Shimelis Nigusse Doni

Background: Cutaneous leishmaniasis (CL) is a major public health concern, particularly in Ethiopia, where about 40 000 new cases occur annually, predominantly caused by Leishmania aethiopica. Clinical phenotypes include localized CL (LCL), mucocutaneous leishmaniasis (MCL) and diffuse CL (DCL). Despite the high disease burden, treatment options and high-quality data on treatment outcomes are limited. Objectives: To evaluate the effectiveness of standard treatments in Ethiopia to inform future clinical trials. Methods: We conducted an observational cohort study of patients with parasitologically confirmed cutaneous leishmaniasis at two specialized dermatology referral hospitals. Clinical- and patient-reported outcomes were assessed at baseline and at standardized times during follow-up. The primary clinical outcome measure (‘cure’) was complete re-epithelialization or flattening of the index lesion at day 90. Patient-reported outcomes were assessed using skin-specific and general quality-of-life scores. Results: We enrolled 666 participants from April 2022 to October 2023. Median patient age was 20 years (interquartile range 14–35) and 405 patients were male (60.8%). More than half (n = 372; 55.9%) had previously received traditional treatment for CL. Most participants had LCL (n = 390; 58.6%) or MCL (n = 261; 39.1%). Intramuscular sodium stibogluconate 20 mg kg–1 daily was the most frequently used systemic therapy, either alone or in combination with lesion-directed therapy (cryotherapy or intralesional sodium stibogluconate). At day 90, 28.3% (n = 83/293) of participants with LCL, 23.5% (v = 47/200) with MCL and 8% (n = 1/12) with DCL were deemed cured. By day 90, all patient-reported outcomes of skin health improved for those with LCL or MCL, but skin and CL-related quality-of-life scores did not improve for those with DCL. Most participants (n = 522/641; 81.4%) experienced at least one clinical adverse event and 7.2% (n = 46/641) had abnormal laboratory findings during treatment. Conclusions: Current treatment strategies have low cure rates in Ethiopia. Well-designed randomized controlled trials are urgently needed to improve management of CL caused by L. aethiopica.

Background: Skin diseases are associated with reduced health‐related quality of life (HRQoL) of children and their families. The Children’s Dermatology Life Quality Index (CDLQI) questionnaire is a skin disease‐specific measure of HRQoL in children. Our study aimed to translate the CDLQI into Amharic, culturally adapt, and evaluate the validity and reliability of the translation. Methods: This study was embedded within a larger hospital‐based cohort study of cutaneous leishmaniasis (CL). Forward–backward translation procedures were conducted, followed by assessment of content and face validity. The psychometric properties were evaluated through reliability (internal consistency and interrater reliability), construct validity (including known‐group, convergent, and discriminant validity), and responsiveness to change. Cronbach’s alpha, intraclass correlation coefficient (ICC), Mann–Whitney U test, Kruskal–Wallis test, confirmatory factor analysis (CFA), and Wilcoxon paired rank test were used to assess internal consistency, interrater reliability, known‐group validity, construct validity, and responsiveness to change validity, respectively. Results: The CDLQI showed acceptable content validity with a modified kappa between 0.7 and 0.9. In a pilot testing, children reported that the items in the translated Amharic version of the CDLQI were unambiguous. Among 188 enrolled participants, 129 (68.62%) were diagnosed with CL and 59 (31.38%) with other skin conditions. The median CDLQI score was 7 (IQR = 10). The overall Cronbach’s alpha and ICC were 0.82 and 0.92, respectively. The median CDLQI score showed statistically significant differences between “mild” vs. “severe” and “moderate” vs. “severe” CL cases ( p < 0.001), as well as between the number of lesions (single vs. multiple) ( p = 0.034) and lesion size (< 40 mm vs. ≥ 40 mm) ( p < 0.001). CFA showed acceptable convergent validity with most items loading strongly (0.50–0.74), and Heterotrait–Monotrait ratio values ranging from 0.614 to 0.744. The CDLQI median score significantly decreased from Day 1 (median = 9) to Day 90 (median = 4; p < 0.001). Conclusions: Our Amharic version of the CDLQI showed acceptable validity and reliability, supporting its use in clinical practice and research to assess the HRQoL of Amharic‐speaking children with skin conditions in Ethiopia.

Localised cutaneous leishmaniasis (LCL) is a common neglected tropical disease in Ethiopia, which is mainly treated with intralesional (IL) pentavalent antimonial such as sodium stibogluconate (SSG) and/or cryotherapy. Both treatments are painful, and studies are lacking on the pain associated with these or affected individuals’ experiences of them. A cross-sectional, observational study was conducted at ALERT Comprehensive Specialized Hospital, Addis Ababa/Ethiopia. The socio-demographic and clinical data of individuals affected by LCL receiving IL SSG and/or cryotherapy was gathered, and their treatment was observed. Participants quantified their treatment-associated pain using the Wong–Baker Pain Scale. Health-related quality of life was measured using the (Children’s) Dermatology Life Quality Index. Adverse effects, participant experiences with local therapies, and dermatologists’ experiences and opinions of local LCL treatment were assessed using structured questionnaires. Of the thirty-six individuals with LCL included (64% male, 14% children), 52% reported a treatment-associated pain score ≥ 8. Cryotherapy administered with a cotton bud was associated with lower pain scores ≤ 6 (odds ratio: 0.15, 95% confidence interval: 0.03–0.89) compared to a cryotherapy spray device. There was wide variation in treatment administration. Local LCL treatment is painful, and most individuals experience significant pain. This study highlights the need for less painful but effective treatments, structured training, and clear standard operating procedures.

Introduction Cutaneous leishmaniasis (CL) remains a major public health challenge, especially in endemic regions like Ethiopia, where an estimated 40,000 new cases occur annually. Effective treatment evaluation for CL relies on consistent clinical assessments, yet variability in lesion descriptions can complicate reliable outcome measures. Methods We conducted an inter-reliability study of clinicians’ evaluations of CL lesion morphology and size at ALERT Hospital, Addis Ababa. Twelve clinicians independently examined 12 patients with parasitologically confirmed CL, each clinician assessing lesion morphology, size, and severity. Results We found high consistency in reporting major morphological categories (e.g., plaques) but significant variability in secondary features like dyspigmentation and scale, as well as mucosal involvement. Lesion size measurements showed limited variability, suggesting its reliability as a potential measure for future clinical trials. Disparities in severity assessments highlight the need for a standardized scoring system in CL. Discussion Our findings underscore the importance of training for consistent, high-quality clinical evaluations of CL and suggests that lesion size could be a reproducible outcome measure in treatment efficacy trials.

Introduction Cutaneous leishmaniasis (CL) remains a major public health challenge, especially in endemic regions like Ethiopia, where an estimated 40,000 new cases occur annually. Effective treatment evaluation for CL relies on consistent clinical assessments, yet variability in lesion descriptions can complicate reliable outcome measures. Methods We conducted an inter-reliability study of clinicians’ evaluations of CL lesion morphology and size at ALERT Hospital, Addis Ababa. Twelve clinicians independently examined 12 patients with parasitologically confirmed CL, each clinician assessing lesion morphology, size, and severity. Results We found high consistency in reporting major morphological categories (e.g., plaques) but significant variability in secondary features like dyspigmentation and scale, as well as mucosal involvement. Lesion size measurements showed limited variability, suggesting its reliability as a potential measure for future clinical trials. Disparities in severity assessments highlight the need for a standardized scoring system in CL. Discussion Our findings underscore the importance of training for consistent, high-quality clinical evaluations of CL and suggests that lesion size could be a reproducible outcome measure in treatment efficacy trials.

Background Cutaneous leishmaniasis (CL) is a skin neglected tropical disease, with an estimated 40,000 new cases each year in Ethiopia. CL causes ulcers, nodules, and plaques on the skin, and in some instances the destruction of the nasopharyngeal mucosa and cartilage. Some CL lesions may heal spontaneously, whilst other lesions may require therapies which are associated with discomfort, adverse effects, prolonged treatment, and a frequent lack of a complete response. Scarring, a sequela of CL, causes permanent disfigurement and is associated with stigma linked with a reduction in health-related quality of life. The choice of treatment for CL is based upon factors including the causative species; the number, extent, size, and location of lesions; and the availability of treatments. The development of robust evidence for CL treatment is hindered by a lack of validated and appropriate outcome measures and few data to support hypothesis-generation and trial design. There is a paucity of prospective data with well-defined treatment outcomes for CL caused by L. aethiopica. Aim The overall aim of this study is to improve the understanding of the health and economic burden of CL. Methods We have designed an observational, multi-centre cohort study to examine treatment outcomes for CL in Ethiopia which includes clinical outcomes, laboratory outcomes, patient reported outcome measures, scar assessments and cost effectiveness. We aim to recruit up to 750 participants across two hospital sites. We present here the protocol for this cohort study with a 12-month follow up period for each participant. Conclusions These data will inform the design of randomized controlled trials to evaluate new treatment strategies, with appropriate economic evaluations. This will help improve evidence-based guidelines and support evidence-led policy decisions, not only in Ethiopia but also globally.

Background: Cutaneous leishmaniasis (CL) is a growing public health threat in Ethiopia. Leishmania aethiopica is the predominant causative organism. Affected individuals develop chronic skin lesions on exposed parts of the body, mostly on the face, which are disfiguring and cause scarring. The effects of CL on the health-related quality of life (HRQoL) of affected individuals has not been assessed in Ethiopia. Objective: To assess HRQoL in adults with active CL at ALERT Hospital, Addis Ababa, Ethiopia. Methods: A cross-sectional study was done using the Amharic version of the Dermatology Life Quality Index (DLQI). Trained health staff administered the DLQI. Results: Three hundred and two adults with active CL participated and all of them exhibited a reduced HRQoL. The median DLQI score was 10 (IQR 8). Almost half of the participants reported very poor HRQoL, 36.4% and 11.3% fell within the very large and extremely large effect categories respectively. DLQI scores were higher (median 18) in patients diagnosed with diffuse cutaneous leishmaniasis (DCL) compared to those with localized cutaneous leishmaniasis (LCL). The DLQI domain of ‘work and school’ was the most affected, scoring 73.3% and 66.6% of total possible score for female and male respectively, followed by that of ‘symptom and feeling’ (at 50.0% and 56.6% for female and male respectively). Men were more affected than women in the domains of ‘leisure’ (P = 0.002) and ‘personal relationships’ (P = 0.001). In the multivariate ordinal logistic regression site of lesion, clinical phenotype and age of participant remained associated with significantly poor HRQoL. Conclusion: The HRQoL impairment associated with CL is significant. Thus, patient-reported outcome measure should be used to assess the efficacy of treatments along with clinical outcome measures.

Background: Cutaneous leishmaniasis (CL) is a skin neglected tropical disease, with an estimated 40,000 new cases each year in Ethiopia. CL causes ulcers, nodules, and plaques on the skin, and in some instances the destruction of the nasopharyngeal mucosa and cartilage. Some CL lesions may heal spontaneously, whilst other lesions may require therapies which are associated with discomfort, adverse effects, prolonged treatment, and a frequent lack of a complete response. Scarring, a sequela of CL, causes permanent disfigurement and is associated with stigma linked with a reduction in health-related quality of life. The choice of treatment for CL is based upon factors including the causative species; the number, extent, size, and location of lesions; and the availability of treatments. The development of robust evidence for CL treatment is hindered by a lack of validated and appropriate outcome measures and few data to support hypothesis-generation and trial design. There is a paucity of prospective data with well-defined treatment outcomes for CL caused by L. aethiopica. Aim: The overall aim of this study is to improve the understanding of the health and economic burden of CL. Methods: We have designed an observational, multi-centre cohort study to examine treatment outcomes for CL in Ethiopia which includes clinical outcomes, laboratory outcomes, patient reported outcome measures, scar assessments and cost effectiveness. We aim to recruit up to 750 participants across two hospital sites. We present here the protocol for this cohort study with a 12-month follow up period for each participant. Conclusions: These data will inform the design of randomized controlled trials to evaluate new treatment strategies, with appropriate economic evaluations. This will help improve evidence-based guidelines and support evidence-led policy decisions, not only in Ethiopia but also globally.

Background: Cutaneous leishmaniasis (CL) is a growing public health threat in Ethiopia. Leishmania aethiopica is the predominant causative organism. Affected individuals develop chronic skin lesions on exposed parts of the body, mostly on the face, which are disfiguring and cause scarring. The effects of CL on the health-related quality of life (HRQoL) of affected individuals has not been formally assessed in Ethiopia. Objective: To assess HRQoL in adults with active CL at ALERT Hospital, Addis Ababa, Ethiopia. Methods: A cross-sectional study was done using the Amharic version of the Dermatology Life Quality Index (DLQI). Trained health staff administered the DLQI. Results: Three hundred and two adults with active CL participated and all of them exhibited a reduced HRQoL. The median DLQI score was 10 (IQR 8). Almost half of the participants reported very poor HRQoL, 36.4% and 11.3% fell within the very large and extremely large effect categories respectively. DLQI scores were higher (median 18) in patients diagnosed with diffuse cutaneous leishmaniasis (DCL) compared to those with localized cutaneous leishmaniasis (LCL). The DLQI domain of ‘work and school’ was the most affected, scoring 73.3% and 66.6% of total possible core for female and male respectively, followed by that of ‘symptom and feeling’ (at 50.0% and 56.6% for female and male respectively). Men were more affected than women in the domains of ‘leisure’ (P=0.002) and ‘personal relationships’ (P=0.001). In the multivariate ordinal logistic regression site of lesion, clinical phenotype and age remained associated with significantly poor HRQoL. Conclusion: The HRQoL impairment in people affected by CL is significant. This warrants improved care and treatment in Ethiopia, counseling on the nature of CL, therapeutic options as well as clinical outcomes and complications. Importantly, patient-reported outcome measures including the DLQI should be used to assess treatment efficacy patient care algorisms. Plain Language Summary: Cutaneous leishmaniasis (CL) is an important public health problem in Ethiopia with an estimated incidence up to 50,000 cases per year. CL is predominately due to Leishmania aethiopica. The transmission is zoonotic by Phlebotomus longipes and Ph. pedifer , and hyraxes being the incriminated reservoir hosts. The lesion is chronic on the exposed part of the body, commonly on the face. Three main clinical phenotypes are recognized; localized (LCL), mucocutaneous (MCL), and diffuse CL (DCL) cutaneous leishmaniasis. The permanent damage and altered anatomy of the skin, nose, eyelids, ears and lips due to scarring is often associated with stigma. This study aimed to assess the health-related quality of life (HRQoL) using the Amharic version of the Dermatology Life Quality Index (DLQI) in adults diagnosed with active CL. Our results show that the impact on HRQoL associated with CL is large. There was no significant difference between men and women, and urban and rural dwellers. Participants with DCL, the more extensive form of CL, had lower HRQoL compared to those with other forms. Those with lesions on their head and neck regions and younger than 50 year (20 to 49 years age group) had significantly low HRQoL (P<0.05). The reduced HRQoL associated with CL in Ethiopia requires warrants improved, counseling on the nature of CL, therapeutic options as well as clinical outcomes and complications. Importantly, patient-reported outcome measures including the DLQI should be used to assess the efficacy of treatments and patient care algorisms.