The need for better design and reporting of RCTs in a neglected but widespread skin disease

Article type
Authors
Gonzalez U, Pinart M, Reveiz L, Alvar J
Abstract
Background: Cutaneous leishmaniasis is a parasitic infection considered one of the most serious skin diseases in many developing countries. Antimonials are the most prescribed treatment, but we still do not have an ideal drug profile that can treat all target species with no serious adverse effects. Objectives: To assess the design and reporting of randomised controlled trials (RCTs) evaluating treatments for cutaneous leishmaniasis. Methods: We assessed RCTs evaluating treatments in cutaneous leishmaniasis included in a Cochrane systematic review. Two authors independently assessed study quality. Results: We included 49 (5559 participants) and 39 trials (2850 participants) evaluating Old World and American cutaneous leishmaniasis respectively. Adequate randomisation method was reported in 35% (17/49) and 28% (11/39) respectively. Only 14% (7/49) and 13% (5/39) had an adequate reporting of allocation concealment. Double-blinding was found in 41% (20/49) and 39% (15/39) of the studies. Inadequate baseline characteristics description was found in 12% (6/49) and 3% (1/39) of the studies. Sample size calculation was reported in 27% (13/49) and 13% (5/39) of the studies. Only one study in each review clearly assessed the compliance. The causative parasite was not mentioned in 25% (12/49) and 5% (2/39) of the studies, and 37% (18/49) and 13% (5/39) of the trials only mentioned the endemic species causing the disease in the area. Lesions were evaluated in 22% (11/49) and 3% (1/39) of the trials while the rest reported it as percentage of patients cured. The timing for outcomes was not reported in 4% (2/49) and 3% (1/39) of the trials. Only 25% (12/49) and 15% (6/39) reported the primary outcome (complete cure at three months post-treatment) as defined in the systematic review. Conclusions: Resources are limited for research into neglected diseases representing major public health problems in developing countries. Execution of properly designed RCTs aimed at the development of effective therapies by adopting rigorous peer-review checks in journals and CONSORT guidelines is needed. Thus, we are creating a platform for establishing standard clinical trial designs and enhancing capacity for high quality trials.