Background: Leprosy is a chronic infectious disease caused by the bacterium Mycobacterium leprae. More than three million individuals currently have, or are disabled by, leprosy worldwide. The seven most affected countries are India, Brazil, Tanzania, Democratic Republic of Congo, Nepal, Madagascar and Mozambique. The total incidence now amounts to about 400,000 new cases per year. In 2000 the proportion of new cases of leprosy in children under 15 years of age was 18%. Main secondary consequences are peripheral neuropathy which in turn leads to thickened and cracked skin insensitive to pressure, to skin dryness and reduced function of the muscles supplied by the affected nerve. In the process of conducting a systematic review on interventions for skin changes caused by nerve damage in leprosy, we assessed several primary papers with respect to the quality of reporting and methods used in the studies.
Objectives: To assess the quality of reporting and of methodology in studies of treatment of ulcers in leprosy patients.
Methods: Items assessed were method of random sequence generation and concealment of allocation (to prevent selection bias); blinding of outcome assessor (to prevent detection bias); degree of follow-up (to prevent attrition bias) and blinding of participant (to prevent performance bias). We also assessed whether the groups in the trials were similar at baseline; whether reliable outcome measures had been used and the appropriateness of statistical analysis. A summary assessment of quality was also done. The checklist for assessing methodological quality was used as a basis in the making of the checklist to assess the quality of reporting of items. Two reviewers (LMR, LF), independently entered data into the data extraction forms.
Results: Five of the 8 studies included were judged to have poor methodological quality with a high risk of selection and detection bias while three studies were judged to have moderate quality. In half of the studies the authors did not or failed to show that the groups were comparable at baseline. Two studies clearly had such losses to follow-up that it could be detrimental to the validity of the results, while another study was unclear as to how many participated in the analyses. Two studies had allocated patients with clearly more than one ulcer, while two others had potentially a unit of analysis error. As for appropriateness of statistical analyses, two studies had not done any significance tests, three studies were assessed as unclear and one study was rated as adequate. Both reporting of methods used in the study and of results were underreported and disorganised. The most under-reported items were concealment of allocation, blinding of patients and outcome assessors, intention to treat and validation of outcomes. Moreover, even if the method used to generate the random allocation sequence was partly described, it was not detailed enough to judge its adequacy. When patients were alternatively assigned, it was not reported how the first patient was assigned. All studies failed to report on concealment of the allocation procedure, as well as who generated the allocation sequence, who enrolled the patients and who assigned the patients to the different treatment groups.
Conclusions: There is an apparent need to stimulate more research and 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, which may result from failure of concealing the allocation process. For the reporting of future studies, journals could promote and encourage the use of the CONSORT statement check list by expecting and require authors to follow it in their reporting.