TY  - JOUR
CY  - London ; Berlin, Heidelberg
EP  - 11
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/26829/
N2  - 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 1/2 to 2/3 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.
JF  - BMC Medical Research Methodology
PB  - BioMed Central ; Springer
ID  - heidok26829
VL  - 19
AV  - public
IS  - 150
Y1  - 2019///
TI  - Adaptive propensity score procedure improves matching in prospective observational trials
SN  - 1471-2288
KW  - Adaptive design
KW  -  Clinical Trials
KW  -  Sample size recalculation
KW  -  Matched cohort
KW  -  Prospective matching
A1  - Weber, Dorothea
A1  - Uhlmann, Lorenz
A1  - Schönenberger, Silvia
A1  - Kieser, Meinhard
SP  - 1
ER  -