| Title: |
Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials |
| Authors: |
Karla Hemming, Jacqueline Y. Thompson, Richard L. Hooper, Obioha C. Ukoumunne, Fan Li, Agnes Caille, Brennan C. Kahan, Clemence Leyrat, Michael J. Grayling, Nuredin I. Mohammed, Jennifer A. Thompson, Bruno Giraudeau, Elizabeth L. Turner, Samuel I. Watson, Beatriz Goulão, Jessica Kasza, Andrew B. Forbes, Andrew J. Copas, Monica Taljaard |
| Source: |
Trials, Vol 26, Iss 1, Pp 1-14 (2025) |
| Publisher Information: |
BMC, 2025. |
| Publication Year: |
2025 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
Cluster randomized trials, Group randomization, Statistical analysis plans, Analysis plans, Guidelines, Medicine (General), R5-920 |
| More Details: |
Abstract Background Guidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients and not groups of patients. There are critical considerations for the analysis of cluster randomized trials, such as accounting for clustering, the risk of imbalances between the arms due to post-randomization recruitment, and the need to use small sample corrections when the number of clusters is small. Methods This paper outlines the protocol for the development of a set of reporting guidelines for the content of statistical analysis plans for cluster randomized trials (including variations such as the stepped wedge cluster randomized trial and other cluster cross-over designs) by extending the minimum reporting analysis requirements as previously defined for individually randomized trials to cluster randomized trials. The guideline will be developed using a consensus-based approach, modifying existing reporting items from the guideline for individually randomized trials and extending to include new items. Discussion The guideline will be developed so it can be used independently of the guideline for individually randomized designs. The consensus guidelines will be published in an open-access journal, including key guidance as well as exploration and elaboration. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1745-6215 |
| Relation: |
https://doaj.org/toc/1745-6215 |
| DOI: |
10.1186/s13063-025-08756-3 |
| Access URL: |
https://doaj.org/article/719149989f9a49fdb0e1722509e037c4 |
| Accession Number: |
edsdoj.719149989f9a49fdb0e1722509e037c4 |
| Database: |
Directory of Open Access Journals |
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