The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed the first step in the revision of its methods paper and published the version "General Methods 4.1" on the Internet on 28 November 2013. From now on the new document forms the basis for the scientific work of the Institute and its external experts and for collaboration with the commissioning agencies (the Federal Joint Committee and the Federal Ministry of Health).
Instead of preparing, as previously, a full update of the methods paper, the Institute is revising the General Methods 4.0 in several steps. The first changes primarily affect Chapter 3 on benefit assessment and Section 7.3.8 on meta-analyses.
What is new?
The levels of certainty of conclusions for different situations of evidence in benefit assessments – proof, indication and hint – are now described in more detail. For this purpose, in the chapter on benefit assessment IQWiG has split former Section 3.1.4 into two sections, namely the new section "Outcome-related assessment" (now 3.1.4) and the former section "Summarizing assessment" (now 3.1.5). In Section 3.1.4 the Institute has extended criteria describing in which exceptional cases proof of benefit, i.e., the highest level of certainty of conclusions, can also be inferred from only one study. IQWiG follows suggestions from the commenting procedure here.
Section 3.3.3 on the early benefit assessment of new drugs now contains a detailed description of how IQWiG operationalizes the determination of the extent of added benefit. A new appendix contains a comprehensive rationale for the underlying methodological approach.
The use of prediction intervals in meta-analyses with random effects was added to Section 7.3.8 on meta-analyses. Prediction intervals are an important instrument in assessing whether and how clearly effects observed in studies are in the same direction. According to the new Section 3.1.4, this again plays an important role when deriving conclusions on the available evidence.
IQWiG published the draft containing the first step of the updates of General Methods 4.0 and the new sections of General Methods 4.1 on 19 April 2013 and invited interested parties to submit comments in a commenting procedure. These comments have been considered in the present Version 4.1.
Together with its methods paper IQWiG has published a "Documentation and evaluation of comments", which contains the full verbatim written comments as well as their evaluation, that is, IQWiG's responses to all the main arguments presented in the comments.
The next step
The draft of the next updates and additions are planned for publication in the first quarter of 2014. This will again be followed by a commenting procedure and the final revision of the corresponding sections of the methods paper, resulting in General Methods 4.2. This document will as usual be published on the Institute's website.
The second step involves, among other things, new sections on the assessment of the potential of non-drug interventions in accordance with the testing regulation (Erprobungsregelung). This type of assessment has been conducted by IQWiG since the Health Care Structure Law (Versorgungsstrukturgesetz, GKV-VStG) became effective in 2013.
The English-language version of the General Methods Version 4.1 will be available soon. If you would like to be informed when this document is available, please send an e-mail to email@example.com.
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