Medical Research Council in Australia (2016) and the US’s Institute of Medicine (2011; now the National Academy of Medicine) include public consultation in their standards for developing guidelines. The consumer and stakeholder topic in the GIN-McMaster Checklist for Guideline Development (2014) recommends consulting consumers and stakeholders who are not directly participating on the guideline panel at specific milestones during the guideline development process. This could start at the stage of priority setting and topics for the guideline. Some guideline developers include consultation as part of a wider strategy or programme of patient and public involvement in guideline development. Documented examples of this approach include: the UK’s National Institute for Health and Care Excellence (NICE) guidelines manual (PMG20; 2014), and the NICE flowchart and accessible text-only version on how to get involved (2018)the Scottish Intercollegiate Guidelines Network (SIGN) handbook for patient and carer representatives (2019) and the SIGN guideline developer’s handbook (2019)the Nationalen Programms für VersorgungsLeitlinien (German National Disease Management Guidelines Programme) patient involvement handbook (2008) and methods report (2017), andthe GuíaSalud (Spanish national guideline development programme) methods manual (2016). Consultation and participation strategies have complementary roles in guidelines work. Using multiple strategies allows guideline developers to benefit from their different strengths and mitigate the limitations of a single strategy. Consultation can help mitigate the limitation associated with participation strategies when a small group of participants may not represent the broader population. For example, Armstrong et al. (2020) conducted a case study of question development for a single clinical guideline. They found that responses from a consultation survey were particularly helpful for reinforcing that a large group of patient stakeholders agreed with the 4 members of the question development group, who were patients, carers or advocates. This consultation benefit was seen to be particularly important given that these 4 members’ views were contrary to professional opinions provided in the public commenting phase. Table 1 outlines various stages of guidelines work when consultation with a broader group of patients or the public beyond the guideline development group may be helpful. Depending on available resources, guideline developers may need to prioritise key stages (such as early input and draft recommendations) to make consultation meaningful and achievable. Developers may also find it useful to consult Armstrong et al.’s 10 steps framework for continuous patient engagement in guideline development, which covers both consultation and participation approaches (2017). Table 1 Options for patient or public consultation at different stages of guidelines work StagePurpose of patient or public consultationExamples of consultation methodsNominating and prioritising the topicIdentify topics of importance to patients, carers and the community• Solicit topic nominations from patient advocacy groups and the public• Survey patient groupsScoping the topic and key research questions (this could extend to consultation on framing research questions, including selection of comparators and prioritisation of outcomes, and the research plan or protocol)Help identify issues that are important to a broad range of patients and ensure these are taken into account from the beginning of the guideline project. This includes patients’ experiences of care (including gaps in delivery), considerations for specific subpopulations, patient preferences and patient- important outcomes• Solicit feedback on draft scope and questions through public comment or targeted consultation with patient advocacy groups and other stakeholders (workshop and online)• Survey patient groups, for example, using criteria-based rating processes• Conduct focus groups on identified topics to help frame the questionsIdentifying evidence on patients’ views and experiencesIdentify sources of information on patients’ views and experiences with a view to supplementing important gaps in the published evidence• Ask stakeholders to suggest sources of information about patients’ views and experiences that are not formally published, such as surveys by patient groupsDeveloping systematic review and forming conclusionsSuggest alternative interpretations of evidence from a patient, carer or community perspective• Post draft evidence review for public comment and targeted consultation with stakeholders. To support meaningful public responses, provide draft review in plain language, with questions to guide responsesDeveloping recommendationsHelp translate evidence-based conclusions into meaningful, clear and respectful recommendations that foster patient or family and professional partnerships Provide input on evidence gaps Describe variability in patient preferences• Conduct focus groups and interviews• Survey patient groups • Post draft recommendations in plain language for public or targeted comment from patient groups and other stakeholdersDeveloping guideline-based performance measures or quality indicatorsRate recommendations from a patient perspective to ensure the professional expert view doesn’t dominate the rating• Survey patient groups using systematic, criteria-based ratingDeveloping guideline-based patient information or patient versions and patient decision aidsProvide input from a broader range of patients beyond those involved in developing the product• Invite feedback on the draft product from patients, carers and advocacy groups• Use research techniques to ‘user test’ the draft productDisseminating and implementing the guidelineGain support and endorsement for the guideline Facilitate engagement of other patients in dissemination Improve legitimacy and trustworthiness of the guideline process such that recommendations are more likely to be implemented• Consult patients, carers and advocacy groups on dissemination and implementation barriers and facilitators (Also engage them in dissemination strategies using a more collaborative approach)Reviewing the need to update a guidelineIdentify when changes in public or stakeholder views might require an update to the guideline (in addition to identifying changes in the formal evidence base)• Solicit patients’ views on when or whether guidelines need updating. Or use a systematic, criteria-based rating or surveyEvaluating methods and impact of patient public involvementIdentify if engagement was meaningful and suggest options for improvement• Conduct a survey with engaged patients and patient groups. (Evaluation could also take a more collaborative approach, for example, working with patient groups to design a survey and discuss results) In summary, there are many good reasons for public and targeted consultation during the development of guidelines. These include: Helping to ensure that issues important to patients and the public are appropriately taken into account from the beginning of the guideline project and reflected in the final product. This complements the contribution of patient and public members on a guideline development group.Supplementing evidence when there are gaps or obtaining a wider source of patient or public experiences and views than can be provided by patient and public members on a guideline development group.Improving the wording and presentation of the guideline and related products (for example, ensuring that the wording is respectful, and the recommendations foster partnership and shared decision making between patient and professional).Helping to ensure the guideline is relevant and acceptable to patients and the public, and to specific groups within the patient population, including those who are unrepresented or seldom heard.Paving the way for patient or public support for the final guideline and receptivity to its uptake and dissemination.In general, enhancing the legitimacy of the development process and the end product from a public perspective.