Authors

A Erber¹; B Arana⁵; I Bennis⁹; A Ben Salah⁶; M Cissé²; M del Mar Castro Noriega ⁴; G Fernandes Cota³; F Handjani⁸; L Lopez Carvajal¹⁰; D Martinez Medina⁷; E Plugge¹; P Olliaro¹¹;  ¹ Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford;  ² Centre MURAZ, Bobo-Dioulasso, Burkina Faso;  ³ Centro de Pesquisa René Rachou (CPqRR), Fundação Oswaldo Cruz (FIOCRUZ), Minas Gerais, Brazil, Brazil;  ⁴ Centro Internacional de Entrenamiento de Investigaciones Médicas (CIDEIM), Cali, Colombia;  ⁵ Drugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland;  ⁶ Institut Pasteur de Tunis, Tunis, Tunisia;  ⁷ Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru;  ⁸ Molecular Dermatology Research Center, Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran;  ⁹ National School of Public Health, Rabat, Morocco;  ¹⁰ Programa de Estudio y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellín, Colombia;  ¹¹ UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR), Geneva

Discussion

Recommendations on the treatment of Cutaneous Leishmaniasis (CL) currently have a weak evidence base: not only are treatment options limited, but also have systematic reviews pointed to a lack of methodological standardization in the conduct and analysis of clinical trials of CL interventions.
Standardized clinical trial methodologies would provide investigators with guidance for the design, conduct, analysis and report of future clinical trials of treatments for CL. This includes the definition of measurable, reproducible and clinically meaningful outcomes. Ideally, standardized methodologies can be applied generally, while at the same time allowing for flexibility to cover diverse disease manifestations.
A published guidance document on the methodology of trials assessing CL interventions provides the basis for further refinement. For this project, an iterative Delphi consensus methodology is used. It involves stakeholders, mostly in disease endemic countries, and aims at obtaining consensus on a set of core outcomes and eligibility criteria for trials.
The targeted stakeholder groups are researchers, health care providers (HCPs) and patients. Researchers working with CL clinical studies and HCPs (physicians and nurses) treating CL patients are invited to contribute via a series of online questionnaires. Patients' perspectives are included via interviews.
Project in progress; preliminary results will be presented