# Cleft@18–23 study research clinics: a protocol for a multicentre observational study across UK cleft centres to understand variation in outcomes at the end of routine cleft care

## TL;DR

This study will investigate how outcomes for people with cleft lip and/or palate vary across the UK to improve future care.

## Contribution

The study introduces a multicentre observational protocol to assess variation in cleft care outcomes at the end of routine treatment.

## Key findings

- The study will collect data on speech, dental health, and psychosocial outcomes from young adults with cleft lip and/or palate.
- It aims to identify how factors like geography and socioeconomic status influence care outcomes.
- Findings will inform strategies to improve equitable care for individuals with cleft lip and/or palate in the UK.

## Abstract

Cleft lip and/or palate (CL/P) is a lifelong condition affecting one in 700 births. In the UK, individuals born with CL/P follow a care pathway at specialist regional cleft centres, which includes input from a range of professionals including surgeons, speech and language therapists, cleft specialist nurses, orthodontists, dentists and clinical psychologists. The cleft centres provide care from diagnosis to early adulthood. Individuals born with CL/P are typically discharged from routine care at their cleft centre between the ages of 15 and 25 years.

Outcome measures of cleft care are currently gathered at different timepoints across the treatment pathway nationally and include outcomes for speech, growth, dental health and psychosocial well-being. However, there is no consistent reporting of outcomes for young adults when they complete routine care, meaning we do not know whether variation in outcomes exists and what this might look like.

This research programme will investigate whether outcomes vary based on factors such as geographical location, biological sex, socioeconomic status or ethnicity. By understanding how outcomes might vary, and the scale and type of variation, we plan to work with young adults born with CL/P and specialist clinicians to develop ways to ensure that everyone born with CL/P in the UK receives the optimum care to meet their needs.

Cleft@18–23 is an observational study of young adults born with CL/P. Recruitment is planned across all regions of the UK, beginning in April 2025 with research clinics scheduled to run between June 2025 and May 2027. The recruitment target is 640 participants born with CL/P. Participants with all cleft diagnoses, including those with additional syndromic diagnoses, will be eligible for recruitment. We will recruit participants from all ethnic and socioeconomic backgrounds. Data collection will include self-report participant questionnaires, speech samples, a hearing screen, two-dimensional and three-dimensional medical photographs, an intraoral scan and a dental assessment. A range of descriptive and inferential statistical analyses will explore variation in outcomes across different groups.

The Cleft@18–23 study obtained ethical approval from the South West-Frenchay Research Ethics Committee on 26 November 2024 (REC reference: 24/SW/0128). Informed consent will be required for participation. Findings from the Cleft@18–23 study will be disseminated through peer-reviewed publications, conference presentations, newsletters, the study website (https://www.bristol.ac.uk/cleft18-23) and social media.

ISRCTN34027276.