Steffen Witte (now Novartis) has worked on the topic of your second
question.
Regards,
Christian
Methods Inf Med. 2004;43(5):470-4.
Some problems with the investigation of noninferiority in meta-analysis.
Witte S, Victor N.
Department of Medical Biometry, University of Heidelberg, Heidelberg,
Germany. [log in to unmask]
Abstract
OBJECTIVES: Noninferiority trials have become commonplace in recent
years. Like individual clinical trials, meta-analyses can also
investigate noninferiority. However, certain important topics have to be
considered. METHODS: The proposed methods in this paper have their
origin in the framework of noninferiority trials and meta-analyses. This
paper can therefore be seen as a combination of both fields. Two issues
are highlighted in the paper; difficulties in the choice of delta for a
noninferiority meta-analysis leading to different deltas and methods for
meta-analyses with different analysis sets, based on the full-analysis
set with the intention-to-treat principle or the per-protocol
population. Analytical methods, sensitivity analyses, meta-regression,
and a bivariate method are introduced. The proposed graphical
presentations support the analytical results. CONCLUSION: The confidence
interval approach using meta-regression or bivariate methods is
appropriate using both analysis sets for meta-analyses investigating
noninferiority.
Jesús López Alcalde schrieb:
> Hello everyone
>
>
>
> My name is Jesús López Alcalde. I'm a systematic reviewer working at
> the Lain Entralgo´s Agency (Madrid, Spain), a Cochrane Collaborating
> Centre. My role is facilitating and promoting Cochrane reviews in Madrid
> by helping with methodological issues and by coordinating the review
> authors.
>
>
>
> I am working in the protocol of a Cochrane systematic review titled:
> "Short course versus long course therapy of the same antibiotic for
> community-acquired pneumonia in adolescent and adult outpatients". This
> review will consider as eligible superiority, non-inferiority and
> equivalence randomised clinical trials.
>
>
>
> Does anyone has experience with systematic reviews
> including non-inferiority or equivalence trials?
>
>
>
> I think this is a relevant topic (non-inferiority trials have become
> very popular) but it is usually not considered in systematic reviews. On
> the other hand, there is scarce published literature on the methodology
> employed in such meta-analyses.
>
>
>
> My specific questions are:
>
> 1.- Should I specify in the review protocol a non-inferiority margin?
> 2.- What is the best analysis approach in the primary studies
> ('intention-to-treat' or 'per-protocol')?
> 3.- How to deal with the heterogeneity in the primary studies (for
> example, some of them being superiority trials, other non-inferiority or
> equivalence trials)?
>
>
>
> Thank you very much
> Jesús
>
>
> --
> Jesús López Alcalde
> Grupo Cochrane Iberoamericano de Seguridad del Paciente
> Centro Cochrane Iberoamericano (CCIb)
> Telf. (0034) 913 089 400 (Ext. 657)
> Telf. móvil: (0034) 633 217 736
>
> Jesús López Alcalde
> Systematic Reviews on Patient Safety Iberoamerican Group
> Iberoamerican Cochrane Centre
> Phone (0034) 913 089 400 (Ext. 657)
> Cel.: (0034) 633 217 736
|