Patients' preferences of cutaneous leishmaniasis treatment outcomes: findings from an international qualitative study
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 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 addressed in clinical care.
Antiprotozoal Agents/therapeutic use, Data Collection, Global Health, Humans, Leishmaniasis, Cutaneous/drug therapy, Patient Preference, Qualitative Research, Quality of Life, Treatment Outcome
Erber, Astrid C.
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Arana, Byron
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Ben Salah, Afif
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Bennis, Issam
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Boukthir, Aicha
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Castro Noriega, María del Mar
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Cissé, Mamoudou
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Cota, Gláucia Fernandes
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Handjani, Farhad
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López-Carvajal, Liliana
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Marsh, Kevin
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Medina, Dalila Martínez
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Plugge, Emma
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Lang, Trudie
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Olliaro, Piero
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Erber, Astrid C.
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Arana, Byron
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Ben Salah, Afif
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Bennis, Issam
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Boukthir, Aicha
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Castro Noriega, María del Mar
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Cissé, Mamoudou
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Cota, Gláucia Fernandes
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Handjani, Farhad
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López-Carvajal, Liliana
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Marsh, Kevin
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Medina, Dalila Martínez
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Plugge, Emma
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Lang, Trudie
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Olliaro, Piero
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Erber, Astrid C., Arana, Byron, Ben Salah, Afif, Bennis, Issam, Boukthir, Aicha, Castro Noriega, María del Mar, Cissé, Mamoudou, Cota, Gláucia Fernandes, Handjani, Farhad, López-Carvajal, Liliana, Marsh, Kevin, Medina, Dalila Martínez, Plugge, Emma, Lang, Trudie and Olliaro, Piero
(2020)
Patients' preferences of cutaneous leishmaniasis treatment outcomes: findings from an international qualitative study.
PLoS Neglected Tropical Diseases, 14 (2), [e0007996].
(doi:10.1371/journal.pntd.0007996).
Abstract
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 addressed in clinical care.
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Accepted/In Press date: 15 December 2019
e-pub ahead of print date: 24 February 2020
Keywords:
Antiprotozoal Agents/therapeutic use, Data Collection, Global Health, Humans, Leishmaniasis, Cutaneous/drug therapy, Patient Preference, Qualitative Research, Quality of Life, Treatment Outcome
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Local EPrints ID: 485233
URI: http://eprints.soton.ac.uk/id/eprint/485233
ISSN: 1935-2727
PURE UUID: 599a77f9-29f8-4be9-b5a1-c256774f7e9f
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Date deposited: 01 Dec 2023 17:45
Last modified: 18 Mar 2024 03:57
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Contributors
Author:
Astrid C. Erber
Author:
Byron Arana
Author:
Afif Ben Salah
Author:
Issam Bennis
Author:
Aicha Boukthir
Author:
María del Mar Castro Noriega
Author:
Mamoudou Cissé
Author:
Gláucia Fernandes Cota
Author:
Farhad Handjani
Author:
Liliana López-Carvajal
Author:
Kevin Marsh
Author:
Dalila Martínez Medina
Author:
Trudie Lang
Author:
Piero Olliaro
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