Article type
Abstract
Background: Clinical guideline development depends on expert panels tasked with evaluating evidence and forming consensus on recommendations. This process faces challenges from differing perspectives, values, and evidence interpretation. Conscious or unconscious biases underscore the difficulty in maintaining scientific objectivity alongside individual judgments.
Objectives: To propose strategies for norming and reconciling varying perspectives for guidelines development.
Methods: We used a structured and empirical methodology grounded in our expertise in guideline development across various U.S. guideline development projects. Our approach began with an environmental scan to identify guideline development and management practices. This was followed by iteratively summarizing our collective experiences.
Results: Our framework for maintaining integrity in guideline development is structured around three components: Prevent (see strategies for norming in Figure) and Manage (see circular diagram in Figure). Prevent focuses on establishing a foundation through a values framework, comprehensive pre-development training, transparent conflict of interest disclosure–including non-financial conflicts—and management, strategic selection of chairs, balanced representation, and implementation of structured deliberation techniques, among others. Manage introduces robust conflict resolution approaches, including detailed documentation of deliberations, structured discussions, mediation, consensus-building processes, and mechanisms for self-recusal or member withdrawal. For example, in one of the scenarios, we will present a discussion regarding recommending one of two treatment options. The panel systematically evaluated the evidence using the GRADE approach, considering the balance between benefits and harms, patient values and preferences, and additional considerations such as cost and accessibility. In one example, the evidence was of very low certainty, suggesting that one treatment offered only a slight net benefit over another. This scenario was further complicated by substantial variation in patient preferences and considerations such as acceptability, equity, and feasibility. Confronted with these complexities, the panel was divided—some members argued for a “strong for” recommendation, while others debated issuing a recommendation based on expert opinion or refraining from making any recommendation due to lack of convincing evidence and variation in implications.
Conclusions: Our framework introduces strategies to enhance the integrity and objectivity of clinical guideline development, mitigating undue influence and promoting evidence-based recommendations.
Objectives: To propose strategies for norming and reconciling varying perspectives for guidelines development.
Methods: We used a structured and empirical methodology grounded in our expertise in guideline development across various U.S. guideline development projects. Our approach began with an environmental scan to identify guideline development and management practices. This was followed by iteratively summarizing our collective experiences.
Results: Our framework for maintaining integrity in guideline development is structured around three components: Prevent (see strategies for norming in Figure) and Manage (see circular diagram in Figure). Prevent focuses on establishing a foundation through a values framework, comprehensive pre-development training, transparent conflict of interest disclosure–including non-financial conflicts—and management, strategic selection of chairs, balanced representation, and implementation of structured deliberation techniques, among others. Manage introduces robust conflict resolution approaches, including detailed documentation of deliberations, structured discussions, mediation, consensus-building processes, and mechanisms for self-recusal or member withdrawal. For example, in one of the scenarios, we will present a discussion regarding recommending one of two treatment options. The panel systematically evaluated the evidence using the GRADE approach, considering the balance between benefits and harms, patient values and preferences, and additional considerations such as cost and accessibility. In one example, the evidence was of very low certainty, suggesting that one treatment offered only a slight net benefit over another. This scenario was further complicated by substantial variation in patient preferences and considerations such as acceptability, equity, and feasibility. Confronted with these complexities, the panel was divided—some members argued for a “strong for” recommendation, while others debated issuing a recommendation based on expert opinion or refraining from making any recommendation due to lack of convincing evidence and variation in implications.
Conclusions: Our framework introduces strategies to enhance the integrity and objectivity of clinical guideline development, mitigating undue influence and promoting evidence-based recommendations.