Background & Setting

1. Are Health Personnel the Best Choice for Directly Observed Treatment (DOT) in Southern Thailand? A Comparison of Treatment Outcomes among Different Types of ObserversPungrassami P1, Chongsuvivatwong V21Zonal Tuberculosis Centre 12, Thailand;2Epidemiology Unit, Faculty Of Medicine, Prince Of Songkla University, Thailand Abstract: Objectives:To determine treatment outcomes in relation to who actually did the observing Setting:The government health system in 24 districts in southern Thailand, with DOTS implemented. Methods:411 patients with new, smear positive, pulmonary tuberculosis were followed-up during 1999-2000. The patients and/or their observers were interviewed about the presence of any person staying with the patient during the drug intake and Data were analysed by logistic regression models. Results: Among 411 analysed patients with tuberculosis, Health personnel (HP), community members (CM), family members (FM), and self-administration (SA) were initially assigned as DOT observers in 43%, 5%, 44% and 8%, respectively. In practice, 56% of the 379 patients with assigned observers changed their observers. Among the patients assigned to HP, CM, FM, or SA 17%, 57%, 75%, and 34% had the type of their main observers as same as the initial assignment, respectively. There were no significant differences in treatment success between the different types of main observers. Adjusted ORs (95% CI) of treatment non-success were 1.1 (0.3-4.7), 0.7 (0.2-3.3), and 0.5 (0.2-1.1) for HP, CM, and FM, over SA groups, respectively. Conclusions: HP may not be the best choice in our setting due to poor sustainability and the availability of another promising choice (CM).Study Funding: Thailand Research Fund

2. Background & Setting • Directly Observed Treatment (DOT), one element of DOTS strategy, has been recommended for the improvement of patient adherence to the TB treatment. Most of the success stories of DOT designate health personnel (HP) and/or community members (CM) as DOT observers and the US CDC suggests that family members (FM) may not be strict observers due to emotional ties. • Three maintypes of DOT observer are used in Thailand: HP (staff members of TB clinics, hospital wards, and health centres), CM (village health volunteers, community leaders, and friends), and FM (close and distant relatives). The National Guidelines recommend that the preferred choice of observer in descending order is HP, CM, and FM. However, the majority of assigned DOT observers were FM. • The study area covered 1.2 million people in 24 districts in southern Thailand with DOTS implemented since 1996.

3. Study Rationale • DOT observers in practice were not the same as noted in the records and changed over time. • Accordingly, reports based on the records may not represent the actual contribution of the observer type to the treatment outcomes. Study Objectives • To describe the pattern of practical observer during the treatment. • To determine treatment outcomes in relation to “main type of practical observer”.

4. Methods 1 • Through the TB Registers at the 22 TB clinics, we identified and followed up all 455 patients with new, smear positive, pulmonary TB; who started treatment between 01/02/1999-30/09/1999. • The patient and/or their observers were interviewed. Data on the practical observer and the actual DOT practice were recorded for each month until the end of treatment. When more than one type of the observer was involved within one month, the one with highest frequency of being observer in that month was used in the analyses. • We defined “main type of practical observer” as the type of practical observer if the period of being observer occupied more than 60% of the treatment period. When a period of more than 60% for any one type of observer was not achieved, such a patient was defined as having a “mixed type of observer”. Accordingly, the comparative analyses were made among 5 main types of practical observer; HP, CM, FM, no practical observer (or self administration - SA), and mixed observer. • The WHO definitions of treatment outcomes were applied at the end of each month until the end of treatment. Accordingly, we classified treatment outcomes into 6 mutually exclusive categories; Cure, Completed treatment, Failure, Death, Default and Transferred out. Cure and completed treatment was combined as “Treatment success”.

5. Methods 2 • We divided co-variates that might be associated with the outcome into 3 groups, 1) Demographic and socio-economic characteristics (sex, age, ethnic group, marital status, education, understanding Thai language, income, feasibility to be free from work/study, number of living places, and independence in travelling), 2) Health Services (TB clinic , drug regimen, use of fixed-dose combination, and DOT assignment), and 3) Disease condition (severity of disease, drug resistance, adverse drug effects, HIV/AIDS and other co-morbidities/conditions including heart disease, hypertension, cerebro-vascular accident, diabetes mellitus, psychosis, alcoholic consumption, liver cirrhosis, drug abuse, and imprisonment). Univariate analyses were performed using cross-tabulation and Pearson’s chi-square test. Only co-variates with at least marginal association with the outcome (p value of < 0.2) were selected to be tested in the models, described in the following paragraph. • Four logistic regression models of increasing numbers of co-variates were applied to determine the association between the exposure and the outcome, 1) without co-variates, 2) with inclusion of the 1st group of co-variates, 3) with inclusion of the 1st and 2nd groups of co-variates, and 4) with inclusion of all 3 groups of co-variates. At each step of incorporating an additional group of co-variates, only co-variates fulfilling the following criteria were retained; 1) having significant association with the outcome (Wald test, p <0.05) or 2) having association with the outcome (p < 0.1) plus leading to a change of more than 15% of OR for any main observers in the larger model, if removed. The results were presented as odds ratio (OR) of treatment non-success over treatment success, with 95% confidence interval (CI).

6. Results 1 • Of the 455 enrolled patients, 44 were excluded because the interviewer was unable to establish contact with them or their DOT observers. Compared with the remaining patients, the excluded patients were younger (median age 31 vs 42 years old), were more often people living with HIV/AIDS (27% vs 11%), and were more often treated at general or regional hospital (48% vs 29%). • The remaining 411 patients were 6 to 86 years of age (mean, sd 44, 17), and 75% were male. Of the 323 patients with available data on income, 76% earned less than the official “minimal daily wage” in the study area (about 3.5 US$).

7. Results 2 Assigned vs practical observers • HP, CM, and FM were initially assigned to be DOT observers in 43%, 5%, and 44% of 411 patients, respectively. Of 379 patients assigned to have an observer, 212 (56%) changed their initially assigned observers during the treatment period, 130 of them on the day of the assignment. Among 177 patients assigned to HP, 153 changed, 84 on the day of the assignment. The number of changes of observer per patient ranged between 0-3 (median 1). Of 258 changes during treatment, 84% were toward a less preferred category according to the National Guidelines. • Table 1 Comparison between the type of initially assigned observer and the main type of practical observers. * Practical observer with the period of being observer of more than 60% of the treatment period.

8. Results 3 Overall distribution by month • Table 2 shows the distribution of patients by type of their practical observers and treatment outcomes from the start of treatment and at the end of each month. The proportion of HP observer was decreased from 23% at the start of treatment to 7% at the end of the 5th month. In contrast, the proportion of SA increased from 18% to 27%. The number of those who received the treatment markedly decreased by the end of the 6th month as 71% of the 411 patients reached the states of cure or treatment completion. *Month 0 = Practical observer at the start of treatment. Month 1-9 = Practical observer and treatment outcome at the end of that month. Five patients who were receiving long course chemotherapy were still on treatment after 9 months.

9. Results 4 Treatment outcome by the main type of practical observer • The overall treatment success rate in the study area was 85%. • Table 3 shows the outcomes at the end of treatment by type of main observer. Logistic regression models were constructed to examine the effects of main observers and variable groups on lack of success, and it was found that male gender, dependence in travel, being treated at general or regional hospital, HIV and other co-morbidity, but not observer type, were all significantly asociated with lack of success. * Practical observer with the period of being observer of more than 60% of the treatment period.

10. Discussion 1 • The National Guidelines recommend HP as the first choice but HPs are not always available or accepted by the patients. A study from India1 showed that HP was assigned to all patients but without alternatives, and 27% of 200 patients did not or could not come to the clinic as scheduled. Outreach approaches have been used in New York City2 to solve the problem of low accessibility of HP-DOT, but it requires more staff and supervision. In our setting with its financial limitation, incentives or outreach approaches were rarely used and the patients were to bear all costs of travel. For the patients with limited income or with limited options for transportation, it was clearly not feasible to assign HP-DOT without alternatives. • As in the study from India,modification of HP-DOT occurred. Some patients met health workers once or twice weekly or monthly, because they were unable, or were not willing, to visit the hospital or the health centre every day. In other cases, health personnel assigned transferred their observer role to CM and/or FM. Sustaining HP observers was a result of not only the patients’ accessibility and willingness to accept a HP observer, but also associated with monitoring DOT observer in practice and the providers’ ability to counteract non-compliance. 1Balasubramanian VN, Oommen K, Samuel R. DOT or not? Direct observation of anti-tuberculosis treatment and patient outcomes, Kerala State, India. Int J Tuberc Lung Dis 2000; 4:409-413. 2 Fujiwara PI, Larkin C, Frieden TR. Directly observed therapy in New York City. History, implementation, results, and challenges. Clin Chest Med 1997; 18:135-148.

11. Discussion 2 • Using CM is a promising alternative because good outcomes have been reported3,4,5,although with no data on actual DOT. In our setting, CM changed to SA less often than non-CM and CM complied with the DOT principle better than FM. However, CM was less often assigned. The sustainability of increasing assignment to this group may need further exploration. • The Centers for Disease Control and Prevention in the United States suggest that FM may not be a good observer due to emotional ties6.Family bonds in our setting may, however, have more advantage than disadvantage in regard to general care and psychological support. The reason for not practising actual DOT was not family bonds but a lack of perceived need. FM may be the only remaining option for the patients with poor performance status. Supervision of FM observers by unannounced home visits by staff members of TB clinics or health centres, has been applied in Thailand but the effectiveness of this activity has not yet been reported. 3Wilkinson D. High-compliance tuberculosis treatment programme in a rural community. Lancet 1994; 343:647-648. 4Wilkinson D, Davies GR. Coping with Africa's increasing tuberculosis burden: are community supervisors an essential component of the DOT strategy? Directly observed therapy. Trop Med Int Health 1997; 2:700-704. 5Zwarenstein M, Schoeman JH, Vundule C, Lombard CJ, Tatley M. A randomised controlled trial of lay health workers as direct observers for treatment of tuberculosis. Int J Tuberc Lung Dis 2000; 4:550-554. 6U.S. Department of Health and Human Services. Improving Patient Adherence to Tuberculosis Treatment. Georgia; Public Health Service, Centers for Disease Control and Prevention, National Center for Prevention Services, Division of Tuberculosis Elimination 1994.

12. Conclusion & Recommendations • We found no significant differences in the probability of treatment success among different types of main practical observer. • HP may not be the best choice in our setting due to poor sustainability and the availability of another promising alternative such as CM. • Changes of the observer types during the treatment may be unavoidable but changes to SA should be avoided.