title: [Health-related quality of life: a pivotal endpoint in benefit assessment of medical procedures].
abstract: BACKGROUND
  According to German law, health-related quality of life is a relevant criterion in the early assessment of the benefits of drug treatment. In spite of its regulatory importance, the role of quality of life assessment in quantifying the additional benefits of novel vs standard treatments is not yet clear.
  
  
  OBJECTIVE
  The paper is aimed at analyzing the theoretical foundation, the methodological foundation, and the empirical evaluation of the criterion "quality of life" in recent benefit dossiers, as published by the Federal Joint Committee (G-BA) and the German Institute for Quality and Efficiency in Health Care (IQWiG).
  
  
  METHODS
  Benefit dossiers assessed by the end of 2013 were quantitatively analyzed regarding the choice, frequency of use, and consequences of quality of life assessment.
  
  
  RESULTS
  In 59 of the 66 dossiers quality of life assessment was performed, frequently using the EQ-5D (n = 16 procedures) and the SF-36 (n = 8 procedures). Of the 107 evaluations of the subpopulation within these 59 dossiers, in only 2 cases was an additional benefit due to the quality of life declared by the IQWiG and G-BA.
  
  
  CONCLUSIONS
  In spite of the acceptance of quality of life measures and their inclusion in the dossiers, they have rarely been the basis for the declaration of additional benefits. This reluctance does not stem from the availability of instruments, but results from problems in their selection, the design and conduct of the study, data interpretation, together with shortcomings regarding the statistical and clinical significance of quality of life data.
authors.affiliation: Institut und Poliklinik für Medizinische Psychologie, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Deutschland, m.bullinger@uke.de.
authors.forename: M
authors.initials: M
authors.lastname: Bullinger
authors.forename: C
authors.initials: C
authors.lastname: Blome
authors.forename: R
authors.initials: R
authors.lastname: Sommer
authors.forename: D
authors.initials: D
authors.lastname: Lohrberg
authors.forename: M
authors.initials: M
authors.lastname: Augustin
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods / Q000592:standards*; D017277:Drug Approval / Q000379:methods*; D023381:Endpoint Determination / Q000592:standards*; D019317:Evidence-Based Medicine / Q000379:methods; D005858:Germany; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D011795:Surveys and Questionnaires / Q000592:standards*; D016896:Treatment Outcome