Core Outcome Measures in Effectiveness Trials

Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis

General Information

Abstract:
The current evidence-base for recommendations on the treatment of cutaneous leishmaniasis (CL) is generally weak. Systematic reviews have pointed to a general lack of standardization of methods for the conduct and analysis of clinical trials of CL, compounded with poor overall quality of several trials. For CL, there is a specific need for methodologies which can be applied generally, while allowing the flexibility needed to cover the diverse forms of the disease. This paper intends to provide clinical investigators with guidance for the design, conduct, analysis and report of clinical trials of treatments for CL, including the definition of measurable, reproducible and clinically-meaningful outcomes. Having unified criteria will help strengthen evidence, optimize investments, and enhance the capacity for high-quality trials. The limited resources available for CL have to be concentrated in clinical studies of excellence that meet international quality standards.

Authors:
Olliaro, Piero Vaillant, Michel Arana, Byron Grogl, Max Modabber, Farrokh Magill, Alan Lapujade, Olivier Buffet, Pierre Alvar, Jorge

Publication

Journal:
PLoS Neglected Tropical Diseases [electronic resource]
Volume:
7
Issue:
3
Pages:
e2130 -
Year:
2013
DOI:
Further Study Information

Date:
December 2009
Funding source(s):
The authors have indicated that no funding was received for this work.

Health Area

Disease Category
Infectious disease
Skin

Disease Name
Cutaneous leishmaniasis (CL)

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Semi structured discussion

Semi structured discussion: workshop


Stakeholders Involved

Not Specified

Study Type

COS for clinical trials or clinical research

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