Artikel
Extended Framework for Evidence Assessment based on GRADE and Application to HPV Vaccination in Males in the European Health Care Context
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Veröffentlicht: | 10. März 2014 |
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Background/Objectives: Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) is a transparent and commonly used framework for translating evidence into recommendations by using a standardized process and tools. Our objective was to develop an extended framework based on GRADE with a focus on primary prevention such as vaccination and apply this framework using the example of human papilloma virus (HPV) vaccination in males in a European health care context.
Methods: A pan-European multidisciplinary expert group was established to develop an extended GRADE framework that includes a transparent and formal assessment of cost-effectiveness, unmet medical needs, as well as ethical, patient and social aspects in addition to benefits and harms. Using an expert panel process, we assessed the feasibility of using this framework by applying it to male HPV vaccination in Europe. Studies were assessed using specific framework tools; results and feasibility were discussed; and consensus was achieved through a modified Delphi method.
Results: We identified three advisory committees (ACIP/USA; NACI/Canada; STIKO/Germany) using GRADE for vaccines assessment. Institutions handled data beyond vaccine efficacy and safety differently and did not formally grade economic evidence. We adopted the grading methodology of ACIP for the key factor ‘Benefits and Harms‘ and developed an extended framework for (1) grading the evidence type and quality for economic evaluations, (2) systematically assessing epidemiology, burden of disease and unmet medical needs, as well as (3) patient aspects, ethical and social issues. The feasibility test demonstrated that all developed framework components were feasible in the application to the case of HPV vaccination.
Conclusions: The GRADE approach is feasible in assessing vaccinations and has been successfully applied to HPV vaccination in males. The assessment of benefits and harms can be extended by explicit assessment of the evidence on cost-effectiveness and other key factors including unmet medical needs, and ethical, social and patient aspects. This extended framework can better inform policy- and decision-makers.