· web viewtuberculosis has affected humanity since the beginning of the recorded time and is...

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA

SYNOPSIS

FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1 Name of the

candidate

Mr.RAMAPPA TALAWAR

2 Name of the

Institution

Diana College of Nursing

No. 68, Chokkanahalli,

Jakkur Post, Bangalore – 64

3 Course of Study and

Subject

Master of Science in Nursing

Medical Surgical Nursing

4 Date of Admission to

Course

27-07-2011

5 Title of the Topic

A study to assess effectiveness of structured teaching programme on knowledge regarding side effects of anti tuberculosis drugs among staff nurses in selected TB hospital at urban Bangalore, Karnataka.

1

6. Brief Resume of Intended Work

Introduction

In an age when we believe that we have tools to conquer most diseases, the ancient

scourage of tuberculosis (TB) still causes 2 million deaths a year world wide –more

than any other single infectious organism reminding us that we still have long way to

go. Even equipped with drugs to treat TB effectively, we haven’t managed to

eradicate this deadly infection.1

Tuberculosis has affected humanity since the beginning of the recorded time and is

associated with poverty, malnutrition, overcrowding, poor socio-economic status,

large family, industrialization.2

Tuberculosis is specific infectious disease caused by mycobacterium tuberculosis. it is

affect the lungs and causes pulmonary tuberculosis. It also affects intestine, meninges,

and bones, tissues of body, joints, lymph glands and skin.3

WHO estimates that largest number of new tuberculosis cases in 2008 occurred in

south East Asia Region, which accounted for 35% of incident cases globally.4

Tuberculosis is one of the most prevalent infectious diseases which causes death around

World. It is estimated by WHO that 1/3rd of the global population is infected with TB and

that 7-8 Million new cases of Tuberculosis occur each year.5

2

Tuberculosis occurs at any age, majority of cases are seen in 20-40 years. Almost

40% of population in India is infected with TB pathogen; every fifth new patient

World wide is living in this sub- content.6

In 2009, it is estimated that 1.7 Million people died of tuberculosis and there were

about 9.5 Million new cases detected.7

In India, every year approximately 1.8 Million persons infected by tuberculosis in

that 0.8 million are new smear positive highly infectious cases. Annual risk of

becoming infected with TB is 1.5%, 2 of 5 Indians are infected with TB bacillus.

Every day about 5000 people are affected by TB. Patients with infectious pulmonary

tuberculosis disease can infect 10-15 persons in a year. 2 persons die every 3 minutes,

more that 1000 people died every day, almost 0.5 Million die every year due to TB.8

Tuberculosis has been treated with combination therapy for over fifty years. Drugs are not

used singly (except in latent TB or chemoprophylaxis), and regimens that use only single

drugs result in the rapid development of resistance and treatment failure. The rationales for

using multiple drugs to treat TB are based on simple probability. The frequencies of

spontaneous mutations that confer resistance to an individual drug are well known: 1 in 10 for

EMB, 1 in 10 for STM and INH, and 1 in 10 for RMP.9

Active tuberculosis will kill about two of every three people affected if left untreated.

Treated tuberculosis has a mortality rate of less than 5%. The standard “short” course

treatment for tuberculosis (TB), is isonized, rifampicin (also known as rifampin in the US),

pyrazinamide, and ethambutol for two months, then isoniazid and rifampicin alone for a

further four months. The patient is considered cured at six months although there is still a

3

relapse rate of 2 to 3%). For latent tuberculosis, the standard treatment is six o nine months

of isoniazid alone. If the organism is known to be fully sensitive, then treatment is with

isoniazid, rifampicin, and pyrazinamide for two months, followed by isoniazid, rifampicin,

for four months. Ethambutol need not be used. All first-line anti-tuberculosis drug names

have a standard three-letter and a single-letter abbreviation:10

• Ethambutol is EMB or E,

• Isoniazid is INH or H,

• Pyrazinamide is PZA or Z,

• Rifampicin is RMP or R,

• Streptomycin is STM or S.

Major adverse reactions to antituberculosis drugs can cause significant morbidity, and

compromise treatment regimens for tuberculosis (TB). Among patients treated for active TB

we estimated the incidence, and risk factors, of major side effects from first-line anti-TB

drugs. Side effects, resulting in modification or discontinuation of therapy, or hospitalization,

were attributed on the basis of resolution after withdrawal, and/or recurrence with rechallnge.

Among 430 patients treated between 1990 and 1999, the incidence of all major adverse

effects was 1.48 per 100 person-months of exposure (95% confidence interval (95% CI), 1.31

to 1.61) for pyrazinamide, compared with 0.49 (95% CI, 0.42 to 0.55) for isoniazid, 0.43

(95% CI, 0.37 to 0.49) for rifampin, and 0.07 (95% CI, 0.04 to 0.10) for ethambutol.

Occurrence of any major side effect was associated with female sex (adjusted hazard ration,

2.5; 95% CI, 1.3 to 4.7), age over 60 years (adjusted hazard ratio, 2.9; 95% CI, 1.3 to 6.3),

birthplace in Asia (adjusted hazard ratio, 2.5; 95% CI, 1.3 to 5.0), and human

immunodeficiency virus-positive status (adjusted hazard ratio, 3.8; 95% CI, 1.05 to 13.4).

Pyrazinamide-associated events were associated with age over 60 years (adjusted hazard

ratio, 2.6; 95% CI, 1.01 to 6.6) ad birthplace in Asia (adjusted hazard ration, 3.4; 95% CI, 1.4

to 8.3), whereas rifampin-associated adverse events were associated with age over 60 years

4

(adjusted hazard ratio, 3.9; 95%, CI, 1.02 to 14.9) and human immunodeficiency virus-

positive status (adjusted hazard ratio, 8.0; 95% CI, 1.5 to 43). The incidence of

pyrazinamide-induced hepatotoxicity and rash during treatment for active TB was

substantially higher than with other first-line anti-TB drugs, and higher than previously

recognized.11

The main adverse effects of anti-TB drugs usually occur during the first two to three weeks of

treatment. The timely strict monitoring for and management of notified adverse effects are

therefore essential. If these side effects are not recognized in time and managed properly they

can lead to treatment interruption or can even be life-threatening. Proper monitoring has to be

carried out during the whole treatment course, including patient education, clinical

examination, laboratory tests, etc. Adverse effects are manageable in anti-TB treatment

provided that appropriate management approaches are applied, including altering dosages

when appropriate, ancillary drugs to treat adverse events, discontinuation of drugs if needed,

special training for staff on adverse events and standard protocols for registration. A patient-

centered, individualized approach to treatment support is a core element of all TB control

efforts.12

5

6.1 NEED FOR THE STUDY

According to World Health Organization’s annual report” Global tuberculosis control 2010’,

around 134.700 people die of tuberculosis daily. India is saddled with highest burden of TB-

With nearly 2 Million new cases recorded in 2009. Out of an estimated 1.3 Million people

who died of tuberculosis in 2008,the nation alone accounted for 2.8 lakh lives . Indias case

detection was around 67% while the estimated number of TB cases that had become Multi

drug resistant was 99,000 in 2009.13

Tuberculosis is one of the most prevalent infectious disease which cause death around the

world. It is estimated by the 1/3rd of the global population is infected with TB and that 7-8

Million new cases of tuberculosis occur each year. Approximately 1.75 Million deaths results

from tuberculosis in 2003.5

Tuberculosis morbidity refers to complications that have arisen during course of treatment.

Tuberculosis morbidities continue to be major health issues that need to be looked in to

critically. Not only for curative but also for preventive and promotive care. Approximately,

1.6 million deaths are attributable to adverse affects of tuberculosis annually. This is an

estimated 34.29% of cases of adversely affected by tuberculosis drugs every year. At least

38.10% of patients are suffering with adverse effects of tuberculosis drugs. At least 34.69%

are suffering from adverse effects of tuberculosis drugs. Many of the complications leading

to tuberculosis morbidity arise during the course of anti-tuberculosis drugs.

Severe hepato toxicity occurs in one out of every thousand cases treated, and is associated

with a high fatality rate of ~2.5%. Hepatitis is the usual clinical manifestation at this degree

of toxicity and the risk of acute liver failure is high. Spontaneous survival after acute liver

failure is <10%. The only treatment increases survival is liver transplantation (survival are is

more than 80%). The incidence of pyrazinamide induced hepato toxicity and rash during

6

treatment for active tuberculosis was substantially higher than with the other 1 st – line anti-

tuberculosis drugs, and higher than previously recognize. Adverse effects are manageable in

tuberculosis treatment provided that appropriate management approaches are applied,

including altering dosages when appropriate, ancillary drugs to treat adverse events,

discontinuation of drugs if needed, special training for nursing staff on adverse events in

standard protocols for registration. A patient-centered, individualized approach to treatment

support is a core element of all tuberculosis control of efforts.

Hepatotoxicity is the most common cause of iatrogenic disease in tuberculosis treatment.

Anti-tuberculosis drugs can induce various degrees of hepato toxicity, form a transitory

asymptomatic rise in transminase (which in extreme cases may lead to interruption of

tuberculosis treatment), to acute liver failure (ALF)(when hepatic encephalopathy occurs and

prothrombin time is <50%, usually leading to the need for liver transplantation or even death).

Hepatotoxicity due to isoniazid is most common. Pyrazenamide is the hepato toxic among

essential anti-tuberculosis drugs, in particular at doses of <30mg per kg per day.

In-depth interviews among both TB patients and local doctors indicate that adverse drug

reaction is a reason for treatment non-adherence. Fear of the risks of adverse drug reactions

leads some TB patients to interrupt treatment. Local health workers often cannot detect this

discontinuation of treatment due to the lack of an active adverse drug reaction surveillance

system under the current DOTS program.

India being a developing country with major population with illiteracy. There is a

indispensable need for creating awareness about tuberculosis.

For the above reason, The investigator personally felt that there is need to assess the

knowledge of staff-nurses regarding side effects of anti-tuberculosis drugs and its prevention

to take proper measures to protect from disease.

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6.2. REVIEW OF LITERATURE

Review of Literature provides with the current theoretical and scientific knowledge about a

particular problem and resulting synthesis of what is known and not known. Current

information is received by regularly searching the literature on topics of particular interest.

The review of literature in quantitative search is conducted to direct the planning and

execution of a study. The major literature is performed at the beginning of the research

process and a limited review provides a basic understanding of the study problem and

evidence hat the study conducted was appropriate as indicated by the current knowledge of

this problem.

• Review of literature related to knowledge on side effects of anti tuberculosis drugs.

• Review of literature related knowledge on management of side effects of anti tuberculosis

drugs.

• Review of literature related to knowledge on tuberculosis and its treatment.

• Review of literature related to tuberculosis conducted among staff nurses.

1) Review of literature related knowledge on side effects of anti tuberculosis drugs.

A study was conducted to anti tuberculosis drugs on oct 2010 the main objectives of

tuberculosis therapy are to cure the patients and to minimize the possibilities of transmission

of the bacillus to healthy subjects. Adverse effect of anti tuberculosis drugs or drug

interaction can make it necessary to modify or discontinue treatment. We describe the general

mechanism of action, absorption, metabolization and excretion of the drugs used to treat multi

drug resistant tuberculosis. We describe adverse drug reaction and interaction, as well as most

appropriate approach to special situation, such as pregnancy, breast feeding, kidney failure,

and liver failure.14

8

A study was conducted on antituberculosis drug-induced liver injury in chronic

hepatitis and cirrhosis on July 27,2010 ,to evaluate the incidence ,risk factors and

outcomes for antituberculosis (TB) drug induced liver injury (DILI) in patients with

chronic liver disease including cirrhosis. Fifty-eight (58%) patients had cirrhosis. Of

93 patients receiving one or more hepatotaxic anti-TB drugs, 18 (17%) experienced

DILI: 11 (24%) among 46 patients with chronic hepatitis and 7 (15%) among 46

patients with compensated liver cirrhosis (P=0.271). Independent risk factors for DILI

were female sex, number of hepatotoxic anti-TB drugs administered and baseline

ALP levels but not cirrhosis itself. Of the 18 patients with DILI, 13 (72%)

successfully completed anti-TB treatment after switching to less hetotoxic drug

regimens. The result was Hepatotoxic anti-TB drugs may be safely used in patients

with chronic liver disease including compensated cirrhosis if number of hepatotoxic

drugs used is adjusted approximately.15

A study was conducted to assess the Incidence of Serious Side Effects from First-Line Anti

tuberculosis Drugs among Patients Treated for Active Tuberculosis. Among 430 patients

treated between 1990 and 1999, the incidence of all major adverse effects was 1.48 per 100

person-months of exposure (95% confidence interval (95% CI), 1.31 to1.61) for

pyrazinamide, compared with 0.49 (95% CI, 0.42 to 0.55) for isoniazid, 0.43 (95% CI, 0.37 to

0.49) for rifampin, and 0.07 (95% CI, 0.04 to 0.10) for ethambutol. Occurrence of any major

side effect was associated with female sex (adjusted hazard ratio, 2.5; 95% CI, 1.3 to 4.7), age

over 60 years (adjusted hazard ratio, 2.9; 95% CI, 1.3 to 6.3), birthplace in Asia (adjusted

hazard ratio, 2.5; 95% CI, 1.3 to 5.0), and human immunodeficiency virus-positive status

(adjusted hazard ratio, 3.8; 95% CI, 1.05 to 13.4). Pyrazinamide-associated adverse events

were associated wit age over 60 years (adjusted hazard ratio, 2.6; 95% CI, 1.01 to .6.6) and

birthplace in Asia (adjusted hazard ratio, 3.4; 95% CI, 1.4 to 8.3), whereas rifampin-

9

associated adverse events were associated with age over 60 years (adjusted hazard ratio, 3.9;

95% CI, 1.02 to 14.9) and human immunodeficiency virus-positive status (adjusted hazard

ratio, 8.0; 95% CI, 1.5 to 43). The incidence of pyrazinamide-induced hepatotoxicity and

rash during treatment for active TB was substantially higher than with the other first-line anti-

TB drugs, and higher than previously recognized.12

A study was conducted with The aim of this study was to determine the current incidence of

side effects severe enough to cause intolerance of standard antituberculosis therapy with

isoniazid, rifampin and pyrazinamide in patients hospitalized as a result of pulmonary

tuberculosis. Five hundred and nineteen patients with proven pulmonary tuberculosis, who

initially received standard antituberculosis therapy, were retrospectively studied in the

department of infectious diseases in a teaching chest hospital. The incidence of severe side-

effects related to the therapy, which led to the definitive termination of one of the three-

standard drugs, was measured and the risk factors for intolerance were analysed. Final

termination of either isoniazid, rifampin or pyrazinamide because of severe side-effecs was

necessary in 121 of the 519 patients (23%). The most severe side effects leading to final

termination of one drug were hepatotoxicity (11%), exanthema (6%), ad arthralgia (2%).

Pyrazinamide showed more severe side-effects (15%) than isoniazid (7%) and rifampin

(1.5%). Significant risk factors for intolerance of the standard therapy following a

multivariate analysis were a history of hepatitis (odds ratio (OR) 3.4; 95% confidence interval

(95% CI) 1.6-7.6; p=0.0026) and an ago=60 years (OR 1.9; 95% CI 1.2-3.2; p=0.017). Both

of these risk factors were also significantly associated with the intolerance of pyrazinamide

(history of hepatitis: OR 2.5; 95% CI 1.4-4.3; p=0.0045; age=60 years: OR 2.1, 95% CI 1.3-

3.5; p=0.0029) but not of isoniazid and rifampin. The side-effects of standard

antituberculosis therapy are frequent in hospitalized patients aged = 60 years or with a history

of previous hepatitis, and are probably due to pyrazinamide.16

10

A study was conducted to assess the prognostic influence of pyrazinamide on the outcome of

fluminant or subfulminant liver failure caused by antituberculous therapy. Eighteen patients

with fulminant or subfulminant liver failure due to antituberculous therapy were studied.

Nine patients received isoniazid and rifampicin without pyrazinamide (group 1), and nine

patients received isoniazid and rifampicin together with pyrazinamide (group 2). The severity

of fulminant and subfulminant liver failure, as judged by the prevalence of coma and he

lowest level of factor V, was similar in the two groups. Spontaneous survival was greater in

group 1 (eight of nine) than in group 2 (two of nine) (P < .2). The authors conclude that

pyrazinamide co-administration was associated with an increased mortality in patients with

fulminant or subfulminant hepatitis occurring during antituberculous therapy. In these

patients, pyrazinamide administration and an interval of more than 15 days between the onset

of antituberculous treatment and jaundice, combined with grade III encephalopathy and factor

V below 20%, predicted death without liver transplantation.17

A prospective study was conducted with the objective to identify factors associated with

defaulting from or dying during antituberculosis treatment. Prospective study of a large

cohort of TB cases diagnosed during 2006-2007 by 61 members of the Spanish Society of

Pneumology and Thoracic Surgery. Predictive factors of completion outcome (cured plus

completed treatment vs. defaulters plus lost to follow-up) and fatality (died vs. the rest of

patients) were based on logistic regression, calculating odds ratios (OR) and 95% confidence

intervals (CI). Of the 1490 patients included, 29.7% were foreign-born. The treatment

outcomes were: cured 792 (53.2%), completed treatment 540 (36.2%), failure 2 (0.1%),

transfer-out 33 (2.2%), default 27 (1.8%), death 27 (1.8%), lost to follow-up 65 (4.4%), other

4 (0.3%). Completion outcome reached 93.5% and poor adherence was associated with:

being an immingrant (OR = 2.03; CI: 1.06-3.88), living alone (OR = 2.35; CI:1.05-5.26),

residents of confined institutions (OR = 4.79; CI:1.74-13.14), previous treatment (OR = 2.93;

CI:1.44-5.98), being an injecting durg user (IDU) (OR=9.51; CI:2.70-33.47) and treatment

11

comprehension difficulties (OR = 2.93; CI: 1.44-5.98). Case fatality was 1.8% and it was

associated with the following variables: age 50 or over (OR = 10.88; CI:1.12-105.01) retired

(OR = 12.26;CI:1.74-86.04), HIV-infected (OR = 9.93; CI:1.48-66.34), comprehension

difficulties (OR = 4.07; CI:1.24-13.29), IDU (OR = 23.59; CI:2.46-225.99) and Directly

Observed Therapy (DOT) (OR = 3.54; CI:1.07-11.77 this study reveals that Immigrants, those

living alone, residents of confined institutions, patients treated previously, those with

treatment comprehension difficulties, and IDU patients have poor adherence ad should be

targeted for DOT. To reduce fatality rates, stricter monitoring is required for patients who are

retired, HIV-infected, IDU, and those with treatment comprehension difficulties.18

A study was conducted to assess the side effects of streptomycin. A 42-years-old woman was

admitted because of cough, sputum, and fever. A chest roentenogram revelaed a nodular

density in the left upper lung field with satellite lesions compatible with tuberculoma.

Mycobacterium tuberculosis was detected from sputum. Five weeks after starting the

treatment with 0.4 g/day of isoniazid, 0.45 g/day of rifampicin, and 0.75 g/day of

streptomycin, she showed itching erythema in the trunk. The white blood cell count was

4.500/mm3 with 14% eosinophils, and serum transaminases were slightly increased (GOT

101 U/L, GPT 74 U/L). Although isoniazid and rifampicin were stopped, the erythema with

blood cell count reached 15,990/mm3 wth 68% eosinophils (10.810/mm3). Stimulation

indices measured wit the Lymphocyte stimulation test (LST) were 109% with rifampicin,

140% with isoniazid, and 275% with streptomycin, suggesting streptomycin-induced allergy.

After cessation of streptomycin, the symptoms gradually improved. After the reaction had

subsided, the treatment with isoniazid, rifampicin and ethambutol was resumed, but she

showed no further adverse reactions. LST seems to be very useful to identify the drug or

drugs responsible for he reactions occurred during the treatment by antituberculosis drugs.19

12

2) Reviews of literature related knowledge on management of side effects of anti

tuberculosis drugs.

A study was conducted on Apoptisis -indusing action of anti tuberculosis drugs on

2010.The influence of main antituberculosis drugs on in vitro Apoptosis of peripheral

blood lymphocytes from patients with pulmonary tuberculosis was researched. It was

shown that all the investigated drugs induced apoptic death of the lymphocytes in

vitro, that could result in disturbance of antigen specific response formation in

pulmonary tuberculosis. 20

A study was conducted on retrobulbar neuritis when EMB is taken for more than 2

months is 18% in subjects receiving greater than 35mg/kg/day, 5-6% with 25 mg/kg/day, and

less than 1% with 15 mg/kg/day. Two types of retro-bulbar neuritis have been described,

with involvement of either the central fibres (central-toxicity) or uncommonly the peripheral

fibres (peripheral toxicity) of the optic nerve. Symptoms and signs of central scotoma and

loss of perception of red-green colour. Peripheral toxicity may cause few visual symptoms

but there is peripheral constriction of visual fields on physical examination. In most

instances, the optic disc appears normal. The exact mechanism by which EMB produces

retro-bulbar neuritis is not known; it may be due to its ability tochelate zinc. In animal

studies, EMB has been shown to deplete zinc from the optic nerves. Unusual idiosyncratic

hypersensitivity with irreversible blindness occurring after six days of treatment with EMB 15

mg/kg/day has also been described. Apart from EMB, INH, though to a lesser extent, has

also been implicated in the development of visually related side effects. Thus, the potential

ocular toxicity of INH should not be overlooked. Recommendations on monitoring and

preventive measures for ocular toxicity duringanti-TB treatment have been made by various

authorities. Opinions do differ on the dose of EMB either throughout or during the initial

treatment phase, and the timing and periodicity of the use of visual tests. It would be useful

13

to summarise the existing data on these issues and lay down some guidelines for reference of

the chest clinic medical staff. 21

A study was conducted on Antituberculosis drug-induced hepatitis: risk factors, prevention

and management. Apart from infectious or viral hepatitis, other most common no-infectious

causes of hepatitis are alcohol, cholestatic, drugs and toxic materials. The most common

mode that leads to liver injuries is antituberculosis drug-induced hepatitis. The severity of

drug-induced liver injury varies from minor nonspecific changes in hepatic structure to

fulminant hepatic failure, cirrhosis and liver cancer. Patients receiving antitubercular durg

frequently develop acute or chronic hepatitis. The time required for the metabolites to reach

hepatotxic levels is much earlier with isoniazid plus rifampicin treatment than isoniazid alone

and this has been shown to be synergistic rather than additive. Antitugerculosis drug (ATT)-

inducible cytochrome P-4502E is constitutively expressed in the liver. Recent studies show

that polymorphism of the N-acetyltransferase 2 (NAT2) genes and glutathione-S-transferase

(GST) are the major susceptibility risk factors for ATT-induced hepatitis. The hepatic NAT

and GST are involved in the metabolism of several carcinogenic arylamines and drugs. The

NAT2 enzyme has a genetic polymorphism in human. N-acetyltransferase 2 genes have been

identified to be responsible for genetic polymorphism of slow and raid acetylation in humans.

Slow acetylators of NAT2 prove to develop more severe hepatotoxicity than rapid acetylators

making it a significant risk factor. Deficienc of GST activity, because of homozygous null

mutations at GSTM1 and GSTT1 loci, may modulate susceptibility to drug and xenobiotic-

induced hepatotoxicity. Polymorphisms at GSTM1, GSTT1 and NAT2 loci had been linked

to various forms of liver injury, including hepatocellular carcinoma.22

A study was conducted estimate survival probabilities and identify risk factors for death of

tuberculosis (TB) patients during treatment period. TB patients registered during May 1999

to December 2004 from a rural TB unit (TU) with a population of 580000 in Tiruvallur

14

district South India, formed study population. Life table and Cox’s regression methods were

used. Of them 3818 TB patients who were initiated on treatment, 96,94 and 97% of category

– I, II and III respectively, were surviving after completion of treatment. Higher death rates

were independently associated with patient’s age (45 years), previous history of treatment,

alcoholism and initial body weight (<35 kgs) are positive culture positive’ and 100% of

‘smear negative culture positive’ samples from tuberculosis suspects diagnosed on the basis

of other routine diagnostics and supporting clinical evidence, Seventeen samples were

positive only by PCR but based on clinical parameters only 7 were considered true positives.

The sensitivity of PCR was 91.5% compared to 51% for smear microscopy and 68% for

sputum culture. This was due to the fact that PCR could pick up bacterial DNA even from

saliva mixed sputum specimens, which are generally not considered appropriate for

microbiology. The specificity of PC (86%) was found to be lower than other than diagnostic

tests mainly due to lack of a suitable gold standard to assess its efficiency. This is an

important limitation in evaluation of the test. The survival probability was found to be similar

in all patients irrespective of categorization. Necessary actions need to be initiated in the

programme to improve body weight and abstain from alcoholism.23

A study was conducted to find out whether PZA has any influence on the course of

haemoptysis Methods One hundred and six patients of active pulmonary tuberculosis and

haemoptysis, having normal baseline coagulators profile, were included in this prospective

study. One half of them were given PZA containing anti-tuberculosis regimens (PZA group)

and the other half were prescribed non PZA containing regimens. (non PZA group). They

were managed conservatively ad followed up for a period of seven days. Blood loss during

therapy was moderate to massive in amount in majority (56.61%) of patients in the PZA

group as compared to non PZA group (35.84%) Though the mean duration of haemoptysis

was almost similar in both the groups (3.98 days in the PZA versus 4.12 days in the non PZA

group), but in patients in whom haemoptysis lasted for more than 4 days, in the non PZA

15

group, majority (62.50%) had minimal blood loss compared to the PZA group (48.27%)

Although PZA does not alter the mean duration of haemoptysis, but omission of PZA can

significantly reduce blood loss during therapy.24

3 Reviews of literature related to knowledge on tuberculosis and its treatment.

A study was conducted on a controlled trial of 6 months chemotherapy in pulmonary

tuberculosis 2 – 6 month regimens of isoniazid and rifampicin supplemented for the first 2

months by streptomycin and pyrazinamide (SHRZ6 regimen), or by ethambutol and

pyrazinamide (EHRZ6 regimen), were compared with a 9 month regimen of isoniazid and

rifampicin supplemented for the first 2 months by ethambutol (EHR9 regimen). All 444

patients who completed chemotherapy had negative sputum cultures by the end of treatment.

Of these, 373 have been followed for a minimum duration of 36 months after the end of

chemotherapy. Relapses have occurred in two of 119 SHRZ6 patients, four of 127 EHRZ6

patients and two of 127 EHR9 patients. These results demonstrate that the two 6 month

regimens are as effective as the currently recommended 9 month regimen. They are equally

well tolerated and have the advantages of being shorter and cheaper. The Research

Committee of the British Thoracic Society now recommends the use of either of the two 6

month regimens as an alternative to the currently recommended 9 month regimen.25

A study was conducted to determine the effectiveness, toxicity, and acceptability of a 6 month

antituberculous regimen compared with a 9 month regimen. A non blinded, unbalanced,

randomized, multicenter clinical trial. Twenty two tuberculosis clinics in public health

departments and hospitals in the United States. Patients were eligible if Mycobacterium

tuberculosis, isolated from sputum cultures, was susceptible to study drugs. Of 1451 patients

enrolled, 75% (617 of 823) assigned to the 6 month regimen and 71% (445 of 628) assigned

to the 9 month regimen were eligible. Patients took self-administered isoniazid and rifampin

16

daily for 24 weeks (6 month regimen) or 36 weeks (9 month regimen). In addition, patients

assigned to the 6 month regimen took self-administered pyrazinamide daily during the first 8

weeks, Patients on the 6 month regimen converted more rapidly than patients on the 9 month

regimen (94.6% compared with 89. 9% after 16 weeks of therapy, with a difference of 4.7%

[95% CI, 0.7% to 8.7%]) had similar rates of adverse drug reactions (7.7% compared with

6.4%, with a difference of 1.3% [95% CI, 0.0% to 4.6%]) had lower noncompliance rates

(16.8% compared with 29.2%, with a difference of 12.4% [95% CI, 6.8% to 6.8% to 18.0%])

and had similar relapse rates 96 weeks after completing therapy (3.5% compared with 2.8%,

with a difference of 0.7% [95% CI, 0.0% to 3.9%]). A significantly greater proportion of

patients assigned to the 6 month regimen successfully completed therapy (61.4% compared

with 50.6%: chi 2 = 11.976), this study suggested that this 6 month regimen is similar in

effectiveness, toxicity, and acceptability to the 9 month regimen for treating pulmonary

tuberculosis.26

A controlled clinical study was conducted to assess the drug regimens used in short-course

chemotherapy for pulmonary tuberculosis. An analysis is presented of the side effects which

occurred in 530 patients treated with 6 months chemotherapy for newly detected pulmonary

tuberculosis. Five treatment regimens wee used. The initial phase of treatment consisted of

daily isoniazid, rifampicin and ethambutol (HRE) or isoniazid, rifampicin, streptomycin and

pyrazinamide (HRRSZ) given for 2 months. The second phase of treatment consisted of

isoniazid and rifampicin given wice weekly (H2R2) or isoniazid, rifampicin and ethambutol

given daily (4HRE) or intermittently (H1R1E1 or H2R2E2) for 4 months. Side effects were

detected in 66 (12.4%) patients. Hepatotoxi reactions occurred in 48 (9%) patients, mainly of

a mild and transient nature and the majority were attributable to isoniazid. The ‘flu like’

syndrome occurred in only 2 patients both during the daily phase of treatment, and it was not

encountered in patients taking rifampicin intermittently (dose 600 mg). Inclusion of

pyrazinamide in the initial phase of 1 regimen did not result in an increase of frequency of

17

side effects. In 56% of patients on pyrazinamide the serum uric acid concentration was

elevated but there was no arthralgia. 27

A study was conducted to update readers on the clinical management of infections caused by

Mycobacterium tuberculosis, to provide a general description of the organism, culture and

susceptibility testing, and clinical manifestations of the disease, and to provide several aspects

of the treatment of he disease, including historical perspective, current approaches, and

research opportunities for the future Data regarding the epidemiology, clinical manifestations,

culture and susceptibility testing, and treatment of tuberculosis are cited. Specific attention

has been focused on the clinical management of patients with noncontiguous infection and

potentially contagious active disease (TB) caused by M. tuberculosis. The study reveled that

tremendous effort and far more funding will be required to eliminate TB in the US. The

selection of drug therapy must be based on the susceptibility data for each isolate. Multiple-

drug therapy must be continued for 6 to > or = 24 months, and patient adherence to prescribed

regimens must be verified in all cases of TB.28

• Review of literature related to tuberculosis conducted among staff nurses.

A study was conducted on Understanding level on tuberculosis among hospital nurses. This

research was aimed to examine “How much interest and recongnition do hospital nurses have

about tuberculosis control. “The Aichi Nursing Association cooperated with this research.

The results showed that 60% of tuberculosis ward nurses were more than forty years old, and

they have served more than ten years in TB word. The levels of understanding on

tuberculosis among nurses working in tuberculosis hospitals were much higher than those in

general hospitals. However, it is necessary to organize a collaboration system between

hospitals and public health center to improve TB case management.29

18

A study was conducted to assesses the level of knowledge and reported practices regarding

tuberculosis among health staff at basic health care facilities in a rural district in Vietnam. A

questionnaire consisting of 17 multiple-choice questions, 6 open question, and five case-

studies was completed by 253 health staff. Nearly half of the respondents (47%) answered at

least 17 out of 23 questions correctly. The mean knowledge score was 15.59 +_ 3.78 (range 5

– 23). The mean practice score was 2.03 +_ 1.28 (range 0-5). Health staff knowledge of

theoretical aspects was better than knowledge related to patient management. Even staff

members who had attended TB training courses had inadequate TB knowledge, particularly in

the area of TB control. District hospital staff reported surprisingly lower knowledge scores

than community health care staff. Practice competency related to the management of

tuberculosis patients during treatment course was low. The importance of targeted education

using multiple educational methods needs to be emphasized within the National Tuberculosis

Programme.30

A study was conducted to assess the knowledge of nurses regarding tuberculosis treatment.

The research, presented at the recent South African TB Conference in the coastal city of

Durban, found that some nurses who had been trained to handle MDR-TB demonstrated

similar levels of knowledge as those who were untrained. Some nurses tried to fill this

knowledge gap with reading and internet research, but many considered MDR-TB a rare

problem, even in KwaZula-Natal, which has the highest incidence of drug-resistant TB in he

country. Inadequate understanding of the disease led to poorly recorded patient histories and

failure to follow up on people who had been in close contact with MDR-TB patients, such as

house hold members. MDR-TB resistant to the two most common first-line TB drugs,

isoniazid and rifampicin, and can develop when patients do not complete their six-month

course of first-line TB treatment. Globally, about five percent of TB patients have the MDR

strain, but Mhlaba estimated that in South Africa around 14 percent of previously treated TB

patients later developed MDR-TB. The study also found that many nrses were unsure about

19

how to treat MDR-TB patients whose sputum still contained TB bacteria after three months of

treatment, and that a shortage of beds in specialized care centres made referrals problematic.

It recommended specific MDR-TB training for nurses, and that South Africa start treating

MDR-TB patients as outpatients, as in neighboring Botswana.31

A study was conducted to investigate nurses knowledge of, and compliance with the multi-

drug-resistant organism (MDRO) infection control guidelines. A survey questionnaire was

developed based on the institutional and national guidelines and was administered to a

convenience sample of 306 nurses in a university hospital. The mean score for knowledge

was 33.87 (percentage of correct answer: 82.61%). The percentages of correc answers for

basic concepts, route of transmission, hand washing/protective devices and environment

management were 74.27%, 94.29%, 92,90% and 75.54% respectively. The mean compliance

score was 4.15 (range: 1-5). The compliance scores for education, communication, contact

precaution, disinfection, surveillance culture, and hand washing were 3.29, 4.05, 4.20, 4.50,

4.40 and 4.48 respectively. Nurses indicated “lack of time (30.06%)’, “lack of means

(10.78%)” and “lack of knowledge (9.48%)” as reasons for noncompliance.32

20

STATEMENT OF THE PROBLEM:

A study to assess effectiveness of structured teaching programme on knowledge regarding

side effects of anti tuberculosis drugs among staff nurses in selected TB hospital at urban

Bangalore.karnataka.

6.3 OBJECTIVE OF THE STUDY:

• To assess the knowledge of the staff nurses regarding side effects of anti

tuberculosis drugs before intervention

• To assess the knowledge of the staff nurses regarding side effects of anti

tuberculosis drugs after intervention.

• To find out the association between post test knowledge scores of staff

nurses regarding side effects of anti tuberculosis drugs with their selected

demographic variables.

OPERATIONAL DEFINITIONS:

• Assess: It refers to the verbal response of the staff nurses to the knowledge

items in structured interview schedule regarding side effects of anti

tuberculosis drugs.

• Effectiveness: It refers to statistical difference between pretest and posttest

knowledge scores of staff nurses regarding side effects of anti tuberculosis drugs.

• Structured Teaching Programme: It refers to systematically organized

series of content on knowledge on side effects of anti tuberculosis drugs among

staff nurses.

21

• SIDE EFFECTS OF TUBERCULOSIS DRUGS: It refers to physiological

adverse reactions to the anti tuberculosis drugs such as streptomycine, isoniazid,

ethambutol, rifampicin.pyrazinamide.

ASSUMPTIONS:

• Staff Nurses may have some knowledge regarding the side effects of anti

tuberculosis drugs.

• Structured teaching programme may enhance the knowledge of staff nurses,

regarding side effects of anti tuberculosis drugs.

HYPOTHESIS:

Ho1: There is no significant difference between pretest and posttest scores of staff

nurses regarding side effects of Antituberculosis drugs.

Ho2: There is no significant association between post test knowledge scores

of staff nurses and their selected demographic variable.

LIMITATIONS:

The study is limited to

• The staff nurses working in the tuberculosis hospital.

• Knowledge on side effects of Anti tuberculosis drugs.

22

7. MATERIAL AND METHODS

7.1 Source of data

The Data will be collected from staff nurses

working in TB hospital urban

Bangalore,,Karnataka.

7.2 Method of Collection of

Data and Research Design.

Quasi experimental approach with one group pre

test and post test design will be used to collect

data on side effects of Antituberculosis drugs

among staff nurses.

Setting Tuberculosis hospital in urban Bangalore,

Karnataka.will be the setting for the study.

Population Staff nurses who are working in Tuberculosis

hospital in urban Bangalore,Karnataka.

Sample Staff nurses working in the TB hospital will be

sample in the study.

Sample size 50 Staff nurses will be taken to collect the data.

Sampling technique Purposive random sampling technique will be

used to select the sample based on sampling

criteria.

SAMPLING CRITERIA;

(a)Inclusion Criteria

The staff nurses

• Working in tuberculosis wards.

• Are the age group of 21-50 years of age.

• Are available at the time of data collection.

23

(b) Exclusion Criteria

The study excludes the staff nurses

• working in other wards.

• not willing to participate in the study

Tools of Research

The Investigator himself will collect the data

from staff nurses by using structured interview on

side effects of Antituberculosis drugs.

Method of Collection of Data Permission will be obtained from concerned

authorities to collect the data. Further consent

will be taken from every subject and

confidentiality will be maintained. The data will

be collected by the investigator himself.

Data Analysis, Data

Presentation

The collected data will be analyzed by using

descriptive and inferential statistical. Chi square

test will be used to find the association between

knowledge and selected demographic variables.

The findings will be presented in the form of

table, diagram and graphs

24

7.3 Does the study require any investigation or intervention to be conducted on staff nurse of other humans or animals? If describe briefly. Yes the study will be conducted on adults at selected at staff nurses working in hospital, Bangalore, 7.4 Has ethical clearance be obtained from your institution in case of 7.3?

Yes, informed consent will be obtained from concerned subjects and authority of selected hospital Bangalore.

Ethical committee

25

Title of the topic

A study to assess effectiveness of

structure teaching programme on

knowledge regarding side effects of

anti tuberculosis drugs among staff

nurses in selected TB hospital at

urban Bangalore, Karnataka.

Name of the Candidate Mr. RAMAPPA TALAWAR

Course of study and subject Master of Science in Nursing

Medical – Surgical Nursing

Name of the guide

Prof. Vasantha Chitra.D

Head of the Department

Department of Medical Surgical Nursing

Diana College of Nursing Bangalore – 64.

Ethical committee APPROVED

Members of Ethical Committee:

26

• Prof. Veda Vivek

Principal and HOD

Department of Community Health Nursing


• Prof. Elizabeth Dora


Department of Child Health Nursing


• Prof. Kalaivani


Department of Obstetrics and Gynecological Nursing


• Prof. Vasantha Chitra.D




• Prof. Kalai Selvi.S


Department of Psychiatric Nursing

Diana College of Nursing Bangalore – 64

• Prof. Rangappa

Biostatistician, Bangalore

8. List of references

27

1. David perlin.Ph,D. Excerpted from the complete idiots Guide to dangerous Deases

and Epidemics 2002.

2. Orcace A,present epidemiology of tuberculosis prevention and control

programmes.2011 march;2uppl.1;2-7

3. Brunner Siddharathas, text book of medical surgical nursing ,10th

edition ,Lippincott Williams Publication;2006

4. WHO global TB report 2010.

5. WHO TB fact sheet no 104 ,April 2005.

6. B T Basavanthappa, Community Health Nursing ,2nd edition, Jaypee Publications;

2008.

7. WHO global Report 2010.

8. WHO global Report 2010

9. David HL, Probability distribution of drug-resistant mutants in unselected

populations of Mycobacterium tuberculosis “Applied microbiology

1970,20(5):P.NO,810-4

10 .http://en.wikipedia.org/wiki/Tuberculosis-treatment

11. .Daphne Yee, Chantal Valiqette, Dick Menzies Incidence of Serious of Side

Effects From First-Line Antituberculosis Drugs among patients Treated for Active

Tuberculosis American Journal of Respiratory and Critical Care Medicine Vol 167.

PP.2003.P.NO:1472-1477.

12.Richard Zaleskis , adversa Effects of Anti-tuberculosis Chemotheraphy Euroean

Respiratory Disease 2006 Published: October 2008.

13. Machan, Epidemiology of TB ,Inter J Epi ,2008;38(4): 1018-2025

14. .J Bras Pneumol. 2010 Oct; 36 (5): 641-56

15. j Infect. 2010 Oct ; 61(4):323-9. Epub 2010 Jul 27

28

16. T Schaberg, K Rebhan and, H Lode Risk factors for side-effects of isoniazid,

rifampin and pyrazinamide in patient hospitalizedfor pulmonary tuberculosis eropean

respiratory journal October 1,1996 vil 9.no 10 p.no:2026-2030.

17. Durand F, Bernuau J, Deleterious of pyrazinamide on the outcome of patient with

fulminant or subfulminant or subfulminant liver failure durins antitubeculous

treatment including isoniazid, Hepatology(Baitmore,Md) 1995 Apr:21(4):p.no:929-

32.

18. Joan A Caylal,, Teresa Rodrigo, Fafael Vidal, Jose M Garcia, Rafael Blanquer et

all tuberculosis treatment Adherence and fatality in span Respiratory research 8 July

2009.

19. MatsuzawaY,A case of pulmonary tuberculosis associated with sever skin

eruption, prominent eosinophilia,and liver dysfunction induced by streptomycin

kekkaku1992 May;67(5):P.NO:413-7.

20. Antibiot Khimioter. 2010; (11-12 ) :25-9

21 . http://ajrccm.atsjournals.org/cgi/reprint/172/2/250.pdf

22. Hussain Z,Kar P, Antituberculosis drug-induced hepatitis: risk factors, prevention

and management, Indian journal of experimental biology, 2003

Nov;41(11):P.NO:1226-32.

23. Vasantha M,. G. Gopi and R. Subramani Survival of tuberculosis patients treated

under DOTS in a rural Tuberculosis Unit,8 Indian.J Tuberc 2008;55:P.NO:77-83.

24. Jain Sudeep N.K, banerjje,S, Pyrazinamide therapy and severity of haemoptysis

indian Journal of Tuberculosis 2004;:P.NO:213-218

25. http://www.ncbi.nlm.nih.gov/pubmed/6386028

26. Combs DL, O`Brien RJ, Tuberculosis Short Course Chemotherapy Trial

21:effectiveness,toxicity,and acceptability

29

27. Zierski M, and E,Bek tubercle and Lung disease volume 61 issue 1, Germany

March1980,P.No:41-49

28. Peloquin CA: Berning SE Infection caused By Mycobacterium Turberculosis: the

Annals Of pharmacotherapy, 1994 Jan:28(1):72-84.

29. M Dossing. J T Wilke, D S Askgaard,B Nybo, Liver injury during

antituberculosis treatment: an 11-year study. Tuber Lung

Dis.1996aug;77(4):P.NO335-40.

30. Nguyen Phuong Hoaab, Vinodkumar Diwanb, Anna Eva-Karin Thorsonb, a

survey of knowledge and reported practices among health staff. Health policy national

Hospital of tuberculosis and respiratory diseases,10 February 2004.

31. Southafrica:Poor MDR-TB knowledge among nurses, Plus News 2010-06-24.

32. Jiyeon Kang Jinwan Cho, Yujung J Korean Acad Nurs:2009Apr;39(20):186-197.

Published online 2009 April 28.

9. Signature of Candidate

30

10.Remarks of the guide There is a great need to Assess the structured

teaching programme on side effects of

Antituberculosis drugs among staff nurses in

selected urban hospitals, Bangalore, Karnataka.

11.1 Name and Designation Of

Guide.





11.2 Signature

11.3 Head Of Department





11.4 Signature

12.1 Remarks of the Principal The study is feasible to conduct and will be

beneficial to nursing profession and Med-Surgery.

Hence permitted to conduct study.

12.2 Signature

31

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