SYNOPSIS (RESEARCH PROPOSAL) FOR THESIS

FOR
M.D. IN PAEDIATRICS
SESSION : 2019-2022

PROPOSED TITLE FOR THE THESIS:

“A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULLNESS OF ACUTE ILLNESS OBSERVATION SCALE (AIOS) IN
COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED IN SNM
WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL”
BY:
DR. RAVEESH KUMAR
POST GRADUATE TRAINEE
DEPARTMENT OF PAEDIATRIC MEDICINE
BURDWAN MEDICAL COLLEGE AND HOSPITAL

GUIDE:
PROF. (DR) KAUSTAV NAYEK
DEPARTMENT OF PAEDIATRIC MEDICINE
BURDWAN MEDICAL COLLEGE AND HOSPITAL
To
The Dean
The West Bengal University of Health Sciences
Salt Lake, DD-36, Sector-1,
Kolkata 700064

Sub:Prayer for approval of research proposal (synopsis) for M.D. Paediatrics session 2019-22

Study Name:” A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULLNESS OF ACUTE ILLNESS OBSERVATION SCALE
(AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED
IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL”

Respected Sir,
I am hereby presenting the above mentioned Clinical Research Protocol for favour of your review and approval.
The proposed study is an Institution based prospective observational study. The proposed study has been 9
approved by Ethical Committee of Burdwan Medical College and Hospital.
I will be highly grateful for your kind consideration and due approval.
Thanking You,
Yours sincerely
Date:
Place: (Dr.Raveesh Kumar)
Post Graduate Trainee,
Department of Paediatrics
Burdwan Medical College and Hospital

Enclosed:
1. Synopsis of thesis work
2. Approval letter of Ethical Committee
3. Copy of Demand Draft
To
The Principal
Burdwan Medical College and Hospital,
Burdwan,
West Bengal

Sub:PROPOSAL FOR CLINICAL RESEARCH PROTOCOL.

Study Name:” A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULLNESS OF ACUTE ILLNESS OBSERVATION
SCALE (AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS
ADMITTED IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL”

Respected Sir,
I am hereby presenting the above mentioned Clinical Research Protocol for favour of your review and approval.
The proposed study is an Institution based prospective observational study.
The detailed protocol along with the informed consent documents,case report form and other relevant
documents are attached. Should any further information be needed, I will be obliged to provide the same.
Thanking You.
Yours Sincerely

(Dr.Raveesh Kumar)
Post Graduate Trainee
Department of Paediatrics
Burdwan Medical College and Hospital

Encl: As stated

Signature of Guide:

Signature of Head of Department:

To
The Chairman,
Ethical Committee,
Burdwan Medical College and Hospital,
Burdwan,

Sub : PROPOSAL FOR CLINICAL RESEARCH PROTOCOL.

Study Name:“A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULLNESS OF ACUTE ILLNESS OBSERVATION SCALE
(AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED
IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL”

Respected Sir,
I am hereby presenting the above mentioned Clinical Research Protocol for favour of your review and approval.
The proposed study is an Institution based prospective observational study.
The detailed protocol along with the informed consent documents,case report form and other relevant documents
are attached. Should any further information be needed, I will be obliged to provide the same.
Thanking You.
Yours Sincerely

(Dr.Raveesh Kumar)
Post Graduate Trainee
Department of Paediatrics
Burdwan Medical College and Hospital

Signature of Guide:

Signature of Head of Department:

To
The Chairman,
Scientific Advisory Committee,
Burdwan Medical College and Hospital,
Burdwan,

Sub : PROPOSAL FOR CLINICAL RESEARCH PROTOCOL.

Study Name:“A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULLNESS OF ACUTE ILLNESS OBSERVATION SCALE
(AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED
IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL”

Respected Sir,
I am hereby presenting the above mentioned Clinical Research Protocol for favour of your review and approval
. The proposed study is an Institution based prospective observational study.
The detailed protocol along with the informed consent documents,case report form and other relevant documents
are attached. Should any further information be needed, I will be obliged to provide the same.
Thanking You.
Yours Sincerely

(Dr.Raveesh Kumar)
Post Graduate Trainee
Department of Paediatrics
Burdwan Medical College and Hospital

Signature of Guide:

Signature of Head of Department:

 A.SUMMARY

1. A. NAME OF CANDIDATE: Dr. Raveesh Kumar

DESIGNATION: Post- Graduate trainee, Department of Paediatrics,
Burdwan Medical College and Hospital

B. PLACE OF PROPOSED RESEARCH WORK: SNM Ward of Department of Paediatrics,

Burdwan Medical College and Hospital

C. BROAD AREA AND SPECIFIC AREA: Clinical area; Paediatric Medicine

2.A. NAME OF PROPOSED SUPERVISOR: Prof. (Dr.) Kaustav Nayek

DESIGNATION: Professor, Department of Paediatrics,
Burdwan Medical College and Hospital

3.PROPOSED TITLE OF RESEARCH: A PROSPECTIVE OBSERVATIONAL STUDY ON THE

USEFULNESS OF ACUTE ILLNESS OBSERVATION SCALE (AIOS) IN
COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN
AGED 2 MONTHS TO 59 MONTHS ADMITTED IN SNM WARD OF
BURDWAN MEDICAL COLLEGE AND HOSPITAL.

4. OBJECTIVE OF PROPOSED RESEARCH: To see the usefulness of AIOS in predicting illness

Severity and to determine the clinical outcome of
Community- Acquired Pneumonia
5. BACKGROUND OF PRESENT STUDY:

Community Acquired Pneumonia can be defined clinically as the presence of signs and
symptoms of Pneumonia in a previously healthy child due to an infection which has been
acquired outside hospital. It is the leading cause of death globally among children younger
than 5 year, accounting for an estimated 9,20,000 deaths each year.
Children with CAP may present with fever, tachypnea, increased work of breathing
accompanied by intercostal , subcostal and suprasternal retractions, nasal flaring and
use of accessory muscles.
Despite substantial gains over the past 15 year, in developing countries less than two-thirds
of children with symptoms of pneumonia are taken to an appropriate care giver, and fewer
than half receive antibiotics.
6. METHODOLOGY:
A total of 90 clinically diagnosed Pneumonia Patients will be selected .
According to the Hospital data, on an average admission of 50 patients
daily in the SNM ward of BMCH, we will have about 18250 admissions in
an year,out of which average 730 patients will have clinically diagnosed
pneumonia. By this data we will be having 6% prevalence of pneumonia
cases. These patients will be evaluated on the basis of Acute Illness
Observation Scale.

7. EXPECTED OUTCOME OF THE STUDY:

AIOS is a simple , yet quite useful scale in
assessment of illness severity and can act as a
prognostic marker for guiding treatment protocols.
 B.OUTLINE OF PROPOSED RESEARCH TOPIC:

1. PROPOSED TOPIC OF RESEARCH: A PROSPECTIVE OBSERVATIONAL STUDY ON THE

USEFULNESS OF ACUTE ILLNESS OBSERVATION SCALE (AIOS) IN
COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN
AGED 2 MONTHS TO 59 MONTHS ADMITTED IN SNM WARD OF
BURDWAN MEDICAL COLLEGE AND HOSPITAL

2:.OBJECTIVE OF RESEARCH:To see the usefulness of AIOS in predicting illness

Severity and to determine the clinical outcome of
Community- Acquired Pneumonia

3.RESEARCH HYPOTHESIS:Acute Illness Observation Scale is a very simple, yet very

Powerful predictor of severity of illness and can be helpful
In predicting the clinical outcome of pneumonia
4. BACKGROUND OF RESEARCH:

A. RATIONALE OF STUDY: Pneumonia is the leading cause of cause- specific

Infectious mortality among children younger than
5 year of age . Hence it is important to predict the
Illness severity , so as to guide the treatment of
Patients

B. INTRODUCTION :
Global distribution of cause-specific infectious mortality among children younger than age 5 yr in 2015
( from WHO and Maternal and Child Epidemiology Estimation Group estimates, 2015) :
1. Pneumonia = 33%
2. Diarrhea = 19%
3. Neonatal Sepsis = 15%
4. Malaria = 11%
5. Measles = 4%
6. Meningitis = 3%
7. HIV/ AIDS = 3%
8. Other Infections = 12%
Streptococcus Pneumoniae is the most common bacterial pathogen in children 3 week to 4 year of age,
whereas Mycoplasma Pneumoniae and Chlamydophila Pneumoniae are the most frequent pathogen in
children age 5 yrs or older.
Viral pathogens are the most common causes of lower respiratory tract infections in infants and children
older than 1 month but younger than 5 yrs of age. Viruses can be detected in 40-80 % of children with
pneumonia. RSV and Rhinoviruses are the most commonly identified pathogens.
C. REVIEW OF LITERATURE: P L McCarthy proposed the Acute Illness
Observation Scale in 1982 In his publication titled- “ Observation Scales
To identify serious illness in febrile children.”

Acute Illness Observation Scale: composition and score description:

OBSERVATION NORMAL MODERATE SEVERE
ITEM IMPAIRMENT IMPAIRMENT

1. QUALITY OF CRY STRONG WITH NORMAL WHIMPERING OR WEAK OR

TONE OR CONTENT AND SOBBING MOANING OR
NOT CRYING HIGH PITCHED
2. REACTION TO PARENT CRIES BRIEFLY THEN STOPS CRIES OFF AND ON CONTINUAL CRY
STIMULATION OR CONTENT AND NOT OR HARDLY
CRYING RESPONDS
3. STATE VARIATION IF AWAKE THEN STAYS EYES CLOSE BRIEFLY WILL NOT ROUSE
AWAKE OR IF ASLEEP THEN AWAKENS, OR OR FALLS TO
AND STIMULATED, THEN AWAKENS WITH SLEEP
WAKES UP QUICKLY PROLONGED STIMULATION
4. COLOR PINK PALE HANDS, FEET OR PALE OR BLUE
ACROCYANOSIS OR ASHEN OR
MOTTLED
5. HYDRATION SKIN NORMAL AND SKIN, EYE NORMAL SKIN DOUGHY
EYES , MOUTH MOIST AND MOUTH DRY OR TENTED AND
SUNKEN EYE
DRY MOUTH
6. RESPONSE TO SOCIAL SMILES OR ALERTS BRIEF SMILE OR DULL,
OVERTURES ALERTS BRIEFLY EXPRESIONLESS
OR NO ALERTING
C. EXPECTED OUTCOME OF THE STUDY: AIOS is a simple , yet quite useful scale in
assessment of illness severity and can act as a
prognostic marker for guiding treatment protocols
5. METHODOLOGY:

TYPE OF STUDY: Hospital-based observational study

STUDY DESIGN: Cross-sectional

STUDY AREA: SNM Ward of Burdwan Medical College and Hospital

STUDY TIMELINE:
Preparatory Phase= 1st December 2019 to 31st December 2019
Data Collection= 1st January 2020 to 31st December 2020
Data Analysis Phase= 1st January 2021 to 30th April 2021
Presentation and report writing phase= 1st May 2021 to 31st July 2021

SAMPLE POPULATION: According to the Hospital data, on an average admission of 50 patients daily in
the SNM ward of BMCH, we will have about 18250 admissions in an year, out of which average 730
patients will have clinically diagnosed pneumonia. By this data we will be having 6% prevalence of
pneumonia cases.

SAMPLE SIZE: A total of 90 clinically diagnosed pneumonia patients are selected (According to study
population and a prevalence of 6%)
SELECTION CRITERIA:

a) INCLUSION CRITERIA- 2 month to 59 months old both male and female patients with
respiratory tract infection presenting with tachypnoea , nasal flare,
cough and cold, difficulty in breathing, chest in-drawing, grunting,
with or without fever and chest X-ray suggestive of Pneumonia.

b) EXCLUSION CRITERIA- 1. Children aged <2 months or >5years

2. Children with associated congenital heart diseases, active TB,
Neoplasms, Acute Bronchiolitis, HIV/ AIDS, Bronchiectasis,
Sickle cell disease, Cystic Fibrosis, Foreign body.
3. Patients whose parents do not give consent.
DATA COLLECTION AND INTERPRETATION :

The study will be carried out in children, both male and female, aged 2 months to 59 months
old. The cases will be selected based on the clinical diagnosis of Pneumonia through full history
taking, thorough clinical examination including general and local examination and radiological
work up (conventional chest X-ray ).

6.STATISTICAL ANALYSIS: Appropriate statistical methods will be followed.

7.ETHICAL CLEARANCE : The research proposal along with other relevant documents will be submitted
before institutional ethical committee for review of approval. This is an observational study, no
interventional approach will be taken during the course of study.

8.WORK PLAN :
a) review of literature, protocol presentation- 1 month
b) collection of data – 1 year
c) analysis of data – 4 months
d) report writing – 3 months
REFERENCES:

1. McCarthy PL, Sharpe MR, Spiesel SZ et al. Observation scales to identify serious illness in febrile children. Paediatrics
1982: 70: 802-809
2. Levels and Trends in Child Mortality: Report 2013; Estimates developed by the UN Inter-Agency Group for Child Mortality
Estimation
3. Statistical snapshot child mortality. UNICEF :2013. WHO Publication
4. Committing to Child Survival: A Promise Renewed. Progress Report UNICEF: 2012
5. Armon K , Stephenson T , Gabriel V, et al. Determing the common medical problems presenting to an accident and
emergency department.
6. Pneumonia: the forgotten killer of children . The United Nations Children’s Fund
7. British Thoracic Society Guidelines for the management of community acquired pneumonia in children: update 2011
8. Gaston B. Pneumonia. Paediatric Rev 2002-23:132-40
9. Nelson Textbook of Pediatrics: 21st edition Volume II
10. Integrated Management of neonatal and Childhood Illness, physician’s handbook
11. O.P. Ghai Textbook of Pediatrics, 9th edition, 2019
12. Smyth A, Carty H,Hart CA. Clinical predictors of hypoxemia in children with pneumonia. Ann Trop Paediatr
1998: 18: 31-40
 PATIENT CONSENT FORM

NAME OF THE STUDY: A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULNESS OF ACUTE ILLNESS OBSERVATION
SCALE (AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS
ADMITTED IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL

I, Mr/ Mrs. ________________________________________________________

S/D/W of ________________________________________________________
Resident of _______________________________________________________________________________________________
_____________________________________________________________ Aged _______________________ Years
Hereby declare that I am voluntarily giving my consent to participate in the study titled “………………………….”
I have been explained to my full satisfaction in my own language about the procedure involved in the study along with my
right to refuse to participate in the study at any time during the course of the study. My refusal however is not going to affect
my right to receive the treatment of my illness from the department.
I do hereby declare that I will provide medical history of the disease, undergo clinical examination and allow collection of
necessary clinical material. I also declare that no one will be responsible for any adverse effect occurring during this period.
I have also been informed to contact Dr. ………………………………. (MD, PGT ……………………………………..), Burdwan Medical College
& Hospital, Burdwan (Mobile No – ……………………………………..) in case of any emergency arising during the course of the study.

Name of the declarant: _____________________________________________________

Signature/ L.T.I. of the declarant: ________________________________________
Dated: _______________________________ Place: Burdwan Medical College, Burdwan
Name of Witness: ____________________________________________________________
Signature/ L.T.I of the witness: ____________________________________________
Dated: ________________________ Place: Burdwan Medical College, Burdwan
Name of the investigator: Dr. …………………………………….
Signature of the investigator: _______________________________________
Dated: ________________________ Place: Burdwan Medical College, Burdwan
 ররোগীর সম্মতি ফর্ ম

অধ্যয়নের োম: A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULNESS OF ACUTE ILLNESS OBSERVATION SCALE
(AIOS) IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED
IN SNM WARD OF BURDWAN MEDICAL COLLEGE AND HOSPITAL

আমম শ্রী/ শ্রীমতী _____________________________________________________________

পুঃ/স্ত্রী __________________________________________________________________
ঠিকাো _____________________________________________________________________
_______________________________________________________ বয়স __________ বছর __________
এতদ্বারা আমম সম্মমত জাোচ্ছি যে আমম “ ................................................................” শীর্কষ সমীক্ষায় যেিায় অংশগ্রহণ
করনত সম্মমত জাোচ্ছি।
এই সমীক্ষার পদ্ধমত সমনে সকল চ্ছজমেস মবস্তামরত ভানব আমানক আমার মেনজর ভার্ায় সপূণ স ষ ন্তুঠিজেক বযাখ্যা যেওয়া
হনয়নছ এবং এই সমীক্ষা চলাকালীে যে যকাে সময় আমার অংশগ্রহণ যেনক মবরত োকার অমধ্কার োকনব। েমেও আমম
অংশগ্রহনণ মবরত হনলও আমার যরানের মচমকৎসা করানোর সম্পূণ অ ষ মধ্কার োকনব।
আমম আরও জাোচ্ছি আমম আমার যরানের ইমতহাস, সমস্ত পূব প ষ রীক্ষা-মেরীক্ষা সমনে জাোনবা এবং পরীক্ষার জেয
য্য়াজেীয় চ্ছজমেস সংগ্রনহর সম্মমত যেনবা। আমম আরও জাোচ্ছি এই সময়কানলর মনধ্য আমার উপর েমে যকাে মবপরীত
্ভাব পনর, তার জেয যকউ োয়ী োকনব ো।
আমানক এও জাোনো হনয়নছ যকানো জরুরী ্নয়াজনে ডাুঃ ......................................, এম.মড. (মপ.চ্ছজ.ঠি., .....................
............................), বধ্মাে
ষ যমমডনকল কনলজ এবং হাসপাতাল, বধ্মাে ষ (যমা – ..............................................) –
এর সনে যোোনোে করার জেয।
েনবর্ক সনে আমম েনবর্োর ফলাফল আনলাচো করনত আগ্রহী।

সম্মমত কারনকর োম _________________________________________________

সম্মমত কারনকর সাক্ষর/ বাম বৃদ্ধােনির ছাপ _______________________________
তাং _________________ স্থাে – বধ্মাে
ষ যমমডনকল কনলজ, বধ্মাে
ষ
সাক্ষীর োম ________________________________________________________
সাক্ষীর সাক্ষর/ বাম বৃদ্ধােনির ছাপ _______________________________________
তাং _________________ স্থাে – বধ্মাে
ষ যমমডনকল কনলজ, বধ্মাে
ষ
সমীক্ষনকর োম ________________ডাুঃ .....................................____________________________________
সমীক্ষনকর সাক্ষর ___________________________________________________
তাং _______________________ স্থাে – বধ্মােষ যমমডনকল কনলজ, বধ্মাে ষ
 रोगी का सहमति फामम
अध्ययन का नाम: োম: A PROSPECTIVE OBSERVATIONAL STUDY ON THE USEFULNESS OF ACUTE ILLNESS OBSERVATION SCALE (AIOS)
IN COMMUNITY-ACQUIRED PNEUMONIA AMONG THE CHILDREN AGED 2 MONTHS TO 59 MONTHS ADMITTED IN SNM WARD OF
BURDWAN MEDICAL COLLEGE AND HOSPITAL

मैं घोषणा करता हूं कक मैं स्वेच्छा से “ ……………………………………………………………………………………………..”शीषषक अध्ययन में भाग लेने के
कलए अपनी सहमकत दे रहा हूँ ।
मुझे अपनी खुद की भाषा में अध्ययन के दौरान ककसी भी समय इस अध्ययन में भाग लेने से मना करने के कलए अपने अकिकार के
साथ-साथ अध्ययन में शाकमल की गई प्रकिया के बारे में मेरी पूणष सूंतुकि से समझाया गया है । मेरे मना करने से हालाूं कक किभाग की
ओर से मेरी बीमारी के उपचार प्राप्त करने में कोई असुकबिा नही होगी।
मैं घोषणा करता/करती हूँ की मैं अपनी बीमारी का पूरा इकतहास बतायूूंगा / बतायूूंगी और सारे परीक्षा कराऊूंगा / करायूूंगी और जरूरी
सैंपल लेने में मदत करू
ूं गा / करूँगी। मैं ये भी घोषणा करता / करती हूँ की इस दौरान अगर कोय कबपरीत प्रभाि मेरे ऊपर परता हैं
तो उसके कलए कोई कजम्मेदार नहीूं होगा।
अध्ययन के दौरान उत्पन्न होने िाली ककसी भी आपात स्थथकत के मामले में - मुझे डॉ. ………………………………….., (एम्. डी. कप.जी.टी.
…………………………………….), बिषमान मेकडकल कॉलेज एूं ड हॉस्िटल, बिषमान (मोबाइल नूं - …………………………….) से सूंपकष करने के कलए
सूकचत ककया गया है ।

घोषक का नाम: ____________________________

हस्ताक्षर/L.T.I. घोषक की:
कदनाूं क: बिषमान
गिाह का नाम:
हस्ताक्षर / L.T.I. घोषक की:
कदनाूं क: बिषमान
अन्वेषक का नाम: डॉ. ………………………………………………..
अन्वेषक के हस्ताक्षर:
कदनाूं क: बिषमान