Core Outcome Measures in Effectiveness Trials

Cutaneous Leishmaniasis (CL) Clinical Trial Methodology Using Crowd Sourcing to define Core Eligibility Criteria and Core Outcome Measures for Cutaneous Leishmaniasis Clinical Trials

General Information

Summary:
Informed by previous literature reviews and a guidance publication, a Delphi survey will be performed aiming at achieving consensus on relevant core sets of outcome measures and eligibility criteria (Inclusion and exclusion criteria) for intervention trials in Cutaneous Leishmaniasis (CL). Panelists have been recruited from the CL research and health care provider community in a crowd sourcing approach. The aim is to cover both the major old world (Old World Cutaneous Leishmaniasis - OWCL, (L. major, L. tropica and L. aethiopica) and new world (New World Cutaneous Leishmaniasis - NWCL; L. (Viannia) braziliensis, L. panamensis, L. mexicana, L. amazonensis) species, and a broad patient spectrum. Patients’ perspectives will be included via patient interviews, conducted by local principal investigators (PI) in endemic regions and covering more specifically L. major, L. tropica, L. aethiopica, L. (Viannia) braziliensis and L. panamensis. One of the study aims is a revision of the Olliaro et al. (2013) guidance paper, with broader input from the CL community.
The main questions that this study tries to answer, with regard to CL, are: Who should be treated/wants to be treated? and What are the outcomes that we want to see/experience or do not want to see/suffer from?

An international qualitative study exploring patients’ experiences of cutaneous leishmaniasis: study set-up and protocol - http://bmjopen.bmj.com/content/8/6/e021372

Contributors:
Piero Olliaro 1, Astrid Erber 2, Liliana López Carvajal 3, Issam Bennis 4, Afif Ben Salah 5, María del Mar Castro Noriega 6, Mamoudou Cissé 7, Gláucia Fernandes Cota 8, Mairie Guizaw Kebede 9, Farhad Handjani 10, Dalila Martinez Medina 11, Emma Plugge 2, Byron Arana 12, Trudie Lang 2

1. UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR), Geneva, Switzerland
2. Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK
3. Programa de Estudio y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellín, Colombia
4. National School of Public Health, Rabat, Morocco
5. Institut Pasteur de Tunis, Tunis, Tunisia
6. Centro Internacional de Entrenamiento de Investigaciones Médicas (CIDEIM), Cali, Colombia
7. Centre MURAZ, Bobo-Dioulasso, Burkina Faso
8. Centro de Pesquisa René Rachou (CPqRR), Fundação Oswaldo Cruz (FIOCRUZ), Minas Gerais, Brazil
9. Ayder Referral Hospital, College of Health Sciences, Mekelle University, Mekelle, Ethiopia
10. Molecular Dermatology Research Center, Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran
11. Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú
12. Drugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland

Further Study Information

Current Stage:
Ongoing
Date:
January 2015 - 2016
Funding source(s):
WHO-TDR

Health Area

Disease Category
Infectious disease
Skin

Disease Name
Cutaneous leishmaniasis (CL)

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Drug

Method(s)

Delphi process
Interview

- A combination of a three-round Delphi survey amongst health care professionals (HCPs) and researchers working with CL and CL patients, and semi-structured patient interviews.
- Elements identified during analysis of the interviews will be incorporated into the questionnaire for the third round of the Delphi survey.


Stakeholders Involved

Consumers (caregivers)
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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