Date: 31 s t October, 2011
From, Dr. Peter Vianey, Junior resident, Department of General Medicine, A.J.Institute of Medical Sciences, Kuntikana, Mangalore.
To, The Chairman/ Member Secretary Institute Ethics Committee, A.J.Institute of Medical Sciences, Kuntikana, Mangalore.
Through the Head of the department of General Medicine
Subject: Submission of synopsis to Ethical committee-reg.
I am herewith submitting my MD dissertation synopsis titled “A CLINICAL STUDY OF DENGUE FEVER IN AJIMS OVER A PERIOD OF TWO YEARS” for the consideration of the Institute Ethics committee. I have also enclosed the proforma for the ethics committee, data collection proforma, consent form and curriculum vitae. I request you to kindly do the needful. Thanking you, Yours sincerely
Dr. Peter Vianey Encl: as above
Institute Ethics Committee A J Institute of Medical Sciences, Kuntikana, Mangalore. Proforma to be filled by the Principal Investigator (PI) for submission to Institutional Ethics Committee (IEC) (for attachment to each copy of the proposal)
Serial No of IEC Management Office:
Proposal Title: “A CLINICAL STUDY OF DENGUE FEVER IN AJIMS OVER A PERIOD OF 2 YEARS”.
Name, Designation Address Signature & Tel & Fax Nos. Qualifications Email ID
Principal Dr. Peter Vianey A.J. Residents Hostel, Investigator Junior Resident, A.J. Institute of Medical Dept.of G.Medicine Sciences, A.J.Institute of Medical Kuntikana, Sciences. Mangalore . Ph: +919632583138 M.B.B.S. [email protected]
Dr. Devdas Rai Guide Professor Dept. of G.Medicine Capitol Apartments, A.J.Institute of Medical No.302, Sciences. Kadri toll gate, Nantoor, M.B.B.S, M.D. Mangalore - 575003 (G.Medicine)
Curriculum Vitae of principal investigator and the guide (with subject specific publications limited to previous 5 years) – attached 1.Type of study: Clinical Study
2: Brief description of the proposal: DENGUE has worldwide distribution and remains a health problem or potential threat in areas infested with Aedes aegypti mosquito. The severe fatal forms of disease, i.e., dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) though common in South East Asia since early 1940's were reported in India for the first time from Calcutta in 1963. Since then epidemics of DSS/DHF have been reported from various states of India. They are found virtually throughout the tropics and cause an estimated 50-100 million illnesses annually, including 250 000--500 000 cases of dengue haemorrhagic fever,a severe manifestation of dengue,and 24 000 deaths. More than two fifths of the world's population (2.5 billion) live in areas potentially at risk for dengue. 3. Subject selection: i. Number of Subjects :All enumerated cases during the study period will be considered for the study ii. Duration of study : 2 years iii. Will subjects from both sexes be recruited: Yes iv. Inclusion / exclusion criteria given: Yes
v. Type of subjects: All patients who are admitted in AJIMS with fever and on investigation found to be Dengue IgM positive
4. Privacy and confidentiality Confidential handling of data : Yes 5. Consent : Please find it attached written informed consent i. Consent form : (included elements)
1. Understandable language 2. Statement that study involves research 3. Statement that consent is voluntary 4. Purpose and procedures 5. Risks & Discomforts 6. Benefits 7. Confidentiality of records 8. Right to withdraw 9. Contact information ii. Who will obtain consent – Principal investigator 6. Will any advertising be done for recruitment of Subjects? (posters, flyers, brochure, websites – if so kindly attach a copy) No 7. Risks & Benefits: No risks, but benefits to the research world 8. Is there compensation for participation? No Checklist for attached documents: 1. Project proposal – 2 Copies 2. Curriculum Vitae of Investigators 3. Curriculum Vitae of Guide 4. Informed Consent form 5. Copy of data collection Proforma
Place: Signature & Designation of Date: Principal investigator CURRICULAM VITAE Dr’s Name : DR. Peter Vianey
Date of Birth & Age : APRIL 3rd, 1984 – 27 Years
Present Designation : PG
Department : General Medicine
College : A.J. Institute of Medical Sciences
City : Mangalore
Residential Address : A.J. Residents Hostel, A.J. Institute of Medical Sciences, Kuntikana, Mangalore .
Phone Number : Residence : 04742701159
Mobile No : 9632583138
E-mail address: [email protected]
Qualifications:
Qualification College University Year Registration Name of the s No. of UG & Medical PG with date Council MBBS JUBILEE CALICUT Feb 2009 41394, Travancore MISSION UNIVERSIT JUN 17, Cochin MEDICAL Y 2010 Medical COLLEGE Council THRISUR KERALA
Details of pervious appointments/teaching experience Designation Department Name of From To Total Institution DD/MM/YY DD/MM/YY experience in years & months PG General A.J. June 7, 2011 Till Date Medicine Institute of Medical Sciences, Mangalore
CURRICULAM VITAE Name : DR. B DEVDAS RAI Date of birth & Age : April 30, 1962- 48 Years Present Designation : Professor Department : General Medicine College : A.J. Institute of Medical Sciences City : Mangalore Residential Address : Capitol apartments No.302 kadri toll gate, Nantoor Mangalore-575003
Phone & Fax Number with code : Office : 0824-2225533
Residence : 0824-2213762/2218310
Mobile number : 9845081148
1. Date of joining present institution: April 29, 2008 as Professor
2. Qualifications:
Qualification College University Year Registration Name of the No.of UG & State Medical PG with date Council MBBS Kasturba Mangalore Mar 1987 26489, Karnataka Medical University dt.sep18,1987 Medical College, council Mangalore MD J.N Medical Karnataka Feb 1993 26489, Karnataka (General college, University dt.sep29,2007 Medical Medicine) Belgaum council DM/M.Ch NA
CURRICULAM VITAE Details of the previous appointments /teaching experience Designation Department Name of From To Total Institution DD/MM/YY DD/MM/YY Experience in years and months Tutor/ General Jawaharlal July 1988 Aug 1991 3 Years Resident Medicine Nehru Medical college,Belgaum Assistant General K.S Hegde 01.01.1999 31.12.2003 5 Years Professor Medicine Medical Academy, Mangalore Associate General K.S Hegde 01.01.2004 31.12.2007 4 Years Professor Medicine Medical Academy, Mangalore Professor General K.S Hegde 01.01.2008 28.04.2008 4 Months Medicine Medical Academy
A.J Institute of 29.04.2008 Till Date Medical Sciences, Mangalore
SYNOPSIS
Submission for ethical clearance to Ethical Committee of AJIMS
“A CLINICAL STUDY OF DENGUE FEVER IN AJIMS
OVER A PERIOD OF 2 YEARS”
Name of the candidate : Dr. Peter Vianey
Guide : Dr. Devdas Rai
Course and Subject : M.D. General Medicine
Department of General Medicine,
A.J. INSTITUTE OF MEDICAL SCIENCES,
Kuntikana, Mangalore – 575004 2011
1. Name of the candidate
& address:
(in block letters)
2. Name of the Institute:
3. Course of study and Subject: M.D. GENERAL MEDICINE
4. Date of admission to course: 7 th JUNE 2011
5. Title of the Topic: “A CLINICAL STUDY OF DENGUE FEVER
IN AJIMS OVER A PERIOD OF 2 YEARS” BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
DENGUE has worldwide distribution and remains a health problem or potential threat in areas infested with Aedes aegypti mosquito.[1,2]
In India, the first outbreak of dengue fever was recorded in 1812, virus was isolated in 1945 and many epidemics have been reported since then. The severe fatal forms of disease, i.e., dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) though common in South East Asia since early 1940's were reported in India for the first time from Calcutta in 1963[3]. Since then epidemics of DSS/DHF have been reported from various states of India.
Dengue viruses, single stranded RNA viruses of the family Flaviviridae, are the most common cause of arboviral disease in the world. They are found virtually throughout the tropics and cause an estimated 50-100 million illnesses annually, including 250 000--500 000 cases of dengue haemorrhagic fever,a severe manifestation of dengue,and 24 000 deaths.[4-6] More than two fifths of the world's population (2.5 billion) live in areas potentially at risk for dengue.[7] Because travellers to endemic areas are also at risk, healthcare providers should have an understanding of the spectrum of infection, how to diagnose it, and what the appropriate treatment is.
Historically, DF/DHF has been reported as occurring predominantly among urban populations where density of dwellings and short flying distance of the vector create the right conditions for transmission. However, the literature shows that dengue transmission and, in some cases, outbreaks occur in rural settings in both Asia and Latin America. In the WHO Western Pacific region, WHO has confirmed that disease spread into rural areas from where it had not been reported previously [20]. In India, entomological investigation showed a widespread distribution of Aedes aegypti, both in rural and urban areas during an outbreak in Gujarat in 1988 and 1989.
6.2 Review of literature:
Dengue virus infection in humans causes a spectrum of illness ranging from inapparent or mild febrile illness to severe and fatal hemorrhagic disease [8] Infection with any of the four serotypes causes a similar clinical presentation that may vary in severity, depending on a number of risk factors. The incubation period varies from 3 to 14 days (average, 4 to 7 days) .In areas where dengue is endemic, the illness is often clinically nonspecific, especially in children, with symptoms of a viral syndrome that has a variety of local names. Important risk factors influencing the proportion of patients who have severe disease during epidemic transmission include the strain and serotype of the infecting virus and the immune status, age, and genetic background of the human host [9]
The WHO scheme classifies symptomatic dengue virus infections into three categories; undifferentiated fever, dengue fever, and DHF .Dengue fever is clinically defined as an acute febrile illness with two or more manifestations (headache, retro-orbital pain, myalgia, arthralgia, rash, haemorrhagic manifestations, or leucopenia) and occurrence at the same location and time as other confirmed cases of dengue fever. A case must meet all four of the following criteria to be defined as DHF: fever or history of fever lasting 2–7 days; a haemorrhagic tendency shown by a positive tourniquet test or spontaneous bleeding; thrombocytopenia (platelet count 100+109/L or less); and evidence of plasma leakage shown either by haemo concentration with substantial changes in serial measurements of packed-cell volume, or by the development of pleural effusions or ascites, or both.[10]
The WHO classification scheme and case definitions are based on substantial clinical experience mainly from Thailand, which, although valuable, is difficult to quantify and might not represent findings in other countries. Undoubtedly, widespread adoption of the WHO system, together with implementation of the accompanying management guidelines, contributed to the striking initial fall in case-fatality rates. However, after the recent global expansion in dengue disease, several investigators have reported difficulties in using the system, with some finding they have to create new categories or altogether new case definitions to represent the observed patterns of disease more accurately. As a result, the terms “dengue fever with unusual haemorrhage” and “dengue with signs associated with shock” have been introduced.[11] 6.3 Objectives of the study:
To study the incidence of Dengue cases in AJIMS
To obtain a statistical data of classification of the cases according to
severity
To study the levels of thrombocytopenia
To know the prognosis and average days of hospital stay needed
according to severity of illness
To know the complications which commonly occur with Dengue in
AJIMS
To detect the mortality rates of patients affected with complications of
Dengue
7. Material and methods:
7.1 Source of data. It will be a prospective hospital based study. All cases of fever with Dengue IgM positive will be considered for the study .
7.2 Method of collection of data (including sampling procedure, if any)
This study will be conducted as a prospective study, wherein written informed consent will be taken prior to the investigation after detailed information given to the participants regarding the study. Fever patients will be screened for Dengue through a through history, detailed examination and lab investigations , cases will be admitted treated and followed up for the treatment outcomes
Sample and sampling technique: Study design: two year prospective study. Set-up: The AJ Institute of Medical Sciences. Study Period: July 2011 up to July 2013. Age group: All age groups All patients with fever with Dengue IgM positive during the study period will be considered for the study.
Study type: Two year prospective study
Inclusion criteria: All cases of Fever with Dengue IgM Positive
. Exclusion criteria: Cases of fever which are proved Dengue IgM Negative. Cases of fever where tests for other diseases like Malaria and Leptospirosis are found to be positive. Undiagnosed causes of fever with thrombocytopenia.
. Plan for data analysis: The various measures of central tendencies and graphical representations will be used to analyze the data.
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.
• Blood investigations ▫ Hb, TC, DC, ESR, Platelet counts • Liver function test and Renal function test • Dengue IgM, Leptospirosis IgM, MPFT ,MP smear • Chest x- ray (PA view). • USG Abdomen • Serology
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Awaited
8. References:
1. Halstead SB. Pathogenesis of dengue: Challenge to molecular biology.
Science 1988; 239: 476-481. 2. Rodhain F. Recent data on the epidemiology of dengue fever. Bull Acad
Natl Med 1992;176:223-236.
3. Konar NK, MandaI AK, Saha AK. Hemorrhagic fever in Calcutta. J Assoc
Phys India 1966; 14: 331-340.
4. World Health Organisation,Dengue haemorrhagic fever: diagnosis,
treatment, prevention and control, 2nd edn. Geneva: WHO, 1997.
5. Monath TP. Dengue: the risk to developed and developing countries. Proc
Natl Acad Sci USA 1994; 91: 2395–2400.
6. Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev
1998; 11: 480–496.
7. Porterfield JS Innis BL. Dengue and dengue hemorrhagic fever. In:
Porterfield JS, ed. Kass handbook of infectious diseases: exotic virus
infections. London: Chapman and Hall Medical, 1995:103–146.
8. Dengue haemorrhagic fever:diagnosis,treatment,prevention and control.
2 n d edition Geneva :World Health Organization 1997
9. Bielefeldt-Ohmann, H. 1997. Pathogenesis of dengue virus diseases:
missing pieces in the jigsaw. Trends Microbiol. 5:409-413.
10. The WHO dengue classification and case definitions: time for a reassessment Jacqueline L Deen, Eva Harris, Bridget Wills, Angel Balmaseda, Samantha Nadia Hammond, Crisanta Rocha, Nguyen Minh Dung,Nguyen Thanh Hung, Tran Tinh Hien, Jeremy J Farrar : Lancet 2006; 368: 170–173. 11. Vector borne viral infections: World Health Organization. Retrieved 17 January 2011.
9. Signature of the candidate:
10. Remarks of the guide
11. Name and Designation of (in block letters):-
11.1 Guide:
11.2 Signature:
11.3 Co-Guide:
11.4 Signature:
11.5 Head of Department:
11.6 Signature:
12. Remarks of the Chairman and Principal:
12.2 Signature:
Proforma:
Case no. : O.P. No. / I.P. No. Name: Dept / Ward Age: Sex: Unit: Address: Date of Admission: Occupation: Religion: Date of discharge Socio-economic status: Upper class / Middle Class / Lower class
HISTORY: I. PRESENTING COMPLAINTS: DURATION 1. 2. 3.
II. HISTORY OF PRESENTING COMPLAINTS : DURATION 1. Fever: mild / moderate /high grade. continuous / intermittent / remittent. chills / rigor 2. Other complaints if any in chronological order
III. HISTORY OF PAST ILLNESS: 1. Immunization status 2. Previous history of Dengue 3. Other illnesses, duration, treatment history. 4. Past surgical history
IV. PERSONAL HISTORY: Diet - Vegetarian / Mixed Appetite - Normal / Decreased Sleep - Normal / Disturbed Bowel/Bladder habits - Habits Smoking Yes / No Duration No. of Beedies / Cigarettes / Day Alcoholism Yes/ No Duration Type Amount
V. FAMILY HISTORY: Single / Married If Married: No. of children: Male / Female Any significant medical / surgical illness in the family VI. SOCIAL AND OCCUPATIONAL HISTORY:
VII. MENSTRUAL AND OBSTETRIC HISTORY (IN FEMALES): 1. Menarche: 2. Regularity of cycles: Regular / Irregular 3. Duration of cycles: 4. No. of days of flow: Normal / Excess / Reduced Quantity 5. LMP No. of deliveries: Abortions if any:
GENERAL PHYSICAL EXAMINATION: 1. Appearance: 2. Built: Well built / moderate / poor 3. Nourishment: Well nourished / moderate / poor 4. Height of Cms : 5. Weight in Kgs : BMI 6. Pallor : Absent / Present : Mild / Moderate / Severe 7. Icterus : Absent / Present : 8. Clubbing: Absent / Present: Grade : I / II / III / IV 9. Cyanosis: Absent / Present: 10. Lymphadenopathy : Absent / Present : Group 11. Edema: Absent / Facial / Lower Limbs / Upper Limbs / Anasarca Pitting / Non Pitting 12. J.V.P. Normal / Raised 13. Vitals: pulse/ Blood pressure/ Temperature/ Respiratory Rate SYSTEMIC EXAMINATION:
I. RESPIRATORY SYSTEM:
Inspection: Symmetrical / asymmetrical Shape of the chest: Tracheal position – central / deviated Drooping of shoulder Kyphosis, scoliosis Movements of chest Accessory muscles of respiration – quiet / active
Palpation: Tracheal position Movements of chest Chest measurements – chest circumference / AP / Transverse / chest expansion Apical impulse Vocal fremitus
Percussion: Resonant / hyper resonant / impaired / dull / stony dull Liver dullness Cardiac dullness Traubes area – normal / obliterated Tidal percussion Shifting dullness
Auscultation: Breath sounds – intensity / quality / bronchophony / added sounds / succession splash / coin test
II. CARDIOVASCULAR SYSTEM: Inspection: Palpation: Percussion: Auscultation:
III. ABDOMINAL AND GENITO URINARY SYSTEM: Inspection: Palpation: Percussion: Auscultation: IV. CENTRAL NERVOUS SYSTEM: i. Higher Mental Functions ii. Cranial nerves iii. Motor system iv. Sensory system v. Cerebellar signs vi. Gait vii. Fundus
CLINICAL DIAGNOSIS:
INVESTIGATIONS: 1. Complete Blood Count: Hb% TC ESR DC B.urea S.creatinine LFT 2. RBS 3. Chest x ray (PA) 4. Serology ,MPFT, Leptospira IgG, Dengue IgG and IgM 7. Urine: albumin / sugar / micro / ketone bodies/ pus cells
TREATMENT GIVEN:
FOLLOW UP AND RESULTS: Written Informed Consent Form
A J INSTITUTE OF MEDICAL SCIENCES, KUNTIKANA, MANGALORE.
Informed consent form for the volunteers at “A J Institute of Medical Sciences, Kuntikana, Mangalore”, who will be participating in the research project (MD dissertation) entitled : “CLINICAL STUDY OF DENGUE IN AJIMS OVER A PERIOD OF 2 YEARS”. Name of Principal Investigator Dr.PETER VIANEY, Postgraduate student Name of Organization Department of General Medicine, A J Institute of Medical Sciences, Kuntikana, Mangalore
This Informed Consent Form has two parts: Information Sheet (to share information about the research with you) Certificate of Consent (for signatures if you agree to take part) You will be given a copy of the full Informed Consent Form
PART I: Information Sheet Introduction
I, Dr. PETER VIANEY, postgraduate student in the Department of GENERAL MEDICINE, A J Institute of Medical Sciences, Kuntikana, Mangalore, am working on my MD dissertation titled “CLINICAL STUDY OF DENGUE IN AJIMS OVER A PERIOD OF 2 YEARS”. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.
There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified.
Purpose of the research DENGUE has worldwide distribution and remains a health problem or potential threat in areas infested with Aedes aegypti mosquito. The severe fatal forms of disease, i.e., dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) though common in South East Asia since early 1940's were reported in India for the first time from Calcutta in 1963. Since then epidemics of DSS/DHF have been reported from various states of India. They are found virtually throughout the tropics and cause an estimated 50-100 million illnesses annually, including 250 000--500 000 cases of dengue haemorrhagic fever,a severe manifestation of dengue,and 24 000 deaths. More than two fifths of the world's population (2.5 billion) live in areas potentially at risk for dengue.
Type of Research Intervention 20 ml of blood will be drawn for routine blood investigations and a urine sample will be sent for analysis. Chest x-ray ,USG Abdomen and E.C.G will be done.
Participant selection All fever cases with Dengue IgM positive
Procedures and Protocol A through history, detailed examination and lab investigations will be done.Dengue IgM positive cases will be admitted treated and followed up for the treatment outcomes.
Duration: till the patient is symptom free Voluntary Participation Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not affect your patient’s treatment process.
Benefits Personally you might be or may not be benefited in any way directly from the research. But by taking part in this research, you will be helping the scientific community to learn more about dengue and its complications so that appropriate measures can be taken to revert it back.
Reimbursements You won’t be given any monetary incentives or gifts for being a part of this research.
Confidentiality The information that we collect from this research project will be kept confidential. Information about the patient that will be collected during the research will be put away and no-one but the researchers will be able to see it. Any information about the patient will have a number on it instead of your name.
Sharing the Results The knowledge that we get from doing this research will be shared with you. Confidential information will not be shared. We will publish the results in order that other interested people may learn from our research.
Right to Refuse or Withdraw You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected. Who to Contact
This proposal has been reviewed and approved by the Research and Ethical committee of A J institute of Medical Science, Kuntikana Mangalore, which is a committee whose task it is to make sure that research participants are protected from harm. You may contact the following member of the Institute Ethics committee for more details
Dr. Kumaraswamy
Dr. B A Shetty You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?
PART II: Certificate of Consent
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.
Name of Participant______Signature of Participant ______Date ______Day/month/year
If illiterate a literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb-print as well.
I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
Name of witness______Thumb print of participant
Signature of witness ______Date ______
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done: 1. Blood investigations: ▫ Hb, TC, DC, ESR, Platelet count RBS, RFT, LFT Dengue IgM, Lepto IgM, MPFT 2. Sputum for culture and sensitivity. 3. Chest x- ray (PA view). USG Abdomen 4. E.C.G I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
A copy of this informed consent from has been provided to the participant.
Name of Researcher/person taking the consent______
Signature of Researcher /person taking the consent______Date ______
Day/month/year