gms | German Medical Science

Prävention zwischen Evidenz und Eminenz
15. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

13.03. - 15.03.2014, Halle (Saale)

Extended Framework for Evidence Assessment based on GRADE and Application to HPV Vaccination in Males in the European Health Care Context

Meeting Abstract

  • corresponding author presenting/speaker Gaby Sroczynski - Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology; Division of Public Health Decision Modelling, Health Technology Assessment and Health Economics, ONCOTYROL Centre for Personalized Cancer Medicine, Hall i. T./Innsbruck, Austria
  • author Gitte Lee Mortensen - AnthroConsult, Aarhus, Denmark
  • author Xavier Castellsagué - Unit of Infections and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology (ICO), CIBER-ESP, L’Hospitalet de Llobregat, Barcelona, Spain
  • author Isabelle Borget - Biostatistic and Epidemiology Department, Studies and Research in Health Economy, Institut Gustave Roussy, Villejuif; and Paris-Sud University, Paris, France
  • author Ruth Chapman - Evidera, London, England
  • author Magnus von Knebel-Doeberitz - Department of Applied Tumor Biology, Institute of Pathology, University of Heidelberg and German Cancer Research Center, Heidelberg, Germany
  • author Peter Baker - Indepdendent Men’s Health Consultant, Brigthon, England
  • author Giuseppe La Torre - Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy
  • author Uwe Siebert - Institute of Public Health, Medical Decision Making and HTA, UMIT - University for Health Sciences, Medical Informatics and Technology / Division of Public Health Decision Modelling, HTA and Health Economics, ONCOTYROL Centre for Personalized Cancer Medicine / Centre for Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health / Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Hall i. T. / innsbruck / Boston, USA, Austria

Prävention zwischen Evidenz und Eminenz. 15. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Halle, 13.-15.03.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. Doc14ebmC2d

doi: 10.3205/14ebm016, urn:nbn:de:0183-14ebm0166

Published: March 10, 2014

© 2014 Sroczynski et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



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.