RAJIV GANDH UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1 Name of the candidate and address
2 Name of the institution
3 Course of study and subject
4 Date of admission to the course
.
5 Title of topic
6 Brief resume of intended work:
6.1 Need for study:
6.2 Review of Literature
6.3 Objectives of the study:
[Link] and Methods:
7.1 Source of data:
7.2Methods Of Collection of Data:
A. Study design: Observational Study
B. Study period: 18 months
[Link] of study:
D. Sample size:
According to a previous study by Chawla N, et al, the present sample size was derived
using the formula,
n= (Zα)2 pq ÷d2
n= (1.96)2 (40)(60) ÷ (15) 2
n= (3.84) (2400) ÷ 225
n= 9216 ÷ 225
n= 40.96 ≈ 45
Zα= 1.96 (95% confidence level)
p- prevalence= 40 (from earlier studies)
q-100-p = 100-40= 60
d- absolute precision = 15%
n=40.96 rounded off to 45
The total sample size n= 45
E. Inclusion Criteria:
F. Exclusion Criteria:
G. Methodology:
H. STATISTICAL ANALYSIS:
Descriptive Statistics
Descriptive analysis of all the explanatory and outcome parameters will be done using
mean and standard deviation for quantitative variables, frequency and proportions for
categorical variables.
Inferential Statistics:
7.3 Does the study require any investigation to be conducted on subject or animals
specify?
The study does not require any special investigation apart from the investigation
routinely carried out. It does not require animal studies.
7.4 Has ethical clearance been obtained from ethics committee of your institution
in case of 7.3?
“YES”. Ethical clearance has been obtained from Institutional Ethics Committee of
8. LIST OF REFERENCES:
1. Rajan VS, Rao L, Sowmya S, Shobha V, Shetty B, Rai R. Expression of
vascular endothelial growth factor and microvessel density in psoriatic skin
lesions. Indian Dermatol Online J. 2018;9(6):373-377.
2. Chawla S, Pujani M, Pujani M, Malik R, Mehendiratta M, Agarwal C.
Significance of vascular endothelial growth factor and CD31 expression in
psoriasis: An immunohistochemical study. Indian J Pathol Microbiol.
2017;60(2):232-236.
3. Bhushan M, McLaughlin B, Weiss JB, Griffiths CE. Levels of endothelial cell
stimulating angiogenesis factor and vascular endothelial growth factor are elevated
in psoriasis. Br J Dermatol. 1999;141(6):1054–1060.
4. Marina ME, Roman II, Constantin AM, Mihu CM, Tătaru AD. VEGF
involvement in psoriasis. Clujul Med. 2015;88(3):247-252.
5. Ghosh S, Ghosh A, Mandal RK, Saha S. Expression of VEGF and CD34 in
psoriasis vulgaris: correlation with histological grading. Natl J Lab Med.
2016;5(4):Path 13-16.
6. Huggenberger R, Detmar M. Calcipotriol inhibits psoriasis-like angiogenesis in
K14-VEGF transgenic mice. Eur J Dermatol. 2022;32(1):72-78.
8. Yang X, Liu X, Liu Y, Tang Y. The association of serum vascular endothelial
growth factor levels and psoriasis vulgaris: A protocol for systematic review and
meta-analysis. Medicine (Baltimore). 2020;99(36):e22009.
9. Shaker OG, Elbaz TM, El-Din WH. Angiogenesis in involved and uninvolved
skin of psoriasis: a clue for disease pathogenesis. Menoufia Med J.
2015;28(1):227-232.
9 SIGNATURE OF THE
CANDIDATE
10 REMARKS OF THE GUIDE
SIGNATURE
11 11.1 NAME AND DESIGNATION
OF GUIDE
11.2 SIGNATURE
11.3 HEAD OF THE
DEPARTMENT
11.4 SIGNATURE
12 CHAIRMAN AND PRINCIPAL
12.1 REMARKS OF CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
ANNEXURE 1: INFORMED CONSENT
ANNEXURE 2: CASE RECORD FORM/ PROFORMA
ANNEXURE 5: PARTICIPANT INFORMATION SHEET
ANNEXURE – 1
ANNEXURE – 1a
PROFORMA FOR WRITTEN INFORMED CONSENT
Date:
I, Mr/Ms/Mrs______________________________________, exercising my free power of
choice, hereby give my consent to be included as a subject in the study “ROLE OF
VASCULAR ENDOTHELIAL GROWTH FACTOR AND
MICROVESSEL DENSITY IN SKIN LESIONS WITH PSORIASIFORM
REACTION PATTERN” at Department of PATHOLOGY, KIMS Hospital, Bangalore
under the principal investigatorship of Dr. BARSHA MUKHERJEE, Department of
Pathology, Kempegowda Institute of Medical Sciences, Bangalore. I have been informed to
my satisfaction, by the attending doctor, the purpose of the study, I understand that the
procedure of ………………….that I am undergoing is performed by persons who are
experienced in the same. I hereby voluntarily give my consent to undergo the procedure.
I am aware that the data generated out of my participation in this study will be used for
research purposes. I confirm that I have not been offered any financial incentives to
participate in this study.
I am aware of my right to opt out of the study at any time during the study, without having to
give the reasons for doing so, as well as the investigator’s right to terminate my participation
and there was not compulsion/coercion for participation.
Signature of the patient Signature of witness/legal guardian
Signature of Investigator
ANNEXURE – 1b
ಮಾಹಿತಿ ಮತ್ತು ಒಪ್ಪಿಗೆ ಪತ್ರ
ದಿನಾಂಕ:____________
ನಾನು, ಶ್ರೀ/ಶ್ರೀಮತಿ/ಶ್ರೀಮತಿ __________________________________________,
ನನ್ನ ಆಯ್ಕೆಯ ಮುಕ್ತ ಅಧಿಕಾರವನ್ನು ಬಳಸಿಕೊಂಡು, ಬೆಂಗಳೂರಿನ ಕೆಂಪೇಗೌಡ
ವೈದ್ಯಕೀಯ ವಿಜ್ಞಾನ ಸಂಸ್ಥೆಯ ರೋಗಶಾಸ್ತ್ರ ವಿಭಾಗದ ಡಾ. ಬಾರ್ಷ ಮುಖರ್ಜಿ ಅವರ
ಪ್ರಧಾನ ತನಿಖಾಧಿಕಾರಿಯಡಿಯಲ್ಲಿ, ಬೆಂಗಳೂರಿನ ಕಿಮ್ಸ್ ಆಸ್ಪತ್ರೆಯ ರೋಗಶಾಸ್ತ್ರ
ವಿಭಾಗದಲ್ಲಿ "ನಾಳೀಯ ಅಂತಃಸ್ರಾವಕ ಬೆಳವಣಿಗೆಯ ಅಂಶ ಮತ್ತು ಸೋರಿಯಾಸಿಫಾರ್ಮ್
ರಿಯಾಕ್ಷನ್ ಮಾದರಿಯೊಂದಿಗೆ ಚರ್ಮದ ಗಾಯಗಳಲ್ಲಿ ಸೂಕ್ಷ್ಮಜೀವಿ ಸಾಂದ್ರತೆಯ
ಪಾತ್ರ" ಎಂಬ ಅಧ್ಯಯನದಲ್ಲಿ ಒಂದು ವಿಷಯವಾಗಿ ಸೇರಿಸಲು ಈ ಮೂಲಕ ನನ್ನ
ಒಪ್ಪಿಗೆಯನ್ನು ನೀಡುತ್ತಿದ್ದೇನೆ. ನಾನು ತೃಪ್ತಿಪಡುವಂತೆ, ಹಾಜರಾದ ವೈದ್ಯರಿಂದ
ನನಗೆ ತಿಳಿಸಲ್ಪಟ್ಟಿದ್ದೇನೆ, ಅಧ್ಯಯನದ ಉದ್ದೇಶ, ನಾನು ಒಳಗಾಗುತ್ತಿರುವ
…………………… ಕಾರ್ಯವಿಧಾನವನ್ನು ಅದೇ ಅನುಭವಿ ವ್ಯಕ್ತಿಗಳು
ನಿರ್ವಹಿಸುತ್ತಾರೆ ಎಂದು ನಾನು ಅರ್ಥಮಾಡಿಕೊಂಡಿದ್ದೇನೆ. ಕಾರ್ಯವಿಧಾನಕ್ಕೆ
ಒಳಗಾಗಲು ನಾನು ಈ ಮೂಲಕ ಸ್ವಯಂಪ್ರೇರಣೆಯಿಂದ ನನ್ನ ಒಪ್ಪಿಗೆಯನ್ನು ನೀಡುತ್ತೇನೆ.
ಈ ಅಧ್ಯಯನದಲ್ಲಿ ನನ್ನ ಭಾಗವಹಿಸುವಿಕೆಯಿಂದ ಉತ್ಪತ್ತಿಯಾಗುವ ಡೇಟಾವನ್ನು
ಸಂಶೋಧನಾ ಉದ್ದೇಶಗಳಿಗಾಗಿ ಬಳಸಲಾಗುತ್ತದೆ ಎಂದು ನನಗೆ ತಿಳಿದಿದೆ. ಈ
ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸಲು ನನಗೆ ಯಾವುದೇ ಆರ್ಥಿಕ ಪ್ರೋತ್ಸಾಹವನ್ನು
ನೀಡಲಾಗಿಲ್ಲ ಎಂದು ನಾನು ದೃಢೀಕರಿಸುತ್ತೇನೆ.
ಅಧ್ಯಯನದ ಸಮಯದಲ್ಲಿ ಯಾವುದೇ ಸಮಯದಲ್ಲಿ, ಕಾರಣಗಳನ್ನು ನೀಡದೆಯೇ, ಅಧ್ಯಯನದಿಂದ
ಹೊರಗುಳಿಯುವ ನನ್ನ ಹಕ್ಕಿನ ಬಗ್ಗೆ ನನಗೆ ತಿಳಿದಿದೆ, ಜೊತೆಗೆ ತನಿಖಾಧಿಕಾರಿಯು
ನನ್ನ ಭಾಗವಹಿಸುವಿಕೆಯನ್ನು ಕೊನೆಗೊಳಿಸುವ ಹಕ್ಕನ್ನು ಹೊಂದಿದ್ದಾನೆ ಮತ್ತು
ಭಾಗವಹಿಸುವಿಕೆಗೆ ಯಾವುದೇ ಬಲವಂತ/ಬಲವಂತವಿರಲಿಲ್ಲ.
ಶ್ ರೋಗಿಯ ಸಹಿ ಎಡ ಹೆಬ್ಬೆಟ್ಟಿನ
ಗುರುತು
ಸಂಶೋಧಕರ ಸಹಿ ಸಾಕ್ಷಿದಾರರ ಸಹಿ
ANNEXURE-2
ROLE OF VASCULAR ENDOTHELIAL GROWTH FACTOR AND
MICROVESSEL DENSITY IN SKIN LESIONS WITH PSORIASIFORM
REACTION PATTERN
Sl no: Date:
Name: IP/OP number:
Age/Sex: HPE number:
Occupation:
Address:
Chief complaints:
Brief history:
- Duration:
- Region/site of lesion:
- Associated comorbidities:
- Past history:
- Family history:
Investigations:
Skin biopsy: HPE observations and diagnosis:
a) Epidermis:
b) Dermis :
MVD:
c) Additional:
VEGF:
- Positive vessels:
- Adjacent squamous cells:
ANNEXURE-5
Participant Information Sheet (Client)
Title of Study:
Purpose of Study
Participants
Study procedure
Risks and Discomforts
There is minimal risk in this procedure.
Benefits
We hope the information learned from this study will help us assess various psoriasiform
reaction pattern and categorize them.
Payment for participation
You will receive no payment or reimbursement for any expenses related to taking part in this
study.
Confidentiality
Information gathered in this research study may be published or presented in public;
however, your name and other identifying information will not be used or revealed. No
identifying information will be collected at any time in the study process. All results will be
presented in aggregate format, with no individual results being reported. All records will be
kept in a locked secure area and only authorized persons will have access to these records.
Voluntary Participation/ Withdrawal from the Study
Your decision to take part in this study is voluntary. You may refuse to participate, or you
may withdraw from the study at any time. Your decision not to participate or to withdraw
from the study will no way affect the services offered to you as a client. If the study staff
feels that it is in your best interest to withdraw you from the study, they will remove you
without your consent.
If you have any doubts or concerns regarding this study kindly contact,
Name Designation and Department Contact Number