Evaluation of a unified treatment regimen for all new cases of tuberculosis using guardian-based supervision

SETTING: Ntcheu District, Malawi, using an oral antituberculosis treatment regimen. OBJECTIVE: To determine whether directly observed treatment (DOT) during th e initial phase of treatment supervised either in hospital, at health centr es or by guardians in the community, was associated with 1) satisfactory 2- month and 8-month treatment outcomes, and 2) with a reduction of in-patient hospital-bed days. DESIGN: Prospective data collection of all tuberculosis (TB) patients regis tered between 1 April 1996 and 30 June 1997, with 2-month and 8-month treat ment outcomes, sputum smear conversion in smear-positive pulmonary TB patie nts (MB) and in-patient hospital-bed days. RESULTS: Among the 600 new patients, 302 had smear-positive PTB, 150 smear- negative PTB and 148 extra-pulmonary TB (EPTB). Eight-month treatment compl etion was 65% for smear-positive PTB patients, which was significantly high er than in patients with smear-negative PTB (45%) and EPTB (54%), due mainl y to high 8-month mortality rates. The site of the intensive phase was dete rmined in 596 patients: 178 (30%) received DOT from guardians, 115 (19%) fr om a health centre and 303 (51%) in hospital. At 2 months, mortality rates were significantly higher in hospitalised patients. Two-month treatment out comes (including sputum smear conversion rates in smear-positive PTB patien ts) were similar between patients receiving DOT at health centres or from g uardians. Decentralised DOT resulted in a 25% reduction in hospital-bed day s in patients alive at 2 months compared with that predicted using the old regimens. CONCLUSION: Decentralising DOT to health centres and to guardians during th e intensive phase is associated with satisfactory treatment outcomes.