Universität zu Köln

Mensch, Alexander ORCID: 0000-0003-0089-4473, Beck, Tanja, Civello, Daniele ORCID: 0000-0001-7905-3292, Kunigkeit, Christopher, Lachmann, Nicole, Stock, Stephanie ORCID: 0000-0002-1726-9300, Gandjour, Afschin and Mueller, Dirk (2018). Applying GRADE Criteria to Clinical Inputs to Cost-Effectiveness Modeling Studies. Pharmacoeconomics, 36 (8). S. 987 - 995. NORTHCOTE: ADIS INT LTD. ISSN 1179-2027

Full text not available from this repository.

Abstract

Background Concerns have been raised about the use of clinical data in cost-effectiveness models. The aim of this analysis was to evaluate the appropriate use of data on clinical effectiveness in cost-effectiveness modeling studies that were published between 2001 and 2015. Methods Assessors rated 72 modeling studies obtained from three therapeutic areas by applying criteria defined by the Grading of Recommendations Assessment, Development and Evaluation group for assessing the quality of clinical evidence: selection of clinical data (publication bias), imprecision, indirectness, inconsistency (i.e., heterogeneity), and study limitations (risk of bias). For all parameters included in the analyses, potential changes over time were assessed. Results Although three out of four modeling studies relied on randomized controlled trials, more than 60% of the modeling studies were based on clinical data with a high or unclear risk of bias, in more than 80%, a risk of publication bias was found, and in about 30%, evidence was based on indirect clinical evidence, having significantly increased over the years. Study limitations were inadequately described in more than one third of the studies. However, less than 10% of clinical studies showed inconsistency or imprecision in study results. Conclusion Despite the fact that the majority of economic evaluations are based on precise and consistent randomized controlled trials, their results are often affected by limitations arising from methodological shortcomings in the underlying data on clinical efficacy. Modelers and assessors should be more aware of aspects surrounding the quality of clinical evidence as considered by the Grading of Recommendations Assessment, Development and Evaluation group.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mensch, Alexander UNSPECIFIED orcid.org/0000-0003-0089-4473 UNSPECIFIED Beck, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Civello, Daniele UNSPECIFIED orcid.org/0000-0001-7905-3292 UNSPECIFIED Kunigkeit, Christopher UNSPECIFIED UNSPECIFIED UNSPECIFIED Lachmann, Nicole UNSPECIFIED UNSPECIFIED UNSPECIFIED Stock, Stephanie UNSPECIFIED orcid.org/0000-0002-1726-9300 UNSPECIFIED Gandjour, Afschin UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-179268
DOI:	10.1007/s40273-018-0651-4
Journal or Publication Title:	Pharmacoeconomics
Volume:	36
Number:	8
Page Range:	S. 987 - 995
Date:	2018
Publisher:	ADIS INT LTD
Place of Publication:	NORTHCOTE
ISSN:	1179-2027
Language:	English
Faculty:	Faculty of Medicine
Divisions:	Faculty of Medicine > Sonstiges > Zentrum für Versorgungsforschung Köln
Subjects:	Medical sciences Medicine
Uncontrolled Keywords:	Keywords Language GUIDELINES; QUALITY Multiple languages Economics; Health Care Sciences & Services; Health Policy & Services; Pharmacology & Pharmacy Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17926