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https://www.arca.fiocruz.br/handle/icict/58483
PATIENTS' PREFERENCES OF CUTANEOUS LEISHMANIASIS TREATMENT OUTCOMES: FINDINGS FROM AN INTERNATIONAL QUALITATIVE STUDY
Author
Affilliation
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom/Department of Epidemiology. Center for Public Health. Medical University of Vienna.Vienna. Austria.
Drugs for Neglected Diseases Initiative. Geneva, Switzerland.
Institut Pasteur de Tunis. Tunis, Tunisia/Department of Family and Community Medicine. College of Medicine and Medical Sciences. Arabian Gulf University. Manama, Bahrain.
National School of Public Health. Rabat, Morocco/Department of Public Health. Institute of Tropical Medicine. Antwerp, Belgium.
Institut Pasteur de Tunis. Tunis, Tunisia.
Centro Internacional de Entrenamiento de Investigaciones Médicas. Cali, Colombia/Universidad Icesi, Cali, Colombia.
Centre MURAZ. Bobo-Dioulasso, Burkina Faso.
Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil.
Molecular Dermatology Research Center. Shiraz University of Medical Sciences. Shiraz, Iran.
Programa de Estudio y Control de Enfermedades Tropicales. Universidad de Antioquia. Medellín, Colombia.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom.
Facultad de Medicina "Alberto Hurtado". Universidad Peruana Cayetano Heredia. Lima, Perú/Departamento de Enfermedades Infecciosas, Dermatológicas y Tropicales. Hospital Cayetano Heredia. Lima, Perú.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom/UK Collaborating Centre for the WHO Health in Prisons Programme. Public Health England. Reading, United Kingdom.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom/Special Programme for Research & Training in Tropical Diseases. Geneva, Switzerland.
Drugs for Neglected Diseases Initiative. Geneva, Switzerland.
Institut Pasteur de Tunis. Tunis, Tunisia/Department of Family and Community Medicine. College of Medicine and Medical Sciences. Arabian Gulf University. Manama, Bahrain.
National School of Public Health. Rabat, Morocco/Department of Public Health. Institute of Tropical Medicine. Antwerp, Belgium.
Institut Pasteur de Tunis. Tunis, Tunisia.
Centro Internacional de Entrenamiento de Investigaciones Médicas. Cali, Colombia/Universidad Icesi, Cali, Colombia.
Centre MURAZ. Bobo-Dioulasso, Burkina Faso.
Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil.
Molecular Dermatology Research Center. Shiraz University of Medical Sciences. Shiraz, Iran.
Programa de Estudio y Control de Enfermedades Tropicales. Universidad de Antioquia. Medellín, Colombia.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom.
Facultad de Medicina "Alberto Hurtado". Universidad Peruana Cayetano Heredia. Lima, Perú/Departamento de Enfermedades Infecciosas, Dermatológicas y Tropicales. Hospital Cayetano Heredia. Lima, Perú.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom/UK Collaborating Centre for the WHO Health in Prisons Programme. Public Health England. Reading, United Kingdom.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom.
Nuffield Department of Medicine. Centre for Tropical Medicine and Global Health. University of Oxford. Oxford, United Kingdom/Special Programme for Research & Training in Tropical Diseases. Geneva, Switzerland.
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.
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