Abstract:
BACKGROUND:Randomized controlled trials are the gold-standard for clinical trials. However, randomization is not always feasible. In this article we propose a prospective and adaptive matched case-control trial design assuming that a control group already exists. METHODS:We propose and discuss an interim analysis step to estimate the matching rate using a resampling step followed by a sample size recalculation. The sample size recalculation is based on the observed mean resampling matching rate. We applied our approach in a simulation study and to a real data set to evaluate the characteristics of the proposed design and to compare the results to a naive approach. RESULTS:The proposed design achieves at least 10% higher matching rate than the naive approach at final analysis, thus providing a better estimation of the true matching rate. A good choice for the interim analysis seems to be a fraction of around [Formula: see text] to [Formula: see text] of the control patients. CONCLUSION:The proposed resampling step in a prospective matched case-control trial design leads to an improved estimate of the final matching rate and, thus, to a gain in power of the approach due to sensible sample size recalculation.
journal_name
BMC Med Res Methodoljournal_title
BMC medical research methodologyauthors
Weber D,Uhlmann L,Schönenberger S,Kieser Mdoi
10.1186/s12874-019-0763-3subject
Has Abstractpub_date
2019-07-16 00:00:00pages
150issue
1issn
1471-2288pii
10.1186/s12874-019-0763-3journal_volume
19pub_type
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