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Updated: Jun 26, 2025
Author Spotlight: Development of a Novel Finite Element Analysis Model for Improved Orthognathic Surgical Techniques
Published on: October 20, 2023
Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery
Matthew Fell1,2, Ginette Phippen2, Stephanie van Eeden3
1The Cleft Collective, University of Bristol, Bristol, UK.
Abstract:
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.
