Decentralisation of treatment for patients with tuberculosis in Malawi: moving from research to policy and practice.

SETTING: Five districts in Malawi. OBJECTIVE: A new oral anti-tuberculosis treatment regimen with different directly observed treatment (DOT) choices in the initial phase of treatment was introduced for new patients in the five districts. The objectives were to determine 1) the site of DOT during the initial phase of treatment, and 2) the effectiveness of the new regimen. DESIGN: Prospective data collection on all tuberculosis (TB) patients registered in a phased approach between 1 July 1997 and 31 December 1998, including site of DOT option in initial phase of treatment, 2-month and 8-month treatment outcomes, 2-month sputum smear conversion in smear-positive pulmonary tuberculosis (PTB) patients and in-patient hospital bed days. RESULTS: There were 6335 new patients: 2671 (42%) with smear-positive PTB, 2211 (35%) with smear-negative PTB and 1453 (23%) with extra-pulmonary TB. The site of the initial phase of treatment was determined in 5790 patients: 1759 (30%) received DOT from guardians, 1465 (25%) from a health centre, 753 (13%) as out-patients from the hospital TB ward and 1813 (32%) remained in hospital. Eight-month treatment completion was 67% for smear-positive PTB patients, 51% for smear-negative PTB patients and 56% for extra-pulmonary TB patients. Two-month outcomes and 8-month treatment outcomes for all out-patient sites of supervision were satisfactory, except that a higher proportion of smear-positive PTB patients under guardian DOT failed to smear convert at 2 months. Over two-thirds of patients received ambulatory treatment out of hospital during the initial phase. CONCLUSION: The new treatment strategy, tested in five districts, was associated with a reduction in hospital bed days and satisfactory treatment outcomes. The results of these studies were vital in helping the National TB Control Programme make an informed decision about phased expansion of the strategy countrywide.

A unified treatment regimen for new cases of tuberculosis in resource-poor countries: a study in a rural district in Malawi.

An oral ambulatory unified treatment regimen was introduced in Ntcheu District, Malawi, between April 1996 and June 1997 for all new patients (600) with tuberculosis (TB). There was no change in the case finding pattern compared with the previous 5 years; 65% of new smear-positive pulmonary tuberculosis (PTB) patients completed treatment, not significantly different compared with the previous 3 years. Treatment completion was significantly lower in patients with smear-negative PTB and extra-pulmonary tuberculosis, due mainly to high mortality rates (40% and 41% respectively). In a rural district with high human immunodeficiency virus sero-prevalence rates in TB patients, case finding and end of treatment outcome of the oral unified regimen were comparable to those of previous regimens.

Care seeking behaviour and diagnostic processes in patients with smear-positive pulmonary tuberculosis in Malawi.

SETTING: Government hospitals in five districts in Malawi. OBJECTIVE: To determine care seeking behaviour and diagnostic processes in patients newly diagnosed with smear-positive pulmonary tuberculosis (PTB). DESIGN: Structured questionnaires completed by interview between January to September 1998. RESULTS: During the study period 1,518 patients were registered with PTB, of whom 1,099 (72%) were interviewed. The median delay between onset of cough and diagnosis was 8 weeks. There was a variable pattern of care seeking behaviour, with 70% of patients initially visiting a place of orthodox medical care and 30% visiting traditional healers, grocery shops, etc. Of these, 867 (79%) patients had one or more subsequent contacts for help, with these visits targeted more to orthodox medical care. At all stages, antibiotics resulted in symptomatic improvement in up to 40% of cases. There was a median time of 7 weeks between cough and first submission of sputum specimens. Almost all patients received sputum smear results after a median length of 4 days; 474 (43%) of patients were only aware of their diagnosis at the time of receiving smear results, this observation being significantly associated with lack of schooling and not knowing another person with TB. CONCLUSION: More needs to be done to educate communities and non-orthodox care providers about the diagnosis and treatment of TB.

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 the initial phase of treatment supervised either in hospital, at health centres 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 registered between 1 April 1996 and 30 June 1997, with 2-month and 8-month treatment outcomes, sputum smear conversion in smear-positive pulmonary TB patients (PTB) and in-patient hospital-bed days. RESULTS: Among the 600 new patients, 302 had smear-positive PTB, 150 smear-negative PTB and 148 extrapulmonary TB (EPTB). Eight-month treatment completion was 65% for smear-positive PTB patients, which was significantly higher than in patients with smear-negative PTB (45%) and EPTB (54%), due mainly to high 8-month mortality rates. The site of the intensive phase was determined in 596 patients: 178 (30%) received DOT from guardians, 115 (19%) from a health centre and 303 (51%) in hospital. At 2 months, mortality rates were significantly higher in hospitalised patients. Two-month treatment outcomes (including sputum smear conversion rates in smear-positive PTB patients) were similar between patients receiving DOT at health centres or from guardians. Decentralised DOT resulted in a 25% reduction in hospital-bed days in patients alive at 2 months compared with that predicted using the old regimens. CONCLUSION: Decentralising DOT to health centres and to guardians during the intensive phase is associated with satisfactory treatment outcomes.

Screening tuberculosis suspects using two sputum smears.

SETTING: Ntcheu district hospital, Malawi. OBJECTIVE: To assess a screening strategy for tuberculosis (TB) suspects using two sputum smears. DESIGN: A strategy of screening all TB suspects with two sputum smears for 6 months (1 July-31 December 1998) was compared with the period 1 January to 30 June 1998 during which the strategy of screening TB suspects with three sputum smears was in use. All chest radiographs of patients with negative sputum smears were assessed, and in those with pulmonary cavities and extensive disease a third sputum smear was examined. Data were collected from the laboratory sputum register and the TB register. The two 6-month periods were compared. RESULTS: In the laboratory register, using a two-sputum strategy, 186 (16%) of 1152 TB suspects were smear-positive, a result that was no different than when the three-sputum strategy was used, where 173 (16%) of 1106 TB suspects were smear-positive. The clinical pattern of TB using the different screening strategies was similar, with 58% of registered patients smear-positive with the two-sputum strategy and 54% smear-positive with the three-sputum strategy. In the first 6 months 3177 sputum smears were examined compared to 2266 smears in the second 6 months, a 29% reduction in the number of smears examined. The cost of consumables using the strategy of three sputum smears was USD $731 compared with USD $521 using the strategy of two sputum smears. C O N C L U S I O N S: Screening TB suspects using two sputum smears is as effective as screening using three sputum smears, and is associated with less laboratory work and savings in costs.