Britto, Maria T.

Objective Prior work has identified numerous barriers to standardized outcome measurement in cleft care. The objective of this study was to evaluate a multifaceted implementation strategy to collect standardized outcomes for children with cleft lip and/or palate (CL/P). Design A one-armed, single-site pilot study of a multifaceted implementation strategy. Setting A metropolitan children's hospital. Patients Five-year-old children with CL/P. Interventions A multifaceted implementation strategy for standardized outcome measurement. Main Outcomes Measures The primary outcome measure was penetration of the intervention, defined as the proportion of children for whom the standardized measures of aesthetic, dental, and speech outcomes were collected. Penetration pre-implementation and 12 months post-implementation were compared. The secondary outcome was acceptability of standardized outcome measurement among providers and staff, evaluated with the Acceptability of Intervention Measure. Results The implementation strategy resulted in high penetration of standardized outcome measurement: measurement of aesthetic outcomes increased from 7% to 82% ( p < .0001); measurement of dental outcomes increased from 0% to 56% ( p < .0001); measurement of speech outcomes increased from 29% to 77% ( p = .0001). Acceptability of standardized outcome measurement was high, with 93% of cleft team providers and staff (n = 14/15) reporting that they somewhat or completely agreed that standardized outcome measurement met their approval, was appealing, was welcomed, and was liked. Penetration continued to improve after the implementation period, with high rates of outcome measure collection sustained for four years following implementation. Conclusions Deployment of a multifaceted implementation strategy led to substantial increases in the collection of aesthetic, dental, and speech outcomes among children with CL/P.

Objective: To identify child-, surgeon-, and hospital-specific factors at the time of primary cleft lip repair that are associated with the use of secondary cleft lip surgery. Design: Retrospective cohort study. Setting: Forty-nine pediatric hospitals. Participants: Children who underwent cleft lip repair between 1999 and 2015. Main outcome measure: Time from primary cleft lip repair to secondary lip surgery. Results: By 5 years after primary lip repair, 24.0% of children had undergone a secondary lip surgery. In multivariable analysis, primary lip repair before 3 months had a 1.22-fold increased hazard of secondary surgery (95% confidence interval [CI]: 1.02-1.46) compared to repair at 7 to 12 months of age, and children with multiple congenital anomalies had a 0.77-fold decreased hazard of secondary surgery (95% CI: 0.68-0.87). After adjusting for cleft type, age at repair, presence of multiple congenital anomalies, and procedure volume, there remained substantial variation in secondary surgery use among surgeons and hospitals ( P < .01). For children with unilateral cleft lip repaired at 3 to 6 months of age, the predicted proportion of children undergoing secondary surgery within 5 years of primary repair ranged from 4.9% to 21.8% across surgeons and from 4.5% to 24.7% across hospitals. Conclusions: There are substantial differences among surgeons and hospitals in the rates of secondary lip surgery. Further work is needed to identify causes for this variation among providers.

Objective: To identify child-, surgeon- and hospital-specific factors at the time of primary cleft palate repair that are associated with the use of secondary palate surgery. Design: Retrospective cohort study. Setting: Forty-nine pediatric hospitals. Participants: Children who underwent cleft palate repair between 1998 and 2015. Main Outcome Measure: Time from primary cleft palate repair to secondary palate surgery. Results: By 5 years after the primary palate repair, 27.5% of children had undergone secondary palate surgery. In multivariable analysis, cleft type and age at primary palate repair were both associated with secondary surgery ( P < .01). Children with unilateral cleft lip and palate had a 1.69-fold increased hazard of secondary surgery (95% confidence interval [CI]: 1.54-1.85) compared to children with cleft palate alone. Primary palate repair before 9 months had a 3.99-fold increased hazard of secondary surgery (95% CI: 3.39-4.07) compared to repair at 16 to 24 months of age. After adjusting for cleft type, age at repair, and procedure volume, there remained substantial variation in secondary surgery use among surgeons and hospitals ( P < .01). For children with isolated cleft palate, the predicted proportion of children undergoing secondary surgery within 5 years of primary repair ranged from 8.5% to 46.0% across surgeons and 9.1% to 49.4% across hospitals. Conclusions: There are substantial differences among surgeons and hospitals in the rates of secondary palate surgery. Further work is needed to identify causes for this variation among providers and develop interventions to reduce the need for secondary surgery.