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.
72d32a15-7e55-4ed3-821a-c5c79c02d77e
Arana, Byron
77d2f35d-87aa-42c6-9e48-825ca47d51f0
Ben Salah, Afif
e907384f-085c-4674-8b18-d54c13a8e009
Bennis, Issam
44d89cc0-1035-44dd-93ee-a66d68d520fa
Boukthir, Aicha
7f623990-5722-472c-aca9-03cdd8d0a043
Castro Noriega, María del Mar
ab82efc1-12ab-4ebb-8446-be64f3bd72b4
Cissé, Mamoudou
6cea4e97-687c-422e-acd8-8fcb1a8102c6
Cota, Gláucia Fernandes
e63fdc4a-28b8-4c63-b672-e529f34bd409
Handjani, Farhad
e63b62f4-ad22-4f5a-b75d-48721bc0d52a
López-Carvajal, Liliana
97b51ef3-3a45-471e-a4af-d2b92f044517
Marsh, Kevin
6da72983-5d59-4c53-ad4d-cfccd5da3dda
Medina, Dalila Martínez
e46132ab-6d7f-4701-9b23-72d41f912c8a
Plugge, Emma
b64d2086-6cf2-4fae-98bf-6aafa3115b35
Lang, Trudie
e965c2a4-0ac4-401d-b21f-54cda897435a
Olliaro, Piero
b81416d3-55fc-4303-9307-ecf79e8ab0cb
Erber, Astrid C.
72d32a15-7e55-4ed3-821a-c5c79c02d77e
Arana, Byron
77d2f35d-87aa-42c6-9e48-825ca47d51f0
Ben Salah, Afif
e907384f-085c-4674-8b18-d54c13a8e009
Bennis, Issam
44d89cc0-1035-44dd-93ee-a66d68d520fa
Boukthir, Aicha
7f623990-5722-472c-aca9-03cdd8d0a043
Castro Noriega, María del Mar
ab82efc1-12ab-4ebb-8446-be64f3bd72b4
Cissé, Mamoudou
6cea4e97-687c-422e-acd8-8fcb1a8102c6
Cota, Gláucia Fernandes
e63fdc4a-28b8-4c63-b672-e529f34bd409
Handjani, Farhad
e63b62f4-ad22-4f5a-b75d-48721bc0d52a
López-Carvajal, Liliana
97b51ef3-3a45-471e-a4af-d2b92f044517
Marsh, Kevin
6da72983-5d59-4c53-ad4d-cfccd5da3dda
Medina, Dalila Martínez
e46132ab-6d7f-4701-9b23-72d41f912c8a
Plugge, Emma
b64d2086-6cf2-4fae-98bf-6aafa3115b35
Lang, Trudie
e965c2a4-0ac4-401d-b21f-54cda897435a
Olliaro, Piero
b81416d3-55fc-4303-9307-ecf79e8ab0cb
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.
Text
file (1)
- Version of Record
More information
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
Identifiers
Local EPrints ID: 485233
URI: http://eprints.soton.ac.uk/id/eprint/485233
ISSN: 1935-2727
PURE UUID: 599a77f9-29f8-4be9-b5a1-c256774f7e9f
Catalogue record
Date deposited: 01 Dec 2023 17:45
Last modified: 12 Jul 2024 02:06
Export record
Altmetrics
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
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics
