Journal Article

Designing and Reporting Clinical Trials on Treatments for Cutaneous Leishmaniasis

Urbà González, Mariona Pinart, Ludovic Reveiz, Monica Rengifo-Pardo, Jack Tweed, Antonio Macaya and Jorge Alvar

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue 4, pages 409-419
Published in print August 2010 | ISSN: 1058-4838
Published online August 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/655134
Designing and Reporting Clinical Trials on Treatments for Cutaneous Leishmaniasis

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Cutaneous leishmaniasis is considered to be one of the most neglected and serious parasitic infectious skin diseases in many developing countries. We have assessed the design and reporting of randomized, controlled trials evaluating treatments included in 2 Cochrane systematic reviews on cutaneous leishmaniasis. The analysis of the methodological quality identified some potential bias that can make it difficult to determine whether truly effective therapies exist for this disease. We found important weaknesses in the adequacy and transparency of randomization, loss of participants, causative Leishmania species, outcome measures, and follow-up times. Given these distorting effects on the evidence base, we propose guidelines for authors who wish to conduct clinical trials aimed at the development of effective therapies in cutaneous leishmaniasis. The recommendations in this report will hopefully deserve the attention of the World Health Organization and assist in the planning and prioritization of global strategies for improving the interpretation and replication of clinical research on cutaneous leishmaniasis.

Journal Article.  6542 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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