DIAGNOSTIC AND THERAPEUTIC UNCERTAINITIES IN TUBERCULOSIS
Dissertation Application Form for Ethics Committee Clearance
Project Title DIAGNOSTIC AND THERAPEUTIC UNCERTAINTIES IN TUBERCULOSIS
To,
The Chairperson / Secretary,
Institutional Ethics Committee – Human Research, Kamineni Institute of Medical Sciences, Narketpally.
Subject: Submission of Dissertation / Thesis for Institutional Ethics Committee Review for MD course in General Medicine
Respected Sir/Madam,
I, Dr.CHENNA KESAVA KEERTHI MADIREDDI , registered for MD General Medicine in the year 2021 under the guidance of Dr.Rakesh Biswas, Professor & HOD , Department of General Medicine, Kamineni Institute of Medical Sciences, Narketpally. I am due to appear for MD. General Medicine in May 2024
I am submitting herewith following documents of the project for review to Institutional Ethics Committee – Human/Animal Research. The study shall be conducted at KIMS Narketpally.
1. Dissertation Topic Approval certificate and Proforma for registration
2. Case Record Proforma
3. Patient Information Sheet
4. Informed consent in English and Telugu
5. Letter from the Department regarding satisfactory scientific scrutiny duly signed by Guide, Co-
guide, and Head of Department.
I shall make a brief presentation for 3 minutes in front of Institutional Ethics Committee.
Dr. CHENNA KESAVA KEERTHI MADIREDDI
Resident
Department of GeneralMedicine
Date: 24.08.2022
Dr. PRAVEEN NAIK -Guide
Associate Professor
Department of General Medicine
Date: 24.08.2022
Dr. K.YUGVEER GOUD- Co-guide Associate Professor
Department of Pulmonary Medicine
Date: 24.08.2022
Rc.No: Dated: 24.08.2022
OFFICE OF THE PRINCIPAL KIMS NARKETPALLY
DISSERTATION TOPIC APPROVAL CERTIFICATE
Certified that Dr. CHENNA KESAVA KEERTHI MADIREDDI is a Post Graduate student in the department of General Medicine during the year 2021 to 2024 her Dissertation topic is approved by the college dissertation committee.
NAME OF THE TOPIC FILED: DIAGNOSTIC AND THERAPEUTIC UNCERTAINTIES IN TUBERCULOSIS
NAME OF THE DEPARTMENT General Medicine
1. PRINCIPAL Dr. Shruti Mohanty
2. VICE PRINCIPAL Dr. Sudheer Babu Padgul
3. CONCERNED H.O.D. Dr. Rakesh Biswas
4. GUIDE/ PROFESSOR CONCERNED Dr. Praveen Naik
CHAIRMAN/PRINCIPAL
COLLEGE NAME: KAMINENI INSTITUTE OF MEDICAL SCIENCES
DEPARTMENT : GENERAL MEDICINE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 NAME OF THE CANDIDATE AND ADDRESS
Dr. CHENNA KESAVA KEERTHI MADIREDDI Kamineni Institute of Medical Sciences Narketpally, Nalgonda (Dt.) Telangana.
2 NAME OF THE INSTITUTION
KAMINENI INSTITUTE OF MEDICAL SCIENCES
3 COURSE OF THE STUDY AND SUBJECT MD ( GENERAL MEDICINE)
4 DATE OF THE ADMISSION TO COURSE MAY 2022
5 TITLE OF THE TOPIC
DIAGNOSTIC AND THERAPEUTIC UNCERTAINTIES IN TUBERCULOSIS
6 BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR STUDY
Tuberculosis is estimated to affect 10 million people each year, but this statistic is remarkably uncertain: 30% are countries' estimates of undiagnosed, untreated, or unreported cases. Furthermore, about half of tuberculosis diagnoses globally are uncertain because they rely entirely on the non-specific clinical features of tuberculosis, without any laboratory confirmation.
To Assess additional exposures, including clinical and demographic features collected at TB treatment initiation. To The study outcome was TB treatment outcomes assessed during 6 months after initiating TB treatment: treatment success (cured and treatment completed), treatment failure, death, defaulted and transferred out
6.2 AIMS AND OBJECTIVES OF THE STUDY
TO REDUCE DIAGNOSTIC AND THERAPEUTIC UNCERTAINITY OF TUBERCULOSIS.
1. TO IDENTIFY AND SHARE THE DIAGNOSTIC AND THERAPEUTIC UNCERTAINTIES IN ALL THE CASES OF SUSPECTED TB PRESENTING TO OUR INSTITUTION.
2. TO IDENTIFY THERAPEUTIC UNCERTAINITY IN CLINICALLY DIAGNOSED VERSUS BACTERIOLOGICALLY CONFIRMED TB.
6.3 STUDY DESIGN OF THE TOPIC
PROSPECTIVE OBSERVATIONAL STUDY
6.4 INCLUSION CRITERIA
CASES WITH FEVER WITH SIGNIFICANT WEIGHT LOSS.
CASES WITH COUGH WITH EXPECTORATION OR DRY COUGH >2WEEKS.
NEWLY DIAGNOSED CASES OF PULMONARY TB AND EXTRA PULMONARY TB
6.5 EXCLUSION CRITERIA
PATIENT BELOW 18 YEARS OF AGE (MINORS).
PATIENTS NOT CAPABLE OF GIVING CONSENT (MENTALLY ILL PATIENTS).
PATIENTS NOT WILLING TO GIVE CONSENT FOR STUDY.
6.6 SAMPLE SIZE AND DURATION OF THE STUDY
PROPOSED NO. OF CASES: 60
OCTOBER 2022- SEP 2024.
7 MATERIALS & METHODS
7.1 SOURCE OF THE DATA
DEPARTMENT OF GENERAL MEDICINE, KAMINENI INSTITUTE OF MEDICAL SCIENCES, NARKETPALLY, NALGONDA ,TS
7.2 INVESTIGATIONS REQUIRED
HEMOGRAM ,FEVER CHARTING ,ESR CHEST X- RAY PA VIEW , VIRAL SEROLOGICAL TESTS ADA , MANTOUX TEST
SPUTUM : 1.AFB
2. GRAM STAIN
3.CULTURE AND SENSITIVITY SPUTUM CBNAAT
IN SELECTED CASES:
X RAY SPINE, CSF ANALYSIS,LN FNAC OR BIOPSY,ASCITIC FLUID ANALYSIS,PLEURAL FLUID ANALYSIS,PERICARDIAL FLUID ANALYSIS, MRI BRAIN,SKIN BIOPSY.
REFERENCES
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