Scandcleft Project Trial 2—Comparison of Speech Outcome in 1- and 2-Stage Palatal Closure in 5-Year-Olds With UCLP

Abstract

Objective: To investigate in-depth speech results in the Scandcleft Trial 2 with comparisons between surgical protocols and centers and with benchmarks from peers without cleft palate. Design: A prospective randomized clinical trial. Setting: Two Swedish and one Finnish Cleft Palate center. Participants: One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair at 3 to 4 months (Arm A), or a closure of both the soft and hard palate at 12 months (Arm C). Main Outcome Measures: A composite measure dichotomized into velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors. In addition, number of speech therapy visits, average hearing thresholds, and secondary surgeries were documented to assess burden of treatment. Results: Across the trial, 53.5% demonstrated VPC and 46.5% VPI with no significant differences between arms or centers. In total, 27% reached age-appropriate PCC scores with no statistically significant difference between the arms. The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors. Number of speech therapy visits was significantly higher in the Finnish center. Conclusion: At age 5, poor speech outcomes with some differences between participating centers were seen but could not be attributed to surgical protocol. As one center had very few participants, the results from that center should be interpreted with caution.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: Speech proficiency at 10 years of age

“…(2017). Outcomes from the main outcome age at 5 years have been reported (e.g., Hammarström et al., 2020; Lohmander et al., 2017a; Persson et al., 2020; Semb et al., 2017; Willadsen et al., 2017, 2019) and follow‐up data from age 10 have been collected. One British centre in Trial 3 ( n = 17) did not continue follow‐up beyond 5 years of age due to lack of resources and ethical approval.…”

“…The highest proportion of children with age-appropriate (> 90%) PCC scores were 44% (Arm D, early hard palate closure with vomer flap at 3-4 months of age and hard palate closure at 12 months). This benchmark measure (PCC > 90%) was not significantly different in any of the three trials (Hammarström et al, 2020;Persson et al, 2020;Willadsen et al, 2019). The outcome of velopharyngeal function at age 5 was based on the validated composite variable (VPC-Sum).…”

“…The surgical method with highest prevalence of velopharyngeal competence (VPC), assessed using the VPC‐Sum, had 62% (Arm B, Trial 1; long delay hard palate closure) (Lohmander et al., 2017a). A comparison across centres at age 5 in the Scandcleft project found a substantial variation in outcome of the same surgical method (Hammarström et al., 2020; Persson et al., 2020; Willadsen et al., 2019). This implied that other factors such as surgeons’ learning curve (Rautio et al., 2017), skills and experience (Williams et al., 1999; Shaw & Semb, 2017) should be taken into account.…”

Speech Outcomes Audit for Unilateral Cleft lip and Palate After 2-Stage Palate Repair: Preliminary Results

“…In a Scandcleft trial involving 2 Swedish and one Finnish center, 112 participants with unilateral cleft lip and palate presented poor speech outcomes at age 5, with some differences between participating centers that could not be attributed to surgical protocol 13 . Also, in this series of clinical trials, no differences were found regarding VPC and hypernasality at age 5 after different methods for primary palatal repair.…”

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft

“…Besides the used VPC measure, a more elaborate variant exists, namely the VPC-Summary (VPC-Sum). This includes assessment of hypernasality, passive VPI symptoms and the transcriptions of active non-oral consonant errors 36. VPC-Sum can either be reported as a score between 0 and 6, or as a dichotomised outcome (velopharyngeal competence or incompetence) 36…”