Quality of reporting and of methodology of studies on interventions for trophic ulcers in leprosy: a systematic review.

BACKGROUND: In the process of conducting a systematic review on interventions for skin lesions due to neuritis in leprosy, we assessed several primary papers with respect to the quality of reporting and methods used in the studies. Awareness of what constitutes weak points in previously conducted studies may be used to improve the planning, conducting and reporting of future clinical trials.

AIMS: To assess the quality of reporting and of methodology in studies of interventions for skin lesions due to neuritis in leprosy.

METHODS: Items of importance for preventing selection bias, detection bias, attrition bias and performance bias were among items assessed. The items for assessing methodological quality were used as a basis for making the checklist to assess the quality of reporting.

RESULTS: Out of the 854 references that we inspected eight studies were included on the basis of the inclusion criteria. The interventions tested were dressings, topical agents and footwear and in all studies healing of ulcers was the main outcome measure. Reporting of both, methods and results suffered from underreporting and disorganization. The most under-reported items were concealment of allocation, blinding of patients and outcome assessors, intention to treat and validation of outcomes.

CONCLUSION: There is an apparent need to improve the methodological quality as well as the quality of reporting of trials in leprosy ulcer treatment. The most important threat in existing studies is the threat of selection bias. For the reporting of future studies, journals could promote and encourage the use of the CONSORT statement checklist by expecting and requiring that authors adhere to it in their reporting.