Objectives The National Cancer Control Programme (NCCP) in Ireland develops national clinical guidelines for cancer. The methodology is evidence based and has been reviewed and updated to incorporate the GRADE process. GRADE is used as a systematic approach to making clinical practice recommendations. There is clear guidance in the literature on how to assess the quality of the evidence with certainty ratings of high, moderate, low or very low being assigned. With risk of bias, imprecision, inconsistency, indirectness and publication bias contributing to the certainty rating. However, the quality of the evidence is only one component of generating recommendations for clinical practice with the final GRADE strong or weak also reflecting the potential for benefit and harm, patient values and resources. There are many publications to aid the guideline developers and clinicians in evaluating the quality of evidence but less information on how to develop a robust transparent and reproducible framework for generating GRADE recommendations. To address this gap, the evidence hub in the NCCP has developed an ‘evidence to recommendation framework’, to aid the generation guideline recommendations. This framework focuses on the integration of the evidence with patient values and clinical expertise.
Methods The membership of each guideline development group (GDG) includes members with clinical expertise, research methodology and library expertise, and patient representatives. We recommend including a medical ethicist or philosopher for the exploration of the epistemic values of patients. Other professionals who are relevant to the implementation of the recommendations, e.g. hospital administration staff, legal experts should be considered. The framework is divided into sections; the clinical question is the first component, it directs the literature search and selection of the evidence. The quality of the body of evidence is agreed and recorded. The quality of the evidence is assessed by the research team prior to the GDG recommendation meeting. At the GDG meeting the quality of the evidence is reviewed. The GDG then discusses and records the potential benefit and harm to the patient of the proposed intervention. The patient’s values regarding the benefits and harms are explored; this is done with the aid of a ‘values word bank’ that has been developed in conjunction with the philosopher/medical ethicist. Equity and acceptability are also discussed. Resources are considered and form part of the final budget impact analysis and implementation plan. Results The evidence statements, recommendations, good practice points and practical issues are written in real time. The guideline is now structured so the quality of the body of evidence, the benefit and harm, the patient values and preferences and resources are all presented thus providing a rational to the user, clinicians or patient, for the final recommendation and its grade. The guidelines are designed so that they can be used in a patient consultation for shared decision making if appropriate. Using this new approach has had a direct impact on the final recommendations.
Conclusions Developing a systematic framework for exploring benefits, harm and patient values has resulted in a change to guideline recommendations. The guidelines have changed from being an evidence review to providing clinical practice recommendations that reflect the values and preferences of the patients. This has been clearly demonstrated when updating previous versions of guidelines. For clinical questions where the evidence base has not changed the GDG have made different recommendations, these changes were driven by the patient preferences around the potential benefits and harms. This structured approach enables guideline groups and clinicians bridge the gap between evidence and recommendations for practice.
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