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 Cotaid, Farhad Handjani, Liliana López-Carvajal, Kevin Marsh, Dalila Martínez Medinaid, Emma Plugge, Trudie Lang, Piero Olliaro

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)
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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.

Original languageEnglish
Article numbere0007996
JournalPLoS Neglected Tropical Diseases
Issue number2
Publication statusPublished - 24 Feb 2020

Bibliographical note

Funding Information: This work was supported by grants from the Special Programme for Research and Training in Tropical Diseases (TDR) ( to ABS, MMCN, MC, GFC, FH and DMM and a grant from the Drugs for Neglected Diseases initiative (DNDi) ( to LLC. ACE is a recipient of a DOC-fFORTE fellowship of the. We would like to thank Dr. Christine Halleux and Mr. Abdul Masoudi for their support with ethics review and administration, respectively, the HERG team at the Nuffield Department of Primary Care Health Sciences at the University of Oxford for the great training in qualitative research during two workshops and L. Pinto Garc?a and Genesis Huera-Vera for their support with data analysis and interpretation. We are particularly grateful to all the CL patients who have contributed to the study. Austrian Academy of Sciences ( en/) at the Nuffield Department of Medicine, University of Oxford. TDR had the dual role of being the funder and having an active role in the planning, execution and interpretation of the research as well as in strengthening the researchers? capacity in qualitative research, in line with its mission to support research and capacity for research.

Open Access: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publisher Copyright: © 2020 Erber et al.

Citation: Erber AC, Arana B, Ben Salah A, Bennis I, Boukthir A, Castro Noriega MdM, et al. (2020) Patients’ preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study. PLoS Negl Trop Dis 14(2): e0007996.



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