Background
Guidelines from various entities exist for many health conditions and health-related activities. Guidelines contain recommendations for health practice, public health, or health policy [
1]. They are used by health care providers as well as policymakers, health system leaders, professional medical bodies, service organizations, funders, and regulatory authorities [
2]. Recommendations in guidelines should be based on available research evidence [
3]. Guideline development requires evaluating, summarizing, and making recommendations based on the available body of evidence regarding patient care, public health, and health systems. This requires weighing the benefits and risks that accompany all care and policy options before making recommendations [
3]. Sonnad [
4] noted that a lack of connection between guideline developers and those who use them often leads to controversy and uncertainty. Indeed, engaging guideline users during the guideline development process has been noted to improve guideline recommendation uptake [
5,
6]. Schünemann and colleagues [
7], for one, consider implementation in policy and practice as part of the guideline development process (steps 14 and 16). Throughout this work, we will use guideline development to encompass the guideline development and implementation processes.
In recent years, we have witnessed considerable shifts in how healthcare research is planned, delivered, shared, and evaluated. It is now increasingly expected that individuals or groups involved in or affected by health- and healthcare-related decisions, programs, or policies (termed “stakeholders”) should have a say in the planning, conduct, dissemination, uptake, and evaluation of healthcare research. In other words, stakeholders should be engaged in the entire process of guideline development. Several entities [
8‐
11], including the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE), recommend involving stakeholders in guideline development. As such, stakeholder engagement has become widely accepted in the production of trustworthy guidelines [
12,
13]. In guideline development, stakeholder engagement is considered critical to ensuring priority guideline topics are identified and that comprehensive assessments of the evidence and other considerations are done [
14‐
16].
Stakeholder involvement can help to ensure a guideline’s acceptability and feasibility to the end users. They can also ensure that equity and human rights issues are taken into consideration and support the adoption of its recommendations into policy and practice. This in turn may lead to improved adherence to any treatments and practices recommended [
7,
17]. Stakeholder engagement in guideline development is part of a wider acceptance by the research community of the value of ensuring the participation of end users in the research and knowledge translation cycles [
18,
19]. There is a moral imperative to engage end users in that people have a right to be involved in activities that may affect them. End user engagement may also improve the relevance, transparency, and usefulness of guidelines [
20].
There are many stakeholder groups equally affected by recommendations in guidelines—e.g., patients, consumers, providers, general public, researchers, and policymakers. However, engagement with patients/public/community stakeholder groups dominates the literature, and guidance of the engagement with patient/public stakeholders is the most prominent [
21‐
23]. In a review of guideline methodologies conducted by Armstrong and Bloom for example, patients/public stakeholders were consulted by 101 different guideline developers [
21]. Many guideline groups that have sought to involve stakeholders have utilized limited numbers of participants or utilized slow and labor-intensive processes (e.g., time and resources needed to administer, collate, and respond to over 200 stakeholder views and comments) [
12]. It is recognized that successful guideline development and implementation requires the engagement of multiple stakeholders [
24] and “shared solutions” (input from patients, clinicians, and policymakers) improve health outcomes [
24‐
26]. Patient/public stakeholders may potentially feel intimidated to contribute if they are only one voice among many. Keeping patient and public stakeholder voices separate from other stakeholder groups potentially shortchanges the input and influence that this group may offer. Equitable engagement of multiple stakeholder groups can help to ensure that guidelines contribute to reducing health disparities [
27,
28]. However, there is a lack of consensus on how to identify and recruit relevant stakeholders, how they should be engaged, what their roles and responsibilities should be, how to evaluate the impact of their engagement in guideline development, and how to best collect and manage conflicts of interest as part of the engagement and guideline development process.
Schünemann et al. identified 18 steps in the guideline development process, based on a review of 35 guideline manuals published between 2003 and 2013 [
7]. Several manuals mentioned the importance of including stakeholders, but few provided details on what stakeholder engagement should entail. In a review of 56 guidance documents for guideline development, 72% mentioned incorporating patients and their views in the process. However, the review did not provide sufficient detail on how to do this for each step of the guideline development process [
29]. Armstrong et al. developed a framework for continuous patient engagement in clinical practice guideline development that outlines options for patient engagement in the steps in which they are most commonly involved [
16]. While providing guidance on when to involve patients, the framework does not provide guidance on how to identify patients to participate and does not discuss other stakeholders.
Effective stakeholder engagement, ideally, facilitates the equitable contribution of relevant stakeholder groups in the guideline development and implementation process. This requires that guideline developers establish processes that prevent more financially powerful, highly vocal, or intellectually conflicted stakeholder groups from dominating the guideline development process. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) equity guidelines, for one, recommend the inclusion of underrepresented stakeholder groups in the guideline development and implementation process [
30]. Stakeholders will have various levels of time, resources, and skills available to dedicate to the process, and ensuring that these differences do not result in certain stakeholder having more influence over the final guideline recommendations is important. A challenging aspect of engaging stakeholders is ensuring that interests are declared and that conflicts of interest are appropriately managed. Despite the importance of conflict of interest for guideline development, there is high variability in the process of disclosure and management of such conflicts across different organizations [
27]. As a consequence, there are many inconsistencies in how stakeholder engagement is considered across guideline development groups. There should be opportunities for a variety of opinions to be heard, but it is vital that the recommendations made are objective and not unduly influenced by vested interests. Strategies such as active outreach activities, giving adequate time for comment on guideline recommendations and using processes with follow-up prompts that ensure all stakeholder comments are systematically addressed may assist in reducing potential inequities and increase guideline development transparency [
12].
Study aim
The study aim is to develop guidance for guideline developers that supports the equitable and meaningful engagement of multiple stakeholders throughout the guideline development and implementation process. Guideline development will be used to encompass development, implementation, and evaluation processes. The objectives, in terms of participants, interventions, and comparators, are stakeholder/stakeholder groups engaged in guideline development, engagement in the guideline development process, and no comparator. Outcomes are outlined below for each phase of the project.
Key definitions
We define below the terms guideline, stakeholder, stakeholder engagement, levels of engagement, and under-represented groups used for this project.
Guideline
Guidelines are “systematically developed evidence-based statements which assist providers, recipients, and other stakeholders informed decisions about appropriate health interventions” [
31].
Stakeholder
A stakeholder is any “individual or group who is responsible for or affected by health- and healthcare-related decisions that can be informed by research evidence” [
32]. Further, we acknowledge that some stakeholders may use guidelines to inform decision-making (CIHR terms these stakeholders, knowledge users), while others may have an interest in the recommendations for other reasons [
32‐
34]. We define eight stakeholder groups for this project, namely (1) persons and the public (e.g., patients, their caregivers, families, and patient and consumer advocacy organizations), (2) providers (individuals/organizations that provide care, e.g., nurses, physicians, pharmacists, mental health counselors, community-based workers), (3) payers (pays for or reimburses for health-related interventions, e.g., insurers, individuals with deductibles, others responsible for reimbursement for health-related interventions), (4) purchasers (e.g., employers, self-insured, governments, and other entities responsible for underwriting the cost of care), (5) policymakers (policymaking entities such as governments and professional associations), (6) product makers (e.g., drug/device manufacturers), (7) principal investigators (e.g., researchers), and (8) the press (e.g., publishers, news media) [
32,
33].
Engagement
“Engagement” refers to the approach to gather input or contribution from stakeholders “toward the development of a guideline, completion of any stages of a guideline, or dissemination, uptake or evaluation of a guideline and its recommendations” [
35]. Engagement is considered multi-directional, resulting in “informed decision-making about the selection, conduct, and use of the research” [
32]. Depending on the context, engagement may also be termed collaboration, involvement, or partnership [
36]. Herein, we will use the term “stakeholder engagement.”
Levels of engagement (Table 1)
The extent to which stakeholders are engaged in the guideline development process can vary. We identify four levels of engagement (see Additional file
1), adapted from previous work [
37‐
39]: (1)
Communication—stakeholders receive information but have no role in contributing; (2)
Consultation—stakeholders provide their views, thoughts, feedback, opinions, or experiences but without a commitment to act on them; (3)
Collaboration—stakeholders are engaged to influence the production of the guidelines (e.g., commenting, advising, ranking, voting, prioritizing, and reaching consensus) but without direct control over decisions; and (4)
Coproduction—stakeholders are equal members of the guideline development team and participate in all steps of the guideline development process. Members benefit from each other’s knowledge, skills, and perspectives and build relationships in an open, trusting, and transparent atmosphere that encourages learning from each other. With ongoing collaboration and engagement, all members have an equal opportunity to influence each aspect of the guideline development process [
25,
35,
37,
40‐
42].
Table 1
Levels of engagement [
37‐
39]
Communication (level 1) | Stakeholders receive information. Stakeholders may be present but have no role in contributing. | e.g., “here’s what we are doing” |
Consultation (level 2) | Stakeholders provide their views, thoughts, feedback, opinions, or experiences but without a commitment to act on them. | e.g., “What do you think about what we are doing?” |
Collaboration (level 3) | Stakeholders are engaged to influence the production of guidelines (e.g., commenting, advising, ranking, voting, prioritizing, reaching consensus). Stakeholders provide information which directly influences the guideline process, but without direct control over decisions. | e.g., “Please get involved in what we are doing” |
Coproduction (level 4) | Stakeholders are equal members of the guideline development team and participate in all steps of the guideline development process. Stakeholders work together in various roles throughout the guideline development process. Stakeholders make collaborative decisions to shape the guideline recommendations | e.g., “Let’s do it together” |
Under-represented groups
Under-represented groups refer to those individuals or groups who may experience health inequities for reasons such as a lack of inclusion in research, health policy, or guideline development; barriers to access of health services; or because of other socially stratifying factors, such as their place of residence, race/ethnicity/culture/language, occupation, gender/sex, subject matter knowledge, religion, education, socioeconomic status, social capital, age, or other individual characteristics [
27,
28].
Discussion
Stakeholder engagement should be multidirectional, meaningful, effective, and enable equity for both the stakeholders and guideline developers throughout all steps in the decision-making process. This project is innovative in that we are committed to an inclusive, comprehensive, and equitable approach to ensure that the guidance we develop is representative and relevant for all stakeholders, including those who are involved in creating and implementing guidelines and those affected by the recommendations developed within those guidelines. Our stakeholder engagement strategy for the project will assist us in effectively engaging our own stakeholders and allow us to monitor our engagement processes in real-time so that course corrections can be made if there is evidence of non-meaningful engagement.
We are not including language or date restrictions on our search strategy. A potential limitation of these reviews is that we are including papers regardless of their methodological quality. This will allow us to collect and synthesize qualitative data that we may miss if standard methodological criteria are applied. We will discuss limitations further in the full review.
These reviews will contribute to the literature by identifying existing guidance, barriers and facilitators, potential impacts, and possible conflict of interest issues related to engagement of stakeholders from many stakeholder groups in guideline development and implementation.
The results of the four reviews will inform the development of draft guidance. Once drafted, we will gather opinions and priorities on the guidance items from a wide range of purposefully selected stakeholders external to the MuSE consortium, including representation from low- and middle-income countries through an anonymous, online survey. We will strive for equity in the identification of survey recipients by engaging with a diversity of respondents representing different physical capabilities, genders, geographies, socio-economic statuses, and ethnicities. We will then present the results of the survey for each candidate item and use structured discussions to reach consensus on the included items for the final guidance paper at a two-day face-to-face consensus meeting as recommended by Moher et al. [
43]. Finally, based on the results of the previous stages, we will develop guidance that provides recommendations for stakeholder roles and modes of engagement at different steps of the guideline development process (including implementation and evaluation) and for managing conflicts of interest. We will use an iterative process of feedback to draft, refine, and finalize the guidance to be provided in each manuscript in consultation with the co-authors of each paper and the other members of the MuSE consortium. The final product will be included in GRADE Working Group Guidance. The GRADE Working Group has developed internationally recognized guidance for the development of clinical practice and public health guidelines [
65].
The expected final guidance will contribute to improving the guideline development and implementation process by identifying strategies for the meaningful and equitable engagement of all relevant stakeholder groups at all stages. Through this project, we aim to contribute to the growing body of literature on stakeholder engagement for better quality guidance, increased uptake of guidance, more relevant health programs, policies and services, and more equitable health outcomes.
We continually welcome additional expressions of interest and suggestions for relevant literature and plan to evaluate our own stakeholder engagement throughout this work to ensure meaningful engagement.
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