Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
Name of the Candidate and Address Dr. P. VAMSEE KRISHNA
(in Block Letters)
S/O P.MALLAIAH,G-59/60,
1ST FLOOR, MADHURA NAGAR,
YOUSUFGUDA, HYDERABAD-500038
ANDHRA PRADESH
2
Name of the Institution
J.J.M. MEDICAL COLLEGE
DAVANGERE – 577 004, KARNATAKA
3
Course of Study and Subject
POSTGRADUATE DEGREE
M.D. GENERAL MEDICINE
4
Date of Admission to Course
31st MAY 2011
5
Title of the Topic
“STUDY OF BODE INDEX AS A
PREDICTOR OF SEVERITY AND
SYSTEMIC INVOLVEMENT IN
PATIENTS WITH COPD”
6
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Chronic obstructive pulmonary disease (COPD) is defined as a preventable
and treatable disease with some significant extra pulmonary effects that may
contribute to the severity in individual patients. Its pulmonary component is
characterized by airflow limitation that is not fully reversible1,2.
The pathogenesis and clinical manifestations of COPD are not restricted to
pulmonary inflammation and structural remodeling1. Rather, this disorder is
associated with clinically significant systemic alterations in biochemistry and
organ function. As in other chronic inflammatory conditions, weight loss,
muscle wasting, hypo proteinemia and tissue depletion are commonly seen in
COPD patients12. Selective wasting of fat-free mass coupled with impaired
respiratory and peripheral muscle function and a reduced capacity for exercise
occur in COPD patients3,5.
The severity of COPD is usually assessed on the basis of a single parameter
– forced expiratory volume in one second (FEV1)4. However the patients with
COPD have systemic manifestations that are not reflected by the FEV1. Hence a
multidimensional grading system that assessed the respiratory and systemic
expressions of COPD was designed to predict outcome in these patients.
The four factors that predicted the severity most were the body-mass index
(B), the degree of airflow obstruction (O) and dyspnea (D), and exercise
capacity (E), measured by the six-minute–walk test4,14. These variables were
used to construct the BODE index, a multidimensional 10-point scale in which
higher scores indicate a higher risk of death13,15.
This study emphasizes on the fact that BODE index can be used as a
valuable predictor of hospitalization and severity of systemic involvement in
patients with COPD.
6.2 Review of Literature
Chronic obstructive pulmonary disease (COPD) is a lung disease
characterized by chronic obstruction of lung airflow that interferes with normal
breathing and is not fully reversible. COPD is one of the leading causes of
morbidity and mortality worldwide and imparts a substantial economic burden
on individuals and society6.
Chronic obstructive pulmonary disease (COPD) was initially defined as ‘a
disease state characterized by chronic airflow limitation due to chronic
bronchitis and emphysema. Chronic bronchitis has been defined in clinical
terms as ‘the presence of chronic productive cough for at least 3 consecutive
months in two consecutive years. Other causes of chronic productive cough
must be ruled out’5.
Emphysema, on the other hand, has been defined by its pathologic
description: ‘11an abnormal enlargement of the air spaces distal to the terminal
bronchioles accompanied by destruction of their walls and without obvious
fibrosis’.
However the definition of COPD has undergone major revision. The new
GOLD guidelines and the ATS/ERS definition7 reflect these scientific advances:
“Chronic obstructive pulmonary disease (COPD) is defined as a preventable and
treatable disease with some significant extra pulmonary effects that may
contribute to the severity in individual patients3. Its pulmonary component is
characterized by airflow limitation that is not fully reversible. The airflow
limitation is usually progressive and associated with an abnormal inflammatory
response of the lung to noxious particles or gases”. While the new guidelines do
not specifically include chronic bronchitis and emphysema in the definition of
COPD, it is made clear that they are considered the predominant causes of
COPD.
The airflow limitation is caused by mixture of small airway disease
(obstructive bronchiolitis) and parenchymal destruction (emphysema) the
relative contribution of each varies from person to person.
The prevalence was found to increase with increasing age, especially in the
males, in those with more than 20 pack–yrs of smoking and in low income
subjects.
Risk factors include: Tobacco smoke8,9, Occupational dusts,7 organic and
inorganic Chemicals, Indoor and Outdoor Air Pollution, Low birth weight, Low
Socioeconomic Status, Severe childhood respiratory Infections10, Poor
nutritional status, Co morbidities.
6.3 Objectives of the Study:
1
To determine whether higher BODE index in chronic obstructive pulmonary
disease correlates with more years of cigarette smoking and more days of
hospitalisation.
2
To determine whether higher BODE index is associated with more severe
cardiac involvement.
3
To determine whether higher BODE index correlates with poor nutritional
status.
4
To determine the correlation between BODE index and the level of systemic
inflammation in patients with COPD.
7.
MATERIALS AND METHODS
7.1 Source of Data:
Minimum 100 patients, both male and female with symptoms suggestive of
COPD; over a period of 1 and half years, admitted in Bapuji Hospital and
Chigateri Government Hospital attached to J.J.M. Medical College will be
included in this study
7.2 Method of collection of Data (including sampling procedures if any):
Minimum 100 patients, with varying degrees of COPD admitted in
Bapuji Hospital and Chigateri Government Hospital will be studied using
random sampling methods over a period of 1 and half years.
Inclusion criteria:

Patients with symptoms suggestive of COPD as cases and patients who came for
master health check up as controls.
Exclusion criteria:

Spirometry proved bronchial asthma defined as an increase in the FEV1 of more
than 15 percent above the base-line value or of 200 ml after the administration
of a bronchodilator.

Recent myocardial infarction < 4months.

Unstable angina.

Congestive heart failure.

Inability to perform spirometry or 6 minute walk test.

Unrelated life threatening major illness.

Liver disease.

Patients with acute exacerbation
Study design:
It’s a cross sectional study to evaluate the BODE as an index for prediction
of hospitalization and severity of systemic involvement in patients with Chronic
Obstructive Pulmonary Disease Evaluation of BODE index will be done by clinical
examination for copd and other tests like BMI, FEV1/FVC, 6 min walk test, MMRC
dyspnea scale, ECG, Echo, CRP, LFT.
7.3 Does the Study require any investigations or interventions to be conducted
on patients or other humans or animals? If so please describe briefly.
Yes
Complete hemogram, ECG, Echo, 6 minute walking test, FEV1/FVC, CRP,
LFT
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8.
LIST OF REFERENCES:
1. Christie R. The elastic properties of the emphysematous lung and their clinical
significance. J Clin Invest 1934; 13: 295.
2. National Heart, Lung and Blood institute. Morbidity and mortality chart book on
cardiovascular, lung and blood diseases. Bethesda, Maryland: US department of
health and human services, public health service, national institute of health
accessed at http://www.nhlbi.nih.gov/resources/docs/chtbook.
3. Global initiative for chronic obstructive lung disease. Global strategy for the
diagnosis, management and prevention of chronic obstructive pulmonary
disease. 2007; available from www.goldcopd.com: accessed Oct 5, 2008.
4. Celli BR, Cote CG, Marin JM, et al. The body-mass index, airflow obstruction,
dyspnoea, and exercise capacity index in chronic obstructive pulmonary disease.
N Engl J Med 2004; 350: 1005–12.
5. Sidney S. Braman. Update on the ATS Guidelines for COPD. Medscape
Pulmonary Medicine. 2005; 9(1); 2005 Medscape.
6. Jindal SK, Aggarwal AN, Chaudhry K, Chhabra SK, D'Souza GA, Gupta D, et
al. A
multicentric study on epidemiology of chronic obstructive pulmonary
disease and its relationship with tobacco smoking and environmental tobacco
smoke exposure. Indian Journal of Chest Diseases and Allied Sciences 2006;
48(1): 23-9.
7. Balmes J, Becklake M, Blanc P, Henneberger P, Kreiss K, Mapp C, et al.
American Thoracic Society Statement: Occupational contribution to the burden
of airway disease. Am J Respir Crit Care Med 2003; 167(5): 787-97.
8. Anthonisen NR, Connett JE, Kiley JP, Altose, Bailey WC, Buist AS, et al.
Effects of smoking intervention and the use of an inhaled anticholinergic
bronchodilator on the rate of decline of FEV1. The Lung Health Study.JAMA
1994; 272(19): 1497-505.
9. Tager IB, Segal MR, Speizer FE, Weiss ST. The natural history of forced
expiratory volumes. Effect of cigarette smoking and respiratory symptoms. Am
Rev Respir Dis 1988; 138(4): 837-49.
10. Shaheen SO, Barker DJ, Shiell AW, Crocker FJ, Wield GA, Holgate ST. The
relationship between pneumonia in early childhood and impaired lung function
in late adult life. Am J Respir Crit Care Med 1994; 149(3 Pt 1): 616-9.
11. Finkelstein R, Fraser RS, Ghezzo H, Cosio MG. Alveolar inflammation and its
relation to emphysema in smokers. Am J Respir Crit Care Med 1995; 152:
1666–1672.
12. Weight loss and skeletal muscle dysfunction in CHRONIC OBSTRUCTIVE
PULMONARY DISEASE: P.S.Shankar, Lung India 2006; 23: 175-177.
13. ATS Committee on Proficiency Standards for Clinical Pulmonary Function
Laboratories. ATS statement: guidelines for the six-minute walk test. American
Journal of Respiratory Critical Care Medicine 2002; 166: 111-117.
14. Could PEFR Replace FEV1 In The Assessment Of COPD Severity using BODE
Index; R Manjula, DJ Christopher, T Balamugesh, V Jeyaseelan Department of
Pulmonary Medicine, Christian Medical College, Vellore.
15. Six-Minute Walk Test in Patients With COPD of Varying Severity and Its
Predictive Value for Adverse Outcome; Sudhir K. Agarwal, Saket Sharma,
Vivekanand Tiwari, and Manoj Meena, Institute of Medical Sciences, BHU,
Varanasi, India.
9.
Signature of the Candidate
10. Remarks of the Guide
11. Name & Designation(in block letters)
11.1 Guide
12
11.2
Signature
11.3
Co-Guide (If any)
11.4
Signature
11.5
Head of the Department
11.6
Signature
12.1 Remarks of the Chairman & the
Principal
12.2 Signature
GOOD STUDY.SHOULD HELP FOR
BETTER MANAGEMENT OF COPD
PATIENTS.
Dr. G. RAJASHEKARAPPA MD
PROFESSOR AND HEAD,
DEPT OF GENERAL MEDICINE,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
Dr. S.S. SAWAKAR MD
PROFESSOR,
DEPT OF GENERAL MEDICINE,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
Dr. G. RAJASHEKARAPPA MD
PROFESSOR AND HEAD,
DEPT OF GENERAL MEDICINE,
J.J.M.MEDICAL COLLEGE,
DAVANGERE-577004