SYNOPSIS

Frequency of Non-Adherence to previous treatment in

Relapse Tuberculosis Patients

BS MLT RESEARCH PROJECT

Submitted by:
ANEES UR RAHMAN
004-CMLT/BS-2015

SUPERVISOR
ARSLAN AHMED SALAM
Research Officer
PHRC CRC NIH
Islamabad
Introduction:
Tuberculosis (TB) is an infectious disease usually caused by Mycobacterium
tuberculosis (MTB) bacteria1.Tuberculosis generally affects the lungs, but can also affect other
parts of the body1.Most infections do not have symptoms, in which case it is known as latent
tuberculosis1. About 10% of latent infections progress to active disease which, if left untreated,
kills about half of those affected1. Treatment requires the use of multiple antibiotics over a long
period of time1. Antibiotic resistance is a growing problem with increasing rates of multiple
drug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) 1 .
Tuberculosis (TB) is one of the top 10 causes of death worldwide 2.

Presently, one-quarter of the world's population is thought to be infected with TB 2.

New infections occur in about 1% of the population each year3. In 2017, there were more than
10 million cases of active TB which resulted in 1.6 million deaths 4. This makes it the number one
cause of death from an infectious disease 4. More than 95% of deaths occurred in developing
countries, and more than 50% in India, China, Indonesia, Pakistan, and the Philippines 4.

Pakistan, with an estimated 510 000 new TB cases emerging each year and approximately
15 000 developing drug resistant TB cases every year, is ranked fifth among B high-burden
countries worldwide and it accounts for 61% of the TB burden in the WHO Eastern
Mediterranean Region5.In 2017 total number of deaths due to TB were 54000 in the country 6.

Relapse of tuberculosis (TB) is defined as re-emergence of clinical symptoms after

stopping anti-TB treatment, while this treatment appeared effective initially 7.Relapse TB is
major factor associated with drug resistance 7. The risk factors associated with relapse TB are
age, gender, race, duration of symptoms, lesion cavitation, extent of disease, diabetes mellitus,
alcoholism, HIV infection, delayed negative sputum conversion, treatment non-compliance, and
medication doses8. The rates of recurrence of TB has been found to vary in various studies from
0% to 14% in one study,9 whilst a study10 amongst South African miners gave a rate of 10.3
episodes per 100 person-years at risk during a follow-up period of 25.1 months.

Relapse of TB can occur in patients that are therapy-compliant, but the risk of relapse is
dramatically increased when patients are non-compliant 7. Poor adherence to treatment of
chronic diseases including TB is a worldwide problem of striking magnitude 11. However, patients
with TB are expected to have adherence levels greater than 90% in order to facilitate cure 12,13
The failure for cure increases the risk of development of relapse TB. In the developing countries
like Pakistan non-compliance to the treatment is thought to be one of major cause of relapse
TB.
OBJECTIVES:

 To study the effects of non-adherence to the treatment on tuberculosis patients.

 To study the relationship between non-adherence and relapse TB.

METHODOLOGY:
Study Design:
Crossectional descriptive study.
Study Settings:
This study will be conducted in National TB Reference Laboratory-National TB control
program Islamabad.
Duration of Study:
3 months, starting after the approval of synopsis.
Sample Size:
200 patients will be included in the study.
Sampling Technique:
Simple random technique.
Sampling Selection:
Inclusion Criteria:
All pulmonary tuberculosis patients who had successfully
taken the treatment of tuberculosis previously.
Exclusion Criteria:
Newly diagnosed patients will be excluded.
DATA COLLECTION PROCEDURE:
o After the approval data will be collected from the respective Laboratory
mentioned in the study settings. Sputum specimen from each selected patient
will be collected for Ziehel Neelsen (ZN) smear microscopy.
o A semi-structured questionnaire will be designed to collect the information from
the patients showing positiveZiehel Neelsen (ZN) smear microscopy.

DATA ANALYSIS PROCEDURE:

All the data collected, will be entered and analyze by using Microsoft excel
software.
FUTURE OUTCOMES:
 Helpful for respective authorities in development of TB management
policy
 Helpful to create general awareness among the masses.
REFERANCES:

1) "Tuberculosis Fact sheet N°104". WHO. October 2015.

https://web.archive.org/web/20120823143802/http://www.who.int/mediacentre/facts
heets/fs104/en/

2) "Tuberculosis Fact sheet ". WHO. September 2018. https://www.who.int/news-

room/fact-sheets/detail/tuberculosis

3) "Tuberculosis Fact sheet". World Health Organization 2002.

https://web.archive.org/web/20130617193438/http://www.who.int/mediacentre/facts
heets/who104/en/print.html

4) "Global tuberculosis report". World Health Organization 2018

https://www.who.int/tb/publications/global_report/en/

5) "country profile:pakistan". World Health Organization 2018

http://www.emro.who.int/pak/programmes/stop-tuberculosis.html

6) "country fact sheet:pakistan". World Health Organization 2018

https://extranet.who.int/sree/Reports?
op=Replet&name=/WHO_HQ_Reports/G2/PROD/EXT/TBCountryProfile&ISO2=PK&outt
ype=pdf

7) Relapse of tuberculosis versus primary tuberculosis; course, pathogenesis and

therapy in mice.de Steenwinkel JE1, de Knegt GJ, ten Kate MT, Verbrugh HA, Hernandez-
Pando R, Leenen PJ, Bakker-Woudenberg IA.
https://www.ncbi.nlm.nih.gov/pubmed/23266260

8) Risk factors for recurrence of tuberculosis*Pedro Dornelles PiconI; Sergio Luiz

BassanesiI; Maria Luiza Avancini CaramoriI; Roberto Luiz Targa FerreiraII; Carla Adriane
JarczewskiIII; Patrícia Rodrigues de Borba VieiraIV http://www.scielo.br/scielo.php?
script=sci_arttext&pid=S1806-37132007000500013&lng=en&nrm=iso&tlng=en

9) Cox H, Morrow M, Deustschmann P. Long Term Efficacy of DOTS regimes for

Tuberculosis: systematic review. BMJ. 2008;336(7642):484–487

10) Sonnenberg P, Murray J, Glynn JR, Shearer S, Kambashi B, Godfrey-Faussett P. HIV-1

and recurrence, relapse, and re-infection of tuberculosis after cure: a cohort study in
South African mineworkers. Lancet. 2002;359(9317):1618–1619.
11) Sabate E (2003) Adhernece to long-term therapies: Evidence for action. Geneva,
Switzerland: WHO.

12) Harries A, Maher D, Graham S (2004) TB/HIV:A CLINICAL MANUAL. Genva World
Health Organization 212 p.

13) Awofeso N (2008) Antituberculous medication side-effects constitute major factor

for poor adherence to tuberculosis treatment. Bulletin of WHO 86