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Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen

Standard

Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen. / Bullinger-Naber, Monika; Blome, C; Sommer, R; Lohrberg, D; Augustin, M.

In: BUNDESGESUNDHEITSBLA, Vol. 58, No. 3, 15.01.2015, p. 283-290.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Bullinger-Naber, M, Blome, C, Sommer, R, Lohrberg, D & Augustin, M 2015, 'Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen', BUNDESGESUNDHEITSBLA, vol. 58, no. 3, pp. 283-290. https://doi.org/10.1007/s00103-014-2107-0

APA

Bullinger-Naber, M., Blome, C., Sommer, R., Lohrberg, D., & Augustin, M. (2015). Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen. BUNDESGESUNDHEITSBLA, 58(3), 283-290. https://doi.org/10.1007/s00103-014-2107-0

Vancouver

Bullinger-Naber M, Blome C, Sommer R, Lohrberg D, Augustin M. Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen. BUNDESGESUNDHEITSBLA. 2015 Jan 15;58(3):283-290. https://doi.org/10.1007/s00103-014-2107-0

Bibtex

@article{a0aa5e9df55745dfa6c6dba296eb8391,
title = "Gesundheitsbezogene Lebensqualit{\"a}t - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Ma{\ss}nahmen",
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.OBJECTIVES: 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).MATERIALS AND 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.",
author = "Monika Bullinger-Naber and C Blome and R Sommer and D Lohrberg and M Augustin",
year = "2015",
month = jan,
day = "15",
doi = "10.1007/s00103-014-2107-0",
language = "Deutsch",
volume = "58",
pages = "283--290",
journal = "BUNDESGESUNDHEITSBLA",
issn = "1436-9990",
publisher = "Springer",
number = "3",

}

RIS

TY - JOUR

T1 - Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen

AU - Bullinger-Naber, Monika

AU - Blome, C

AU - Sommer, R

AU - Lohrberg, D

AU - Augustin, M

PY - 2015/1/15

Y1 - 2015/1/15

N2 - 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.OBJECTIVES: 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).MATERIALS AND 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.

AB - 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.OBJECTIVES: 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).MATERIALS AND 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.

U2 - 10.1007/s00103-014-2107-0

DO - 10.1007/s00103-014-2107-0

M3 - SCORING: Zeitschriftenaufsatz

C2 - 25589357

VL - 58

SP - 283

EP - 290

JO - BUNDESGESUNDHEITSBLA

JF - BUNDESGESUNDHEITSBLA

SN - 1436-9990

IS - 3

ER -