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, Maria del Mar Castro Noriega, Mamoudou Cisse, Glaucia Fernandes Cota, Farhad Handjani, Liliana Lopez-Carvajal, Kevin Marsh, Dalila Martinez Medina, Emma Plugge, Trudie Lang, Piero Olliaro

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    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.

    Author summary

    Cutaneous Leishmaniasis (CL) is a parasitic disease transmitted by sand fly vectors causing lesions and potentially life-long scars. Trials for CL treatments so far have not included patients' input, such as their preferences on outcomes. This study reports treatment outcomes seen as important by patients that were explored through semi-structured interviews conducted in CL-endemic regions in Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia. In addition to outcomes mostly considered in trials centered on lesion evolution and adverse events, patients reported a wide range of further outcomes and concerns. These are related to their quality of life, but also parasitological cure, potential for recurrence and sequelae of the disease. We suggest possibilities on how to include and measure a number of these patient-preferred outcomes into trials, and discuss ways of considering others in the context of treatment and clinical trials, e.g. via information provided to patients.

    Original languageEnglish
    Article numbere0007996
    JournalPLoS Neglected Tropical Diseases
    Volume14
    Issue number2
    Number of pages21
    ISSN1935-2735
    DOIs
    Publication statusPublished - 2020

    Keywords

    • CLINICAL-TRIALS
    • INFANTUM
    • IMPACT
    • SCARS

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