Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations]
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 spont...
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F1000 Research Ltd
2024-12-01
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| Online Access: | https://openresearch.nihr.ac.uk/articles/3-49/v2 |
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| author | Fewzia Shikur Mohammed Amel Beshir Mohammed Shimelis Doni Nigusse Feleke Tilahun Zewdu Abebaw Yeshambel Alemu Teklu Cherkose Kidist Bobosha Eshetu Molla Iris Mosweu Vanessa Yardley Saba Maria Lambert Mirgissa Kaba Endalamaw Gadisa Yohannes Hailemichael Catherine Pitt Elizabeth Allen Stephen L. Walker Michael Marks |
| author_facet | Fewzia Shikur Mohammed Amel Beshir Mohammed Shimelis Doni Nigusse Feleke Tilahun Zewdu Abebaw Yeshambel Alemu Teklu Cherkose Kidist Bobosha Eshetu Molla Iris Mosweu Vanessa Yardley Saba Maria Lambert Mirgissa Kaba Endalamaw Gadisa Yohannes Hailemichael Catherine Pitt Elizabeth Allen Stephen L. Walker Michael Marks |
| author_sort | Fewzia Shikur Mohammed |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9a65d92c5c444475ab17f363f8893c24 |
| institution | Kabale University |
| issn | 2633-4402 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj-art-9a65d92c5c444475ab17f363f8893c242025-01-18T01:00:00ZengF1000 Research LtdNIHR Open Research2633-44022024-12-01315037Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations]Fewzia Shikur Mohammed0Amel Beshir Mohammed1Shimelis Doni Nigusse2https://orcid.org/0000-0003-0455-2518Feleke Tilahun Zewdu3Abebaw Yeshambel Alemu4https://orcid.org/0000-0001-5722-250XTeklu Cherkose5https://orcid.org/0000-0003-2344-5435Kidist Bobosha6Eshetu Molla7https://orcid.org/0000-0001-8262-0622Iris Mosweu8Vanessa Yardley9https://orcid.org/0009-0005-3744-7003Saba Maria Lambert10https://orcid.org/0000-0003-4376-5495Mirgissa Kaba11Endalamaw Gadisa12https://orcid.org/0000-0002-5179-6278Yohannes Hailemichael13https://orcid.org/0000-0002-4831-6077Catherine Pitt14Elizabeth Allen15Stephen L. Walker16https://orcid.org/0000-0002-2034-8376Michael Marks17https://orcid.org/0000-0002-7585-4743ALERT Hospital, Addis Ababa, EthiopiaALERT Hospital, Addis Ababa, EthiopiaALERT Hospital, Addis Ababa, EthiopiaBoru Meda Hospital, Boru Meda, EthiopiaDepartment of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, EthiopiaDepartment of Malaria and Neglected Tropical Disease Research, Armauer Hansen Research Institute, Addis Ababa, EthiopiaDepartment of Malaria and Neglected Tropical Disease Research, Armauer Hansen Research Institute, Addis Ababa, EthiopiaDepartment of Malaria and Neglected Tropical Disease Research, Armauer Hansen Research Institute, Addis Ababa, EthiopiaDepartment of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UKDepartment of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UKALERT Hospital, Addis Ababa, EthiopiaSchool of Public Health, Addis Ababa University, Addis Ababa, EthiopiaDepartment of Malaria and Neglected Tropical Disease Research, Armauer Hansen Research Institute, Addis Ababa, EthiopiaDepartment of Malaria and Neglected Tropical Disease Research, Armauer Hansen Research Institute, Addis Ababa, EthiopiaDepartment of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UKDepartment of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UKDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UKDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UKBackground 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.https://openresearch.nihr.ac.uk/articles/3-49/v2Cutaneous leishmaniasis L. aethiopica clinical outcomes measure scar assessment cost effectiveness patient reported outcome measureseng |
| spellingShingle | Fewzia Shikur Mohammed Amel Beshir Mohammed Shimelis Doni Nigusse Feleke Tilahun Zewdu Abebaw Yeshambel Alemu Teklu Cherkose Kidist Bobosha Eshetu Molla Iris Mosweu Vanessa Yardley Saba Maria Lambert Mirgissa Kaba Endalamaw Gadisa Yohannes Hailemichael Catherine Pitt Elizabeth Allen Stephen L. Walker Michael Marks Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] NIHR Open Research Cutaneous leishmaniasis L. aethiopica clinical outcomes measure scar assessment cost effectiveness patient reported outcome measures eng |
| title | Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_full | Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_fullStr | Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_full_unstemmed | Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_short | Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_sort | protocol for a prospective observational cohort study of cutaneous leishmaniasis in ethiopia version 2 peer review 2 approved 1 approved with reservations |
| topic | Cutaneous leishmaniasis L. aethiopica clinical outcomes measure scar assessment cost effectiveness patient reported outcome measures eng |
| url | https://openresearch.nihr.ac.uk/articles/3-49/v2 |
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