8th Winter Symposium

Christian Medical College, Vellore

3rd South Asian Regional Symposium on
Evidence Informed Healthcare

Theme: “Evidence for Better Health”

Date: 11th - 14th January 2010
Venue: Scudder Auditorium, CMC Campus, Bagayam, Vellore

Supplement

Plenary Session Abstracts &

Poster Abstracts
Organised by

Prof BV Moses & ICMR Centre for Advanced Research and

Prof BV Moses & ICMR Centre for Advanced Research and Training in Evidence Informed Healthcare &
Training in Evidence Informed Healthcare,
South Asian Cochrane Network & Centre, II Floor, Carman Block, South Asian Cochrane Network & Centre
Christian Medical College, Bagayam, Vellore 632 002
Tel: +91 416 2284499 / 2284504 Fax: +91 416 2260085
Sasika's
9443686650

Email: cochrane@cmcvellore.ac.in
Website: www.cochrane-sacn.org
www.cochrane-sacn.org

Comparison of effectiveness of allopathic treatment with
herbal treatment for uncomplicated upper respiratory
tract infection in Jamunamarathur Tribal Primary Health
Care Centre of Tamil Nadu
(Dr. M.Abdul Kareem *, Dr. M. S. Subramaniam **,
Dr. K. R. John***)
*Senior Program Officer, Foundation for Revitilization of
Local Health Tradition, Bangalore,
** Department of Botany, Kongunadu Arts and Science
College, Coimbatore,
***Professor, Department of Community Medicine,
Chiristian Medical College, Vellore
BACKGROUND: Today it is very evident that the local health
traditions at house hold level show that there is a decline
in the usage of home remedies, traditional diets and health
customs. This situation demands a movement that
incorporates local resources and local knowledge for
enhancing health security by promoting under a public
health system for the wider use. Hence there is a need to
research and promote the proper use of traditional medicine
by developing and providing international standards,
technical guidelines and methodologies on the
effectiveness. In this study one formulation for cough due
to upper respiratory tract infection has been selected from
the ethno botanical documentation of the local healer.
AIM: To study the effectiveness of herbal cough syrup
compared to allopathic treatment for uncomplicated upper
respiratory tract infection.
METHODOLOGY: Randomized control clinical trial. Settings:
Out patients of Jamunamarathur Primary Healthcare Centre
in the Javadu hills, in Thiruvanamalai. Participants: 64
participants (32 in each arm) were recruited from amongst
the patients suffering from uncomplicated upper respiratory
tract infection. Intervention: One group received the
allopathic treatment of benadryl syrup, paracetamol tablets
and a saline nasal drop. The other group got the herbal
cough syrup, with masked tablets and nasal drops.
Examined twice (3rd and 7th day), during the length of the
week long follow-up. Method: Patients were randomly
allocated to receive either the herbal cough syrup or
allopathic treatment.
RESULTS: Baseline sex and age of both groups were similar.
Thirty-one patients completed the follow-up in each arm.
The results of the trial indicated that 20 out of 31 patients
(65%) were cured with the allopathic drug and 18 out of the
31 patients (58%) were cured with the herbal syrup. There
was no report of any adverse events or side effects. Epi-
Info 6.04 (CDC, Atlanta, USA) software was used for analysis.
Conclusions:
• The study drug has been found effective (58 % cure rate)
for the population under condition.
• There is only 7% difference in the cure rate between the
allopathic arm (65%) and the herbal arm (58%). The P
value= 0.602, P>.05, the difference of effectiveness
between two arms is not significant. Hence the herbal
cough syrup can be acceptable as alternative cure for
cough due to URI.
• No adverse effects have been reported during the present
clinical study.
Editorial policy and the reporting of Randomized
Controlled Trials in Indian Medical Journals
in 2004 & 2005 compared to 2007 & 2008
Aneesh George, Richard Kirubakaran, Prathap Tharyan,
Jabez Paul, Manuel Raj
Prof. BV Moses & Indian Council of Medical Research
Center for Advanced Research and Training in Evidence
Informed Healthcare;
South Asian Cochrane Network & Centre, Christian
Medical College, Vellore, India
Background: Editorial requirements for submission of
reports of Randomized Controlled Trials (RCTs) in 2005 and
the quality of reporting of RCTs in 2004 and 2005 in Indian
medical journals were suboptimal [1].
Objectives: To assess the changes in editorial policy for
manuscript submission in 65 Indian medical journals in
2008 compared to 2005 the quality of reporting of RCTs
published in these journals in 2007-2008 versus 2004-2005
Methods: We included 65 Indian medical journals
identified from the South Asian Database of Controlled
Clinical Trials (www.cochrane-sadcct.org) that provided
data for the earlier survey.AG and RK independently analyzed
their instructions to authors for endorsement of the
CONSORT statement and the ICMJE requirements for
reporting of RCTs.AG and RK independently evaluated reports
of all RCTs published in these journals in 2007 and 2008
against 13 selected CONSORT items and the ICMJE
requirements. All data were verified by PT. We compared
the proportion of reports in 2004-2005 versus 2007-2008
that endorsed selected CONSORT and ICMJE items
RESULTS: Of the 65 journals, 38 (59%) in 2005 and 37 (57%)
in 2008 mentioned the ICMJE requirements in their
instructions for authors, but only 20 (31%) in 2005 and 22
(33%) in 2008 specifically required authors to submit
manuscripts in accordance with the CONSORT statement.
Of 151 RCTs published in 2004-2005, and 145 RCTs
35
published in 2007-2008, only 4/13 (31%) of selected
CONSORT items were reported in > 50% of trial reports.
Reporting was better for some items reflecting internal
validity but worse or unchanged for others. Ethical issues
continued to be poorly reported, though reporting funding
sources and conflicts of interest had significantly improved.
Adequacy of reporting was not related to endorsing
CONSORT or the ICMJE requirements.
CONCLUSIONS: Editorial policy in leading Indian medical
journals regarding manuscript submission for RCTs
continues to be suboptimal. The reporting of RCTs for
CONSORT items reflecting internal validity was better in
2007-2008 over 2004-2005 for random sequence generation
but continued to be suboptimal for allocation concealment,
blinding and intention to treat analyses. The reporting of
conflicts of interest and funding sources had significantly
improved in RCTS published in 2007-2008 Urgent measures
to educate Indian medical journal editors are needed and
is planned.
Google Insights into The Cochrane Library usage in India: is
the national subscription being used?
Asokan GV1, Dave Sinclair2 and Prathap Tharyan3
BACKGROUND: Google Insights is a free-to-use internet tool
which tracks the popularity of specific internet search terms
over time.1 This simple tool has the potential to provide
real time data on public health concerns.2
OBJECTIVE: To investigate the way health information is
searched for in India via Google, and to evaluate interest in
searching for The Cochrane Library since the national
subscription was purchased by the Indian Council for
Medical Research in 2007.3
METHODS: Using “Cochrane” as the search term under the
category of “Health”, “medical literature and resources” as
the primary subcategory, and the period 2004 to 2009 as
the time frame, we evaluated
1. The most popular search terms in India used to identify
health websites/portals in India
2. Variation over time and between states in India and the
top four countries of Cochrane usage.
3. The volume of Cochrane-related searches compared to
some popular Indian and International medical
journals and health-related websites.
We also compared the Google Insights data with usage
statistics provided by Wiley-Blackwell, publishers of The
Cochrane Library.
RESULTS: ‘Cochrane’ consistently scored more frequently
than the four top-ranked Indian health portals (MedInd,
36
Health Library, Doctor NDTV and web health centre), over
the period studied. Interest increased dramatically since
the provision of the national subscription with the
maximum interest over time seen in Tamil Nadu,
Maharashtra, Delhi and Karnataka. Interest was sustained,
with peaks reflecting national Cochrane-related symposia
and activities. Australia, the UK, and Canada showed the
maximum interest in ‘Cochrane’, but since 2007, India has
overtaken the US. ‘Cochrane’ also scored above Indian
journals (Indian Journal of Medical Research, National
Medical Journal of India, Journal of the Association of
Physicans of India, the Postgraduate Medical Journal and
others) and international journals (NEJM, The Lancet, BMJ
and JAMA). However, ‘PubMed’ was by far the most
commonly-searched term in Google during these years. Data
from Wiley-Blackwell on actual usage of The Cochrane
Library from 2006-2008 mirrors the increased interest in
usage captured by Google Insights since the provision of
the national subscription
CONCLUSION: Google Insights is a proxy to evaluate interest
in Cochrane in India, and may reflect healthcare information
seeking behavior of healthcare professionals, researchers,
students, consumers, etc. These results are only indicative
and restricted to trends captured by a single search engine
with this capability. They also do not reflect direct access
to health-portal, journal, or database websites though
stored or forwarded web-links. However, they correlate with
direct data of usage statistics of The Cochrane Library. The
National subscription has increased and sustained interest
in The Cochrane Library, though high interest is limited to
certain states.
REFERENCES
1. Google Insights. Available at http://www.google.com/
insights/search
2. Ginsberg J, Mohebbi MH, Patel RS, Brammer L,
Smolinski MS, Brilliant L. Detecting influenza
epidemics using search engine query data. Nature.
2009 Feb 19;457:1012-4.
3. Tharyan P. Access to the Cochrane library for
everyone in India. National Medical Journal of India
2007; 20 (1): 49.
AUTHOR AFFILIATIONS
1
Research Officer, Institute of Veterinary Preventive
Medicine, Ranipet, Vellore District, India
2
Visiting Adjunct Fellow, South Asian Cochrane Network &
Centre; International Health Group, Liverpool School of
Tropical Medicine, UK.
3
Director, South Asian Cochrane Center, Prof BV Moses and
ICMR Centre for Research and Training in Evidence-Informed
Healthcare, CMC Vellore, India

COMPARISON OF CEFOXITIN AND OXACILLIN DISC
DIFFUSION TEST WITH OXACILLIN SCREEN AGAR FOR
DETECTION OF MRSA
Authors
Azhar Sheikh a
Dr.Vijayshri Deotale b
a
Student II MBBS| Mahatma Gandhi Institute of Medical
Sciences, Sevagram | Maharashtra
b was for penicillin after oxacillin.On comparison with
Professor of Microbiology| Mahatma Gandhi Institute of
Medical Sciences, Sevagram | Maharashtra
Correspondent Author: azhar4u27@gmail.com
INTRODUCTION: Today MRSA strains are worldwide major
cause of nasocomial infection. Mec A based detection
identifies even the most heterogenous strains of MRSA and
considered as gold standard. Cefoxitin surrogate marker
for for detection of mec A gene mediated methicillin
resistance.
Clinical and laboratory standard institute (CLSI) guidelines
2006: Cefoxitin disc diffusion test recommended for
detection of MRSA.
Why this research?:To evaluate the efficacy of cefoxitin disc
diffusion test to detect MRSA and compare it with oxacillin
agar screening.
METHODOLOGY: A total of 50 consecutive non-repeat
isolates of MRSA isolated from clinically relevant source
for period of 2 month. Isolates were identified by culture
and biochemical tests and were subjected for antibiotic
susceptibility testing by Kirby bauer disc diffusion method
(CLSI method). All Co-agulase positive staphylococcus were
tested for oxacillin susceptibility test.Inoculation of 0.5
MacFarland standard was done on Mueller Hinton agar
and detection for cefoxitin was done with help of disc of
cefoxitin 30 microgram applied on surface of media. On
Oxacillin screen agar inoculation of 0.5 MacFarland
standard was done. Even growth of single colony indicated
methicillin resistance.
RESULTS: Resistogram of MRSA strains:
ANTIBIOTICS RESISTANT
Erythromycin 34(68%)
Penicillin 46(92%)
Ciprofloxacin 28(56%)
Oxacillin 50(100%)
Cefoxitin 21(42%)
Linezolid 19(38%)
Chloramphenicol 22(44%)
Comparison of oxacillin disc,cefoxitin disc with oxacillin
screen agar:
Oxacillin disc Oxacillin screen agar Cefoxitin disc
50(100%) 50(100%) 21(42%)
Highest isolation of MRSA isolates were from pus
specimen(42%) followed by blood (14%) and conjuctival
swabs (14%).The prevalent age group from which samples
were obtained was 0-5 yrs age group. Maximum resistance
oxacillin disc with cefoxitin disc the oxacillin disc showed
100% co-relation with oxacillin screen agar whereas
cefoxitin disc could detect only 42% isolates.
CONCLUSION: Oxacillin disc diffusion test was found better
than cefoxitin disc diffusion test for detection of MRSA
strains.
The Cochrane Ark: are there animals studies hiding in
CENTRAL?
Clive E Adams1, Samantha Roberts1, Drew Davey1, Julie
Monalisa 2
1
Cochrane Schizophrenia Group, University of Nottingham,
UK. Email: Samantha.Roberts@nottingham.ac.uk
2
South Asian Cochrane Network and Centre, Christian
Medical College, Vellore, India
BACKGROUND: The Cochrane Central Register of Controlled
trials (CENTRAL) is a specialist register of electronic reports
of trials focused on living human beings.
AIMS: To investigate whether animal studies hide in
CENTRAL.
METHODS: We searched CENTRAL (Issue 1, 2009) using terms
for animals in title and then the title, abstract, keywords
combined function. The results were downloaded and
manually searched twice to ascertain whether trial
participants were indeed living human beings or animals.
RESULTS: CENTRAL positively clucks, moos, squeaks, meows
and even barks with the sound of wildlife. We initially
retrieved 11,443 records. After screening and removing
duplicates, 53 records were identified within CENTRAL as
reporting trials conducted on animals, and not on human
participants.
Conclusions: This small number is likely to be an
underestimate of what animal trials are really in CENTRAL,
because of the very strict inclusion criteria we used. The
inclusion of non-human trials [and other types of studies]
in CENTRAL devalues this key product of the Collaboration.
Simple measures could be adopted to clean much irrelevant
data from this important but flawed database.
37

Clinical Management of Acute Undifferntiated Febrile
(AUF) Illnesses with complications- Malaria during
Pregancy in India: Evidence gaps in Intermittent
Preventive Treatment (IPT)
Authors:
*
A.George Vasanthan *Anand Manoharan **Dilip
Mathai
Affliation: *Scientist (Research)
Infectious Diseases Training and Research Center (IDTRC)
Dept.of Medicine Unit 1 and Infectious Diseases
**Professor and Head
Department of Internal Medicine
Chief Mentor: Infectious Diseases Training and Research
Center
Prof.Benjamin Pulimood Laboratories for Infection
Inflammation and Immunity (BMPLIII)
ACC-CMC Trust for Infectious Diseases
Author for Correspondence:
Dr.Dilip Mathai MD PhD FCAMS FICP FIDSA
Professor and Head
Dept.of Internal Medicine
Christian Medical College
PO Box.No.3, 4th Floor SP Complex
Ida Scudder Road
Vellore 632 004
Tel: +00-91-416-228-2921/2923/2804
Email:dilipmathai@hotmail.com
Clinical management of acute undifferentiated febrile
illnesses in the community in India may be difficult as there
will be no single feature of any disease or common clinical
presentation to suggest etiology of a diagnosis. In most of
cases failure of an empirical therapy provided by a private
health care provider or lack of an intervention may lead to
severe complications as in case of malaria or dengue.
Malaria endemic in India (estimated 70-100 million cases
each year (1.6-1.8 million reported by NVBDCP) causes
complications during pregnancy if not treated early resulting
in still births, low birth weight, anemia, and maternal
mortality. In remote rural areas in malaria endemic zones
of Enhanced Malaria Control Project (EMCP) states,42.79%
among 12 million malaria positive pregnant women die
due to P.falciparum alone either at home or in the private
sector. This mandates further decentralization of health
care to such areas which have been adopted by the Norway
India Partnership Initiative (NIPI) to prevent maternal
deaths due to malaria or other causes in line with the MDG
5.Recognition of malaria in pregnancy as an important
public health problem in India, its delimitation,
stratification, and realistic calculations for planning and
interventions is a major health care measure to meet the
target in MDG5.
38
Though WHO recommends intermittent preventive treatment
(IPT) as the foremost intervention for preventing these
complications during pregnancy, Drug Policy of India, 2008
is not aligned with the evidence-based best practices
recommended by the Roll Back Malaria (RBM) initiative.
Global data (limited) suggest that artemisinins are effective
and unlikely to be cause of foetal loss or abnormalities,
when used in late pregnancy. However, none of these studies
had adequate power to rule out rare serious adverse events,
even in 2nd and 3rd trimesters and there is not enough
evidence to effectively assess the risk-benefit profile of
artemisinin compounds for pregnant women particularly
for 1st trimester exposure. Such evidence gaps in effective
IPT in the care and management of malaria in pregnant
women in India remains to be addressed through systematic
reviews of the effects of this intervention.
Accuracy of clinical assessment of Hyperbilirubinemia in
Hospitalized Neonates.
Authors
Gondnale Ga,
Taksande Ab ,Vilhekar KYc
a
II Year MBBS, Mahatma Gandhi Institute of Medical
Sciences, Sevagram
b
Associate Professor, Dept. of Pediatrics, Mahatma
Gandhi Institute of Medical Sciences, Sevagram.
c
Professor and Head, Dept. of Pediatrics, Mahatma
Gandhi Institute of Medical Sciences, Sevagram
Correspondent Author: cool.goral@gmail.com.
INTRODUCTION: Jaundice, a frequently encountered
diagnostic and therapeutic problem in newborns is quite
common affecting nearly 60% term and 80% preterm
neonates during first week of life. The standard method of
serum bilirubin estimation requires blood specimen taken
by heel prick or venepuncture which is painful and
expensive. Clinical evaluation of neonate through a
comprehensive history and physical examination is
considered as a cornerstone in neonatology.
Material and Methods: All newborns delivered in the
hospital were enrolled on 3rd day of life after a written
informed consent from the parents. Neonates who had
received exchange transfusion or phototherapy prior to
inclusion were excluded. 3 independent and blinded
observers- a trained medical student, a neonatology nurse
and a pediatric resident examined all the enrolled newborns
for jaundice in the standard manner and predicted total
serum bilirubin according to the cephalocaudal extent of
jaundice. Irrespective of interpretation of the index test
(clinical examination), blood was withdrawn from all
newborns immediately for estimation of total serum
bilirubin. The diagnostic accuracy of clinical examination
was measured by computation of sensitivity, specificity,
and positive likelihood ratios (LR+), negative likelihood
ratios (LR–). The precision of these estimates will be
evaluated by using 95% confidence intervals.
RESULTS: A total of 99 neonates were included in the study
between April and May 2009. A total of 64(%) neonates had
hyperbilirubinemia above 10mg/dL and 30 (%) above 15
mg/dL respectively. The sensitivity of clinical examination
for detection of hyperbilirubinemia was poor (range 10 to
70.3%). The specificity was reasonable (range 81.6 to 99.9%).
The positive likelihood ratios ranged from 2.19 to 22.2 and
negative likelihood ratios from 0.43 to 0.78. In event of a
positive clinical test, the chances of neonatal
hyperbilirubinemia are high, however a negative clinical
test does not rule it out.
CONCLUSION:All neonates need to be screened for
hyperbilirubinemia using standard bilirubin estimation
tests. Clinical assessment is likely to miss many neonates
with high bilirubin levels.
Key Words: Clinical Assessment, Neonatal
Hyperbilirubinemia, Accuracy, Reliability
Medicine: profession or trade?
Hari Prasad1, 2, Rishi Raj1, KR Bhagavan2, Sangeeta Das
Bhattacharya1
1
School of Medical Science and Technology, IIT Kharagpur,
India
2
Department of General Surgery, KS Hegde Medical
Academy, Deralakatte, Mangalore, India
BACKGROUND: Health information is now part of patients’
rights. Although physicians frequently underestimate the
importance of patient information, there are variations in
the extent to which patients want to be involved in active
decision making. It is therefore important to find out in-
advance whether some information may be unwanted, as
illustrated in our case.
CASE REPORT: A 3-months-old female with Tubular colonic
duplication with Recto-vaginal fistula underwent successful
right transverse colostomy along with side-to-side
anastomosis of the native and duplicated rectum aiming at
internal drainage. A few days after the surgery the surgeon
learnt that biopsy of the duplicated segment revealed
dysplastic changes. The parents were informed that the child
has an additional high risk of developing malignancy of
the duplicated segment. The new information however had
a negative effect on them. They stopped being well adjusted
and optimistic. Her parents believed that entire surgery has
been completed and she has to live rest of her life with the
colostomy in-situ. Hence they did not get the closure done
at the right time and since past 19 years she stools out
through this colostomy.
Now prior to her marriage, they were anxious to know her
fertility and made them to present her to us. We explained
her condition in detail along with a possibility of a
corrective procedure. The ascending colon, which initially
emptied into the colostomy, was anastomosed to the rectum.
The patient had an uncomplicated post-operative course.
DISCUSSION: It would be in conflict with the principle of
patient autonomy if the surgeon withheld important
information. But in our case, her parents already knew that
she requires a long term follow up and hence new
information does not imply any benefit other than a more
careful follow up. Hence the communication of the
information in this case probably could have been
postponed. On the other hand, her parents actually needed
more information and education regarding the type of the
defect, surgery done and the need for timely closure of the
colostomy and regular follow up.
CONCLUSION: General feeling of the public is that, “The job
of a doctor is to reassure and comfort the sick, not to frighten
them”. In our opinion, physicians need to be warned against
an attitude biased towards what “the rules say” more than
towards what the patient wants or needs. The respect enjoyed
in our society imposes certain moral responsibilities on
them, one being balanced presentations of necessary facts
which neither unduly alarm nor entice patients but
facilitates decision-making.
The Cochrane Schizophrenia Group Specialised Register
Julie Monalisa1, Samantha Roberts2, Clive E Adams2
1
South Asian Cochrane Network and Centre, Christian Medical
College, Vellore, India. Email: julie_sacn@cmcvellore.ac.in
2
Cochrane Schizophrenia Group, University of Nottingham, UK
BACKGROUND: The Cochrane Schizophrenia Group (CSG)
Specialised Register contains all reports of controlled trials
on severe mental/psychiatric illness, psychosis,
schizophrenia and related disorders with comorbid
disorders such as substance abuse, depression, personality
disorder or problematic behaviours/adverse effects
(aggression/antipsychotic-induced tardive dyskinesia). The
group maintains its register in a Microsoft Access database
(Meerkat 1.5 http://cochrane.co.uk/en/newPage1.html).
Meerkat stores references as studies (is a study-based
register), attaches to full text of reports, stores contact
addresses of group reviewers, tracks reports sent to authors
and has the capacity to link to the datasets within existing
Cochrane Reviews.
39
AIMS: To describe the specialized register of the Cochrane
Schizophrenia Group.
METHODS: Studies in the CSG register are identified from 83
databases and trial registers. Many of these searches are
undertaken on a regular basis (e.g. MEDLINE,
Clinicaltrials.gov). Records are formatted (using Endnote)
and relevant trials within the scope of the group are selected
and imported into Meerkat. Each imported study is coded
for method, participant, intervention and outcome. If a
record is identified as being part of another trial already in
the register the incoming record is merged into the existing
study. The register can be searched by either individual
reference or study using standard search terms and limited
boolean operator functions.
RESULTS: The CSG register contains both randomised
controlled trials (RCTs) and controlled clinical trials (CCTs).
It holds 14,217 individual references (all available with
full text), which form 11,675 coded studies in the register.
These references are in over 20 different languages, and
only 54% are found on PubMed or Medline.
CONCLUSIONS: The CSG register, built in free-ware software,
is a formidable tool for authors of reviews. It greatly
enhances the efficiency of supply of information to
reviewers, and reduces time taken to review.
Thai databases
Kamolthip Atsawawaranunt1, Clive E Adams2, Samantha
Roberts2
1
Faculty of Medicine, University of Srinakharinwirot,
Thailand. Email: y_rean@hotmail.com
2
Cochrane Schizophrenia Group, University of Nottingham,
UK
BACKGROUND: Thailand is a poor but highly literate country
of over 60m people in South-East Asia. Much biomedical
research is undertaken but dissemination is limited.
OBJECTIVES: To identify relevant Thai bibliographic
databases and investigate accessibility, functionality and
content - particularly in relation to randomised controlled
trials (RCTs) and clinical controlled trials (CCTs).
METHODS: A systematic search for institutions productive
of research, and the databases in their libraries. Use each
accessible database and recording of functionality and
content.
RESULTS: We found 32 different databases (29 accessible
in UK); of various sizes, coverage and functionality but many
with unique records of RCTs and CCTs (total n=781). 209 of
781 trials were accessible on PubMed (27%).
40
CONCLUSIONS: More collaboration within Thailand would
help merge databases and allow greater dissemination of
local work. Those undertaking comprehensive searches for
biomedical literature cannot afford to ignore the
considerable efforts of researchers in Thailand.
META ANALYSIS – Physiotherapy perspectives
Lenny Vasanthan T
Dept of Physiotherapy, Manipal University, Manipal.
Background: There is a wide gap existing between evidence
and practice because of large volume of literature, with
which physiotherapy practitioners are inundated.
Practitioners lack considerable time, skills to evaluate the
literature. One way of addressing this problem is to search
for a review article. Meta-analysis is an analytical strategy
used to analyse and combine the results of previous reports,
which gives a precise estimate of treatment effect.
AIMS: Meta-analysis aims to identify facts more accurately
than traditional narrative review. It delivers facts with
objectivity, helps in determining magnitude of effect and
resolve differences in literature.
METHODS: Meta-analysis is a 2 stage process
1. Data extraction and calculation of summary statistic
along with confidence interval
2. Calculation of a pooled average if appropriate.
It looks at results within each study and calculates weighted
average. QUOROM(Quality of reporting of meta-analysis)
is recommended, which is an explicit and objective criteria
for inclusion or rejection of studies. Funnel plot can be
done to examine publication bias. Sensitivity analysis can
be done to explore ways in which main findings are changed
by various approach to aggregation.
RESULTS: Great care has to taken to assess methodological
quality of design and execution of study. Quality check using
appropriate check list needs to be done, Heterogeneity of
studies should be checked as it influences the further method
of analysis. Forest plot is a pictorial representation used
to present the findings.
CONCLUSION: Helpful in determining small but clinically
significant effects with precise estimate of effect size, which
helps to add to the evidence base, thereby treat patients in
a better way. Pitfalls include overgeneralization, ignoring
qualitative difference between studies, dealing with main
effects only. Fundamentally meta-analysis is limited by
quality of underlying studies “GIGO” (garbage IN garbage
OUT)
References:
1. Cochrane open learning material 2002
2. Crombie.,EBM series 2009
3. DeCoster J.,Meta-analysis notes 2004
4. Helewa A., Critical evaluation of research in physical
rehabilitation 2000.
Ethics of inaccessibility of funded research publications
Dr.N.Isai Vani.
Assistant Professor, Department of Anatomy, Sri
Venkateshwaraa Medical College & Research Centre,
Pondicherry. Email: drisaivani@gmail.com
India is becoming the hub of clinical research. In
commensurate with these advances, the government funding
for biomedical research in thrust areas is also increasing.
Indian Council of Medical Research (ICMR), Department of
Biotechnology (DBT), Department of Science & Technology
(DST) are some of the government organisations which
provide financial support for various research projects.
The results of the funded research projects are published
in various international journals. Most of these journals
have an access to paid subscribers only. Hence it is unethical
to use the research grants from government (people’s tax)
and not allowing the scientific community a free access to
the results of the study.
This ethical issue can be overcome by forming a body to
which every investigator who has got grants would submit
the full text of the paper published from his study and these
can be made freely accessible to everyone in the website of
the newly formed body.
Such an initiative – PubMed central (PMC) already exists in
USA. Every investigator getting grants from National
Institutes of Health has to submit the full text of the article
published from his study, which would be made freely
accessible at PMC. The funding bodies in India should also
form an initiative similar to PMC and put an end to this
unethical act.
Bedside Capillary blood glucose measurement by
glucometers compared to venous blood glucose in critically
ill patients and find the Reliability Sensitivity and
Accuracy of point of care glucometer in MICU.
Authors
Manish Chandra Prabhakar a
SP Kalantri b
a
Student II MBBS| Mahatma Gandhi Institute of
Medical Sciences, Sevagram | Maharashtra
b
Professor of Medicine | Mahatma Gandhi Institute of
Medical Sciences, Sevagram | Maharashtra
Correspondent Author: prabhakar4u07@gmail.com
BACKGROUND: Healthcare professionals routinely measure
blood glucose measurement of all critically ill patients in
intensive care unit. The traditional reference standard,
venous blood glucose requires a venepuncture and
laboratories usually return the test results after 60 minutes.
We wondered if a point of care capillary glucose measured
by glucometer could be as accurate and reliable as blood
venous glucose.
METHODS: I studied consecutive patients admitted to an
intensive care unit between 1 May and 10 May 2009. I
compared the diagnostic accuracy of two- point of care
glucometers with laboratory venous glucose, the reference
standard. I used Bland- Altman plots and Clark error grid
method to analyse the results.
RESULTS: I studied a total of 110 patients (38[34%] women;
mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteen
patients (12%) were known to have diabetes. The mean
glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1);
range= 48 to 501 mg/dL; that by glucometer 2 was 152.2
mg/dL (SD 76.2); range= 30 to 458 mg/dL and by the
laboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480
mg/dL. Of the 110 subjects, 2(2%) had blood glucose below
70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)
had blood glucose exceeding 180 mg/dL. The Bland- Altman
plot showed a bias of 4 mg% (95% confidence intervals, -
9.8 to +1.1); and the limits of agreement were -63 and +54
mg%. The area under the receiver operating characteristic
curve for the two glucometers was 0.92 and 0.93
respectively. The error grid analysis showed that 80% (78/
110) samples lay within zone A, 22(110) in zone B and 1%
(1/110) in zone C.
CONCLUSIONS: Point of care glucose, measured by
glucometers was in agreement with the venous glucose
estimation. Both glucometers were equally accurate and
performed uniformly well across the wide range of blood
glucose values.
KEY WORD: Capillary blood glucose, Venous blood glucose
,Point of Care, Glucometer
GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS
Manusri Naredla, Keerthi Maddi.
St.Peter’s institute of Pharmaceutical sciences,
vidyanagar, Hanamkonda
Users of clinical practice guidelines and other
recommendations need to know how much confidence they
can place in the recommendations. Systematic and explicit
methods of making judgments can reduce errors and
improve clinical trials. Large scale healthcare interventions
are likely to improve the health of the public only if the
evidence clearly shows that the benefits outweigh harms
and costs. Often, however, the evidence if is the other way
41

the trials may fail to improve health, or may even cause
harm, while costing dearly. Moreover, when a large scale
intervention is implemented careful evaluation of the
evidence must and should replace wishful thinking and
guesswork or else the trials may prove to be enduring but
possibly result in harmful standard of care. Such
interventions should be implemented, therefore, only when
the evidence shows that expected benefits outweigh harms
and costs and this can be achieved by the implementation
of systematic evaluation.
Obtaining definitive evidence on the effects of large scale
interventions can be difficult and implementation with
careful monitoring is justified but how ever acting without
proof of net benefit is both costly and potentially damaging
to health. Graded evidence follows a hierarchy of evidence
consistent with randomized trials of high methodological
quality, followed by randomized trials with methodological
limitations, observational studies, and unsystematic
clinical observations. Inferences are stronger when the
evidence is summarized in systematic ways of representing
the evidence for better interpretation of the clinical as well
as observational trials.
EVIDENCE FOR BETTER HEALTH
SURVEILLANCE ON HOSPITAL ACQUIRED INFECTIONS IN A
TERTIARY CARE SET UP
Mrs. Meenakshi Sekar,M.Sc N
Associate Professor, College of Nursing, CMC Vellore
Former Infection Control Nurse Supervisor, CMC, Vellore
Dr. Karen Jacob, D.A.
P.G. Registrar, Department of Anesthesia, CMC Vellore
Former Hospital Infection Control Officer, CMC, Vellore
BACKGROUND:This surveillance of Hospital Acquired
Infections (HAI) was conducted among the inpatients of
Christian Medical College; Vellore which is a 2,572 bedded
Hospital located in Southern India. Surveillance of HAI in
any health care facility is an important aspect of Infection
Control. The early recognition of HAI through a
surveillance system is the first step to control HAIs. This
enhances quality care.
infection in the hospital by one third and improve the
morbidity and mortality figures of the hospital.
AIM AND CONTENT: The aim was to assess the incidence of
HAI among the inpatients of Christian Medical College;
Vellore. The surveillance was conducted in the 63-inpatient
areas of the Hospital. This included the wards; the ICUs
(Medical ICU, Surgical ICU, Neurosurgical ICU, Cardio
thoracic ICU, Pediatric ICU& Neonatal ICU) and other High
risk areas (Renal transplant Unit, Burns Unit and Bone
Marrow Transplant Unit).
METHODOLOGY: The Surveillance included all patients
admitted in the hospital for a period of one year (March
2005 to February 2006). All Patients who developed fever
after 48 hours of hospitalization were included in the group
of “Probable HAI”. HAI was ruled out in patients who
presented with fever at the time of admission or who
developed fever with in 48 Hours of Hospitalization.
The Infection Control Nurse (ICN) visited all the patients
admitted in the 63 areas of the hospital weekly twice. In
each ward/ICU, the ICN notes down the total number of
patients admitted and the number of patients with fever.
All patients with fever are then investigated to determine
if the fever originated 48 hours after hospitalization.
Following the CDC guidelines these patients were tentatively
designated as a case of HAI. The appropriate
microbiological investigations sent for each patient was
followed up to confirm the presence of HAI.
Following the CDC guidelines, the incidence of HAI was
calculated using the formula given below:
Infection Rate = Number of HAI per month x 100
Number of discharges per month
RESULTS: The following table gives the incidence of HAI per
month.

A protocol based on CDC (Centers for Disease Control)

Criteria for diagnosing HAI was designed for this purpose.
Hospital Acquired Infection results in (1). Substantial
morbidity, 2) prolonged hospital stay, 3) increased indirect
patient care cost and 4) mortality. They continue to affect
about five percent of hospitalized patients. (Roy, 2004)

Steed,C,J(1999) strongly states that there is evidence that

active hospital infection control programmes lead to
reduced infection and better patient care. Wiseman, S.
(2004).emphasizes that Routine surveillance can reduce

42
HAI and Infection Rate in CMC, Vellore (May 2005 to April Unequal Randomisation in Cancer Trials – A New
2006) Paradigm!

MONTH DISCHARGES HAI INFECTION AUTHORS: Meghana Surlikar , Sadhana Kannan and
RATE Vikram Gota.

March 2005 5588 14 0.25 % INSTITUTION: Advanced Centre for Treatment Research and
Education in Cancer (ACTREC), Tata Memorial Centre, Sector-
April 2005 5245 23 0.44 % 22, Kharghar, Navi Mumbai
May 2005 5558 22 0.44 % BACKGROUND: Randomised Controlled Trial (RCT) with
June 2005 5415 18 0.33 % balanced allocation of participants to the experimental and
control arms is a commonly practiced study design. The
July 2005 5645 18 0.32 % design is simplistic and therefore very appealing. However,
circumstances warrant unequal allocation of subjects to
Aug 2005 5852 21 0.36 % the different arms of the study. This systematic review
focuses on the trends in unequal randomization (UR) in
Sept 2005 5249 20 0.38 %
cancer clinical trials and the most common reasons for
Oct 2005 5249 31 0.59 % resorting to this approach.

Nov 2005 6013 34 0.57 %
Dec 2005 5760 39 0.68 %
Jan 2006 5307 53 0.99 %
Feb 2006 5147 58 1.10 %
There has been a slight increase in the Infection Rates over
the last six months. This is due to the fact that the criteria
for including patients was slightly revised. Patients who
were admitted with fever were also kept under constant
observation and any worsening of the fever or reappearance
of fever after becoming afebrile was included in he
surveillance.
CONCLUSION: The incidence of HAI for a period of one year
was found to be less than 1.1%. Low incidence of HAI is
evidence that Quality Care is being provided for the patients.
Regular surveillance for HAI contributes significantly to
ensure quality patient care especially in tertiary care
hospitals where many invasive procedures are carried
out. Abiding to the Hospital’s Infection Control Policies help
to reduce the risk of patients acquiring HAI.
REFERENCES: Roy,V.(2004). Clamp down on increased
nosocomial infections ways to arrest the high level of
nosocomial infections in hospital Express Health Care
Management. Issue dtd. 16th to 30th Retrived from http://
www.expresshealthcaremgmt.com/20040430/edit02.shtm
on Dec 2005.
Steed,C,J.(1999). Common Infections Acquired in the
Hospitals. The Nursing Clinics of North America Contemporary
Infection Control For Nurses, 34,(2),pp 443- 460.
AIM: A systematic review to identify reasons for UR in
oncology clinical trials published in five major cancer
journals over the last ten years.
Methods: A PUBMED search was undertaken to identify RCTs
in cancer published from January 1999 to December 2008
in five major cancer journals namely JCO, Annals of
Oncology, BJC, Lancet Oncology and JNCI. Forty three RCTs
that reported UR of subjects to different arms were selected.
Data was extracted for randomization ratio, reason for UR,
phase of the trial and trial location (Single or multicentre).
If the rationale for UR was not mentioned in the article, the
corresponding author was e-mailed to obtain the reason.
RESULTS: 1863 RCTs were identified. UR was employed in 43
studies (2.3%). The number of studies increased over the
years (0 in 1999 to 9 in 2006). Only 13/43 gave clear reasons
for adopting UR. Seven out of the remaining 30 authors
responded to an email request. The reason is not clear in
the remaining 23 reports. 29/43 trials used 2:1 ratio
followed by 2:1:1 ratio used in 11 % of the studies. The
reasons for UR in the 20 available reports are (a) to meet
statistical endpoint – 7 (b) to facilitate faster recruitment–
4 (c) to get more data on new intervention – 4 (d) ethics and
safety reasons – 2 (e) Others – 3. Fourteen were single centre
studies and 29 were multicentre. In 27 reports where phase
of the study was mentioned, there were 12 phase II, 14 phase
III and one phase IV trial.
CONCLUSION: UR appears to be an attractive alternative to
balanced allocation especially in small randomized phase
II trials. Statistical considerations and faster recruitment
are important reasons for resorting to UR.

Wiseman, S. (2004). Implementing effective Infection

Control in the Hospital Environment. Nursing Times, 100,
(38),pp 41-61.

43
 Aromatase inhibitors in clomiphene resistant women:
A randomized double blind placebo controlled trial.
Mohan S Kamath, Aleyamma T.K, Achamma Chandy, and
Korula George1
Reproductive Medicine Unit, Department of Obstetrics &
Gynecology, Christian Medical College, Vellore ,Tamil Nadu,
India - 632004.
BACKGROUND: Twenty five percent of anovulatory women
with polycystic ovarian syndrome do not respond to
standard clomiphene citrate therapy and are known as
clomiphene resistant. We investigated the use of letrozole,
an aromatase inhibitor as an alternative ovulation inducing
agent in these women.
METHODS: 36 women with clomiphene resistance were
randomized into two groups: one receiving letrozole 2.5mg
daily from day 2 to day 6 of the cycle while the other an
identical placebo. The primary outcome was the ovulation
rate with analysis being intention-to-treat.
RESULTS: The ovulation rate was significantly higher in the
letrozole group 6/18 (33.33%) as compared to none in the
placebo group (P= 0.015). The mean day 21 serum
progesterone was also significantly higher in the letrozole
group (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014).
One women in the letrozole group conceived and delivered
normally giving a clinical pregnancy and live birth rate of
5.5%
CONCLUSION: In clomiphene resistant women, letrozole can
be used as an effective and simple alternative ovulation
inducing agent. The trial is registered with clinical trial
registry of India (UTRN -017753618-3112200762223).
Clinical Trials Methods
Nailesh.T SLIMS, Villianur, Pondy605502 Email:
Nailesh.reddy@gmail.com
BACKGROUND: After completing the preclinical testing of the
drug in animals, the company files an investigational new
drug (IND) application with the regulatory authority for
permission to test the drug in humans.
AIMS: To collect the safety and efficacy data for new drugs or
devices.
METHODS: Depending on the type of product and the stage
of development, investigators enroll healthy volunteers and/
or patients into small pilot studies followed by larger scale
studies in patients that often compare the new product with
the currently prescribed treatment. As positive safety and
efficacy data are gathered, the number of patients is typically
increased. Clinical trials can vary in size from a single center in
44
one country to multicenter trials in multiple countries, trials
are conducted in 5 Phases
RESULTS: Phase 0 trials is a recent designation known as
human micro dosing studies has no data on safety or efficacy
of drug. Phase 1 trials Examines the pharmacologic actions
and safe dosage range of a drug; how it is absorbed,
distributed, metabolized, and excreted; and its duration of
action. Phase 2 trials are controlled studies in volunteers to
assess the effectiveness and safety of a drug. Phase 3 trials
are testing using a greater number of volunteer patients. The
drug is administered by practicing physicians to those suffering
from the condition the drug is intended to treat. These studies
must confirm earlier efficacy studies and determine low-
incidence adverse reactions. Phase 4 trials are studies
conducted after FDA approval, during general use of the drug
by medical practitioners, also referred to as post marketing
studies. Fast-track approval is provided for drugs that meet
unmet medical needs for patients with serious or life-
threatening conditions. Labeling is information distributed
about a drug by the manufacturer, even if it is not physically
affixed to the product. Misbranding is “false or misleading in
any particular” renders the product misbranded, making it
subject to FDA regulatory action.
Conclusion: These trials provide the tolerability,
Pharmacovigilance, Pharmacokinetic, and
Pharmacodynamics of the drug.
Access to evidence from countries in South Asia: The
South Asian Database of Controlled Clinical Trials and the
South Asian Cochrane Network and Centre’s Digital
Library – An Update
Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh
Parthasarathy
Prof BV Moses & Indian Council of Medical Research Centre
for Advanced Research and Training in Evidence Informed
Healthcare, South Asian Cochrane Centre, Christian Medical
College, Vellore, India
BACKGROUND: Many trials conducted in middle and low
income countries are published in journals that are not
indexed in commonly searched databases. Their exclusion
from systematic reviews could bias conclusions, rendering
them unreliable and potentially irrelevant to health care in
these countries.
OBJECTIVES: To describe the development of the South Asian
Database of Controlled Clinical Trials (www.cochrane-
sadcct.org) and the South Asian Cochrane Network &
Center’s Digital Library that aim to: provide a comprehensive
source in the public domain of all controlled clinical
interventional trials involving humans conducted in the
South Asian region, and published in regional journals,
and contribute information about these trials to the
Cochrane Central Register of Controlled Clinical Trials
(CENTRAL) in The Cochrane Library.
METHODS: Health Science Journals published from
Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,
Pakistan and Sri Lanka and reporting interventional trials
in humans conducted in these countries were sought from
multiple electronic and other sources and 168 journals were
identified. Online and print issues of these journals are
searched in regular cycles. Citations and abstracts of all
interventional trials identified from online editions and
hand-searching of print editions are entered into Endnote.
Trials are coded as RCTs or CCTs using standard criteria
and cleaned records imported to MeerKat, with web-links
provided to the original article, where possible. Full text
articles are indexed and stored using the Greenstone Digital
Library Software to create the South Asian Cochrane Network
& Center’s Digital Library that can be retrieved by Titles,
Author, Year, Journal and Keywords. All records are regularly
transmitted for inclusion in the Cochrane Central Register
of Controlled Clinical Trials (CENTRAL) in The Cochrane
Library.
RESULTS: The South Asian Database of Controlled Clinical
Trials, initiated in November, 2008, was launched on January
1, 2009 (www.cochrne-sadcct.org) and is searchable free
of charge. It currently contains the citations, abstracts and
web-links (where possible) to 2830 records [(CCT-1350
(47%); RCT-1477 (53%)] published in 65 Indian medical
journals, and 76 Pakistan Medical Journals. From
submitted records, the citations and web-links (where
available) to 1859 trials conducted in these South Asian
countries are now included in the Cochrane Central Register
of Controlled Trials (CENTRAL). Full text articles, in
downloaded or scanned portable document format (pdf),
are stored for most trials in the South Asian Cochrane
Network & Center’s Digital Library. In the ongoing second
phase, all 168 South Asian Journals (of which 101 (60%)
are not indexed in Medline) and newer journals identified
by ongoing searches will contribute trials, supplemented
by searches of conference abstracts, dissertations and other
sources.
CONCLUSIONS: The Cochrane Collaboration now has a
resource to access all the evidence generated from
interventional trials conducted in countries in the South
Asian Region. Many of these, hitherto unidentified, trials
can now be considered for inclusion in systematic reviews
of the effects of interventions in healthcare conditions
relevant to people in the region; these systematic reviews
have the potential to be of greater relevance in informing
healthcare and health-policy in these countries than before
the creation of this resource.
When ‘Evidence’ goes against the grain:
Quetiapine for Bipolar depression
S. Mohan Raj,
Consultant Psychiatrist, Chennai
BACKGROUND: Quetiapine is an antipsychotic medication.
In the last 3 years, there are attempts to promote Quetiapine
as being efficacious in Bipolar depression. Trials have
claimed efficacy and FDA has approved the use of Quetiapine
for Bipolar depression.
But, clinicians do not find Quetiapine to be effective in
Bipolar depression.
AIM: To analyse the possible reasons for this disparity
between trial results and actual clinical practice.
METHODS: Evaluation of the BOLDER II study1 (study titled
‘Efficacy of Quetiapine Monotherapy in Bipolar I and II
Depression’), using the Risk of bias table of Revman 5.
RESULTS:
The biases noticed were
1) Selection bias
Exclusion criteria mention
1.1 Current episode duration more than 12 months and
less than 4 weeks
(Comment: spontaneous remission is possible
around 6 months)
1.2 History of non-response to an adequate trial (6
weeks) of more than 2 classes of antidepressants
(Comment: Resistant depression is excluded)
1.3 Current serious suicidal or homicidal risk as judged
by the investigator
(Comment: Severe depression is excluded)
2) Incomplete outcome data were not adequately
addressed.
The other problems were
1) Definition of response as > or = to 50% reduction
from baseline score of Montgomery Asberg
Depression Rating Scale (MADRS)2
2) There are 3 items on MADRS scale (decreased sleep,
decreased appetite and inner tension) in which
Quetiapine can bring about 100% reduction in
symptoms irrespective of its antidepressant effects.
45

Another area of concern is that all the studies regarding
Quetiapine in bipolar depression were prepared with
‘editorial assistance’ from a medical communication
company called PAREXEL MMS), irrespective of the authors’
institution. PAREXEL’s website3 offers to write up a scientific
paper and boast of a 92% first time journal acceptance rate
in 2008.
Conclusion:
Mechanism need to be evolved to restrict approval of drugs
by regulatory bodies for indications for which no effect is
seen in clinical practice.
References:
1. Michael E Thase et al. Efficacy of Quetiapine
Monotherapy in Bipolar I and II Depression. A
double-blind, placebo controlled study (The BOLDER
II study) J Clin Psychopharmacol 2006;26:600-609.
2. Montgomery SA and Asberg M. A new depression
scale designed to be sensitive to change. Br J
Psychiatry 1979;134:382-389.
3. Parexel MedCom. http://www.parexelmms.com/
EVIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in
a medical college hospital
AUTHORS:John K R,Rakesh P S
AUTHORS AFFILIATION
1. Professor in charge of RNTCP$Head of the
Department,Department of Community Health,CMC
Vellore
2 Post graduate registrar,department of Community
Health,CMC Vellore
CORRESPONDING AUTHOR:John K R,Professor,Department
of Community Health,CMC,VELLORE
Email:mony@cmcvellore.ac.in
Ph:09443242603
BACKGROUND: The Revised National Tuberculosis Control
Programme(RNTCP) based on Directly Observed Treatment
Short course(DOTS) strategy was launched in India as a
national programme in 1997.As private sector is the first
point of contact for more than fifty percent TB
patients,RNTCP has collaborated with a wide range of
health care providers which establishes a unique model of
public private mix in RNTCP.
As medical colleges treat a significant number of patients
with TB and also provide care to seriously ill and
complicated TB cases,efforts have been made to include
medical colleges into the purview of RNTCP.
46
The Christian Medical College,Vellore ,joined hands with
RNTCP in the year 2002.
OBJECTIVES: To study the epidemiological trend of
tuberculosis among patients registered in DOTS clinic,
Christian Medical College,Vellore between 2002 to 2008.
METHODOLOGY: The existing quarterly RNTCP reports of
CMC DOTS Clinic from 2002 to 2008 were consolidated. The
data was entered in Microsoft Excel and analysed.
RESULTS and CONCLUSION:The proportion of chest
symptomatics referred for sputum examination from
various departments in CMC were between 3 to 4% .This is
above the suggested target of at least 2%.
The sputum positivity rate is between 6.7 to 8% which lies
between the recommended 5-15%.
Among the cases 33% were sputum positive,14% sputum
negative pulmonary and 53% were extra pulmonary
tuberculosis. The maximum proportion of extrapulmonary
TB as per RNTCP guidelines is 50%.
88% of all the cases were transferred out, 35.1% of all
transfers were to ‘out of the state’, among which 43.4%
were referred to northern states. Among those referred, 27%
were sputum positive and 58% were extra pulmonary TB.
Among those who received care from CMC unit, sputum
conversion rates were consistently above 90% except for
year 2003 when it was 86.9%.Cure rate was above 80%
consistently.
The CMC data shows that most of the recommendations
laid down by RNTCP guidelines are achieved and it is
functioning as per the guidelines of RNTCP.
Evidence Based Policy for Isoniazid Prophylaxis Therapy in
Health care workers
Authors:
Dr. Sangeeta Das Bhattacharya, Assistant Professor, School
of Medical Science and Technology, IIT Kharagpur.
Lt Col (Dr) Rishi Raj, School of Medical Science and Technology,
IIT Kharagpur.
Dr. Hari Prasad, School of Medical Science and Technology, IIT
Kharagpur.
Dr. T.Shyam, School of Medical Science and Technology, IIT
Kharagpur.
Dr. Bikas K Arya, School of Medical Science and Technology,
IIT Kharagpur.
BACKGROUND: India accounts for nearly one-fifth of global
burden of tuberculosis. Every year, approximately 2 million
persons develop tuberculosis of which about 0.87 million practiced universally among surgeons. Wider use of EBS
are new smear positive highly infectious cases and about requires an understanding of EBS, a positive attitude, as
3.3 lakh die of TB every year. There are approximately 2.5 well as removal of perceived barriers to its practice.
million health care workers in India (NHP 2007) providing
health services to the population. They are not only exposed AIMS: The aim of this study was to assess the knowledge
to a high number of active TB cases but also they are and attitude of surgical trainees towards EBS and their
constantly exposed to a high number of debilitated patients perceived barriers to its practice.
throughout their professional work.
METHODS: The McColl questionnaire and the BARRIERS scale
AIM: To frame a policy regarding Isoniazid prophylactic were modified and incorporated into a single questionnaire.
therapy for health care workers in India. Surgical trainees attending a Continuing Surgical Education
meeting at the author’s institution were asked to voluntarily
METHODS: An evidence based search is conducted to find fill in this questionnaire.
effectiveness of INH prophylaxis in Health care workers in
India. Search was conducted in electronic medical resources RESULTS: A total of 93 out of 110 (84.5%) trainees returned
to find the related studies performing Meta analysis and the filled in questionnaire. Attitudes towards EBS were
randomized control trials comparing Isoniazid and welcoming, although colleagues were considered less
placebo/other anti tubercular drugs in different population welcoming than self. There was high level of agreement with
groups. Appropriate statistical methodology was adopted usefulness of EBS in everyday practice and EBS improving
to analyze the results and formulate the policy. The Criteria patient care. About 50 % of actual practice was considered
for evaluation were Numbers needed to be treated to prevent to be evidence based. 12.6 % (11/87) participants had
one active case of TB/ One death, number needed to harm received formal training in EBM. 64.3 % (54/84) were aware
(Hepatitis), adherence and compliance, ease of of the Cochrane database of systemic reviews but only 35.7%
implementation, cost benefits analysis. (30/84) read it regularly. 67.8 % (61/90) used protocols and
guidelines developed by colleagues to practice EBS. However,
RESULTS: The best suited evidence suggesting the prevalence 61.5 % (56/91) were interested in learning the skills of EBS.
of LTBI in health care workers in India is by M. Pai et al The terms absolute risk, relative risk and clinical
(JAMA 2005) indicating a prevalence of 40% in the health effectiveness were understood by > 80 % of respondents,
care workers in India. The Prevalence of Latent TB is while publication bias, confidence interval and
dramatically increases from 25% for persons who have served heterogeneity were poorly understood. The major perceived
less than 5 years in health care profession to 62% for persons barriers to practice of EBS were inability to understand
serving for 6 to 10 years and 71% for persons serving more statistical analysis, inadequate facilities for
than 10 years. The numbers needed to treat to prevent one implementation, lack of a single compiled source of
case of TB in general population is 35 (Smeija et al 2004) literature, relevant literature not being readily available
and insufficient time on the job.
CONCLUSION: In India as per RNTCP recommendations no
guidelines are available for prevention of TB in healthcare CONCLUSIONS: Surgical trainees have a positive attitude
workers. India’s RNTCP is the largest DOTS program in the towards EBS, and have some familiarity with the common
world. It is of paramount importance that they are given the terms used in EBS. There is a need to increase awareness of,
best possible protection from occupational health hazards and provide access to available sources of medical
including TB. So we recommend incorporation of Isoniazid literature. Formal training in EBS, as well as basic statistical
prophylaxis therapy among health care workers in India if analysis should form a part of the surgical curriculum to
they are found to be a case of LTBI. The therapy should be foster an environment favorable to the practice of EBS.
with 300 mg Isoniazid daily for six months. The maximum
effect of Isoniazid prophylaxis is shown to be for 3 years CAN CLINICIANS ACTUALLY PRACTICE EBM?
(Debre), so it is recommended that every healthcare worker
Authors:
should be examined while joining health care services and
Sanchaya Selvaraj*, Balaji D*, Nagamani*, Surapaneni
then should be reviewed every three years.
Krishna Mohan**
Evidence Based Surgery: knowledge, attitudes, and
Affiliation:
perceived barriers among surgical trainees
*II MBBS Student, Saveetha Medical College & Hospital,
Rohin Mittal, Benjamin Perakath Saveetha University, Saveetha Nagar, Thandalam,
Christian Medical College, Vellore CHENNAI – 602 105, T.N, INDIA.

BACKGROUND: Evidence Based Surgery (EBS) has been shown **Assistant Professor, Department of Biochemistry,
to improve efficiency and outcomes. It is, however, not Saveetha Medical College & Hospital, Saveetha University,
Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.

47
BACKGROUND: The term “Evidence Based Medicine” (EBM)
was first used in the early 1990s to describe a framework
for integrating clinical epidemiology with routine clinical
decision making. It was initially described as an
“enlightened scepticism towards the application of
diagnostic, therapeutic and prognostic technologies in the
day-to-day management of patients’.
AIM: To conduct a literature survey to find out whether the
clinicians actually practice EBM and to know the impact of
EBM in our country.
METHODS: Our survey mainly focuses on 3 research
questions: First of all, do full-time clinicians really recognize
working in these modes? Second, even if they recognize these
modes, can they actually get at the evidence quickly enough
to consider it on a busy clinical service? Third, even if they
can get at it, can clinicians actually provide evidence-based
care to their patients?
RESULTS: First of all, do full-time clinicians really recognize
working in these modes? It appears so. In a survey of UK
GPs, majority reported practicing at least part of their time
in the “searching” mode, 72% using evidence- based
summaries generated by others and 84% using evidence-
based practice guidelines or protocols. Far fewer claimed
to understand the “appraising” tools of NNTs (35%) and
confidence intervals (20%). Only 5% believed that “learning
the skills of evidence-based medicine” (all five steps) was
the most appropriate method for “moving from opinion-
based medicine to evidence-based medicine”.
Second, even if they recognize these modes, can they actually
get at the evidence quickly enough to consider it on a busy
clinical service? Again, it appears so, but examples are few.
When a busy in-patient medical service brought electronic
summaries of evidence previously appraised either by team
members (“CATs”) or by the summary journals to working
rounds, it was documented that, on average, the former
could be accessed in 10 seconds and the latter in 25
seconds. When assessed from the view of the junior member
of the team caring for the patient, this evidence changed
25% of their diagnostic and treatment suggestions and
added to a further 23% of them.
Third, even if they can get at it, can clinicians actually
provide evidence-based care to their patients? Again, it
appears so from audits carried out on clinical services
that attempt to operate in the searching and appraising
modes. It is documented that 82% of them were evidence-
based. Out of which 53% based on systematic reviews of
randomized trials and 29% based on convincing non-
experimental evidence.
CONCLUSIONS: Similar results have been obtained from
audits of psychiatric, surgical, pediatric and general
practice. But in our setup usually, about developing country
this trend is taking a snail pace.
48
Key Methodological Issues in Randomised Controlled
Studies and Observational Studies
Santosh Philip Mathew1 MBBS student, Sonia Mary
Philip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,
MRCP, FRCR
1 Presenting Author: MBBS Student, MOSC Medical
College, Kolenchery, Ernakulam, Kerala- 682311
2 Queen Mary , University of London, School of Medicine
and Dentistry, Mile End Road, London, UK - E1 4NS
3 Consultant Radiologist, Dorset County Hospital NHS
Foundation Trust, Dorset County Hospital, Williams
Avenue, Dorchester, UK - DT1 2JY
Presenting author email: santoshphilip@gmail.com ;
Contact number: 9496334595
BACKGROUND: Analytical studies are broadly categorised
into experimental studies including randomised controlled
studies (RCTs) and non-experimental studies which include
observational studies (OSs). Many consider RCTs as
providing better evidence than OSs, but are not always
possible, appropriate or ethical to conduct.
AIMS: To identify key methodological issues relevant to RCTs
and OSs.
METHODS: Multiple articles were referred to from peer
reviewed journals as well as our own experience in
designing our poster with illustrations.
RESULTS: We will elucidate the advantages of RCTs including
its efficiency in postulating and testing clinical hypothesis,
use of analysis based on statistical theory, allocation
concealment and patient and assessor blinding thereby
reducing bias. The disadvantages of RCTs include its cost,
difficulty in organising, obtaining informed consent and
ethical approval made difficult by the nature of the study
and also failure to report negative results.
We will also review the advantages of OSs including its low
cost, easy access to ethical approval, informed consent
which is frequently unnecessary, use of statistical methods
like propensity and multivariate analysis with tests for
interaction. It also benefits from retrieving data from large
number of patient groups in a short amount of time from
databases. One of the main disadvantages include bias from
unknown confounders as well as treatment allocation bias
which can be offset to an extent by the use of propensity
analysis.
While RCTs have pride of place in studies of efficacy, OSs
have been limited to safety or adverse events data analysis.

CONCLUSIONS: After reading this poster, one should be able
to identify the key methodological issues involved in
analytical studies. Although some would consider RCTs as
the ‘gold standard’ in analytical studies, it is important to
understand that there is no perfect methodology to answer
clinical questions. Clinicians will need to take account of
the published data, decide which of the studies are best
designed to answer their questions and also consider the
generalisability and reproducibility of the intervention and
come to a conclusion based not only on the published
evidence but also rely on their medical experience and
judgement.
Modafinil for clozapine induced adverse effects in people
with schizophrenia and schizoaffective disorder in
remission: a randomized, placebo-controlled trial stopped
early for harms.
Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, Clive
Adams4
BACKGROUND: Hyper-salivation, sedation and weight gain
are common troublesome effects of Clozapine.
OBJECTIVES: To evaluate the efficacy and safety of modafinil
in clozapine-induced drowsiness, hyper-salivation, weight
gain, mental state, and global functioning.
METHODS: Design: Randomized, parallel-group, single-
centre, participant, investigator, observer and data-entry-
blinded trial conducted between October 2007 and October
2008. Offsite computer-generated, variable-block-size
randomization and pharmacist-dispensed, pre-packed,
serially numbered, containers ensured allocation
concealment.
Participants: Consenting adults with a diagnosis of
schizophrenia or schizoaffective disorder (DSM IV) in
remission, with troublesome drowsiness or hyper-
salivation, with/without weight gain, without unstable
medical conditions, and on stable doses of clozapine for at
least 4 weeks.
Intervention and comparator: Modafinil 100mg/day for first
week and 200mg/day for 8 weeks or identical placebo once
daily for 9 weeks.
Estimated Sample size: 35 in each arm (80% power; 5% alpha
error)
Outcomes: Primary: Proportion without daytime sleepiness
and hyper-salivation, scores on Epworth Sleepiness Scale
(ESS) and Nocturnal Hyper-salivation rating scale (NHRS).
Secondary: change in weight, pulse rate, systolic and
diastolic blood pressures; scores on Positive and Negative
Symptom Scale (PANSS); Clinical Global Impression (CGI)
for alertness, hyper-salivation and overall improvement;
Indian Disability Evaluation Assessment Scale (IDEAS) and
adverse events check list. Assessment: End of weeks 1, 5 and
9. Analysis; by intention to treat.
RESULTS: A pre-planned interim analysis (if more than 5%
developed adverse events necessitating discontinuation)
was done after 34 people (Modafinil 16, placebo 18) were
randomized, because of marked worsening of psychosis in
one and anxiety symptoms in one (both on Modafinil). One
person on placebo discontinued treatment due to lack of
improvement. Groups did not differ on the baseline
variables. Modafinil significantly reduced hyper-salivation
at 1 week compared to placebo (7/16 (44%) vs. 0/18; OR 1.8,
95% CI 1.2 to 2.7; P= 0.002) and non-significantly by week 9
(9/16 (56%) vs. 7/18 (44%); OR 2.6, 95% CI 0.6 to 10.8; P=
0.7). Modafinil did not differ from placebo on the NHRS or
ESS scores but significantly reduced duration of sleep by
week 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05).
No significant differences were noted in PANNS or IDEAS
scores, CGI overall improvement, weight, pulse rate, blood
pressure or other adverse effects in both groups.
CONCLUSION: This trial was stopped early due to pre-
determined stopping rules and was insufficiently powered
to draw firm conclusions. Modafinil may have the potential
to significantly improve hyper-salivation and drowsiness
due to Clozapine. Further trials, particularly at lower does,
may be warranted, but any potential benefits must be
weighed against the risk of worsening of psychosis or anxiety
and the cost of Modafinil.
TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI)
identification number: CTRI/2007/091/000020, 04-10-2007
Funding: Fluid Research Fund of CMC Vellore; Modafinil
and placebo supplied by Sun Pharmaceuticals (who had no
other role in the study)
AUTHOR AFFILIATIONS:
1
Dr. Sebind Kumar: Former Tutor in Psychiatry,
Department of Psychiatry, Christian Medical College,
Vellore 632002, Tamil Nadu; email: sebind@gmail.com
2
Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV Moses
Centre for Clinical Trials and Evidence Based Medicine,
Christian Medical College, Vellore 632002, Tamil Nadu.
3
Dr. Naveen Thomas, Assistant Professor in Psychiatry,
Christian Medical College, Vellore 632002, Tamil Nadu.
4
Dr. Clive Adams, Professor of Psychiatry and Chair of
Mental Health Services Research, Division of Psychiatry,
University of Nottingham, Nottingham, NG7 2TU, UK.
49
 Bedside Capillary blood glucose measurement by
glucometers compared to venous blood glucose in
critically ill patients and find the Reliability Sensitivity and
Accuracy of point of care glucometer in MICU.
Authors
Manish Chandra Prabhakar a
SP Kalantri b
a
Student II MBBS| Mahatma Gandhi Institute of Medical
Sciences, Sevagram | Maharashtra
b
Professor of Medicine | Mahatma Gandhi Institute of
Medical Sciences, Sevagram | Maharashtra
Correspondent Author: prabhakar4u07@gmail.com
BACKGROUND: Healthcare professionals routinely measure
blood glucose measurement of all critically ill patients in
intensive care unit. The traditional reference standard,
venous blood glucose requires a venepuncture and
laboratories usually return the test results after 60 minutes.
We wondered if a point of care capillary glucose measured
by glucometer could be as accurate and reliable as blood
venous glucose.
METHODS: I studied consecutive patients admitted to an
intensive care unit between 1 May and 10 May 2009. I
compared the diagnostic accuracy of two- point of care
glucometers with laboratory venous glucose, the reference
standard. I used Bland- Altman plots and Clark error grid
method to analyse the results.
RESULTS: I studied a total of 110 patients (38[34%] women;
mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteen
patients (12%) were known to have diabetes. The mean
glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1);
range= 48 to 501 mg/dL; that by glucometer 2 was 152.2
mg/dL (SD 76.2); range= 30 to 458 mg/dL and by the
laboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480
mg/dL. Of the 110 subjects, 2(2%) had blood glucose below
70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)
had blood glucose exceeding 180 mg/dL. The Bland- Altman
plot showed a bias of 4 mg% (95% confidence intervals, -
9.8 to +1.1); and the limits of agreement were -63 and +54
mg%. The area under the receiver operating characteristic
curve for the two glucometers was 0.92 and 0.93
respectively. The error grid analysis showed that 80% (78/
110) samples lay within zone A, 22(110) in zone B and 1%
(1/110) in zone C.
CONCLUSIONS: Point of care glucose, measured by
glucometers was in agreement with the venous glucose
estimation. Both glucometers were equally accurate and
performed uniformly well across the wide range of blood
glucose values.
50
KEY WORD: Capillary blood glucose, Venous blood glucose
,Point of Care, Glucometer
GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS
Manusri Naredla, Keerthi Maddi.
St.Peter’s institute of Pharmaceutical sciences,
vidyanagar, Hanamkonda
Users of clinical practice guidelines and other
recommendations need to know how much confidence they
can place in the recommendations. Systematic and explicit
methods of making judgments can reduce errors and
improve clinical trials. Large scale healthcare interventions
are likely to improve the health of the public only if the
evidence clearly shows that the benefits outweigh harms
and costs. Often, however, the evidence if is the other way
the trials may fail to improve health, or may even cause
harm, while costing dearly. Moreover, when a large scale
intervention is implemented careful evaluation of the
evidence must and should replace wishful thinking and
guesswork or else the trials may prove to be enduring but
possibly result in harmful standard of care. Such
interventions should be implemented, therefore, only when
the evidence shows that expected benefits outweigh harms
and costs and this can be achieved by the implementation
of systematic evaluation.
Obtaining definitive evidence on the effects of large scale
interventions can be difficult and implementation with
careful monitoring is justified but how ever acting without
proof of net benefit is both costly and potentially damaging
to health. Graded evidence follows a hierarchy of evidence
consistent with randomized trials of high methodological
quality, followed by randomized trials with methodological
limitations, observational studies, and unsystematic
clinical observations. Inferences are stronger when the
evidence is summarized in systematic ways of representing
the evidence for better interpretation of the clinical as well
as observational trials.
Unequal Randomisation in Cancer Trials – A New
Paradigm!
AUTHORS: Meghana Surlikar , Sadhana Kannan and
Vikram Gota.
INSTITUTION: Advanced Centre for Treatment Research and
Education in Cancer (ACTREC), Tata Memorial Centre, Sector-
22, Kharghar, Navi Mumbai
Background: Randomised Controlled Trial (RCT) with
balanced allocation of participants to the experimental and
control arms is a commonly practiced study design. The
design is simplistic and therefore very appealing. However,
circumstances warrant unequal allocation of subjects to
the different arms of the study. This systematic review
focuses on the trends in unequal randomization (UR) in
cancer clinical trials and the most common reasons for
resorting to this approach.
AIM: A systematic review to identify reasons for UR in
oncology clinical trials published in five major cancer
journals over the last ten years.
METHODS: A PUBMED search was undertaken to identify
RCTs in cancer published from January 1999 to December
2008 in five major cancer journals namely JCO, Annals of
Oncology, BJC, Lancet Oncology and JNCI. Forty three RCTs
that reported UR of subjects to different arms were selected.
Data was extracted for randomization ratio, reason for UR,
phase of the trial and trial location (Single or multicentre).
If the rationale for UR was not mentioned in the article, the
corresponding author was e-mailed to obtain the reason.
RESULTS: 1863 RCTs were identified. UR was employed in 43
studies (2.3%). The number of studies increased over the
years (0 in 1999 to 9 in 2006). Only 13/43 gave clear reasons
for adopting UR. Seven out of the remaining 30 authors
responded to an email request. The reason is not clear in
the remaining 23 reports. 29/43 trials used 2:1 ratio
followed by 2:1:1 ratio used in 11 % of the studies. The
reasons for UR in the 20 available reports are (a) to meet
statistical endpoint – 7 (b) to facilitate faster recruitment–
4 (c) to get more data on new intervention – 4 (d) ethics and
safety reasons – 2 (e) Others – 3. Fourteen were single centre
studies and 29 were multicentre. In 27 reports where phase
of the study was mentioned, there were 12 phase II, 14 phase
III and one phase IV trial.
CONCLUSION: UR appears to be an attractive alternative to
balanced allocation especially in small randomized phase
II trials. Statistical considerations and faster recruitment
are important reasons for resorting to UR.
Aromatase inhibitors in clomiphene resistant women: A
randomized double blind placebo controlled trial.
Mohan S Kamath, Aleyamma T.K, Achamma Chandy, and
Korula George1
Reproductive Medicine Unit, Department of Obstetrics &
Gynecology, Christian Medical College, Vellore ,Tamil Nadu,
India - 632004.
BACKGROUND: Twenty five percent of anovulatory women
with polycystic ovarian syndrome do not respond to
standard clomiphene citrate therapy and are known as
clomiphene resistant. We investigated the use of letrozole,
an aromatase inhibitor as an alternative ovulation inducing
agent in these women.
METHODS: 36 women with clomiphene resistance were
randomized into two groups: one receiving letrozole 2.5mg
daily from day 2 to day 6 of the cycle while the other an
identical placebo. The primary outcome was the ovulation
rate with analysis being intention-to-treat.
RESULTS: The ovulation rate was significantly higher in the
letrozole group 6/18 (33.33%) as compared to none in the
placebo group (P= 0.015). The mean day 21 serum
progesterone was also significantly higher in the letrozole
group (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014).
One women in the letrozole group conceived and delivered
normally giving a clinical pregnancy and live birth rate of
5.5%
CONCLUSION: In clomiphene resistant women, letrozole can
be used as an effective and simple alternative ovulation
inducing agent. The trial is registered with clinical trial
registry of India (UTRN -017753618-3112200762223).
Clinical Trials Methods
Nailesh.T SLIMS, Villianur, Pondy605502 Email:
Nailesh.reddy@gmail.com
BACKGROUND: After completing the preclinical testing of the
drug in animals, the company files an investigational new
drug (IND) application with the regulatory authority for
permission to test the drug in humans.
AIMS: To collect the safety and efficacy data for new drugs or
devices.
METHODS: Depending on the type of product and the stage
of development, investigators enroll healthy volunteers and/
or patients into small pilot studies followed by larger scale
studies in patients that often compare the new product with
the currently prescribed treatment. As positive safety and
efficacy data are gathered, the number of patients is typically
increased. Clinical trials can vary in size from a single center in
one country to multicenter trials in multiple countries, trials
are conducted in 5 Phases
RESULTS: Phase 0 trials is a recent designation known as
human micro dosing studies has no data on safety or efficacy
of drug. Phase 1 trials Examines the pharmacologic actions
and safe dosage range of a drug; how it is absorbed,
distributed, metabolized, and excreted; and its duration of
action. Phase 2 trials are controlled studies in volunteers to
assess the effectiveness and safety of a drug. Phase 3 trials
are testing using a greater number of volunteer patients. The
drug is administered by practicing physicians to those suffering
from the condition the drug is intended to treat. These studies
must confirm earlier efficacy studies and determine low-
incidence adverse reactions. Phase 4 trials are studies
conducted after FDA approval, during general use of the drug
by medical practitioners, also referred to as post marketing
studies. Fast-track approval is provided for drugs that meet
unmet medical needs for patients with serious or life-
threatening conditions. Labeling is information distributed
about a drug by the manufacturer, even if it is not physically
affixed to the product. Misbranding is “false or misleading in
any particular” renders the product misbranded, making it
subject to FDA regulatory action.
51
CONCLUSION: These trials provide the tolerability,
Pharmacovigilance, Pharmacokinetic, and
Pharmacodynamics of the drug.
Access to evidence from countries in South Asia: The
South Asian Database of Controlled Clinical Trials and the
South Asian Cochrane Network and Centre’s Digital
Library – An Update
Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh
Parthasarathy
Prof BV Moses & Indian Council of Medical Research Centre
for Advanced Research and Training in Evidence Informed
Healthcare, South Asian Cochrane Centre, Christian Medical
College, Vellore, India
BACKGROUND: Many trials conducted in middle and low
income countries are published in journals that are not
indexed in commonly searched databases. Their exclusion
from systematic reviews could bias conclusions, rendering
them unreliable and potentially irrelevant to health care in
these countries.
OBJECTIVES: To describe the development of the South Asian
Database of Controlled Clinical Trials (www.cochrane-
sadcct.org) and the South Asian Cochrane Network &
Center’s Digital Library that aim to: provide a comprehensive
source in the public domain of all controlled clinical
interventional trials involving humans conducted in the
South Asian region, and published in regional journals,
and contribute information about these trials to the
Cochrane Central Register of Controlled Clinical Trials
(CENTRAL) in The Cochrane Library.
METHODS: Health Science Journals published from
Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,
Pakistan and Sri Lanka and reporting interventional trials
in humans conducted in these countries were sought from
multiple electronic and other sources and 168 journals were
identified. Online and print issues of these journals are
searched in regular cycles. Citations and abstracts of all
interventional trials identified from online editions and
hand-searching of print editions are entered into Endnote.
Trials are coded as RCTs or CCTs using standard criteria
and cleaned records imported to MeerKat, with web-links
provided to the original article, where possible. Full text
articles are indexed and stored using the Greenstone Digital
Library Software to create the South Asian Cochrane Network
& Center’s Digital Library that can be retrieved by Titles,
Author, Year, Journal and Keywords. All records are regularly
transmitted for inclusion in the Cochrane Central Register
of Controlled Clinical Trials (CENTRAL) in The Cochrane
Library.
RESULTS: The South Asian Database of Controlled Clinical
Trials, initiated in November, 2008, was launched on January
1, 2009 (www.cochrne-sadcct.org) and is searchable free
52
of charge. It currently contains the citations, abstracts and
web-links (where possible) to 2830 records [(CCT-1350
(47%); RCT-1477 (53%)] published in 65 Indian medical
journals, and 76 Pakistan Medical Journals. From
submitted records, the citations and web-links (where
available) to 1859 trials conducted in these South Asian
countries are now included in the Cochrane Central Register
of Controlled Trials (CENTRAL). Full text articles, in
downloaded or scanned portable document format (pdf),
are stored for most trials in the South Asian Cochrane
Network & Center’s Digital Library. In the ongoing second
phase, all 168 South Asian Journals (of which 101 (60%)
are not indexed in Medline) and newer journals identified
by ongoing searches will contribute trials, supplemented
by searches of conference abstracts, dissertations and other
sources.
CONCLUSIONS: The Cochrane Collaboration now has a
resource to access all the evidence generated from
interventional trials conducted in countries in the South
Asian Region. Many of these, hitherto unidentified, trials
can now be considered for inclusion in systematic reviews
of the effects of interventions in healthcare conditions
relevant to people in the region; these systematic reviews
have the potential to be of greater relevance in informing
healthcare and health-policy in these countries than before
the creation of this resource.
When ‘Evidence’ goes against the grain:
Quetiapine for Bipolar depression
S. Mohan Raj,
Consultant Psychiatrist, Chennai
BACKGROUND: Quetiapine is an antipsychotic medication.
In the last 3 years, there are attempts to promote Quetiapine
as being efficacious in Bipolar depression. Trials have
claimed efficacy and FDA has approved the use of Quetiapine
for Bipolar depression.
But, clinicians do not find Quetiapine to be effective in
Bipolar depression.
AIM: To analyse the possible reasons for this disparity
between trial results and actual clinical practice.
METHODS: Evaluation of the BOLDER II study1 (study titled
‘Efficacy of Quetiapine Monotherapy in Bipolar I and II
Depression’), using the Risk of bias table of Revman 5.
RESULTS:
The biases noticed were
1) Selection bias
Exclusion criteria mention
1.1 Current episode duration more than 12 months and
less than 4 weeks
(Comment: spontaneous remission is possible
around 6 months)
1.2 History of non-response to an adequate trial (6
weeks) of more than 2 classes of antidepressants
(Comment: Resistant depression is excluded)
1.3 Current serious suicidal or homicidal risk as judged
by the investigator
(Comment: Severe depression is excluded)
2) Incomplete outcome data were not adequately
addressed.
The other problems were
1) Definition of response as > or = to 50% reduction
from baseline score of Montgomery Asberg
Depression Rating Scale (MADRS)2
2) There are 3 items on MADRS scale (decreased sleep,
decreased appetite and inner tension) in which
Quetiapine can bring about 100% reduction in
symptoms irrespective of its antidepressant effects.
Another area of concern is that all the studies regarding
Quetiapine in bipolar depression were prepared with
‘editorial assistance’ from a medical communication
company called PAREXEL MMS), irrespective of the authors’
institution. PAREXEL’s website3 offers to write up a scientific
paper and boast of a 92% first time journal acceptance rate
in 2008.
CONCLUSION: Mechanism need to be evolved to restrict
approval of drugs by regulatory bodies for indications for
which no effect is seen in clinical practice.
REFERENCES:
1. Michael E Thase et al. Efficacy of Quetiapine
Monotherapy in Bipolar I and II Depression. A
double-blind, placebo controlled study (The BOLDER
II study) J Clin Psychopharmacol 2006;26:600-609.
2. Montgomery SA and Asberg M. A new depression
scale designed to be sensitive to change. Br J
Psychiatry 1979;134:382-389.
3. Parexel MedCom. http://www.parexelmms.com/
VIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in
a medical college hospital
AUTHORS: John K R,Rakesh P S
AUTHORS AFFILIATION
1. Professor in charge of RNTCP$Head of the
Department,Department of Community Health,CMC
Vellore
2 Post graduate registrar,department of Community
Health,CMC Vellore
CORRESPONDING AUTHOR:John K R,Professor,Department
of Community Health,CMC,VELLORE
Email:mony@cmcvellore.ac.in
Ph:09443242603
BACKGROUND: The Revised National Tuberculosis Control
Programme (RNTCP) based on Directly Observed Treatment
Short course(DOTS) strategy was launched in India as a
national programme in 1997.As private sector is the first
point of contact for more than fifty percent TB
patients,RNTCP has collaborated with a wide range of
health care providers which establishes a unique model of
public private mix in RNTCP.
As medical colleges treat a significant number of patients
with TB and also provide care to seriously ill and
complicated TB cases,efforts have been made to include
medical colleges into the purview of RNTCP.
The Christian Medical College,Vellore ,joined hands with
RNTCP in the year 2002.
OBJECTIVES: To study the epidemiological trend of
tuberculosis among patients registered in DOTS clinic,
Christian Medical College,Vellore between 2002 to 2008.
METHODOLOGY: The existing quarterly RNTCP reports of
CMC DOTS Clinic from 2002 to 2008 were consolidated. The
data was entered in Microsoft Excel and analysed.
RESULTS and CONCLUSION: The proportion of chest
symptomatics referred for sputum examination from
various departments in CMC were between 3 to 4% .This is
above the suggested target of at least 2%.
The sputum positivity rate is between 6.7 to 8% which lies
between the recommended 5-15%.
Among the cases 33% were sputum positive,14% sputum
negative pulmonary and 53% were extra pulmonary
tuberculosis. The maximum proportion of extrapulmonary
TB as per RNTCP guidelines is 50%.
88% of all the cases were transferred out, 35.1% of all
transfers were to ‘out of the state’, among which 43.4%
53

were referred to northern states. Among those referred, 27%
were sputum positive and 58% were extra pulmonary TB.
Among those who received care from CMC unit, sputum
conversion rates were consistently above 90% except for
year 2003 when it was 86.9%.Cure rate was above 80%
consistently.
The CMC data shows that most of the recommendations
laid down by RNTCP guidelines are achieved and it is
functioning as per the guidelines of RNTCP.
Evidence Based Policy for Isoniazid Prophylaxis Therapy in
Health care workers
Authors:
Dr. Sangeeta Das Bhattacharya, Assistant Professor, School
of Medical Science and Technology, IIT Kharagpur.
Lt Col (Dr) Rishi Raj, School of Medical Science and
Technology, IIT Kharagpur.
Dr. Hari Prasad, School of Medical Science and Technology,
IIT Kharagpur.
Dr. T.Shyam, School of Medical Science and Technology, IIT
Kharagpur.
Dr. Bikas K Arya, School of Medical Science and Technology,
IIT Kharagpur.
BACKGROUND: India accounts for nearly one-fifth of global
burden of tuberculosis. Every year, approximately 2 million
persons develop tuberculosis of which about 0.87 million
are new smear positive highly infectious cases and about
3.3 lakh die of TB every year. There are approximately 2.5
million health care workers in India (NHP 2007) providing
health services to the population. They are not only exposed
to a high number of active TB cases but also they are
constantly exposed to a high number of debilitated patients
throughout their professional work.
AIM: To frame a policy regarding Isoniazid prophylactic
therapy for health care workers in India.
METHODS: An evidence based search is conducted to find
effectiveness of INH prophylaxis in Health care workers in
India. Search was conducted in electronic medical resources
to find the related studies performing Meta analysis and
randomized control trials comparing Isoniazid and
placebo/other anti tubercular drugs in different population
groups. Appropriate statistical methodology was adopted
to analyze the results and formulate the policy. The Criteria
for evaluation were Numbers needed to be treated to prevent
one active case of TB/ One death, number needed to harm
(Hepatitis), adherence and compliance, ease of
implementation, cost benefits analysis.
54
RESULTS: The best suited evidence suggesting the prevalence
of LTBI in health care workers in India is by M. Pai et al
(JAMA 2005) indicating a prevalence of 40% in the health
care workers in India. The Prevalence of Latent TB is
dramatically increases from 25% for persons who have served
less than 5 years in health care profession to 62% for persons
serving for 6 to 10 years and 71% for persons serving more
than 10 years. The numbers needed to treat to prevent one
case of TB in general population is 35 (Smeija et al 2004)
CONCLUSION: In India as per RNTCP recommendations no
guidelines are available for prevention of TB in healthcare
workers. India’s RNTCP is the largest DOTS program in the
world. It is of paramount importance that they are given the
best possible protection from occupational health hazards
including TB. So we recommend incorporation of Isoniazid
prophylaxis therapy among health care workers in India if
they are found to be a case of LTBI. The therapy should be
with 300 mg Isoniazid daily for six months. The maximum
effect of Isoniazid prophylaxis is shown to be for 3 years
(Debre), so it is recommended that every healthcare worker
should be examined while joining health care services and
then should be reviewed every three years.
Evidence Based Surgery: knowledge, attitudes, and
perceived barriers among surgical trainees
Dr. Rohin Mittal (Presenting author)
Assistant Professor
Department of Surgery Unit 5
Christian Medical College, Vellore
rohinmittal@gmail.com
Dr. Benjamin Perakath
Professor
Department of Surgery Unit 5
Christian Medical College, Vellore
benjamin@cmcvellore.ac.in
BACKGROUND: Evidence Based Surgery (EBS) has been
shown to improve efficiency and outcomes. It is, however,
not practiced universally among surgeons. Wider use of
EBS requires an understanding of EBS, a positive attitude,
as well as removal of perceived barriers to its practice.
AIMS: The aim of this study was to assess the knowledge
and attitude of surgical trainees towards EBS and their
perceived barriers to its practice.
METHODS: The McColl questionnaire and the BARRIERS scale
were modified and incorporated into a single questionnaire.
Surgical trainees attending a Continuing Surgical Education
meeting at the author’s institution were asked to voluntarily
fill in this questionnaire.
RESULTS: A total of 93 out of 110 (84.5%) trainees returned
the filled in questionnaire. Attitudes towards EBS were
welcoming, although colleagues were considered less
welcoming than self. There was high level of agreement with
usefulness of EBS in everyday practice and EBS improving
patient care. About 50 % of actual practice was considered
to be evidence based. 12.6 % (11/87) participants had
received formal training in EBM. 64.3 % (54/84) were aware
of the Cochrane database of systemic reviews but only 35.7%
(30/84) read it regularly. 67.8 % (61/90) used protocols and
guidelines developed by colleagues to practice EBS. However,
61.5 % (56/91) were interested in learning the skills of EBS.
The terms absolute risk, relative risk and clinical
effectiveness were understood by > 80 % of respondents,
while publication bias, confidence interval and
heterogeneity were poorly understood. The major perceived
barriers to practice of EBS were inability to understand
statistical analysis, inadequate facilities for
implementation, lack of a single compiled source of
literature, relevant literature not being readily available
and insufficient time on the job.
CONCLUSIONS: Surgical trainees have a positive attitude
towards EBS, and have some familiarity with the common
terms used in EBS. There is a need to increase awareness of,
and provide access to available sources of medical
literature. Formal training in EBS, as well as basic statistical
analysis should form a part of the surgical curriculum to
foster an environment favorable to the practice of EBS.
CAN CLINICIANS ACTUALLY PRACTICE EBM?
Sanchaya Selvaraj*, Balaji D*, Nagamani*, Surapaneni
Krishna Mohan**
AFFILIATION:
*II MBBS Student, Saveetha Medical College & Hospital,
Saveetha University, Saveetha Nagar, Thandalam, CHENNAI
– 602 105, T.N, INDIA.
**Assistant Professor, Department of Biochemistry,
Saveetha Medical College & Hospital, Saveetha University,
Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.
BACKGROUND: The term “Evidence Based Medicine” (EBM)
was first used in the early 1990s to describe a framework
for integrating clinical epidemiology with routine clinical
decision making. It was initially described as an
“enlightened scepticism towards the application of
diagnostic, therapeutic and prognostic technologies in the
day-to-day management of patients’.
AIM: To conduct a literature survey to find out whether the
clinicians actually practice EBM and to know the impact of
EBM in our country.
METHODS: Our survey mainly focuses on 3 research
questions: First of all, do full-time clinicians really recognize
working in these modes? Second, even if they recognize these
modes, can they actually get at the evidence quickly enough
to consider it on a busy clinical service? Third, even if they
can get at it, can clinicians actually provide evidence-based
care to their patients?
RESULTS: First of all, do full-time clinicians really recognize
working in these modes? It appears so. In a survey of UK
GPs, majority reported practicing at least part of their time
in the “searching” mode, 72% using evidence- based
summaries generated by others and 84% using evidence-
based practice guidelines or protocols. Far fewer claimed
to understand the “appraising” tools of NNTs (35%) and
confidence intervals (20%). Only 5% believed that “learning
the skills of evidence-based medicine” (all five steps) was
the most appropriate method for “moving from opinion-
based medicine to evidence-based medicine”.
Second, even if they recognize these modes, can they actually
get at the evidence quickly enough to consider it on a busy
clinical service? Again, it appears so, but examples are few.
When a busy in-patient medical service brought electronic
summaries of evidence previously appraised either by team
members (“CATs”) or by the summary journals to working
rounds, it was documented that, on average, the former
could be accessed in 10 seconds and the latter in 25
seconds. When assessed from the view of the junior member
of the team caring for the patient, this evidence changed
25% of their diagnostic and treatment suggestions and
added to a further 23% of them.
Third, even if they can get at it, can clinicians actually
provide evidence-based care to their patients? Again, it
appears so from audits carried out on clinical services
that attempt to operate in the searching and appraising
modes. It is documented that 82% of them were evidence-
based. Out of which 53% based on systematic reviews of
randomized trials and 29% based on convincing non-
experimental evidence.
CONCLUSIONS: Similar results have been obtained from
audits of psychiatric, surgical, pediatric and general
practice. But in our setup usually, about developing country
this trend is taking a snail pace.
Key Methodological Issues in Randomised Controlled
Studies and Observational Studies
Santosh Philip Mathew1 MBBS student, Sonia Mary
Philip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,
MRCP, FRCR
1 Presenting Author: MBBS Student, MOSC Medical
College, Kolenchery, Ernakulam, Kerala- 682311
2 Queen Mary , University of London, School of Medicine
and Dentistry, Mile End Road, London, UK - E1 4NS3
Consultant Radiologist, Dorset County Hospital NHS
Foundation Trust, Dorset County Hospital, Williams
Avenue, Dorchester, UK - DT1 2JY
55
Presenting author email: santoshphilip@gmail.com;
Contact number: 9496334595
BACKGROUND: Analytical studies are broadly categorised
into experimental studies including randomised controlled
studies (RCTs) and non-experimental studies which include
observational studies (OSs). Many consider RCTs as
providing better evidence than OSs, but are not always
possible, appropriate or ethical to conduct.
AIMS: To identify key methodological issues relevant to RCTs
and OSs.
METHODS: Multiple articles were referred to from peer
reviewed journals as well as our own experience in
designing our poster with illustrations.
RESULTS: We will elucidate the advantages of RCTs including
its efficiency in postulating and testing clinical hypothesis,
use of analysis based on statistical theory, allocation
concealment and patient and assessor blinding thereby
reducing bias. The disadvantages of RCTs include its cost,
difficulty in organising, obtaining informed consent and
ethical approval made difficult by the nature of the study
and also failure to report negative results.
We will also review the advantages of OSs including its low
cost, easy access to ethical approval, informed consent
which is frequently unnecessary, use of statistical methods
like propensity and multivariate analysis with tests for
interaction. It also benefits from retrieving data from large
number of patient groups in a short amount of time from
databases. One of the main disadvantages include bias from
unknown confounders as well as treatment allocation bias
which can be offset to an extent by the use of propensity
analysis.
While RCTs have pride of place in studies of efficacy, OSs
have been limited to safety or adverse events data analysis.
CONCLUSIONS: After reading this poster, one should be able
to identify the key methodological issues involved in
analytical studies. Although some would consider RCTs as
the ‘gold standard’ in analytical studies, it is important to
understand that there is no perfect methodology to answer
clinical questions. Clinicians will need to take account of
the published data, decide which of the studies are best
designed to answer their questions and also consider the
generalisability and reproducibility of the intervention and
come to a conclusion based not only on the published
evidence but also rely on their medical experience and
judgement.
56
Modafinil for clozapine induced adverse effects in people
with schizophrenia and schizoaffective disorder in
remission: a randomized, placebo-controlled trial stopped
early for harms.
Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, Clive
Adams4
BACKGROUND: Hyper-salivation, sedation and weight gain
are common troublesome effects of Clozapine.
OBJECTIVES: To evaluate the efficacy and safety of modafinil
in clozapine-induced drowsiness, hyper-salivation, weight
gain, mental state, and global functioning.
METHODS: Design: Randomized, parallel-group, single-
centre, participant, investigator, observer and data-entry-
blinded trial conducted between October 2007 and October
2008. Offsite computer-generated, variable-block-size
randomization and pharmacist-dispensed, pre-packed,
serially numbered, containers ensured allocation
concealment.
Participants: Consenting adults with a diagnosis of
schizophrenia or schizoaffective disorder (DSM IV) in
remission, with troublesome drowsiness or hyper-
salivation, with/without weight gain, without unstable
medical conditions, and on stable doses of clozapine for at
least 4 weeks.
Intervention and comparator: Modafinil 100mg/day for first
week and 200mg/day for 8 weeks or identical placebo once
daily for 9 weeks.
Estimated Sample size: 35 in each arm (80% power; 5% alpha
error)
Outcomes: Primary: Proportion without daytime sleepiness
and hyper-salivation, scores on Epworth Sleepiness Scale
(ESS) and Nocturnal Hyper-salivation rating scale (NHRS).
Secondary: change in weight, pulse rate, systolic and
diastolic blood pressures; scores on Positive and Negative
Symptom Scale (PANSS); Clinical Global Impression (CGI)
for alertness, hyper-salivation and overall improvement;
Indian Disability Evaluation Assessment Scale (IDEAS) and
adverse events check list. Assessment: End of weeks 1, 5 and
9. Analysis; by intention to treat.
RESULTS: A pre-planned interim analysis (if more than 5%
developed adverse events necessitating discontinuation)
was done after 34 people (Modafinil 16, placebo 18) were
randomized, because of marked worsening of psychosis in
one and anxiety symptoms in one (both on Modafinil). One
person on placebo discontinued treatment due to lack of
improvement. Groups did not differ on the baseline
variables. Modafinil significantly reduced hyper-salivation
at 1 week compared to placebo (7/16 (44%) vs. 0/18; OR 1.8,
95% CI 1.2 to 2.7; P= 0.002) and non-significantly by week 9

(9/16 (56%) vs. 7/18 (44%); OR 2.6, 95% CI 0.6 to 10.8; P=
0.7). Modafinil did not differ from placebo on the NHRS or
ESS scores but significantly reduced duration of sleep by
week 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05).
No significant differences were noted in PANNS or IDEAS
scores, CGI overall improvement, weight, pulse rate, blood
pressure or other adverse effects in both groups.
CONCLUSION: This trial was stopped early due to pre-
determined stopping rules and was insufficiently powered
to draw firm conclusions. Modafinil may have the potential
to significantly improve hyper-salivation and drowsiness
due to Clozapine. Further trials, particularly at lower does,
may be warranted, but any potential benefits must be
weighed against the risk of worsening of psychosis or anxiety
and the cost of Modafinil.
TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI)
identification number: CTRI/2007/091/000020, 04-10-2007
FUNDING: Fluid Research Fund of CMC Vellore; Modafinil
and placebo supplied by Sun Pharmaceuticals (who had no
other role in the study)
AUTHOR AFFILIATIONS:
1
Dr. Sebind Kumar: Former Tutor in Psychiatry,
Department of Psychiatry, Christian Medical College,
Vellore 632002, Tamil Nadu; email: sebind@gmail.com
2
Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV Moses
Centre for Clinical Trials and Evidence Based Medicine,
Christian Medical College, Vellore 632002, Tamil Nadu.
3
Dr. Naveen Thomas, Assistant Professor in Psychiatry,
Christian Medical College, Vellore 632002, Tamil Nadu.
4
Dr. Clive Adams, Professor of Psychiatry and Chair of
Mental Health Services Research, Division of Psychiatry,
University of Nottingham, Nottingham, NG7 2TU, UK.
Internet based clinical trials: An Expanding Horizon
Authors: Siddhartha D, Lalith Chandra K,
Gandhi Medical College, Secunderabad
BACKGROUND: Internet is being widely utilized in medical
research. It offers many benefits when used as a medium
for carrying out clinical trials. Being able to reach a wide
population, participant privacy, easier blinding and
randomization, studying geographically scattered
populations are a few such benefits. Online trials so far,
have mostly been focusing on educational, preventive,
rehabilitative and follow up issues which can have a
beneficial impact on patient health, health service quality,
health service availability and finances. In a society where
the utilization of Information Technology seems to be rising
exponentially, online trials have a significant role to play
in shaping up the future of the health care industry.
Aim: To carry out a systematic search for the areas in which
internet trials have been carried out till date and to analyze
the advantages and limitations of using internet as a
medium to conduct clinical trials.
Methods: The online U.S NIH database
(www.clinicaltrials.gov), was searched for internet based
trials. Both active and closed trials were included.Relevant
results were categorized under separate subject headings
based on the health condition/category the trial was
addressing. Both interventional and observational trials
were included in the categorization. PubMed literature
search was performed to study the advantages and
limitations of online trials separately.
Results: Of the 432 search results obtained using the keyword
“ internet”, 383 were appropriate. These trials were
categorized into subject headings as described. A wide
variety of health conditions such as alcoholism, diabetes,
psychiatric conditions, smoking cessation, weight control,
hypertension etc. were addressed in these trials*. A majority
of these trials have been carried out in the USA and Europe.
Surprisingly, Asian countries have carried out only a
negligible number of such trials(~2%).
Conclusion**: Online trials have many advantages.
However, multiple log-ins, remuneration, internet spamming
and internet squatting are a few limitations. We propose a
solution to these problems, which could be an interesting
area for future research.
(* Involves numerical data that cannot be condensed)
(**Not elaborated due to word limit restriction)
Presenting Author and Author for Correspondence:
Siddhartha Devarakonda
“Premabandham”, Near Birla Mandir
5-9-22/38 G Adarshnagar
Hyderabad 500063, AP
India
email- siddarth.dt@gmail.com
BODY MASS INDEX AND EXOCRINE PANCREATIC INSUFFI-
CIENCY ARE PREDICTORS OF PANCREATIC OSTEODYSTRO-
PHY IN SUBJECTS WITH FIBROCALCIFIC PANCREATITIS WITH
DIABETES.
Presenting author: Sudeep.K
Co-Authors: Selvakumar R, Chacko A, George B, Kavitha M,
Paul T, Seshadri MS, Thomas N
Department; Department of Endocrinology, Department of
Biochemistry, Gastroenterology.
57
Institution: Christian Medical College, Vellore. Phone
(0416)-2282528,2282491.Fax-416-4205844
Address for correspondence: Dr .Nihal Thomas, Professor,
Department of Endocrinology, Diabetes and Metabolism,
Christian Medical College, Vellore. India.
Email ID: nihal_thomas@yahoo.com.
Email ID: drsudeepmd@rediffmail.com
BACKGROUND: Chronic pancreatitis with exocrine
insufficiency, inflammation, diabetes, low body weight and
undernutrition alter bone metabolism leading to a relatively
novel entity entitled pancreatic osteodystrophy.
AIMS: To determine the relationship between bone mineral
content and pancreatic exocrine and endocrine dysfunction
in subjects with chronic non-alcoholic pancreatitis.
MATERIALS AND METHODS: A prospective study of
consecutive eligible males aged between 20 and 60 years.
BMD was measured using Hologic DXA machine. Vitamin D
was measured using radioimmuno-assay. Stool fat
excretion rate was measured in a 72 hour stool collection.
Statistical analysis was done applying Pearsons
correlation, independent t-test and nonparametric tests.
RESULTS: Thirty-one males with a mean BMI of 18.46 (±
2.86) Kg/m2 and radiologically documented pancreatitis
were studied.The mean 72 hour stool fat was 25.30 (±
18.09)gms and the mean VitaminD was 18.44 (± 10.97) ng/
ml. Nineteen (61%) subjects had an abnormal T score.There
was a significant positive correlation between BMC and
BMI (r = 0.426 ; P = 0.017) and a significant negative
correlation BMC and 72 hour stool fat (r = minus 0.468;P =
0.028). Twenty one (68%) inclusive of eleven FCPD subjects
had diabetes.Subjects with diabetes had a lower BMI (17.7
±2.4 vs 20.0 ± 3.31 Kg/ m2 ;P = 0.087) and lower VitaminD
(16.01 ± 9.03 vs 26.03 ± 13.9 ng/ml P= 0.056) than those
without diabetes. A significant linear correlation (r = 0.448;
P= 0.041) between BMC and BMI was seen only in subjects
with diabetes.
CONCLUSIONS: In subjects with chronic pancreatitis and
diabetes a linear correlation exists between BMC and BMI
presumably due to severe undernutrition. Subjects with
steatorrhea had a significantly reduced BMC which could
not be accounted for by differences in BMI or diabetes or
vitamin D deficiency. Pancreatic osteodystrophy in chronic
pancreatitis is an underrecognized co-morbidty requiring
a more extensive evaluation.
Evidence based policy formulation on Isoniazid prophylaxis
for Latent Tuberculosis infection in Indian context.
BACKGROUND: India has the highest burden of tuberculosis
cases for any country in the world. It has an Incidence rate
of 168 cases per 100000 population. It reported 331,268
58
deaths per year (1 every 90 seconds) of the total 1.3 million
worldwide (25.5% or one in four deaths). Mortality rate due
to TB is 28/100000 population per year in India.
AIM: To investigate whether INH prophylaxis for cases with
latent tuberculosis infection can be incorporated in the
routine health care system in Indian scenario.
METHODS: An evidence based search is conducted to find
effectiveness of INH prophylaxis in cases with latent
tuberculosis infection with or without associated medical
conditions. Search was conducted in electronic medical
resources to find the related studies performing Meta
analysis and randomized control trials comparing Isoniazid
and placebo/other anti tubercular drugs in different
population groups. Appropriate statistical methodology was
adopted to analyse the results (Numbers needed to treat,
relative risk reduction) and formulate the policy.
RESULTS: The study best suited to answer our question for
Non HIV general population was a Meta analysis done by
Smieja Marek et al., titled “Isoniazid for preventing
tuberculosis in non HIV infected persons” (1999) available
at Cochrane database. The risk ratio (RR) of the persons on
INH prophylaxis was 0.40 (95%CI 0.31 to 0.52) with a P
value of <<.01. Numbers needed to treat (NNT) is 35. The
study we used for HIV children was “Effect of Isoniazid
prophylaxis on mortality and incidence of tuberculosis in
children with HIV: randomised controlled trial” by Heather
J Zar et al, available at PUBMED. Numbers needed to treat is
16 for preventing Incidence of one case and 12 for preventing
one death.
CONCLUSION: Although a definite reduction of risk is seen
in groups on INH prophylaxis, INH prophylaxis cannot be
instituted in cases with all latent TB infection in India
because the incidence of latent TB is very high and following
up them all is impossible. However, it can be administered
in high risk groups like HIV positives, health care workers
and people in prisons and army barracks.
AUTHORS:
1. Dr. T.Shyam, School of medical science and technology,
IIT Kharagpur.
2. Dr. Bikas Kumar Arya, School of medical science and
technology, IIT Kharagpur.
Presenting Author:
Dr. T.Shyam, B – 002,
Gokhale hall of residence,
Indian Institute of Technology, Kharagpur,
West Bengal. PIN: 721302
Email: tshyamiitkgp@gmail.com
Nature, prevalence, explanatory models and correlates of
sexual dysfunction among men attending primary health
setting in south India
Dr. P. Thangadurai, MBBS, DPM, DNB,
Assistant professor,
Department of Psychiatry, Christian Medical College,
Vellore - 632002, India.Email ID: thanga@cmcvellore.ac.in
BACKGROUND: Sexual dysfunction is common in all health
care settings. However, this remains under-reported, under-
recognized and under-treated, leading to significant
morbidity and reduction in quality of life.
AIMS: We aimed to determine the nature, prevalence,
explanatory models and correlates of sexual dysfunction
among men attending primary health setting.
METHODS: We conducted a cross-sectional study
investigating 270 consecutive consenting men aged 16 and
above attending the department of community health, CMCH.
Those with severe language, hearing or cognitive impairment
were excluded. We screened for sexual dysfunction using
Sexual History Questionnaire. Those who screened positive
were further evaluated using the International Index of
Erectile Function-5 (IIEF5) and the Chinese Index of
Premature Ejaculation-5 (CIPE5). Explanatory models of
sexual dysfunction were assessed using the modified Short
Explanatory Model Interview (SEMI). We employed Tamil
version of Clinical Interview Schedule- Revised (CISR) to
diagnose common mental disorders.
RESULTS: 75.9% men (95% CI 70.9-81.1) were tested positive
for sexual dysfunction. The most common disorder was
premature ejaculation followed by erectile dysfunction and
their co morbidity. Poverty, advancing age, less education,
history of diabetes, hypertension and presence of a common
mental disorder were significantly associated with sexual
dysfunction (P<0.05). Primary health care physicians under-
diagnosed sexual dysfunction and documented poor inter
rater reliability when compared with diagnoses by a
psychiatric professional (Kappa=0.01).
DISCUSSION: Sexual dysfunction is widely prevalent but
under diagnosed among men attending primary health
clinics. Strengths of this study include adequate sample
size, minimal refusal rates, use of standardized instruments
and eliciting explanatory models. We acknowledge the
limitations such as absence of consensus on normal
ejaculatory latency, varying diagnostic cut off scores of
IIEF-5 and CIPE-5, debatable cross cultural validity and the
possibility of high false positive rates due to poor positive
predictive values. We minimized selection and reporting
bias by consecutive sampling and by interviews conducted
by a single investigator well versed in local culture and
language.
CONCLUSION: We suggest the need to include effective
management of sexual dysfunction in the existing primary
health system. Future longitudinal studies to evaluate
incidence and correlates of sexual dysfunction are desired.
The impact of family attachment programme in
undergraduate curriculum to appreciate the concept of
evidence informed public health.
BACKGROUND: Evidence based public health is the
integration of science based intervention with community
preference to develop the health of the public. The latter
stages of this process of evidence based public health
involve vigilant decision making in order to address specific
public health problems, where the adaptation of the
research knowledge to the local context prior to the
implementation of the adapted evidence in to practice or
policy development is of crucial value. This adaptation is
mainly based on the recognition and analysis of needs/
preferences specific to the community under consideration.
AIM/OBJECTIVE: To describe the importance of family
attachment programme in undergraduate curriculum to
appreciate the concept of evidence informed public health.
METHOD/ACTIVITY: Medical students of the Faculty of
Medical Sciences, University of Sri Jayewardenepura, Sri
Lanka were allocated in to groups of three students and
assigned a household in the university project area for a
period of two months during their final year training.
Weekly seminars were held to discuss the health related
issues faced by each family and possible interventions that
could be made to overcome them. The students then
undertook a practical approach in to decision making and
implementing the necessary interventions under supervised
guidance from the departments of Community Medicine,
Family Medicine, Paediatrics, Psychiatry and public health
staff from the university project area.
The students were assessed by a Viva Voce examination as
part of their final MBBS examination.
Conclusions and Recommendations
Conventionally the undergraduate training is hospital
centred and mainly focused on relieving physical infirmity.
But through this innovative programme the students got the
opportunity to explore the possible interventions while
considering the individuals, family and community as a
whole. Thus enabling them to understand how to adapt the
research knowledge to the local context by recognizing the
needs/preferences specific to that community, thereby
achieving better decision making in the process of evidence
informed public health. Therefore,including this innovative
programme in the undergraduate public health training is
highly recommended.
59
 Using evidence to inform policy making &
implementation: A case of tobacco control in Karnataka
Dr. Upendra Bhojani
Faculty,
Institute of Public Health
250, Master’s cottage, 2 C Main, 2 C Cross, Girinagar 1st
Phase, Bangalore 560085
(080) 26421929, 09342349121
upendra@iphindia.org
BACKGROUND: India was among the earlier countries to
ratify the WHO’s Framework Convention on Tobacco Control
(FCTC). In fact India enacted a national legislation, ‘The
Cigarettes and Other Tobacco Products Act (COTPA) 2003’
even before FCTC came in force. Though, not free of lacuna,
COTPA provided good framework with inclusion of evidence-
based strategies including 1) prohibition on smoking in
public spaces 2) prohibition on tobacco advertising 3)
prohibition of sale of tobacco products to minors and near
educational institutions and 4) mandatory display of
picture warnings on tobacco products including others.
However, framing of rules and their notifications to
implement COTPA presented complex challenges for public
health community as it became evident from repeated delays
and dilutions of the original provisions of the Act.
AIM: To describe how needed evidences to strengthen
tobacco control policies and its implementation were
generated and were disseminated using innovative tools
and channels to relevant stakeholders by Institute of Public
Health (IPH) in Karnataka.
METHOD: Situational and stakeholder analysis helped to
identify issues and influential stakeholders in context of
tobacco control in India. Discourses regarding employment
of tobacco industry workers, effectiveness and acceptance
of suggested warnings, impact of tobacco control measures
on general economy surfaced by tobacco industry, media,
and at times politicians created negative environment for
effective and undiluted implementation of proposed Act.
In this context, through short studies and surveys IPH
generated relevant evidences and used innovative tools
and to disseminate it to media (Media tool kit, Sensitization
meetings, Provision of relevant information), law makers
(Stories in local and national newspapers, Advocacy kit on
pictorial warnings, memoranda, and campaigns), law
enforcers (news stories on legal violations, Complaints to
various departments, PIL in Karnataka high court) and
community (Awareness campaigns, painting competitions
and fact sheets for schools).
RESULTS: These efforts resulted in publication of IEC
materials and more than 20 news stories in local and
national papers on periodic basis. Karnataka High Court
passed an interim order instructing various stakeholders
60
to strengthen implementation of law. Increased awareness
among students, teachers and community in general.
URINARY METANEPHRINES IN THE DIAGNOSIS OF
PHEOCHROMOCYTOMA
Vasanthi K*, Kanakamani J*, Rajaratnam S*, Gracy V$,
Fleming J$,
*Departments of Endocrinology, Diabetes and Metabolism
& $Clinical Biochemistry
Christian Medical College, Vellore.
BACKGROUND: Though pheochromocytomas are rare
tumors, they need to be considered in a large number of
patients with hypertension because they are dangerous and
are potentially curable. Measurement of plasma or urinary
metanephrines are said to be diagnostically superior than
measurement of catecholamines or vanillyl mandelic acid.
OBJECTIVE: The objective was to study the diagnostic value
of urinary total metanephrines in the diagnosis of
pheochromocytomas.
METHODS: Outcomes of patients tested in our center for
pheochromocytomas from June 2008 to June 2009 were
retrospectively studied. Urinary total metanephrines (uMN)
and normetanephrines (uNMN) were measured by enzyme
immunoassay. The upper limit of the laboratory reference
range was used to calculate the diagnostic accuracy
parameters.
RESULTS: There were 66 patients (49 males and 17 females).
Fifteen patients had histopathologically proven
pheochromocytomas. 11 of them were adrenal tumors and
4 were paragangliomas. 45 patients had hypertension in
whom secondary causes were not found. Six had adrenal
masses of other origin, proven by biopsy. The median uMN
in the pheochromocytoma group was 363 (59 – 5640) mg/
day and uNMN 4000 (329 – 10400) mg/day and that of non-
pheochromocytoma group was 168 (43-638) mg/day and
734 (85-2763) mg/day. The sensitivity and specificity of
uMN was 53.3% & 90.2% respectively and that of uNMN
was 86.6% & 21.57%. Area under the receiver operating
characteristic curve was 0.737 (95% CI: 0.566-0.909) for
uMN and 0.851(95% CI: 0.693-1.009) for uNMN.If both uMN
and uNMN were combined together, negative predictive
value is 100% but positive predictive value is only 26%.
Conclusion: Urinary total metanephrines is a valuable test
to exclude pheochromocytoma in a population who need to
be screened for the tumor. However with a low pretest
probability, it cannot be used to confirm a diagnosis of
pheochromocytoma.

A Randomized Double Blind Comparative trial of
Antidepressant Augmentation by High and Low Dosage
Folic Acid in Depressive Disorder
ABSTRACT
BACKGROUND: Several studies show elevated incidence of
folate deficiency in patients suffering from depression.
Systematic-reviews suggest that folate may have a potential
role as supplement to antidepressants but have called for
further trials. Few trials have shown that in females than in
males; administering folic acid with antidepressants
augments the antidepressant response.
OBJECTIVE: In this study we compared the add on effect of
high (5mg) versus low dose (1.5mg) folic acid to fluoxetine
(20 mg) in female patients suffering from moderate/severe
depressive episode (either first episode or recurrent
depressive disorder)
METHODOLOGY: 42 drug naïve female outpatients clinically
diagnosed to have moderate or severe depressive episode
(ICD-10 criteria) were randomized into two groups 1 and 2.
Both groups received fluoxetine 20 mg. In addition, group 1
received folic acid 1.5 mg/day, while group 2 received 5
mg/day of folic acid in a double blind fashion. Out come
measures were Hamilton Depression Rating Scale (17 item
version) and Beck Depression Inventory administered every
week for a period of 6 weeks. Appropriate statistics was
used to analyze the data
RESULTS: Both groups were comparable at baseline in terms
of socio-demographic and illness variables (p>0.05). There
was no significant difference across two groups with
respect to baseline HDRS and BDI scores (p>0.05). Within
both the groups there was a significant decline in mean
depression scores on both HDRS, BDI (p=0.00). Across the
two groups, the decline in BDI scores was statistically
significant which was more in group 2 (p = 0.04). The
decline in HDRS scores was not statistically significant
across the two groups (p > 0.05). 66% of patients in group 2
and 33 % in group 1 showed a 50% decline from the baseline
score in both scales.
CONCLUSION AND LIMITATION: Hence supplementing 5 mg
folic acid to fluoxetine in the treatment algorithm in women
with depressive episode, produces a better add on effect
than 1.5 mg of folic acid. The results could have been better
substantiated with a laboratory measurement of serum folic
acid and homocysteine levels.
Authors:
1) Dr. R. Venkatasubramanian*, MD
2) Dr. Ravi Shankara Pandey***, MD
3) Dr. Venkateshwaran.R**, MBBS
Affiliation address:
* Assistant Professor, Department of Psychiatry, PSG
Institute of Medical Sciences and Research,
Coimbatore-641004
** Professor of Psychiatry, National Institute of Mental
Health and Neurosciences, Hosur Road, Bangalore-
560029
*** Junior Resident, Department of Psychiatry, PSG Institute
of Medical Sciences and Research, Coimbatore-641004
Presenting author:
Dr. R. Venkatasubramanian, MD
Assistant Professor,
Department of Psychiatry,
PSG Institute of Medical Science and Research,
Coimbatore- 641004.
Tamilnadu, India.
Phone number: +91-9791802486; + 91-9944059997
Fax number: +91 422 2594400
E-mail: rvs.1947@gmail.com
psychiatry.venkat@hotmail.com
Study of Depression among Diabetics in a General
hospital: Consequences in Diabetes Management &
Quality of Life
BACKGROUND: Recent studies quote high prevalence of
depressive episodes in diabetics, which leads to increased
risk for various complications of the metabolic disorder.
Yet depression is often unrecognized and untreated in
approximately two thirds of patients with diabetes.
Underdiagnosis of co-morbid depression may reflect a
perception among clinicians that psychological issues are
less important than medical concerns in patients with
diabetes. To maximize overall patient outcome, this needs
to be addressed adequately.
OBJECTIVE: To estimate the prevalence of depression among
the diabetics in the study population. To ascertain and
compare the level of diabetes self care management and
the health-related quality of life between the depressed and
non-depressed.
METHODOLOGY: 50 consecutive diabetic out-patients of
either sex, after informed consent were administered
Hamilton Depression Rating Scale (HAM-D), Summary of
Diabetes Self Care Activities (SDSCA), and Rand 36 Health
status inventory. Based on the HAM-D scores, patients were
initially grouped as depressed and non-depressed.
Depressed were further sub-grouped into mild, moderate,
severe and very severe. Comparison of the level of diabetes
management self care and Quality of Life between the
depressed and non-depressed was done using the mean
61
scores of SDSCA, Rand 36 inventory. Appropriate statistics
was used to analyze the data.
RESULTS: The proportion of depression among the study
population was 46% and of them 50% was mildly depressed.
All components of SDSCA scores were lower among
depressed compared to normal population (p<0.01). There
is a decline in the all the components of SDSCA scores as
the severity of depressive symptoms increases, with severe
& very severely depressed having the least score. Rand 36
inventory items were also significantly different between
depressed and non-depressed (<0.05). The mean scores of
SDSCA, RAND 36 also show a statistically significant decline
as the severity of depression increases.
CONCLUSION: Results substantiate that prevalence of
depression among diabetics is higher than in the general
population which is in the range of 7.8% to 17%. Identifying
depression among the diabetics at an earlier stage would
improve the Physical & Mental domain of Health Related
Quality of Life and breaking the vicious cycle of depression
and diabetes. Eclectic interventions need to be planned for
each individual. However rater-blind studies are required
for further validation of our findings.
AUTHORS:
1. Dr. Venkateswaran. R*, MBBS
2. Dr. Mario Victor Newton. L**, MBBS
3. Dr. Venkatasubramanian. R***, MD
Affiliation address:
* Junior Resident, Department of Psychiatry, PSG
Institute of Medical Sciences and Research,
Coimbatore-641004
** Under-graduate Student, PSG Institute of Medical
Sciences and Research, Coimbatore-641004
*** Assistant Professor, Department of Psychiatry, PSG
Institute of Medical Sciences and Research,
Coimbatore-641004
Presenting author:
Dr. R. Venkateswaran, MBBS
Junior Resident,
Department of Psychiatry,
PSG Institute of Medical Science and Research,
Coimbatore- 641004.
Tamilnadu, India.
Phone number: +91-9994474538; + 91-9655590526
Fax number: +91 422 2594400
E-mail: drwaran005@gmail.com
62
Assessment of the reporting quality of non-inferiority and
equivalence trials in cancer post CONSORT, using a
modified CONSORT checklist
AUTHORS: Vikram Gota1, Sadhana Kannan1, Priya
Ranganathan2, Nithya Gogtay3, Sandeep Bavdekar3, CS
Pramesh2
1
ACTREC, Tata Memorial Centre, Sector-22, Kharghar, Navi
Mumbai 410 210, India
2
Tata Memorial Hospital, Parel, Mumbai 400 012, India
3
Seth GS Medical College and KEM Hospital Parel,
Mumbai 400 012, India
BACKGROUND: The revised CONSORT was published in 2006
to improve the reporting of RCTs. Non-inferiority (NI) and
equivalence (Eq) trials are a subset of RCTs that differ
methodologically from superiority trials. An extension to
the CONSORT checklist was published in 2006 for reporting
NI/Eq trials. This checklist provides a framework for
minimum reporting standards, but leaves several points
open to interpretation. Studies that evaluated the impact of
the extended CONSORT statement on the quality of reporting
of NI/Eq trials in AIDS and ophthalmology concluded that
reviewers and editors need to reinforce their standards for
acceptance of NI/Eq RCTs.
AIM:
1) Assess the impact of the CONSORT statement, on the
quality of reporting of NI/Eq trials in oncology.
2) Validate a modified CONSORT checklist for NI/EQ trials
by checking the intraclass correlation coefficient (ICC)
between three sets of raters.
METHODS: All RCTs in cancer with NI/Eq design published
post CONSORT till November 2008 were selected from
PUBMED. A modified CONSORT checklist was developed
that included all 22 items of the extended CONSORT for NI/
Eq trials. Additional items considered important from a NI/
Eq trial perspective were also included. Each of the 22 items
was further subcategorized to render objectivity to the
checklist. Three groups of reviewers scored the checklist
independently for all post CONSORT trials. After scoring,
the reviewers got together to arrive at a composite score
based on consensus. The interrater agreement was assessed
using ICC. Compliance of each article to CONSORT was also
assessed.
RESULTS: Twenty six studies were identified. The overall
interrater agreement for the modified checklist was 71%.
The agreement was greatest for the ‘results section’ (77%)
and least for the ‘discussion section’ (49%) of the articles.
The maximum possible score was 49 points. Only 7/26
studies scored above 75% of the maximum score. Major
areas that require improved reporting include specifying
a) NI margin b) rationale for choice of delta c) methods
used to implement random allocation. No difference was
found in the reporting quality of industry sponsored and
investigator initiated trials (P=0.80).
CONCLUSION: Compliance to CONSORT statement for NI/Eq
trials in cancer is poor. We have attempted to validate a
modified CONSORT checklist for NI/Eq trials.
Presenting author (Also contact author)
Dr. Vikram Gota
Assistant Professor
Clinical Pharmacology
Advanced Centre for Treatment Research & Education in
Cancer (ACTREC)
Tata Memorial Centre
Kharghar
Navi Mumbai
Tel: 022 2740 5130
vgota@actrec.gov.in
Who is using The Cochrane Library?
Usage statistics of Wiley InterScience for India and
Worldwide.
Jaslyn Tan, Piyush Gupta, Ashish Sood, Laura Sampson;
Wiley InterScience
BACKGROUND: The dissemination of high quality, timely
evidence is a priority for The Cochrane Collaboration and
for the ICMR who fund a national access licence for India.
By monitoring usage, exploring user activity, and identifying
trends we can build on our understanding of how people
use The Cochrane Library, where they come from, and which
reviews they access. We can use these data to help us
identify ways of increasing access to and usage of The
Cochrane Library in India and worldwide.
METHODS: For the worldwide data the periods of 1st
January 2008 to 31st December 2008, the number of unique
visits to www.thecochranelibrary.com, number of visits by
country, and most accessed Cochrane reviews on Wiley
InterScience were taken from the Wiley InterScience Data
Warehouse, an analysis tool that stores and tracks usage
data. Another set of usage data was obtained from all other
licensed providers of The Cochrane Library, showing the
number of abstracts and full text articles that were accessed
during 2008 from Wiley InterScience, EBSCO, OVID, La
Biblioteca Cochrane, BIREME and www.cochrane.org. For
the India usage data the periods calendar year 2006, 2007,
2008 and Jan – August 2009 were considered, so as to help
investigate the impact of introducing national access, using
the IP ranges for India to identify India usage activity as
registered from Wiley InterScience Data Warehouse.
Results: In India, in 2008 a full text article was downloaded
from Wiley InterScience every 7 minutes. For India this
represents an increase in usage of The Cochrane Library of
648% from Year 2006 to Year 2007 and 14% from Year 2007
to Year 2008 and by August 2009, the total full text download
is already 68% of the total Year 2008 figures. Data taken
from all websites of The Cochrane Library show that during
2008: A search of The Cochrane Library took place every 2
seconds; A Cochrane abstract was viewed every 3 seconds;
A full text article was downloaded every 4 seconds. The
total full text download for Cochrane Library in India in
Year 2008 is 70,090; making India as one of the top 10
countries from Asia that visited Cochrane Library worldwide
Conclusions: In summary, usage of The Cochrane Library in
2008 has increased considerably in comparison to 2007.
Over half the world’s population now have access to The
Cochrane Library via one-click access (no login required),
and it is clear that worldwide usage of The Cochrane Library
is increasing as a consequence. Usage in India, since the
national license was provided, access nationally has grown
significantly and the usage levels now surpass many other
developed countries with established national access
schemes including Norway, Ireland and Poland establishing
India as one of the top countries visiting and using The
Cochrane Library.
EVIDENCE BASED MEDICINE: A NEW APPROACH TO TEACH
MEDICINE
Authors:
Yeshwant*, Elakkiya*, Prarthana Saraswathi*, Surapaneni
Krishna Mohan**
Affiliation:
*II MBBS Student, Saveetha Medical College & Hospital,
Saveetha University, Saveetha Nagar, Thandalam, CHENNAI
– 602 105, T.N, INDIA.
**Assistant Professor, Department of Biochemistry,
Saveetha Medical College & Hospital, Saveetha University,
Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.
BACKGROUND: No clinician would consider entering
clinical practice without knowing the rudiments of history-
taking and physical examination, nor would clinicians
consider independent practice without a basic
understanding of how the drugs they prescribe act on their
patients. Yet, traditionally, clinicians have started practice
without an ability to understand evidence about how they
should interpret what they find on history and physical
examination, or the magnitude of the effects they might
expect when they offer patients medication. Evidence-based
medicine (EBM) provides a remedy for this problem.
63
AIM: Our Aim of this presentation is to introduce EBM to Under NRHM programme we will study JANANI SURAKSHA
the beginners. YOJNA (JSY) carried out in RAJASTHAN.

WHAT IS EBM? Evidence-based medicine (EBM) is the AIMS:

integration of best research evidence with clinical expertise
and patient values. 1) Reduction in MATERNAL MORTALITY RATE (MMR)

WHY THE INTEREST IN EBM? The EBM approach seeks to
apply evidence from rigorous clinical research to the care
of individual patients and has been defined as the
“conscientious explicit and judicious use of current best
evidence in making decisions about the care of individual
patients”.
STEPS IN EBM PACTICE? It consists of FIVE related steps.
Step 1: ASKING focused clinical questions that arise in
caring for patients.
Step 2: ACQUIRING the best available evidence through
electronic searching.
Step 3: APPRAISING the quality of the evidence acquired
against explicit methodological criteria.
Step 4: APPLYING the evidence appropriately to the clinical
management of individuals.
2) Reduction in INFANT MORTALITY RATE (IMR) by 50%
from existing levels in next seven years.
METHODS: Government of RAJASTHAN has appointed ASHA
(Accredated Social Health Activist) in every village who
ensures early registration of pregnant woman and three
institutional Antenatal Care check ups, two doses of Tetanus
Toxoid vaccine and hundred tablets of Iron Folic acid to
each pregnant woman. Also she promotes Institutional
Delivery and for doing this government provides Referral
Transport facility from the home of beneficiary to the health
care system. ASHA also ensures five Post Natal check ups
and Immunisation of the child. The financial scale of
assistance under the scheme is as follows:
RURAL AREA
Mother’s package ASHA package Total Rs.
1400/- 200+300+100=600/- 2000/-

Step 5: ASSESSING performance in relation to the previous 200-ANC check up

four steps. 300-Referral transport
100-PNC check up
LIMITATIONS OF EBM: The commonly cited limitations of
EBM are as follows-1)Universal to the practice of medicine URBAN AREA
2) Shortage of coherent, consistent scientific evidence 3)
Difficulties in applying evidence to the care of individual Mother’s package ASHA package Total Rs
patients 4) Barriers to the practice of high-quality medicine
1000/- 200/- 1200/-
5) Unique to the practice of evidence-based medicine 6) The
need to develop new skills 7) Limited time and resources 8) RESULTS: Comparative study of Institutional Delivery in the
Paucity of evidence that evidence-based medicine “works”. year 2007-08 and 2008-09 in state of RAJASTHAN.
ADDRESS OF THE PRESENTING AUTHOR: Statement showing progress of JSY beneficiaries in state
of RAJASTHAN:
YESHWANT KUMAR N.N.T,
II MBBS Student, Total ANC Registration 12,78,503
Saveetha Medical College & Hospital, Beneficiaries 2007-08 4,68,886
Saveetha University, Saveetha Nagar,
Thandalam, CHENNAI – 602 105, Beneficiaries 2008-09 598772
Tamilnadu, INDIA. Percentage % 27.70
Email address: yeshwantprofo@gmail.com
CONCLUSION: This programme has encouraged Institutional
Contact Number: +91-9962833305
Delivery as a result-
EVIDENCE INFORMED PUBLIC HEALTH:
1) MMR has decreased
BACKGROUND: NATIONAL RURAL HEALTH MISSION (NRHM)
2) IMR has decreased
is evidence based programme. NRHM is a national effort at
ensuring effective health care through a range of PRESENTING AUTHOR: SAUMYA AGARWAL
interventions at individual, household, community and 32/347 OUTSIDE SURAJPOLE ABOVE IDBI BANK ATM,
most critically at the health system. UDAIPUR, RAJASTHAN.

64
 Plagiarism in Indian Medical Journals, a pilot study
Aneesh George, Richard Kirubakaran, Prathap Tharyan
Prof. BV Moses and ICMR Centre for Research and
Training in Evidence-Informed Healthcare
BACKGROUND: Plagiarism is the reproducing of the work
or ideas of others as ones own, without giving the original
author proper credit or acknowledgement. Plagiarism is
considered as research misconduct. However, there are
cultural differences in attitudes towards plagiarism.
OBJECTIVE: To detect plagiarism in a small sample of
indexed and non-indexed Indian Medical Journals (in 2008)
and to assess guidelines on avoiding plagiarism in the
‘Instructions to Authors” of these selected Journals.
METHODS: We selected 65 Indian medical journals and
classified them as indexed and non- indexed based on the
citation in Pub med. We randomly selected four journals
each, from both these categories, using a random number
table and selected all Review articles and Original articles
in all issues for 2008. We used the free online plagiarism
detecting tool, Duplichecker, and used Google and Yahoo as
our primary and secondary search engines. We checked all
sections of each article and, in the absence of a standard
working definition of plagiarism, we defined plagiarism as
the detection of more than five consecutive words in a
sentence from another publication, without giving credit to
the original author; or more than fifteen consecutive words
with acknowledgement but without copyright permission
from the original author(s) or publishers. We classified
plagiarism as substantial if there were more than five
instances of the former in any article or the detection of
any instance of the latter.
RESULTS: We selected 194 articles (44 reviews (22.7%); 150
original articles (77.3%)) from the 8 selected journals. We
detected plagiarism in 70 (36%) articles (26/79 articles from
indexed journals (32.9%) and 44/115 (38%) articles from
non indexed journals) with the highest rates in review
articles (70%). Google (the primary search engine in this
study) detected more than 80% of the plagiarized articles.
Indexed and non indexed journals did not significantly
differ with respect to plagiarism (OR=1.26 and CI=0.66-
2.41).41/70 (58.6%) plagiarized articles were categorized
as ‘substantially plagiarized’ as per our working definition.
CONCLUSION: Over a third of the articles in this pilot sample
had examples of plagiarism. None of the selected journals
except the National Medical Journal of India had guidelines
with respect to plagiarism. Measures to develop standard
working definitions of plagiarism and to educate authors
and peer-reviewers and provide better guidance in editorial
policy are needed.
CHANGING MEDICAL PRACTICE BY DISSEMINATING
EVIDENCE
AUTHOR
Dr. Anna Mathew M. D. (Pharm),
Associate Professor in Pharmacology & Co-ordinator,
CME Department, Christian Medical College, Vellore.
BACKGROUND: The CME department, consisting of the
coordinator and two office staff, plan and conduct CME
Updates and prepare CME materials and media for updating
medical practitioners with the help of the valuable expert
teaching input from the committed faculty of various
departments in CMC.
OBJECTIVES: The objectives of the Continuing Medical
Education (CME) department of Christian Medical College,
(CMC) Vellore is to update doctors working in peripheral
hospitals and rural areas and so to enable them to practice
evidence based medicine in primary and secondary care
through relevant and need-based CME. This is important as
the Medical Council of India, now recertifies doctors every
five years and requires thirty credit hours of CME per year
before recertification.
METHODS: Current Medical Issues (CMI) is a bi-monthly
journal (ISSN 0973 4651) of the CME department, which
summarises current issues and features Cochrane reviews,
Evidence updates and Practical evidence about real life
situations (PEARLS) to update its readership of
approximately 1000 doctors located in various parts of the
country both in rural and urban areas. The evidence based
material provided by the Cochrane network is reviewed by
a member of the faculty of CMC from the concerned specialty,
who makes comments about the relevance of the update in
our situation in India. These expert comments from the
faculty are included with the update in the journal.
RESULTS AND CONCLUSIONS: The Cochrane Evidence
Updates have been well received by the readers judging by
the responses that have come back to specific questions
asked in the quality survey in each issue. The feedback
reveals that the Cochrane reviews are read and are
influencing the practice of the doctors. The readers have
sent in anecdotes about how their practice has been affected
and also ask thought-provoking questions which are then
passed on to faculty to be answered. This has resulted in a
dialogue between the doctors in peripheral hospitals and
the faculty at CMC and some of these are featured in the
‘Readers Write’ column of CMI.
To date 118 summaries of Cochrane reviews, Evidence
Updates and PEARLS have been included in the CMI journal
and around 60 faculty from over 20 specialties in CMC have
commented on these issues.
67
As one of the doctors working in a mission hospital has
written, “It is very difficult for busy doctors in short-staffed
hospitals to keep abreast of what is happening in the
medical world. Besides we cannot subscribe to journals
and do not have easy access to the internet. The Cochrane
network has done a fine job of summarising evidence and
the CME journal. ‘Current Medical Issues’ brings us the
concise information in an easily readable format so that
we too, working in the rural areas can practice evidence
based medicine”.

ACKNOWLEDGEMENTS: The CME department is grateful to

the faculty of CMC who are eminently competent and ever
willing to share their expertise to enhance the skills of
doctors working in peripheral hospitals.

The activities of the CME department are enhanced by the

diligence and hard work of the support staff, Mr. T. Suresh
Babu and Mr. C. Nagarajan and their good work is hereby
acknowledged.

68
 Validating Ayurveda formulations using Arthritis model – A Clinical Approach

Girish Tillu1, 2, Manjit Saluja1, Sanjeev Sarmukaddam1, Arvind Chopra1

Background:

Validation of Ayurveda interventions needs proper research questions and appropriate designs. For example, the Ayurvedic formulations that we have used in many
trials contained several ‘Rasayana’ medicinal plants, these formulations are expected to improve quality of life apart from other actions. We have screened
Ayurveda drugs with modern medicine in superiority and equivalence designs. We present results of representative trials for Rheumatoid Arthritis (RA) and
Osteoarthritis (OA).

Results of RA and OA trials

Trial Design Participants Intervention (n) Outcome Result

(sample size)

RA-1 RDB Patients with active-on-chronic Plant extracts of Withania Swollen joint count Superiority over
Placebo controlled RA (182) somnifera, Boswellia serrata, Swollen joint score placebo (Not Signifi-
Zingiber officinale and Curcuma ACR 20 cant)
longa

IRA-01 RDB Patients with active-on-chronic Boswellia serrata (Salai Guggul), Swollen joint count  Superiority over
Placebo controlled RA (130) Trigonella foenum-graecum Swollen joint score placebo for all
(Fenugreek), Linum usitatissimum ACR 20 efficacy measures.
(Flaxseed), Camellia sinensis  Significant
(Green tea), Curcuma longa improvement with
(Turmeric), Tribulus terrestris respect to
(Gokshur), and Piper nigrum physician global
(Black pepper). assessment
 1 year of follow-up
showed significant
improvement in all
efficacy variables

NMITLI/B1 Single blind Patients with active RA (121) 1. Plant extracts of Guduchi Swollen joint count No significant
Hydroxychloroquin (Tinospora cordifolia), Swollen joint score difference in any of
Ashwagandha (Withania ACR 20 the efficacy measures
somnifera),Gokshur (Tribulus except physician
terrestris) and Shunthi (Zingiber global assessment.
officinale)
2. Bhallataka (Semecarpus
anacardium)

65
 RA-11 RDB Patients of symptomatic Plant extracts of Withania Pain VAS Active group showed
Placebo controlled primary OA knees with Pain VAS somnifera, Boswellia serrata, WOMAC a significant
> 4 (90) Zingiber officinale and Curcuma reduction
longa

NMITLI/ RDB Placebo Patients of symptomatic Formulations containing Shunthi Pain VAS No significant
C-01 and Glucosamine primary OA knees with Pain VAS (Zingiber officinale), Guduchi WOMAC differences for pain
> 4 (245) (Tinospora cordifolia), Amalaki and WOMAC
(Emblica officinale), Ashwagandha
(Withania somnifera) and Gokshur
(Tribulus terrestris)

NMITLI/ RDB Patients of symptomatic Formulations containing Shunthi Pain VAS Ayurvedic formula-
C-02 Equivalence trial primary OA knees with Pain VAS (Zingiber officinale), Guduchi WOMAC tion shown equiva-
Control as Celecoxib > 4 (440) (Tinospora cordifolia) lent efficacy
and Glucosamine

(RDB = Randomized Double Blind, VAS = Visual Analogue Scale, WOMAC = Western Ontario McMaster Univ OA Index)

Conclusion:

Ayurvedic drugs, as demonstrated by results of controlled drug trials reviewed in this abstract, are capable of providing both short and long term relief to patients
of RA and OA. Though the efficacy of Ayurveda drugs is modest, the safety is excellent. This could be considered in ‘Integrative way’ using both modern and Ayurveda
treatments thus can lead towards effective solutions for difficult to treat chronic disorders.

Acknowledgement

We acknowledge several experts and institutes who participated in CSIR - New Millenium Indian Technology Leadership Initiative program.

Authors’ affiliations

1. Centre for Rheumatic Diseases, Pune

2. Centre for Development of Advanced Computing, Pune

Address of presenting author:

Girish Tillu
High Performance Business Computing Group,
Centre for Development of Advanced Computing,
Pune University Campus, Ganeshkhind, Pune 411007 (India)
Mobile no: +919850026597
Email: gtillu@rediffmail.com, gtillu@gmail.com

66