Public Health Action VOL
3 SUPPLEMENT 1
PUBLISHED
InternaƟonal Union Against Tuberculosis and Lung Disease Health soluƟons for the poor
4 NOVEMBER 2013
Characteristics of patients with diabetes screened for tuberculosis in a tertiary care hospital in South India S. Kumpatla,1 A. Sekar,1 S. Achanta,2 B. N. Sharath,2,3 A. M. V. Kumar,4 A. D. Harries,5,6 V. Viswanathan1 http://doi.dx.org/10.5588/pha.13.0035
Setting: Tertiary care hospital for diabetes mellitus (DM) in Tamil Nadu, South India. Objective: To compare the socio-demographic, clinical and biochemical characteristics in DM patients with and without tuberculosis (TB). Design: A descriptive study involving a review of routinely maintained records to capture the results of screening of DM patients for TB between March and December 2012. DM patients were first asked whether they already had TB, and if not they were screened for TB symptoms, followed by investigations for and possible diagnosis of TB. Results: Of 7083 DM patients, 38 already had TB. Of the remainder, 125 (1.8%) had TB symptoms; 71 were investigated and 12 were newly diagnosed with TB. Of the 50 TB patients, 64% had smear-positive pulmonary TB (PTB). DM-TB patients were older, and had lower education level and economic status, a higher frequency of alcohol use, lower body mass index, a longer duration of DM, a greater likelihood of receiving insulin and poorer glycaemic control. Conclusion: Screening of DM patients for TB was feasible in a tertiary care hospital. The yield of new TB cases was low and merits further investigation. Socio-demographic and clinical characteristics were different in patients with DM and TB compared to those with DM only.
D
iabetes mellitus (DM) has become a global epidemic, especially in low- and middle-income countries, where 80% of DM-related mortality is estimated to occur.1 Currently, there are more than 61 million people living with DM in India.2 In a similar vein to DM, about one third of the world’s population is currently infected with Mycobacterium tuberculosis, and approximately 8.8 million new cases of active TB are identified globally each year.3 India also has a huge TB burden, with an estimated 2.3 million new cases every year.4 There is good evidence that the risk of TB among people with DM is three times higher than in those without DM,5 and patients with both DM and TB have poorer TB treatment outcomes.6–8 India, which has a high dual burden of DM and TB,9,10 could benefit if patients were screened early for either disease. The World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Disease (The Union) launched the ‘Collaborative framework for the Care and Control of Diabetes and Tuberculosis’, with one of several important recommendations being the routine implementation of bidirectional
screening of the two diseases.11 However, screening methods, recording and reporting for the two diseases in routine health care settings have not been well determined, and operational research is needed to provide better information in this area.12 Based on these recommendations, a standardised procedure for bidirectional screening, a monitoring tool and a quarterly system of recording and reporting were recently developed and implemented in eight tertiary centres and more than 60 peripheral health facilities across India. Our hospital was one of the eight tertiary health care facilities that participated in the pilot screening of DM patients for TB. Evaluation of this pilot in 2012 by the India Diabetes Mellitus–Tuberculosis Study Group showed that it is feasible to screen DM patients for TB within the routine setting, resulting in high rates of detection of TB.13 Despite these good results, there is a paucity of information on the association of socio-demographic characteristics and clinical features in DM patients with TB. In the present study, we therefore aimed to describe the screening of DM patients for TB and the socio-demographic characteristics, clinical features and biochemical variables of DM patients in relation to the diagnosis of TB in a tertiary care hospital for DM in South India.
AFFILIATIONS 1 MV Hospital for Diabetes and Prof M Viswanathan Diabetes Research Centre, Chennai, India (World Health Organization Collaborating Centre for Research, Education and Training in Diabetes) 2 World Health Organization Country Office in India, New Delhi, India 3 Department of Community Medicine, Employees State Insurance Corporation (ESIC) Medical College, Bangalore, India 4 International Union Against Tuberculosis and Lung Disease ( The Union), South-East Asia Office, New Delhi, India 5 The Union, Paris, France 6 London School of Hygiene & Tropical Medicine, London, UK
METHODS
KEY WORDS DM; TB; India; screening
CORRESPONDENCE Vijay Viswanathan MV Hospital for Diabetes & Prof M Viswanathan Diabetes Research Centre No. 4 Main Road, Royapuram, Chennai–600013, India Tel: (+91) 44259 54913 Fax (+91) 44259 54919 e-mail: drvijay@mvdiabetes. com
Study design This was a descriptive study involving a review of records maintained during the pilot screening of DM patients for TB.
Setting The study was conducted at the MV Hospital for Diabetes, a 100-bed tertiary care hospital for DM in the state of Tamil Nadu, South India. More than 200 000 DM patients have been registered in care at the hospital since its opening, and 100–200 patients visit the hospital every day on an out-patient basis. Patients attending the hospital and suspected of having DM are screened using the 2 h 75 g oral glucose tolerance test. The diagnosis of DM is based on previous DM history or on the WHO’s criteria for the classification of glucose intolerance.14 Fasting and postprandial samples are collected from known cases of DM. For the TB screening, all DM patients presenting to the out-patient department were asked whether they had already been diagnosed with TB and were on TB treatment. If the answer was yes, this was recorded and the patient was not asked again about TB until
Received 24 May 2013 Accepted 17 July 2013
PHA 2013; 3(S1): S23–S28 © 2013 The Union
Public Health Action
Screening DM patients for TB
completion of TB treatment. If the answer was no, the patient was screened for symptoms by trained staff, based on the Revised National TB Control Programme (RNTCP) guidelines.13,15 Briefly, patients with cough for ⩾2 weeks or any suspicion of active pulmonary TB (PTB) or extra-pulmonary TB were categorised as having presumptive TB and were further investigated to confirm the disease. Two same-day sputum specimens from presumptive TB patients were collected in the DM clinic and transported to the government-run microscopy centre (1.5 km away) for sputum smear microscopy by Ziehl-Neelsen staining.15 Patients with negative sputum smears or extra-pulmonary TB suspects underwent appropriate investigations such as chest radiography to confirm TB. Those subsequently diagnosed with TB were referred to the RNTCP for TB treatment. All patient data were recorded on treatment cards and captured in an electronic database. The TB screening process started in March 2012 and was performed when the patient visited the clinic. Screening was done on every patient visit. For the purpose of this study, however, we only describe the results of screening on the first visit.
smoking in the last 3 months) and alcohol consumption (60 ml of alcohol daily). Occupation status was classified as skilled (carpenter, painter, electrician, fitter, etc.), unskilled (farmer, labourer), business, and ‘others’ for categories such as retired people, homemakers and the unemployed. Economic status was classified as low (family income US$400 per month); 2) clinical features: family history of DM, weight and height (for body mass index [BMI]), duration of DM and current medication for DM; and 3) blood glucose measurements performed at the time of TB screening, including fasting and postprandial glucose in mg/dl and glycosylated haemoglobin (HbA1c) in %. Plasma glucose was estimated using the glucose oxidase peroxidase method. HbA1c was estimated using the high-performance liquid chromatography method with Bio-Rad Variant Turbo equipment (Bio-Rad Laboratories, Hercules, CA, USA; Appendix Table A). Data were also collected on the TB screening process, diagnosis of TB, type of TB and referral for TB care.
Study population
Data were extracted from the electronic database and analysed using SPSS (Statistical Package and Service Solutions, version 16.0, SPSS Inc, Chicago, IL). The flow of patients from screening to diagnosis of TB was described, and the socio-demographic characteristics, clinical features and biochemical variables of DM patients without TB symptoms (DM only) and with TB (previously known and newly diagnosed DM-TB) were evaluated. Patients with symptoms of TB who were either not investigated or not diagnosed with TB and patients with missing data were not included in this
All DM patients aged ⩾15 years attending the MV hospital for their routine DM care and screened for TB between March and December 2012 were included in the study.
Data variables and sources of data Data variables included: 1) socio-demographic characteristics: DM registration number, age, sex, residence, education, occupation and socio-economic status, smoking (current smoker was defined as a history of
Analysis and statistics
FIGURE Flow chart showing the results of screening DM patients for TB in a tertiary care hospital in South India, March–December 2012. DM = diabetes mellitus; TB = tuberculosis; M = male; F = female.
S24
ACKNOWLEDGEMENTS The authors acknowledge the help rendered by R Priyadarshini, Krishna, M Rajalakshmi, V Arulmozhi and C Deepika for data collection. They also acknowledge Selvan and A Vigneswari for conducting data analysis. The authors thank all their patients for cooperating with them throughout the study. A workshop was convened in Delhi, India, for the purpose of writing the papers that are published in this supplement. The workshop was run by the Centre for Operational Research, International Union Against Tuberculosis and Lung Disease (The Union), Paris, France; The Union South-East Asia Office, New Delhi, India; the Operational Research Unit, Médecins Sans Frontières, Luxembourg; the World Health Organization Country Office in India, New Delhi, India; the All India Institute of Medical Sciences, New Delhi, India; and ESIC Medical College, Bangalore, India. Funding for the workshop and open access publication was received from the World Diabetes Foundation, Gentofte, Denmark. Conflict of interest: none declared.
Public Health Action
Screening DM patients for TB
comparative analysis. Mean and standard deviations (SD) were calculated. Continuous variables such as age, BMI and duration of DM were converted to categorical variables and compared using the χ² test where appropriate. Levels of significance were set at 5%.
Ethics approval Ethics approval for the study was obtained from the Institutional Ethics Committee of MV Diabetes Research Centre and The Union Ethics Advisory Group.
TABLE 1 Types and categories of TB in DM patients screened for TB in a tertiary care hospital between March and December 2012 Patients n
Category and type of TB New Smear-positive PTB Smear-negative PTB Extra-pulmonary TB Not recorded Retreatment Relapse smear-positive PTB Failure smear-positive PTB Return after default smear-positive PTB
45 27 12 4 2 5 1 1 3
TB = tuberculosis; DM = diabetes mellitus; PTB = pulmonary tuberculosis.
TABLE 2 Socio-demographic characteristics of DM patients with and without TB* in a tertiary care hospital in South India, March–December 2012
Characteristic Total Sex Male Female Age, years, mean ± SD Age, years 15– 44 45–64 ⩾65 Residence Urban Rural Educational status No school Primary/high school Technical/diploma University degree Occupation Skilled Unskilled Business Other Economic status Low Middle High Current smoking Alcohol consumption
DM patients with TB n (%)
DM patients with no TB* n (%)
47 (100)
6113 (100)
39 (83) 8 (17) 57.4 ± 12.7
3544 (58) 2569 (42) 53.8 ± 11.2
3 SUPPLEMENT 1
PUBLISHED
InternaƟonal Union Against Tuberculosis and Lung Disease Health soluƟons for the poor
4 NOVEMBER 2013
Characteristics of patients with diabetes screened for tuberculosis in a tertiary care hospital in South India S. Kumpatla,1 A. Sekar,1 S. Achanta,2 B. N. Sharath,2,3 A. M. V. Kumar,4 A. D. Harries,5,6 V. Viswanathan1 http://doi.dx.org/10.5588/pha.13.0035
Setting: Tertiary care hospital for diabetes mellitus (DM) in Tamil Nadu, South India. Objective: To compare the socio-demographic, clinical and biochemical characteristics in DM patients with and without tuberculosis (TB). Design: A descriptive study involving a review of routinely maintained records to capture the results of screening of DM patients for TB between March and December 2012. DM patients were first asked whether they already had TB, and if not they were screened for TB symptoms, followed by investigations for and possible diagnosis of TB. Results: Of 7083 DM patients, 38 already had TB. Of the remainder, 125 (1.8%) had TB symptoms; 71 were investigated and 12 were newly diagnosed with TB. Of the 50 TB patients, 64% had smear-positive pulmonary TB (PTB). DM-TB patients were older, and had lower education level and economic status, a higher frequency of alcohol use, lower body mass index, a longer duration of DM, a greater likelihood of receiving insulin and poorer glycaemic control. Conclusion: Screening of DM patients for TB was feasible in a tertiary care hospital. The yield of new TB cases was low and merits further investigation. Socio-demographic and clinical characteristics were different in patients with DM and TB compared to those with DM only.
D
iabetes mellitus (DM) has become a global epidemic, especially in low- and middle-income countries, where 80% of DM-related mortality is estimated to occur.1 Currently, there are more than 61 million people living with DM in India.2 In a similar vein to DM, about one third of the world’s population is currently infected with Mycobacterium tuberculosis, and approximately 8.8 million new cases of active TB are identified globally each year.3 India also has a huge TB burden, with an estimated 2.3 million new cases every year.4 There is good evidence that the risk of TB among people with DM is three times higher than in those without DM,5 and patients with both DM and TB have poorer TB treatment outcomes.6–8 India, which has a high dual burden of DM and TB,9,10 could benefit if patients were screened early for either disease. The World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Disease (The Union) launched the ‘Collaborative framework for the Care and Control of Diabetes and Tuberculosis’, with one of several important recommendations being the routine implementation of bidirectional
screening of the two diseases.11 However, screening methods, recording and reporting for the two diseases in routine health care settings have not been well determined, and operational research is needed to provide better information in this area.12 Based on these recommendations, a standardised procedure for bidirectional screening, a monitoring tool and a quarterly system of recording and reporting were recently developed and implemented in eight tertiary centres and more than 60 peripheral health facilities across India. Our hospital was one of the eight tertiary health care facilities that participated in the pilot screening of DM patients for TB. Evaluation of this pilot in 2012 by the India Diabetes Mellitus–Tuberculosis Study Group showed that it is feasible to screen DM patients for TB within the routine setting, resulting in high rates of detection of TB.13 Despite these good results, there is a paucity of information on the association of socio-demographic characteristics and clinical features in DM patients with TB. In the present study, we therefore aimed to describe the screening of DM patients for TB and the socio-demographic characteristics, clinical features and biochemical variables of DM patients in relation to the diagnosis of TB in a tertiary care hospital for DM in South India.
AFFILIATIONS 1 MV Hospital for Diabetes and Prof M Viswanathan Diabetes Research Centre, Chennai, India (World Health Organization Collaborating Centre for Research, Education and Training in Diabetes) 2 World Health Organization Country Office in India, New Delhi, India 3 Department of Community Medicine, Employees State Insurance Corporation (ESIC) Medical College, Bangalore, India 4 International Union Against Tuberculosis and Lung Disease ( The Union), South-East Asia Office, New Delhi, India 5 The Union, Paris, France 6 London School of Hygiene & Tropical Medicine, London, UK
METHODS
KEY WORDS DM; TB; India; screening
CORRESPONDENCE Vijay Viswanathan MV Hospital for Diabetes & Prof M Viswanathan Diabetes Research Centre No. 4 Main Road, Royapuram, Chennai–600013, India Tel: (+91) 44259 54913 Fax (+91) 44259 54919 e-mail: drvijay@mvdiabetes. com
Study design This was a descriptive study involving a review of records maintained during the pilot screening of DM patients for TB.
Setting The study was conducted at the MV Hospital for Diabetes, a 100-bed tertiary care hospital for DM in the state of Tamil Nadu, South India. More than 200 000 DM patients have been registered in care at the hospital since its opening, and 100–200 patients visit the hospital every day on an out-patient basis. Patients attending the hospital and suspected of having DM are screened using the 2 h 75 g oral glucose tolerance test. The diagnosis of DM is based on previous DM history or on the WHO’s criteria for the classification of glucose intolerance.14 Fasting and postprandial samples are collected from known cases of DM. For the TB screening, all DM patients presenting to the out-patient department were asked whether they had already been diagnosed with TB and were on TB treatment. If the answer was yes, this was recorded and the patient was not asked again about TB until
Received 24 May 2013 Accepted 17 July 2013
PHA 2013; 3(S1): S23–S28 © 2013 The Union
Public Health Action
Screening DM patients for TB
completion of TB treatment. If the answer was no, the patient was screened for symptoms by trained staff, based on the Revised National TB Control Programme (RNTCP) guidelines.13,15 Briefly, patients with cough for ⩾2 weeks or any suspicion of active pulmonary TB (PTB) or extra-pulmonary TB were categorised as having presumptive TB and were further investigated to confirm the disease. Two same-day sputum specimens from presumptive TB patients were collected in the DM clinic and transported to the government-run microscopy centre (1.5 km away) for sputum smear microscopy by Ziehl-Neelsen staining.15 Patients with negative sputum smears or extra-pulmonary TB suspects underwent appropriate investigations such as chest radiography to confirm TB. Those subsequently diagnosed with TB were referred to the RNTCP for TB treatment. All patient data were recorded on treatment cards and captured in an electronic database. The TB screening process started in March 2012 and was performed when the patient visited the clinic. Screening was done on every patient visit. For the purpose of this study, however, we only describe the results of screening on the first visit.
smoking in the last 3 months) and alcohol consumption (60 ml of alcohol daily). Occupation status was classified as skilled (carpenter, painter, electrician, fitter, etc.), unskilled (farmer, labourer), business, and ‘others’ for categories such as retired people, homemakers and the unemployed. Economic status was classified as low (family income US$400 per month); 2) clinical features: family history of DM, weight and height (for body mass index [BMI]), duration of DM and current medication for DM; and 3) blood glucose measurements performed at the time of TB screening, including fasting and postprandial glucose in mg/dl and glycosylated haemoglobin (HbA1c) in %. Plasma glucose was estimated using the glucose oxidase peroxidase method. HbA1c was estimated using the high-performance liquid chromatography method with Bio-Rad Variant Turbo equipment (Bio-Rad Laboratories, Hercules, CA, USA; Appendix Table A). Data were also collected on the TB screening process, diagnosis of TB, type of TB and referral for TB care.
Study population
Data were extracted from the electronic database and analysed using SPSS (Statistical Package and Service Solutions, version 16.0, SPSS Inc, Chicago, IL). The flow of patients from screening to diagnosis of TB was described, and the socio-demographic characteristics, clinical features and biochemical variables of DM patients without TB symptoms (DM only) and with TB (previously known and newly diagnosed DM-TB) were evaluated. Patients with symptoms of TB who were either not investigated or not diagnosed with TB and patients with missing data were not included in this
All DM patients aged ⩾15 years attending the MV hospital for their routine DM care and screened for TB between March and December 2012 were included in the study.
Data variables and sources of data Data variables included: 1) socio-demographic characteristics: DM registration number, age, sex, residence, education, occupation and socio-economic status, smoking (current smoker was defined as a history of
Analysis and statistics
FIGURE Flow chart showing the results of screening DM patients for TB in a tertiary care hospital in South India, March–December 2012. DM = diabetes mellitus; TB = tuberculosis; M = male; F = female.
S24
ACKNOWLEDGEMENTS The authors acknowledge the help rendered by R Priyadarshini, Krishna, M Rajalakshmi, V Arulmozhi and C Deepika for data collection. They also acknowledge Selvan and A Vigneswari for conducting data analysis. The authors thank all their patients for cooperating with them throughout the study. A workshop was convened in Delhi, India, for the purpose of writing the papers that are published in this supplement. The workshop was run by the Centre for Operational Research, International Union Against Tuberculosis and Lung Disease (The Union), Paris, France; The Union South-East Asia Office, New Delhi, India; the Operational Research Unit, Médecins Sans Frontières, Luxembourg; the World Health Organization Country Office in India, New Delhi, India; the All India Institute of Medical Sciences, New Delhi, India; and ESIC Medical College, Bangalore, India. Funding for the workshop and open access publication was received from the World Diabetes Foundation, Gentofte, Denmark. Conflict of interest: none declared.
Public Health Action
Screening DM patients for TB
comparative analysis. Mean and standard deviations (SD) were calculated. Continuous variables such as age, BMI and duration of DM were converted to categorical variables and compared using the χ² test where appropriate. Levels of significance were set at 5%.
Ethics approval Ethics approval for the study was obtained from the Institutional Ethics Committee of MV Diabetes Research Centre and The Union Ethics Advisory Group.
TABLE 1 Types and categories of TB in DM patients screened for TB in a tertiary care hospital between March and December 2012 Patients n
Category and type of TB New Smear-positive PTB Smear-negative PTB Extra-pulmonary TB Not recorded Retreatment Relapse smear-positive PTB Failure smear-positive PTB Return after default smear-positive PTB
45 27 12 4 2 5 1 1 3
TB = tuberculosis; DM = diabetes mellitus; PTB = pulmonary tuberculosis.
TABLE 2 Socio-demographic characteristics of DM patients with and without TB* in a tertiary care hospital in South India, March–December 2012
Characteristic Total Sex Male Female Age, years, mean ± SD Age, years 15– 44 45–64 ⩾65 Residence Urban Rural Educational status No school Primary/high school Technical/diploma University degree Occupation Skilled Unskilled Business Other Economic status Low Middle High Current smoking Alcohol consumption
DM patients with TB n (%)
DM patients with no TB* n (%)
47 (100)
6113 (100)
39 (83) 8 (17) 57.4 ± 12.7
3544 (58) 2569 (42) 53.8 ± 11.2
