TITLE: Social Determinants and Co-morbidities of Tuberculosis Patients in

Ernakulam General Hospital TB Unit.

INTRODUCTION:

Worldwide, Tuberculosis is one of the top 10 1 causes of death and the leading cause from a single
infectious agent (above HIV/AIDS). Millions of people continue to fall sick with Tuberculosis each
year. The End Tuberculosis Strategy milestones can only be achieved if Tuberculosis diagnosis,
treatment and prevention services are provided within the context of progress towards universal
health coverage (UHC), and if there is multi sectoral action to address the social and economic
factors that drive Tuberculosis epidemics. In 2016, nearly a fifth of the people who were diagnosed
and known to be treated for tuberculosis had adverse outcomes, including 1·3 million 2 deaths.

TUBERCULOSIS: - Tuberculosis (TB) is a potentially serious infectious disease that mainly affects the
lungs. The bacteria that cause tuberculosis spread from one person to another through tiny
droplets released into the air via coughs and sneezes.

SYMPTOMS

Although human body may harbor the bacteria that cause tuberculosis (TB), the immune
system can prevent the disease from occurring. For this reason, doctors make a distinction
between:

Latent TB. In this condition, patient having TB infection, but the bacteria remain in body
with an inactive state and cause no symptoms. Latent TB, also called inactive TB or TB
infection, isn't contagious. It can turn into active TB, so treatment is important for the
person with latent TB and to help control the spread of TB.

Active TB. This condition makes one sick and in most cases can spread to others. It can
occur in the first few weeks after infection with the TB bacteria, or it might occur years
later.
Signs and symptoms of active TB include:

Coughing that lasts three or more weeks

Coughing up blood

Chest pain or pain with breathing or coughing

Unintentional weight loss

Fatigue

Fever

Night sweats

Chills

Loss of appetite

Tuberculosis can also affect other parts of your body, including your kidneys, spine or brain. When
TB occurs outside your lungs, signs and symptoms vary according to the organs involved. For
example, tuberculosis of the spine may give you back pain, and tuberculosis in your kidneys might
cause blood in your urine.

SOCIAL DETERMINANTS: - The social determinants of health are the conditions in which people are
born, grow, live, work and age. These circumstances are shaped by the distribution of money,
power and resources at global, national and local levels. The social determinants of health are
mostly responsible for health inequities - the unfair and avoidable differences in health status seen
within and between countries.

CO MORBIDITY: - In medicine, co morbidity is the presence of one or more additional

conditions co-occurring with (that is, concomitant or concurrent with) a primary condition.

NEED OF THE STUDY: Most studies address different aspects of tuberculosis alone or co
morbidities alone. No studies have been carried out till date about social determinants and co
-morbidities with Tuberculosis in Ernakulam district of Kerala state. So this study aims to elicit both
social determinants and co morbidities of Tuberculosis patients in Ernakulam General hospital TB
unit. Hence the study assumes significance.
REVIEW OF LITERATURE

WHO (2018) Global Tuberculosis Report –- The main aim of the report is to provide a
comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention,
diagnosis and treatment of the disease at global, regional and country levels {1}. Bibha Marak
et.al (2016) Non-communicable disease co morbidities and risk factors among tuberculosis
patients, Meghalaya, India- cross-sectional study to estimate the prevalence of tobacco, alcohol
use, hypertension and diabetes among tuberculosis (TB) patients in comparison to the non-TB
patients{2}. Shivani Chandra et.al (2014) Resurrecting social infrastructure as a determinant of
urban tuberculosis control in Delhi, India - The study explains how development of social
infrastructure impacts health and development outcomes, especially with respect to TB in urban
settings {3}. Jose M. Valderas et.al (2009) Defining Co morbidity: Implications for Understanding
Health and Health Services. - Mechanisms that may underlie the coexistence of 2 or more
conditions in a patient (direct causation, associated risk factors, heterogeneity, independence) are
examined, and the implications for clinical care considered {4}. M Muniyandi et.al (2008)
socioeconomic inequalities of tuberculosis in India - The association between poverty and
tuberculosis (TB) is well established and widespread {5}.

MATERIALS AND METHODS

Research questions:

1. What are the social determinants of Tuberculosis.?

2. What are the co morbidities with Tuberculosis.?

Aims and Objectives:

- To study the social determinants in Tuberculosis

- To study the co morbidities and treatment outcome

- To assess the potential impact of co morbidities as a risk factor for incident tuberculosis
 HYPOTHESIS

H01: There is no relation between socio economic status and Tuberculosis.

H02: There are no co morbidities with Tuberculosis.

 STUDY DESIGN: Cross sectional Study

 SETTING: TB Unit, Ernakulam General Hospital

 SAMPLING: Systematic sampling method

Systematic sampling is a probability sampling method where the elements are chosen from a target
population by selecting a random starting point and selecting other members after a fixed ‘sampling
interval’. Sampling interval is calculated by dividing the entire population size by the desired sample
size. In this study it is an appropriate method for sampling as the patient’s register is available and
each patient having a permanent OP number.

 SAMPLE: Tuberculosis patients in Ernakulam General Hospital TB unit

 SAMPLE SIZE: 80

 STUDY PERIOD: 2 Months

INCLUSION CRITERIA

 All Tuberculosis patients (Pulmonary and Extra pulmonary) coming for treatment at
Ernakulam GH TB unit during the study period
 Patients who willing to participate

EXCLUSION CRITERIA

 Those who are not willing to participate in this study

 Severely ill patients who can’t participate in interview

METHODS OF DATA COLLECTION

Primary data collection: Standardized structured questionnaire- Interview Method.

Secondary data collection: Journals, Research papers, available documents.

ANALYSIS OF DATA

Data entry and analysis by software’s like MS Excel and SPSS. The consent from authority and
participants will be obtained prior to the study.

EXPECTED OUTCOME MEAUSURMENT

 The influence of social determinants in Tuberculosis burden can be elicited.

 Co morbidities with Tuberculosis can be studied.

REFERENCES

1. Global Health Observatory (GHO) data- WHO- 2018

2. Addressing social determinants to end Tuberculosis- The Lancet- 2018
3. Bibha Marak- Non-communicable disease co morbidities and risk factors among tuberculosis
patients- 2016
4. Jose M. Valderas- Defining Co morbidity: Implications for Understanding Health and Health
Services- 2009
5. M Muniyandi- Socioeconomic inequalities of tuberculosis in India-2008
6. Shivani Chandra- Resurrecting social infrastructure as a determinant of urban tuberculosis control
in Delhi, India-2014
7. WHO- Global Tuberculosis report-2018

ACKNOWLEDGEMENT

I thank researchers, authors, publishers etc. for enlightening with the vast information which shaped my
thoughts for this study.

BUDGET

No funding from agencies and fund from outside involved.

ANNEXURE
 QUESTIONNAIRE

TITLE: Social Determinants and Co-morbidities of Tuberculosis Patients in Ernakulam General Hospital
TB Unit.

This study is being conducted on Social determinants and co-morbidities .Your responses will
be kept confidential. Your honest answer will be appreciated. Participation is not compulsory.
Thank you for responding and for your time.

Scholar: Jayakrishna Pai B Research guide: Dr. Shibu Puthenparambil

Mob.no:9447543025 Mobs. No: 9496161106
Email.ID: jayakrishnapai@gmail.com

DATA COLLECTION FORM

Case ID:

___________

1.Patient Name First: Last:_________________________

2.Age: Years/ Months/ Days Weight: kg Height: cm

3.Date of birth: (mm/dd/yyyy) / /

4. Sex:□ Male □ Female □ TG

5. Area: Tribal□ Rural□ Urban□ Urban Slum□
6. Marital Status: Un Married □ Married □ Divorced □

7. Occupation: Govt. employee □ Private employee□ Entrepreneur□ Daily labourer□

Other □

8.Socio-economic Status:

APL □ BPL□

10. Place of residence:

9. Is the patient keralite? Yes □ No□ Unknown □ Street address:

If No, state of birth: Year emigrated to Kerala City:

11.Type of treatment adherence – DOT/Family DOT/ICT supported, specify______/Other________

12.Symptoms:

13.Number of health care providers visited before diagnosis for current episode

14. Did the patient receive any Tb vaccination? Yes □ No□ Unknown□

15. Site of disease: Pulmonary Extra-pulmonary (specify:_____________)

16. Type of patient:

□New □Recurrent □Treatment after failure □Treatment after lost to follow

up □ Transferred in □Others, previously treated (specify)

17. Definition of case:

□Microbiologically confirmed
□Clinically diagnosed
18. Investigations: □ZN □ FM □CBNAAT □ Liquid C □Solid C

• Pre Treatment: Sample taken date:__/__/__ Reporting date: __/__/__

Test result:___________________ DST result:__________________

End of Intensive Phase: Sample taken date:__/__/__ Reporting date: __/__/__
Test result:___________________ DST result:__________________________

•End of treatment: Sample taken date:__/__/__ Reporting date: __/__/__

Test result:___________________ DST result:__________________________

19Other investigation:

•Chest X-ray:

•Other:

20. H/O of previous ATT months of treatment ______ months since end of last episode

21Source of treatment: □Public

22. Previous regimen:

23. Addiction related information:

•H/O tobacco use □Yes □No

 • Current tobacco user □Yes □No If yes, □ Smoking □Smokeless
Linked for cessation □Yes □No

If tobacco user, status of tobacco use at end of treatment: □Quit □Not quit

•H/O alcohol intake □Yes □No

If yes, linked for DE addiction □Yes □No

•Current alcohol user □Yes □No

Nutrition support Status:

BMI: □Underweight □Healthy Weight

□Overweight □Obese

Diet:

___________________
24No. of children less than 6yrs given chemoprophylaxis with details:

25. Comorbidities

•Diabetes Mellitus Status: Unknown □ Diabetic□

Non-Diabetic □

RBS FBS _____

•CLD □

•COPD □

•Hypertension : Unknown □ Known□

•HIV / AIDS : Negative □ Positive□ Unknown□

26.Date of initiation of intensive phase _______ Date of initiation of continuation phase
27. Regimen: New/Previously treated Dosage frequency: □Daily □Intermittent

28. Drug formulations: □FDC □Combipack □Loose drugs Drug packaging: □PWB □Strips

29. Weight Band: Adult: □25-39kg □40-54kg □55-69kg □≥70kg

30. Dosages: FDC/Combipack per day

31 Loose drugs

Dose

Pills

HRZES

32. Did the patient complete the regimen _______

33. Doses taken under direct observation Doses which was not observed_______

34.No. of missed doses during treatment_______

35.Duration of treatment

36. Reasons for missing doses: Retrieval action taken:

37.Outcome of retrieval action:

38.Post treatment follow up clinical &sputum(Results with date)

□Cured □Treatment Completed □Treatment Failure □Died

39.Treatment Outcome:

□Lost to follow up □Not evaluated □Treatment Success

 INFORMED CONSENT

Title of the study: Social Determinants and Co-morbidities of Tuberculosis Patients in Ernakulam
General Hospital TB Unit.

Purpose of the study:The study aims to assess the Social Determinants and Co-morbidities of
Tuberculosis Patients

Details of researcher: Jayakrishna Pai B, Centre for Professional and Advanced Studies [CPAS], SME,
Gandhinagar, Phone : 9447543025

I, …………………………………………………………………………………………………………………………………………….…………………

[Name and address of participant] here by voluntarily consent to participate in the research study on
Social Determinants and Co-morbidities of Tuberculosis Patients in Ernakulam General Hospital TB Unit.

I here state that I have understood the purpose of the study and I am participating on my own will .I also
understood that the information collected will be kept confidential.

Date:

Place: Signature of participant