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


1. WHO . World Health Organization; Geneva: 2020. Global tuberculosis report 2019. [Google Scholar]

2. Global Laboratory Initiative GLI model TB diagnostic algorithms. June, 2018. http://www.stoptb.org/wg/gli/assets/documents/GLI_algorit hms.pdf

3. Divala TH, Fielding KL, Kandulu C. Utility of broad- spectrum antibiotics for diagnosing pulmonary tuberculosis in adults: a systematic review and meta-analysis. Lancet Infect Dis. 2020 doi: 10.1016/S1473-3099(20)30143-2. published online May 18. [PMC free article] [PubMed] [CrossRef] [Google Scholar]

4. Melsen WG, Bootsma MCJ, Rovers MM, Bonten MJM. The effects of clinical and statistical heterogeneity on the predictive values of results from meta-analyses. Clin Microbiol Infect. 2014;20:123–129. [PubMed] [Google Scholar]

5. Barac A, Karimzadeh-Esfahani H, Pourostadi M. Laboratory cross-contamination of Mycobacterium tuberculosis: a systematic review and meta-analysis. Lung. 2019;197:651– 661. [PubMed] [Google Scholar]

6. Oberhelman RA, Soto-Castellares G, Gilman RH. A controlled study of tuberculosis diagnosis in HIV-infected and uninfected children in Peru. PLoS One. 2015;10 [PMC free article] [PubMed] [Google Scholar]

7. Walusimbi S, Semitala F, Bwanga F. Outcomes of a clinical diagnostic algorithm for management of ambulatory smear and Xpert MTB/Rif negative HIV infected patients with presumptive pulmonary TB in Uganda: a prospective study. Pan Afr Med J. 2016;23:154. [PMC free article] [PubMed] [Google Scholar]







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