The ALERT MDT Field Evaluation Study (AMFES): a descriptive study of leprosy in Ethiopia. Patients, methods and baseline characteristics

The ALERT MDT Field Evaluation Study (AMFES) is a long-term prospective stu dy of 650 patients (594 new cases and 56 relapses after dapsone monotherapy ), treated with fixed-duration multiple-drug therapy (MDT), as recommended by WI-IO. Follow-up has continued for up to 11 years from the start of trea tment. This paper presents the methodology of the study and the baseline ch aracteristics of the cohort, while accompanying papers examine the incidenc e of, and possible risk factors for, the various complications of leprosy, including relapse, reactions and nerve function impairment. The methods of diagnosis, classification and treatment with MDT are described; nerve funct ion was assessed at every visit to the clinic using a standardized methodol ogy, so that reactions and new impairment could be detected early and treat ed. Eighty-four per cent of new case had at least one thickened nerve, with the ulnar nerve most commonly involved. Seventy-seven per cent of cases co mpleted treatment and only one adverse reaction to the MDT drugs was noted. Twenty-eight per cent of all patients were given steroids at one time or a nother, almost always for new nerve function impairment, and 3% of these de veloped significant complications of steroid treatment. Twenty-nine patient s (5%) received hospital care, including 14 patients who underwent major su rgery. Sixty-one per cent of the women over 19 years of age had at least on e pregnancy, but pregnancies were much less common after leprosy was diagno sed.