Hemming, Karla;
Thompson, Jacqueline Y;
Taljaard, Monica;
Watson, Samuel I;
Kasza, Jessica;
Thompson, Jennifer A;
Kahan, Brennan C;
(2024)
Re-analysis of data from cluster randomised trials to explore the impact of model choice on estimates of odds ratios: study protocol.
Trials
, 25
(1)
, Article 818. 10.1186/s13063-024-08653-1.
Preview |
Text
s13063-024-08653-1.pdf - Published Version Download (897kB) | Preview |
Abstract
Background: There are numerous approaches available to analyse data from cluster randomised trials. These include cluster-level summary methods and individual-level methods accounting for clustering, such as generalised estimating equations and generalised linear mixed models. There has been much methodological work showing that estimates of treatment effects can vary depending on the choice of approach, particularly when estimating odds ratios, essentially because the different approaches target different estimands. Methods: In this manuscript, we describe the protocol for a planned re-analysis of data from a large number of cluster randomised trials. Our main objective is to examine empirically whether and how odds ratios estimated using different approaches (for both primary and secondary binary outcomes) vary in cluster randomised trials. We describe the methods that will be used to identify the datasets for inclusion and how they will be analysed and reported. Discussion: There have been a number of small comparisons of empirical differences between the different approaches to analysis for CRTs. The systematic approach outlined in this protocol will allow a much deeper understanding of when there are important choices around the model approach and in which settings. This will be of importance given the heightened awareness of the importance of estimands and the specification of statistical analysis plans.
| Type: | Article |
|---|---|
| Title: | Re-analysis of data from cluster randomised trials to explore the impact of model choice on estimates of odds ratios: study protocol |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13063-024-08653-1 |
| Publisher version: | https://doi.org/10.1186/s13063-024-08653-1 |
| Language: | English |
| Additional information: | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
| Keywords: | Science & Technology, Life Sciences & Biomedicine, Medicine, Research & Experimental, Research & Experimental Medicine |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10205412 |
Archive Staff Only
 |
View Item |
