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Indirect comparisons of therapeutic interventions

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Abstract:

Health political background: The comparison of the effectiveness of health technologies is not only laid down in German law (Social Code Book V, § 139 and § 35b) but also constitutes a central element of clinical guidelines and decision making in health care. Tools supporting decision making (e. g. Health Technology Assessments (HTA)) are therefore in need of a valid methodological repertoire for these comparisons. Scientific background: Randomised controlled head-to-head trials which directly compare the effects of different therapies are considered the gold standard methodological approach for the comparison of the efficacy of interventions. Because this type of trial is rarely found, comparisons of efficacy often need to rely on indirect comparisons whose validity is being controversially debated. Research questions: Research questions for the current assessment are: Which (statistical) methods for indirect comparisons of therapeutic interventions do exist, how often are they applied and how valid are their results in comparison to the results of head-to-head trials? Methods: In a systematic literature research all medical databases of the German Institute of Medical Documentation and Information (DIMDI) are searched for methodological papers as well as applications of indirect comparisons in systematic reviews. Results of the literature analysis are summarized qualitatively for the characterisation of methods and quantitatively for the frequency of their application. The validity of the results from indirect comparisons is checked by comparing them to the results from the gold standard – a direct comparison. Data sets from systematic reviews which use both direct and indirect comparisons are tested for consistency by of the z-statistic. Results: 29 methodological papers and 106 applications of indirect methods in systematic reviews are being analysed. Four methods for indirect comparisons can be identified: 1. Unadjusted indirect comparisons include, independent of any comparator, all randomised controlled trials (RCT) that provide a study arm with the intervention of interest. 2. Adjusted indirect comparisons 3. and metaregression analyses include only those studies that provide one study arm with the intervention of interest and another study arm with a common comparator. While the aforementioned methods use conventional metaanalytical techniques, 4. Mixed treatment comparisons (MTC) use Bayesian statistics. They are able to analyse a complex network of RCT with multiple comparators simultaneously. During the period from 1999 to 2008 adjusted indir

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