Operational Research Study for Evaluation of the Effectiveness of the National DOTS Programme and to propose alternate models

to improve provision of DOTS

in various settings

K.C.S. Dalpatadu Chandra Sarukkali Chamara Anuranga Kasun Chandradasa Chitramali Rodrigo Sameera Ruwanpriya

Institute for Health Policy, Colombo, Sri Lanka June 2010

Acknowledgements
This review was carried out by a research team based at the Institute for Health Policy, Colombo, Sri Lanka, and led by Dr. K.C.S. Dalpatadu. Funding for this study was provided from the GFATM Round six TB grant through Sarvodya, Principle Recipient 2. The views in this report are those of the authors, and should not be attributed to the Institute for Health Policy (IHP). The research team wishes to acknowledge the support and input of many colleagues for this work, and in particular officials of Ministry of Healthcare and Nutrition, National Programme for Tuberculosis Control and Chest Diseases and the Provincial Health Authorities.

We thank the Secretary of Ministry of Healthcare and Nutrition Dr Athula Kahandaliyanage and The Director General of Health Services Dr Ajith Mendis for the approval and support given for conducting this study in Sri Lanka. Our thanks are also due to Dr P. Mahipala (Deputy Director General, Public Health Services (1) and to Dr Sunil de Alwis D/NPTCCD and his staff in particular, for the valuable insights given to us which immensely helped us in completion of the study, as it focused on the performance of the national DOTS programme. We acknowledge the assistance rendered to us and to our survey teams by the PDHSs and RDHSs of the six provinces and nine districts where the field surveys were carried out which enabled us to conduct the field surveys without hindrance within the time frame we had planned. We thank all the DTCOs from the selected districts for their supervisory roles and their Public Health Inspectors, who helped us to collect accurate data for this study through the field surveys.

We thank Dr Lalith Chandradasa and his staff at Sarvodya for the support extended to us. We thank Dr Ravi Rannan Eliya, Director IHP for all the support and facilities extended to the team to conduct this study.

Finally, we thank Mr P Christian and staff of IHP who helped us in numerous ways to complete this research study within a short period of time.

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Content page
Content page .......................................................................................................................................... iii List of tables............................................................................................................................................ v List of figures .......................................................................................................................................... x List of abbreviations .............................................................................................................................. xi Executive Summary .............................................................................................................................. xii 1. Introduction ..................................................................................................................................... 1 1.1. 1.2. Background: ............................................................................................................................ 3 Justification: ............................................................................................................................ 6

2.Methodology........................................................................................................................................ 8 2.1 2.2 Sample design ......................................................................................................................... 8 Sample Coverage and response rate...................................................................................... 11

2.3 Pre-testing of draft questionnaires .............................................................................................. 12 2.4 Survey Period .............................................................................................................................. 12 3 Data Tabulation and Analysis ....................................................................................................... 13 3.1 3.2 Data extraction ..................................................................................................................... 13 Data entry ............................................................................................................................. 13

4 Trend analysis of treatment out comes from commencement of DOTS programme ...................... 14 4.1 Cure Rates ............................................................................................................................. 14

4.2 Default Rate ................................................................................................................................... 15 4.3 Treatment Failure Rate ............................................................................................................... 16 5. Trend Analysis by Province of treatment outcomes of TB patients ............................................. 18 5.1 5.2 5.3 5.4 5.5 5.6 5.7 Western Province.................................................................................................................. 18 Southern Province................................................................................................................. 19 Central Province .................................................................................................................... 20 Uva Province ......................................................................................................................... 21 North Central Province ......................................................................................................... 22 Sabaragamuwa Province ....................................................................................................... 23 North Western Province ....................................................................................................... 24 iii

5.8 5.9 6. 7.

Eastern Province ................................................................................................................... 25 Northern Province................................................................................................................. 26

Survey Findings and Results ......................................................................................................... 27 Conclusions and Recommendations ............................................................................................. 33 7.1 Recommendations ................................................................................................................ 36

Survey Results ............................................................................................................................... 39

9.Bibliography ....................................................................................................................................... 82 Annexes .................................................................................................................................................. 1 Annexure1: Draft Report of the workshop ............................................................................................. 2 Annexure 2: Guidelines for Administering Questionnaires .................................................................... 6 Annexure 3: Consent Form for the Patients ......................................................................................... 10 Annexure 4: Questionnaire No:1 for the TB Patients ........................................................................... 13 Annexure 5: Questionnaire No. 2 for defaulters ................................................................................. 29 Annexure 6: Questionnaire No: 3 for the DOTS Providers ................................................................... 48 Annexure 7: District Survey Teams ...................................................................................................... 63

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List of tables
Table 1: TB case Detection by Districts 2009 ........................................................................................ 2 Table 2:Treatment Outcome of New sputum-smear positive PTB Cases registered in Q1, Q2 and Q3 of2008 ..................................................................................................................................................... 9 Table 3: Allocation of Sample and Coverage ....................................................................................... 11 Table 4: Response rates by District....................................................................................................... 11 Table 5 Relationship between age distribution and treatment outcome............................................... 39 Table 6 Relationship between sex distribution and treatment outcome. ............................................... 40 Table 7 Relationship between ethnicity and treatment outcome. ......................................................... 40 Table 8: Analysis of the treatment outcome and level of education .................................................... 41 Table 9. Relationship between level of education and treatment outcome. .......................................... 41 Table 10: Analysis of the treatment outcome and level of education .................................................. 42 Table 11. Relationship between marital status and treatment outcome. .............................................. 42 Table 12: Analysis of the treatment outcome and marital status ......................................................... 43 Table 13.Relationship between occupation and treatment outcome. .................................................... 43 Table 14. Relationship between nature of occupation and treatment outcome. ................................... 44 Table 15. Relationship between treatment outcome and being in prison.............................................. 44 Table 16: Analysis of the treatment outcome and imprisonment ........................................................ 45 Table 17.Relationship of smoking with treatment outcome. ................................................................ 45 Table 18. Relationship of alcohol use and treatment outcome ............................................................. 45 Table 19. Relationship of use of narcotic substances and treatment outcome ...................................... 45 Table 20: Analysis of the treatment outcome and smoking habits ....................................................... 46 Table 21: Analysis of the treatment outcome and smoking habits ...................................................... 46 Table 22. Relationship between monthly income and treatment outcome. .......................................... 47 Table 23. Relationship between patients understanding about the disease and treatment outcome. ... 47 Table 24: Analysis of the treatment outcome and patients understanding about the disease ............. 47 Table 25. Relationship between mode of acquiring information and treatment outcome. ................... 48 Table 26. Relationship of impact of having TB on the occupation and to the treatment outcome ....... 49 v

Table 27: Analysis of the treatment outcome and affect to the work .................................................. 49 Table 28 . The distance to the DOT center in relation to the treatment outcome ................................. 49 Table 29 . The place where the patient had to go for DOT and the distance to the DOT center (All patients) ................................................................................................................................................. 50 Table 30. Effect of the monthly income and the expenditure for each visit to the DOT center on the treatment outcome ................................................................................................................................. 51 Table 31. Relationship of the loss of income after the diagnosis of TB and the expenditure for each visit to the DOT center with the treatment outcome ............................................................................. 51 Table 32. Relationship of the treatment outcome to the time spent for each visit to the DOT center . 52 Table 33: Analysis of the treatment outcome and time spend of each visit ......................................... 52 Table 34. Relationship of mode of transport to the DOT center and the treatment outcome. .............. 53 Table 35. Relationship of the place where they had to go for DOT with the treatment outcome and daily intake of drugs.............................................................................................................................. 53 Table 36: Analysis of the treatment outcome and where they go for DOT ......................................... 54 Table 37. Relationship of Defaulters travel expenditure to the DOT center with the place where they have to go for DOT. .............................................................................................................................. 54 Table 38. Relationship of the patients perceived need to attend at a specific time of a day to the DOT center on the treatment outcome ........................................................................................................... 55 Table 39. Relationship of the treatment outcome of those who found it difficult / impossible to attend the DOT center at a specific time with the place where they have to go for DOT. .............................. 55 Table 40. The treatment outcome in relation to whether they swallowed the tablets daily in front of the DOT provider at the time of visiting the DOT center ..................................................................... 56 Table 41. The place of the DOT center of those who did not swallow the tablets daily in front of the DOT provider at the time of visiting..................................................................................................... 56 Table 42.Treatment outcome in relation to frequency of DOT ............................................................ 57 Table 43. Point of default after initiation of treatment in relation to the frequency of DOT ................ 57 Table 44. Reasons given by patients for non daily DOT during the course of treatment (IP / CP / IP + CP) ........................................................................................................................................................ 58 Table 45. Reasons for the patient to request the drugs to be taken home among those with different treatment outcomes ............................................................................................................................... 58 Table 46 .The views of the patients regarding the need to visit DOT center daily for treatment with different treatment outcomes. ............................................................................................................... 59

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Table 47. Reasons for defaulting as stated by the defaulters who have said that the need to visit DOT center daily for treatment is very good and acceptable & good but not always ................................... 59 Table 48. Relationship of the awareness & the development of side effects to the treatment outcome60 Table 49: Analysis of the treatment outcome and awareness of side effects ....................................... 60 Table 50: Analysis of the treatment outcome and development of side effects................................... 60 Table 51. Relationship of the response to the side effects of the patients who had developed side effects to treatment................................................................................................................................ 61 Table 52. Relationship of stigma to the treatment outcome.................................................................. 61 Table 53. Perception on DOT of the patients with different treatment outcomes ................................ 62 Table 54. Treatment outcome in relation to the family support to the patient ...................................... 62 Table 55: Analysis of the treatment outcome and with whom patient living with .............................. 63 Table 56.Awareness of the family members that the patient was suffering from TB in relation to the treatment outcome ................................................................................................................................. 63 Table 57: Analysis of the treatment outcome and awareness of the family......................................... 64 Table 58. Patient perception regarding the family support in relation to the treatment outcome ......... 64 Table 59: Analysis of the treatment outcome and family support ....................................................... 65 Table 60. Reasons given by defaulters for not completing the whole regimen of treatment ................ 65 Table 61. Reasons for seeking treatment again (for Cat 2) after defaulting ......................................... 66 Table 62 . Patients views with regard to the prevention of defaulting of treatment ............................ 66 Table 63. Patients perception regarding the need of visiting the chest clinic regularly in relation to the treatment outcome ........................................................................................................................... 67 Table 64. Reasons given why regular chest clinic visits are necessary ................................................ 67 Table 65. Reasons given why regular chest clinic visits are not necessary. ......................................... 68 Table 66 .Patients suggestions to improve compliance. ...................................................................... 68 Table 67. Relationship between consulting a private doctor and treatment outcome. .......................... 69 Table 68.Education level of the DOT providers ................................................................................... 69 Table 69. Employment classification of the DOT providers of the different positions ........................ 69 Table 70.Relationship of the training of the DOT provider to the period of been involved as a supervisor in the programme ................................................................................................................ 70 Table 71. Modular training experience of DOT providers ................................................................... 70 vii

Table 72: Analysis of the trained for the dot provider and working experience.................................. 71 Table 73. Availability of DOT manuals with the DOT providers ........................................................ 71 Table 74: Analysis of attending to DOTS modular training and working experience ......................... 72 Table 75.Relationship of the knowledge on TB and DOTS strategy as perceived by the DOT provider to the period of been involved as a supervisor in the programme ........................................................ 72 Table 76: Analysis of knowledge on TB and working experience ...................................................... 73 Table 77. Relationship of familiarity with the concept of DOTS as perceived by the DOT provider to the period of had been involved as a supervisor in the programme. ..................................................... 73 Table 78: Analysis of familiarity with DOTS and working experience .............................................. 73 Table 79.Relationship of awareness of DOTS strategy as perceived by the DOT provider before being a DOT supervisor .................................................................................................................................. 74 Table 80.Mode of acquiring knowledge regarding TB by the DOT providers ..................................... 74 Table 81.DOTS providers views regarding DOTS vs. the previous methods of TB control to the period of been involved as a supervisor in the programme. ................................................................. 75 Table 82.Reasons given by the DOT providers for saying that DOTS is better than the previous method for TB control activities ........................................................................................................... 75 Table 83.a DOT providers views regarding the necessity of DOT at a DOT center for TB patients. .. 76 Table 84.b DOT providers views regarding the categories that do not need DOT at a DOT center .... 76 Table 85.Number of patients that the DOT provider is supervising at the moment to the position of the DOT provider ........................................................................................................................................ 76 Table 86.Mode of acquiring knowledge about DOTS in relation to the position of the DOT provider77 Table 87.Knowledge of the DOT provider about the disease and management as perceived by the interviewer ............................................................................................................................................ 77 Table 88. Action taken by DOT providers when patients interrupt treatment. ..................................... 78 Table 89.Frequency distribution of constraints faced or experienced in implementation of DOT at the DOT center in relation to the position .................................................................................................. 79 Table 90. The drug supply to the DOT center and the storage of drugs at the DOT center ................ 79 Table 91. Availabilty of facilities at the DOT centers in different types of government health institutions as observed by the Interviewer ........................................................................................... 80 Table 92.Maintenance of DOT registers and supervision of DOT Centers in government health institutions ............................................................................................................................................. 80

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Table 93. Frequency distribution of DOT providers in government health institutions and private hospitals ................................................................................................................................................ 81 Table 94.Average number of DOT providers working at a DOT center .............................................. 81

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List of figures
Figure 1: National TB Cure Rates before and after commencement of DOTS .................................... 14 Figure 2 National TB Default Rates before and after commencement of DOTS ................................. 15 Figure 3: National TB Treatment Failure Rates before and after commencement of DOTS ............... 16 Figure 4: Treatment Outcomes of DOTS TB patients - Western Province ......................................... 18 Figure 5 Treatment Outcomes of DOTS TB patients Southern Province ......................................... 19 Figure 6 Treatment Outcomes of DOTS TB patients Central Province .......................................... 20 Figure 7 Treatment Outcomes of DOTS TB patients Uva Province................................................. 21 Figure 8 Treatment Outcomes of DOTS TB patients North Central Province ................................. 22 Figure 9 Treatment Outcomes of DOTS TB patients Sabaragamuwa Province ............................... 23 Figure 10 Treatment Outcomes of DOTS TB patients North Western Province.............................. 24 Figure 11 Treatment Outcomes of DOTS TB patients Eastern Province ......................................... 25 Figure 12 Treatment Outcomes of DOTS TB patients Northern Province .......................................... 26

List of abbreviations
ARTI- Annual Risk of Tuberculosis Infection CAT 1- Category 1 CAT 2- Category 2 CP- Continuous Phase
De- Defaulters

DOT- Directly Observed Treatment DOTS- Directly Observed Treatment Short course DTCOs - District Tuberculosis Control Officers GFATM Global Fund for AIDS Tuberculosis and Malaria GP General Practioner IHP- Institute for Health Policy IP- Intensive Phase MDR-TB- Multi Drug Resistant Tuberculosis MoH- Ministry of Health MO- Medical Officer NGO- Non Governmental Organization NPTCCD- National Programme for Tuberculosis Control & Chest Diseases PHIs- Public health Inspectors PHMs- Public Health Midwife PTB- Pulmonary Tuberculosis SAARC- South Asian Association for Regional Cooperation TB - Tuberculosis
TS- Treatment successors TF- Treatment Failures

US $ - United States Dollars WHO- World Health Organization

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Executive Summary
The operational research study was undertaken to; evaluate the effectiveness of the national DOTS programme and to propose alternate models to improve provision of DOTS at various settings with the following objectives. Asses the treatment outcomes of the TB patients at various settings which use DOTS & identify unsuccessful treatment out come. Asses the knowledge, attitudes & perceptions of patients under DOTS regarding their treatment and to identify reasons for unsuccessful treatment To Asses the knowledge, attitudes & perceptions of DOT

Methods Data was collected by perusing relevant registers reports maintained by NPTCCD at the center and by DTCOs at central chest clinics. i.e. District TB registers, Quarterly reports on case detection, Quarterly reports on treatment outcome Using this data, trend analysis of treatment out comes was compiled from commencement of the DOTS programme for all districts To assess the knowledge, attitudes and perceptions of patients under DOTS regarding their treatment & to identify reasons for unsuccessful treatment outcomes A sample of patients diagnosed as Pulmonary TB patients in the year 2008 i.e from all new sputum smear positive cases registered 12 to 15 months prior to commencement of the study were selected. Patients from nine districts from six provinces was selected for the study. Target population represented more than 70% sputum positive patients reported during the 1st three quarters for the year 2008 in Sri Lanka. Survey was carried out using an interviewer administered questionnaires by trained TB campaign PHIs in Sinhala, Tamil, and English. Two separate questionnaires one for the Treatment success and Treatment failure patients and the other for the defaulters was administered. A total of 244 patients were interviewed.

xii

A random sample of 180 DOT providers who were active during 2008 were also surveyed by the DTCOs to assess the knowledge, attitudes & perceptions of DOT providers using an interviewer administered questionnaires. All districts survey teams were trained at a work shop before starting the survey and the survey was carried out during the period December 2009 and February 2010. Data entry Data from the completed three sets of questionnaires from all the districts entered into electronic format at IHP. Considering the similarity of the treatment success and defaulters a single data base was created and a separate one for the DOT providers was maintained. Special statistical package Stata 11 was used for the analysis. All the analysis and data appending and cleaning were carried out using Stata 11. Conclusions and Recommendations Sri Lanka has adopted DOTS as a policy in 1996 and has, gradually expanded coverage and is currently implemented in 22 districts. The national cure rate which was 74.9 in the year 2000 has improved to 81.3. By the end of 2008. National Default Rate In the year 2000 was 14.9 and has come down to 6.8.In the year 2008. National Treatment Failure Rate was 0.8 in the year 2000.But had increased to 1.5.by end of 2008. A high percentage of patients educational level was observed to be low and it was noted that a significant majority of the defaulters were those who had no formal education at all or education up to grade 5. Highest treatment failures were also in the same level of education. This study highlights the fact that there are a significant number of defaults among those who have ever been imprisoned than others. Also a significant number of defaulters have dropped out 2 months after the initiation of treatment and mostly when not under daily/weekly DOT. It is observed that in most instances DOT as per the guidelines provided does not take place and is not fully implemented as expected. And in most places the DOT providers did not get the patients to swallow the tablets in front of them even though there were adequate facilities for this purpose.

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The results clearly indicate that daily DOT throughout the course of treatment or daily DOT in the IP with weekly DOT in the CP as laid down in the guidelines is not being practiced. DOTS providers are varied and results showed wide variation in the knowledge attitudes and skills of these persons. In this study 96.7% of the DOT providers were government health staff. This study revealed that services of the large numbers of community health workers trained as DOT providers have not been utilized. Fair percentage of the DOT providers has used literature, mass media and other means to acquire additional knowledge. The knowledge component of the DOT providers has been graded by the interviewer as unsatisfactory in a significant number of providers Mass communication and other health educational material have not played a major role in information transfer as regards to patients. It is believed that stigma as a challenge for TB control but we found in this study that only a significantly low number of patients have been stigmatized. DOT registers were not maintained uniformly in most of the DOT centers in the districts. Written remarks or feed back reports from supervisors of the DOT centers were not available in majority of the DOT centers surveyed. The results do not reveal that the income of the patient and the expense to travel to the DOT center daily had an effect on the treatment outcomes But the findings raise concerns about the loss of income of the patients after the diagnosis of TB as they are mostly from lower socio economic classes.

Recommendations Defaulters characteristics show that they are mostly from people of lower social classes It is best that without having a generic treatment schedule, those patients who could be classified as high risk to default should be institutionalized and treated, to prevent the spread of the disease as well as prevent emergence of drug-resistant TB which may pose significance danger in the future.

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The financial benefits given to the patients should be increased as they are economically deprived once they get the disease Measures to be adopted, aimed at promoting the effective utilization of the services of already trained community health workers who are currently under utilized to provide DOT and training of the community DOT providers be discontinued.

Emphasis should be given to provide adequate information and education needed to the patient and the family on individual basis to make them understand the importance of continuing the medication by adhering to the treatment regime.

To develop competent and committed DOT providers on the job training be provided by their supervisors in addition to the regular formal training as DOT providers. The supervision at all levels should be strengthened to improve the quality of the programme and to ensure that correct and routine recording and reporting are carried out.

DTCOs/PHIs should closely monitor and supervise DOT centers to improve the provision of DOT services. A uniform register for DOT patients should be maintained in all districts. In the Western province a different strategy should be followed as against what is happening in the rural dominated districts. Here the programme should be more intensive with individual customized treatment plans with emphasis on one to one basis on dissemination of the TB health education messages stressing the need for continuation of therapy.

Finally taking into consideration all of above to further improve the already successful DOTS programme, The study team does not recommend generic models to be adopted at various settings. Instead we recommend that time is now right to consider possibility of implementation of individual treatment plans. The individual treatment plans for each patient need to be decided at the time of diagnosis by the DTCO and the PHIs .This should be done after discussing with the patient and the family members taking into consideration the patient factors and the service delivery factors at the respective setting.

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1. Introduction
Globally, Tuberculosis (TB) infects over one third of the worlds population, causes 8 million new cases of disease, and over 2 million deaths every year. The WHO South-East Asia Region carries the highest burden of tuberculosis among all WHO Regions: 35% of the global burden. Within this Region, five countries (Bangladesh, India, Indonesia, Myanmar and Thailand) belong to the 22 TB high-burden countries, which contribute 80% of the global case load. Another SAARC Member country, Pakistan, belongs to the 22 high-burden countries, but is located in the WHO Eastern Mediterranean Region. India alone contributes 20% of the global disease burden.

Sri Lanka is not among the high-burden countries. However, tuberculosis remains a widespread problem and poses a continuing threat to the health and development of the people.

It is estimated that about 60% of adults and 45% of the general population have been infected with the disease. The annual risk of tuberculosis infection (ARTI) is falling slowly, with the decline estimated at about 2% per year. The highest rates of infection have been found in the most densely populated areas, such as Colombo and other urban areas.

In 2007 there were 11676 cases of tuberculosis estimated in Sri Lanka i.e. 60 per 100,000 population. Estimated Incidence of new sputum smear positive tuberculosis was 27 per 100,000 population in 2007. The estimated prevalence in the same year is 79 per 100,000 population.

The WHO-recommended strategy for for TB control is the Stop TB . "Directly Observed Treatment, Short-course" (DOTS) which remains as the number one component of this strategy includes five basic key elements: Political commitment with increased and sustained financing; Case detection through quality-assured bacteriology; Standardized short-course chemotherapy with supervision and patient support;

Table 1: TB case Detection by Districts 2009

An effective drug supply and management system; 5. Monitoring and evaluation system and impact measurement Once patients with infectious TB (bacilli visible in a sputum smear) have been identified using microscopy services, health and community workers and trained volunteers observe and record patients swallowing the full course of the correct dosage of anti-TB medicines (treatment lasts six to eight months). The 1st line anti-TB drugs are Isoniazid, Rifampicin, Pyrazinamide, Streptomycin and Ethambutol.

Sputum smear testing is repeated after two months to check progress, and again after 5 months and at the end of treatment. A recording and reporting system documents patients' progress throughout, and the final outcome of treatment. DOTS produces cure rates of up to 95 percent even in the poorest countries. DOTS prevents new infections by curing infectious patients.
2

DOTS prevents the development of MDR-TB by ensuring the full course of treatment is followed. A six-month supply of drugs for DOTS costs US $14 per patient in some parts of the world. The World Bank has ranked the DOTS strategy as one of the "most costeffective of all health interventions."

Since DOTS was introduced on a global scale, millions of infectious patients have received effective DOTS treatment. In half of China, cure rates among new cases are 96 percent. In Peru, widespread use of DOTS for more than five years has led to the successful treatment of 91 percent of cases.

By the end of 1998, all 22 high burden countries which bear 80% of the estimated incident cases had adopted DOTS. 43 percent of the global population had access to DOTS, double the fraction reported in 1995. In the same year, 21 percent of estimated TB patients received treatment under DOTS, also double the fraction reported in 1995.

In 2005, an estimated 60% of new smear-positive cases were treated under DOTS just short of the 70% target. Treatment success in the 2004 DOTS cohort of 2.1 million patients was 84% on average, close to the 85% target. However, cure rates in the African and European regions were only 74%. The 2007 WHO report Global TB Control concluded that both the 2005 targets were met by the Western Pacific Region, and by 26 individual countries (including 3 of the 22 high-burden countries: China, the Philippines and Viet Nam.

1.1.

Background:

Sri Lanka adopted DOTS as a policy in 1996 and implemented initially in Galle district in 1997. It was then, gradually expanded into other districts. Currently its been implemented in 23 districts but due to conflict situation in Kilinochchi, Mulativu and Mannar districts DOTS was not implemented even up to the end of 2008. Order of implementation: 1997 - Galle
3

1998 1999 2000 2001 2004 2005

- Kandy - Anuradhapura, Colombo, Matara - Kurunegala, Ratnapura, Kalutara, Puttalam - Hambantota, Kegalle, Polonnaruwa, Gampaha - Nuwaraeliya, Matale, Badulla, Moneragala, Vavuniya - Trincomalee, Batticaloa, Ampara,Kalmunai, Jaffna

There are number of DOT centres located at various settings in a single district. Government Sector o Teaching Hospitals o Base Hospitals o District Hospitals o Peripheral Units o Central Dispensaries o Other Hospitals such as Prison Hospital Private Sector o Hospitals o Dispensaries o Healthcare workers, NGO workers, Community leaders In these centres the treatment providers can be doctors, nurses, pharmacists, dispensers, or any healthcare worker. Sometimes NGO workers, Gramasevaka and Religious leaders also undertake to become direct observers of treatment.

A typical Directly Observed Treatment (DOT) Centre provides the following services, Direct observation of treatment Early detection of the side effects of treatment Regular health education

e.g In Colombo ideally two months requirement of drugs are delivered to the DOT centres from the Central Chest Clinic, Colombo. Health education of patients is usually done at the chest clinic and then by the directly observed treatment provider.
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Training of health care personnel who are involved in DOTS is also mandatory. Training of the Medical officers and the Primary Health Care Personnel were carried out initially in each district prior to implementation of DOTS. Retraining was started in 2004 and its an ongoing process.

Monitoring and evaluation is being carried out by collecting and collating data from the following reports from each district; monthly, quarterly and annually. TB treatment card (TB-01) and patients personal records (TB Files) District TB register TB laboratory register Quarterly report on case finding Quarterly report on sputum conversion of smear positive patients at the end of intensive phase Quarterly report on the results of treatment of patients registered 12-15 months earlier Quarterly report on microscopy activities and logistics Quarterly report of programme management (District level) Quarterly report from TB wards (District level) Quarterly report, Chest Hospital, Welisara Quarterly report, National TB reference laboratory

Based on the above routine data the following indicators are compiled and are used to monitor the National Programme for Tuberculosis Control & Chest Diseases (NPTCCD).
Case Detection Rate Case Detection Rate under DOTS Detection of Re-treatment TB cases Detection of New extra- pulmonary TB cases Sputum conversion rate at the end of the initial phase of treatment for new TB cases Sputum conversion rate at the end of the initial phase of treatment for re-treatment TB cases Cure rate of new TB cases Cure rate of Re-treatment cases Treatment success rate for new smear positive pulmonary TB cases 5

Treatment failure rate for new cases Default rate for new cases Treatment success rate for re-treatment casesTreatment failure rate for re-treatment cases Default rate for re-treatment cases Sputum smear positivity rate among all new cases Sputum smear positivty rate among all new pulmonary TB cases

1.2. Justification:
Effective TB control depends on the rapid and accurate identification of infectious TB cases (sputum smear positive patients) and cure of the infectious cases which is currently carried out under DOTS. The gold standard of identifications is by examination of sputum of patients with cough lasting more than three weeks which is not responding to routine treatment. In addition to this, night sweats, low grade fever lasting, haemoptysis etc. are also taken in to account.

NPTCCD has identified a number of DOT providing centres in each district in Sri Lanka based on the resources available to the programme. But due to certain resource constraints mainly human resources, there are challenges to deliver high quality DOTS services in some districts. It was considered important to assess treatment outcome at various centres to identify treatment failures and the reasons for those failures. In this study it was planned to identify treatment failures at various centres taking a selected district from five provinces and all the districts from the western province. It is envisaged that the results of this study will help to improve the effectiveness of the National DOTS Programme in Sri Lanka.

Currently in Sri Lanka the direct observation is being carried out by health staff personnel at district level and the services have been extended up to the lowest health institution as well as through public health personnel. It was important to assess the knowledge, attitudes and perceptions of treatment providers regarding DOTS, as it is noted that some times the treatment failures may be directly attributable to quality of services provided by them.

Though ideally the treatment should be directly observed for the full course, in most instances in Sri Lanka it is being done in the first two months of treatment because of the
6

difficulties that the patient may have to face when visiting a health institution or DOTS centres daily to swallow the drugs. The stigma attached to TB may be another reason which prevents patients using the services of DOTS centres. Hence it is necessary to assess the knowledge, attitudes and perceptions of patients under DOTS regarding services provided and their adherence to treatment procedures.

Even though DOTS programme has been implemented in Sri Lanka for the past eleven years, literature review has shown that studies to evaluate the effectiveness of national DOTS programme on an island wide basis have not been carried out so far.

It was felt that by evaluating the effectiveness of the National Programme for DOTS and developing alternate models to improve provision of DOTS, would lead to improvement of the national TB control programme. Ultimately enabling the country to achieve the 100% cure rate and prevent other people contracting this disease.

Taking into consideration of the above justification, this operational research study was undertaken, To evaluate the effectiveness of the national DOTS programme and to develop alternate models to improve provision of DOTS in various settings With the following specific objectives 1. To assess the treatment outcomes of the TB patients at various settings which use DOTS & identify unsuccessful treatment out come by observation of records. 2. To assess the knowledge, attitudes & perceptions of patients under DOTS regarding their treatment and identify reasons for unsuccessful treatment outcomes. 3. To assess the knowledge, attitudes & perceptions of DOT providers. 4. To develop alternate models to improve treatment success

2.Methodology
In order to 1. Asses the treatment outcomes of the TB patients at various settings which use DOTS & identify unsuccessful treatment out come by observation of records. 2. Asses the knowledge, attitudes & perceptions of patients under DOTS regarding their treatment and identify reasons for unsuccessful treatment outcomes. 3. Asses the knowledge, attitudes & perceptions of DOT providers. 4. Develop alternate models to improve treatment success Following methodology was adopted A. Relevant registers and reports maintained by NPTCCD at the center and by DTCOs at district chest clinics were accessed and studied, i.e. District TB registers Quarterly reports on case detection Quarterly reports on treatment outcome To undertake the trend analysis of treatment outcomes from the time of introduction of national DOTS programme in the respective districts. B. To assess the knowledge, attitudes & perceptions of patients under DOTS regarding their treatment & identify reasons for unsuccessful treatment outcomes as well as to asses the knowledge, attitudes & perceptions of DOT providers following procedures were adopted.

2.1Sample design
A sample of patients diagnosed as Pulmonary TB patients in 2008 were selected. Selection of Sample The district in each province which had the highest number of New sputum-smear positive PTB cases was selected for the survey except the North and Uva provinces due to resource constraints. The all three districts in the Western province were included as these districts had the highest case load for the year 2008.

Target population All new sputum smear positive cases registered 12 to 15 months prior to commencement of the study.( 1st ,2nd and 3rd Quarters of 2008) refer table 1 below

Table 2:Treatment Outcome of New sputum-smear positive PTB Cases registered in Q1, Q2 and Q3 of2008
District Colombo Gampaha Kalutara Kandy Galle Trincomalee Kurunagala Anuradhapura Rathnapura Total Grand Total Total No registered Q 1 Q 2 Q 3 Total 218 256 324 798 114 121 162 397 95 98 105 298 83 69 60 212 54 57 55 166 16 20 16 52 55 60 67 182 32 47 36 115 72 86 85 243 739 814 910 2463 2463 Cured Treatment Failure Defaulted Q 1 Q 2 Q 3 Total Q 1 Q 2 Q 3 Total Q 1 Q 2 Q 3 Total 170 186 242 598 2 2 2 6 21 26 40 87 83 89 127 299 1 2 2 5 10 18 19 47 77 86 91 254 6 3 1 10 3 4 5 12 73 55 53 181 1 2 1 4 5 4 3 12 49 50 50 149 0 0 0 0 0 4 3 7 13 20 14 47 1 0 0 1 0 0 2 2 40 52 53 145 0 1 4 5 8 4 3 15 24 35 30 89 2 3 0 5 0 0 0 0 64 76 72 212 0 2 1 3 4 4 5 13 593 649 732 1974 1974 13 15 11 39 39 51 64 80 195 195

All defaulters and treatment failures for the year under investigation in the six districts other than the Western province were included. For western province all treatment failures and a sample of defaulters were selected. From all districts equal numbers of treatment success cases were also selected for the control group. Target population selected represented more than 70% of sputum-smear positive PTB patients reported during the 1st three quarters for the year 2008 in Sri Lanka.

To carry out the survey it was decided to Administer an interviewer administered questionnaires by trained interviewers in Sinhala, Tamil, & English. PHIs attached to the respective District Chest Clinics were selected to complete the questionnaires for the three categories of patients. It was thought best to administer two separate questionnaires one for the group with Treatment success and Treatment failure patients and the other for the defaulters to obtain the desired information.

Inclusion criteria for Questionnaire No. 1 (Target population was treatment success and treatment failures) a) New patients registered in the first 3 quarters in 2008 who have been treated successfully a) New patients registered in the same period who have failed treatment (Reregistered later as Treatment after Failure and may be still on Cat II treatment at the time of administering the questionnaire)

Questionnaire No. 2 (Target population was defaulters) b) New patients registered in the first 3 quarters in 2008 who have defaulted treatment c) New patients registered initially in the same period who have defaulted and returned for treatment later (Re-registered later as Treatment after Default and may be still on Cat II treatment at the time of administering the questionnaire) In addition a random sample of DOT providers who were active during this period were also surveyed to assess the knowledge, attitudes & perceptions of DOT providers. 10% of all these selected patients and DOT providers were cross checked for consistency. Overall supervision

During the field survey in addition to the supervision of the survey carried out by the respective DTCOs, the Team leader and the research assistant also visited all the districts and did some field visits and cross checked data collected in some of these patients and providers who have already been surveyed.

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2.2 Sample Coverage and response rate

Table below gives the details of the sample selected from the districts as selected above

Table 3: Allocation of Sample and Coverage

Sampled District Colombo Gampaha Kalutara Kandy Kurunagala Anuradhapura Trincomalee Rathnapura Galle Total Cured 37 27 30 20 25 10 4 19 7 179 Failures 25 17 10 12 15 0 2 13 7 101 Defaulters 35 25 25 20 20 15 10 20 15 185 Cured 32 25 22 16 19 5 3 13 7 142 28 Responded Failures 1 4 8 3 9 0 1 2 Defaulters 18 18 7 8 8 0 2 5 8 74

Table 4: Response rates by District.

Sampled District Colombo Gampaha Kalutara Kandy Kurunagala Anuradhapura Trincomalee Rathnapura Galle Total Cured 86.5 92.6 73.3 80 76 50 75 68.4 100 79.3 Failures 4 23.5 80 25 60 50 15.4 0 27.7 Defaulters 51.4 72 28 40 40 0 20 25 53.3 40

The response rates from the cured patients were good. But tracing of treatment failures was poor. Survey found it difficult to locate these persons as they have either left the district or had passed away. Defaulters too the problem was locating them due to non availability of these patients at their residence even after three consecutive visits by the interviewer.

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2.3 Pre-testing of draft questionnaires

This was carried out at Kegalle District Chest Clinic, Making use of: 6 Treatment success Cases 2 Treatment failure Cases 4 Defaulters 4 DOT providers By the Team leader and the research team.. The questionnaires were further modified and improved to get the intended results

Training of district survey teams After selection of the districts and the samples a training work shop was conducted by the team leader along with the research team at NPTCCD center in November 2009 for all district survey teams. Objective of this workshop was to discuss and practice the filling of the questionnaires and provide the survey teams with guidelines for conducting the surveys and the sampling frame for selection of the patients. This was to ensure uniformity in the collection of data for the study before commencing the field work in December 2009. Participants were the DTCOs and PHIs attached to the respective districts chest clinics.

a) The work shop report .including the list of participants is given in annex 1 b) Guidance for field survey and submission of completed questionnaires and administrative requirements were also discussed. Refer annex 2 c) Consent for participation was also to be obtained from the patients and the consent form used is given in annex 3 d) Questionnaires administered toTB patients, Defaulters and DOT providers are given in annexes 4,5 and 6 e) List of the District survey teams is given in annex 7

2.4 Survey Period

Survey was carried out during the period of 7th December 2009 to 28th February 2010.Survey took a little longer than anticipated due to the presidential election that was held in January 2010.
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3 Data Tabulation and Analysis 3.1 Data extraction

Data was collected from three groups namely defaulters, treatment success and DOT providers using interviewer the administered questionnaires designed by IHP. Questionnaire had few multiple response and few open ended questions.

3.2 Data entry

The data submitted by the district survey teams ( completed questionnaires) were entered into electronic format using Microsoft excel spread sheet. Three data entry sheets for three sets of questionnaires were prepared initially. Considering the similarity of the treatment success and default group questionnaires, it was decided to create a single data base and to generate new variable to identify the respondent category. For the DOT providers questionnaire a separate data set was maintained. Special statistical package Stata 11 was used for the analysis of both this sets of data. All the analysis and data appending and cleaning was carried out using Stata 11. For the multiple response questions though it was required to mention the priority accordingly respondents preferences most of the time it was noted that it had not been coded correctly. Considering this draw back all the responses for multiple answers were considered as equally important for the analysis. There were no response for some of the skip questions. Data cleaning was carried out considering those records as if they were missing or by applying appropriate methods. The analyses of open ended questions were done selecting major categories considering similar types of response for each of these questions.

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4 Trend analysis of treatment out comes from commencement of DOTS programme

Trend analysis using, cure rates, default rates and treatment failure rates were carried out from the year 2000 to 2008 in 22 districts where the national DOTS program has been implemented. Ampara district had two divisions reporting i.e Ampara and Kalmunai. Following three maps depicts the national figures for the three rates used for trend analysis i.e Cure Rate. Default rate and treatment success rate by districts.

4.1

Cure Rates

Figure 1: National TB Cure Rates before and after commencement of DOTS

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In the year 2000 ,the national cure rate was 74.9.It is observed that twelve districts had cure rates above the national figure while one district had reached the national average. But in 7 districts cure rates were below the national figure. At this point of time cure rate data was not taken into account in three of the districts as data was not available. By the year 2008,the national cure rate has improved to 81.3.And there were 22 districts implementing the DOTS program. The number of districts having cure rates above the national figure had increased up to 14 while 1 district had reached the national average. But in 8 of the districts cure rates were still below the national average.

Figure 2 National TB Default Rates before and after commencement of DOTS

4.2 Default Rate

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In the year 2000 the national default rate was 14.9.It is observed that in 4 districts default rates were above the national default average while 16 districts had below national figure. By the year 2008,the national default rate has come down to 6.8.In the year 2008 the number of districts having default rates above the national average were 5, while those below national level were 16.There were two districts which had reached national default rate.

4.3 Treatment Failure Rate

Figure 3: National TB Treatment Failure Rates before and after commencement of DOTS

National Treatment Failure Rate was 0.8 in the year 2000. It is noted that only 3 districts had treatment failure rates above the national figure, while 9 districts had values below national rate. 3 districts had the same treatment failure rate as the national rate. Data from 8 districts
16

were not available at this point of time. By the year 2008, the national treatment failure rate was 1.5. The number of districts having treatment failure rates above national rate has increased up to 9 by 2008 though 10 districts had managed to maintain a failure rate lower than national figure. 3 districts had same failure rates as national level while data from 1 district was not available.

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5. Trend Analysis by Province of treatment outcomes of TB patients

The following sections gives in details the trend analysis and interpretation of these results by provinces and districts after the commencement of the DOTS programme in the country for the period 2000 to 20008

5.1

Western Province

Figure 4: Treatment Outcomes of DOTS TB patients - Western Province

Western Province had the highest TB Patient load during the last decade

Cure Rates Kalutara district shows the highest cure rates for TB while Gampaha district shows the lowest. Cure rates have been lowest in Gampaha during the year of 2003. It has gradually
18

improved but it is still below the national average.It should be noted with concern that both Kalutara and Gampaha rates appear to be coming down during the last three years.

Default Rates It is important to note that default rate is seen lowest in Kalutara district throughout the years and is below the national average. But in the other two districts in Western Province it has been above the national average and appears to be still going up after an initial drop in 2003.

Treatment Failure Rates Among the districts in the Western province Kalutara had the lowest treatment failure rates up to 2004 after which the failure rate has started to rise from 2005 onwards and is well above the national rates. This has to be further investigated.

5.2

Southern Province

Figure 5 Treatment Outcomes of DOTS TB patients Southern Province

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Cure Rates In the Southern Province Cure Rates are now above the national average.Hambantota has improved after dipping below the national averages in the years 2003 and 2004 Default Rates It is noted that the default rates had been gradually coming down up to 2005 in all districts. The Default rate at Hambantota had increased in 2007 but still remains below the national rates Treatment Failure Rates. Presently in all three districts this rate is below the national average

5.3

Central Province

Figure 6 Treatment Outcomes of DOTS TB patients Central Province

In the year 2001 a low cure rate and a high default rate was seen in the Matale district with a high rate of treatment failures in 2006 and 2008.But the default rate is now satisfactory and is
20

below the national averages. The cure rate which was very high in 2003 appears to be decreasing now. There seems to be a general increase in treatment failures towards the latter part of the decade in the Central province has come below the national rates in 2007 but again it appears to be going up in 2008. Default rates has been below the national rates after 2003 except for Nuwara Eliya where it has gone up above the national average in 2005 and 2006.It has again dipped below the national average in 2008.

5.4

Uva Province

Figure 7 Treatment Outcomes of DOTS TB patients Uva Province

Data from Monaragala district for the early part of the decade was not available Cure Rates In the Uva Province Cure rates which were below the national average in the period 2003 to 2005 went above the national average in 2007 but again seems to be coming down in 2008. Default rate is far below the national rates.

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Treatment Failure rate after being below the national average from 2003 to 2007 had gone up in 2008 in both districts

5.5

North Central Province

Figure 8 Treatment Outcomes of DOTS TB patients North Central Province

Within the North Central province Anuradhapura district has maintained high cure rates and low default rate through out. It is noted that there has been a rise in treatment failures in the latter part of the decade. In the Polonnaruwa district where the cure rates has been below national figures for many years has gone above the national average since 2005.Default rates in both districts are now very low and below the national averages.

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5.6

Sabaragamuwa Province

Figure 9 Treatment Outcomes of DOTS TB patients Sabaragamuwa Province

Kegalle district has maintained higher cure rates than national figures throughout the years. It is important to note that in Ratnapura there have been high failure rates during the years of 2000 and 2006. It has now come down below the national average in 2007. Defaulter rates has come down gradually during the period 2002 to2006 but now appears to be on the rise in both districts. In Ratnapura where the default rate had been very high since 2000 showed a decline in 2006 but has started to increase in 2007/8.

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5.7

North Western Province

Figure 10 Treatment Outcomes of DOTS TB patients North Western Province

In Kurunagela district there has been a rise in the cure rate and was equal to the national average in 2008. But in Puttalam the rate is still below the national average. In Kurunagela the default rate is below the national averages but appears to have increased in 2008. In Puttalam it is high.Treatment failure rates have been satisfactory in both districts but in the year 2007 in Kurunagela it has gone far above the national average..

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5.8

Eastern Province

Figure 11 Treatment Outcomes of DOTS TB patients Eastern Province

In Batticloa cure rates have been persistently lower than national figures throughout the years but is observed to be gradually improving. It has the highest default rates for the province and far above the national average. Batticloa reports a default rate as high as 20% in 2007 although no failures are reported during this period. Trincomalee district shows variable cure and failure rates throughout the decade with a sudden increase in the failure rate during 2006. Ampara and Kalmunai health divisions in Ampara district show increases in failure rate in 2006 to 2008.

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5.9

Northern Province

Figure 12 Treatment Outcomes of DOTS TB patients Northern Province

In the Northern Province cure rates have been below national figures throughout the decade but now appears to be improving and has reached national average by 2007.In Jaffna it has gone above this in 2008. Vavuniya district where initially the default rate was very high now reports a decline and is below the national average. There is no reporting of failures throughout the decade in Vavuniya . The Treatment failures in Jaffna which had been rising from 2003 to 2005 shows a sudden drop in 2006 .

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6. Survey Findings and Results

To assess the knowledge, attitudes & perceptions of patients under DOTS regarding their treatment & identify reasons for unsuccessful treatment outcomes, a sample of patients diagnosed as sputum smear-positive pulmonary TB patients in 2008 were selected and surveyed using two questionnaires. To assess the knowledge, attitudes & perceptions of DOT providers a random sample of DOT providers who were active during 2008 were also surveyed using a questionnaire.

The survey was conducted in six provinces. The age breakdown of the patients in the study sample correspond with the age breakdown of the sputum smear positive TB patients reported nationally where the highest number of patients are found between the age group of 45 54 years (Annual report 2007, National Programme for Tuberculosis Control and Chest Diseases). Significant differences between the treatment outcome categories among the different age groups were not found (Table 5). Among the TB patients surveyed more males were seen than the females with a ratio of 3.3 : 1 (Table 6). Most of the patients in the survey were Sinhalese and there does not appear to be any significant increase in any treatment outcome category as these are closer to the national ethnic distribution (Table 7). Higher percentage of patients educational level was observed to be low and it is noted from the results of the survey that majority of the defaulters (63.5%) were those who had no formal education at all or education up to grade 5. Highest treatment failures were also in the same level of education (Table 9). 80.7% of the study population were married and a significant difference in treatment outcome categories were not seen (Table 11).

This study shows that there was a tendency for those employed or self employed to default and the highest rates were among the unskilled labourers (Table 13 &Table 14). It is observed that the impact of having TB on the occupation with inability to attend work daily was mostly among the defaulters (Table 26). This study highlights the fact that there is a significant number of defaults among those who have ever been imprisoned than others (Table 15). Both defaults and treatment failures were high among those in the lower income groups (Table 22).

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The results do not reveal that the income of the patient and the expense to travel to the DOT center daily had an effect on the treatment outcomes (Table 30). But the findings raise concerns about the loss of income of the patients after the diagnosis of TB (Table 31) which is likely to cause greater economic and social impact on their families. Most of the DOT centers were accessible and convenient to the patients with regard to the distance, mode of transport and the time spent for each visit (Table 28,Table 32 & Table 34). We observed that these factors have no effect to the unfavourable treatment outcomes.

In Sri Lanka in principle all components of the DOTS strategy has been accepted and is being implemented, but we found that DOT is not fully implemented as expected. In this study it was revealed that the drug intake of 22.5% of the patients had not been supervised and the patients had not swallowed the drugs under the watchful eyes of the treatment supervisor (DOT provider). Also it is worth to note that most of the patients whose drug intake had not been supervised were those attending DOT centers in the government institutions (Table 41 & Table 42). Significantly fewer numbers were identified as having their DOT providers as community volunteers, family member, GP and others. The burden of observing patients taking their medication while attending on their routine work has been stated as a constraint faced by 16.7% of the DOT providers (Table 89). Such patients may have received lower quality of care. Even though they had visited the DOT center daily they might not have received the care that was expected.

This study reveals that 98.6% of the DOT providers are government health staff and most of them had educational levels above Grade 10 (Table 68). It is observed that in the government institutions, dispensers (30.5%) were the main category recruited as DOT providers (Table
69). The next highest category was found to be the nursing officers (22.8%). In this sample

the number of minor staff serving as DOT providers was 37 (15%) which is still significant. The involvement of the PHMs and PHIs are 4.5% & 5.7% respectively and less than the involvement of minor staff and even pharmacists (22%). This study shows that the services of the large numbers of community health workers trained as DOT providers have not been utilized. Most of the government DOT centers had an average of 4 trained DOT providers per center.

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Majority of the DOT providers (88.3%) were trained for the task but we found that a significant proportion had not attended modular training even though some of them have functioned as DOT providers for more than 4 years. Only 54.4% of the DOT providers had the manual with them although 63.3% had been trained on the module (Table 70, Table 71 &
Table 73). 72.4 % of the Govt. health staff has acquired knowledge regarding TB from the

DOTS training. But it is observed that only 16.7% in the other group has benefitted from DOTS training. Significant numbers of the DOT providers has used literature, mass media and other means to acquire additional knowledge (Table 80).

It is observed that out of the 16.1% who are not familiar with concept of DOTS, 55% had been in the programme for more than 4 years (Table 77). The knowledge component of the DOT providers has been graded by the interviewer as unsatisfactory in a significant number of providers and mostly on treatment categories & regimen and on the awareness of the side effects. Very few numbers have been graded as highly satisfactory (Table 87).

Despite the documented benefits of daily DOT we found that there are no defaulters among those who attended DOT center weekly during both intensive and continuation phases (Table
42). We observed that a significant number of defaulters have dropped out 2 months after the

initiation of treatment and mostly when not under daily/weekly DOT (Table 43). The results clearly indicate that daily DOT through out the course of treatment or daily DOT in the IP with weekly DOT in the CP as laid down in the guidelines (Page 82, General Manual for Tuberculosis Control-January 2005) is not being practiced. In most instances patients have requested to take drugs home and the most frequently occurring reasons as expressed by them were it is easy, nature of occupation and difficulty in transport(Table 33). Patients dissatisfaction with attending the DOT center daily (Table 46) and attending the DOT center at a specific time of the day (Table 38) was observed only in a small proportion of patients. Though a significant number of DOT providers expressed their views as DOT at a DOT center was not necessary for professionals and health workers (Table 84) it is not possible to predict at the commencement of treatment which patient will adhere to treatment till the end. An observation made was that 51.4% of defaulters feel that the need to attend the DOT center daily is very good and acceptable or good but not always (Table 46) but had dropped out due to various other reasons which are discussed later in this report.
29

DOT is being perceived by a significant number of patients (52%) as necessary for all patients with a high proportion of treatment failures within that. Need of a supervisor to take care of themselves were also felt by most of the treatment failures (table 53). Most of the DOT providers stated that cure rates were higher with DOTS and patient compliance was better (Table 82).

The key factor in the success of DOTS is the uninterrupted supply of drugs to the DOT centers. Although the drug supply in most of the DOT centers were satisfactory, still the drug supply to 3.4% of the government DOT centers has not been satisfactory (Table 90). It has been observed that drugs were out of stock at 8 centers in the government sector and one nongovernment DOT center. Drug storage has not been maintained as expected to be in 14 (8 %) government DOT centers but in the private DOT centers it was better. Drugs have not been kept under lock and key in 58(33%) of government DOT centers and in 3 out of 6 private DOT centers (Table
90).

High proportion, 85.9% of the treatment successors and 89.3% of the treatment failures have perceived that they had a good understanding about the disease. But it was only 50% among the defaulters who thought that they had a good understanding of the disease (Table 23). It is observed that significant number of defaulters have stopped medication because they felt better and the reappearance of the symptoms was found as the main reason for them to seek care again after defaulting (Table 60 & Table 61). With respect to the mode of education of the patients we found that 65.4% had been educated at a chest clinic by Medical Officers. Mass communication and other health educational material have not played a major role in information transfer (Table 25). Awareness of the side effects by the patient has been beneficial in that the majority of patients had sought medical advice while continuing treatment (Table 48 & Table 51). It is believed that stigma as a challenge for TB control but we found in this study that only a significantly low number of patients have been stigmatized. The numbers stigmatized are high among the defaulters. An interesting finding was that substantially high proportion is stigmatized by family (Table 52).

30

This study revealed that 67.6% of the patients in the sample had been living with the spouse and 16% with other relatives. 6.6% have been living alone and 75% out of them have defaulted These findings in the study corroborate the fact that the family support to the patient has an effect on the treatment outcome by having a significant difference in the proportion of treatment successors living with the spouse and those living alone (Table 40). The study revealed that none of the treatment successors or treatment failures had said that the family support was poor but 17.6% of the defaulters have said that it was poor (Table 58). The results show that there is a need to accelerate the current effort to decentralize the treatment centers and to extend the DOT services to the community level. Higher proportion of the patients (68.4%) felt that regular chest clinic visits were not necessary (Table 63) and when needed it was for only sputum microscopy and investigations (Table43). A significant proportion of all patients 34.5% has suggested distributing the drugs closer to the home for improving compliance. Most of the treatment successors and treatment failures were of this view, while most of the defaulters have suggested minimizing travel for better compliance (Table 64). A High proportion of defaulters has also suggested DOT at home and Drugs to be provided to the patient to reduce default (Table 62). It is observed that the nongovernment DOT providers had gone to the patients residences and traced them when they interrupted treatment while informing the relevant personnel and hence are more likely to prevent defaulting than government DOT providers (Table 88). We recognized the constraints faced by the DOT providers in providing quality services to the patients. The main problems encountered were the poor facilities at the DOT centers, difficulty in tracing the patients once they interrupt treatment and poor cooperation of the patients (Table 89). DOT registers were not maintained in a fair number (34.5%) of the DOT centers and there was no uniformity of recording in these registers in most of the centers .It is noted that the treatment cards have been updated daily in a very high proportion of DOT centers. But written remarks or feedback reports from supervisors of the DOT centers were not available in most of the DOT centers surveyed (Table 92). This is a reflection of the inadequate supervision of the DOT centers by the DTCO/PHI.

31

This study had limitations. Due to the resource constraints the study was limited to six out of the nine provinces in the country. We identified the PHIs attached to the chest clinics as data collectors since they were the most suitable persons to trace the patients and administer the questionnaire within the limited time period we had for conducting the survey. But this would have created some bias on certain factors identified.

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7. Conclusions and Recommendations

Sri Lanka has adopted DOTS as a policy in 1996 and implemented national DOTs programme initially in Galle district in 1997. It was then, gradually expanded into other districts. Currently its been implemented in 22 districts. Implementation had not been possible due to the conflict situation that existed up to May 2009 in Kilinochchi, Mulativu and Mannar districts. Trend analysis using, cure rates, default rates and treatment failure rates were carried out to assessed the effectiveness of the National DOTs programme

The national cure rate was 74.9 in the year 2000 and by the year 2008, the national cure rate has improved to 81.3. But it is observed that in 8 of the districts, cure rates were still below the national average. National Default Rate In the year 2000 was 14.9. By the year 2008, the national default rate has come down to 6.8.In the year 2008 the number of districts having default rates above the national average were only 5. National Treatment Failure Rate was 0.8 in the year 2000.By the year 2008; the national treatment failure rate had increased to 1.5. The number of districts having treatment failure rates above national rate was 9 in the year 2008.

In Colombo and Gampaha districts the cure and default rates were below the national average. They also have the highest patient load and concerted efforts need to be carried out to improve implementation of DOTS to have an impact on the national averages. In this survey that was conducted in six provinces the age breakdown of the patients in the sample corresponded with the age breakdown of the sputum smear positive TB patients reported nationally Most of the patients in the survey were Sinhalese and there does not appear to be any significant increase in any treatment outcome category as these are closer to the national ethnic distribution

The patients characteristics show that certain groups of people are vulnerable to the diseases in Sri Lanka which is also noted from other country findings as well. A high percentage of patients educational level was observed to be low and it was noted that a significant majority of the defaulters were those who had no formal education at all or education up to grade 5. Highest treatment failures were also in the same level of education.
33

Also this study

highlights the fact that there is a significant number of defaults among those who have ever

been imprisoned than others. Both defaults and treatment failures were high among those in the lower income groups. Also a significant number of defaulters have dropped out 2 months after the initiation of treatment and mostly when not under daily/weekly DOT. These findings indicate that there is a need for continuous monitoring of the patients with frequent contact to ensure that they adhere to treatment Inmates at detention centers and prisons should be monitored to detect early cases of TB and prevent the spread of the disease in these places of residences. Additional interventions are needed to reduce default among those who have been imprisoned.

It is observed that in most instances DOT as per the guidelines provided does not take place. This study and our field observations and discussions with the field staff revealed that DOT is not fully implemented as expected. In spite of the word DOT meaning that the patient swallows the drugs under the watchful eyes of the treatment supervisor, most places do not insist that the patients swallow the tablets in front of them even though there are adequate facilities for this purpose. This short coming was noted even during the treatment of patients in the intensive phase. The results clearly indicate that daily DOT through out the course of treatment or daily DOT in the IP with weekly DOT in the CP as laid down in the guidelines is not being practiced. The DOT have been followed according to the whims and fancies of the DOT provider some times weekly some times once in three days and some times even longer duration with drugs provided to the patient to take to homes and take their medications at home with out adequate supervision.

For Intensive period it is essential that DOT as per the guidelines should be given and this can be relaxed during the next phase after correct assessment of the patient. But every effort should be made not to extend beyond weekly DOT as there were more defaulters among those who had DOT other than daily or weekly in the continuation phase. DOTS providers are varied and results showed wide variation in the knowledge attitudes and skills of these persons. In this study 96.7% of the DOT providers were government health staff. It was observed that DOT provided at places where dispensers do the work is not the best. As far as possible it is best that this task be given to nurses. This study shows that services of the large numbers of community health workers trained as DOT providers have not been utilized. Most of the DOT providers were trained for the task but we found that a significant proportion had
34

not attended modular training even though some of them have functioned as DOT providers for more than 4 years. Fair percentage of the DOT providers has used literature, mass media and other means to acquire additional knowledge.

The findings of the study address the need for continued capacity building of the DOT providers both in the government and non-government sector. The knowledge component of the DOT providers has been graded by the interviewer as unsatisfactory in a significant number of providers and mostly on treatment categories & regimen and on the awareness of the side effects. Very few numbers have been graded as highly satisfactory .A vast knowledge of the subject is not necessary but they should be able to give guidance regards to the disease, side effects and should have the basic knowledge of the variety of drugs used and the treatment schedule. Complex issues could always be referred to the Central Chest Clinics. In most instances patients and a significant numbers of the DOT providers has used literature, mass media and other means to acquire additional knowledge. Mass communication and other health educational material have not played a major role in information transfer as regards to patients. The findings reinforce that adequate information and education needs to be provided to the patient and the family on individual basis to make them understand the importance of continuing the medication by adhering to the treatment regime prescribed.

It is believed that stigma as a challenge for TB control but we found in this study that only a significantly low number of patients have been stigmatized. The numbers stigmatized are high among the defaulters. An interesting finding was that substantially high proportion is stigmatized by family members and relatives. Therefore it is necessary to adopt measures to educate the family members. It was also observed during the field supervision that patients were more stigmatized by the higher social classes rather than the low as they felt threatened through inadequate knowledge they had gained and hence educational thrusts should also be focused on this aspect as there are patients from this sector as well.

DOT registers were not maintained uniformly in most of the DOT centers in the districts. Written remarks or feed back reports from supervisors of the DOT centers were not available
35

in majority of the DOT centers surveyed. Logistical constraints at DOT centers need to be addressed by the MoH/NPTCCD to facilitate the delivery of quality care and DTCOs should closely monitor and supervise these DOT centers to improve the provision of DOT services at these centers. Although the results do not reveal that the income of the patient and the expense to travel to the DOT center daily had an effect on the treatment outcomes But the findings raise concerns about the loss of income of the patients after the diagnosis of TB which is likely to cause greater economic and social impact on their families as these patients are mostly from lower socio economic classes. The key factor in the success of DOTS is the uninterrupted supply of drugs to the DOT centers. Although the drug supply in most of the DOTS centers were satisfactory but still the drug supply to a few government DOT centers had not been satisfactory. In these centers drugs have been out of stock for more than one month .

7.1

Recommendations

Defaulters characteristics show that they are mostly from people of lower social classes who are unreliable and it is best that with out having a generic treatment schedule, those patients who could be classified as high risk to default should be institutionalized and treated in the best interest of the community as they can spread the disease as well as transform the disease to drug-resistant TB and pose significance danger in the future even though this is not a major concern at present.

Special attention should also be paid to inmates at detention centers and prisons and they should be monitored to detect early cases of TB and prevent spread of the disease in their places of residences. The program should concentrate on having additional interventions to reduce the prisoners defaulting treatment.

The financial benefits given to the patients should be increased as they are economically deprived once they get the disease as well as they come mainly from the poor strata of the community. Some does not have adequate finances to go even to the closest DOT center provided, which are far and wide due to escalating transport costs.
36

Findings in the study corroborate the fact that the family support to the patient has an effect on the treatment outcome by having a significant difference in the proportion of treatment successors living with the spouse and those living alone In this regard it is recommended to adopt measures aimed at promoting the effective utilization of the services of the already trained community health workers who are currently under utilized to provide DOT. This will improve patient compliance and reduce default.

Further training of the community DOT providers need to be discontinued.

Mass communication and other health educational material have not played a major role in information transfer. The findings reinforce that emphasis should be given to provide adequate information and education needed to the patient and the family on individual basis to make them understand the importance of continuing the medication by adhering to the treatment regime prescribed as mass media approach has not had the desired effects.

The knowledge component of the DOT providers has been found to be inadequate. The findings of the study address the need for continued capacity building of the DOT providers both in the government and non-government sector. It is recommended that in order to develop competent and committed DOT providers they should be provided on the job training by their supervisors in addition to the regular formal training as DOT providers.

The supervision at all levels need strengthening to improve the quality of the programme and to ensure that correct and routine recording and reporting are carried out. Logistical constraints at DOT centers need to be addressed by the MoH/NPTCCD to facilitate the delivery of quality care at DOT centers and DTCOs/PHIs should closely monitor and supervise these DOT centers to improve the provision of DOT services. Supervisors should provide a written feed back after their supervisory visits to these centers.

37

A uniform register for DOT patients should be maintained in all districts. The disease being more a problem in the urban setting it is found that large number of cases are from the Western province mainly in Colombo district with large number of defaulters as well. A different strategy to overcome this problem should be followed as against what is happening in the rural dominated districts. Here the programme should be more intensive with individual customized treatment plans with emphasis on one to one basis on dissemination of the TB health education messages stressing the need for continuation of therapy.

Finally taking into consideration all of above to further improve the already successful DOTS programme, we do not recommend generic models to be adapted at various settings. Instead we recommend that time is now right to consider possibility of implementation of individual treatment plans taking into consideration both the patients and service delivery factors in various settings.

We feel that the flexible nature of DOTS strategy will enable the health worker to adapt innovatively to the best model to suit the patients interest. Therefore the plan of action for each patient need to be decided at the time of diagnosis by the DTCO and the PHIs .This should be done after discussing with the patient and the family members taking into consideration the patient factors and the service delivery factors at the respective setting to minimize defaulting and to ensure that they strictly adhere to daily intake of drugs.

38

8 Survey Results
Introduction Chi square test and Fishers exact test was used to test the statistical relationship between two groups of the treatment outcome and other interest variable. As a rule of thumb if the observed number of any cell is less than 5 Fishers exact has been used for the significant test.Some of the data tables were regrouped for significant tests in order to get sufficient numbers for some categories. Those who did not respond to the questions were excluded from the statistical analysis.

As chi square test or Fishers exact test is not able to identify which category/categories have the significant relationship and the direction of the relationship to the treatment outcome, standardized residual has been calculated for identified relevant categories.
Table 5 Relationship between age distribution and treatment outcome.

Age Distribution (Years) <15 15-24 25-34 35-44 45-54 55-64 65-74 >75 Not responded Total

TS % Number 2.1 3 12 17 17.6 25 12 17 24.6 35 20.4 29 9.2 13 1.4 2 0.7 1 100 142

Treatment outcome TF % Number 3.6 1 0 0 7.1 2 17.9 5 35.7 10 17.9 5 17.9 5 0 0 0 0 100 28

De Number 1.4 1 1.4 1 12.2 9 27 20 37.8 28 17.6 13 2.7 2 0 0 0 0 100 74

Total Number 2 5 7.4 18 14.8 36 17.2 42 29.9 73 19.3 47 8.2 20 0.8 2 0.4 1 100 244

Source: IHP TB survey 2009

Majority of the patients in the sample were in the ages between 25 and 65. Out of them 29.9% of patients were between 45 and 54 years of age, while only 2% and 0.8% were in the age groups below 15 years and above 75 years respectively.

39

Table 6 Relationship between sex distribution and treatment outcome.

Treatment outcome TF % Number 82.1 23 17.9 5 100.0 28

Sex Distribution Male Female Total

TS % Number 68.3 97 31.7 45 100.0 142

De % Number 91.9 68 8.1 6 100.0 74

Total % Number 77.0 188 23.0 56 100.0 244

Source: IHP TB survey 2009

These results indicate that there is no statistically significant relationship between the treatment outcome and gender (chi-square with two degree of freedom = 15.7631, p = 0.000). Most of the patients in this survey were males 77 % .It is observed that males were in the majority in all treatment outcome categories and contributed to 68.3%, 82.1%and 91.9% to the treatment successors, failures and defaulters respectively.
Table 7 Relationship between ethnicity and treatment outcome.

Ethnicity Sinhalese Tamil Muslim Burgher Total

TS Number

Treatment outcome TF % Number

De Number

Total Number

78.9 11.3 8.5 1.4 100

112 16 12 2 142

78.6 14.3 7.1 0 100

22 4 2 0 28

66.2 18.9 14.9 0 100

49 14 11 0 74

75 13.9 10.2 0.8 100

183 34 25 2 244

Source: IHP TB survey 2009

Majority of the patients sampled in the study were Sinhalese while Tamil and Muslim participation is 13.9% and 10.2% respectively. There does not appear to be any significant increase in any category as these are closer to the national ethnic distribution.

40

Table 8: Analysis of the treatment outcome and level of education

Treatment outcome TS TF De 112 22 49 (0.60) (0.18) (-0.93) Tamil 16 4 14 (-0.83) (0.03) (1.12) Muslim 12 2 11 (-0.65) (-0.52) (1.21) Fisher's exact = 0.255

Ethnicity Sinhalese

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a no statistically significant relationship between treatment outcome and ethnicity (p = 0.255).

Table 9. Relationship between level of education and treatment outcome.

Level of education TS No formal education Up to Grade 5 Up to Grade 10 Up to O/L Up to A/L Tertiary education Other Not Responded Total % Number 14.1 20 19.7 19.7 24.6 18.3 2.1 0.7 0.7 100 28 28 35 26 3 1 1 142 Treatment outcome TF % Number 17.9 5 42.9 21.4 7.1 7.1 0 3.6 0 100 12 6 2 2 0 1 0 28 % 27 36.5 28.4 5.4 2.7 0 0 0 100 Total De Number 20 27 21 4 2 0 0 0 74 % Number 18.4 45 27.5 22.5 16.8 12.3 1.2 0.8 0.4 100 67 55 41 30 3 2 1 244

Source: IHP TB survey 2009

Educational level of the patients in the sample was low. 46.1% had no formal education or was educated up to grade 5. 18.5% of study population has had no formal education and they contributed to 27% and 17.9% to default and failure rates respectively. Only 1.2 % of the study population had undergone tertiary education and there were no reported defaulters or treatment failures among them. Highest treatment failures were seen amongst the patients with no formal education and educated up to grade 5 (60.8%).Similarly in the default category they contributed to 63.5 % of the defaulters.

41

These results suggest that there is a statistically significant relationship between treatment outcome and level of education (p = 0.000). It is clear that among the educated people there is a higher possibility to be a treatment success and less possibility be a defaulter. Education level does not have considerable effect to be a treatment failure. The positive value of the standardized residual indicates that the observed frequency of the cell is significantly above its expected frequency. Among the patients who have the education level up to grade 5, number of reported patients is higher than expected and also it is statistically significant. Among the patients who have higher education level of up to A/L or above more likely to be a treatment success than be a defaulter.

Table 10: Analysis of the treatment outcome and level of education

Level of education Up to grade 5 Up to grade 10 Up to O/L Up to A/L and above Fisher's exact = Treatment outcome TS TF De 48 17 47 (-2.12*) (1.26) (2.15*) 28 6 21 (-0.70) (-0.07) (1.00) 35 2 4 (2.29*) (-1.21) (-2.42*) 29 2 2 (2.25*) (-0.88) (-2.55*) 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

Table 11. Relationship between marital status and treatment outcome.

Treatment outcome TF % Number 92.9 26 7.1 2 0 0 0 0 0 0 100 28

Marital Status Married Unmarried Divorced Separated Widowed Total

TS % Number 81 115 19 27 0 0 0 0 0 0 100 142

De % Number 75.7 56 23 17 0 0 1.4 1 0 0 100 74

Total % Number 80.7 197 18.9 46 0 0 0.4 1 0 0 100 244

Source: IHP TB survey 2009

There is no any effect to the treatment outcome whether the patent is married or not (chisquare with two degree of freedom = 3.4388 , p = 0.179).

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Table 12: Analysis of the treatment outcome and marital status Treatment outcome Marital Status TS TF De 26 56 Married 115 (-0.01) (0.69) (-0.41) Unmarried 27 2 17 (0.02) (-1.43) (0.86) Fisher's exact = 0.177
Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

Married patients get family support and more likely to interest to cure as it spread to others. Since it is expected married people to be treatment success and unmarried patients to be defaulters. Though we expect a relationship between marital status and treatment outcome, the result suggests that there is no statistical relationship between treatment outcome and marital status.

Table 13.Relationship between occupation and treatment outcome.

Occupation TS % Number 39.4 56 23.2 33 32.4 46 4.9 7 0 0 100 142

Unemployed Self employed Employed Retired Not respondend Total

Treatment outcome TF % Number 28.6 8 35.7 10 32.1 9 3.6 1 0 0 100 28

De % Number 29.7 22 24.3 18 44.6 33 0 0 1.4 1 100 74

Total % Number 35.2 86 25 61 36.1 88 3.3 8 0.4 1 100 244

Source: IHP TB survey 2009

These results suggest that there is no statistically significant relationship between Treatment outcome and occupation (p = 0.152). In the sample majority of the patients were either unemployed (35.2%) or self employed (25%). Among treatment successors 39.4% were unemployed, while among defaulters those employed were 44.6%.

43

Table 14. Relationship between nature of occupation and treatment outcome.

Nature of occupation TS % Number 6.3 9 0.7 0.7 2.1 1.4 1.4 18.3 23.9 45.1 100 1 1 3 2 2 26 34 64 142 Treatment outcome TF % Number 3.6 1 0 0 7.1 0 14.3 14.3 28.6 32.1 100 0 0 2 0 4 4 8 9 28 De Number 4.1 3 0 1.4 0 0 2.7 44.6 17.6 29.7 100 0 1 0 0 2 33 13 22 74 Total Number 5.3 13 0.4 0.8 2 0.8 3.3 25.8 22.5 38.9 100 1 2 5 2 8 63 55 95 244

Technical and professional Administration and management Trained officer Clerical work Teacher Agriculture and farming Unskilled labourer Others Not responded Total

Source: IHP TB survey 2009

44.6% of the defaulters were unskilled labourers while there were only 18.3% and 14.3% unskilled labourers among treatment successors and treatment failures respectively.

Table 15. Relationship between treatment outcome and being in prison.

Treatment outcome TS TF De Total

Ever been imprisoned Yes % Number 31.1 14 11.1 5 57.8 26 100 45 No % Number 65.1 127 11.8 23 23.1 45 100 195 Not Responded % Number 25 1 0 0 75 3 100 4 Total % Numb 58.2 1 11.5 30.3 100 2

Source: IHP TB survey 2009

Out of the patients who have ever been in prison 57.8% have defaulted the treatment regime. While among the patients who have never been to prison 65.1% have successfully completed the treatment regime. It is noted that 18.44% of the patients had been in prison one time or other which is significant.

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Table 16: Analysis of the treatment outcome and imprisonment

Treatment Outcome TS Ever been imprisoned Yes No 14 127 (1.16) 23 (0.05) 45 (-1.67)

(-2.42*) TF 5 (-0.11) De 26 (3.48**) Pearson chi2(2) = 22.0984 Pr = 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results indicate that there is no statistically significant relationship between the treatment outcome and imprisonment (chi-square with two degree of freedom = 22.098, p = 0.000). Imprisonment of tuberculosis patient causes him to be a defaulter. Most of the imprison people come from lower level of the society. Being a prisoner has a significant affect to the treatment outcome.
Table 17.Relationship of smoking with treatment outcome.
Smoking habits Never smoked Smoked in the past & stopped completely Currently smoking Not Responded Total TS % Number 45.1 64 21.1 30 32.4 46 1.4 2 100 142 TF % Number 39.3 11 25 7 35.7 10 0 0 100 28 De % Number 21.6 16 41.9 31 33.8 25 2.7 2 100 74 Total % Number 37.3 91 27.9 68 33.2 81 1.6 4 100 244

Source: IHP TB survey 2009

Table 18. Relationship of alcohol use and treatment outcome
Use of alcohol Occasionally Regularly Never Not Responded Total TS % Number 36.6 52 9.9 14 52.1 74 1.4 2 100 142 TF % Number 42.9 12 21.4 6 35.7 10 0 0 100 28 De % Number 45.9 34 33.8 25 20.3 15 0 0 100 74 Total % Number 40.2 98 18.4 45 40.6 99 0.8 2 100 244

Source: IHP TB survey 2009

Table 19. Relationship of use of narcotic substances and treatment outcome

Use of narcotic substances % Heroin Other Total TS Number 100 4 0 0 100 4 TF % Number 0 0 100 1 100 1 De % Number 66.7 2 33.3 1 100 3 % Total Number 75 6 25 2 100 8

Source: IHP TB survey 2009

Note: This table takes into account only those patients who responded as narcotic substances and others.
45

It is observed that majority of the patients had been smoking or were currently smoking (61.1%).Even Alcohol use have been high with 58.6% reporting that they take alcohol regularly or occasionally. Among patients who had completed treatment successfully 45.1% had never smoked, 52.1% had never used alcohol and 4 people had used heroin. Among the failures 35.7% were currently smoking and 21.4% were taking alcohol regularly. Among defaulters 33.8% were currently smoking and 33.8% were regularly consuming alcohol.
Table 20: Analysis of the treatment outcome and smoking habits Treatment outcome Smoking habits TS TF De 64 11 16 Never smoked (1.50) (0.12) (-2.16*) Smoked in the past & stopped completely 30 7 31 (-1.53) (-0.33) (2.35*) Currently smoking 46 10 25 (-0.18) (0.18) (0.14) Pearson chi2(4) = 14.9948 Pr = 0.005
Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between treatment outcome and smoking habit (p = 0.000). Most of the defaulters have smoked in the past and stopped smoking completely. The never smoking TB patient is less likely to be a defaulter.
Table 21: Analysis of the treatment outcome and smoking habits
Smoking habits Occasionally
Regularly Never

Treatment outcome TS TF De 52
(-0.62) 14 (-2.36*) 74 (2.21*)

12
-0.2 6 -0.35 10 (-0.43)

34
-0.74 25 (3.03**) 15 (-2.78**)

Pearson chi2(4) = 28.6089 Pr = 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results shows that there is a statistically significant relationship between treatment outcome and smoking habit (p = 0.000). Treatment success patients are not regularly smokers. The TB patient who never smokes is likely to be a treatment success person. Among the defaulters there are more patients who
46

are regularly smokers than never smoking. This indicates that smoking habits have an effect to the treatment outcome.
Table 22. Relationship between monthly income and treatment outcome.
Monthly income(Rs) No regular income <3,500 3.501 7,500 7,501 12,000 12,001 20,000 >20,000 Does not like to disclose Total TS % Number 28.9 41 8.5 12 13.4 19 15.5 22 19 27 3.5 5 11.3 16 100 142 TF % Number 32.1 9 3.6 1 25 7 14.3 4 17.9 5 0 0 7.1 2 100 28 De % Number 36.5 27 9.5 7 25.7 19 6.8 5 12.2 9 0 0 9.5 7 100 74 Total % Number 31.6 77 8.2 20 18.4 45 12.7 31 16.8 41 2 5 10.2 25 100 244

Source: IHP TB survey 2009

31.6% of the sample was without a regular income. Large numbers of patients in all treatment outcome categories were without regular income. i.e 28.9%, 32.1%and 36.5% in the treatment successors, failures and defaulters categories respectively were with out any income.
Table 23. Relationship between patients understanding about the disease and treatment outcome.
Patient's perception Have a good understanding Yes No Not Responded Total TS % Number 85.9 122 14.1 20 0 100 142 TF % Number 89.3 25 10.7 3 0 0 100 28 % De Number 50 37 48.6 36 1.4 1 100 74 Total % Number 75.4 184 24.2 59 0.4 1 100 244

Source: IHP TB survey 2009

85.9% of the treatment successors and 89.3% of the treatment failures have perceived that they have a good understanding about the disease. But it was only 50% among the defaulters who thought that they had a good understanding of the disease.

Table 24: Analysis of the treatment outcome and patients understanding about the disease
Patient's perception Patient perceived as having a good understanding about the disease Yes No Treatment Outcome TS 122 (1.40) 20 (-2.47*) TF 25 (0.82) 3 (-1.46) De 37 (-2.46*) 36 (4.34**)

Fisher's exact =

0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

47

These results suggest that there is a statistically significant relationship between treatment outcome and patients understanding about the disease (p = 0.000). It is clear that those who have good understanding about the disease more likely to be a treatment success. There is a possibility to be a defaulter among those who do not have a good understanding about the disease. The factor of the understanding about the disease does not have any effect on the treatment failures.
Table 25. Relationship between mode of acquiring information and treatment outcome.
Mode TS % Education by MOs at chest clinic Education by Nurses at chest clinic/DOT center Education by other health care personnel From other patients Health leaflets Internet Mass media 46 32 14 1.1 7.3 0 0 Number 81 56 25 2 13 0 0 Treatment outcome TF % 41 26 17 7.1 9.5 0 0 Number 17 11 7 3 4 0 0 Total De % Number 65.4 34 19.2 11.5 1.9 1.9 0 0 10 6 1 1 0 0 % Number 48.7 132 28.4 14 2.2 6.6 0 0 77 38 6 18 0 0

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question Most of the patients had received information and education regarding TB through government health personal mainly by MOs and Nurses at chest clinics and at DOT centers.

Among patients who had completed treatment successfully, 46% of them were educated at a chest clinic by Medical Officers. Among treatment failures 7.1% had acquired information from other patients while only 9.5% had referred health leaflets for acquiring information. But it is to be noted that out of the defaulters 65.4% had been educated at a chest clinic by Medical Officers. It appears that mass communication and other health educational material has not played a major role in information transfer.

48

Table 26. Relationship of impact of having TB on the occupation and to the treatment outcome
Impact No impact Unable to attend work daily Transferred to a different work place Kept off work during treatment Dismissed from the job Others Not Responded Total TS % Number 67.6 96 23.9 34 0.7 1 2.8 4 0 0 2.8 4 2.1 3 100 142 Treatment Outcome TF % Number 53.6 15 39.3 11 0 0 3.6 1 0 0 3.6 1 0 0 100 28 % De Number 50 37 44.6 33 0 0 0 0 1.4 1 2.7 2 1.4 1 100 74 Total % Number 60.7 148 32 78 0.4 1 2 5 0.4 1 2.9 7 1.6 4 100 244

Source: IHP TB survey 2009

32% of the patients were unable to attend work daily. Out of the defaulters 44.6% have mentioned that they were unable to attend work daily. 39.3% of the treatment failures also have mentioned the same while it was only 23.9% among the treatment successors.
Table 27: Analysis of the treatment outcome and affect to the work
Treatment Outcome Impact No impact TS 96 (1.11) Unable to attend work daily 34 (-1.66) Other 9 (0.31) Fisher's exact = 0.028
Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

TF 15 (-0.55) 11 (0.63) 2 (0.29)

De 37 (-1.19) 33 (1.90) 3 (-0.61)

These results suggest that there is a statistically significant relationship between treatment outcome and impact to the work (p = 0.000). However Results need to be interpreted cautiously since those who are not employed will not have any impact to their work.
Table 28 . The distance to the DOT center in relation to the treatment outcome
Outcome <5km % Number 58.1 111 13.1 25 28.8 55 100 191 Distance 5-20km >20km % Number % Number 60 21 33.3 1 5.7 2 0 0 34.3 12 66.7 2 100 35 100 3

TS TF De Total

Not Responded % Number 60 9 6.7 1 33.3 5 100 15

Total % Number 58.2 142 11.5 28 30.3 74 100 244

Source: IHP TB survey 2009

49

Only 1.23% of the patients had to travel >20kms to attend the DOT center. 78.3% had less than 5kms to travel. Out of those who had less than 5kms to travel 28.8% were defaulters. 18.9% of the defaulters had to travel >5kms.

Table 29 . The place where the patient had to go for DOT and the distance to the DOT center (All patients)
Place where they have to go for DOT The chest clinic Government hospital Central dispensary PHM /PHN GP Work place Family member at home With community volunteer Other Not responded Total <5km % Number 17.8 34 30.4 29.8 9.9 1.6 0 1.6 3.1 3.7 2.1 100 58 57 19 3 0 3 6 7 4 191 Distance >20km 5-20km % Number % Number 25.7 9 33.3 1 57.1 17.1 0 0 0 0 0 0 0 100 20 6 0 0 0 0 0 0 0 35 66.7 0 0 0 0 0 0 0 0 100 2 0 0 0 0 0 0 0 0 3 Not Respond % Number 6.7 1 26.7 0 6.7 0 0 20 0 40 0 100 4 0 1 0 0 3 0 6 0 15 % 18.4 34.4 25.8 8.2 1.2 0 2.5 2.5 5.3 1.6 100 Total Number 45 84 63 20 3 0 6 6 13 4 244

Source: IHP TB study 2009

15.57% of the patients had to travel >5kms to attend the chest clinics, government hospitals or the CDs for DOT.

50

Table 30. Effect of the monthly income and the expenditure for each visit to the DOT center on the treatment outcome
Monthly income (Rs)
%

Expenditure in rupees TS
Number %

Nil TF
Number

Defaulter
% Number %

TS
Number %

<20 TF
Number %

De
Number %

TS
Number %

>20 TF
Number %

De
Number %

TS 2 0 1 0 2 0 1 6 22.2 22.2 11.1 0.0 11.1 0.0 33.3 100.0

Not Responded TF
% Number %

Total De
Number % Number

Number

No regular 33.3 <3,500 11.1 3.501 7,500 18.5 7,501 16.7 12,001 11.1 >20,000 1.9 Does not like 7.4 Total 100.0

18 6 10 9 6 1 4 54

40.0 6.7 26.7 13.3 13.3 0.0 0.0 100.0

6 1 4 2 2 0 0 15

25.0 14.3 28.6 7.1 14.3 0.0 10.7 100.0

7 4 8 2 4 0 3 28

32.4 2.7 13.5 16.2 16.2 8.1 10.8 100.0

12 1 5 6 6 3 4 37

14.3 0.0 28.6 14.3 28.6 0.0 14.3 100.0

1 26.7 0 6.7 2 53.3 1 6.7 2 6.7 0 0.0 1 0.0 7 100.0

4 1 8 1 1 0 0 15

21.4 7.1 7.1 16.7 33.3 2.4 11.9 100.0

9 3 3 7 14 1 5 42

25.0 0.0 25.0 25.0 25.0 0.0 0.0 100.0

1 0 1 1 1 0 0 4

33.3 0.0 16.7 0.0 33.2 0.0 16.7 100.0

2 50.0 2 0.0 1 0.0 0 0.0 1 0.0 0 0.0 3 50.0 9 100.0

1 0 0 0 0 0 1 2

33.3 0.0 16.7 0.0 33.3 0.0 16.7 100.0

2 0 1 0 2 0 1 6

31.6 8.2 18.4 12.7 16,8 2.0 10.2 100.0

77 20 45 31 41 5 25 244

Source: IHP TB survey 2009

39.75% 0f the patients did not have to spend money to visit the DOT center daily. 15.6% of the patients who had to spend more than 20 rupees for each visit had no regular income.
Table 31. Relationship of the loss of income after the diagnosis of TB and the expenditure for each visit to the DOT center with the treatment outcome
Loss of income after the diagnosis of TB
%

Expenditure in rupees Nil TS

Number %

<20 Defaulter
% Number %

>20 De
% Number %

Not Responded De
% Number %

Total De
% % Number Number

TF
Number

TS
Number %

TF
Number

TS
Number %

TF
Number

TS
Number %

TF
Number

Yes No Not Responded Total

46.3 35.2 18.5 100.0

25 53.3 19 33.3 10 13.3 54 100.0

8 50.0 5 32.1 2 17.9 15 100.0

14 9 5 28

43.2 27.0 29.7 100.0

16 57.1 10 14.3 11 28.6 37 100.0

4 53.3 1 20.0 2 26.7 7 100.0

8 3 4 15

40.5 35.7 23.8 100.0

17 50.0 15 50.0 10 0.0

2 66.7 2 16.7 0 16.7 4 100.0

4 1 1 6

11.1 44.4 44.4 100.0

1 50.0 4 0.0 4 50.0 9 100.0

1 66.7 0 16.7 1 16.7 2 100.0

4 1 1 6

46.7 31.1 22.1 100.0

114 76 54 244

42 100.0

Source: IHP TB survey 2009

46.7% of the patients have lost their income after the diagnosis of TB. Out of them 20.2% had to spend more than Rs. 20 for each visit to the DOT center.

51

Table 32. Relationship of the treatment outcome to the time spent for each visit to the DOT center
Treatment outcome TS TF De Total <15 mins % Number 58.1 72 13.7 17 28.2 35 100 124 15-30 mins % Number 65.8 48 12.3 9 21.9 16 100 73 Time spent for each visit 30 mins 1 hr. % Number 46.2 12 3.8 1 50 13 100 26 1 2 hrs. % Number 50 2 0 50 2 100 4 >2 hrs % Number 47.1 8 5.9 1 47.1 8 100 17 Total % Number 58.2 142 11.5 28 30.3 74 100 244

Source: IHP TB survey 2009

Only 8.6% of patients had to spend more than 1 hr for each visit to the DOT center.13.5% of the defaulters and 7.0% of the treatment successors had spend more than I hour. 50.8% of the patients had spent less than 15 mins. 68.9% of the defaulters had spent less than 30 mins for each visit.. 65.8% of those who had to spend 15 30 mins were in the treatment successors group while 21.9% were defaulters.
Table 33: Analysis of the treatment outcome and time spend of each visit
Treatment outcome TS TF Defaulters Fisher's exact = Time spent for each visit <15 mins 15-30 mins 30 mins 1 hr. >1 hrs. 72 48 12 10 (-0.02) (0.85) (-0.80) (-0.64) 17 9 1 1 (0.73) (0.22) (-1.15) (-0.91) 35 16 13 10 (-0.43) (-1.30) (1.82) (1.44) 0.085

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a no any statistically significant relationship between treatment outcome and time spent for each visit (p = 0.085) at 1% and 5% significant level.

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Table 34. Relationship of mode of transport to the DOT center and the treatment outcome.
Mode of Transport Walking Private vehicle Public transport Hired vehicle Not Responded Total TS % Number 31.7 45 21.8 36.6 4.2 5.6 100 31 52 6 8 142 TF % Number 42.9 12 28.6 21.4 0 7.1 100 8 6 0 2 28 De % Number 35.1 26 12.2 39.2 4.1 9.5 100 9 29 3 7 74 Total Number 34 83 48 87 9 17 244

19.7 35.7 3.7 7 100

Source: IHP TB survey 2009

35.7% of the patients had used public transport while 34% had walked to the DOT center. 3.7% had used a hired vehicle. 42.9% the treatment failures and 35.1% of the defaulters had walked to the DOT center.
Table 35. Relationship of the place where they had to go for DOT with the treatment outcome and daily intake of drugs.
Place where they have to go for DOT Did take drugs daily TS % Number 20.3 27 33.1 23.3 8.3 0.8 0 3.8 2.3 5.3 3 100 44 31 11 1 0 5 3 7 4 133 TF % Number 11.5 3 42.3 19.2 11.5 0 0 0 0 15.4 0 100 11 5 3 0 0 0 0 4 0 26 TS % Number 37.5 3 37.5 0 12.5 0 0 0 0 12.5 0 100 3 0 1 0 0 0 0 1 0 8 % Did not take drugs daily TF Number 0 0 100 0 0 0 0 0 0 0 0 100 1 0 0 0 0 0 0 0 0 1 Not Responded % Number 0 0 50 0 50 0 0 0 0 0 0 100 1 0 1 0 0 0 0 0 0 2 Total % Number 19.4 33 35.3 21.2 9.4 0.6 0 2.9 1.8 7.1 2.4 100 60 36 16 1 0 5 3 12 4 170

The chest clinic Government hospital Central dispensary PHM /PHN GP Work place Family member at home With community Other Not Responded Total

Source: IHP TB survey 2009

93.6% of treatment successors and 93% of the treatment failures have taken drugs daily.

53

Table 36: Analysis of the treatment outcome and where they go for DOT
Place where they have to go for DOT The chest clinic Did take drugs daily TS 27 (0.41) 44 (-0.26) 31 (0.19) 11 (-0.19) 16 (-0.16) Fisher's exact = 0.711
Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

TF 3 (-0.91) 11 (0.58) 5 (-0.42) 3 (0.43) 4 (0.35)

Government hospital

Central dispensary

PHM /PHN

Other

These results suggest that there is a no statistically significant relationship between treatment outcome to be a treatment successors or treatment failure and time spent for each visit (p = 0.711).
Table 37. Relationship of Defaulters travel expenditure to the DOT center with the place where they have to go for DOT.
Place where they have to go for DOT Did take drugs daily TS % Number 20.3 27 33.1 23.3 8.3 0.8 0 3.8 2.3 5.3 3 100 44 31 11 1 0 5 3 7 4 133 TF % Number 11.5 3 42.3 19.2 11.5 0 0 0 0 15.4 0 100 11 5 3 0 0 0 0 4 0 26 TS % Number 37.5 3 37.5 0 12.5 0 0 0 0 12.5 0 100 3 0 1 0 0 0 0 1 0 8 % Did not take drugs daily TF Number 0 0 100 0 0 0 0 0 0 0 0 100 1 0 0 0 0 0 0 0 0 1 Not Responded % Number 0 0 50 0 50 0 0 0 0 0 0 100 1 0 1 0 0 0 0 0 0 2 Total % Number 19.4 33 35.3 21.2 9.4 0.6 0 2.9 1.8 7.1 2.4 100 60 36 16 1 0 5 3 12 4 170

The chest clinic Government hospital Central dispensary PHM /PHN GP Work place Family member at home With community Other Not Responded Total

Source: IHP TB survey 2009

4% of the defaulters had attended the chest clinics, govt. hospitals or CDs for DOT spending more than Rs. 60 for each visit. 82.1% of the defaulters who did not spend money to visit the DOT center had DOT at places other than the chest clinics or the govt. hospitals.
54

Table 38. Relationship of the patients perceived need to attend at a specific time of a day to the DOT center on the treatment outcome TS TF & De Feasibility of attending % Number % Number Possible always 78.2 111 52 53 Possible mostly 12 17 27.5 28 Difficult 1.4 2 8.8 9 Impossible 2.8 4 3.9 4 Not Responded 5.6 8 7.8 8 Total 100 142 100 102

Source: IHP TB survey 2009

78.2% of the treatment successors had mentioned that attending the DOT center at a specific time of the day was possible always but only 52% of the TFs and defaulters had said that it was possible always. Only 2.8% of the treatment successors and 3.9% of the TFs & defaulters have mentioned that it was impossible to attend the DOT center at a specific time. 27.5% of the TFs & defaulters had mentioned that it is possible mostly.
Table 39. Relationship of the treatment outcome of those who found it difficult / impossible to attend the DOT center at a specific time with the place where they have to go for DOT.
TS Place where they have to go for DOT The chest clinic Government hospital Central dispensary PHM /PHN GP Work place Family member at home With community volunteer Other Difficult % 0 0 50 0 0 0 0 0 50 Number 0 0 1 0 0 0 0 0 1 Impossible % 50 25 0 0 0 0 0 0 25 Number 2 1 0 0 0 0 0 0 1 % 0 0 0 100 0 0 0 0 0 Difficult Number 0 0 0 1 0 0 0 0 0 TF Impossible % 0 0 0 0 0 0 0 0 0 Number 0 0 0 0 0 0 0 0 0 % 12.5 37.5 50 0 0 0 0 0 0 Difficult Number 1 3 4 0 0 0 0 0 0 De Impossible % 0 25 50 0 0 0 0 25 0 Number 0 1 2 0 0 0 0 1 0

Source: IHP TB survey 2009

Note: Totals do no add up to sample size due to the response being determined by previous answer(Table 22). Most of those who have said that it is difficult / impossible to attend the DOT center at a specific time of the day had to attend chest clinics, Government hospitals and central dispensaries for DOT. One person found it difficult to attend at a specific time of the day to the DOT center of the community volunteer.

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Table 40. The treatment outcome in relation to whether they swallowed the tablets daily in front of the DOT provider at the time of visiting the DOT center
Treatment outcome Swallowed the tablets daily in front of the DOT provider at the time of visiting the DOT center Yes % TS TF De 73.2 78.6 78.4 N 104 22 58 % 25.4 14.3 20.3 No N 36 4 15 % 1.4 7.1 1.4 Not Responded N 2 2 1 % 100 100 100 Total N 142 28 74

Source: IHP TB survey 2009

75.4% of the patients had swallowed the tablets in front of the DOT provider.
Table 41. The place of the DOT center of those who did not swallow the tablets daily in front of the DOT provider at the time of visiting.
Place of the DOT center Did not swallow the tablets daily in front of the DOT provider at the time of visiting % The chest clinic Government hospital Central dispensary PHM /PHN GP Work place Family member at home With community volunteer Other Not Responded Total 20 29.1 21.8 7.3 1.8 0 3.6 7.3 7.3 1.8 100 Number 11 16 12 4 1 0 2 4 4 1 55

Source: IHP TB survey 2009

70.9% of those who did not swallow the tablets in front of the DOT providers had attended government health institutes. It is also noted that 10.9% of those who did not swallow the tablets in front of the DOT providers had family members or community volunteers as DOT providers.

56

Table 42.Treatment outcome in relation to frequency of DOT

Frequency of DOT % Daily DOT in IP + CP Daily DOT in IP & Weekly in IP + CP Daily DOT in IP & other Other in IP + CP Total 3.5 22.5 1.4 53.5 19 100 TS Number 5 32 2 76 27 142 % 17.9 28.6 0 42.9 10.7 100 TF Number 5 8 0 12 3 28 % 2.7 13.5 0 59.5 24.3 100 De Number 2 10 0 44 18 74 5 2 %

Source: IHP TB survey 2009

There are no treatment failures and defaulters among those who had weekly DOT through out the course of treatment. Defaulters are higher in comparison to the treatment successors and failures in category other in IP and CP.

Table 43. Point of default after initiation of treatment in relation to the frequency of DOT
Frequency of DOT point of default after initiation of treatment 12 months % Number 0 7.1 0 78.6 14.3 100 0 1 0 11 2 14 2-4 months % Number 5.1 17.9 0 46.2 20.5 100 2 7 0 18 8 39 46 months % Number 0 15.4 0 61.5 15.4 100 0 2 0 8 2 13

<1 month Number % Daily DOT in IP + CP Daily DOT in IP & Weekly DOT in CP Weekly in IP + CP Daily DOT in IP & other in CP Other in IP + CP Total 0 0 0 63.6 36.4 100 0 0 0 7 4 11

Not Responded % Number 0 0 0 0 100 100 0 0 0 0 2 2

Total Number 2.7 2 10 0 44 18 74

13.5 0 59.5 24.3 100

Source: IHP TB survey 2009

52.7% of the defaulters had discontinued treatment between 2 4 months while 18.9% and 17.56% had discontinued between 1 2 months and 4 -6 months respectively. Most of the defaulters are those who had daily DOT in IP and weekly / other in CP and had defaulted in the CP (59.5%).

57

Table 44. Reasons given by patients for non daily DOT during the course of treatment (IP / CP / IP + CP) Reason for Non daily DOT TS TF De Total DOT provider requested to take drugs at home Patient requested to take drugs at home After the IP requested to come once a week 11 55 89 2 4 20 5 17 37 18 76 146

Source: IHP TB survey 2009

Note : Totals does not add up to sample size as the numbers on daily DOT has been excluded

Table 45. Reasons for the patient to request the drugs to be taken home among those with different treatment outcomes
Reasons for the patient to request the drugs to be taken home % It was easy Nature of occupation Daily travelling was difficult Travelling was costly Difficulty in transport As there was no one to go with him Needed to maintain privacy Due to problems at the treatment place Poor reception at the treatment center Fearing social stigma Other Total 40.9 27.3 40.9 4.5 13.6 0 9.1 2.3 0 9.1 6.8 100 TS Number 18 12 18 2 6 0 4 1 0 4 3 44 % 40 40 40 0 0 0 0 0 0 0 20 100 TF Number 2 2 2 0 0 0 0 0 0 0 1 5 % 54.5 45.5 81.8 18.2 54.5 18.2 0 0 0 0 0 100 De Number 6 5 9 2 6 2 0 0 0 0 0 11 % 43.3 31.7 48.3 6.7 20 3.3 6.7 1.7 0 6.7 6.7 100 Total Number 26 19 29 4 12 2 4 1 0 4 4 60

Source: IHP TB survey 2009

Note: Totals do not add up due to multiple responses to the question Commonest reason for requesting drugs to be taken home was that they felt it was easy. Difficulty in travelling daily and the nature of the occupation were some other reasons mentioned.Out of the treatment successors 40.9% thought it was easier to take drugs at home while the same percentage preferred to take drugs at home due to difficulties in daily travelling. In the treatment failure group the main reasons given as requesting to take drugs at home were the following. Due to nature of the occupation (40%), it was easy (40%), and difficulties in daily travelling (40%).
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Table 46 .The views of the patients regarding the need to visit DOT center daily for treatment with different treatment outcomes.
Treatment outcome Patients view Very good and acceptable Good but not always Troublesome but does not interfere with daily activities Troublesome as it interferes with daily activities Waste of time Important reason for defaulting Not Responded Total TS % Number 52.8 75 29.6 2.8 8.5 2.1 0 4.2 100 42 4 12 3 0 6 142 TF % Number 57.1 16 35.7 3.6 3.6 0 0 0 100 10 1 1 0 0 0 28 De % Number 25.7 19 25.7 1.4 32.4 1.4 5.4 8.1 100 19 1 24 1 4 6 74 Total % Number 45.1 110 29.1 2.5 15.2 1.6 1.6 4.9 100 71 6 37 4 4 12 244

Source: IHP TB survey 2009

52.8% of the treatment successors, 57.1% of the TFs and 25.7% of the defaulters have said that the need to visit a DOT center daily for treatment was very good and acceptable. 29.6% of the TSs and 35.7% of TFs have said that it was good but not always. 32.4% of the defaulters have said that it was troublesome as it interfered with daily activities and 5.4% have said that it was an important reason for defaulting.
Table 47. Reasons for defaulting as stated by the defaulters who have said that the need to visit DOT center daily for treatment is very good and acceptable & good but not always
Treatment outcome Patients view Reasons for defaulting Distance to DOT center Income Problems Occupational problems Stigma Poor family support Stopped on own because felt better Decided to go to other place Attitudes & practices of staff at Dot centre Lack of proper awareness about the treatment other Very good and acceptable & Good but not always 5 13 9 1 8 17 2 2 3 13

Source: IHP TB survey 2009

Note : Totals do not add up due to multiple responses to the question Most of the defaulters who have said that the need to visit DOT center daily for treatment is very good and acceptable & good but not always, have stopped treatment on their own because they have felt better. The other common reasons were income problems, occupational problems and the poor family support.

59

Table 48. Relationship of the awareness & the development of side effects to the treatment outcome
Treatment outcome Awareness & development of side effects TS % Awareness of side effects Development of side effects Yes No Yes No Not Responded Total Number 69 98 31 18.3 81 0.7 100 44 26 115 1 142 % TS Number 75 21 25 42.9 57.1 0 100 28 7 12 16 De % Number 45.9 34 54.1 16.2 82.4 1.4 100 40 12 61 1 74 Total % Number 62.7 153 37.3 20.5 78.7 0.8 100 91 50 192 2 244

Source: IHP TB survey 2009

62.7% of the patients were aware of the side effects of the drugs. But 54.1% of the defaulters were not aware of the side effects. Only 20.5% of the patients had developed side effects during treatment. 42.9% of the treatment failures have developed side effects while only 18.3% and 16.2% of the TSs and defaulters respectively had developed side effects.
Table 49: Analysis of the treatment outcome and awareness of side effects
Awareness of side effects Yes Treatment Outcome TS TF De 98 21 34 (0.95) (0.82) (-1.82) No 44 7 40 (-1.23) (-1.07) (2.36*) Pearson chi2(2) = 13.1143 Pr = 0.001

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

Table 50: Analysis of the treatment outcome and development of side effects
Development of side effects Yes Treatment Outcome TS TF De 26 12 12 (-0.58) (2.58*) (-0.79) No 115 16 61 (0.30) (-1.32) (0.41) Pearson chi2(2) = 9.6338 Pr = 0.008

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

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These results suggest that there is a statistically significant relationship between treatment outcome and development of side effects (p = 0.000). Those who have developed side effects are likely to be a treatment failure. As we notice most of the other factors do not have significant effect to treatment failure category.
Table 51. Relationship of the response to the side effects of the patients who had developed side effects to treatment.
TS Patients response to the side effects % Ignored & continued treatment Sought medical advice while continuing treatment Discontinued treatment & sought medical advice Discontinued treatment & stayed at home Other Not Responded and Not applicable Total 3.8 92.3 0 3.8 0 0 100 Number 1 24 0 1 0 0 26 % 0 100 0 0 0 0 100 Number 0 12 0 0 0 0 12 % Number 16.7 2 58.3 0 25 0 0 100 7 0 3 0 0 12 % 6 86 0 8 0 0 100 Number 3 43 0 4 0 0 50 TF De Total

Source: IHP TB survey 2009

86% of the patients who developed side effects have sought medical advice while continuing treatment. 52% of those who developed side effects were in the treatments success group while 24% were in the treatment failure group. 8% have discontinued treatment and stayed at home. One patient out of that has been successfully treated later.
Table 52. Relationship of stigma to the treatment outcome
Situation % Stigmatized as a TB Yes patient in public No Stigmatization by Family member Relative Colleague at work Villagers Person at the Other 7 93 0 20 40 30 10 10 TS Number 10 132 0 2 4 3 1 1 % 10.7 89.3 0 33.3 0 66.7 0 0 TF Number 3 25 0 1 0 2 0 0 % 20.3 79.7 73.3 40 0 26.7 0 0 De Number 15 59 11 6 0 4 0 0 % 11.5 88.5 39.3 32.1 14.3 32.1 3.6 3.6 Total Number 28 216 11 9 4 9 1 1

Source: IHP TB survey 2009

Only 9% of the patients have been stigmatized as a TB patient in public. Of those who had been stigmatized most of them have been stigmatized by a family member.

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Table 53. Perception on DOT of the patients with different treatment outcomes

Perception on DOT TS % Necessary for all patients Yes No Not Responded Total Need an observer / Yes supervisor to take care of No himself Not Responded Total Would have continued Yes medicines without any No interruption even without a Not Responded supervisor Total 54.22535 45.07042 0.704225 100 35.2 64.1 0.7 100 70.4 27.5 2.1 100 Number 77 64 1 142 50 91 1 142 100 39 3 142 % 64.28571 32.14286 3.571429 100 60.7 35.7 3.6 100 71.4 25 3.6 100 TF

Treatment outcome De % 43.24324 54.05405 2.702703 100 24.3 73 2.7 100 Number 32 40 2 74 18 54 2 74 % 18 9 1 28 17 10 1 28 20 7 1 28

Total Number 127 113 4 244 85 155 4 244 120 46 4 170 52.04918 46.31148 1.639344 100 34.8 63.5 1.6 100 70.6 27.1 2.4 100

Number

Source: IHP TB survey 2009

21.6% of the defaulters and 32.1% of the TFs have perceived that DOT was necessary for all patients. 73% of the defaulters and 64.1% of the treatment successors had said that they do not need an observer to take care of themselves. There were 70.6% of the patients felt that they could have continued medicines without any interruption even without a supervisor.

Table 54. Treatment outcome in relation to the family support to the patient
Family support % Patients living alone Patients living with Spouse Married child Other relative Friends Other Total 1.4 73.2 4.2 12 0 9.2 100 TS Number 2 104 6 17 0 13 142 % 7.1 78.6 3.6 7.1 0 3.6 100 TF Number 2 22 1 2 0 1 28 De % Number 16.2 12 52.7 1.4 27 0 2.7 100 39 1 20 0 2 74 % 6.6 67.6 3.3 16 0 6.6 100 Total Number 16 165 8 39 0 16 244

Source: IHP TB survey 2009

67.6% of the patients in the sample had been living with the spouse and 16% with other relatives. 6.6% have been living alone and 75% out of them have defaulted. 73.2% of the treatment successors and 78.6% of the treatment failures were living with the spouse. Out of those who were living with the spouse only 23.6% have defaulted.

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Table 55: Analysis of the treatment outcome and with whom patient living with
Parients living with Alone Spouse Married child Relatives Other Fisher's exact = Treatment Outcome TS TF De 2 2 12 (-2.40*) (0.12) (3.24**) 104 22 39 (0.81) (0.70) (-1.56) 6 1 1 (0.62) (0.09) (-0.92) 17 2 20 (-1.20) (-1.17) (2.38*) 13 1 2 (1.21) (-0.62) (-1.29) 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between treatment outcome and with whom patient living with (p = 0.000). Patients who live alone are more likely to default.
Table 56.Awareness of the family members that the patient was suffering from TB in relation to the treatment outcome
Awareness of the family Yes No Not Responded Total TS % Number 97.9 139 1.4 0.7 100 2 1 142 TF % Number 89.3 25 10.7 NA 100 3 0 28 De % Number 87.8 65 12.2 0 100 9 0 74 % 93.9 5.7 0.4 100 Total Number 229 14 1 244

Source: IHP TB survey 2009

93.9% of the patients have stated that the family members were aware that they were suffering from TB. 10.7% of the treatment failures and 12.2% of the defaulters have said that the family members were not aware while in the treatment successors it was 1.4%.

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Table 57: Analysis of the treatment outcome and awareness of the family
Awareness of the family Yes No Fisher's exact = Treatment Outcome TS TF 139 25 (0.53) (-0.27) 2 3 (-2.15*) (1.09) 0.001 De 65 (-0.57) 9 (2.29*)

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between treatment outcome and awareness of the family about the disease (p = 0.001). Most of the family members of the treatment success group knew about the patient disease while among the defaulters, family members did not know about the disease of the TB patient. This indicates that awareness of the disease among family members may prevent defaulting.

Table 58. Patient perception regarding the family support in relation to the treatment outcome
TS Family support Excellent Good Satisfactory Poor Indifferent Not Responded Total % Number 73.9 105 20.4 4.9 0 0 0.7 100 29 7 0 0 1 142 % Number 67.9 19 21.4 10.7 0 0 0 100 6 3 0 0 0 28 % Number 20.3 15 37.8 20.3 17.6 4.1 0 100 28 15 13 3 0 74 % 57 25.8 10.2 5.3 1.2 0.4 100 Number 139 63 25 13 3 1 244 TF De Total

Source: IHP TB survey 2009

73.9% of the treatment successors and 67.9% of the treatment failures have said that the family support was excellent while it was only 20.3% among the defaulters. None of the treatment successors or treatment failures had said that the family support was poor but 17.6% of the defaulters have said that it was poor.

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Table 59: Analysis of the treatment outcome and family support

Family support Excellent Good Satisfactory Poor Indifferent Fisher's exact = Treatment Outcome TS TF De 105 19 15 (2.71**) (0.75) (-4.20**) 29 6 28 (-1.25) (-0.47) (2.01*) 7 3 15 (-1.97*) (0.07) (2.68**) 0 0 13 (-2.75**) (-1.22) (4.54**) 0 0 3 (-1.32) (-0.59) (2.18*) 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between treatment outcome and family support (p = 0.000). Most of the families of patients from the treatment success category feel that the support of the family is excellent. As well as defaulters feel that their family support is poor.
Table 60. Reasons given by defaulters for not completing the whole regimen of treatment
Reason Given by Defaulters Distance to DOT center Income problems Occupational problems Stigma Poor family support Stopped on own because felt better Because I felt that Im being wrongly diagnosed as TB and treated Decided to take treatment from somewhere else Side effects are intolerable Attitude and practices by health staff at DOT center Attitude and practices by health staff at other place (Specify) Others ( Specify) Frequency % Number 17.6 33.8 27 1.4 16.2 45.9 9.5 2.7 1.4 4.1 1.4 20.3 13 25 20 1 12 34 7 2 1 3 1 15

Source: IHP TB survey 2009

* Note : Totals do not add up to sample size due to multiple responses to the question
65

Stopped on own because felt better was the most common reason given by most of the defaulters for not completing the whole regimen. The other important reasons given were income problems, occupational problems and poor family support.
Table 61. Reasons for seeking treatment again (for Cat 2) after defaulting Reason Frequency N % Reappearance of symptoms 33.8 25 20 Persuasion by PHI 27 Any other health personnel 0 0

Relative and friends Chest clinic DOT provider Community leaders Work place staff On own Legally Other

2.7 4.1 0 0 0 0 0 0

2 3 0 0 0 0 0 0

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question The most common reason for seeking treatment again after defaulting was the reappearance of symptoms. The next was the persuasion by the PHI.
Table 62 . Patients views with regard to the prevention of defaulting of treatment Patients views with regard to preventing default % Number Dot at home 27 20

Drugs to be provided to the patient Hospitalization DOT at the nearest health institution Dot by community providers No views

37.8 16.2 4.1 1.4 29.7

28 12 3 1 22

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question Most of the patients who had defaulted were of the view that drugs to be provided to the patient would have prevented defaulting. The next view for prevention of defaulting was that DOT at home.
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Table 63. Patients perception regarding the need of visiting the chest clinic regularly in relation to the treatment outcome
Treatment outcome TS TF De Total Regular chest clinic visits necessary % Number 69.4 9.7 20.8 100 50 7 15 72 Regular chest clinic visits not necessary % Number 53 11.9 35.1 100 89 20 59 168 Not Responded % 75 25 0 100 Number 3 1 0 4 Total Number % 58.2 142 11.5 30.3 100 28 74 244

Source: IHP TB survey 2009

68.4% of the patients felt that regular chest clinic visits were not necessary. Out of 29.5% of those who felt that regular chest clinic visits were necessary 69.4% were treatment successors. But 62.7% of the treatment successors, 71.4% of the treatment failures and 79.7% of the defaulters felt that it was not necessary to visit the chest clinic regularly.

Table 64. Reasons given why regular chest clinic visits are necessary Cause Frequency TS & TF De Number % % Number For investigations 35.41 33.3 17 4 To get advices and 31.25 41.7 15 5

Good patient care Closeness Other Total

14.5 4.16 14.58 100

7 2 7 48

0 8.3 16.7 100

0 1 2 12

Source: IHP TB survey 2009

Note : Totals do not add up due to multiple responses to the question

The reason given by most of the patients who have said that regular chest clinic visits were necessary was for investigations and sputum microscopy.

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Table 65. Reasons given why regular chest clinic visits are not necessary. Frequency

Cause Better service from local clinic Financial difficulties Traveling difficulties Drugs being taken at home properly Waste of time Other Total

TS & TF % Number 19.8 16 12.3 28.4 16 2.5 21 100 10 23 13 2 17 81

De % Number 2.12 1 12.76 21.27 14.89 4.25 44.68 100 6 10 7 2 21 47

Source: IHP TB survey 2009

Note : Totals do not add up due to multiple responses to the question The reason given by most of the patients who have said that regular chest clinic visits were not necessary was the long distance they had to travel to the chest clinic. Among other it is noted that most of the patient feel that chest clinic visits are necessary when needed but not regularly.

Table 66 .Patients suggestions to improve compliance.

Patients suggestions to improve compliance. To visit home and give the tablets daily Arranging somebody to to take you to the place Minimize travel Better reception at place of treatment To have some other health personnel/ volunteer Closer to the home to distribute drugs Other TS % Number 13.6 17 1.6 14.4 4.8 2.4 39.2 24 2 18 6 3 49 30 TF % Number 21.7 5 0 13 0 8.7 47.8 8.7 3 0 2 11 2 De % Number 21.8 12 1.8 32.7 0 3.6 18.2 21.8 1 18 0 2 10 12 Total % Number 16.7 34 1.5 3 19.2 3 3.4 34.5 21.7 39 6 7 70 44

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question 34.5% of the patients has suggested distributing the drugs closer to the home for improving compliance Most of the treatment successors and treatment failures were of this view, while most of the defaulters have suggested to minimize travel for better compliance.

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Table 67. Relationship between consulting a private doctor and treatment outcome.
Thought of consulting a private doctor % Yes No Not Responded Total 9.2 88.7 2.1 100 TS Number 13 126 3 142 % 3.6 92.9 3.6 100 TF Number 1 26 1 28 % 2.7 95.9 1.4 100 De Number 2 71 1 74 % 6.6 91.4 2 100 Total Number 16 223 5 244

Source: IHP TB survey 2009

Majority of the patients felt that it is not necessary to consult private sector doctors.

Table 68.Education level of the DOT providers

Level of education Govt. health staff % No formal education Up to Grade 5 Up to Grade 10 Up to O/L Up to A/L Tertiary education Other Not Responded Total 0 0 3.4 20.1 66.1 7.5 2.3 0.6 100 Number 0 0 6 35 115 13 4 1 174 % 0 0 0 33.3 66.7 0 0 0 100 DOT provider Position Other Number 0 0 0 2 4 0 0 0 6 % 0 0 3.3 20.6 66.1 7.2 2.2 0.6 100 Total Number 0 0 6 37 119 13 4 1 180

Source: IHP TB survey 2009

Of the total DOT providers in the sample 96.7% were govt. health staff, .6% private health staff (1) and 2.8% (5) were community DOT providers. Since most of the DOTS providers were heath sector employees their level of education was high 75.8 % of them having a level above O level.
Table 69. Employment classification of the DOT providers of the different positions

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Classification

Technical and professional Administration and management Trained officer Clerical work Teacher Agriculture and farming Unskilled labourer Other Total

Position of the DOT provider Govt. health staff Other % Number % Number 36.8 64 0 0 0 61.5 0 0 0 0.6 1.1 100 0 107 0 0 0 1 2 174 0 50 33.3 0 0 16.7 0 100 0 3 2 0 0 1 0 6

Total % Number 35.6 64 0 61.1 1.1 0 0 1.1 1.1 100 0 110 2 0 0 2 2 180

Source: IHP TB survey 2009

Majority (61.1%) were trained officers out of whom 97.3% were government officers . 35.6% were classified as Technical & professional and they were all from the government sector.
Table 70.Relationship of the training of the DOT provider to the period of been involved as a supervisor in the programme
Trained for the task % Yes No Indifferent Total 61.5 38.5 0 100 1 yr. Number 16 10 0 26 % 83.3 16.7 0 100 2 yrs. Number 15 3 0 18 % 100 0 0 100 3 yrs. Number 20 0 0 20 % 87.5 12.5 0 100 Period 4 yrs. Number 14 2 0 16 % 95.5 4.5 0 100 Total 5 yrs Number 21 1 0 22 % 93.5 6.5 0 100 >5 yrs. Number 72 5 0 77 Not Responded % 100 0 0 100 Number 1 0 0 1 % 88.3 11.7 0 100 Number 159 21 0 180

Source: IHP TB survey 2009

It is observed that most (88.3%) of DOT providers are trained for the task. Out of those below 1 year only 38.5% are not trained. But it is noted that that out of the 21 who were not trained, 38% (8) has still not under gone this training to be a supervisor even after being in the programme for more than 4 years.
Table 71. Modular training experience of DOT providers
Attended DOTS modular training programme % Yes No Not Responded Total 19.2 80.8 0 100 Total Period 1 yr. Number 5 21 0 26 % 66.7 33.3 0 100 2 yrs. Number 12 6 0 18 % 75 25 0 100 3 yrs. Number 15 5 0 20 % 62.5 37.5 0 100 4 yrs. Number 10 6 0 16 % 68.2 27.3 4.5 100 5 yrs Number 15 6 1 22 % 72.7 24.7 2.6 100 >5 yrs. Number 56 19 2 77 Not Responded % 100 0 0 100 Number 1 0 0 1 % 63.3 35 1.7 100 Number 114 63 3 180

Source: IHP TB survey 2009 70

63.3% has attended DOTS modular training programme. But it is to be noted that 49.2% of those who had not under gone modular training had been in the programme for more than 4 years.

Table 72: Analysis of the trained for the dot provider and working experience
Period Trained for the task Yes No Fisher's exact = 1 Year 2 Years 16 15 (-1.45) (-0.22) 10 3 (3.98**) (0.61) 0.001 3 Years 20 (0.56) 0 (-1.53) 4 Years 14 (-0.03) 2 (0.09) 5 Years 21 (0.36) 1 (-0.98) More than 5 Years 72 (0.49) 5 (-1.34)

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between trained for the task and working experience (p = 0.001). Most of the DOT providers who had one year experience wer not trained for that task. Among other categories of working experience this was not statistically significant.

Table 73. Availability of DOT manuals with the DOT providers

Manual on DOT available with him Yes No Total Period 1 yr. % 23.1 76.9 100 Number 6 20 26 % 55.6 44.4 100 2 yrs. Number 10 8 18 % 80 20 100 3 yrs. Number 16 4 20 % 68.8 31.3 100 4 yrs. Number 11 5 16 % 54.5 45.5 100 5 yrs Number 12 10 22 % 54.5 45.5 100 >5 yrs. Number 42 35 77 Not Responded % 100 0 100 Number 1 0 1 % 54.4 45.6 100 Number 98 82 180 Total

Source: IHP TB survey 2009

Only 54.4% of the DOT providers had the manual with them even though 63.3% had been trained on the module (Ref. Table 50)

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Table 74: Analysis of attending to DOTS modular training and working experience
Attended DOTS modular training program Yes Period 1 Year 2 Years 12 (0.13) 6 (-0.17) 3 Years 15 (0.60) 5 (-0.81) 4 Years 10 (-0.09) 6 (0.11) 5 Years 15 (0.41) 6 (-0.55) More than 5 Years 56 (1.13) 19 (-1.51)

5 (-2.86**) No 21 (3.83**) Pearson chi2(5) = 28.0129 Pr = 0.000

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between attended DOTS modular training program and working experience (p = 0.000). Most of those who had one year working experience had not attended DOTS modular training program.

Table 75.Relationship of the knowledge on TB and DOTS strategy as perceived by the DOT provider to the period of been involved as a supervisor in the programme
Knowledge on TB Period 1 yr. % Number 65.4 17 34.6 0 100 9 0 26 2 yrs. % Number 94.4 17 5.6 0 100 1 0 18 % 3 yrs. Number 90 18 5 5 100 1 1 20 % 4 yrs. Number 100 16 0 0 100 0 0 16 5 yrs % Number 86.4 19 13.6 0 100 3 0 22 >5 yrs. % Number 96.1 74 3.9 0 100 3 0 77 Not Responded % Number 100 1 0 0 100 0 0 1 % 90 9.4 0.6 100 Total Number 162 17 1 180

Yes No Not Responded Total

Source: IHP TB survey 2009

90% of the DOT providers have perceived that they do have knowledge on TB and it has improved with years of experience. Out of those who perceived that they have no knowledge 64.7% were involved for less than 4 years in the programme.

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Table 76: Analysis of knowledge on TB and working experience

Knowledge on TB 1 Year 17 (-1.34) 9 (4.14**) 2 Years 17 (0.18) 1 (-0.55) Period 3 Years 18 (0.20) 1 (-0.60) 4 Years 16 (0.40) 0 (-1.24) 5 Years 19 (-0.20) 3 (0.62) More than 5 Years 74 (0.52) 3 (-1.61)

Yes No

Fisher's exact =

0.001

Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

These results suggest that there is a statistically significant relationship between knowledge on TB and work experience of the DOT providers (p = 0.001). If the DOT provider had more than one year working experience he/she may have good knowledge on TB as expected.
Table 77. Relationship of familiarity with the concept of DOTS as perceived by the DOT provider to the period of had been involved as a supervisor in the programme.
Familiarity with the concept of DOTS Yes No Not Responded Total Period 1 yr. % Number 80.8 21 19.2 0 100 5 0 26 2 yrs. % Number 72.2 13 27.8 0 100 5 0 18 % 3 yrs. Number 85 17 15 0 100 3 0 20 4 yrs. % Number 81.3 13 18.8 0 100 3 0 16 5 yrs % Number 81.8 18 18.2 0 100 4 0 22 % >5 yrs. Number 87 67 9 1 77 1.3 100 Not Responded % Number 100 1 0 0 100 0 0 1 Total % Number 83.3 150 16.1 29 0.6 100 1 180

11.7

Source: IHP TB survey 2009

83.3% of the DOT providers were familiar with the concept of DOTS. But it is noted that out of those who were not familiar 55% had been in the programme for more than 4 years.
Table 78: Analysis of familiarity with DOTS and working experience Period Familiarity with the concept of DOTS 1 Year 2 Years 3 Years 4 Years Yes 21 13 17 13 (-0.16) (-0.53) (0.06) (-0.11) No 5 5 3 3 (0.37) (1.21) (-0.14) (0.24) Fisher's exact = 0.606
Note: standardized residual values (z) in parenthesis. ** and * indicate significance at 1% and 5% respectively. Source: IHP TB survey 2009

More than 5 Years 5 Years 18 67 (-0.10) (0.42) 4 9 (0.22) (-0.96)

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These results suggest that there is no statistically significant relationship between familiarity with the concept of DOTS of the DOT providers and working experience (p = 0.001).
Table 79.Relationship of awareness of DOTS strategy as perceived by the DOT provider before being a DOT supervisor
Awareness of DOTS strategy before being a DOT supervisor Yes No Not Responded Total

Period 1 yr. % Number 26.9 7 69.2 3.8 100 18 1 26 2 yrs. % Number 27.8 5 72.2 0 100 13 0 18 % 35 65 0 100 3 yrs. Number 7 13 0 20 4 yrs. % Number 18.8 3 81.3 0 100 13 0 16 5 yrs % Number 13.6 3 86.4 0 100 19 0 22 >5 yrs. % Number 22.1 17 77.9 0 100 60 0 77 Not Responded % 100 0 0 100 Number 1 0 0 1 Total % Number 23.9 43 75.6 136 0.6 100 1 180

Source: IHP TB survey 2009

75.6% of the DOT providers had not been aware of DOTS strategy before being recruited as a DOT supervisor even though they are mostly government health staff.

Table 80.Mode of acquiring knowledge regarding TB by the DOT providers Mode of acquiring Position of the DOT provider knowledge Govt. health staff Other
% DOTS training Chest Clinic Literature Mass media Other 72.4 31.6 16.7 15.5 11.5 Number 126 55 29 27 20 % 16.7 66.7 16.7 33.3 16.7 Number 1 4 1 2 1 %

Total Number 127 59 30 29 21 70.6 32.8 16.7 16.1 11.7

Source: IHP TB survey 2009

72.4 % of the Govt. health staff has acquired knowledge regarding TB from the DOTS training. But it is observed that only 16.7% in the other group has benefitted from DOTS training. Significant numbers of the DOT providers has used literature, mass media and other means to acquire additional knowledge.

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Table 81.DOTS providers views regarding DOTS vs. the previous methods of TB control to the period of been involved as a supervisor in the programme.
DOTS is better than the previous method for TB control activities Yes No Not Responded Total Period

1 yr. % Number 92.3 24 3.8 3.8 100 1 1 26

2 yrs. % Number 88.9 16 11.1 0 100 2 0 18 %

3 yrs. Number 100 20 0 0 100 0 0 20 %

4 yrs. Number 100 16 0 0 100 0 0 16 %

5 yrs Number 100 22 0 0 100 0 0 22 %

>5 yrs. Number 87 67 9 1 77 1.3 100

Not Responded % Number 100 1 0 0 100 0 0 1

Total % Number 92.2 166 6.7 12 1.1 100 2 180

11.7

Source: IHP TB survey 2009

92.2% of the DOT providers feel that DOTS is better than the previous method. Out of those who said no 75% (9) were involved for more than 5 years (5% of all DOT providers).
Table 82.Reasons given by the DOT providers for saying that DOTS is better than the previous method for TB control activities Reasons Frequency
% Cure rate is higher Patients compliance is better Low default rates Can take early actions when side effects develop Can take early action when patients interrupt treatment Other 61.7 72.2 52.2 40.6 43.3 5.6 Number 111 130 94 73 78 10

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question Out of the 166 who had said that DOT is better than previous method of TB control, most of them said that the patient compliance was better with DOTS and the cure rate was higher. Some of them felt that the default rate could also be reduced and early action could be initiated if side effects developed or if the patient interrupt treatment by adopting this method

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Table 83.a DOT providers views regarding the necessity of DOT at a DOT center for TB patients.
Necessary for all TB patients Yes No Not Responded Total

Frequency % 50.6 48.3 1.1 100 Number 91 87 2 180

Source: IHP TB survey 2009

Table 84.b DOT providers views regarding the categories that do not need DOT at a DOT center DOT need Category Frequency
% Not necessary for Professionals Children <5 yrs. School children Health personnel Other Total 22.1 28.4 21.1 20.1 8.3 100 Number 45 58 43 41 17 204

Source: IHP TB survey 2009

Only 50.6% of the DOT providers said that DOT at a DOT center is necessary for all patients. Out of those (87) who said it was not necessary 58 of the DOT providers felt that for children <5 years it was not needed and 45 said that it is not necessary for professionals.

Table 85.Number of patients that the DOT provider is supervising at the moment to the position of the DOT provider
Number of patients 59 % 8.6 0 8.3 Number 15 0 15 104 4 108

Position Govt. health staff Other Total

No patients % 19 33.3 19.4 Number 33 2 35 %

14 Number 59.8 66.7 60

10 or above % 12.6 0 12.2 Number 22 0 22 %

Total Number 100 100 100 174 6 180

Source: IHP TB survey 2009

In this random sample 19.4% of the DOT providers interviewed had no patients for supervision at the time of the interview. 60% of the DOT providers had 1 - 4 patients. 21.3% of the government staff had more than 5. It is also noted that 12.2% of them had more than 10 patients.
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Table 86.Mode of acquiring knowledge about DOTS in relation to the position of the DOT provider
Mode Govt. health staff % Number 3.4 8 23.6 7.2 8.4 0 3.4 51.5 2.5 56 17 20 0 8 122 6 Position Other % Number 0 0 0 0 14.3 0 0 71.4 14.3 0 0 1 0 0 5 1 Total Number 3.3 8 23 7 8.6 0 3.3 52 2.9 56 17 21 0 8 127 7

In undergraduate training After joining health dept. After joining NPTCCD Mass media & internet In postgraduate training In basic training (MLT/Pharmacist/Dispenser) After being recruited as a DOT provider Other (Specify)

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question Majority of the DOT providers (52%) had acquired knowledge about DOTS after being recruited as a DOT provider. Only 8 (3.3%) had acquired the knowledge in their basic training even though large majority of them were health staff.

Table 87.Knowledge of the DOT provider about the disease and management as perceived by the interviewer
Knowledge of DOT provider About the disease About DOTS Treatment categories and regimen Awareness of side effects Duration of treatment Important TB messages Highly satisfactory % Number 19.4 35 11.1 13.3 9.4 15.6 13.3 20 24 17 28 24 Satisfactory % Number 46.1 83 42.8 30 37.2 45.6 47.2 77 54 67 82 85 Fair % Number 28.9 52 36.1 37.2 36.7 28.3 32.8 65 67 66 51 59 Unsatisfactory % Number 5 9 9.4 18.3 15.6 9.4 4.4 17 33 28 17 8 Highly unsatisfactory % Number 0 0 0 0.6 0 0 0 0 1 0 0 0 Not Responded % Number 0.6 1 0.6 0.6 1.1 1.1 2.2 1 1 2 2 4 Total % Number 100 180 100 180 100 100 100 100 180 180 180 180

Source: IHP TB survey 2009

Only one DOT provider has been graded as highly unsatisfactory in their knowledge on the treatment categories and the regimen but none regarding their knowledge on the other factors mentioned. Most of the DOT providers has been graded as satisfactory in their knowledge about the disease, DOTS, duration of treatment and about the important TB messages. But the knowledge on treatment categories and the regimen has been graded as fair or unsatisfactory in 55.5% of the DOT providers. Also 52.3% of them have been graded as fair or unsatisfactory on the awareness of the side effects.
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Table 88. Action taken by DOT providers when patients interrupt treatment.
Action taken Govt. health staff % Call patient if contact number is available Send a letter to the patient Go to the patient's place and contact him or her Inform the chest clinic DTCO PHI of chest clinic other over phone By letter Inform MOH Inform PHI Inform the officer in charge of the DOT provider Inform head of the institution Others Total 27.6 4 17.8 68.4 56.9 1.1 36.8 6.3 20.1 17.8 8 15.5 4 100 Number 48 7 31 119 99 2 64 11 35 31 14 27 7 174 % 33.3 0 100 33.3 16.7 0 0 0 16.7 33.3 0 16.7 16.7 100 Position Other Number 2 0 6 2 1 0 0 0 1 2 0 1 1 6 Total Number % 27.8 50 3.9 7 20.6 67.2 55.6 1.1 35.6 6.1 20 18.3 7.8 15.6 4.4 100 37 121 100 2 64 11 36 33 14 28 8 180

Source: IHP TB survey 2009

All the DOT providers in the non-govt. category have gone to the patients' places to trace when interrupted treatment while informing the other relevant personnel. Only 31 out of 174 govt. DOT providers had gone to the patients places to trace them. Most of the govt. DOT providers had informed DTCO, chest clinic PHI or any other in the chest clinic

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Table 89.Frequency distribution of constraints faced or experienced in implementation of DOT at the DOT center in relation to the position
Constraint Govt. health staff % Poor facilities at the DOT center Difficulty in tracing the patients once they interrupt treatment Poor cooperation of the patients No time due to heavy work load with other work Not being trained adequately for DOTS Inadequate and irregular drug supply to the DOT center Inadequate staff cooperation Difficulties in monitoring Inadequate managerial support Other (Specify) Difficulties in reporting and feedback Inadequate guidance Total 40.8 36.2 25.3 17.2 3.4 4 4 3.4 2.9 2.9 1.7 1.1 100 Number 71 63 44 30 6 7 7 6 5 5 3 2 174 % 66.7 0 0 0 33.3 0 0 0 0 0 0 0 100 Position Other Number 4 0 0 0 2 0 0 0 0 0 0 0 6 % 41.7 35 24.4 16.7 4.4 3.9 3.9 3.3 2.8 2.8 1.7 1.1 100 Total Number 75 63 44 30 8 7 7 6 5 5 3 2 180

Source: IHP TB survey 2009

Note : Totals do not add up to sample size due to multiple responses to the question Most of the DOT providers in the govt sector and the non- government has mentioned that the poor facilities at the DOT center as a constraint. 63 of the govt. DOT providers have faced with the difficulty in tracing the patients while 44 of them have mentioned that the corporation of the patients was poor. 30 of the govt. DOT providers had felt lack of time due to high work load was a constraint.
Table 90. The drug supply to the DOT center and the storage of drugs at the DOT center
Position Govt. health staff(174 ) Drug supply / storage % Drug supply is satisfactory (Q 37G) Any of the drugs out of stock for more than one month Drugs stored without exposure to sunlight Drugs are kept separately for each patient Drugs are labeled Drugs are placed in containers Drugs are kept safely under lock and key 94.3 8 89.7 89.7 89.7 94.3 64.9 Yes Number 164 14 156 156 156 164 113 % 3.4 89.7 8 8 7.5 3.4 33.3 No Number 6 156 14 14 13 6 58 % 100 16.7 100 100 100 100 50 Yes Number 6 1 6 6 6 6 3 % 0 83.3 0 0 0 0 50 Other(6) No Number 0 5 0 0 0 0 3

Source: IHP TB survey 2009

The drug supply to 3.4% of the govt. DOT centers has not been satisfactory. It has been observed that drugs were out of stock at 8 centers in the government sector. Drug storage has not been
79

maintained as expected to be in 14 (8 %) govt. DOT centers but in the private DOT centers it is as expected to be. Drugs have not been kept under lock and key in 58(33%) of govt. DOT centers and in 3 out of 6 private DOT centers
Table 91. Availabilty of facilities at the DOT centers in different types of government health institutions as observed by the Interviewer
Facility Separate place for DOT Easy Access and location of the DOT center Comfortable place Telephone Chair and other seating facilities Safe water Drug cupboard Drug container Sharp bin Waste disposal bins Instruction leaflets HE material 1/BH(16) % Number 31.3 5 87.5 75 68.8 68.8 50 87.5 68.8 37.5 56.3 25 25 14 12 11 11 8 14 11 6 9 4 4 % 1/CD(45) Number 9.1 4 100 69 53.3 60 46.7 66.7 71.1 17.8 26.7 8.9 6.7 43 29 24 27 21 30 32 8 12 4 3 1/DH(36) % Number 41.7 15 97.2 91.7 50 86.1 69.4 77.8 66.7 66.7 66.7 27.8 27.8 35 33 18 31 25 28 24 24 24 10 10 1/PU(13) % Number 23.1 3 100 84.6 46.2 84.6 46.2 61.5 69.2 69.2 61.5 15.4 7.7 13 11 6 11 6 8 9 9 8 2 1 1/RH(13) % Number 23.1 3 100 92.3 76.9 76.9 69.2 84.6 84.6 69.2 61.5 23.1 15.4 13 12 10 10 9 11 11 9 8 3 2 Other(51) % Number 46 23 98 90 66.7 72.5 62.7 64.7 56 39.2 60.8 27.5 47.1 48 45 34 37 32 33 28 20 31 14 24 Total( % 30.8 97.6 83.5 59.2 73 58 71.3 66.5 43.7 52.9 21.3 25.3

Source: IHP TB survey 2009

Very few of the govt. health institutions (30.8%) have a separate place for DOT. The location of the DOT center was easy to find in almost all (97.6%) of the institutions but comparatively less in BHs (87.5%). Instruction leaflets & HE material was not available in many DOT centers in all types of govt. health institutions. Availability of safe water was found only in 58% of the DOT centers in the govt. health institutions. Even availability of drug containers waste disposal bins were not adequate in most places

Table 92.Maintenance of DOT registers and supervision of DOT Centers in government health institutions
State of DOT register DOT register available DOT register is uniform with the same in the district Treatment cards are daily updated Remarks on supervision of the DOT center by DTCO/PHI available 1/BH(16) % Number 81.3 13 53.3 93.8 56.3 8 15 9 1/CD(45) % Number 65.1 28 76.5 88.6 34.1 26 39 14 1/DH(36) % Number 80.6 29 83.3 97.2 33.3 25 35 12 1/PU(13) % Number 84.6 11 83.3 100 58.3 10 13 7 1/RH(13) % Number 69.2 9 50 92.3 30.8 5 12 4 Other(51) % 49 58.8 100 43.8 Num

Source: IHP TB survey 2009

DOT registers were maintained only in 65.5% of the DOT centers. The uniformity of the register within the district has been maintained in Most of the DHs (83.3%) and in PUs (83.3%) but not in others. Daily update of the treatment cards has been observed in 93.1% of the DOT
80

centers. Written reports on supervision of the DOT center by DTCO/PHI had not been recorded or maintained in most of the DOT centers.
Table 93. Frequency distribution of DOT providers in government health institutions and private hospitals
Government i % tit ti Number 30.5 22.8 15 8.9 5.7 4.9 4.5 3.3 4.5 75 56 37 22 14 12 11 8 11 Institution Other % 0 0 16.7 0 0 0 16.7 66.7 0 Number 0 0 1 0 0 0 1 4 0 % 29.8 22.2 15.1 8.7 5.6 4.8 4.8 4.8 4.4 Total Number 75 56 38 22 14 12 12 12 11

DOT providers Category Dispensers Nursing officer Minor staff Pharmacist PHI MO PHM Other (Specify) RMO

Source: IHP TB survey 2009

In this sample in most of the selected districts it is observed that in the govt. institutions, dispensers (30.5%) were the main category recruited as DOT providers. The next highest category was the nursing officers (22.8%). The number of minor staff serving as DOT providers was 37 (15%) which is still significant. The involvement of the PHMs and PHIs are 4.5% & 5.7% respectively and less than the involvement of minor staff and even pharmacists (8.9%).

Table 94.Average number of DOT providers working at a DOT center

Category Government Average number of DOT providers working at the DOT center at present Number of trained DOT providers 4.27 4.02 Institution Other 1 1.2 Total 4.18 3.94

Source: IHP TB survey 2009

Most of the DOT centers had an average of 4 trained DOT providers per center.

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9.Bibliography
1. Sunil Bernard De Alwis, Provincial Director of Health Services, North Western Province, Sri Lanka An assessment of the impact of a DOTS programme in North Western Province, Sri Lanka http://www.tropika.net/specials/forum11/schedule/a162.html 2. Katherine Floyd, VK Arora, KJR Murthy, Knut Lonnroth, Neeta Singla, Y Akbar, Matteo Zignol, & Mukund Uplekar Cost and cost-effectiveness of PPM-DOTS for tuberculosis control: evidence from India http://www.who.int/bulletin/volumes/84/6/437.pdf 3. Vary Jacquet, Willy Morose, Kevin Schwartzman, Olivia Oxlade, Graham Barr, Franque Grimard and Dick Menzies 2 Impact of DOTS expansion on tuberculosis related outcomes and costs in Haiti http://www.hawaii.edu/hivandaids/Impact_of_DOTS_expansion_on_tuberculosis_related_outc omes_and_costs_in_Haiti.pdf 4. Wright J, Walley J, Philip A, Pushpananthan S, Dlamini E Direct observation of treatment for tuberculosis: a randomized controlled trial of community health workers versus family members. Tropical Medicine and International Health, 2004 May; 9(5):559-565. http://www.popline.org/docs/192447 5. Walley JD, Khan MA, Newell JN, et al. Direct observation of tuberculosis treatment did not promote higher cure rates than self administered treatment Lancet 2001 Mar 3;357:664 9.[Medline] Evidence-Based Medicine 2001; 6:142 2001 Evidence-Based Medicine 6. WHO Recommended Strategy for TB Control: DOTS http://www.cgcptd.health.kiev.ua/tbcontrol/eng/set_up_DOTS.htm

7. WHO fact Sheets http://www.who.int/mediacentre/factsheets/fs104/en/

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83

Annexes

Annexure1: Draft Report of the workshop

Date 24th November 2009 Auditorium/NPTCCD

GFATM TB Operational Research Study for Evaluation of the Effectiveness of the National DOTS Programme
Note for Record Participants Dr.Sunil De Alwis, D/NPTCCD Dr.Rohitha Dharmasiri, DTCO/Colombo Chest Clinic Dr.D.Wijesinghe, MO/Welisra Chest Clinic Dr.Anoma De Silva, DTCO/Kandy Chest Clinic Dr.Ajith Kariyawasam, DTCO/Galle Dr.S.Mahanama, DTCO/Rathnapura Dr.W.M.D.N.K.Wijesinhe ,DTCO/Kurunegala Dr.Suresh Kumar, DTCO/Trincomalee Mr.L.D.A.N.Kumarasinghe, PHI/Colombo Chest Clinic Mr.K.U.Shantha, PHI/ Colombo Chest Clinic Mr.K.S.Ranasinghe, PHI/ Colombo Chest Clinic Mr.K.A.R.S.Weerakoon, PHI/ Colombo Chest Clinic Mr.D.Wickramaratne, PHI/Gampaha Mr.Y.Rathnayake, PHI/Gampaha Mr.M.Bandara, PHI/Kalutara Mr.S.Fernando, PHI/Kalutara Mr.Chanaka Hewawasam, PHI/Kandy Mrs.Indra Kumari, PHI/Kandy Mr.Gunasekara, PHI/Galle Mr.Udaya Gunaratne, PHI/Rathnapura Mr.B.M.S.O.G.Balasooriya, PHI/Kurunegala Mr.T.Sivakumara, PHI/Trincomalee

IHP Dr.Shanti Dalpatadu, Senior Fellow Dr.Kasun Chandradasa, Research Intern Dr.Achana Obris, Research Intern

Excuses Dr.Samaraweera, Consultant Community Physician/NPTCCD Dr.Ruwanie Perera, DTCO/Colombo Chest Clinic Dr.Deepthi Waidyaratne, DTCO/Anuradhapura Mr.Indika Thilakaratne, PHI/Aniradhapura

Absent Dr.K.K.Abeyweera, DTCO/Kalutara Mr.Vajira Rathnayake, PHI/Kurunegala

Dr. Achana Obris welcomed the participants on behalf of Institute for Health Policy and gave a brief introduction to the work shop and the programme. Dr. Sunil De Alwis D/NPTCCD addressed the gathering and said that this was a important operational research study for improving the management aspects of the DOTs programme in Sri Lanka and requested the participants to give their fullest cooperation to the IHP research team to carry out the field survey.

Dr.Shanti Dalpatadu explained the objectives of the workshop. This was followed by a presentation and discussion on the methodology and guidance for conducting the field survey. He informed that this survey will be done in 9 selected districts and the sample will represent 70% sputum positive patients reported during the first three quarters of the year 2008.

Target population selected for the study was all new sputum positive cases registered 12 to 15 months prior to commencement of the TB study and randomly selected DOTS providers from the same district and who were active during the same time period. Three categories of patients were to be selected from the sample. Those who were categorized as: Treatment success Treatment failures & 3

Defaulters He said that three interviewer administered questionnaires were prepared field tested and finalized with the assistance of technically competent external consultants with experienced in the National TB control programme. For the Treatment success and Treatment failures there was one single questionnaire. And there were separate questionnaires for Defaulters and DOTS providers. Questionnaires for Treatment success and Treatment failures were to be completed by the relevant PHIs of the districts. Dr Shanti instructed 10% of these to be cross checked by the DTCO of the relevant district for consistency. DOTS providers questionnaire was to be completed by the DTCOs. Survey teams were informed to carry out the survey of patients and DOT providers without interrupting their day to day activities during working hours while doing routine field work as well as during off hours. Survey to commence on 1st December 2009 and end by 31st January 2010. All completed Questionnaires to be forwarded to IHP within 2 months. Although the PHIs requested for an extension of the time period as it involved additional time specially in tracing Defaulters. Dr. Shanti Dalpatadu regretted saying that this cannot be done due to the limited time period available for the study He asked the participants to send all completed questionnaires to IHP through the DTCO by registered post once a week or in 10 days till all the assigned patients and DOT providers were surveyed. The three questionnaires and guidelines were presented and discussed by Dr. Shanti Dalpatadu in detail. All queries were taken into consideration and clarifications were given to questions and issues raised as regards to content in the questionnaires and in conducting the survey. As compensation and an incentive for doing this survey it was informed that Each PHI will be paid Rs.250 per completed questionnaire DTCOs will also be paid Rs.250 per completed questionnaire in addition Rs.5000 will be paid for providing supervision and guidance to the PHIs for conducting the survey. If the PHIs have come across any issues or needs any clarifications while conducting the survey they should contact their DTCOs. And if the DTCO needs any clarification he/she may contact the research team at the Institute for Health Policy.

All the PHIs and the DTCOs were given invoices to be filled up and send back to the IHP after they have completed all the work. They were told that payment can be done at the end or a halfway payment can be done.

PHIs requested that they need to have a letter from the D/NPTCCD to the DTCOs stating that they have been given permission to conduct this survey during their working hours while doing their routine field work as well as off hours.

Dr. Shanti Dalpatadu agreed to get a letter of permission from the D/NPTCCD and promised to send it to the DTCOs within next couple of days. Participants were registered and were assigned an enumerators number to be used in case there is a need to trace the questionnaires they have completed .(Annex 1) Finally all the questionnaires were handed over to the relevant districts.

All the participants were given a registration number. DTCOs D1-Dr. Ruwanie Perera, DTCO/Colombo Chest Clinic D2-Dr.Rohitha Dharmasiri, DTCO/Colombo Chest Clinic D3-Dr.P.V.D.S.Francis,DTCO/Welisra Chest Clinic D4-Dr.Abeyweera, DTCO/Kalutara D5-Dr.Anoma De Silva, DTCO/Kandy Chest Clinic D6-Dr.Ajith Kariyawasam, DTCO/Galle D7-Dr.S.Mahanama, DTCO/Rathnapura D8-Dr.W.M.D.N.K.Wijesinhe ,DTCO/Kurunegala D9-Dr.Deepthi Waidyaratna, DTCO/Anuradhapura D10-Dr.Suresh Kumar, DTCO/Trincomalee

PHIs P1-Mr.L.D.A.N.Kumarasinghe, PHI/Colombo Chest Clinic P2-Mr.K.U.Shantha, PHI/ Colombo Chest Clinic P3-Mr.K.S.Ranasinghe, PHI/ Colombo Chest Clinic 5

P4-Mr.K.A.R.S.Weerakoon, PHI/ Colombo Chest Clinic P5-Mr.D.Wickramaratne, PHI/Gampaha P6-Mr.Y.Rathnayake, PHI/Gampaha P7-Mr.M.Bandara, PHI/Kalutara P8-Mr.S.Fernando, PHI/Kalutara P9-Mr.Chanaka Hewawasam, PHI/Kandy P10-Mrs.Indra Kumari, PHI/Kandy P11-Mr.Gunasekara, PHI/Galle P12-Mr.Udaya Gunaratne, PHI/Rathnapura P13-Mr.Vajira Rathnayake, PHI/Kurunegala P14-Mr.B.M.S.O.G.Balasooriya, PHI/Kurunegala P15-Mr.Indika Thalakaratna, PHI/Anuradhapura P16-Mr.T.Sivakumara, PHI/Trincomalee

Annexure 2: Guidelines for Administering Questionnaires

Guidelines for Administering Questionnaires

Operational Research Study for Evaluation of the effectiveness of the National DOTS Programme and to develop alternate models to improve of DOTS treatment in various settings. This is an interviewer administered questionnaire & PHIs attached to the chest clinics of selected districts will conduct the interview and complete the questionnaires after tracing selected sample of cases from their districts.

Selection of patients
6

Questionnaire No. 1 is for patients whose treatment outcome is categorized as

1) Treatment success New sputum smear positive patients registered in the first 3 quarters in 2008 who have been treated successfully 2) Treatment failure

New sputum smear positive patients registered in the same period who have failed treatment (Re-registered later as Treatment after Failure and may be still on Cat II treatment at the time of administering the questionnaire)
Questionnaire No. 2 Is for Defaulters.

1) New sputum smear positive patients registered in the first 3 quarters in 2008 who have defaulted treatment 2) New sputum smear positive patients registered initially in the same period who have defaulted and returned for treatment later (Re-registered later as Treatment after Default and may be still on Cat II treatment at the time of administering the questionnaire)

Except for the three districts in the Western Province all New sputum smear positive TB patients categorized as Treatment Failure and Default as the treatment outcome will be included for the survey. A matching number of New sputum smear positive patients categorized as Success as the outcome should be randomly selected for these districts. In Western Province; Sample frame for the New sputum - smear positive TB patients categorized Default as the outcome will be provided. Interviews should be continued until the required number for this category is interviewed. All New sputum - smear positive TB patients categorized as Treatment Failure as the outcome will be included. A matching number of New sputum - smear positive patients categorized as Treatment Success as the outcome should be randomly selected for these districts also and interviewed. Treatment

Note: Only the New Sputum - smear Positive patients falling in to the mentioned treatment outcome categories are included in the sample.

Regarding the questionnaires

Questionnaire includes some general core demographic information and some other questions to assess the various aspects of the Directly Observed Treatment.

Note The questionnaire for defaulters has been designed to collect details from New TB
patients registered in the first 3 quarters in 2008 who have defaulted treatment. Among these defaulters there may be some patients who have been restarted on treatment (CAT 2) and currently on CAT 2 regimen. They also must be included, since they have defaulted CAT I treatment when in the diagnostic category of New. Those patients should be administered with the same questionnaire and it should be carried out with extra caution. When you are interviewing these patients (defaulter who has restarted treatment) you should advise them that they should answer the questions as they were defaulters. The interview should be carried out in such a way that the questions and answers are directed for the period before they were registered in the Retreatment category (i.e. while on CAT I treatment and during defaulted period). In order to ensure anonymity of patients responses, the following procedures are appropriate when you are filling the questionnaires. Please tick the relevant box in front of the responses and if you happen to choose Other as a response, please do not forget to specify the patients response. Questions 1) to 19) include general demographic details of the patient and most of them are very straight forward questions. Q15A), Number of pack years means a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
Number of Pack Years = (Packs smoked per day) x (years as a smoker) Or Number of pack years = (number of cigarettes smoked per day x number of years smoked)/20 (1 pack has 20 cigarettes). Q 15 A) and Q 16 B), responders can use more than one substance at a time and if it is so, you may tick more than one box. 8

Q 20) Give the correct date he/she was diagnosed as having TB for the first time following microscopic examination of the sputum. Q 21A) you have to find the date on which he/she has started treatment as a new TB patient for the first time i.e. CAT 1 regimen. This date may differ from the date given in Q 20) or may be the same. Q 31) is an open ended question and for us to make analysis easier try to be specific in your answers. Q 36) in questionnaire 1 and Q 37) in questionnaire 2 is only applicable to responders who have selected response No 2 for Q 34A), 35A) in questionnaire 1 and Q 35A), Q 36A) in questionnaire 2. Here they can choose more than one response. Mark them according to their preference. 1, 2, 3 etc. Following guidelines are specifically for Questionnaire No. 2 (Defaulters) Q 21 B) To be filled only if the responder is a defaulter who has come back for re treatment. Then the date when he/she restarted the treatment under CAT 2 regimen. Q 22) if you are interviewing a defaulter who has come back for re treatment, the nearest chest clinic would be the clinic where he had gone for his CAT 1 treatment. Q 64), Q 66) and Q 67B) are only for defaulters who have started re treatment and currently being on CAT 2 regimen.

General Instructions
You may use English, Sinhalese or the Tamil questionnaire forms. But it will be better if you could use one (language) of the above for all patients that you will be interviewing. Please get answers to all questions and complete the entire questionnaire and do not leave any blanks. Try to get the Patients to respond to your questions with minimal prompting to get their frank answers and opinions to the questions posed. If there is more than one response to some of the questions rank those up to three according to the patients view of importance or priority. Make sure that your hand writing is legible to read when entering answers to open ended questions. Ensure that the form for consent to participate is annexed to each completed questionnaire. Make every effort to trace the Defaulters and the Treatment failures by visiting at least three times as the numbers in the sample is small. All completed questionnaires should be sent through your supervising DTCO weekly to Institute for Policy Studies till the survey is completed. If any questions or queries should arise while conducting the survey please contact your DTCO. For further verifications the DTCO may contact, Dr Kasun Chandradasa, 9

Institute for Health Policy, No. 72, Park Street, Colombo 2. Phone. 011 231 4041/4042/4043/4045 Email.kasun@ihp.lk

Annexure 3: Consent Form for the Patients

CO

CONSENT FORM FOR THE PATIENTS PARTICIPATING in the Evaluation of the effectiveness of the National DOTS Programme and to develop alternate models to improve of DOTS treatment in various settings. We, the Institute for Health Policy (IHP) is undertaking the above study on behalf of the Ministry of Health to evaluate the effectiveness of National DOTS programme and to develop alternate models to improve provision of DOTS treatment in Sri Lanka. We would like to invite you to participate in this research project. You should only participate if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to take part, it is important for
10

you to understand why the research is being done. And what your participation will involve. Our field Research Investigator PHI attached to your area TB chest clinic will explain and educate you in this regard. He will specifically explain in detail the purpose of this, what is expected from you. You may ask him if there is anything that is not clear or if you would like more information. We appreciate your willingness to contribute to the successful conduction of this survey. Please take a little time and read the consent document annexed and if you agree give your consent to be a study participant by signing this consent form before you start answering the questionnaire. Thanking you. Dr.K.C.Shanti.Dalpatadu Research Team Leader Senior Fellow IHP
NSENT FORM FOR PARTICIPANTS

Serial number: Name of the Central Chest clinic: Respondent Identification Number for study:

Please complete this form after you have listened to an explanation about this research study. Title of Study: Evaluation of the effectiveness of the National DOTS Programme and to develop alternate models to improve of DOTS treatment in various settings.

11

Thank you for considering taking part in this research. The person organizing the research must explain the project to you before you agree to take part.

I confirm that I have been well informed by the research investigator regarding above study and understood the purpose of the study I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reasonf I no longer wish to participate in this project and I can notify the researchers involved to be withdrawn from it immediately. I consent to the processing of my personal information for the purposes of this research study. I understand that such information will be treated as strictly confidential. I understand that relevant sections of any of my medical notes and data collected during the study may be looked at by responsible individuals from IHP where it is relevant to my taking part in this research. I give permission for them to have access to my records

Participants Statement: I _____________________________________________________________________ Agree that the research project named above has been explained to me to my satisfaction and I agree to take part in the study. I understand what the research study involves. Signed .. Date ..

Investigators Statement:

I _____________________________________________________________________ confirm that I have carefully explained the nature, of the proposed research to the volunteer. Signed .. Date ..

Researchers

Statement (IHP)

Confirmed as acceptable Signed ..

12

Date

..

Annexure 4: Questionnaire No:1 for the TB Patients

Serial number-

District code Respondent identification Number

All Information collected at this questionnaire will be treated as strictly confidential.

Questionnaire for Evaluation of the effectiveness of the National DOTS Programme

Questionnaire No. 1 for TB patients in outcome category of Treatment Success & Treatment failure of CAT 1 (Including those who are now on treatment as CAT 2)

1) Name of Patient

2) District TB Number

3) Diagnostic Category

13

4) MOH area

5) Age (Years)

.............................................................................................................

1. <15

Years

2. 15 24 Years 3. 25 34 Years 4. 35 44 Years 5. 45 54 Years 6. 55 64 Years 7. 65 74 Years 8. > 75 Years

6) Sex 1. 2. 7) Permanent Address Male Female .

8) Current place of residence 1. 2. 3. 4. 5. 6. 7. 8. 9) Ethnicity 1. 2. 3. 4. Sinhalese Tamil Muslim Burgher In a permanent residence (own or rented house) In a temporary residence Relatives house Boarding house Hostel Work place Street Prison

14

5.

Other ( Specify)

10) Level of education 1. 2. 3. 4. 5. 6. 7. No formal Education Up to Grade 5 Up to Grade 10 Up to O/L Up to A/L Tertiary education Other ( Specify)

11) Marital status 1. 2. 3. 4. 5. Married Unmarried Divorced Separated Widowed

12) No. of children

13) Occupation 1. 2. 3. 4. Unemployed Self employed Employed Retired

13 A) If employed, Nature of employment 1. 2. 3. 4. 5. 6. 7. 8. Technical and Professional Administration and Management Trained officer Clerical work Teacher Agriculture and farming Unskilled laborer Others (Specify)

13 B) After diagnosis of TB, was there an impact on occupation 1. 2. Yes No

15

13 B 1) If yes, what was the change? 1. 2. 3. 4. 5. 14) Monthly income 1. 2. 3. 4. 5. 6. 7. Unable to attend work daily Transferred to a different work place Kept off work during treatment Dismissed from the job Other ( Specify) Amount

No regular income Less than 3500 3501- 7500 7501-12,000 12,001-20,000 Over 20,000 Does not like to disclose

14 A) After diagnosis of TB, was there loss of your income 1. 2. Yes No

15) Smoking habits 1. 2. 3. Never smoked Currently smoking Smoked in the past and stopped completely

15A) If currently smoking,

Type Cigarette Cigars Beedi Cannabis Pipe Other

1 to 5

6 to 10

No per day 11 to 15 16 to 20

>20

No of pack years

16

16) Do you use alcohol? 1. 2. 3. Occasionally Regularly Never

16A) If Regularly or Occasionally, type of substance 1. 2. 3. 4. 5. Arrack Toddy Illicit alcohol (kassippu) Beer Other ( Specify)

16B) Frequency of use,

Frequency of Use Once in three months Once a month Once a week 2 to 3 times per week Once a day 2 to 3 times per day Other

Arrack

Toddy

Substance Use illicit Beer

Other

16C) Do you think that taking alcohol may affect your compliance? 1. 2. 17)Do you use any other narcotic substances? 1. 2. Yes No Yes No

17 A 1) If Yes, Type of substance

1. Heroin 2. Others (Specify)

18) Have you ever been imprisoned? 1. 2. 19) With whom are you living? 1. 2. Alone Spouse/ children Yes No

17

3. 4. 5. 6.

Married child Other relatives Friends Other ( Specify)

20) When were you initially diagnosed as having TB? ..........................................................................................................

20 A) Who/Institute confirmed your diagnosis as a TB patient 1. 2. At a chest clinic At chest hospital, Welisara

3. 4. 5.

At another government hospital By a general practitioner By a consultant at a private hospital

21) When did you start taking treatment for TB (Initiation of treatment)?

21 A) As a new case (CAT 1) 21 B) Treatment after failures (CAT 2) (For treatment failures only)

22) Distance to the nearest chest clinic 1. 2. 3. 4. 5. 6. < 10 km 11-20 km 21- 30 km 31 - 50 km 51-75 km >75 km

23) Place where you have to go for DOT 1. 2. 3. 4. 5. 6. 7. 8. 9. The chest clinic Government hospital Central dispensary Public health worker (PHM/PHI) GP Work place Family member at home With community volunteer Other ( Specify)

24) Distance to the DOT center from home

18

1. 2. 3. 4. 5. 6. 7. 25) Mode of transport to DOT center 1. 2. 3. 4. 5. 26) How much time does it take? 1. 2. 3. 4. 5. 27) Expenditure for each visit 1. 2. 3. 4. 5. 6.

Less than 1 km 1-5 km 6 10 km 11 20 km 21-50 km 51-75 km >75 km

Walking Private vehicle By public transport Hired vehicle Other ( Specify)

Less than 15 minutes 15 -30 minutes 30 minutes 1 hour 1 2 hours More than 2 hours

Nil < 20 Rs 21 40 Rs 41 60 Rs 60 100 Rs > 100 Rs

28) With whom did you usually travel to the DOT center? 1. 2. 3. 4. 5. 6. Alone Spouse Child Relative Friend Other ( Specify)

29) If you were a person who went with someone, did you feel that you would have been able to go alone to the DOT center? 1. 2. Yes No

30) Was it possible for you to attend for treatment daily to the DOT center at a specific time?

19

1. 2. 3. 4.

Possible always Possible mostly Difficult Impossible

31) If not possible reasons?

32) Did you take the drugs daily from the beginning after registering as a TB patient? 1. 2. Yes No

33) Did you swallow the tablets daily in front of the DOT provider at the time of visiting the DOT center? 1. 2. Yes No

34) How frequently did you visit the DOT center during intensive phase? 1. 2. 3. Daily Weekly Other (Specify)

34 A) If the answer is weekly or other, what is the reason for not visiting daily 1. 2. DOT provider requested to take the drugs at home Patient requested to take the drugs at home

35) How frequently did you visit to the DOT center during continuation phase ? 1. 2. 3. Daily Weekly Other (Specify)

35 A) If the answer is weekly or other, what is the reason for not visiting daily 1. 2. 3. DOT provider requested to take the drugs at home Patient requested to take the drugs at home After the first two months requested to come to the DOT center once a week

20

36) If the answer for Q 34 A) or Q 35 A) is response No 2, what were the reasons for requesting drugs to be taken home? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. It was easy Nature of Occupation Daily traveling was difficult Traveling was costly Difficulty in transport As there was no one to go with me Needed to maintain privacy Due to problems at treatment place Poor reception at treatment center Fearing Social stigma Other ( Specify)

37) What are your views regarding the need to visit DOT center daily to take drugs 1. 2. 3. 4. 5. 6. Very good and acceptable Good but not always Troublesome but still does not interfere with daily activities Troublesome as it interferes with daily activities Waste of time Important reason for defaulting

38) What are your suggestions to improve the compliance of treatment? 1. 2. 3. 4. 5. 6. 7. Health personnel to visit home and give the tablets daily Arranging somebody to take you to the place Minimize travel Better reception at place of treatment To have some other health personnel / volunteer Closer to the home to distribute drugs Other (Specify)

39) Did the treating MO explain to you that you are suffering from TB? 1. 2. 40) Did the PHI at chest clinic explain to you that you are suffering from TB? 1. 2. 41) Were your family members aware that you were suffering from TB? 1. 2. Yes No Yes No Yes No

21

42) Did you have any family member living with you, who is on treatment for TB now or earlier? 1. 2. Yes No

43) Psychological impact of disease

43 A) Attitude of patient after diagnosis of TB 1. 2. 3. Minimally affected Moderately affected Greatly affected

43 B) Acceptance of patient by family 1. 2. 3. Good Tolerable Rejected

43 C) Willingness to accept DOTS at nearest health institution 1. 2. 3. 4. Readily accepted Accept through persuasion Rejected Indifferent

43 D) Written communications with patient by post from chest clinic 1. 2. 3. Accepted Rejected Indifferent

43 E) Home visits by health care personnel 1. 2. 3. Accepted Rejected Indifferent

43 F) How did you feel while you were on treatment? 1. 2. 3. 4. Completely well Moderately well No improvement No idea

44) Do you think that Anti TB drugs have many side-effects? 1. Yes

22

2.

No

45) If yes, how did you become aware of it? From 1. 2. 3. MOs at chest clinic Nurses at chest clinic/ DOT center Other health care personnel

4. 5. 6. 7.

Other patients Health leaflets Internet Mass media

46) Did you ever come across any side effects while on TB drugs? 1. 2. 46 A 1) If yes what did you do at that time? 1. 2. 3. 4. 5. Ignored it & continued treatment Sought medical advice while continuing treatment Discontinued treatment & sought medical advice Discontinued treatment & stayed at home Other (specify) Yes No

47) Are you taking medication for any disease other than TB? 1. 2. 47 A 1) If Yes (Presence of other co-morbidity) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Diabetes mellitus Hypertension Ischemic heart disease Bronchial asthma COPD Bronchiectasis Chronic liver disease Chronic renal disease Cancer Other ( Specify) Yes No

48) Do you think that the health care personnel around you are sensitive enough to care for TB patients? 1. 2. 3. Yes No No idea

23

49) Do you think that the health care personnel around you, are trained adequately to care for TB patients 1. 2. 3. 50) Were you ever stigmatized as a TB patient in public? 1. 2. 50 A 1) If Yes, by whom? 1. 2. 3. 4. 5. 6. Family member Relation At work place Villagers Treatment center Other ( Specify) Yes No Yes No No idea

50 B) Were you able to cope with the situation? 1. 2. 50C) Was this stigmatization a problem to you at any time? 1. 2. Yes No Yes No

51) Do you think our society is educated enough to accept TB patients as any other patient without any discrimination 1. 2. Yes No

52) Do you think DOT is necessary for all our patients? 1. 2. 53) Do you think you need an observer/supervisor to take care of yourself? 1. 2. Yes No Yes No

24

54) Do you think that you would have continued medicines without any interruption even without a supervisor? 1. 2. Yes No

55) Have you ever tried to hide personal information at the time of registration? 1. 2. 55A 1) If Yes why 1. 2. 3. 4. 5. 6. 7. Due to Social stigma Fear of losing the job Family problems Problem with residence (may lose rented house) PHI visits to the residence Fear of embarrassment to you in clinic Others (Specify) Yes No

56) If you had a need to go for an outstation visit for more than a day how did you take your medicine? 1. 2. 3. Interrupted treatment Requested from DOT center to supply drugs Other (Specify)

57) Do you think that you have a good understanding about the disease? 1. 2. Yes No

57 A) If yes, from where did you get that knowledge? 1. 2. 3. 4. 5. 6. 7. 8. Chest Clinic DOT center MOH Hospital From leaflets Television News papers Internet

58) Do you wish to know newer things about the disease? 1. 2. Yes No

59) Did you ever think of consulting a private sector doctor for your treatment after you were diagnosed as having TB?

25

1. 2.

Yes No

59 A 1 ) If yes, what made you to think like that? 1. 2. 3. 4. 5. 6. 7. 8. Social stigma Uncertainty about the diagnosis Long waiting hours in govt. institutions Convenient times in the private sector To receive good quality drugs Embarrassment in a TB clinic Problems with government health staff Others( Specify)

60) Did you ever consult a private sector doctor for your treatment? 1. 2. Yes No

60 A 1) If yes, what made you come back to the govt. sector again? 1. 2. 3. 4. 5. 6. Private sector doctor persuaded you to go back to DOT center No reasonable solution found at private sector Unable to afford the expenses Unavailability of drugs at private sector Malpractices at private sector Other ( Specify)

61) Have you ever changed your unit (DOT center) 1. 2. 61 A 1) If Yes, why 1. 2. 3. 4. 5. 6. 7. Social stigma Change of residence Problem with DOT center Due to distance Disability Not being aware of the closest DOT center at the onset Other (Specify) Yes No

62) Have you ever change your district of registration at the time of diagnosis 1. 2. Yes No

26

62 A) If Yes, why 1. 2. 3. 4. 5. 6. Needed to return to home town Loss of job Change of residence For occupation Due to illness Other ( Specify)

63) Were you hospitalized before starting on Anti TB treatment?

63 A) At the time of starting CAT 1 treatment 1. 2. Yes No

63 B) At the time of starting CAT 2 treatment (for treatment failures only) 1. 2. Yes No

64) Do you think that is it necessary to have regular chest clinic visits? 1. 2. Yes No

64 A) If Yes, why

64 B) If No, why

65) Is the family support you were getting when ill? 1. 2. Excellent Good

27

3. 4. 5.

Satisfactory Poor Indifferent

66) What is your opinion on the staff courtesy?

Staff Chest clinic Medical officers Nursing officers PHIs Pharmacists Dispensers DOTS providers DOTS centere DOTS providers PHIs Hospitals Medical officers Nursing officers PHIs Pharmacists Dispensers

Excellent

Good

Satisfactory

Poor

No comment

Enumerators view:

Enumerators Number28

Annexure 5: Questionnaire No. 2 for defaulters

Serial number-

District code Respondent identification Number

All Information collected at this questionnaire will be treated as strictly confidential.

Questionnaire for Evaluation of the effectiveness of the National DOTS Programme

Questionnaire NO. 2 for defaulters (Including those who have defaulted and returned for treatment as CAT 2)

1) Name of Patient

2) District TB Number

3) Diagnostic Category

29

4) MOH area

5) Age (Years)

............................................................................................................. 1. <15 Years

2. 15 24 Years 3. 25 34 Years 4. 35 44 Years 5. 45 54 Years 6. 55 64 Years 7. 65 74 Years 8. > 75 Years

6) Sex 3. 4. 7) Permanent Address Male Female .

8) Current place of residence 9. 10. 11. 12. 13. 14. 15. 16. 9) Ethnicity 6. 7. 8. 9. 10. Sinhalese Tamil Muslim Burgher Other ( Specify) In a permanent residence (own or rented house) In a temporary residence Relatives house Boarding house Hostel Work place Street Prison

30

10) Level of education 8. 9. 10. 11. 12. 13. 14. No formal Education Up to Grade 5 Up to Grade 10 Up to O/L Up to A/L Tertiary education Other (Specify)

11) Marital status 6. 7. 8. 9. 10. Married Unmarried Divorced Separated Widowed

12) No. of children

13) Occupation 5. 6. 7. 8. Unemployed Self employed Employed Retired

13 A) If employed, Nature of employment 9. 10. 11. 12. 13. 14. 15. 16. Technical and Professional Administration and Management Trained officers Clerical work Teachers Agriculture and farming Unskilled laborer Other (Specify)

13 B) After diagnosis of TB, was there an impact on occupation 3. 4. Yes No

31

13B 1) If yes, what was the change? 6. 7. 8. 9. 10. 14) Monthly income 8. 9. 10. 11. 12. 13. 14. Unable to attend work daily Transferred to a different work place Kept off work during treatment Dismissed from the job Other (Specify) Amount

No regular income Less than 3500 3501- 7500 7501-12,000 12,001-20,000 Over 20,000 Does not like to disclose

14 A) After diagnosis of TB, was there loss of your income 3. 4. Yes No

15) Smoking habits 4. 5. 6. Never smoked Currently smoking Smoked in the past and stopped completely

15A) If currently smoking,

Type Cigarette Cigars Beedi Cannabis Pipe Other

1 to 5

6 to 10

No per day 11 to 15 16 to 20

>20

No of pack years

32

16) Do you use alcohol? 4. 5. 6. Occasionally Regularly Never

16A) If Regularly or Occasionally, type of substance 6. 7. 8. 9. 10. Arrack Toddy Illicit alcohol (kassippu) Beer Other (Specify)

16B) Frequency of use,

Frequency of Use Once in three months Once a month Once a week 2 to 3 times per week Once a day 2 to 3 times per day Other

Arrack

Toddy

Substance Use illicit Beer

Other

16C) Do you think that taking alcohol may affect your compliance? 3. 4. Yes No

17) Do you use any other narcotic substances? 3. 4. 17 A 1) If Yes, Type of substance 3. Heroin 4. Other ( Specify) 18) Have you ever been imprisoned? 3. 4. Yes No Yes No

33

19) With whom are you living? 7. 8. 9. 10. 11. 12. Alone Spouse/ children Married child Other relatives Friends Other ( Specify)

20) When were you initially diagnosed as having TB? ..........................................................................................................

20 A) Who/Institute confirmed your diagnosis as a TB patient 6. 7. 8. 9. 10. At a chest clinic At chest hospital, Welisara At another government hospital By a general practitioner By a consultant at a private hospital

21) When did you start taking treatment for TB (Initiation of treatment)?

21 A) As a new case (CAT 1) 21 B) Treatment after defaulter (CAT 2)

....

22) Distance to the nearest chest clinic 7. 8. 9. 10. 11. 12. < 10 km 11-20 km 21- 30 km 31 50 km 51-75 km >75 km

23) Place where you have to go for DOT 10. 11. 12. 13. 14. 15. 16. The chest clinic Government hospital Central dispensary Public health worker (PHM/PHI) GP Work place Family member at home

34

17. With community volunteer 18. Other ( Specify) 24) Distance to the DOT center from home 8. 9. 10. 11. 6. 7. 8. Less than 1 km 1-5 km 6 10 km 11 20 km 21-50 km 51-75 km >75 km

25) Mode of transport to DOT center 6. 7. 8. 9. 10. Walking Private vehicle By public transport Hired vehicle Other ( Specify)

26) How much time does it take? 6. 7. 8. 9. 10. Less than 15 minutes 15 -30 minutes 30 minutes 1 hour 1 2 hours More than 2 hours

27) Expenditure for each visit 7. 8. 9. 10. 11. 12. Nil < 20 Rs 21 40 Rs 41 60 Rs 60 100 Rs > 100 Rs

28) With whom did you usually travel to the DOTs center? 2. 3. 4. 5. 6. 7. Alone Spouse Child Relative Friend Other ( Specify)

35

29) If you were a person who went with someone, did you feel that you would have been able to go alone to the DOT center? 3. 4. Yes No

30) Was it possible for you to attend for treatment daily to the DOT center at a specific time? 5. 6. 7. 8. Possible always Possible mostly Difficult Impossible

31) If not possible reasons?

32) When did you default taking treatment? 1. Less than 1 month after initiation of treatment 2. 1 to 2 months after initiation of treatment 3. 2 to 4 months after initiation of treatment 4. 4 to 6 months after initiation of treatment

33) When did you restart treatment (CAT 2) after defaulting? ..

34) Did you swallow the tablets daily in front of DOT provider at the DOT center? 3. 4. 35) How frequently did you visit to the DOT center during intensive phase? 1. Daily 2. Weekly 3. Other (Specify) Yes No

36

35 A) If the answer is weekly or other, what is the reason for not visiting daily 3. 4. DOT provider requested to take the drugs at home Patient requested to take the drugs at home

36) How frequently did you visit to the DOT center during the continuation phase ? 4. 5. 6. Daily Weekly Other (Specify)

36 A) If the answer is weekly or other, what is the reason for not visiting daily 1. 2. 3. DOT provider requested to take the drugs at home Patient requested to take the drugs at home After the first two months requested to come to the DOT center once a week

37) If the answer for Q 35A) or Q 36A) is response No 2, what were the reasons for requesting drugs to be taken home? 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. It was easy Nature of Occupation Daily traveling was difficult Traveling was costly Difficulty in transport As there was no one to go with me Needed to maintain privacy Due to problems at treatment place Poor reception at treatment center Fearing Social stigma Other ( Specify)

38) What are your views regarding the need to visit DOT center daily to take drugs 7. 8. 9. 10. 11. 12. Very good and acceptable Good but not always Troublesome but still does not interfere with daily activities Troublesome as it interferes with daily activities Waste of time Important reason for defaulting

39) What are your suggestions to improve the compliance of treatment? 8. 9. 10. 11. 12. Health personnel to visit home and give the tablets daily Arranging somebody to take you to the place Minimize travel Better reception at place of treatment To have some other health personnel / volunteer

37

13. Closer to the home to distribute drugs 14. Other (Specify) 40) Did the treating MO explain to you that you are suffering from TB? 3. 4. 41) Did the PHI at chest clinic explain to you that you are suffering from TB? 3. 4. 42) Were your family members aware that you were suffering from TB? 3. 4. Yes No Yes No Yes No

43) Did you have any family member living with you, who is on treatment for TB now or earlier? 3. 4. 44) Psychological impact of disease 44 A) Attitude of patient after diagnosis of TB 4. 5. 6. Minimally affected Moderately affected Greatly affected Yes No

44 B) Acceptance of patient by family 4. 5. 6. Good Tolerable Rejected

44 C) Willingness to accept DOTS at nearest health institution 5. 6. 7. 4. Readily accepted Accept through persuasion Rejected Indifferent

44 D) Written communications with patient by post from chest clinic 4. Accepted

38

5. 3.

Rejected Indifferent

44 E) Home visits by health care personnel 3. 4. 3. Accepted Rejected Indifferent

44 F) How did you feel while you were on treatment? 5. 6. 7. 8. Completely well Moderately well No improvement No idea

45) Do you think that Anti TB drugs have many side-effects? 3. 4. 46) If yes, how did you become aware of it? 8. 9. 10. 11. 12. 13. 14. MOs at chest clinic Nurses at chest clinic/ DOT center Other health care personnel Other patients Health leaflets Internet Mass media Yes No

47) Did you ever come across any side effects while on TB drugs? 3. 4. 47 A 1) If yes what did you do at that time? 6. 7. 8. 9. 10. Ignored it & continued treatment Sought medical advice while continuing treatment Discontinued treatment & sought medical advice Discontinued treatment & stayed at home Other (specify) Yes No

48) Are you taking medication for any disease other than TB?

39

3. 4. 48 A 1) If Yes (Presence of other co-morbidity) 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Diabetes mellitus Hypertension Ischemic heart disease Bronchial asthma COPD Bronchiectasis Chronic liver disease Chronic renal disease Cancer Other ( Specify)

Yes No

49) What were the reasons for stopping medication? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Distance to DOT center Income problems Occupational problems Stigma Poor family support Stopped on own because felt better Because I felt that Im being wrongly diagnosed as TB and treated Decided to take treatment from somewhere else Affects the treatment of other illnesses Side effects are intolerable Attitude and practices by health staff at DOT center Attitude and practices by health staff at district chest clinic Attitude and practices by health staff at other place (Specify) Others ( Specify)

50) Do you think that the health care personnel around you are sensitive enough to care for TB patients? 4. 5. 6. Yes No No idea

51) Do you think that the health care personals around you, are trained adequately to care for TB patients 4. 5. 6. Yes No No idea

52) Were you ever stigmatized as a TB patient in public? 3. 4. Yes No

40

52 A 1) If Yes, by whom? 7. 8. 9. 10. 11. 12. Family member Relation At work place Villagers Treatment center Other ( Specify)

52 B) Were you able to cope with the situation? 2. 3. Yes No

52 C) Was this stigmatization a problem to you at any time? 3. 4. Yes No

53) Do you think our society is educated enough to accept TB patients as any other patient without any discrimination 2. 3. Yes No

54) Do you think DOT is necessary for all our patients? 3. 4. Yes No

55) Did you think you needed an observer/supervisor to take care of yourself to continue treatment? 3. 4. Yes No

56) Did you try to hide personal information at the time of registration? 3. 4. 56A) If Yes why 8. 9. 10. 11. 12. 13. Due to Social stigma Fear of losing the job Family problems Problem with residence (may lose rented house) PHI visits to the residence Fear of embarrassment to you in clinic Yes No

41

14. Others (Specify) 57) If you had a need to go for an outstation visit for more than a day how did you take your medicine? 4. 5. 6. Interrupt treatment Request from DOT center to supply drugs Other (Specify)

58) Do you think that you have a good understanding about the disease? 3. 4. Yes No

58 A) If yes, from where did you get that knowledge? 9. 10. 11. 12. 13. 14. 15. 16. Chest Clinic MOH Hospital DOT center From leaflets Television News papers Internet

59) Do you wish to know newer things about the disease? 3. 4. Yes No

60) Did you ever think of consulting a private sector doctor for your treatment after you were diagnosed as having TB? 3. 4. Yes No

60 A 1) If yes, what made you to think like that? 9. 10. 11. 12. 13. 14. 15. 16. Social stigma Uncertainty about the diagnosis Long waiting hours in govt. institutions Convenient times in the private sector To receive good quality drugs Embarrassment in a TB clinic Problems with government health staff Other ( Specify)

42

61) Did you ever consult a private sector doctor for your treatment? 3. 4. Yes No

61 A 1) If yes, what made you come back to the govt. sector again? 7. 8. 9. 10. 11. 12. Private sector doctor persuaded you to go back to DOT center No reasonable solution found at private sector Unable to afford the expenses Unavailability of drugs at private sector Malpractices at private sector Other ( Specify)

62) Why did you not complete the whole regimen? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Felt well Side effects of drugs Disability Did not want DOT Due to the reasons related to the DOT provider Difficulties in collecting drug Family problems Occupational problems Financial problems Residential problems Not feeling well even after starting treatment Other (Specify)

63) What made you seek treatment again after defaulting? (For CAT 2) 1. 2. Reappearance of symptoms Persuasion by a. PHI b. Any other health personnel c. Relatives & friends d. Chest clinic e. DOT provider f. Community leaders g. Work place staff h. On your own i. Legally Other (Specify)

3.

64) What are your views with regard to the prevention of defaulting of the treatment? 1. 2. 3. 4. DOT at home Drugs to be provided to the patient Hospitalization DOT at the nearest health institute

43

5. 6.

DOT by Community DOT providers No views

65) Did you change your DOT center after restarting treatment (CAT 2)? 3. 4. 65 A) If Yes, why 8. 9. 10. 11. 12. 13. 14. Social stigma Change of residence Problem with DOT center Due to distance Disability Not being aware of the closest DOT center at the onset Other (Specify) Yes No

66) Did you change your district of registration at the time of diagnosis, after restarting treatment (CAT 2)? 3. 4. 66 A 1) If Yes why 7. 8. 9. 10. 11. 12. Needed to return to home town Loss of job Change of residence For occupation Due to illness Other ( Specify) Yes No

67) Were you hospitalized before starting on Anti TB treatment?

67 A) At the time of starting CAT 1 treatment 2. 2. Yes No

67 B) At the time of starting CAT 2 treatment 3. 4. Yes No

44

68) Do you think that is it necessary to have regular chest clinic visits? 1. 2. Yes No

68 A) If Yes, why

68 B) If No, why

69) Is the family support you were getting when ill? 6. 7. 8. 9. 10. Excellent Good Satisfactory Poor Indifferent

70) What is your opinion on the staff courtesy?

45

Staff Chest clinic Medical officers Nursing officers PHIs Pharmacists Dispensers DOTS providers DOTS centere DOTS providers PHIs Hospitals Medical officers Nursing officers PHIs Pharmacists Dispensers

Excellent

Good

Satisfactory

Poor

No comment

Enumerators view:

Enumerators Number-

46

47

Annexure 6: Questionnaire No: 3 for the DOTS Providers

Serial number-

District code Respondent identification Number

All Information collected at this questionnaire will be treated as strictly confidential.

Questionnaire for Evaluation of the effectiveness of The National DOTS Programme

Questionnaire for DOT Providers

1) Name

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2) Address

3) Name of the DOT centre

4) MOH area

5) DTCO area

...................................

6) Position

A) Government health staff member 1. Medical Officer 2. Mid wife 3. Staff Nurse 4. Attendant 5. Pharmacist 6. Minor staff 7. PHI 8. Dispenser 9. Other (Specify)

B) Private health staff member 1. Medical officer 2. Mid wife 3. Staff Nurse 4. Pharmacist 5. Other (Specify)

49

C) Community leader 1. Gramasevaka 2. Priest 3. Sammurdhi Niyamaka 4. NGO 5. School principal 6. School teacher 7. Other (Specify) D) Relative

1. Parent 2. Grand parents

3. Sibling 4. Other relation 5. Spouse 6. Other (Specify)

7) Education Qualifications 1. 2. 3. 4. 5. 6. 7. No formal Education Up to Grade 5 Up to Grade 10 Up to O/L Up to A/L Tertiary education Other (Specify)

8) Nature of employment

1.Technical and Professional 2. Administration and Management 3. Trained officers 4. Clerical work

50

5. Teachers 6. Agriculture and farming 7. Unskilled labourer 8. Other (Specify)

9) Are you trained for the task of being a supervisor? 1. Yes 2. No 3. Indifferent

9A 1) If Yes, By whom 1. DTCO 2. MO chest clinic 3. PHI 4. Other (Specify)

10) Are you motivated to do this task of a supervisor? 1. 2. 3. Yes No Indifferent

11) Did you attend a DOTS modular training programme? 1. 2. 12) Is the manual on DOT available with you? 1. 2. Yes No Yes No

51

13) Do you think you have a good knowledge regarding TB? 1. Yes 2. No

14) From where did you get that knowledge? 1. 2. 3. 4. 5. DOTS training Chest clinic Literature Mass media Other ( Specify)

15) How many patients are you supervising at the moment? 1. 2. 3. 4. No patients 1-4 patients 5-9 patients 10 or above

16) Do you have a good knowledge of where your patients reside? 1. Yes 2. No

17) How long have you been involved as supervisor in the DOTS programme? (Completed years) 1. 2. 3. 4. 5. 6. 18) Are you familiar with the concept of DOTS? 1. 2. Yes No 1 year 2 years 3 years 4 years 5 years More than 5 years

52

19) Were you aware of DOTS Strategy before being a DOT supervisor? 1. Yes 2. No

20) How did you get to know about DOTS (More than one answer is possible) 1. In your undergraduate education

2. After joining the health department 3. After joining the NPTCCD 4. Other means (Media, News papers, Internet) 5. In your postgraduate training 6. In your basic training (MLT / Pharmacist /Dispenser) 7.After being recruited as a DOT provider 8. Other (specify)

21) Do your patients attend the DOT center regularly? 1. Yes 2. No 3. Not always

22) When patients interrupt treatment, what action do you take? 1. 2. 3. 4. Call the patient if contact number is available Send a letter to patient Go to the patients place & trace him/her Inform chest clinic a. To whom i. DTCO ii. PHI of chest clinic iii. Other (specify) b. How i. Over the phone ii. By letter Inform MOH

5.

53

6. 7. 8. 9.

Inform PHI Inform the officer in charge of the DOTS center Head of the institution Others (specify)

23) Do you know the contact details of A) DTCO 1.Yes 2. No

B) PHI of chest clinic 1. Yes 2. No

C) Patients 1. Yes 2. No

E) Range PHI/MOH 1. Yes 2. No

D) Relatives (Specify) 1. Yes 2. No

24) What do you think are the possible reasons for irregular attendance of patients at your DOT center? (More than one answer is possible)

54

1. Stigma 2. Transport difficulties 3. Occupational & schooling problems 4. Lack of money 5. Patients not having any one to accompany them 6. Poor awareness of the disease 7. Physical & mental disability of patients 8. Development of side effects to Anti TB treatment 9. Lack of understanding about the drugs and their action 10. Lack of confidence in treatment success 11. Problems at DOTS center Due to over crowding Delay in medical attention Other (Specify) 12. Other (Specify)

25) Have you been involved in the TB control activities before being recruited as a DOTS provider? 1. 2. Yes No

26) Do you think that DOTS is better than the previous method for TB control activities 1. 2. Yes No

If the answer is Yes, go to Q 26A) & If the answer is NO, go to Q 26B)

26 A) If yes, why? (More than one answer is possible) 1. 2. 3. Cure rate is higher Patients compliance is better Low default rates

55

4. 5. 6.

Can take early actions when side effects develop Can take early action when patients interrupt treatment Other (specify)

26 B) If No, Why? (More than one answer is possible) 1. 2. 3. 4. 5. As patients do not come regularly to the centre for various reasons Difficult to convince the patients Lack of cooperation by the staff Difficult to supervise the intake of drugs due to high workload Other (specify)

27) What are the constraints you have faced or experienced in implementation of DOTS at your center? (More than one answer is possible) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Poor facilities at the DOT center Difficulty in tracing the patients once they interrupted treatment Inadequate & irregular Drug supply to the DOT center No time due to heavy work load with other work Inadequate staff cooperation Poor cooperation of the patients In adequate managerial support Difficulties in reporting & feedback Difficulties in monitoring Inadequate guidance Not being trained adequately for DOTS Other (specify)

If the answer to above is 3, 27 A) Was any of the drugs out of stock at any time during last year 1. Yes 2. No

27 B) If yes, Name the drugs and for how long?

56

28) Do you think that DOT at a DOT center is necessary for all TB patients? 1. Yes 2. No

28 A) If No, to whom do you think DOT is not necessary? 1. 2. 3. 4. 5. Professionals Children less than 5 years School children Health personnel Other (specify)

29) Do the DTCO or PHI supervise the DOT center regularly? 1. Yes 2. No

29A) If yes, how often? ..............................................

30) Knowledge of DOT provider as perceived by the interviewer ( Use the annexed questions ) A) About the disease 1. 2. 3. 4. 5. B) About DOTS 1. 2. 3. 4. 5. Highly Satisfactory Satisfactory Fair Un satisfactory Highly Unsatisfactory Highly satisfactory Satisfactory Fair Unsatisfactory Highly Unsatisfactory

C) Treatment categories & regimens 1. 2. Highly satisfactory Satisfactory

57

3. 4. 5.

Fair Un satisfactory Highly Unsatisfactory

D) Awareness of side effects 1. 2. 3. 4. 5. Highly satisfactory Satisfactory Fair Un satisfactory Highly Unsatisfactory

E) Duration of treatment 1. 2. 3. 4. 5. Highly satisfactory Satisfactory Fair Un satisfactory Highly Unsatisfactory

F) Important TB messages 1. 2. 3. 4. 5. Highly satisfactory Satisfactory Fair Un satisfactory Highly Unsatisfactory

31) What are the suggestions to improve TB control activities/DOTS in your area?

Supervisors / DOT centre detail

32) Type of Institute 1. Government i. Hospital TH BH DH PU RH

58

2. 3. 4. 5. 6. 7.

ii. Dispensary CD CD&MH center) iii. Chest clinic iv. MOH office v. PHMs office vi. PHIs office vii. Municipal dispensary viii. Other govt. institute Private hospital Private pharmacy General practitioner Other Private place (Specify) Work place of NGO Work place of community leader

EMC (Estate medical

33) Is there a separate place for DOT? 1. 2. Yes No

34) Is the location of the DOT Center easy to find? 1. 2. Yes No

35) Is the Place comfortable to the patient? 1. 2. 36) Facilities available 1. 2. 3. 4. 5. 6. 7. Telephone Chairs & other seating facilities Safe water Drug cupboard Drug container Sharp bin Waste disposal bins Yes No

59

8. 9.

Instruction leaflets Health education materials

Drugs

37) Are the drugs properly stored? 37A) Without exposure to sunlight 1. Yes 2. No

37C) Whether drugs are kept separately for each patient? 1. Yes 2. No

37D) Are they labeled? 1. Yes 2. No

37E) Are they placed in containers? 1. Yes 2. No

37F) Are the drugs are kept safely under lock & key? 1. Yes 2. No

37G) Is the drug supply satisfactory?

60

1. Yes

2. No

37H) Were any of the drugs out of stock for more than 1 month? 1. Yes 2. No

38) Is there a DOT register? 1. 2. Yes No

38A) Is it uniform with the DOTS registers in the district? 1.Yes 2. No

39) Currently how many patients registered for DOTS? (Check with the answer to Q 15.)

40) How many patients were given DOTS over last month?

41) How many patients were on DOTS for this year?

..

42) Are treatment cards daily updated? 1. 2. Yes No

43) Are the remarks on supervision of the DOT center by the DTCO/PHI available? 1. Yes

61

2. No

44) Category of the DOT providers at the working center 1. 2. 3. 4. 5. 6. 7. 8. 9. MO RMO Nursing officer Pharmacist Dispensers PHM PHI Minor staff Other ( Specify)

45) Number of DOTS providers working at the DOTS center at present? ...................................

46) Number of trained DOT providers? ........................................

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Annexure 7: District Survey Teams

There were nine survey teams deployed and the surveys were carried out in the following district by the following teams headed by District DTCO.

Province Western Province

District Colombo

Name Dr. Ruwanie Perera Dr. Rohitha Darmasiri Mr. L.D.A.N.Kumarasinghe Mr. K.U.Shantha Mr.K.S.Ranasinghe Mr.K.A.R.S.Weerakoon Dr. D.Wijesighe Mr. D. Wickramarathna Mr.Y. Rathnayake Dr. K.K.Abeyweera Mr.M. Bandara Mr.S.Fernando Dr. Anoma De Silva Mr. Chanaka Hewawasam Mrs. Indra Kumari Dr.Ajith Kariyawasam Mr. Gunasekara Dr. S. Mahanama Mr. Udaya Gunaratne Dr. W.M.D.N.K.Wijesinghe Mr. Vajira Ratnayake Mr.B.M.S.C. Balasooriya

Designation DTCO DTCO PHI PHI PHI PHI DTCO PHI PHI DTCO PHI PHI DTCO PHI PHI DTCO PHI DTCO PHI DTCO PHI PHI DTCO PHI DTCO PHI

Gampaha

Kaluthara

Central Province

Kandy

Southern Province Sabaragamuwa province North Western Province

Galle Ratnapura Kurunegala

North Central Province Eastern Province

Anuradhapura Dr. Deepthi Waidyaratna Mr. Indika Thikarathne Trincomalee Dr. Suresh Kumar Mr. T. Sivakumara

63

64