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.     

Is TB contact screening relevant in a developing country setting? Experiences from eastern Nepal, 1996-1998.

SETTING: A tuberculosis programme run by a non-governmental organisation in eight hill and mountain districts of eastern Nepal. OBJECTIVE: To assess the impact of contact screening on case-finding. DESIGN: A retrospective cohort study of contacts of smear-positive, smear-negative and extra-pulmonary tuberculosis patients diagnosed and registered during 1996-1998 ('index cases'). Contacts, defined as household members identified by index cases, were screened by sputum examination; two positive smears were taken to indicate smear-positive pulmonary disease. RESULTS: Approximately 50% (668) of registered cases identified contacts; 75% (2298) of the contacts identified provided one or more sputum specimens. An overall smear-positive case yield of 0.61% (14) was obtained from contacts tested, all except one of which were contacts of smear-positive index cases. For smear-positive index cases with a smear grading of > or = 2+, the yield was 7.2 times greater (P = 0.04) than for those with a grading of 1+. CONCLUSION: In this setting, sputum examination of household contacts of smear-negative and extrapulmonary tuberculosis cases is not justified. Further assessment is needed to evaluate the utility of testing contacts of smear-positive cases without symptom screening, and whether cost effectiveness can be improved by restricting testing to contacts of cases with high bacterial (> or = 2+) loads.     

High early death rate in tuberculosis patients in Malawi.

SETTING: Thirty-eight district and mission hospitals in Malawi. OBJECTIVES: In patients registered with all types of tuberculosis (TB) in 1997 to determine 1) treatment outcomes, and 2) when in the course of anti-tuberculosis treatment TB deaths occurred. DESIGN: A retrospective study using information from TB registers, health centre registers, TB treatment cards and TB ward admission books. RESULTS: A total of 16,004 patients were registered with all types of TB, 6471 with smear-positive pulmonary tuberculosis (PTB), 5305 with smear-negative PTB and 4228 with extra-pulmonary tuberculosis (EPTB). Of patients with all types of TB, 3720 (23%) died: death rates were 22% in smear-positive PTB, 26% in smear-negative PTB and 22% in EPTB. Month of death was known in 3371 patients (91% of those who died) and day of death in 3326 patients (89% of those who died). In patients who died, 19% of deaths occurred by day 7 and 41% by the end of the first month of treatment. A higher proportion of early deaths occurred in patients with smear-negative PTB and EPTB and in relation to increasing age. CONCLUSIONS: There was a high overall death rate in TB patients registered in 1997, with 40% of deaths occurring in the first month of treatment. Strategies to combat this problem are needed.     

The impact of directly-observed treatment on the epidemiology of tuberculosis in Beijing.

SETTING: Fully supervised chemotherapy, or directly observed treatment (DOT), for newly detected smear-positive cases in Beijing, has been successfully implemented for two decades. OBJECTIVE: To evaluate the progress made in tuberculosis control, and in particular to evaluate the impact of DOT on tuberculosis epidemiology in Beijing. DESIGN: Epidemiological parameters on tuberculosis, consisting of mortality, prevalence, notification rate, tuberculous meningitis in children and initial drug resistance rate, were collected and analysed. Their trends were evaluated and compared with DOT implemented for new smear-positive cases in Beijing from 1978 to 1996. RESULTS: The coverage of DOT for new smear-positive pulmonary tuberculosis cases has increased from 10% in 1978 to more than 90% since 1990. Since DOT was introduced in 1978, mortality from tuberculosis has declined by an average of more than 7% per year. The reduction rate of 17.2%, and the rates of chronic cases and tuberculous meningitis in children decreased dramatically. The rate of newly registered smear-positive cases decreased from 18.9/100000 in 1986 to 7.3/100000 in 1996, giving an average annual reduction rate of 9.1 during this period. Initial resistance to isoniazid and streptomycin decreased from respectively 13.9% and 12.3% in 1978-1979 to 4.2% and 5.8% by 1996. The level of multidrug resistance was low and stable, at 0.8% in 1996. CONCLUSION: The experience of the Beijing tuberculosis control programme convincingly demonstrates that it is possible to improve the epidemiological situation rapidly in a low-income country, at very low cost and in a manner that is self-sufficient and sustainable.     

Ten-year experiences of the tuberculosis control programme in the southern region of Ethiopia.

SETTINGS: The tuberculosis control programme, southern region of Ethiopia. OBJECTIVE: To assess the impact of the expansion of the DOTS strategy on tuberculosis (TB) case finding and treatment outcome. DESIGN: Reports of TB patients treated since the introduction of DOTS in the region were reviewed. Patients were diagnosed and treated according to World Health Organization (WHO) recommendations. Case notification and treatment outcome reports were compiled quarterly at district level and submitted to the regional programme. RESULTS: Of 136,572 cases registered between 1995 and 2004, 47% were smear-positive, 25% were smear-negative and 28% had extra-pulmonary tuberculosis (EPTB). In 2004, 94% of the health institutions were covered by DOTS. Between 1995 and 2004, the smear-positive case notification rate increased from 45 to 143 per 100,000 population, the case detection rate from 22% to 45%, and the treatment success rate from 53% to 85%. The default and failure rates decreased from 26% to 6% and from 7% to 1%, respectively. DISCUSSION: There was a steady increase in the treatment success rate with the decentralisation of DOTS. Although 94% coverage was achieved after 10 years, the stepwise scale-up was important in securing resources and dealing with challenges. The programme achieved 85% treatment success; however, with the current low case detection rate (45%), the 70% WHO target seems unachievable in the absence of alternative case-finding mechanisms.     

Treatment results of DOTS in 1797 Sudanese tuberculosis patients with or without HIV co-infection.

SETTING: Consecutive new tuberculosis (TB) patients, from eight states in Sudan, who had never been previously treated for as much as 1 month between 1998 and 2000. OBJECTIVE: To determine the impact of human immunodeficiency virus (HIV) co-infection on tuberculosis treatment outcome. DESIGN: All patients presenting with symptoms suggestive of tuberculosis underwent sputum microscopy for acid-fast bacilli (AFB). Treatment is free of charge, and directly observed for all smear-positive patients. Treatment outcomes were those defined by the World Health Organization. All patients were tested anonymously for human immunodeficiency virus (HIV) using the Bionor test. RESULTS: Of 10 494 patients suspected of TB and referred for sputum microscopy, 1797 were TB cases; 983 had smear-positive pulmonary tuberculosis, 521 smear-negative pulmonary tuberculosis, and 293 extra-pulmonary tuberculosis. Smear-positive cases showed a cure rate of 77.2% and a failure rate of 1%. Smear-negative and extra-pulmonary patients had a completion rate of 79.4%. Cure rates for the smear-positive cases were 68.3% for HIV-positive and 77.6% for HIV-negative patients (P = 0.164). Case fatality was significantly higher among HIV-positive (12%) than among HIV-negative cases (1.8%) (OR 7.7, 95% CI 3.51-16.8). CONCLUSION: To date, a relatively low proportion of tuberculosis patients in Sudan also have HIV infection. These patients are substantially more likely to die while on treatment for their tuberculosis, a fact that underlines their need for more comprehensive care if their lives are to be prolonged. In addition, every effort is required to diminish the transmission of HIV infection to prevent the tragedy this infection represents to the community.     

Tuberculosis treatment in nepal: a rapid assessment of government centers using different types of patient supervision.

SETTING: Urban and periurban government tuberculosis (TB) treatment clinics in Nepal. OBJECTIVE: To assess TB treatment supervision strategies and outcomes. DESIGN: Three types of treatment centers were selected according to intensity of treatment supervision: Group A-all patients supervised by directly observed therapy (DOT) at the treatment center during the intensive phase; Group B-flexible DOT where patient-nominated treatment supervisors include community or family members; Group C-drugs dispensed monthly and no supervised treatment. The cohort studied comprised all new patients starting treatment during a 5-month period in 1996 (n = 759). RESULTS: At group A treatment centers, 100% of patients had daily DOT supervised by treatment center staff during the intensive phase. At group B sites, 75% of nominated supervisors were family or community members and 13% of patients had no supervisor. At group C sites 93% of patients were unsupervised. Bacteriologically confirmed cure rates for smear-positive patients were 91% (95%CI 80.3-97.2) for A sites, 57% (95%CI 48.8-64.0) for B, and 34% (95%CI 25.1-40.4) for C. Treatment centers with the best results had good access to laboratory facilities, uninterrupted drug supply, longer clinic hours, standardized TB case management, and support from a non-governmental organization. CONCLUSION: At government facilities in Nepal, only group A treatment centers achieved World Health Organization global targets for cure. Group B treatment centers showed better outcomes than unsupervised therapy but did not achieve cure targets. Rapid low-cost assessments to collect data that are not routinely reported can improve the evaluation of program aspects such as supervision strategies.     

The status and prospects of tuberculosis control in India.

SETTING: India, where much of the global strategy for tuberculosis control was established, but where, every year, there are an estimated 2 million cases of tuberculosis. OBJECTIVE: To describe the policies, initial results, and lessons learned from implementation of a Revised National Tuberculosis Control Programme using the principles of DOTS (Directly Observed Treatment, Short-course). DESIGN: A Revised National Tuberculosis Control Programme (RNTCP) was designed and implemented starting in 1993. With funding from the Government of India, State Governments, the World Bank and bilateral donors, regular supply of drugs and logistics was ensured. Persons with chest symptoms who attend health facilities are referred to microscopy centres for diagnosis. Diagnosed cases are categorized as per World Health Organization guidelines, and treatment is given by direct observation. Systematic recording and cohort reporting is done. RESULTS: From October 1993 through mid-1999, 146,012 patients were put on treatment in the programme. The quality of diagnosis was improved, with the ratio of smear-positive to smear-negative patients being maintained at 1:1. Case detection rates varied greatly between project sites and correlated with the percentage of patients who were smear-positive among those examined for diagnosis, suggesting heterogeneous disease rates. Treatment success was achieved in 81% of new smear-positive patients, 82% of new smear-negative patients, 89% of patients with extra-pulmonary tuberculosis, and 70% of re-treatment patients. CONCLUSION: The RNTCP has successfully treated approximately 80% of patients in 20 districts of 15 states of India. Treatment success rates are more than double and death rates are less than a seventh those of the previous programme. Starting in late 1998, the programme began to scale up and now covers more than 130 million people. Maintaining the quality of implementation during the expansion phase is the next challenge.     

DOT in rural China: experience from a case study in Shandong Province, China.

SETTING: Four counties at varying levels of economic development in Shandong Province were sampled. All offered tuberculosis (TB) directly observed treatment (DOT) treatment at the County TB Dispensary (CTBD). OBJECTIVE: To empirically document how DOT and home visits were implemented in rural China and to shed light on whether DOT is one of the key elements through which China achieves its high cure rates for TB. DESIGN: A total of 404 rural smear-positive TB patients registered in the CTBDs were interviewed face-to-face with structured questionnaires. Village doctors and key informants from the CTBDs were also interviewed. RESULTS: The majority of TB patients in rural areas do not receive DOT from village doctors and rarely get support, such as visits as required, from the CTBDs or township health providers in Shandong, China. CONCLUSION: The lack of DOT in Shandong does not have a negative effect on TB treatment outcomes. Given that the DOTS strategy is still the core measure of TB control in China, implementation of other programme elements apart from DOT is necessary to ensure a successful TB treatment programme.     

Practice of directly observed treatment (DOT) for tuberculosis in southern Thailand: comparison between different types of DOT observers.

SETTING: A government health system in southern Thailand where the directly observed treatment, short-course (DOTS) strategy has been implemented. OBJECTIVE: To compare the practice of actual directly observed treatment (DOT) and the observer sustainability for different types of observer. METHODS: During 1999-2000, 411 patients with new smear-positive pulmonary tuberculosis were followed up. The patients and/or their observers were interviewed about the presence of any person with the patient during drug intake and the practice of watching the patient swallowing the medicine (actual DOT). Data were recorded monthly and analysed by Cox and logistic regression models. RESULTS: For health personnel (HP), community member (CM), and family member (FM) observers, the proportions who did not practise actual DOT were respectively 11%, 23%, and 35%, and the proportions who changed to no observer or self administration were respectively 11%, 1%, and 2%, during the first 9 months of treatment. Health personnel had the lowest risk of not practising actual DOT (odds ratio HP/FM 0.1, 95%CI 0.1-0.2; CM/FM 0.9, 95%CI 0.5-1.6) but the highest risk for change to self administration. CONCLUSION: To increase the coverage of actual DOT, strategies are needed to maintain health personnel as the DOT observers and to promote actual DOT among family member observers.     

Under-diagnosis of smear-positive pulmonary tuberculosis in Nairobi, Kenya.

SETTING: Nairobi City Council Chest Clinic, Nairobi, Kenya. OBJECTIVE: To determine if under-reading of sputum smears is a contributing factor in the disproportionate increase in smear-negative tuberculosis in Nairobi, Kenya. METHODOLOGY: Between October 1997 and November 1998, patients fulfilling the local programme definition of smear-negative presumed pulmonary tuberculosis were enrolled in the study. Two further sputum specimens were collected for examination in a research laboratory by fluorescence microscopy. RESULTS: Of 163 adult subjects enrolled, 55% were seropositive for the human immunodeficiency virus type 1 (HIV-1). One hundred subjects had had two pre-study sputum smears assessed before recruitment and produced two further sputum specimens for re-examination in the research laboratory; of these 19 (19%) were sputum smear-positive on re-examination and a further seven (7%) became smear-positive on second re-examination. CONCLUSIONS: Of those patients with smear-negative presumed pulmonary tuberculosis by the local programme definition, 26% were smear-positive when reexamined carefully with two repeat sputum smears. This suggests that the high rates of smear-negative tuberculosis being seen may in part be due to under-reading. This is probably as a result of the overwhelming burden of tuberculosis leading to over rapid and inaccurate sputum examination. Retraining of existing technicians and training of more technicians is likely to reduce underreading and increase the yield of smear-positive tuberculosis. This finding also stresses the need for regular quality assurance.     

Microscopic examination and treatment outcomes of new pulmonary tuberculosis cases in Istanbul dispensaries between 1998 and 2000.

SETTING: Twenty-four public tuberculosis dispensaries in Istanbul. OBJECTIVE: To investigate microscopic examination of new pulmonary tuberculosis (TB) cases and treatment outcomes of smear-positive cases. DESIGN: A retrospective analysis of 12572 new pulmonary tuberculosis cases between 1998 and 2000. METHODS: Microscopic examination of sputum smears of all patients and treatment outcomes of smear-positive cases were evaluated. RESULTS: Of 12572 new TB cases registered between 1998 and 2000, 78.1% (n = 9822) were pulmonary and 21.9% (n = 2750) were extra-pulmonary TB cases. Of 9822 new pulmonary TB cases, 5438 (55.4%) were sputum smear-positive and 2154 (21.9%) had no sputum examination. In smear-positive pulmonary cases, treatment outcomes were classified as follows: 2521 (46.4%) cured, 1926 (35.4%) treatment completed, 128 (2.4%) treatment failure, 514 (9.4%) default, 260 (4.8%) transfer out and 72 (1.3%) died. Treatment success was 81.8% (n = 4447). Between 1998 and 2000, the smear-positive case rate improved from 47.5% to 61.5% and the cure rate improved from 41.8% to 51.1%. CONCLUSION: The microscopic diagnosis and cure rates are low in Istanbul dispensaries. The laboratories should be re-organised and directly observed treatment should be performed.     

The diagnosis of smear-negative pulmonary tuberculosis: the practice of sputum smear examination in Malawi.

SETTING: Forty hospitals in Malawi (3 central, 22 district and 15 mission) performing smear microscopy and registering tuberculosis patients. OBJECTIVE: To determine, in patients aged 15 years or above, 1) the proportion with smear-negative pulmonary tuberculosis (PTB) who had sputum smears examined, 2) the number of sputum smears examined per patient, and 3) the proportion of patients registered with smear-positive and smear-negative PTB. DESIGN: Data collection during three 6-month periods, from January 1997 to June 1998, using tuberculosis registers, laboratory sputum registers and quarterly reports. RESULTS: Of 6301 smear-negative PTB patients, 84% had sputum smears examined, the rate increasing from 76% in January-June 1997, to 85% in July-December 1997, to 89% in January-June 1998. Of patients who submitted sputum (where the number of smears was recorded), 99% had two or more smears examined and 93% had three smears examined. In district and mission hospitals performance improved over time, while in central hospitals results were more variable. During the same 18-month period 21 422 patients aged 15 years or more were registered with PTB: 59% with smear-positive PTB and 41% with smear-negative PTB; this pattern was similar in each 6-month period. CONCLUSION: The study suggests that it is reasonable to aim for a target of 90% or more of smear-negative PTB patients having sputum smears examined.     

HIV testing, HIV status and outcomes of treatment for tuberculosis in a major diagnosis and treatment centre in Yaounde, Cameroon: a retrospective cohort study

ABSTRACT: BACKGROUND: Human immuno-deficiency virus (HIV) infection and tuberculosis are common and often co-occurring conditions in sub-Saharan Africa (SSA). We investigated the effects of HIV testing and HIV status on the outcomes of tuberculosis treatment in a major diagnosis and treatment centre in Yaounde, Cameroon. METHODS: Participants were 1647 adults with tuberculosis registered at the Yaounde Jamot's Hospital between January and December 2009. Multinomial logistic regression models were used to relate HIV testing and HIV status to the outcomes of tuberculosis treatment during follow-up, with adjustment for potential covariates. RESULTS: Mean age of participants was 35.5 years (standard deviation: 13.2) and 938 (57%) were men. Clinical forms of tuberculosis were: smear-positive (73.8%), smear-negative (9.4%) and extra-pulmonary (16.8%). Outcomes of tuberculosis treatment were: cure/completion (68.1%), failure (0.4%), default (20.1%), death (5.2%) and transfer (6.3%). Using cure/completion as reference, not testing for HIV was associated with adjusted odds ratio of 2.30 (95% confidence interval: 1.65-3.21), 2.26 (1.29-3.97) and 2.69 (1.62-4.46) for the risk of failure/default, death and transfer respectively. The equivalents for a positive test among those tested (1419 participants) were 1.19 (0.88-1.59), 6.35 (3.53-11.45) and 1.14 (0.69-1.86). CONCLUSIONS: Non-consent for HIV testing in this setting is associated with all unfavourable outcomes of tuberculosis treatment. However been tested positive was the strongest predictor of fatal outcome. Efforts are needed both to improve acceptance of HIV testing among patients with tuberculosis and optimise the care of those tested positive.     

Implementation of the DOTS strategy in prisons at provincial level, Thailand.

SETTINGS: Sixteen prisons located in four geographic regions in Thailand. OBJECTIVES: To assess treatment outcomes of tuberculosis (TB) patients under the DOTS strategy in a prison programme. METHOD: The programme prospectively included 1412 consecutive TB patients registered during Year 1 (June 1999-May 2000), Year 2 (June 2000-May 2001) and Year 3 (June 2001-May 2002). DOTS implementation consisted of government commitment; passive detection by sputum smear microscopy; standardised short-course chemotherapy, including directly observed treatment by prison nurses; maintenance of drug stocks at provincial health offices; and a recording and reporting system. Data were collected using prison TB registers. RESULTS: The number of TB patients increased from 348 in Year 1 to 490 in Year 2 and to 574 in Year 3. New smear-positive patients accounted for 82.0% of the total. Of the 1158 new smear-positive cases, 68.7% were cured, 17.6% died, 10.6% were transferred out, 2.6% failed, and 0.5% completed treatment. CONCLUSIONS: DOTS implementation in these prisons could not achieve the national target to cure 85% of new smear-positive cases. More interventions are needed to help reduce the deaths and transferred cases that mainly affected the treatment outcomes in these settings.     

Prospective evaluation of in-house polymerase chain reaction for diagnosis of mycobacterial diseases in patients with HIV infection and lung infiltrates.

SETTING: Rapid diagnosis of tuberculosis (TB) in AIDS is critical for optimal treatment to reduce mycobacterial dissemination, HIV-1 replication and mortality. The inadequate sensitivity of Ziehl-Neelsen staining and its inability to distinguish atypical mycobacteria delays accurate diagnosis. OBJECTIVE: To evaluate the polymerase chain reaction (PCR) for diagnosis of TB in bronchoalveolar lavage (BAL), blood and extra-pulmonary samples from patients with AIDS and pulmonary infiltrates. DESIGN: Specimens from 103 HIV-1-infected patients were prospectively analysed using bacteriological methods and IS6110-PCR. Smear-positive samples were also tested using 16S ribosomal-DNA-PCR to identify Mycobacterium avium complex (MAC) infections. Gold standard diagnosis relied on positive cultures or treatment outcome. RESULTS: Thirty-four patients exhibited TB, one TB and MAC and four MAC. The sensitivity of IS6110-PCR was 100% in smear-positive samples, 81.8% in smear-negative BAL, 66.7% in extra-pulmonary samples and 42.9% in blood. Its specificity was 97.1% in BAL and 100% in extra-pulmonary and blood specimens. The 16S rDNA-PCR identified M. avium from all smear-positive samples that grew MAC. CONCLUSIONS: IS6110-PCR proved useful in evaluating episodes with probable clinical diagnosis of pulmonary or mixed TB and negative smears, whereas 16S rDNA-PCR would be helpful for prompt differential diagnosis of MAC in smear-positive specimens.     

Tuberculosis case-finding in Nicaragua: evaluation of routine activities in the control programme

Setting: The new International Union Against Tuberculosis and Lung Disease (IUATLD) tuberculosis strategy developed in the 1980s in Tanzania, Malawi and Mozambique, was simultaneously implemented in Nicaragua.Objective: Present results of case-finding, identify trends in incidence and limitations in case-finding and reporting.Design: Data are based upon the traditional reporting system until 1987, replaced as the programme was reorganized. Data were also collected directly from the Central Laboratory, Programme and Laboratory registers during supervision of health centres.Results: Quality control of sputum smears shows 1.8% discordance between peripheral and central laboratories. Notification rate of smear-positive tuberculosis declined 1.7% yearly 1983–1991 and 2.6% for all cases. Half of the patients are new smear-positive pulmonary cases, 40% smear-negative pulmonary cases. Relapses represent 11–13% of all smear-positive patients, children 7–30% of all cases. One-third of extrapulmonary tuberculosis cases are pleural effusions, another third lymphadenitis. 41% of adult patients entered as smear-negative in the programme had no smear reported in the laboratory.Conclusions: Quality control of sputum smears was established and the reporting system improved in spite of adverse conditions. Notification rate declined gradually. Smears should be done in all patients classified as smear-negative pulmonary tuberculosis.     

A randomised controlled clinical trial of the efficacy of family-based direct observation of anti-tuberculosis treatment in an urban, developed-country setting.

SETTING: A randomised, controlled clinical trial of the effectiveness of a family-based programme of directly observed treatment (DOT) for tuberculosis. METHODS: TB patients seen in Victoria, Australia, were randomly allocated to DOT observed by a family member (FDOT), or to standard supervised but non-observed therapy (ST). The outcome measure was compliance, measured by blinded testing of isoniazid levels in urine. An intention-to-treat analysis was used. RESULTS: Of 173 patients, 87 were allocated to FDOT and 86 to ST. Only 58% in the FDOT group were able to receive FDOT, the major reason being living alone and not having a family member to observe treatment. The rate of non-compliance was 24% (41/173), with no significant difference between FDOT (22/87) and ST (19/86). No clinical or socio-demographic variable predicted compliance. CONCLUSIONS: We were unable to demonstrate a benefit of FDOT in an urban, industrialised country setting. FDOT may be more appropriate in developing countries, where extended family support is often available and the burden of TB is much higher. Poor compliance and the difficulty in predicting non-compliance shown in this study highlights the need for DOT for all TB patients.