Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial-Reference-Cited by-同舟云学术

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

Published:2024-05-09 Issue: Volume: Page:
ISSN:1055-6656
Container-title:The Cleft Palate Craniofacial Journal
language:en
Short-container-title:The Cleft Palate Craniofacial Journal

Author:

Fell Matthew¹²^ORCID,Phippen Ginette²,van Eeden Stephanie³^ORCID,Chong David⁴,Swan Marc C.²,van Eeden Simon⁵,Carlin John B.⁶⁷

Affiliation:

1. The Cleft Collective, University of Bristol, Bristol, UK

2. The Spires Cleft Centre, Oxford University Hospitals NHS Foundation Trust/Salisbury NHS Foundation Trust, Oxford, UK

3. School of Education, Communication and Language Sciences, Newcastle University, Newcastle upon Tyne, UK

4. Plastic and Maxillofacial Surgery, The Royal Children's Hospital, Melbourne, Australia

5. Alder Hey Children's and Aintree University Hospitals, Liverpool, UK

6. Murdoch Children's Research Institute, Melbourne, Australia

7. Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia

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.

Publisher

SAGE Publications

Link

https://journals.sagepub.com/doi/pdf/10.1177/10556656241253949

Reference43 articles.

1. Timing of Primary Surgery for Cleft Palate

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3. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

4. Mind the Gap — Timing of Cleft Palate Repair