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Qualitative research
Protocol
An international qualitative study exploring patients’ experiences of cutaneous leishmaniasis: study set-up and protocol
  1. Astrid Christine Erber1,2,
  2. Byron Arana3,
  3. Issam Bennis4,5,
  4. Afif Ben Salah6,7,
  5. Aicha Boukthir6,
  6. Maria del Mar Castro Noriega8,9,
  7. Mamoudou Cissé10,
  8. Gláucia Fernandes Cota11,
  9. Farhad Handjani12,
  10. Mairie Guizaw Kebede13,
  11. Trudie Lang1,
  12. Liliana López Carvajal14,
  13. Kevin Marsh1,
  14. Dalila Martinez Medina15,16,
  15. Emma Plugge1,
  16. Piero Olliaro1,17
  1. 1 Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK
  2. 2 Department of Epidemiology, Center for Public Health, Medical University of Vienna, Vienna, Austria
  3. 3 Drugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland
  4. 4 National School of Public Health, Rabat, Morocco
  5. 5 Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
  6. 6 Institut Pasteur de Tunis, Tunis, Tunisia
  7. 7 Department of Family and Community Medicine, College of Medicine and Medical Sciences, Arabian Gulf University (AGU), Manama, Bahrain
  8. 8 Centro Internacional de Entrenamiento de Investigaciones Médicas (CIDEIM), Cali, Colombia
  9. 9 EDCTP/TDR Fellow, European Vaccine Initiative (EVI), Heidelberg, Germany
  10. 10 Centre MURAZ, Bobo-Dioulasso, Burkina Faso
  11. 11 Centro de Pesquisa René Rachou (CPqRR), Fundação Oswaldo Cruz (FIOCRUZ), Minas Gerais, Brazil
  12. 12 Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  13. 13 Ayder Referral Hospital, College of Health Sciences, Mekelle University, Mekelle, Ethiopia
  14. 14 Programa de Estudio y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellín, Colombia
  15. 15 Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru
  16. 16 Departamento de Enfermedades Infecciosas, Dermatológicas y Tropicales, Hospital Cayetano Heredia, Lima, Peru
  17. 17 Special Programme for Research & Training in Tropical Diseases (WHO/TDR), Geneva, Switzerland
  1. Correspondence to Professor Piero Olliaro; olliarop{at}who.int

Abstract

Introduction Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients’ quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments.

Methods and analysis This international qualitative study uses interviews with patients to explore their experiences with CL to (1) elicit outcomes and eligibility criteria for clinical trials important to them and (2) to better understand their needs and views about the disease and their requirements and expectations from treatment. Here, we describe the set-up of this collaborative study and the protocol. Data collection is ongoing.

The protocol includes study design, preparation, conduct and analysis of individual interviews with approximately 80 patients in seven countries (Burkina Faso, Brazil, two sites in Colombia, Iran, Morocco, Peru and Tunisia) where CL is prevalent. Principal investigators and sites were selected through an open call, and two workshops were organised for protocol development and training in conduct and analysis of qualitative health research. Patient recruitment aims at covering a maximum variation of experiences. Transcripts will be analysed to identify outcomes and eligibility criteria as well as further topics that are expected to emerge from the interviews, such as direct and indirect costs related to CL, its psychological impact, preferred modes of drug administration and traditional treatments.

Ethics and dissemination The study received ethical approval by the responsible committees of each of the participating institutions. Findings will be disseminated through publication in peer-reviewed journals, scientific meetings and to participants and their communities.

  • public health
  • epidemiology
  • tropical medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

http://dx.doi.org/10.1136/bmjopen-2017-021372

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    Footnotes

    • Contributors PO, BA, ACE, LLC and EP conceived the study and ACE was responsible for drafting the initial study protocol. All authors were involved in finalising the protocol and designing the interview topic guide and the sampling strategy. They have also agreed on the final version of this article, having been involved in drafting or critically revising draft versions of the manuscript.

    • Funding This work was supported by grants from the Special Programme for Research and Training in Tropical Diseases (TDR) and the Drugs for Neglected Diseases initiative (DNDi). ACE is a recipient of a DOC-fFORTE fellowship of the Austrian Academy of Sciences at the Nuffield Department of Medicine, University of Oxford.

    • Disclaimer The opinions expressed in this paper are those of the authors and may not reflect those of their employing organisations. PO is a staff member of the WHO; the authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the WHO.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval World Health Organization Research Ethics Review Committee (WHO ERC), Geneva, Switzerland as well as the IRBs and ethics committees (ECs) responsible for the respective sites: Comité d'éthique de la Faculté de Médecine et du CHU Hassan II Fes, Fez, Morocco; Comité d'éthique Biomédicale de l’Institut Pasteur de Tunis, Institut Pasteur de Tunis, Tunis, Tunisia; Comité Institucional de Ética de Investigación en Humanos (CIEIH), Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Comité d'éthique institutionnel du Centre MURAZ, Bobo-Dioulasso, Burkina Faso; Centro de Pesquisa René Rachou (CPqRR), Fundação Oswaldo Cruz (FIOCRUZ), Minas Gerais, Brazil; Comissão Nacional de Ética em Pesquisa—CONEP, Brazilia, Brazil; IRB of Mekelle University, College of Health Sciences, Mekelle, Ethiopia; Shiraz University of Medical Sciences (SUMS) Ethics in Research Committee, Shiraz, Iran; Comité de Bioética de Investigación en Humanos, Sede de Investigación Universitaria (CBEIH-SIU) of the University of Antioquia, Medellin, Colombia; Comité Institucional de Etica para Humanos, Universidad Peruana Cayetano Heredia (CIEH—UPCH), Lima, Perú; Oxford Tropical Research Committee (OxTREC), University of Oxford, Oxford, UK.

    • Provenance and peer review Not commissioned; externally peer reviewed.