eprintid: 26829 rev_number: 13 eprint_status: archive userid: 1589 dir: disk0/00/02/68/29 datestamp: 2019-08-15 08:24:27 lastmod: 2019-09-22 01:14:03 status_changed: 2019-08-15 08:24:27 type: article metadata_visibility: show creators_name: Weber, Dorothea creators_name: Uhlmann, Lorenz creators_name: Schönenberger, Silvia creators_name: Kieser, Meinhard title: Adaptive propensity score procedure improves matching in prospective observational trials subjects: ddc-610 divisions: i-911100 divisions: i-911800 keywords: Adaptive design, Clinical Trials, Sample size recalculation, Matched cohort, Prospective matching 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 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. date: 2019 publisher: BioMed Central ; Springer id_scheme: DOI ppn_swb: 1672126622 own_urn: urn:nbn:de:bsz:16-heidok-268295 language: eng bibsort: WEBERDOROTADAPTIVEPR2019 full_text_status: public publication: BMC Medical Research Methodology volume: 19 number: 150 place_of_pub: London ; Berlin, Heidelberg pagerange: 1-11 issn: 1471-2288 citation: Weber, Dorothea ; Uhlmann, Lorenz ; Schönenberger, Silvia ; Kieser, Meinhard (2019) Adaptive propensity score procedure improves matching in prospective observational trials. BMC Medical Research Methodology, 19 (150). pp. 1-11. ISSN 1471-2288 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/26829/1/12874_2019_Article_763.pdf