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Deenanath Mangeshkar Hospital & Research Centre
Research Division, 6th Floor, C4, Erandawane, Pune 411004.
Tel No: 20 4015 1149/50
Email:[email protected]
1
Annual Report of
Research@ DMHRC
May 2012 to April 2013
2
Abbreviations
DMHRC Deenanath Mangeshkar Hospital and Research Centre
IEC Institutional Ethics Committee
SIRO Scientific & Industrial Research Organization
DSIR Dept. of Scientific & Industrial Research
CCPR Core Committee for Promotion of Research
SOP Standard Operating Procedure
SAC Scientific Advisory Committee
SACIR Scientific Advisory Committee for Integrated Research
CRO
JAPI
Contract Research Organization
Journal of Associations Of Physicians of India.
2
Preface
“Quality means doing it
right when no one is
looking."
Henry Ford
3
I believe in innovation and
that the way you get innovation
is you fund research and you
learn basic facts
Bill Gates
Message by Medical Director
A great treatment offers benefit to an individual
patient and a good hospital should provide such good
treatment to multitude of patients. A good research
offers solutions to millions of patients across the
globe and is a far more powerful tool for serving
patients than just good treatment alone. A great
hospital must offer quality research and hence
contribute towards improvements in treatment
options. Deenanath Mangeshkar Hospital is
committed to make this transition to a great hospital
by undertaking Clinical Research. As a part of
management of Deenanath Mangeshkar Hospital we
are firmly committed to this research endeavor .
Medical Director
Deenanath Mangeshkar Hospital and Research
Centre.
Scientific & Industrial Research Organization (SIRO) &
Dept. of Scientific & Industrial Research
(DSIR), Government of India, New Delhi.
Research division started in 2002. Research @ DMHRC provides admin support to
Institutional Ethics Committee (IEC) and makes sure that the Regulatory
requirements are met by the principal Investigator of the Sponsored Clinical Trials
& In-house research studies.
Promotes and encourages in-house research in one pathy as well as more than one
pathy.
4
Recognition by
IERC- 2004
Research co-ordination department in 2002
SAC - 2005
SOP-May2007
CCPR-2008
Dept of Research-2009SIRO accreditation - 2009
Regulation and Facilitation Dept- 2010
Renewal of SIRO Accreditation -2011
Growth of Research Department
Regular Training started from 2011
January 2012: Quarterly News letter
5
Partnership with Quintiles for Sponsored
Clinical Trials (2012).
March 2013 :DCGI registration,
No- ECR/15/Inst/Maha/2013 “Emerging Issues In
Ethics & Regulation
Of Medical Research”
Conference on 12th Jan 2013
Research Infrastructure
(1) State of Art Laboratory and diagnostic facilities – Our Pathology and Microbiology
laboratory is accredited in accordance with ISO 15189:2007 standard by National Accreditation
Board for Testing and Calibration Laboratories (NABL), Dept. of Science & Technology, Govt. of
India. Other diagnostic facilities include imaging (1.5 Tesla MRI, 64 slice CT scan, USG, digital
radiology etc.) and imaging for cardiovascular purposes viz. Color Doppler, 2 D Echo and cardiac
cathlab. 12-lead ECG is available.
(2) Telecommunication - Dedicated high speed telecommunication facilities including internet
and videoconferencing in addition to conventional telephonic and fascimile (fax) transmission.
Medical Records - Facility to Archive Medical Records. Striving towards making the medical
record system paperless (electronic).
(3) Good Human Resource Development & Administrative Set Up - ‘Green channel’ for
clinical trial participants - Express registration, check-in, check-out and utilization of diagnostic
facilities.
(4) Strong patient referral network-
Primary source - Clientele of DMHRC from Pune city and adjoining town and districts
Secondary source - Referral via network of associates (physicians & general practitioners).
(5) Excellent Service provider - By maintaining high standards through recruitment and retention
of excellent staff, physicians, dentists and volunteers.
(6) SPSS software and expert guidance from Senior statisticians
(7) End note soft ware
6
77
Contact information
Deputy Director, Research
(020 6602300 Extn 1150)
Sponsored Clinical
Trials
CCPR
(For Promotion of Basic
In house Research)
SAC –IR
(For Promotion of
Integrated Research,
In house projects)
Research officer
Admin Assistant
(020 6602300 Extn 1671)
Research Associate
(020 6602300 Extn 1652)
Research Associate
(020 6602300 Extn 1149)
E mail: [email protected]
In House studies
7
Department of Research: Functions
DEPARTMENT OF RESEARCH
Facilitation Regulation Research services
Assistant director & HOD of research
department
Receive all
study related
documents
Communicate
with PI and
CRCs and
Sponsors
Review and evaluate
documents ensuring regulatory
compliance as per ICH-GCP,
WHO, Schedule Y and ICMR
guidelines.
Conducts sub committee and
ethics committee meetings.
Encourages In-House research
Help in writing protocols
Designing of Questionnaire
Sample size
Data Analysis
Interpretation of results
provide help with writing
manuscripts, case studies
TrainingMonitor ongoing sponsored and In-house
trials / studies
8
9
An overview of Sponsored Clinical Trials
Figure 2a: Percent of Trials
from year 2002 – 2012
Figure 1a: No of Trials per month
May 2012 to April2013
Figure 1b: No. of sponsored
Clinical Trials by Specialty
2 18
19
34
64
7772
61
37
29
0
10
20
30
40
50
60
70
80
90
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
1
3
4
3
7
4
0
3
2 2
0
4
0
1
2
3
4
5
6
7
8
May
June Ju
ly
Augus
t
Septm
ber
Oct
ober
Nov
embe
r
Dec
embe
r
Janu
ary
Febr
uary
Mar
chApr
il
* Due to Gazette Rules no new
protocols were reviewed in March
11
34
1 12
34
0
2
4
6
8
10
12
ONCO
GASTRO
CARD
IO
NEUR
O
ENDO
CRIN
EPSY
MED
OTHER
9
10
Figure 2b: No. of Trials by CROs from 2002 to 2013
5 3 11 11 74 2 1
62
52
11
821
1611353674
60
6 1 8 1 1
1
1
1
1
6
Reliance Life Science Accutest Research Laboratories Amarex Bio
APOTHECARIES LIM ITED BIO Evaluat ion Boston M edtech
Chiltern Internat ional Clinirx Research Clinivent
Consort ium Covance Credence Clinical Research Pvt.Ltd
Diagnosearch Life Sciences George Inst itute for Internat ional Health-India. Hanul M edizen pvt Ltd
I 3 Research Icon clinical research iGATE CLINICAL RESEARCH INTERNATIONAL INC.
Inf initus Clinical Research Pvt.Ltd. inventiv internat ional KENDLE INDIA PVT. LTD
Lambda Therapeutic Research limited. LUPIN LTD. M anipal Acunova Ltd.
M ax Neeman Internat ional Ltd. Novart is Oncology Services India Ltd.
Parexel Internat ional Ltd. PHARM ALEAF INDIA LTD. Pharm-Olam Internat ional
PPD Internat ional PPD Internat ional PRA Internat ional
Quint iles Reliance Life Science SERDIA PHARM ACEUTICALS (INDIA) PVT. Ltd.
Siro Clinpharm Pvt.Ltd Veeda Clinical Research Ltd Ventureast Pharmaceutical Services, LLC
Out of 187 trials maximum trials ie 60 trials are from Quintiles
10
11
In-house studies @ DMHRC May 2012 to April 2013
Figure 3: No of completed and ongoing In-house studies from 2008 to 2013.
Closed, 26 2 Query, 7 Rejected, 9 Terminated, 14 Ongoing, 34
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
1
9%
6%
9%
6%
9%
3%11%
3%
6%
3%
14%
3%
3%
3%
6%6%
Endoscopy Genitics ICU Medicine
Oncology Opthalmology Pathology Rhumatology
SAC_IR Research Orthopedic Neurology
OBG1 IVF ENT Pediatrics
Total 21 new protocols
were reviewed in this year
11
12
Slide 13,14&15
Conference Brochure and Photos
12
13
Speakers:
Dr. Roli Mathur [Key Note Speaker]
Scientist „C‟,
Division of Basic Medical Sciences, ICMR, Delhi
Dr. Urmila Thatte
Professor & Head
Dept. Of Clinical Pharmacology,
KEM Hospital, G. S. Medical College, Mumbai
Dr. Sunil Pandya
Editor Emeritus
Indian Journal of Medical Ethics, Mumbai
Mr. Pruthviraj Sawant
Deputy Manager, Corporate Merketing Team,
Bajaj Allianz General Insurance Co. Ltd.
Mr. Mudassir Khalil
Deputy Manager- Liability Insurance
Bajaj Allianz General Insurance Co. Ltd.
Organizing Committee:
Dr.Avinash Joshi (Chairperson, IEC, DMH&RC)
Dr.Veena Joshi (Member Secretary, IEC, DMH&RC)
Col.J.C.Pendse,VSM (Retd.) (Joint Member Secretary, IEC, DMH&RC)
Secretariat Staff (IEC, DMH&RC)
Advisory Committee:
Dr.S.M.Karandikar (Chairperson, IRB,Chest Research Foundation, Pune)
Dr.A. Chakranarayan (Chairman, IRB, Lupin Bioresearch, Pune)
Dr.V.S. Padbidri (Director, Research, KEM Hospital, Pune)
EMERGING ISSUES IN ETHICS & REGULATION OF MEDICAL RESEARCH
A Conference Arranged By
Deenanath Mangeshkar
Hospital
& Research Centre,
Erandawane, Pune-411004
Date: 12th January 2013
Venue: 8th Floor, Saud Bahwan
Auditorium, DMH& RC
Coming together for a new beginning………
Highlights:
Formation of an Association of all ECs / IRBs in Pune
Accreditation of Ethics Committees
Insurance for Clinical Trial Participants
Talks by eminent speakers
Open discussions with experts
14
Dear Colleagues,
Greetings from Deenanath Mangeshkar Hospital & Research Centre!
We are glad to announce the Conference on „Emerging Issues in Ethics & Regulation of Medical Research‟ in our institute on 12th
Jan 2013. The full day conference would comprise of talks by eminent speakers from the field of clinical research & ethics, free paper presentations, panel discussion with questions & answer sessions.
We as „Ethics Committee members‟ are committed towards the well-being of the research participants. We are also answerable to the public at large. There is variety of topics like biosimilar drugs, pharmacogenomic research, evaluation of safety issues, assessing the compensations for the SAEs etc. for which we need to share our views in order to deliver the concrete judgment. The conference is also an excellent opportunity to keep oneself update with the upcoming regulatory requirements in India.
Undoubtedly, the conference will serve as an initial step to bring together all the EC members, clinical research industry people, investigators from Pune district to work towards a robust framework & a effective environment for clinical trials.
Dr. Dhananjay Kelkar Dr. Veena Joshi
Medical Director Assist. Director, Research,
DMH & RC, Pune Member Secretary, IEC, DMH & RC, Pune
Deenanath Mangeshkar Deenanath Mangeshkar
Hospital & Research Centre Super-Specialty Hospital
Schedule of EventsMorning Session:
08:00 – 08:45 am Registration & breakfast
08:45 – 09:00 am Inauguration………………………...Dr.Dhananjay Kelkar
09:00 – 09:30 am „Current scenario & prospects
in Clinical Research in India‟……...Dr.Roli Mathur
09:30 – 09:45 am Questions & Answers
09:45 – 10:15 am „Accreditation of ECs‟………………Dr.Urmila Thatte
10:15 – 10:30 am Questions & Answers
10:30 – 11:00 am „Current issues in Ethics of
Medical Research‟............................Dr.Sunil Pandya
11:00 – 11:15 am Questions & Answers
11:15 – 11:30 am Tea Break
11:30 – 12:00 am „Insurance for Trial Participants‟.......Mr.Sawant/Mr.Khalil
12:00 – 12.30 pm Questions & Answers
12.30 – 01:30 pm Lunch Break
Post Lunch Session:
01:30 – 03:30 pm Presentation by Researchers
03:30 – 03:45 pm Tea Break
03:45 – 05:00 pm Panel Discussion on Forming an Association of ECs
05:00 – 05:10 pm Closing address
Themes for abstracts1.Trials on elderly patients
2. Ethics in nursing
3. Informed consent in emergencies
4. Ethics for assisted reproductive technologies
Interested students can submit an abstract on any topic on Ethics
in Human Research.
Last Date of submission:
10th Nov 2012
Who should attend?
-All EC members and EC secretariat staff
-Medico-legal experts
-Anyone involved in Human Research
DMH & RC is planning to take the initiative in the formation of an Association of all ECs in Pune. The purpose would be to provide -
- a forum for interaction among various ECs
- support in the capacity building
- support for statutory requirements like registration, accreditation etc.
- training
Note:
2 MMC credit points
1515
“Emerging Issues In Ethics & Regulation Of Medical Research” –
Conference on 12th Jan 2013
The meeting was attended by 270 participants.
Each speaker through his presentation must have left indelible mark on the thought process of all the delegates.
Hope the similar issues would be tackled more proficiently in future.
1616
Publications of In-house studies
Is Germline transmission of MAD2 gene deletion associated with human fetal loss?
Somsubhra Nath, Mrinalini Moghe, Abhishek Chowdhury, Koumudi Godbole, et al : Mol Hum Report. 2012 Nov;18(11):554-62.
Abstract:
Spindle assembly checkpoint (SAC) monitors proper attachment of spindles to the kinetochore during mitotic and meiotic cell divisions and thus prevents aneuploidy. Chromosomal aneuploidy has been associated with pregnancy loss and birth defects. Mad2 is one of the critical molecules of SAC. Deregulated Mad2 expression has been associated with defective SAC mediated abnormal meiotic progression in cell studies using animal models. Whether mutation in MAD2L1 is associated with the loss of Mad2 expression in aborted human foetuses is unknown. In this study, a correlation between aneuploidy and MAD2
defect was examined in primary fibroblast cultures obtained from abortuses. We report three trisomic abortuses with undetectable Mad2 expression. Further, quantitative Real-Time-PCR revealed copy number deletion of MAD2 gene in these foetuses. Analysis of parental DNA samples available from two families revealed copy number loss of the same gene suggesting Mendelian inheritance of MAD2 deletion. This germline transmission of exonic deletion of MAD2 is possibly associated with its loss of expression resulting in abnormal SAC function, subsequent aneuploidy and pregnancy loss.
Cytomegalovirus Infection as a Cause of Cytopenia After Chemotherapy for Hematological MalignanciesKanvinde S, Bhargava P, Patwardhan S. Indian Pediatr. 2013 Feb;50(2):197-201. Abstract:Objective: Unlike hematopoietic stem cell transplantation (HSCT), there is very little information on cytomegalovirus (CMV) related cytopenias occurring in patients having acute lymphoblastic leukemia (ALL) or Non Hodgkins lymphoma (NHL) receiving standard dose chemotherapy (SDCT). We present our experience regarding role of CMV infection in causing cytopenias after SDCT for childhood ALL or NHL. Design: Retrospective study Setting:Pediatric Oncology Unit. Method: Between January 2007 and March 2010, we screened in children having ALL/ NHL having prolonged cytopenia (ANC<1,000/cmm and / or platelets<1,00,000/cmm; > 10 days beyond date for next chemotherapy; not explainable on basis of previously administered chemotherapy) for CMV infection. Testing for CMV infection was done by pp65 antigen assay, qualitative or quantitative RTPCR. CMV positive episodes were analyzed for relationship to previous chemotherapy, clinical features and response to treatment. Result: As defined, 24 episodes of cytopenia were identified. CMV infection detected in 13 / 24 (54%) episodes in 9 patients. Duration of cytopenia in patients having CMV infection: 14-126 days (median 28 days). Neutropenia or thrombocytopenia seen in 11/13 and 13/13 episodes, respectively. Fever (2-20 days) and loose motions (3-60 days) in 11/13 and 9/13 episodes, respectively. Eye examination records were available in 5 children; simultaneous or delayed chorioretinitis. Gancyclovir was used in all but 1 CMV-positive episodes. In treated cases, counts recovered after a median of 8 days (3-56 days). Conclusion: Following chemotherapy for ALL/NHL, cytopenia that is prolonged or not explainable on the basis of chemotherapy toxicity should be evaluated for CMV infection.
Therapeutic hypothermia for non ventricular fibrillation / ventricular tachycardia cardiac arrest.
S Jog, D Patel, M Patel, et al : 32nd International Symposium 12th March 2013
Abstract:
Introduction: Although efficacy of therapeutic hypothermia (TH) for cardiac arrest following ventricular tachycardia (VT)/ventricular fibrillation (VF) is a recommended therapy, the efficacy of TH for non-VF/VT cardiac arrest is still not well studied. We conducted a study to evaluate efficacy and outcomes of TH in non-VF/VT cardiac arrest patients in terms of survival and neurological outcome. Methods TH was initiated with intravenous ice-cold saline and maintained with an external servo controlled cooling system (ESCCS); by Blanketrol II Hypo-Hyperthermia system (Cincinnati Sub-Zero Inc.) between 34 and 32°C for 24 hours. Gradual rewarming was also done with ESCCS. Non-VF/VT cardiac arrest patients with GCS ≤7 at 60 minutes of return of spontaneous circulation (ROSC) were enrolled. Standard hemodynamic monitoring and management was continued in all patients. Results A total of 13 patients with average GCS of 3.4 at 1 hour after ROSC were enrolled in the study. Average time for ROSC was 16.5 minutes. Demographic and baseline variables were comparable amongst survivors and nonsurvivors except age (survivors 43 years and nonsurvivors 65 years). Average duration to achieve target temperature was 4.9 hours. Five out of 13 (38.46%) patients survived without any neurological deficit or cognitive dysfunction (Cerebral Performance Category - 1). Out of eight nonsurvivors, six died due to cardiogenic shock, one died due to refractory hypoxia and in one case relatives opted for withhold of aggressive care. Cardiac arrest was out of hospital in eight patients (three survivors and five nonsurvivors) and intra-hospital in five (two survivors and three nonsurvivors). Conclusion: TH may have beneficial effects in the neurological outcome of patients having non-VT/VF cardiac arrest. Additional controlled studies are warranted to establish efficacy of TH as a treatment for non-VT/VF cardiac arrest
Early application of high frequency oscillatory ventilation in „H1N1 influenza‟ related ARDS is associated with better outcome: a retrospective study.
S Jog, D Patel, T Dravid et al. Critical Care 2012, 16:P111
Abstract:
Introduction: High-frequency oscillatory ventilation (HFOV) is a promising rescue modality for refractory hypoxia and was used extensively in H1N1 influenza-related ARDS in 2009 and 2010. The aim of this study was to find predictors of successful outcome of HFOV in H1N1 influenza-related severe ARDS
Method: Patients with H1N1 influenza-related severe ARDS by the new Berlin definition (applied retrospectively) receiving volume-controlled ventilation (VCV) as per the ARDS net protocol with PO2/FiO2 ≤100 at PEEP ≥12 cmH2O and FiO2 ≥0.7 were connected to HFOV as a rescue therapy for refractory hypoxia. All patients were followed until discharge from the hospital (survivors) or death (nonsurvivors).
Result: About 80 parameters were evaluated as outcome predictors of HFOV like demographics, comorbidity, clinical features, laboratory parameters, X-rays, ventilatory and blood gas parameters and therapy-related complications. Previously collected data of 19 patients were analysed applying the new Berlin definition. Demographic, clinical, comorbidity, laboratory and radiological parameters were comparable in survivors and nonsurvivors. Table 1 shows comparison of survivors and nonsurvivors with respect mainly to ventilatory and gas exchange parameters before application of HFOV. Duration of conventional mechanical ventilation before HFOV, 1.4 ± 0.69 versus 3.66 ± 3.53 days (P = 0.03), was the only discriminating parameter between survivors and nonsurvivors.
Conclusion: In H1N1 influenza-related severe ARDS, early application of HFOV is a significant predictor of successful outcome.
17
1818
Validity and Reliability of English and Marathi Oswestry Disability Index (ODI) in Indian population
V. D. Joshi, P.. D. Pai Raiturker and A. A. Kulkarni
Spine: 2013/02/06
Abstract:
Study Design: Survey. Total 200 LBP patients completed English and Marathi ODI questionnaire (100 each), visual analogue scale (VAS) and Roland Morris Disability Questionnaire (RMDQ).
Objective: To validate English and Marathi version of ODI. Background Data: Patient-orientated assessment methods are important in the evaluation of treatment outcome. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with patients with low back pain (LBP).
Methods: An adaptation of the ODI for Marathi language was carried out according to established guidelines.
Results: Average age of patients who answered English ODI was 42 +/- 15 while Marathi patients were 52 +/- 15 years. About 40% were men. Cronbach's alfa reliability was 0.877 for English and 0.943 for Marathi. 47 and 53 of these patients were retested with English and Marathi ODI within 2 weeks (to assess test-retest reliability). The interclass correlation coefficient (ICC) for the test-retest reliability of the questionnaire was 0.877 and, 0.943 for English and Marathi respectively. The ODI scores correlated with VAS pain intensity (r = 0.67, P < 0.0001) and RMDQ score (r = 0.71, P < 0.0001) for English and VAS (r = 0.325, P < 0.001) and RMDQ scores (r = 0.503, P < 0.0001) for Marathi. Receiving Operating Curve analysis showed comparable performance in discriminating the existence of sign and symptoms (AUC = 0.947 p<.0001, 95% CI: .893 - .999 for English and Marathi (AUC: 0.834, p<.0001, 95% CI: 0.735 - 0.933) for severe compared to non severe LBP proving discriminative validity. Results showed that English ODI is valid and reliable. Conclusion: Marathi version of Oswestry questionnaire is reliable and valid, and shows psychometric characteristics as good as English version. It should represent a valuable tool for use in future patient-orientated outcome studies for population with LBP in India.
Public awareness of clinical trials: A qualitative pilot study in Pune:
Veena Joshi, Aditi A. Kulkarni: Perspect Clin Res. 2012 Oct-Dec; 3(4): 125–132.
Abstract :
Context: Medical expertise combined with availability of patients with varied diseases have resulted in rapid increase in number of clinical trials ( CTs) recruiting millions of patients in India. Yet, few researchers have tried to understand if the public in India is aware of CTs.
Aims: To explore the awareness, perceptions of and attitudetowards participating in CTs among general public in Pune. Materials and Methods: Focus group discussions (FGDs)and interviews were conducted by contacting people in the community of various age groups and socio economic status with 7 Trial participants (TPs) and 17 Non Trial Participants(NTPs). The survey tool consisted of open-ended questions that assessed the awareness and attitudes of the individuals regarding the CTs. Interview were recorded on paper and translated from (Marathi) local language to English for analysis. Qualitative analysis was used to report the findings. Results: Most participants could associate CTs with medicine or development of new medicine; however they did not have a good understanding of the manner and safeguards with which CTs are conducted. Participants were not aware about different types of CTs and phases of the CTs. CTs were felt to be of benefit to the community and advancement of science. However, due to fear of adverse effe cts, 80% of the respondents were not ready to participate in the CTs. Conclusions: The Indian Pharmaceutical company is the world‟s 3rd largest by volume as per Dr. Shivathanu Pillai‟s report 17th March 2010, in spite of that it has been noticed that the awareness about CTs is very low; therefore there is a need to create awareness about CTs which helps the participants to participate in CTs based on their own decision. These FGD findings require validation in a larger sample.
1919
Tuberculosis of Larynx Revisited: a Report on Clinical Characteristics in 10 Cases.Gandhi, Sachin; et al : Indian Journal of Otolaryngology & Head & Neck Surgery;Jul-Sep2012, Vol. 64 Issue 3, p244
Abstract
Tuberculosis is the most frequent granulomatous disease
involving larynx. In most cases it is secondary to pulmonary
tuberculosis. Incidence of tuberculosis is now on a rise due to
increase in incidence of immune deficiency states. Here we
present a report of clinical characteristic of laryngeal tuberculosis
based on our experience of 10 cases. A detailed retrospective
analysis of 10 patients of laryngeal tuberculosis was done at our
tertiary care laryngology centre. Majority of patients had change
of voice and dry cough. All the patients had hyperemia and
edema of vocal cords. 80% patients had involvement of the
arytenoids and ary-epiglottic folds. Frank granulomatous growth
was seen in 70% of patients. In all patients histopathological
report was consistent with tubercular granuloma. Two patients
had associated pulmonary tuberculosis. Eight patients did not
reveal any feature suggestive of previous or co-existent
pulmonary tuberculosis. All patients responded to chemotherapy
with complete resolution. Primary laryngeal tuberculosis is not as
rare as generally considered. This series provides an insight
towards clinical feature, growth pattern and management of
tuberculosis of larynx.
Case Reports - Prenatal diagnosis of subglottic
hemangioma
S Gandhi: Journal of Laryngology And Voice
Association Vol-2 Issue – 2 (2012) 93-94
Abstract:
Hemangioma is by far the most common lesion of
the subglottic airway in newborn and infants. It may
cause severe, even life-threatening respiratory
obstruction. A definitive diagnosis is based on direct
endotracheal inspection of the subglottic airway.
Plain radiograph of the neck may aid in establishing
the diagnosis prior to endoscopy. This is a case
report of prenatal diagnosis of subglottic
hemangioma by fetal MRI and its management by
planned delivery and tracheostomy.
20
Remission in juvenile-onset recurrent respiratory papillomatosis
Sachin Gandhi, Reba Jacob: J Laryngol Voice 2012;2:30-4
Abstract:
Background: Juvenile-onset recurrent respiratory papillomatosis
(JORRP) is a distressing disease due to relentless recurrence and
progression. In JORRP, recurrence is a rule, but remission can be
considered if the disease-free period after a particular treatment
modality is more than one year. Objective : The present study was
undertaken with the aim to address this dilemma of remission in
JORRP. Materials and Methods: A total of 30 patients of JORRP
presenting over 2 years were included. Detailed history,
aggressiveness of disease, number of surgical interventions, and
surgical modality used were elicited. Videolaryngostroboscopy was
performed in all patients using Kays RLS 9100B stroboscope.
Papilloma excision was done using CO 2 laser and all patients were
followed up three monthly for 1 year, then were kept on yearly
follow-up. Results: It was observed that majority of the patients
(83%) underwent recurrent excision of papillomas for 1 to 5 times. Of
the 30 patients, 15 (50%) showed remission. Eleven of the 30 patients
(36.67%) had minimal papillomas and symptomatic recurrence of
papilloma was seen in four of the 30 patients (13.33%) and required
further surgeries. Nine of the 30 patients who showed remission were
diagnosed and managed within 1- to 15-year age group. Six of the 30
patients who presented with recurrence and minimal papillomas were
in the age group 31 to 45 years. These patients had transition of
JORRP to adult papilloma. Conclusion: The present study shows that
the chance of remission is higher in children who had an early onset
of JORRP. Remission was more when surgical excision was done
only with CO2 laser.
Trucut biopsy - An effective diagnostic tool in laryngeal and hypopharyngeal cancers: A preliminary study .Gandhi S et al. J Laryngol Voice 2012;2:85-8
Abstract:
Background: Laryngeal and hypopharyngeal cancers
are commonly diagnosed by histopathological
examination of a punch biopsy specimen from the
lesion. The histopathological report of the punch
biopsy specimen in certain cases is inconclusive,
most commonly in cases of endophytic
growths. Objective: To evaluate the efficacy of trucut
biopsy as a diagnostic procedure in such cases of
laryngeal and hypopharyngeal growth which are
clinically malignant but histopathology report by
punch biopsy is inconclusive. Materials and
Methods: Seven cases with clinical suspicion of
laryngeal or hypopharyngeal malignancies but with
inconclusive histopathological examination on punch
biopsy were included. Trucut biopsy was performed
in them. 6 out of the 7 trucut biopsies were found to
be malignancies on histopathological
examination. Conclusion: Trucut biopsy is promising
diagnostic tool in laryngeal and hypopharyngeal
malignancies especially in those cases where there is
strong suspicion of malignancy and the punch biopsy
does is inconclusive.
20
2121
Prevalence and Causalities of Tobacco Consumption (TC) among Adolescents: A Cross Sectional
Study at Pune:
DS Kelkar , M Patwardhan , VD Joshi: JAPI • March 2013 • VOL. 61:174 - 178.
Abstract:
Background: Health risks associated with tobacco consumption (TC) are well known. The aim of this study was to assess
the prevalence and causality of tobacco consumption among adolescents.
Methods: A cross-sectional study was conducted with 6577 participants aged 12 to 20 years from 21 schools & colleges
in Pune during year 2005/6. Data on socio demographic profile, family members‟ tobacco habits & respondents‟ tobacco
consumption habits were collected by self-administered questionnaire. Convenience sampling method was used for data
collection.
Results: Complete information on age, gender and participants‟ consumption of tobacco was available for 6119 students.
This data was used for analysis. Average age of the students was 16.9 ±1.79 years. 51% were boys. 9% lived in the
hostels. Prevalence of TC was 4.2% (256). Prevalence increased from 2.1% at <14 years to 9.8% at 18 to 20 years of age.
Respondents aged <14 years spent about Rs. 110 per month on tobacco while those over 18 years of age spent about
Rs.142 per month (P<0.05). Significantly (p< 0.0001) more boys (85.2%) consumed tobacco compared to girls (14.8%).
Hostel residents consumed tobacco more than those not living in hostel (13% Vs 8.6%). Significantly more (p<0.0001)
number of fathers and brothers of TCs consumed tobacco than non TCs. (Fathers: 53.1% Vs 29.7%), (Brothers: 5.7% Vs
1.1%).
Conclusion: Tobacco consumption among adolescents in Pune is low. However to reduce it further, intervention should
start prior to teenage before they form their opinion & start consuming tobacco
Report on“Conference on emerging issues in ethics and regulation of medical research”
Veena Joshi, Avinash L Joshi
Indian Journal of Medical Ethics Vol X No 2 April-June 2013.
“Case Report On Johanson-Blizzard Syndrome”
Koumudi Godbole, Sukalo Maja, Hiremath Leena And Zenker Martin
Indian Pediatrics Volume 50__May 16, 2013
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Presented as Moderated Discussion in the Conference: Advancing Ethical Research 3 to 6 Dec 2012,
San Dieago, USA
Public Awareness of Clinical trials: A Pilot study in central west India
Veena Joshi, Gauri Oak, Aditi Kulkarni, Varada Bivalkar
Background: Over 100 companies are currently conducting clinical trials (CTs) in India recruiting millions of participants. But, few researchers have thought about public‟s awareness of CTs. The objective of this study was to explore public awareness of CTs and their opinion on various methods to create CT awareness.
Method: Cross sectional survey was conducted (Dec 2011 - Feb 2012) with 200 Non Trial Participants (NTP) and 40 Trial Participants (TP) by contacting friends / relatives of patients who were seeking treatment at outpatient clinics at a tertiary hospital in Pune city. TPs and NTPs had to answer same eight questions on CT awareness.
Results: 200 out of 235 (85%) NTPs and 40 out of 43 (93%) TPs agreed to participate in the study and completed the questionnaire. TPs were significantly (p <.0001) older than NTPs (51 ± 15 vs 39 ± 14 years). There were more men TPs than NTPs (60% vs 48%). Care was taken to include NTPs from all socio economic categories. 25% of the NTPs claimed that they were aware of CTs. However, among them, few percent participants did not know that CTs are conducted on animals (20%); CTs are conducted on humans (16%), CTs are conducted for the development of new drugs (6%) and18% thought that CTs are conducted only on terminally ill patients. None of the NTPs were aware of the number of phases conducted in CT and only one participant (1/200) knew about the various different types of trials conducted. Among TPs, 72% participated because they trusted the doctor. 95% confirmed that trial was explained to them; however, 20% of TPs did not know which type of trial they had participated. 96% of all participants felt that CT awareness must be created among general public. Conducting seminars, workshops, talks (96%). imparting results of completed studies, use of print media, including clinical trial related topics in higher secondary syllabus, TV serial on clinical study, putting posters in hospitals and clinics (all 87%) are the best ways to create CT awareness.
Conclusion: Clinical Trials are not well understood by general public. There is urgent need to create CT awareness in India so that participation can be a conscious decision.
Validity and Reliability of Public Awareness of Clinical Trials questionnaire.
Veena Joshi, Gauri Oak, Aditi Kulkarni, Varada Bivalkar
Background: Thousands of people participate in various Clinical Trials (CTs). We designed a survey questionnaire based on focus group discussions and interviews with non-trial participants (NTPs). The aim of this pilot study was to determine the factor structure, reliability and validity of statements in Public Awareness and Perceptions of Clinical Trials survey questionnaire. Method: After deciding the face and content validity, cross-sectional study gathered data on 200 NTPs, age >/=21 years in Erandawane area of Pune city from December 2011 through February 2012. Fifty participants were re tested within one week. Data was analyzed using an exploratory factor (principal component) analysis [PCA] to obtain the factors. The survey employed 27 statements on knowledge about CT, CT benefits / risks, reasons for participation and awareness of CTs which participants ranked on a five-point Likert scale. We determined construct validity, Cronbach's alpha coefficient to determine internal consistency reliability, test retest reliability, and correlation of the sub-scales with age, occupation and education to determine convergent and divergent validity. Results: Average age of the participants was 39 +/- 14 years. 48% were men. After checking the interclass correlations, four items were removed due to poor item-total correlation. The exploratory factor analysis identified five critical factors (F). Benefits of CT (F1), Risks of participation in CT (F2), Knowledge of participation and consent (F3) and Awareness about CTs (F4 & F5). These factors explained 66.19% of the variance (using PCA), The result was confirmed using Principle axis factoring (PAF). Reliability Cronbach's alpha was .817 for all 23 statements. Test retest reliability was .858. Correlation of items within subscales was higher than correlation of items outside subscales in 90% of the cases. CT participation and. consent formalities subscale significantly (p </=.05) differentiated between those who were aware and those who were not aware about CTs. Knowledge of participation, benefits and risks subscales were found to have significant associations with socio economic status, confirming convergent and divergent validity.
Conclusion: This pilot study provided practical, reliable and valid survey instrument to assess public perceptions of clinical trials. The result needs to be confirmed with large, diverse population by applying Confirmatory Factor Analysis.
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Grants awarded by DMHRC for various projects
Name of PI Name of Project
Dr Koumudi
Godbole
Outcome of pregnancies with a high risk maternal serum screen for chromosomal
aneuploidy.
Dr Sanjeev
Mangrulkar Overview of trends of management of hypertension in the city of Pune
Dr Anand
Shinde
The pilot study to find out the prevalence of Metabolic Syndrome and Erectile
Dysfunction young males with Infertility
Dr Sampada
Patwardhan
Clinicomicrob analysis of tuberculous spondylodiscitis, A Retrospective Study
Dr. Sadanand
Naik
Role of Maternal Nutrition in breast milk quality and fetal metabolism
Dr Vaishali R
Deshmukh
Knowledge change in adolescent
Table 1: Grants given by DMHRC
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Name of PI Name of Project Grant received
Dr D.S. Kelkar
Manisha
Bhattacharya
The Provider perspective on Oncology Care System
in India
Duke University School of
Medicine
Dr Rahul
Kulkarni
A prospective, longitudinal, case control,
observational study of cerebral venous sinus
thrombosis in Western Maharashtra, India risk
factors, clinical presentations and complications
Poona Vascular Group and
Pfizer
Dr Sameer Jog FENICE Trial ( Fluid Challenges in Intensive Care) European Society Of
Intensive Care
Grants Received from outside agenciesTable 2: Grants given by Outside Agencies
Our Collaborators:Mr. Anil Nene & Dr.Ashwini Nene UK. Dr. Gokhale had supported Neem project.
supports Integrated Research;
JPSS: Five psycho-social projects, Dhavle trust : Promotion of homeopathic research
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Awards & Achievements
Table 3: Awards received from May 2012 to April 2013
Received Registration from DCGI no-
ECR/15/Inst/Maha/2013
Dr. Vrunda Sethi, Dr. Veena Joshi, Dr. Vijayshri Bhide, Dr. Amol
Bapaye Second prize at International CME in Pathology, Histopathology and
Cytopathology, Goa Medical College, 7-9th February 2013
for oral presentation on Diagnostic Utility of endoscopic ultrasound
guided FNAC/FNAB and the role of on-site cytopathologist
Completed Ph.D in Biochemistry from Pune University in March 2013
Student: Namita Mahalle, Biochemistry Section, Pathology
Department, DMH Guide: Dr. M.V.Kulkarni, Biocehmistry division, Chemistry
department, University of Pune Co-Guide: Dr.S.S.Naik, Biochemistry Section,
Pathology Department, DMH
Subject: A study on risk factors for cardiovascular disease: An I
ntegrated approach involving Biochemical and Ayurvedic principles
Dr. Veena Joshi received full scholarship from Public
Responsibility in Medicine and Research ( PRIM&R) to present a paper at
Advancing Ethical Research (AER) Conference at San Dieago, Dec. 2012.
News paper Article on Smoking among Adolescents “Prevalence and
Causalities of Tobacco Consumption (TC) among Adolescents: A
Cross Sectional Study at Pune”( 17th April 2013, DNA).
1st prize: Ethical Issues in HIV Positive Couples‟ Fertility, Dr. Kaveri Gavade1,
Dr. Anand Shinde2: 1 Research Department, 2 IVF center: 12 jan 2013:
Emerging Issues In Ethics & Regulation Of Medical Research.
Total No. of papers published 15
Total No of papers accepted 03. 26
DNA Article: 17th April 2013 Loksatta Article: 14th Jan 2013
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Training programs conducted Table 4: Training Conducted from May 2012 to April 2013
Topic Date Trainer
Informed Consent Document 13/09/2012 Dr Chetan Deshmukh
GCP training 18/12/2012 Pfizer
ICH GCP 22/02/2013 Quintiles
Revised SOP and GR 21/03/2013 Dr Avinash Joshi
“Conference on Emerging issues in Ethics and Regulation
of Medical Research” Held on 12/01/2013
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Training attended by Research staff-
1. Research methodology workshop by JPSS
2. ICH GCP work shop by BJMC
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What next….?
• Enhance core competencies of research staff
• Increase research culture and awareness
• Further Improve Quality of research studies
• National and International grants for research studies
• Research Collaboration with other hospitals/Institutions
• Further impetus to Integrated Research
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