A cross-sectional survey of 5-year-old children with non-syndromic unilateral cleft lip and palate: the Cleft Care UK study. Part 1: background and methodology.

M Persson,A K Wills,A J Hall,J R Sandy,R Al‐Ghatam,H Worthington,W Hollingworth,A Waylen,T Jones,A J Ireland,R Preston,D Sell,T J Peters,A R Ness,J Smallridge

doi:10.1111/ocr.12104

Abstract

Structured ObjectivesWe describe the methodology for a major study investigating the impact of reconfigured cleft care in the United Kingdom (UK) 15 years after an initial survey, detailed in the Clinical Standards Advisory Group (CSAG) report in 1998, had informed government recommendations on centralization.Setting and Sample PopulationThis is a UK multicentre cross-sectional study of 5-year-olds born with non-syndromic unilateral cleft lip and palate. Children born between 1 April 2005 and 31 March 2007 were seen in cleft centre audit clinics.Materials and MethodsConsent was obtained for the collection of routine clinical measures (speech recordings, hearing, photographs, models, oral health, psychosocial factors) and anthropometric measures (height, weight, head circumference). The methodology for each clinical measure followed those of the earlier survey as closely as possible.ResultsWe identified 359 eligible children and recruited 268 (74.7%) to the study. Eleven separate records for each child were collected at the audit clinics. In total, 2666 (90.4%) were collected from a potential 2948 records. The response rates for the self-reported questionnaires, completed at home, were 52.6% for the Health and Lifestyle Questionnaire and 52.2% for the Satisfaction with Service Questionnaire.ConclusionsResponse rates and measures were similar to those achieved in the previous survey. There are practical, administrative and methodological challenges in repeating cross-sectional surveys 15 years apart and producing comparable data.

Highlights

The organization of care for children born with a cleft of the lip and/or palate in the United Kingdom (UK) underwent significant change over the last 15 years as the Clinical Standards Advisory Group (CSAG) report was published in 1998 [1] and the onset of the CCUK study
The cleft centres identified 359 eligible children born in the period 1 April 2005 to 31 March 2007, and this figure was corroborated through the national database CRANE
The study was officially closed on the 15 May 2013 when we had recruited 268 (87 females, 181 males) of the 359 eligible children 5-year-olds born with unilateral cleft lip and palate (UCLP) (74.7%)

Summary

Introduction

The organization of care for children born with a cleft of the lip and/or palate in the United Kingdom (UK) underwent significant change over the last 15 years as the Clinical Standards Advisory Group (CSAG) report was published in 1998 [1] and the onset of the CCUK study. The implementation period has been prolonged, but all cleft services are in an ongoing process of centralization. The impact of these changes on care and outcome is unclear [7]. The CSAG survey team identified 326 5-year-olds born with UCLP in the UK over a 2-year period, and outcome records were collected for 239 of these children. The findings of the report were far-reaching and accepted for the following reasons: 1. The evidence in the CSAG report was compelling and arose from a detailed and meticulous observational study

Methods

Results

Conclusion