Development and Application of a Novel Patient-Reported Outcome Measure on QoL and Facial Aesthetics-A Study on South Indian Population.

BACKGROUND: The goal of cleft therapy has progressed from simply correcting the deformity to uplifting the patient's quality of life (QoL). At the end of comprehensive treatment, a patient with cleft lip and palate (CLP) should report with satisfactory QoL scores in all domains such as aesthetics, speech, function, and psychology. OBJECTIVE: To develop and validate a novel, disease-specific questionnaire designed in 2 regional languages to assess the QoL in young adult patients with CLP of South India following comprehensive treatment. METHODS: A preliminary questionnaire was created from the literature review and patient interviews, considering regional sociodemographic conditions. The questionnaire was then validated by subject experts and pilot tested. The resultant tool was implemented on patients at treatment completion. Data collected were assimilated for statistical evaluation. RESULTS: The questionnaire was deemed reliable (Cronbach alpha = .854 and test-retest reliability, kappa = 0.8) and was administered to 100 young adult patients with CLP (mean age: 22 years). A large majority (83%) of the population felt more confident about themselves, with positive responses to familial relations, social interaction, and self-image. About 25% of the patients faced problems with speech regularly, while a majority of patients did not face problems with chewing and swallowing. Nearly 60% of patients were fully satisfied with their facial appearance, while others had concerns about their lip and nose aesthetics. The results were descriptive of the local population. CONCLUSIONS: Most patients achieved satisfactory QoL in all domains following comprehensive multispeciality therapy. The novel tool is simple, reliable, and can be adapted to homogenous population groups.