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Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial

Lookup NU author(s): Dr Stephanie Van Eeden

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2024, American Cleft Palate Craniofacial Association.The Timing of Primary Surgery (TOPS) trial was published August 2023 in the New England Journal of Medicine and is a milestone achievement for a study focused on cleft palate. Due to the complexity of outcome reporting in cleft and the rarity of such comparative trials, TOPS presents a useful opportunity to critically review the design, analysis and reporting strategies utilised. This perspective article focused on the inclusion of participants, the choice of the primary outcome measure and the analysis of ordinal data within the trial. Considerations for future comparative studies in cleft care are discussed.

Publication metadata

Author(s): Fell M, Phippen G, van Eeden S, Chong D, Swan MC, van Eeden S, Carlin JB

Publication type: Article

Publication status: Published

Journal: Cleft Palate Craniofacial Journal

Year: 2024

Pages: epub ahead of print

Online publication date: 09/05/2024

Acceptance date: 02/04/2024

Date deposited: 29/05/2024

ISSN (print): 1055-6656

ISSN (electronic): 1545-1569

Publisher: SAGE Publications Ltd

URL: https://doi.org/10.1177/10556656241253949

DOI: 10.1177/10556656241253949

PubMed id: 38725271

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