Directly observed therapy (DOT) for tuberculosis: why, when, how and if?
Authors: L. P. Ormerod
Journal: Thorax (1999)

Background.Tuberculosis is a major public health problem in South Africa, made worse by poor adherence to and frequent interruption of treatment.Direct observation (DO) of tuberculosis patients taking their drugs is supposed to improve treatment completion and outcome.We compared DO with self-supervision, in which patients on the same drug regimen are not observed taking their pills, to assess the effect of each on the success of tuberculosis treatment.Methods.We undertook an unblinded randomised controlled trial in two communities with large tuberculosis caseloads.The trial included 216 adults who started pulmonary tuberculosis treatment for the first time, or who had a second course of treatment (re-treatment patients).No changes to existing treatment delivery were made other than randomisation.Analysis was by intention to treat.Individual patient data from the two communities were combined.Findings.Treatment for tuberculosis was more successful among self-supervised patients (60% of patients) than among those on DO (54% of patients, difference between groups 6% (90% CI -5.1 to 17.0)).Re-treatment patients had significantly more successful outcomes if self-supervised (74% of patients) than on DO (42% of patients, difference between groups 32% (11% to 52%)).Interpretation.At high rates of treatment interruption, self-supervision achieved equivalent outcomes to clinic DO at lower cost.Self-supervision achieved better outcomes in re-treatment patients.Supportive patient-carer relations, rather than authoritarian surveillance implicit in DO, may improve treatment outcomes and help to control tuberculosis.(Lancet 1998;352:1340-3) Directly observed therapy (DOT), and preferably short contained in the prespecified equivalence range of -20% to +20% and indicated zero rate difference.Male sex, course chemotherapy (DOTS), is one of the five key elements in the WHO global tuberculosis control pro-unemployment, and "new" patient status showed no difference in treatment success.Women, employed gramme strategy and has been widely publicised as a "breakthrough" and strongly promoted globally by the patients, and patients whose income derived from family or social support were more successful with self-WHO 1 2 and others. 3 The impetus for increasing DOT has largely been based on observational studies against supervised treatment but, although the upper limit of the equivalence interval was exceeded, favouring self-historical controls, with little or no randomised data of "head to head" DOT versus self-administered therapy.supervision, the confidence interval included zero rate difference.Re-treatment patients, however, were sig-The Introductory Article by Zwarenstein et al is the first randomised trial of DOT against self-administered nificantly more successful with self-supervision than with DO (74% versus 42%; difference 32%, 90% CI therapy to compare adherence and outcome. 4After random assignment of patients to direct observation 11 to 52), exceeding the 20% upper limit of equivalence and excluding zero difference.However, since only 60% (DO) or self-treatment with weekly checks of drug collection and use, the outcome measures (with cure or completed treatment in the self-treatment arm and a smaller proportion in the DO arm, a null effect of completed treatment regarded as a successful outcome) were compared on an intention to treat basis.Data for DOT cannot be concluded.The equivalence of the two methods could, however, be due to a failure of DOT the two sites combined showed treatment success, as defined, in 60% of self-supervised and 54% of DO itself to improve outcome or of more widespread resource and structural problems resulting in difficulties patients.The 6% difference (90% CI -5.1 to 17) was on July 10, 2023 by guest.