A Task-Shifted Speech Therapy Program for Cleft Palate Patients in Rural Nepal: Quality of Life, Impact, and Associated Healthcare Barriers

Abstract

Background: Access to surgical care for cleft lip/palate (CL/P) has improved in low- and middle-income countries (LMICs). After surgery, however, children with cleft palate often have speech deficits such as velopharyngeal insufficiency (VPI) that significantly impact quality of life and development. Speech therapy is therefore required but often lacking in low-resource settings due to limited staff and healthcare infrastructure. Innovative programs that improve cleft care delivery in low-resource settings and tools to measure quality of life among patients with cleft palate are desperately needed. Objectives: 1) Translate and validate the VPI Effects on Life Outcomes (VELO) instrument in Nepali; 2) Evaluate the impact of task-shifted speech therapy on a standardized speech score; 3) Describe the experiences of families and associated barriers towards achieving cleft care; 4) Explore cleft care optimization informed by the experiences of families whose children had nominal improvements after task-shifted speech therapy. Methods: For objective 1, the VELO instrument was translated to Nepali, piloted, and modified using patient cognitive interviews. It was then administered to children aged 8-18. Internal consistency was evaluated using Cronbach’s α coefficient. Concurrent validity and discriminant validity were assessed using a two-sample t-test, assuming unequal variances. For objectives 2-4, we evaluated the experience of children and families who received speech therapy from lay workers (i.e., in a task-shifted model) with a convergent parallel mixed-methods study. Standardized speech scores were compared by a blinded speech-language pathologist before and after the speech intervention. Semi-structured interviews (SSIs) and focus groups with families evaluated cleft care experiences and barriers. Qualitative and quantitative data were merged and analyzed. Results: The VELO-Nepali demonstrated excellent internal consistency, with Cronbach’s α coefficients of 0.93, 0.94, and 0.90 for VPI cases, guardians of VPI cases, and non-VPI controls, respectively. VELO-Nepali exhibited strong discriminant validity between VPI cases (x̅=45.4, SD 22.1) and non-VPI controls (x̅=84.9, SD 12.3), (p<0.001). VELO-Nepali showed strong concurrent validity with similarities in VPI case scores (x̅=45.4, SD 22.1), and guardian scores (x̅=52.9, s=22.8), (p=0.473). Thirty-nine children with speech deficits after palatoplasty (ages 3-18) underwent task-shifted speech therapy and demonstrated significant improvements in composite speech scores (p<0.0001) and weakness (p=0.0002), with borderline improvements in misarticulation (p=0.07) and glottal stop (p=0.05). Forty-seven SSIs demonstrated that the greatest barriers to follow-up were family responsibilities (62%), travel/distance (53%), and work (34%). In five focus groups, families expressed a desire to improve their child’s speech and seek formal speech therapy. The speech intervention was found to be beneficial because of the compassionate staff, free lodging/food, and ability to socialize with other patients and families. After merging quantitative and qualitative data, we noted that younger children between 3-5 years old and families who traveled greater distances for healthcare access benefited less from the speech therapy intervention. Conclusion: The translated VELO-Nepali demonstrates strong internal consistency, discriminant validity, and concurrent validity, and can assess quality of life for Nepali patients with VPI. This instrument represents the first VPI quality-of-life assessment validated in a low- or low-middle-income county; it supports the feasibility of its validation and implementation in other such countries, especially those in South Asia where the burden of CL/P is significant. Task-shifted speech therapy has the potential to improve cleft lip/palate speech in LMICs. Multiple biosocial issues limit access to appropriate post-operative care.