Navigating Key Challenges in Engaging Stakeholders for Health and Healthcare Guideline Development

Effective stakeholder engagement is essential for developing trustworthy, relevant, and implementable health and healthcare guidelines. As the landscape of medical research and policy evolves, so does the recognition that involving diverse groups—patients, clinicians, policymakers, and others—enhances the quality and applicability of clinical recommendations. This overview explores the major issues faced when integrating stakeholder perspectives into guideline creation, emphasizing best practices, considerations for meaningful participation, and strategies to manage potential conflicts and ensure transparency.

Introduction

Stakeholder involvement in health guideline development has gained prominence over recent years, driven by the need for more inclusive and patient-centered decision-making processes. Stakeholders encompass individuals and groups responsible for or affected by health-related decisions, such as patients, caregivers, healthcare providers, payers, policymakers, and researchers [3]. Engaging these groups can improve the relevance of guidelines, facilitate their acceptance, and promote implementation, ultimately improving health outcomes.

The concept of engagement involves actively seeking input from stakeholders to inform research and decision-making processes, fostering informed and shared decisions about health interventions [8]. Recognizing the diversity of stakeholder roles and perspectives is vital, as each group offers unique insights that can influence guideline quality and applicability.

The international MuSE (Multi-Stakeholder Engagement) Consortium, established in 2015, exemplifies collaborative efforts to refine stakeholder engagement practices. With a network of over 120 individuals across 20 countries, MuSE aims to develop guidance that supports meaningful involvement throughout all phases of guideline development. Its work includes addressing core issues such as stakeholder identification, roles, levels of engagement, evaluation, transparency, and conflict of interest management.

Methods

Identifying the appropriate stakeholders involves careful consideration of their roles, expertise, and capacity to contribute effectively. The consortium employs a structured approach to select co-leads from each stakeholder category, ensuring diversity across geographic and socioeconomic contexts. For example, stakeholders are chosen based on their ability to represent their group, commitment, and previous engagement experience, considering factors like communication skills, influence, and potential conflicts of interest [12].

A crucial step involves clarifying each individual’s positionality—specifying which stakeholder groups they represent and can influence—through a ‘positionality statement’ [13]. This ensures transparency and appropriate representation during guideline development.

The engagement process considers varying degrees of stakeholder involvement. Based on an adaptation of existing frameworks, activities are categorized into two levels: advice/feedback, where stakeholders provide perspectives without decision authority, and decision-making, where stakeholders actively influence the development process. This simplified model aids in operationalizing engagement and evaluating its effectiveness.

To assess the quality of stakeholder involvement, the consortium plans to develop evaluation tools inspired by existing measures such as the PARADIGM framework and the Patient Engagement in Research Scale (PEIRS) [https://onlinelibrary.wiley.com/doi/10.1111/hex.13191]. Transparency is prioritized by advocating for detailed reporting of engagement activities, roles, and conflicts of interest, building on existing standards like the RIGHT checklist [18].

Managing conflicts of interest is particularly critical in multi-stakeholder settings. Recognizing that interests—financial, intellectual, personal—may influence judgment, guidelines will include strategies for disclosure and mitigation to ensure balanced and unbiased recommendations [11, 19, 20].

Results

Six key issues have emerged as central to effective stakeholder engagement:

Definitions, roles, and settings: Clarifying who stakeholders are, their responsibilities, and the contexts in which they participate. Differentiating between patient and public perspectives ensures diverse insights, given their distinct experiences and expectations [11].
Stakeholder identification and selection: Employing criteria such as expertise, willingness, representativeness, and influence to choose appropriate individuals. Using a ‘positionality statement’ helps delineate the scope of each participant’s role, enhancing clarity and accountability [12, 13].
Levels of engagement: Distinguishing between feedback-oriented activities and active co-production allows for tailored involvement suited to each group’s capacity and the guideline’s complexity. Simplifying engagement into two categories—advice/feedback and decision-making—facilitates practical implementation and assessment.
Evaluation of engagement: Developing tools to measure how well stakeholder involvement meets its goals is vital. These assessments should consider the relevance of contributions, their integration into decisions, and the overall impact on guideline quality [17].
Documentation and transparency: Transparent reporting of stakeholder roles, engagement methods, and conflicts of interest fosters trust and accountability. An extension of the RIGHT checklist is proposed to standardize reporting practices in this area [18].
Conflict of interest management: Systematic disclosure and mitigation strategies are required to address potential biases arising from stakeholder interests. Differentiating between conflicts and legitimate interests ensures balanced participation while respecting stakeholder motivations [11, 19].

Discussion

Addressing these core issues involves ongoing development of guidance tailored for multi-stakeholder involvement across the entire guideline lifecycle. Future publications will focus on managing conflicts of interest, reporting standards, and lessons learned from the MuSE project. The ultimate goal is to produce a comprehensive GIN-McMaster Guideline Development Checklist Extension that offers flexible, context-sensitive recommendations for stakeholder engagement.

This guidance aims to support a variety of settings, recognizing that engagement strategies must adapt to resource levels, cultural contexts, and stakeholder capacities. Although existing frameworks provide foundational approaches for involving patients and providers [26, 27], this project is pioneering efforts to systematically involve multiple stakeholder groups throughout health guideline development, enhancing the transparency, relevance, and uptake of recommendations.

The principles and tools developed by MuSE can also be adapted for related areas such as health technology assessments (HTA) and systematic reviews, broadening their impact on evidence-based health decision-making [https://medappinsider.blog/elevating-healthcare-through-corporate-social-responsibility-initiatives/].

Acknowledgements

The authors thank Pearl Atwere, Tammy Clifford, Christine Laine, Regina Greer-Smith, and Maureen Smith for their valuable contributions to discussions shaping this manuscript.

Additional Resources:

For guidance on involving stakeholders in health research and guideline development, see practical frameworks here.
To understand how to manage conflicts of interest in multi-stakeholder processes, consult this comprehensive framework.
For a complete guide on the roles of various healthcare professionals, including patient advocates and other team members, explore your complete 2024 guide.