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The study objective was to construct and validate a tool to assess, measure, and evaluate the barriers and obstacles that patients with orofacial clefts (OFCs), and their families, face during treatment. The Effective Accessibility and Accommodation subscale, based on the translated Primary Care Assessment Survey and Primary Care Assessment Tool scales, was used as a reference for the questionnaire. A total of 165 parents from three main cleft referral centers in Saudi Arabia were interviewed. Questionnaire content validity was conducted by calculation of a content validity index for each item (I-CVI) as well as for the total scale (S-CVI). Reliability was tested using Cronbach's alpha. Factor analysis and principal components analysis were performed to determine the factor structure of the instrument. The final questionnaire had nine items. Rating results showed both I-CVI and S-CVI scores of 1 and Cronbach's alpha was 0.86. There were three factors (geographic accessibility, appointment availability and accessibility, and scheduling-related barriers) with eigenvalues above 1.00, which collectively accounted for 73% of the variance. In conclusion, this tool is valid and reliable to evaluate accessibility and barriers to care of patients with OFCs in Saudi Arabia.

Instrument Development and Validation to Assess Care Barriers for Patients in Saudi Arabia with Oral Clefts