An international qualitative study exploring patients’ experiences of cutaneous leishmaniasis: study set-up and protocol

Abstract

IntroductionLack 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 analysisThis 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 disseminationThe 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.

Patients’ preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study

“…We conducted 74 individual, semi-structured in-depth interviews with CL patients at sites in seven endemic countries (Brazil, Burkina Faso, two regions in Colombia, Iran, Morocco, Peru, and Tunisia), as described in the protocol [21]. These countries were chosen due to their CL disease burden, prevalent Leishmania species, and accessibility for research.…”

“…All sites used collaboratively-developed, equivalent protocols and interview topic guides ( [21], supplementary file 1), with minor adaptations depending on the country specific ethics committees' requirements. For this study, a two-step sampling approach was used.…”

“…Maximum variation was sought within a defined patient spectrum along characteristics such as patients' gender, age, treatment status (before, during, after treatment), clinical lesion presentation and causative Leishmania species, under the assumption that this would cover the range of patients'/disease profiles. The background parameters informing the sampling strategy, including CL epidemiology at each site, can be found in [21], supplementary file 2.…”

“…To obtain consent from participants who were unable to sign, at least one literate witness was chosen, whenever possible by the participants themselves, from outside the research team. Ethical procedures at each site observed the respective IRB guidance, and are further detailed in the study protocol [21].…”

“…The characteristics of the interviewed patients are listed in S 1 File. Sixty-two percent (n = 46) of participants were male (reflecting an estimated distribution of 60% men and 40% women overall at the sites [21]). At each site, the distribution was also in line with previous estimates of gender distribution among patients in the study area [21].…”