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.

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.

Evaluation of a standardized recording tool for sputum smear microscopy for acid-fast bacilli under routine conditions in low income countries.

SETTING: Laboratories performing sputum smear microscopy for tuberculosis in Benin, Malawi, Nicaragua and Senegal. METHODS: Analysis of computerized laboratory registers to ascertain workload, yield from serial smear examination, and demographic characteristics of examinees. RESULTS: Data from more than 60,000 examinees in 42 laboratories showed that the average number of smears examined per day ranged from 4 to 19 (mean 6) per country. To find one case of tuberculosis, on average 21 smears of suspects were examined (range 8 to 50). Of all cases with ultimately at least one positive result, 87% were already positive on the first examination. Demographic characteristics of cases differed considerably by country and gender. In 35 of 42 laboratories, males were more frequently found to be cases than females, and with increasing age an increasingly larger number of female than male suspects had to be examined to identify one case. CONCLUSIONS: This study demonstrates the usefulness of a standardized recording system for results of acid-fast microscopy in obtaining essential information for program management and on demographic characteristics of persons presenting for examination.

Sputum-smear examination in patients with extrapulmonary tuberculosis in Malawi.

In Malawi, it has been the practice for several years to obtain sputum for smear microscopy of acid-fast bacilli (AFB) from all patients with extrapulmonary tuberculosis (EPTB). We audited this practice, and determined in patients aged > or = 15 years (i) the proportion of EPTB patients who had sputum smears examined, (ii) the number of sputum smears examined per patient, and (iii) the proportion of patients with EPTB who had sputum samples smear positive for AFB. Forty-one hospitals (3 central, 22 district and 16 mission) performing smear microscopy and registering EPTB patients were visited in 1998 and 1999, and a retrospective and prospective study was carried out using TB registers and laboratory sputum registers. In the retrospective study, 1124 (69%) of the 1637 patients with EPTB had sputum smears examined; 988 (88%) of the 1124 submitted 3 sputum specimens. In the prospective study, 2026 (84%) of the 2411 patients with EPTB had sputum smears examined: 94% of the 2026 submitted 3 sputum specimens. In both studies, high rates of sputum submission were found in patients with pleural effusion, miliary TB, lymphadenopathy and pericardial effusion. In the prospective study, only 34 (1.7%) EPTB patients submitting sputum were smear positive, and the proportion who were smear positive exceeded 3% only in patients with lymphadenopathy, miliary TB and TB meningitis. As a result of this study, the Malawi TB Control Programme has changed its policy, and now only insists on sputum-smear examination if patients with EPTB have a cough for > 3 weeks. These policy changes will be audited by further operational research.

Tuberculosis programme changes and treatment outcomes in patients with smear-positive pulmonary tuberculosis in Blantyre, Malawi.

PIP: The rates of tuberculosis (TB) notifications and treatment outcomes in Queen Elizabeth Central Hospital in Blantyre, Malawi, and the measures introduced to improve treatment were assessed by analyzing patient records and treatment outcomes. From 1989 to 1991, the number of TB cases registered increased by 58%. From 1991 to 1993, the number of cases per year did not change. However, from 1991 onward the number of TB patients within Blantyre district continued to rise, and treatment outcomes in new smear-positive TB patients deteriorated substantially. In 1991 the cure rate for the last two quarters was 32% and the default rate was more than 40%. The increase in TB patients between 1989 and 1991 strained TB services and contributed to the deterioration in treatment outcomes. In 1991 measures were taken to counter the worsening trend with a focus on staffing, staff activities, treatment regimens, and sputum-collection procedures. The arrival of a physician in July 1991 and another in October 1992 led to improved diagnosis and more extensive health education of patients. In May 1993 a health surveillance assistant was hired for health education and supervision of patients. In July 1993 a district health TB officer was appointed to supervise TB activities in health centers. Also, monthly TB meetings were started for all health staff. At the end of 1993 the number of nurses were also increased. In October 1991 an outpatient regimen for smear-negative pulmonary TB and moderate extrapulmonary TB replaced the standard regimen. This new regimen consisted of 2 months of rifampicin, isoniazid, and pyrazinamide each given three times per week, followed by 2 months of daily isoniazid and ethambutol, and then 4 months of isoniazid. Then, in March 1992, another regimen was introduced: 1 month of daily streptomycin, rifampicin, isoniazid, and pyrazinamide followed by 1 month of these drugs three times per week, and then 6 months of maintenance treatment with isoniazid and thiacetazone.^ieng