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

## TL;DR

This study translated and validated a questionnaire to assess the impact of cutaneous leishmaniasis on quality of life in Ethiopia, showing it is reliable and useful for tracking treatment outcomes.

## Contribution

The study provides a validated Amharic version of the Cutaneous Leishmaniasis Impact Questionnaire (CLIQ) for use in Ethiopia.

## Key findings

- The Amharic CLIQ showed strong internal consistency (α = 0.913) and high stability (ICC: 0.935).
- The questionnaire effectively differentiated between mild, moderate, and severe cases of CL.
- CLIQ scores significantly improved after 90 days of treatment, indicating its ability to track meaningful health changes.

## Abstract

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.

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.

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.

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.

Cutaneous leishmaniasis is a skin disease that can cause long-lasting wounds, pain, and emotional distress. To better understand how the disease affects people’s daily lives, we tested an Amharic version of a questionnaire called the Cutaneous Leishmaniasis Impact Questionnaire (CLIQ). A total of 250 people with the disease took part in this study. Most participants were young adults, and many had the common form of disease that affects the skin. Doctors rated their illness as mild, moderate, or severe. After 90 days of treatment, more than half of the participants showed clear improvement, and some were completely cured. We examined how well the questionnaire measured people’s experiences about general impact as well as health service and treatment. The tool showed strong reliability, meaning it gives consistent results when used at different times. It also showed good ability to measure what it is meant to measure, such as the general impact of the disease and people’s feelings about treatment and health services. The questionnaire was also able to show differences in impact between mild, moderate, and severe cases. Scores improved after treatment among those who felt better, showing that the tool can track meaningful changes in health. Overall, the Amharic CLIQ is a useful and trustworthy tool for understanding how cutaneous leishmaniasis affects people in Ethiopia