The Cutaneous leishmaniasis impact questionnaire: Translation, cross-cultural adaptation and validation in adults with Cutaneous leishmaniasis in Ethiopia

Background Cutaneous leishmaniasis (CL) is a vector-borne, neglected tropical disease of the skin. It is a public health problem in Ethiopia, associated with reduced health-related quality of life (HRQoL). The Cutaneous Leishmaniasis Impact Questionnaire (CLIQ), a CL-specific measurement, was developed and validated in Brazil. This study aimed to translate, culturally adapt, and validate the CLIQ in Amharic. Methods Translation, cultural adaptation, and pilot-testing of an Amharic version of the CLIQ were performed, involving a group of experts and affected individuals. The translated Amharic version of the CLIQ was administered to adults with confirmed active CL between February and September 2023. The Amharic version of the CLIQ was evaluated using Cronbach’s α, inter-rater reliability, and assessments of face, content, construct, and criterion validity. Results The translated and culturally modified Amharic version of the CLIQ was administered to 250 adults with CL. Of these, 158 (63.2%) participants had localized CL, and 114 (45.6%) were categorized as having moderately severe CL at enrolment. The Amharic version of the CLIQ had acceptable internal consistency (α = 0.913) and very good stability (ICC: 0.935 (95% C.I.: 0.908, 0.957)). It exhibited acceptable content validity with a modified kappa coefficient of 0.33 to 1.0. Confirmatory Factor Analysis revealed a two-cluster tool with factor loading of 0.33–0.83 for cluster 1 and 0.19 to 0.7 for cluster 2. A statistically significant difference was observed in median scores of severities (P < 0.001) and clinical phenotypes (P = 0.009). There was a significant reduction in CLIQ scores at Day 90 compared to Day 1 (P < 0.05). The clinically important difference of the CLIQ was calculated to be 12. Conclusion The Amharic version of the CLIQ is a reliable and valid instrument to measure the HRQoL associated with CL in adults in Ethiopia and can be used as a patient-reported outcome measure in the assessment of CL and its treatment.