Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.
Background Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and condu...
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ftdoajarticles:oai:doaj.org/article:c36fe4e790ad4afe9fc49dadcbb4d093 2023-05-15T15:14:42+02:00 Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. Astrid C Erber Byron Arana Afif Ben Salah Issam Bennis Aicha Boukthir María Del Mar Castro Noriega Mamoudou Cissé Gláucia Fernandes Cota Farhad Handjani Liliana López-Carvajal Kevin Marsh Dalila Martínez Medina Emma Plugge Trudie Lang Piero Olliaro 2020-02-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0007996 https://doaj.org/article/c36fe4e790ad4afe9fc49dadcbb4d093 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0007996 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0007996 https://doaj.org/article/c36fe4e790ad4afe9fc49dadcbb4d093 PLoS Neglected Tropical Diseases, Vol 14, Iss 2, p e0007996 (2020) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2020 ftdoajarticles https://doi.org/10.1371/journal.pntd.0007996 2022-12-31T11:44:55Z Background Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials. Methodology/principal findings We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae. Conclusions/significance The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 14 2 e0007996 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Astrid C Erber Byron Arana Afif Ben Salah Issam Bennis Aicha Boukthir María Del Mar Castro Noriega Mamoudou Cissé Gláucia Fernandes Cota Farhad Handjani Liliana López-Carvajal Kevin Marsh Dalila Martínez Medina Emma Plugge Trudie Lang Piero Olliaro Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials. Methodology/principal findings We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae. Conclusions/significance The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be ... |
format |
Article in Journal/Newspaper |
author |
Astrid C Erber Byron Arana Afif Ben Salah Issam Bennis Aicha Boukthir María Del Mar Castro Noriega Mamoudou Cissé Gláucia Fernandes Cota Farhad Handjani Liliana López-Carvajal Kevin Marsh Dalila Martínez Medina Emma Plugge Trudie Lang Piero Olliaro |
author_facet |
Astrid C Erber Byron Arana Afif Ben Salah Issam Bennis Aicha Boukthir María Del Mar Castro Noriega Mamoudou Cissé Gláucia Fernandes Cota Farhad Handjani Liliana López-Carvajal Kevin Marsh Dalila Martínez Medina Emma Plugge Trudie Lang Piero Olliaro |
author_sort |
Astrid C Erber |
title |
Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
title_short |
Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
title_full |
Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
title_fullStr |
Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
title_full_unstemmed |
Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. |
title_sort |
patients' preferences of cutaneous leishmaniasis treatment outcomes: findings from an international qualitative study. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2020 |
url |
https://doi.org/10.1371/journal.pntd.0007996 https://doaj.org/article/c36fe4e790ad4afe9fc49dadcbb4d093 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 14, Iss 2, p e0007996 (2020) |
op_relation |
https://doi.org/10.1371/journal.pntd.0007996 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0007996 https://doaj.org/article/c36fe4e790ad4afe9fc49dadcbb4d093 |
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https://doi.org/10.1371/journal.pntd.0007996 |
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PLOS Neglected Tropical Diseases |
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e0007996 |
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