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

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.

Timing of Primary Surgery for Cleft Palate.

Background: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown.

Methods: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments.

Articulating the issues: speech assessment and intervention in cleft lip and palate.

This paper describes the impact of cleft lip and palate on speech. It provides an overview for the dental clinician of the key issues affecting speech development and clarity. The paper summarises the complex speech mechanism and cleft-related factors that affect speech, including palatal, dental and occlusal anomalies.

Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS).

Canonical babbling (CB) is commonly defined as present when at least 15% of all syllables produced are canonical, in other words a canonical babbling ratio (CBR) ≥0.15. However, there is limited knowledge about inter-rater reliability in classification of CB status based on CBR and inter-rater differences in assessment of CBR.

A cross-sectional cohort study of speech in five-year-olds with cleft palate ± lip to support development of national audit standards: benchmarking speech standards in the United Kingdom.

Objective: To develop national standards for speech outcomes and processes of care for children with cleft palate ± lip and to test the standards using national data.

Design, Setting, And Participants: In this large, multicenter, prospective cohort study, speech recordings of 1110 five-year-olds with cleft palate involvement (born 2001 to 2003) were collected by 12 cleft centers in Great Britain and Ireland. Recordings were analyzed by consensus by specialist speech and language therapists using the Cleft Audit Protocol for Speech-Augmented.

Multiple Individual Audit Outcome Web--a novel tool to evaluate patient outcomes.

Multiple Individual Audit Outcome Web (MIAOW) is a pictorial representation of outcomes, which is used widely in industry, finance, and sports, but not, to the best of our knowledge, in our specialty. It was developed to display multiple audit outcomes for patients in cleft surgery and we show its use in that area, but equally it could be applied to other areas such as orthognathic surgery, and head and neck oncology. We report how it can be used to display surgical outcomes.