Universität zu Köln

Hasford, J., Bramlage, P., Koch, G., Lehmacher, W., Einhaeupl, K. and Rothwell, P. M. (2010). Inconsistent trial assessments by the National Institute for Health and Clinical Excellence and IQWiG: standards for the performance and interpretation of subgroup analyses are needed. J. Clin. Epidemiol., 63 (12). S. 1298 - 1305. OXFORD: PERGAMON-ELSEVIER SCIENCE LTD. ISSN 0895-4356

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Abstract

Objectives: The methodology for the critical assessment of medical interventions is well established. Regulatory agencies and institutions adhere, in principle, to the same standards. This consistency, however, is not always the case in practice. Study Design and Setting: Using the evaluation of the CAPRIE (Clopidogrel versus Aspirin in Patients at risk of Ischemic Events) trial by the British National Institute for Health and Clinical Excellence (NICE) and the German Institute for Quality and Efficiency in Health Care (IQWiG), we illustrate that there was no consensus for the interpretation of possible heterogeneity in treatment comparisons across subgroups. Results: The NICE concluded that CAPRIE demonstrated clinical benefit for the overall intention-to-treat (ITT) population with sufficient robustness to possible sources of heterogeneity. The IQWiG interpreted the alleged heterogeneity as implying that the clinical benefit only applied to the subgroup of patients with a statistically significant result irrespective of the results of the ITT analysis. Conclusion: International standards for the performance and interpretation of subgroup analyses as well as for the assessment of heterogeneity between strata are needed. (C) 2010 Elsevier Inc. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hasford, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bramlage, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Koch, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmacher, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Einhaeupl, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rothwell, P. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-491638
DOI:	10.1016/j.jclinepi.2009.10.009
Journal or Publication Title:	J. Clin. Epidemiol.
Volume:	63
Number:	12
Page Range:	S. 1298 - 1305
Date:	2010
Publisher:	PERGAMON-ELSEVIER SCIENCE LTD
Place of Publication:	OXFORD
ISSN:	0895-4356
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RANDOMIZED CONTROLLED-TRIALS; ST-SEGMENT ELEVATION; MYOCARDIAL-INFARCTION; CLOPIDOGREL; ASPIRIN; POWER Multiple languages Health Care Sciences & Services; Public, Environmental & Occupational Health Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/49163