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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
Conclusions:
Comparison of effectiveness of allopathic treatment with
herbal treatment for uncomplicated upper respiratory • The study drug has been found effective (58 % cure rate)
tract infection in Jamunamarathur Tribal Primary Health for the population under condition.
Care Centre of Tamil Nadu
• There is only 7% difference in the cure rate between the
(Dr. M.Abdul Kareem *, Dr. M. S. Subramaniam **, allopathic arm (65%) and the herbal arm (58%). The P
Dr. K. R. John***) value= 0.602, P>.05, the difference of effectiveness
between two arms is not significant. Hence the herbal
*Senior Program Officer, Foundation for Revitilization of
cough syrup can be acceptable as alternative cure for
Local Health Tradition, Bangalore,
cough due to URI.
** Department of Botany, Kongunadu Arts and Science
• No adverse effects have been reported during the present
College, Coimbatore,
clinical study.
***Professor, Department of Community Medicine,
Chiristian Medical College, Vellore Editorial policy and the reporting of Randomized
Controlled Trials in Indian Medical Journals
BACKGROUND: Today it is very evident that the local health
in 2004 & 2005 compared to 2007 & 2008
traditions at house hold level show that there is a decline
in the usage of home remedies, traditional diets and health Aneesh George, Richard Kirubakaran, Prathap Tharyan,
customs. This situation demands a movement that Jabez Paul, Manuel Raj
incorporates local resources and local knowledge for
enhancing health security by promoting under a public Prof. BV Moses & Indian Council of Medical Research
health system for the wider use. Hence there is a need to Center for Advanced Research and Training in Evidence
research and promote the proper use of traditional medicine Informed Healthcare;
by developing and providing international standards,
technical guidelines and methodologies on the South Asian Cochrane Network & Centre, Christian
effectiveness. In this study one formulation for cough due Medical College, Vellore, India
to upper respiratory tract infection has been selected from Background: Editorial requirements for submission of
the ethno botanical documentation of the local healer. reports of Randomized Controlled Trials (RCTs) in 2005 and
AIM: To study the effectiveness of herbal cough syrup the quality of reporting of RCTs in 2004 and 2005 in Indian
compared to allopathic treatment for uncomplicated upper medical journals were suboptimal [1].
respiratory tract infection. Objectives: To assess the changes in editorial policy for
METHODOLOGY: Randomized control clinical trial. Settings: manuscript submission in 65 Indian medical journals in
Out patients of Jamunamarathur Primary Healthcare Centre 2008 compared to 2005 the quality of reporting of RCTs
in the Javadu hills, in Thiruvanamalai. Participants: 64 published in these journals in 2007-2008 versus 2004-2005
participants (32 in each arm) were recruited from amongst Methods: We included 65 Indian medical journals
the patients suffering from uncomplicated upper respiratory identified from the South Asian Database of Controlled
tract infection. Intervention: One group received the Clinical Trials (www.cochrane-sadcct.org) that provided
allopathic treatment of benadryl syrup, paracetamol tablets data for the earlier survey.AG and RK independently analyzed
and a saline nasal drop. The other group got the herbal their instructions to authors for endorsement of the
cough syrup, with masked tablets and nasal drops. CONSORT statement and the ICMJE requirements for
Examined twice (3rd and 7th day), during the length of the reporting of RCTs.AG and RK independently evaluated reports
week long follow-up. Method: Patients were randomly of all RCTs published in these journals in 2007 and 2008
allocated to receive either the herbal cough syrup or against 13 selected CONSORT items and the ICMJE
allopathic treatment. requirements. All data were verified by PT. We compared
RESULTS: Baseline sex and age of both groups were similar. the proportion of reports in 2004-2005 versus 2007-2008
Thirty-one patients completed the follow-up in each arm. that endorsed selected CONSORT and ICMJE items
The results of the trial indicated that 20 out of 31 patients RESULTS: Of the 65 journals, 38 (59%) in 2005 and 37 (57%)
(65%) were cured with the allopathic drug and 18 out of the in 2008 mentioned the ICMJE requirements in their
31 patients (58%) were cured with the herbal syrup. There instructions for authors, but only 20 (31%) in 2005 and 22
was no report of any adverse events or side effects. Epi- (33%) in 2008 specifically required authors to submit
Info 6.04 (CDC, Atlanta, USA) software was used for analysis. manuscripts in accordance with the CONSORT statement.
Of 151 RCTs published in 2004-2005, and 145 RCTs

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published in 2007-2008, only 4/13 (31%) of selected Health Library, Doctor NDTV and web health centre), over
CONSORT items were reported in > 50% of trial reports. the period studied. Interest increased dramatically since
Reporting was better for some items reflecting internal the provision of the national subscription with the
validity but worse or unchanged for others. Ethical issues maximum interest over time seen in Tamil Nadu,
continued to be poorly reported, though reporting funding Maharashtra, Delhi and Karnataka. Interest was sustained,
sources and conflicts of interest had significantly improved. with peaks reflecting national Cochrane-related symposia
and activities. Australia, the UK, and Canada showed the
Adequacy of reporting was not related to endorsing maximum interest in ‘Cochrane’, but since 2007, India has
CONSORT or the ICMJE requirements. overtaken the US. ‘Cochrane’ also scored above Indian
journals (Indian Journal of Medical Research, National
CONCLUSIONS: Editorial policy in leading Indian medical
Medical Journal of India, Journal of the Association of
journals regarding manuscript submission for RCTs
Physicans of India, the Postgraduate Medical Journal and
continues to be suboptimal. The reporting of RCTs for
others) and international journals (NEJM, The Lancet, BMJ
CONSORT items reflecting internal validity was better in
and JAMA). However, ‘PubMed’ was by far the most
2007-2008 over 2004-2005 for random sequence generation
commonly-searched term in Google during these years. Data
but continued to be suboptimal for allocation concealment,
from Wiley-Blackwell on actual usage of The Cochrane
blinding and intention to treat analyses. The reporting of
Library from 2006-2008 mirrors the increased interest in
conflicts of interest and funding sources had significantly
usage captured by Google Insights since the provision of
improved in RCTS published in 2007-2008 Urgent measures
the national subscription
to educate Indian medical journal editors are needed and
is planned. CONCLUSION: Google Insights is a proxy to evaluate interest
in Cochrane in India, and may reflect healthcare information
Google Insights into The Cochrane Library usage in India: is
seeking behavior of healthcare professionals, researchers,
the national subscription being used?
students, consumers, etc. These results are only indicative
Asokan GV1, Dave Sinclair2 and Prathap Tharyan3 and restricted to trends captured by a single search engine
with this capability. They also do not reflect direct access
BACKGROUND: Google Insights is a free-to-use internet tool to health-portal, journal, or database websites though
which tracks the popularity of specific internet search terms stored or forwarded web-links. However, they correlate with
over time.1 This simple tool has the potential to provide direct data of usage statistics of The Cochrane Library. The
real time data on public health concerns.2 National subscription has increased and sustained interest
in The Cochrane Library, though high interest is limited to
OBJECTIVE: To investigate the way health information is
certain states.
searched for in India via Google, and to evaluate interest in
searching for The Cochrane Library since the national REFERENCES
subscription was purchased by the Indian Council for
Medical Research in 2007.3 1. Google Insights. Available at http://www.google.com/
insights/search
METHODS: Using “Cochrane” as the search term under the
category of “Health”, “medical literature and resources” as 2. Ginsberg J, Mohebbi MH, Patel RS, Brammer L,
the primary subcategory, and the period 2004 to 2009 as Smolinski MS, Brilliant L. Detecting influenza
the time frame, we evaluated epidemics using search engine query data. Nature.
2009 Feb 19;457:1012-4.
1. The most popular search terms in India used to identify
health websites/portals in India 3. Tharyan P. Access to the Cochrane library for
everyone in India. National Medical Journal of India
2. Variation over time and between states in India and the 2007; 20 (1): 49.
top four countries of Cochrane usage.
AUTHOR AFFILIATIONS
3. The volume of Cochrane-related searches compared to
1
some popular Indian and International medical Research Officer, Institute of Veterinary Preventive
journals and health-related websites. Medicine, Ranipet, Vellore District, India
2
We also compared the Google Insights data with usage Visiting Adjunct Fellow, South Asian Cochrane Network &
statistics provided by Wiley-Blackwell, publishers of The Centre; International Health Group, Liverpool School of
Cochrane Library. Tropical Medicine, UK.
3
RESULTS: ‘Cochrane’ consistently scored more frequently Director, South Asian Cochrane Center, Prof BV Moses and
than the four top-ranked Indian health portals (MedInd, ICMR Centre for Research and Training in Evidence-Informed
Healthcare, CMC Vellore, India
36
Comparison of oxacillin disc,cefoxitin disc with oxacillin
COMPARISON OF CEFOXITIN AND OXACILLIN DISC
screen agar:
DIFFUSION TEST WITH OXACILLIN SCREEN AGAR FOR
DETECTION OF MRSA Oxacillin disc Oxacillin screen agar Cefoxitin disc
Authors 50(100%) 50(100%) 21(42%)
Azhar Sheikh a
Dr.Vijayshri Deotale b Highest isolation of MRSA isolates were from pus
specimen(42%) followed by blood (14%) and conjuctival
a
Student II MBBS| Mahatma Gandhi Institute of Medical swabs (14%).The prevalent age group from which samples
Sciences, Sevagram | Maharashtra were obtained was 0-5 yrs age group. Maximum resistance
b was for penicillin after oxacillin.On comparison with
Professor of Microbiology| Mahatma Gandhi Institute of
oxacillin disc with cefoxitin disc the oxacillin disc showed
Medical Sciences, Sevagram | Maharashtra
100% co-relation with oxacillin screen agar whereas
Correspondent Author: azhar4u27@gmail.com cefoxitin disc could detect only 42% isolates.

INTRODUCTION: Today MRSA strains are worldwide major CONCLUSION: Oxacillin disc diffusion test was found better
cause of nasocomial infection. Mec A based detection than cefoxitin disc diffusion test for detection of MRSA
identifies even the most heterogenous strains of MRSA and strains.
considered as gold standard. Cefoxitin surrogate marker
The Cochrane Ark: are there animals studies hiding in
for for detection of mec A gene mediated methicillin
CENTRAL?
resistance.
Clive E Adams1, Samantha Roberts1, Drew Davey1, Julie
Clinical and laboratory standard institute (CLSI) guidelines
Monalisa 2
2006: Cefoxitin disc diffusion test recommended for
detection of MRSA. 1
Cochrane Schizophrenia Group, University of Nottingham,
UK. Email: Samantha.Roberts@nottingham.ac.uk
Why this research?:To evaluate the efficacy of cefoxitin disc
diffusion test to detect MRSA and compare it with oxacillin 2
South Asian Cochrane Network and Centre, Christian
agar screening. Medical College, Vellore, India
METHODOLOGY: A total of 50 consecutive non-repeat BACKGROUND: The Cochrane Central Register of Controlled
isolates of MRSA isolated from clinically relevant source trials (CENTRAL) is a specialist register of electronic reports
for period of 2 month. Isolates were identified by culture of trials focused on living human beings.
and biochemical tests and were subjected for antibiotic
susceptibility testing by Kirby bauer disc diffusion method AIMS: To investigate whether animal studies hide in
(CLSI method). All Co-agulase positive staphylococcus were CENTRAL.
tested for oxacillin susceptibility test.Inoculation of 0.5
MacFarland standard was done on Mueller Hinton agar METHODS: We searched CENTRAL (Issue 1, 2009) using terms
and detection for cefoxitin was done with help of disc of for animals in title and then the title, abstract, keywords
cefoxitin 30 microgram applied on surface of media. On combined function. The results were downloaded and
Oxacillin screen agar inoculation of 0.5 MacFarland manually searched twice to ascertain whether trial
standard was done. Even growth of single colony indicated participants were indeed living human beings or animals.
methicillin resistance. RESULTS: CENTRAL positively clucks, moos, squeaks, meows
RESULTS: Resistogram of MRSA strains: and even barks with the sound of wildlife. We initially
retrieved 11,443 records. After screening and removing
ANTIBIOTICS RESISTANT duplicates, 53 records were identified within CENTRAL as
reporting trials conducted on animals, and not on human
Erythromycin 34(68%) participants.
Penicillin 46(92%)
Ciprofloxacin 28(56%) Conclusions: This small number is likely to be an
Oxacillin 50(100%) underestimate of what animal trials are really in CENTRAL,
Cefoxitin 21(42%) because of the very strict inclusion criteria we used. The
Linezolid 19(38%) inclusion of non-human trials [and other types of studies]
Chloramphenicol 22(44%) 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.

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Though WHO recommends intermittent preventive treatment
Clinical Management of Acute Undifferntiated Febrile
(IPT) as the foremost intervention for preventing these
(AUF) Illnesses with complications- Malaria during
complications during pregnancy, Drug Policy of India, 2008
Pregancy in India: Evidence gaps in Intermittent
is not aligned with the evidence-based best practices
Preventive Treatment (IPT)
recommended by the Roll Back Malaria (RBM) initiative.
Authors: Global data (limited) suggest that artemisinins are effective
*
A.George Vasanthan *Anand Manoharan **Dilip and unlikely to be cause of foetal loss or abnormalities,
Mathai when used in late pregnancy. However, none of these studies
Affliation: *Scientist (Research) had adequate power to rule out rare serious adverse events,
even in 2nd and 3rd trimesters and there is not enough
Infectious Diseases Training and Research Center (IDTRC) evidence to effectively assess the risk-benefit profile of
Dept.of Medicine Unit 1 and Infectious Diseases artemisinin compounds for pregnant women particularly
**Professor and Head for 1st trimester exposure. Such evidence gaps in effective
Department of Internal Medicine IPT in the care and management of malaria in pregnant
Chief Mentor: Infectious Diseases Training and Research women in India remains to be addressed through systematic
Center reviews of the effects of this intervention.
Prof.Benjamin Pulimood Laboratories for Infection
Inflammation and Immunity (BMPLIII) Accuracy of clinical assessment of Hyperbilirubinemia in
ACC-CMC Trust for Infectious Diseases Hospitalized Neonates.

Author for Correspondence: Authors


Dr.Dilip Mathai MD PhD FCAMS FICP FIDSA Gondnale Ga,
Professor and Head Taksande Ab ,Vilhekar KYc
Dept.of Internal Medicine a
II Year MBBS, Mahatma Gandhi Institute of Medical
Christian Medical College
Sciences, Sevagram
PO Box.No.3, 4th Floor SP Complex
Ida Scudder Road b
Associate Professor, Dept. of Pediatrics, Mahatma
Vellore 632 004 Gandhi Institute of Medical Sciences, Sevagram.
Tel: +00-91-416-228-2921/2923/2804
c
Professor and Head, Dept. of Pediatrics, Mahatma
Email:dilipmathai@hotmail.com Gandhi Institute of Medical Sciences, Sevagram
Clinical management of acute undifferentiated febrile Correspondent Author: cool.goral@gmail.com.
illnesses in the community in India may be difficult as there
will be no single feature of any disease or common clinical INTRODUCTION: Jaundice, a frequently encountered
presentation to suggest etiology of a diagnosis. In most of diagnostic and therapeutic problem in newborns is quite
cases failure of an empirical therapy provided by a private common affecting nearly 60% term and 80% preterm
health care provider or lack of an intervention may lead to neonates during first week of life. The standard method of
severe complications as in case of malaria or dengue. serum bilirubin estimation requires blood specimen taken
by heel prick or venepuncture which is painful and
Malaria endemic in India (estimated 70-100 million cases expensive. Clinical evaluation of neonate through a
each year (1.6-1.8 million reported by NVBDCP) causes comprehensive history and physical examination is
complications during pregnancy if not treated early resulting considered as a cornerstone in neonatology.
in still births, low birth weight, anemia, and maternal
mortality. In remote rural areas in malaria endemic zones Material and Methods: All newborns delivered in the
of Enhanced Malaria Control Project (EMCP) states,42.79% hospital were enrolled on 3rd day of life after a written
among 12 million malaria positive pregnant women die informed consent from the parents. Neonates who had
due to P.falciparum alone either at home or in the private received exchange transfusion or phototherapy prior to
sector. This mandates further decentralization of health inclusion were excluded. 3 independent and blinded
care to such areas which have been adopted by the Norway observers- a trained medical student, a neonatology nurse
India Partnership Initiative (NIPI) to prevent maternal and a pediatric resident examined all the enrolled newborns
deaths due to malaria or other causes in line with the MDG for jaundice in the standard manner and predicted total
5.Recognition of malaria in pregnancy as an important serum bilirubin according to the cephalocaudal extent of
public health problem in India, its delimitation, jaundice. Irrespective of interpretation of the index test
stratification, and realistic calculations for planning and (clinical examination), blood was withdrawn from all
interventions is a major health care measure to meet the newborns immediately for estimation of total serum
target in MDG5.

38
bilirubin. The diagnostic accuracy of clinical examination at the right time and since past 19 years she stools out
was measured by computation of sensitivity, specificity, through this colostomy.
and positive likelihood ratios (LR+), negative likelihood
ratios (LR–). The precision of these estimates will be Now prior to her marriage, they were anxious to know her
evaluated by using 95% confidence intervals. fertility and made them to present her to us. We explained
her condition in detail along with a possibility of a
RESULTS: A total of 99 neonates were included in the study corrective procedure. The ascending colon, which initially
between April and May 2009. A total of 64(%) neonates had emptied into the colostomy, was anastomosed to the rectum.
hyperbilirubinemia above 10mg/dL and 30 (%) above 15 The patient had an uncomplicated post-operative course.
mg/dL respectively. The sensitivity of clinical examination
for detection of hyperbilirubinemia was poor (range 10 to DISCUSSION: It would be in conflict with the principle of
70.3%). The specificity was reasonable (range 81.6 to 99.9%). patient autonomy if the surgeon withheld important
The positive likelihood ratios ranged from 2.19 to 22.2 and information. But in our case, her parents already knew that
negative likelihood ratios from 0.43 to 0.78. In event of a she requires a long term follow up and hence new
positive clinical test, the chances of neonatal information does not imply any benefit other than a more
hyperbilirubinemia are high, however a negative clinical careful follow up. Hence the communication of the
test does not rule it out. information in this case probably could have been
postponed. On the other hand, her parents actually needed
CONCLUSION:All neonates need to be screened for more information and education regarding the type of the
hyperbilirubinemia using standard bilirubin estimation defect, surgery done and the need for timely closure of the
tests. Clinical assessment is likely to miss many neonates colostomy and regular follow up.
with high bilirubin levels.
CONCLUSION: General feeling of the public is that, “The job
Key Words: Clinical Assessment, Neonatal of a doctor is to reassure and comfort the sick, not to frighten
Hyperbilirubinemia, Accuracy, Reliability them”. In our opinion, physicians need to be warned against
an attitude biased towards what “the rules say” more than
Medicine: profession or trade? towards what the patient wants or needs. The respect enjoyed
Hari Prasad1, 2, Rishi Raj1, KR Bhagavan2, Sangeeta Das in our society imposes certain moral responsibilities on
them, one being balanced presentations of necessary facts
Bhattacharya1
which neither unduly alarm nor entice patients but
1
School of Medical Science and Technology, IIT Kharagpur, facilitates decision-making.
India
The Cochrane Schizophrenia Group Specialised Register
2
Department of General Surgery, KS Hegde Medical
Julie Monalisa1, Samantha Roberts2, Clive E Adams2
Academy, Deralakatte, Mangalore, India
1
South Asian Cochrane Network and Centre, Christian Medical
BACKGROUND: Health information is now part of patients’
College, Vellore, India. Email: julie_sacn@cmcvellore.ac.in
rights. Although physicians frequently underestimate the
importance of patient information, there are variations in 2
Cochrane Schizophrenia Group, University of Nottingham, UK
the extent to which patients want to be involved in active
decision making. It is therefore important to find out in- BACKGROUND: The Cochrane Schizophrenia Group (CSG)
advance whether some information may be unwanted, as Specialised Register contains all reports of controlled trials
illustrated in our case. on severe mental/psychiatric illness, psychosis,
schizophrenia and related disorders with comorbid
CASE REPORT: A 3-months-old female with Tubular colonic disorders such as substance abuse, depression, personality
duplication with Recto-vaginal fistula underwent successful disorder or problematic behaviours/adverse effects
right transverse colostomy along with side-to-side (aggression/antipsychotic-induced tardive dyskinesia). The
anastomosis of the native and duplicated rectum aiming at group maintains its register in a Microsoft Access database
internal drainage. A few days after the surgery the surgeon (Meerkat 1.5 http://cochrane.co.uk/en/newPage1.html).
learnt that biopsy of the duplicated segment revealed Meerkat stores references as studies (is a study-based
dysplastic changes. The parents were informed that the child register), attaches to full text of reports, stores contact
has an additional high risk of developing malignancy of addresses of group reviewers, tracks reports sent to authors
the duplicated segment. The new information however had and has the capacity to link to the datasets within existing
a negative effect on them. They stopped being well adjusted Cochrane Reviews.
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

39
AIMS: To describe the specialized register of the Cochrane CONCLUSIONS: More collaboration within Thailand would
Schizophrenia Group. help merge databases and allow greater dissemination of
local work. Those undertaking comprehensive searches for
METHODS: Studies in the CSG register are identified from 83 biomedical literature cannot afford to ignore the
databases and trial registers. Many of these searches are considerable efforts of researchers in Thailand.
undertaken on a regular basis (e.g. MEDLINE,
Clinicaltrials.gov). Records are formatted (using Endnote) META ANALYSIS – Physiotherapy perspectives
and relevant trials within the scope of the group are selected
and imported into Meerkat. Each imported study is coded Lenny Vasanthan T
for method, participant, intervention and outcome. If a Dept of Physiotherapy, Manipal University, Manipal.
record is identified as being part of another trial already in
Background: There is a wide gap existing between evidence
the register the incoming record is merged into the existing
and practice because of large volume of literature, with
study. The register can be searched by either individual
which physiotherapy practitioners are inundated.
reference or study using standard search terms and limited
Practitioners lack considerable time, skills to evaluate the
boolean operator functions.
literature. One way of addressing this problem is to search
RESULTS: The CSG register contains both randomised for a review article. Meta-analysis is an analytical strategy
controlled trials (RCTs) and controlled clinical trials (CCTs). used to analyse and combine the results of previous reports,
It holds 14,217 individual references (all available with which gives a precise estimate of treatment effect.
full text), which form 11,675 coded studies in the register. AIMS: Meta-analysis aims to identify facts more accurately
These references are in over 20 different languages, and than traditional narrative review. It delivers facts with
only 54% are found on PubMed or Medline. objectivity, helps in determining magnitude of effect and
CONCLUSIONS: The CSG register, built in free-ware software, resolve differences in literature.
is a formidable tool for authors of reviews. It greatly METHODS: Meta-analysis is a 2 stage process
enhances the efficiency of supply of information to
reviewers, and reduces time taken to review. 1. Data extraction and calculation of summary statistic
along with confidence interval
Thai databases
2. Calculation of a pooled average if appropriate.
Kamolthip Atsawawaranunt1, Clive E Adams2, Samantha
Roberts2 It looks at results within each study and calculates weighted
1
average. QUOROM(Quality of reporting of meta-analysis)
Faculty of Medicine, University of Srinakharinwirot,
is recommended, which is an explicit and objective criteria
Thailand. Email: y_rean@hotmail.com
for inclusion or rejection of studies. Funnel plot can be
2
Cochrane Schizophrenia Group, University of Nottingham, done to examine publication bias. Sensitivity analysis can
UK be done to explore ways in which main findings are changed
by various approach to aggregation.
BACKGROUND: Thailand is a poor but highly literate country
of over 60m people in South-East Asia. Much biomedical RESULTS: Great care has to taken to assess methodological
research is undertaken but dissemination is limited. quality of design and execution of study. Quality check using
appropriate check list needs to be done, Heterogeneity of
OBJECTIVES: To identify relevant Thai bibliographic studies should be checked as it influences the further method
databases and investigate accessibility, functionality and of analysis. Forest plot is a pictorial representation used
content - particularly in relation to randomised controlled to present the findings.
trials (RCTs) and clinical controlled trials (CCTs).
CONCLUSION: Helpful in determining small but clinically
METHODS: A systematic search for institutions productive significant effects with precise estimate of effect size, which
of research, and the databases in their libraries. Use each helps to add to the evidence base, thereby treat patients in
accessible database and recording of functionality and a better way. Pitfalls include overgeneralization, ignoring
content. qualitative difference between studies, dealing with main
effects only. Fundamentally meta-analysis is limited by
RESULTS: We found 32 different databases (29 accessible quality of underlying studies “GIGO” (garbage IN garbage
in UK); of various sizes, coverage and functionality but many OUT)
with unique records of RCTs and CCTs (total n=781). 209 of
781 trials were accessible on PubMed (27%). References:

1. Cochrane open learning material 2002

40
2. Crombie.,EBM series 2009 BACKGROUND: Healthcare professionals routinely measure
blood glucose measurement of all critically ill patients in
3. DeCoster J.,Meta-analysis notes 2004 intensive care unit. The traditional reference standard,
venous blood glucose requires a venepuncture and
4. Helewa A., Critical evaluation of research in physical
laboratories usually return the test results after 60 minutes.
rehabilitation 2000.
We wondered if a point of care capillary glucose measured
Ethics of inaccessibility of funded research publications by glucometer could be as accurate and reliable as blood
venous glucose.
Dr.N.Isai Vani.
Assistant Professor, Department of Anatomy, Sri METHODS: I studied consecutive patients admitted to an
Venkateshwaraa Medical College & Research Centre, intensive care unit between 1 May and 10 May 2009. I
Pondicherry. Email: drisaivani@gmail.com compared the diagnostic accuracy of two- point of care
glucometers with laboratory venous glucose, the reference
India is becoming the hub of clinical research. In standard. I used Bland- Altman plots and Clark error grid
commensurate with these advances, the government funding method to analyse the results.
for biomedical research in thrust areas is also increasing.
Indian Council of Medical Research (ICMR), Department of RESULTS: I studied a total of 110 patients (38[34%] women;
Biotechnology (DBT), Department of Science & Technology mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteen
(DST) are some of the government organisations which patients (12%) were known to have diabetes. The mean
provide financial support for various research projects. glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1);
The results of the funded research projects are published range= 48 to 501 mg/dL; that by glucometer 2 was 152.2
in various international journals. Most of these journals mg/dL (SD 76.2); range= 30 to 458 mg/dL and by the
have an access to paid subscribers only. Hence it is unethical laboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480
to use the research grants from government (people’s tax) mg/dL. Of the 110 subjects, 2(2%) had blood glucose below
and not allowing the scientific community a free access to 70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)
the results of the study. had blood glucose exceeding 180 mg/dL. The Bland- Altman
plot showed a bias of 4 mg% (95% confidence intervals, -
This ethical issue can be overcome by forming a body to 9.8 to +1.1); and the limits of agreement were -63 and +54
which every investigator who has got grants would submit mg%. The area under the receiver operating characteristic
the full text of the paper published from his study and these curve for the two glucometers was 0.92 and 0.93
can be made freely accessible to everyone in the website of respectively. The error grid analysis showed that 80% (78/
the newly formed body. 110) samples lay within zone A, 22(110) in zone B and 1%
(1/110) in zone C.
Such an initiative – PubMed central (PMC) already exists in
USA. Every investigator getting grants from National CONCLUSIONS: Point of care glucose, measured by
Institutes of Health has to submit the full text of the article glucometers was in agreement with the venous glucose
published from his study, which would be made freely estimation. Both glucometers were equally accurate and
accessible at PMC. The funding bodies in India should also performed uniformly well across the wide range of blood
form an initiative similar to PMC and put an end to this glucose values.
unethical act.
KEY WORD: Capillary blood glucose, Venous blood glucose
Bedside Capillary blood glucose measurement by ,Point of Care, Glucometer
glucometers compared to venous blood glucose in critically
ill patients and find the Reliability Sensitivity and GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS
Accuracy of point of care glucometer in MICU.
Manusri Naredla, Keerthi Maddi.
Authors St.Peter’s institute of Pharmaceutical sciences,
Manish Chandra Prabhakar a vidyanagar, Hanamkonda
SP Kalantri b
Users of clinical practice guidelines and other
a
Student II MBBS| Mahatma Gandhi Institute of recommendations need to know how much confidence they
Medical Sciences, Sevagram | Maharashtra can place in the recommendations. Systematic and explicit
methods of making judgments can reduce errors and
b
Professor of Medicine | Mahatma Gandhi Institute of improve clinical trials. Large scale healthcare interventions
Medical Sciences, Sevagram | Maharashtra are likely to improve the health of the public only if the
evidence clearly shows that the benefits outweigh harms
Correspondent Author: prabhakar4u07@gmail.com
and costs. Often, however, the evidence if is the other way

41
infection in the hospital by one third and improve the
the trials may fail to improve health, or may even cause
morbidity and mortality figures of the hospital.
harm, while costing dearly. Moreover, when a large scale
intervention is implemented careful evaluation of the AIM AND CONTENT: The aim was to assess the incidence of
evidence must and should replace wishful thinking and HAI among the inpatients of Christian Medical College;
guesswork or else the trials may prove to be enduring but Vellore. The surveillance was conducted in the 63-inpatient
possibly result in harmful standard of care. Such areas of the Hospital. This included the wards; the ICUs
interventions should be implemented, therefore, only when (Medical ICU, Surgical ICU, Neurosurgical ICU, Cardio
the evidence shows that expected benefits outweigh harms thoracic ICU, Pediatric ICU& Neonatal ICU) and other High
and costs and this can be achieved by the implementation risk areas (Renal transplant Unit, Burns Unit and Bone
of systematic evaluation. Marrow Transplant Unit).
Obtaining definitive evidence on the effects of large scale METHODOLOGY: The Surveillance included all patients
interventions can be difficult and implementation with admitted in the hospital for a period of one year (March
careful monitoring is justified but how ever acting without 2005 to February 2006). All Patients who developed fever
proof of net benefit is both costly and potentially damaging after 48 hours of hospitalization were included in the group
to health. Graded evidence follows a hierarchy of evidence of “Probable HAI”. HAI was ruled out in patients who
consistent with randomized trials of high methodological presented with fever at the time of admission or who
quality, followed by randomized trials with methodological developed fever with in 48 Hours of Hospitalization.
limitations, observational studies, and unsystematic
clinical observations. Inferences are stronger when the The Infection Control Nurse (ICN) visited all the patients
evidence is summarized in systematic ways of representing admitted in the 63 areas of the hospital weekly twice. In
the evidence for better interpretation of the clinical as well each ward/ICU, the ICN notes down the total number of
as observational trials. patients admitted and the number of patients with fever.
All patients with fever are then investigated to determine
EVIDENCE FOR BETTER HEALTH if the fever originated 48 hours after hospitalization.
SURVEILLANCE ON HOSPITAL ACQUIRED INFECTIONS IN A Following the CDC guidelines these patients were tentatively
TERTIARY CARE SET UP designated as a case of HAI. The appropriate
microbiological investigations sent for each patient was
Mrs. Meenakshi Sekar,M.Sc N
followed up to confirm the presence of HAI.
Associate Professor, College of Nursing, CMC Vellore
Former Infection Control Nurse Supervisor, CMC, Vellore Following the CDC guidelines, the incidence of HAI was
calculated using the formula given below:
Dr. Karen Jacob, D.A.
P.G. Registrar, Department of Anesthesia, CMC Vellore Infection Rate = Number of HAI per month x 100
Former Hospital Infection Control Officer, CMC, Vellore
Number of discharges per month
BACKGROUND:This surveillance of Hospital Acquired
Infections (HAI) was conducted among the inpatients of RESULTS: The following table gives the incidence of HAI per
Christian Medical College; Vellore which is a 2,572 bedded month.
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.

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

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: one country to multicenter trials in multiple countries, trials
A randomized double blind placebo controlled trial. are conducted in 5 Phases

Mohan S Kamath, Aleyamma T.K, Achamma Chandy, and RESULTS: Phase 0 trials is a recent designation known as
Korula George1 human micro dosing studies has no data on safety or efficacy
of drug. Phase 1 trials Examines the pharmacologic actions
Reproductive Medicine Unit, Department of Obstetrics & and safe dosage range of a drug; how it is absorbed,
Gynecology, Christian Medical College, Vellore ,Tamil Nadu, distributed, metabolized, and excreted; and its duration of
India - 632004. action. Phase 2 trials are controlled studies in volunteers to
assess the effectiveness and safety of a drug. Phase 3 trials
BACKGROUND: Twenty five percent of anovulatory women
are testing using a greater number of volunteer patients. The
with polycystic ovarian syndrome do not respond to
drug is administered by practicing physicians to those suffering
standard clomiphene citrate therapy and are known as
from the condition the drug is intended to treat. These studies
clomiphene resistant. We investigated the use of letrozole,
must confirm earlier efficacy studies and determine low-
an aromatase inhibitor as an alternative ovulation inducing
incidence adverse reactions. Phase 4 trials are studies
agent in these women.
conducted after FDA approval, during general use of the drug
METHODS: 36 women with clomiphene resistance were by medical practitioners, also referred to as post marketing
randomized into two groups: one receiving letrozole 2.5mg studies. Fast-track approval is provided for drugs that meet
daily from day 2 to day 6 of the cycle while the other an unmet medical needs for patients with serious or life-
identical placebo. The primary outcome was the ovulation threatening conditions. Labeling is information distributed
rate with analysis being intention-to-treat. about a drug by the manufacturer, even if it is not physically
affixed to the product. Misbranding is “false or misleading in
RESULTS: The ovulation rate was significantly higher in the any particular” renders the product misbranded, making it
letrozole group 6/18 (33.33%) as compared to none in the subject to FDA regulatory action.
placebo group (P= 0.015). The mean day 21 serum
progesterone was also significantly higher in the letrozole Conclusion: These trials provide the tolerability,
group (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014). Pharmacovigilance, Pharmacokinetic, and
One women in the letrozole group conceived and delivered Pharmacodynamics of the drug.
normally giving a clinical pregnancy and live birth rate of
Access to evidence from countries in South Asia: The
5.5%
South Asian Database of Controlled Clinical Trials and the
CONCLUSION: In clomiphene resistant women, letrozole can South Asian Cochrane Network and Centre’s Digital
be used as an effective and simple alternative ovulation Library – An Update
inducing agent. The trial is registered with clinical trial
Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh
registry of India (UTRN -017753618-3112200762223).
Parthasarathy
Clinical Trials Methods
Prof BV Moses & Indian Council of Medical Research Centre
Nailesh.T SLIMS, Villianur, Pondy605502 Email: for Advanced Research and Training in Evidence Informed
Nailesh.reddy@gmail.com Healthcare, South Asian Cochrane Centre, Christian Medical
College, Vellore, India
BACKGROUND: After completing the preclinical testing of the
drug in animals, the company files an investigational new BACKGROUND: Many trials conducted in middle and low
drug (IND) application with the regulatory authority for income countries are published in journals that are not
permission to test the drug in humans. indexed in commonly searched databases. Their exclusion
from systematic reviews could bias conclusions, rendering
AIMS: To collect the safety and efficacy data for new drugs or them unreliable and potentially irrelevant to health care in
devices. these countries.
METHODS: Depending on the type of product and the stage OBJECTIVES: To describe the development of the South Asian
of development, investigators enroll healthy volunteers and/ Database of Controlled Clinical Trials (www.cochrane-
or patients into small pilot studies followed by larger scale sadcct.org) and the South Asian Cochrane Network &
studies in patients that often compare the new product with Center’s Digital Library that aim to: provide a comprehensive
the currently prescribed treatment. As positive safety and source in the public domain of all controlled clinical
efficacy data are gathered, the number of patients is typically interventional trials involving humans conducted in the
increased. Clinical trials can vary in size from a single center in South Asian region, and published in regional journals,
and contribute information about these trials to the

44
Cochrane Central Register of Controlled Clinical Trials
When ‘Evidence’ goes against the grain:
(CENTRAL) in The Cochrane Library.
Quetiapine for Bipolar depression
METHODS: Health Science Journals published from
S. Mohan Raj,
Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,
Consultant Psychiatrist, Chennai
Pakistan and Sri Lanka and reporting interventional trials
in humans conducted in these countries were sought from BACKGROUND: Quetiapine is an antipsychotic medication.
multiple electronic and other sources and 168 journals were In the last 3 years, there are attempts to promote Quetiapine
identified. Online and print issues of these journals are as being efficacious in Bipolar depression. Trials have
searched in regular cycles. Citations and abstracts of all claimed efficacy and FDA has approved the use of Quetiapine
interventional trials identified from online editions and for Bipolar depression.
hand-searching of print editions are entered into Endnote.
Trials are coded as RCTs or CCTs using standard criteria But, clinicians do not find Quetiapine to be effective in
and cleaned records imported to MeerKat, with web-links Bipolar depression.
provided to the original article, where possible. Full text
articles are indexed and stored using the Greenstone Digital AIM: To analyse the possible reasons for this disparity
Library Software to create the South Asian Cochrane Network between trial results and actual clinical practice.
& Center’s Digital Library that can be retrieved by Titles, METHODS: Evaluation of the BOLDER II study1 (study titled
Author, Year, Journal and Keywords. All records are regularly ‘Efficacy of Quetiapine Monotherapy in Bipolar I and II
transmitted for inclusion in the Cochrane Central Register Depression’), using the Risk of bias table of Revman 5.
of Controlled Clinical Trials (CENTRAL) in The Cochrane
Library. RESULTS:

RESULTS: The South Asian Database of Controlled Clinical The biases noticed were
Trials, initiated in November, 2008, was launched on January
1, 2009 (www.cochrne-sadcct.org) and is searchable free 1) Selection bias
of charge. It currently contains the citations, abstracts and
Exclusion criteria mention
web-links (where possible) to 2830 records [(CCT-1350
(47%); RCT-1477 (53%)] published in 65 Indian medical 1.1 Current episode duration more than 12 months and
journals, and 76 Pakistan Medical Journals. From less than 4 weeks
submitted records, the citations and web-links (where
available) to 1859 trials conducted in these South Asian (Comment: spontaneous remission is possible
countries are now included in the Cochrane Central Register around 6 months)
of Controlled Trials (CENTRAL). Full text articles, in
1.2 History of non-response to an adequate trial (6
downloaded or scanned portable document format (pdf),
weeks) of more than 2 classes of antidepressants
are stored for most trials in the South Asian Cochrane
(Comment: Resistant depression is excluded)
Network & Center’s Digital Library. In the ongoing second
phase, all 168 South Asian Journals (of which 101 (60%) 1.3 Current serious suicidal or homicidal risk as judged
are not indexed in Medline) and newer journals identified by the investigator
by ongoing searches will contribute trials, supplemented
by searches of conference abstracts, dissertations and other (Comment: Severe depression is excluded)
sources.
2) Incomplete outcome data were not adequately
CONCLUSIONS: The Cochrane Collaboration now has a addressed.
resource to access all the evidence generated from
interventional trials conducted in countries in the South The other problems were
Asian Region. Many of these, hitherto unidentified, trials 1) Definition of response as > or = to 50% reduction
can now be considered for inclusion in systematic reviews from baseline score of Montgomery Asberg
of the effects of interventions in healthcare conditions Depression Rating Scale (MADRS)2
relevant to people in the region; these systematic reviews
have the potential to be of greater relevance in informing 2) There are 3 items on MADRS scale (decreased sleep,
healthcare and health-policy in these countries than before decreased appetite and inner tension) in which
the creation of this resource. Quetiapine can bring about 100% reduction in
symptoms irrespective of its antidepressant effects.

45
The Christian Medical College,Vellore ,joined hands with
Another area of concern is that all the studies regarding
RNTCP in the year 2002.
Quetiapine in bipolar depression were prepared with
‘editorial assistance’ from a medical communication OBJECTIVES: To study the epidemiological trend of
company called PAREXEL MMS), irrespective of the authors’ tuberculosis among patients registered in DOTS clinic,
institution. PAREXEL’s website3 offers to write up a scientific Christian Medical College,Vellore between 2002 to 2008.
paper and boast of a 92% first time journal acceptance rate
in 2008. METHODOLOGY: The existing quarterly RNTCP reports of
CMC DOTS Clinic from 2002 to 2008 were consolidated. The
Conclusion: data was entered in Microsoft Excel and analysed.
Mechanism need to be evolved to restrict approval of drugs RESULTS and CONCLUSION:The proportion of chest
by regulatory bodies for indications for which no effect is symptomatics referred for sputum examination from
seen in clinical practice. various departments in CMC were between 3 to 4% .This is
above the suggested target of at least 2%.
References:
The sputum positivity rate is between 6.7 to 8% which lies
1. Michael E Thase et al. Efficacy of Quetiapine
between the recommended 5-15%.
Monotherapy in Bipolar I and II Depression. A
double-blind, placebo controlled study (The BOLDER Among the cases 33% were sputum positive,14% sputum
II study) J Clin Psychopharmacol 2006;26:600-609. negative pulmonary and 53% were extra pulmonary
tuberculosis. The maximum proportion of extrapulmonary
2. Montgomery SA and Asberg M. A new depression
TB as per RNTCP guidelines is 50%.
scale designed to be sensitive to change. Br J
Psychiatry 1979;134:382-389. 88% of all the cases were transferred out, 35.1% of all
transfers were to ‘out of the state’, among which 43.4%
3. Parexel MedCom. http://www.parexelmms.com/
were referred to northern states. Among those referred, 27%
EVIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in were sputum positive and 58% were extra pulmonary TB.
a medical college hospital
Among those who received care from CMC unit, sputum
AUTHORS:John K R,Rakesh P S conversion rates were consistently above 90% except for
year 2003 when it was 86.9%.Cure rate was above 80%
AUTHORS AFFILIATION consistently.
1. Professor in charge of RNTCP$Head of the The CMC data shows that most of the recommendations
Department,Department of Community Health,CMC laid down by RNTCP guidelines are achieved and it is
Vellore functioning as per the guidelines of RNTCP.
2 Post graduate registrar,department of Community Evidence Based Policy for Isoniazid Prophylaxis Therapy in
Health,CMC Vellore Health care workers
CORRESPONDING AUTHOR:John K R,Professor,Department Authors:
of Community Health,CMC,VELLORE
Email:mony@cmcvellore.ac.in Dr. Sangeeta Das Bhattacharya, Assistant Professor, School
Ph:09443242603 of Medical Science and Technology, IIT Kharagpur.

BACKGROUND: The Revised National Tuberculosis Control Lt Col (Dr) Rishi Raj, School of Medical Science and Technology,
Programme(RNTCP) based on Directly Observed Treatment IIT Kharagpur.
Short course(DOTS) strategy was launched in India as a
Dr. Hari Prasad, School of Medical Science and Technology, IIT
national programme in 1997.As private sector is the first
Kharagpur.
point of contact for more than fifty percent TB
patients,RNTCP has collaborated with a wide range of Dr. T.Shyam, School of Medical Science and Technology, IIT
health care providers which establishes a unique model of Kharagpur.
public private mix in RNTCP.
Dr. Bikas K Arya, School of Medical Science and Technology,
As medical colleges treat a significant number of patients IIT Kharagpur.
with TB and also provide care to seriously ill and
complicated TB cases,efforts have been made to include BACKGROUND: India accounts for nearly one-fifth of global
medical colleges into the purview of RNTCP. burden of tuberculosis. Every year, approximately 2 million

46
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)
Key Methodological Issues in Randomised Controlled
was first used in the early 1990s to describe a framework
Studies and Observational Studies
for integrating clinical epidemiology with routine clinical
decision making. It was initially described as an Santosh Philip Mathew1 MBBS student, Sonia Mary
“enlightened scepticism towards the application of Philip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,
diagnostic, therapeutic and prognostic technologies in the MRCP, FRCR
day-to-day management of patients’.
1 Presenting Author: MBBS Student, MOSC Medical
AIM: To conduct a literature survey to find out whether the College, Kolenchery, Ernakulam, Kerala- 682311
clinicians actually practice EBM and to know the impact of
EBM in our country. 2 Queen Mary , University of London, School of Medicine
and Dentistry, Mile End Road, London, UK - E1 4NS
METHODS: Our survey mainly focuses on 3 research
questions: First of all, do full-time clinicians really recognize 3 Consultant Radiologist, Dorset County Hospital NHS
working in these modes? Second, even if they recognize these Foundation Trust, Dorset County Hospital, Williams
modes, can they actually get at the evidence quickly enough Avenue, Dorchester, UK - DT1 2JY
to consider it on a busy clinical service? Third, even if they
can get at it, can clinicians actually provide evidence-based Presenting author email: santoshphilip@gmail.com ;
care to their patients? Contact number: 9496334595

RESULTS: First of all, do full-time clinicians really recognize BACKGROUND: Analytical studies are broadly categorised
working in these modes? It appears so. In a survey of UK into experimental studies including randomised controlled
GPs, majority reported practicing at least part of their time studies (RCTs) and non-experimental studies which include
in the “searching” mode, 72% using evidence- based observational studies (OSs). Many consider RCTs as
summaries generated by others and 84% using evidence- providing better evidence than OSs, but are not always
based practice guidelines or protocols. Far fewer claimed possible, appropriate or ethical to conduct.
to understand the “appraising” tools of NNTs (35%) and
confidence intervals (20%). Only 5% believed that “learning AIMS: To identify key methodological issues relevant to RCTs
the skills of evidence-based medicine” (all five steps) was and OSs.
the most appropriate method for “moving from opinion- METHODS: Multiple articles were referred to from peer
based medicine to evidence-based medicine”. reviewed journals as well as our own experience in
Second, even if they recognize these modes, can they actually designing our poster with illustrations.
get at the evidence quickly enough to consider it on a busy
RESULTS: We will elucidate the advantages of RCTs including
clinical service? Again, it appears so, but examples are few.
its efficiency in postulating and testing clinical hypothesis,
When a busy in-patient medical service brought electronic
use of analysis based on statistical theory, allocation
summaries of evidence previously appraised either by team
concealment and patient and assessor blinding thereby
members (“CATs”) or by the summary journals to working
reducing bias. The disadvantages of RCTs include its cost,
rounds, it was documented that, on average, the former
difficulty in organising, obtaining informed consent and
could be accessed in 10 seconds and the latter in 25
ethical approval made difficult by the nature of the study
seconds. When assessed from the view of the junior member
and also failure to report negative results.
of the team caring for the patient, this evidence changed
25% of their diagnostic and treatment suggestions and We will also review the advantages of OSs including its low
added to a further 23% of them. cost, easy access to ethical approval, informed consent
Third, even if they can get at it, can clinicians actually which is frequently unnecessary, use of statistical methods
provide evidence-based care to their patients? Again, it like propensity and multivariate analysis with tests for
appears so from audits carried out on clinical services interaction. It also benefits from retrieving data from large
that attempt to operate in the searching and appraising number of patient groups in a short amount of time from
modes. It is documented that 82% of them were evidence- databases. One of the main disadvantages include bias from
based. Out of which 53% based on systematic reviews of unknown confounders as well as treatment allocation bias
randomized trials and 29% based on convincing non- which can be offset to an extent by the use of propensity
experimental evidence. analysis.

CONCLUSIONS: Similar results have been obtained from While RCTs have pride of place in studies of efficacy, OSs
audits of psychiatric, surgical, pediatric and general have been limited to safety or adverse events data analysis.
practice. But in our setup usually, about developing country
this trend is taking a snail pace.

48
adverse events check list. Assessment: End of weeks 1, 5 and
CONCLUSIONS: After reading this poster, one should be able
9. Analysis; by intention to treat.
to identify the key methodological issues involved in
analytical studies. Although some would consider RCTs as RESULTS: A pre-planned interim analysis (if more than 5%
the ‘gold standard’ in analytical studies, it is important to developed adverse events necessitating discontinuation)
understand that there is no perfect methodology to answer was done after 34 people (Modafinil 16, placebo 18) were
clinical questions. Clinicians will need to take account of randomized, because of marked worsening of psychosis in
the published data, decide which of the studies are best one and anxiety symptoms in one (both on Modafinil). One
designed to answer their questions and also consider the person on placebo discontinued treatment due to lack of
generalisability and reproducibility of the intervention and improvement. Groups did not differ on the baseline
come to a conclusion based not only on the published variables. Modafinil significantly reduced hyper-salivation
evidence but also rely on their medical experience and at 1 week compared to placebo (7/16 (44%) vs. 0/18; OR 1.8,
judgement. 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=
Modafinil for clozapine induced adverse effects in people
0.7). Modafinil did not differ from placebo on the NHRS or
with schizophrenia and schizoaffective disorder in
ESS scores but significantly reduced duration of sleep by
remission: a randomized, placebo-controlled trial stopped
week 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05).
early for harms.
No significant differences were noted in PANNS or IDEAS
Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, Clive scores, CGI overall improvement, weight, pulse rate, blood
Adams4 pressure or other adverse effects in both groups.

BACKGROUND: Hyper-salivation, sedation and weight gain CONCLUSION: This trial was stopped early due to pre-
are common troublesome effects of Clozapine. determined stopping rules and was insufficiently powered
to draw firm conclusions. Modafinil may have the potential
OBJECTIVES: To evaluate the efficacy and safety of modafinil to significantly improve hyper-salivation and drowsiness
in clozapine-induced drowsiness, hyper-salivation, weight due to Clozapine. Further trials, particularly at lower does,
gain, mental state, and global functioning. may be warranted, but any potential benefits must be
weighed against the risk of worsening of psychosis or anxiety
METHODS: Design: Randomized, parallel-group, single- and the cost of Modafinil.
centre, participant, investigator, observer and data-entry-
blinded trial conducted between October 2007 and October TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI)
2008. Offsite computer-generated, variable-block-size identification number: CTRI/2007/091/000020, 04-10-2007
randomization and pharmacist-dispensed, pre-packed,
serially numbered, containers ensured allocation Funding: Fluid Research Fund of CMC Vellore; Modafinil
concealment. and placebo supplied by Sun Pharmaceuticals (who had no
other role in the study)
Participants: Consenting adults with a diagnosis of
schizophrenia or schizoaffective disorder (DSM IV) in AUTHOR AFFILIATIONS:
remission, with troublesome drowsiness or hyper- 1
Dr. Sebind Kumar: Former Tutor in Psychiatry,
salivation, with/without weight gain, without unstable
Department of Psychiatry, Christian Medical College,
medical conditions, and on stable doses of clozapine for at
Vellore 632002, Tamil Nadu; email: sebind@gmail.com
least 4 weeks.
2
Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV Moses
Intervention and comparator: Modafinil 100mg/day for first
Centre for Clinical Trials and Evidence Based Medicine,
week and 200mg/day for 8 weeks or identical placebo once
Christian Medical College, Vellore 632002, Tamil Nadu.
daily for 9 weeks.
3
Dr. Naveen Thomas, Assistant Professor in Psychiatry,
Estimated Sample size: 35 in each arm (80% power; 5% alpha
Christian Medical College, Vellore 632002, Tamil Nadu.
error)
4
Dr. Clive Adams, Professor of Psychiatry and Chair of
Outcomes: Primary: Proportion without daytime sleepiness
Mental Health Services Research, Division of Psychiatry,
and hyper-salivation, scores on Epworth Sleepiness Scale
University of Nottingham, Nottingham, NG7 2TU, UK.
(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

49
Bedside Capillary blood glucose measurement by KEY WORD: Capillary blood glucose, Venous blood glucose
glucometers compared to venous blood glucose in ,Point of Care, Glucometer
critically ill patients and find the Reliability Sensitivity and
Accuracy of point of care glucometer in MICU. GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS

Authors Manusri Naredla, Keerthi Maddi.


Manish Chandra Prabhakar a St.Peter’s institute of Pharmaceutical sciences,
SP Kalantri b vidyanagar, Hanamkonda

a
Student II MBBS| Mahatma Gandhi Institute of Medical Users of clinical practice guidelines and other
Sciences, Sevagram | Maharashtra recommendations need to know how much confidence they
can place in the recommendations. Systematic and explicit
b
Professor of Medicine | Mahatma Gandhi Institute of methods of making judgments can reduce errors and
Medical Sciences, Sevagram | Maharashtra improve clinical trials. Large scale healthcare interventions
are likely to improve the health of the public only if the
Correspondent Author: prabhakar4u07@gmail.com evidence clearly shows that the benefits outweigh harms
BACKGROUND: Healthcare professionals routinely measure and costs. Often, however, the evidence if is the other way
blood glucose measurement of all critically ill patients in the trials may fail to improve health, or may even cause
intensive care unit. The traditional reference standard, harm, while costing dearly. Moreover, when a large scale
venous blood glucose requires a venepuncture and intervention is implemented careful evaluation of the
laboratories usually return the test results after 60 minutes. evidence must and should replace wishful thinking and
We wondered if a point of care capillary glucose measured guesswork or else the trials may prove to be enduring but
by glucometer could be as accurate and reliable as blood possibly result in harmful standard of care. Such
venous glucose. interventions should be implemented, therefore, only when
the evidence shows that expected benefits outweigh harms
METHODS: I studied consecutive patients admitted to an and costs and this can be achieved by the implementation
intensive care unit between 1 May and 10 May 2009. I of systematic evaluation.
compared the diagnostic accuracy of two- point of care
glucometers with laboratory venous glucose, the reference Obtaining definitive evidence on the effects of large scale
standard. I used Bland- Altman plots and Clark error grid interventions can be difficult and implementation with
method to analyse the results. careful monitoring is justified but how ever acting without
proof of net benefit is both costly and potentially damaging
RESULTS: I studied a total of 110 patients (38[34%] women; to health. Graded evidence follows a hierarchy of evidence
mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteen consistent with randomized trials of high methodological
patients (12%) were known to have diabetes. The mean quality, followed by randomized trials with methodological
glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1); limitations, observational studies, and unsystematic
range= 48 to 501 mg/dL; that by glucometer 2 was 152.2 clinical observations. Inferences are stronger when the
mg/dL (SD 76.2); range= 30 to 458 mg/dL and by the evidence is summarized in systematic ways of representing
laboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480 the evidence for better interpretation of the clinical as well
mg/dL. Of the 110 subjects, 2(2%) had blood glucose below as observational trials.
70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)
had blood glucose exceeding 180 mg/dL. The Bland- Altman Unequal Randomisation in Cancer Trials – A New
plot showed a bias of 4 mg% (95% confidence intervals, - Paradigm!
9.8 to +1.1); and the limits of agreement were -63 and +54 AUTHORS: Meghana Surlikar , Sadhana Kannan and
mg%. The area under the receiver operating characteristic Vikram Gota.
curve for the two glucometers was 0.92 and 0.93
respectively. The error grid analysis showed that 80% (78/ INSTITUTION: Advanced Centre for Treatment Research and
110) samples lay within zone A, 22(110) in zone B and 1% Education in Cancer (ACTREC), Tata Memorial Centre, Sector-
(1/110) in zone C. 22, Kharghar, Navi Mumbai

CONCLUSIONS: Point of care glucose, measured by Background: Randomised Controlled Trial (RCT) with
glucometers was in agreement with the venous glucose balanced allocation of participants to the experimental and
estimation. Both glucometers were equally accurate and control arms is a commonly practiced study design. The
performed uniformly well across the wide range of blood design is simplistic and therefore very appealing. However,
glucose values. 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

50
cancer clinical trials and the most common reasons for RESULTS: The ovulation rate was significantly higher in the
resorting to this approach. letrozole group 6/18 (33.33%) as compared to none in the
placebo group (P= 0.015). The mean day 21 serum
AIM: A systematic review to identify reasons for UR in progesterone was also significantly higher in the letrozole
oncology clinical trials published in five major cancer group (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014).
journals over the last ten years. One women in the letrozole group conceived and delivered
normally giving a clinical pregnancy and live birth rate of
METHODS: A PUBMED search was undertaken to identify
5.5%
RCTs in cancer published from January 1999 to December
2008 in five major cancer journals namely JCO, Annals of CONCLUSION: In clomiphene resistant women, letrozole can
Oncology, BJC, Lancet Oncology and JNCI. Forty three RCTs be used as an effective and simple alternative ovulation
that reported UR of subjects to different arms were selected. inducing agent. The trial is registered with clinical trial
Data was extracted for randomization ratio, reason for UR, registry of India (UTRN -017753618-3112200762223).
phase of the trial and trial location (Single or multicentre).
If the rationale for UR was not mentioned in the article, the Clinical Trials Methods
corresponding author was e-mailed to obtain the reason.
Nailesh.T SLIMS, Villianur, Pondy605502 Email:
RESULTS: 1863 RCTs were identified. UR was employed in 43 Nailesh.reddy@gmail.com
studies (2.3%). The number of studies increased over the
years (0 in 1999 to 9 in 2006). Only 13/43 gave clear reasons BACKGROUND: After completing the preclinical testing of the
for adopting UR. Seven out of the remaining 30 authors drug in animals, the company files an investigational new
responded to an email request. The reason is not clear in drug (IND) application with the regulatory authority for
the remaining 23 reports. 29/43 trials used 2:1 ratio permission to test the drug in humans.
followed by 2:1:1 ratio used in 11 % of the studies. The AIMS: To collect the safety and efficacy data for new drugs or
reasons for UR in the 20 available reports are (a) to meet devices.
statistical endpoint – 7 (b) to facilitate faster recruitment–
4 (c) to get more data on new intervention – 4 (d) ethics and METHODS: Depending on the type of product and the stage
safety reasons – 2 (e) Others – 3. Fourteen were single centre of development, investigators enroll healthy volunteers and/
studies and 29 were multicentre. In 27 reports where phase or patients into small pilot studies followed by larger scale
of the study was mentioned, there were 12 phase II, 14 phase studies in patients that often compare the new product with
III and one phase IV trial. the currently prescribed treatment. As positive safety and
efficacy data are gathered, the number of patients is typically
CONCLUSION: UR appears to be an attractive alternative to
increased. Clinical trials can vary in size from a single center in
balanced allocation especially in small randomized phase
one country to multicenter trials in multiple countries, trials
II trials. Statistical considerations and faster recruitment
are conducted in 5 Phases
are important reasons for resorting to UR.
RESULTS: Phase 0 trials is a recent designation known as
Aromatase inhibitors in clomiphene resistant women: A
human micro dosing studies has no data on safety or efficacy
randomized double blind placebo controlled trial.
of drug. Phase 1 trials Examines the pharmacologic actions
Mohan S Kamath, Aleyamma T.K, Achamma Chandy, and and safe dosage range of a drug; how it is absorbed,
Korula George1 distributed, metabolized, and excreted; and its duration of
action. Phase 2 trials are controlled studies in volunteers to
Reproductive Medicine Unit, Department of Obstetrics & assess the effectiveness and safety of a drug. Phase 3 trials
Gynecology, Christian Medical College, Vellore ,Tamil Nadu, are testing using a greater number of volunteer patients. The
India - 632004. drug is administered by practicing physicians to those suffering
BACKGROUND: Twenty five percent of anovulatory women from the condition the drug is intended to treat. These studies
with polycystic ovarian syndrome do not respond to must confirm earlier efficacy studies and determine low-
standard clomiphene citrate therapy and are known as incidence adverse reactions. Phase 4 trials are studies
clomiphene resistant. We investigated the use of letrozole, conducted after FDA approval, during general use of the drug
an aromatase inhibitor as an alternative ovulation inducing by medical practitioners, also referred to as post marketing
agent in these women. studies. Fast-track approval is provided for drugs that meet
unmet medical needs for patients with serious or life-
METHODS: 36 women with clomiphene resistance were threatening conditions. Labeling is information distributed
randomized into two groups: one receiving letrozole 2.5mg about a drug by the manufacturer, even if it is not physically
daily from day 2 to day 6 of the cycle while the other an affixed to the product. Misbranding is “false or misleading in
identical placebo. The primary outcome was the ovulation any particular” renders the product misbranded, making it
rate with analysis being intention-to-treat. subject to FDA regulatory action.

51
CONCLUSION: These trials provide the tolerability, of charge. It currently contains the citations, abstracts and
Pharmacovigilance, Pharmacokinetic, and web-links (where possible) to 2830 records [(CCT-1350
Pharmacodynamics of the drug. (47%); RCT-1477 (53%)] published in 65 Indian medical
journals, and 76 Pakistan Medical Journals. From
Access to evidence from countries in South Asia: The submitted records, the citations and web-links (where
South Asian Database of Controlled Clinical Trials and the available) to 1859 trials conducted in these South Asian
South Asian Cochrane Network and Centre’s Digital countries are now included in the Cochrane Central Register
Library – An Update of Controlled Trials (CENTRAL). Full text articles, in
downloaded or scanned portable document format (pdf),
Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh
are stored for most trials in the South Asian Cochrane
Parthasarathy
Network & Center’s Digital Library. In the ongoing second
Prof BV Moses & Indian Council of Medical Research Centre phase, all 168 South Asian Journals (of which 101 (60%)
for Advanced Research and Training in Evidence Informed are not indexed in Medline) and newer journals identified
Healthcare, South Asian Cochrane Centre, Christian Medical by ongoing searches will contribute trials, supplemented
College, Vellore, India by searches of conference abstracts, dissertations and other
sources.
BACKGROUND: Many trials conducted in middle and low
income countries are published in journals that are not CONCLUSIONS: The Cochrane Collaboration now has a
indexed in commonly searched databases. Their exclusion resource to access all the evidence generated from
from systematic reviews could bias conclusions, rendering interventional trials conducted in countries in the South
them unreliable and potentially irrelevant to health care in Asian Region. Many of these, hitherto unidentified, trials
these countries. can now be considered for inclusion in systematic reviews
of the effects of interventions in healthcare conditions
OBJECTIVES: To describe the development of the South Asian relevant to people in the region; these systematic reviews
Database of Controlled Clinical Trials (www.cochrane- have the potential to be of greater relevance in informing
sadcct.org) and the South Asian Cochrane Network & healthcare and health-policy in these countries than before
Center’s Digital Library that aim to: provide a comprehensive the creation of this resource.
source in the public domain of all controlled clinical
interventional trials involving humans conducted in the When ‘Evidence’ goes against the grain:
South Asian region, and published in regional journals, Quetiapine for Bipolar depression
and contribute information about these trials to the
S. Mohan Raj,
Cochrane Central Register of Controlled Clinical Trials
Consultant Psychiatrist, Chennai
(CENTRAL) in The Cochrane Library.
BACKGROUND: Quetiapine is an antipsychotic medication.
METHODS: Health Science Journals published from
In the last 3 years, there are attempts to promote Quetiapine
Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,
as being efficacious in Bipolar depression. Trials have
Pakistan and Sri Lanka and reporting interventional trials
claimed efficacy and FDA has approved the use of Quetiapine
in humans conducted in these countries were sought from
for Bipolar depression.
multiple electronic and other sources and 168 journals were
identified. Online and print issues of these journals are But, clinicians do not find Quetiapine to be effective in
searched in regular cycles. Citations and abstracts of all Bipolar depression.
interventional trials identified from online editions and
hand-searching of print editions are entered into Endnote. AIM: To analyse the possible reasons for this disparity
Trials are coded as RCTs or CCTs using standard criteria between trial results and actual clinical practice.
and cleaned records imported to MeerKat, with web-links
provided to the original article, where possible. Full text METHODS: Evaluation of the BOLDER II study1 (study titled
articles are indexed and stored using the Greenstone Digital ‘Efficacy of Quetiapine Monotherapy in Bipolar I and II
Library Software to create the South Asian Cochrane Network Depression’), using the Risk of bias table of Revman 5.
& Center’s Digital Library that can be retrieved by Titles,
RESULTS:
Author, Year, Journal and Keywords. All records are regularly
transmitted for inclusion in the Cochrane Central Register The biases noticed were
of Controlled Clinical Trials (CENTRAL) in The Cochrane
Library. 1) Selection bias

RESULTS: The South Asian Database of Controlled Clinical Exclusion criteria mention
Trials, initiated in November, 2008, was launched on January
1, 2009 (www.cochrne-sadcct.org) and is searchable free

52
1.1 Current episode duration more than 12 months and
VIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in
less than 4 weeks
a medical college hospital
(Comment: spontaneous remission is possible
AUTHORS: John K R,Rakesh P S
around 6 months)
AUTHORS AFFILIATION
1.2 History of non-response to an adequate trial (6
weeks) of more than 2 classes of antidepressants 1. Professor in charge of RNTCP$Head of the
(Comment: Resistant depression is excluded) Department,Department of Community Health,CMC
Vellore
1.3 Current serious suicidal or homicidal risk as judged
by the investigator 2 Post graduate registrar,department of Community
Health,CMC Vellore
(Comment: Severe depression is excluded)
CORRESPONDING AUTHOR:John K R,Professor,Department
2) Incomplete outcome data were not adequately
of Community Health,CMC,VELLORE
addressed.
Email:mony@cmcvellore.ac.in
The other problems were Ph:09443242603

1) Definition of response as > or = to 50% reduction BACKGROUND: The Revised National Tuberculosis Control
from baseline score of Montgomery Asberg Programme (RNTCP) based on Directly Observed Treatment
Depression Rating Scale (MADRS)2 Short course(DOTS) strategy was launched in India as a
national programme in 1997.As private sector is the first
2) There are 3 items on MADRS scale (decreased sleep, point of contact for more than fifty percent TB
decreased appetite and inner tension) in which patients,RNTCP has collaborated with a wide range of
Quetiapine can bring about 100% reduction in health care providers which establishes a unique model of
symptoms irrespective of its antidepressant effects. public private mix in RNTCP.
Another area of concern is that all the studies regarding As medical colleges treat a significant number of patients
Quetiapine in bipolar depression were prepared with with TB and also provide care to seriously ill and
‘editorial assistance’ from a medical communication complicated TB cases,efforts have been made to include
company called PAREXEL MMS), irrespective of the authors’ medical colleges into the purview of RNTCP.
institution. PAREXEL’s website3 offers to write up a scientific
paper and boast of a 92% first time journal acceptance rate The Christian Medical College,Vellore ,joined hands with
in 2008. RNTCP in the year 2002.

CONCLUSION: Mechanism need to be evolved to restrict OBJECTIVES: To study the epidemiological trend of
approval of drugs by regulatory bodies for indications for tuberculosis among patients registered in DOTS clinic,
which no effect is seen in clinical practice. Christian Medical College,Vellore between 2002 to 2008.

REFERENCES: METHODOLOGY: The existing quarterly RNTCP reports of


CMC DOTS Clinic from 2002 to 2008 were consolidated. The
1. Michael E Thase et al. Efficacy of Quetiapine data was entered in Microsoft Excel and analysed.
Monotherapy in Bipolar I and II Depression. A
double-blind, placebo controlled study (The BOLDER RESULTS and CONCLUSION: The proportion of chest
II study) J Clin Psychopharmacol 2006;26:600-609. symptomatics referred for sputum examination from
various departments in CMC were between 3 to 4% .This is
2. Montgomery SA and Asberg M. A new depression above the suggested target of at least 2%.
scale designed to be sensitive to change. Br J
Psychiatry 1979;134:382-389. The sputum positivity rate is between 6.7 to 8% which lies
between the recommended 5-15%.
3. Parexel MedCom. http://www.parexelmms.com/
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
RESULTS: The best suited evidence suggesting the prevalence
were referred to northern states. Among those referred, 27%
of LTBI in health care workers in India is by M. Pai et al
were sputum positive and 58% were extra pulmonary TB.
(JAMA 2005) indicating a prevalence of 40% in the health
Among those who received care from CMC unit, sputum care workers in India. The Prevalence of Latent TB is
conversion rates were consistently above 90% except for dramatically increases from 25% for persons who have served
year 2003 when it was 86.9%.Cure rate was above 80% less than 5 years in health care profession to 62% for persons
consistently. serving for 6 to 10 years and 71% for persons serving more
than 10 years. The numbers needed to treat to prevent one
The CMC data shows that most of the recommendations case of TB in general population is 35 (Smeija et al 2004)
laid down by RNTCP guidelines are achieved and it is
functioning as per the guidelines of RNTCP. CONCLUSION: In India as per RNTCP recommendations no
guidelines are available for prevention of TB in healthcare
Evidence Based Policy for Isoniazid Prophylaxis Therapy in workers. India’s RNTCP is the largest DOTS program in the
Health care workers world. It is of paramount importance that they are given the
best possible protection from occupational health hazards
Authors: including TB. So we recommend incorporation of Isoniazid
Dr. Sangeeta Das Bhattacharya, Assistant Professor, School prophylaxis therapy among health care workers in India if
of Medical Science and Technology, IIT Kharagpur. they are found to be a case of LTBI. The therapy should be
Lt Col (Dr) Rishi Raj, School of Medical Science and with 300 mg Isoniazid daily for six months. The maximum
Technology, IIT Kharagpur. effect of Isoniazid prophylaxis is shown to be for 3 years
(Debre), so it is recommended that every healthcare worker
Dr. Hari Prasad, School of Medical Science and Technology, should be examined while joining health care services and
IIT Kharagpur. then should be reviewed every three years.

Dr. T.Shyam, School of Medical Science and Technology, IIT Evidence Based Surgery: knowledge, attitudes, and
Kharagpur. perceived barriers among surgical trainees

Dr. Bikas K Arya, School of Medical Science and Technology, Dr. Rohin Mittal (Presenting author)
IIT Kharagpur. Assistant Professor
Department of Surgery Unit 5
BACKGROUND: India accounts for nearly one-fifth of global Christian Medical College, Vellore
burden of tuberculosis. Every year, approximately 2 million rohinmittal@gmail.com
persons develop tuberculosis of which about 0.87 million
are new smear positive highly infectious cases and about Dr. Benjamin Perakath
3.3 lakh die of TB every year. There are approximately 2.5 Professor
million health care workers in India (NHP 2007) providing Department of Surgery Unit 5
health services to the population. They are not only exposed Christian Medical College, Vellore
to a high number of active TB cases but also they are benjamin@cmcvellore.ac.in
constantly exposed to a high number of debilitated patients
throughout their professional work. BACKGROUND: Evidence Based Surgery (EBS) has been
shown to improve efficiency and outcomes. It is, however,
AIM: To frame a policy regarding Isoniazid prophylactic not practiced universally among surgeons. Wider use of
therapy for health care workers in India. EBS requires an understanding of EBS, a positive attitude,
as well as removal of perceived barriers to its practice.
METHODS: An evidence based search is conducted to find
effectiveness of INH prophylaxis in Health care workers in AIMS: The aim of this study was to assess the knowledge
India. Search was conducted in electronic medical resources and attitude of surgical trainees towards EBS and their
to find the related studies performing Meta analysis and perceived barriers to its practice.
randomized control trials comparing Isoniazid and
placebo/other anti tubercular drugs in different population METHODS: The McColl questionnaire and the BARRIERS scale
groups. Appropriate statistical methodology was adopted were modified and incorporated into a single questionnaire.
to analyze the results and formulate the policy. The Criteria Surgical trainees attending a Continuing Surgical Education
for evaluation were Numbers needed to be treated to prevent meeting at the author’s institution were asked to voluntarily
one active case of TB/ One death, number needed to harm fill in this questionnaire.
(Hepatitis), adherence and compliance, ease of
RESULTS: A total of 93 out of 110 (84.5%) trainees returned
implementation, cost benefits analysis.
the filled in questionnaire. Attitudes towards EBS were

54
welcoming, although colleagues were considered less modes, can they actually get at the evidence quickly enough
welcoming than self. There was high level of agreement with to consider it on a busy clinical service? Third, even if they
usefulness of EBS in everyday practice and EBS improving can get at it, can clinicians actually provide evidence-based
patient care. About 50 % of actual practice was considered care to their patients?
to be evidence based. 12.6 % (11/87) participants had
received formal training in EBM. 64.3 % (54/84) were aware RESULTS: First of all, do full-time clinicians really recognize
of the Cochrane database of systemic reviews but only 35.7% working in these modes? It appears so. In a survey of UK
(30/84) read it regularly. 67.8 % (61/90) used protocols and GPs, majority reported practicing at least part of their time
guidelines developed by colleagues to practice EBS. However, in the “searching” mode, 72% using evidence- based
61.5 % (56/91) were interested in learning the skills of EBS. summaries generated by others and 84% using evidence-
The terms absolute risk, relative risk and clinical based practice guidelines or protocols. Far fewer claimed
effectiveness were understood by > 80 % of respondents, to understand the “appraising” tools of NNTs (35%) and
while publication bias, confidence interval and confidence intervals (20%). Only 5% believed that “learning
heterogeneity were poorly understood. The major perceived the skills of evidence-based medicine” (all five steps) was
barriers to practice of EBS were inability to understand the most appropriate method for “moving from opinion-
statistical analysis, inadequate facilities for based medicine to evidence-based medicine”.
implementation, lack of a single compiled source of Second, even if they recognize these modes, can they actually
literature, relevant literature not being readily available get at the evidence quickly enough to consider it on a busy
and insufficient time on the job. clinical service? Again, it appears so, but examples are few.
When a busy in-patient medical service brought electronic
CONCLUSIONS: Surgical trainees have a positive attitude
summaries of evidence previously appraised either by team
towards EBS, and have some familiarity with the common
members (“CATs”) or by the summary journals to working
terms used in EBS. There is a need to increase awareness of,
rounds, it was documented that, on average, the former
and provide access to available sources of medical
could be accessed in 10 seconds and the latter in 25
literature. Formal training in EBS, as well as basic statistical
seconds. When assessed from the view of the junior member
analysis should form a part of the surgical curriculum to
of the team caring for the patient, this evidence changed
foster an environment favorable to the practice of EBS.
25% of their diagnostic and treatment suggestions and
CAN CLINICIANS ACTUALLY PRACTICE EBM? added to a further 23% of them.

Sanchaya Selvaraj*, Balaji D*, Nagamani*, Surapaneni Third, even if they can get at it, can clinicians actually
Krishna Mohan** provide evidence-based care to their patients? Again, it
appears so from audits carried out on clinical services
AFFILIATION: that attempt to operate in the searching and appraising
modes. It is documented that 82% of them were evidence-
*II MBBS Student, Saveetha Medical College & Hospital,
based. Out of which 53% based on systematic reviews of
Saveetha University, Saveetha Nagar, Thandalam, CHENNAI
randomized trials and 29% based on convincing non-
– 602 105, T.N, INDIA.
experimental evidence.
**Assistant Professor, Department of Biochemistry,
CONCLUSIONS: Similar results have been obtained from
Saveetha Medical College & Hospital, Saveetha University,
audits of psychiatric, surgical, pediatric and general
Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.
practice. But in our setup usually, about developing country
BACKGROUND: The term “Evidence Based Medicine” (EBM) this trend is taking a snail pace.
was first used in the early 1990s to describe a framework
Key Methodological Issues in Randomised Controlled
for integrating clinical epidemiology with routine clinical
Studies and Observational Studies
decision making. It was initially described as an
“enlightened scepticism towards the application of Santosh Philip Mathew1 MBBS student, Sonia Mary
diagnostic, therapeutic and prognostic technologies in the Philip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,
day-to-day management of patients’. MRCP, FRCR
AIM: To conduct a literature survey to find out whether the 1 Presenting Author: MBBS Student, MOSC Medical
clinicians actually practice EBM and to know the impact of College, Kolenchery, Ernakulam, Kerala- 682311
EBM in our country.
2 Queen Mary , University of London, School of Medicine
METHODS: Our survey mainly focuses on 3 research and Dentistry, Mile End Road, London, UK - E1 4NS3
questions: First of all, do full-time clinicians really recognize Consultant Radiologist, Dorset County Hospital NHS
working in these modes? Second, even if they recognize these Foundation Trust, Dorset County Hospital, Williams
Avenue, Dorchester, UK - DT1 2JY

55
Presenting author email: santoshphilip@gmail.com;
Modafinil for clozapine induced adverse effects in people
Contact number: 9496334595
with schizophrenia and schizoaffective disorder in
BACKGROUND: Analytical studies are broadly categorised remission: a randomized, placebo-controlled trial stopped
into experimental studies including randomised controlled early for harms.
studies (RCTs) and non-experimental studies which include
Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, Clive
observational studies (OSs). Many consider RCTs as
Adams4
providing better evidence than OSs, but are not always
possible, appropriate or ethical to conduct. BACKGROUND: Hyper-salivation, sedation and weight gain
are common troublesome effects of Clozapine.
AIMS: To identify key methodological issues relevant to RCTs
and OSs. OBJECTIVES: To evaluate the efficacy and safety of modafinil
in clozapine-induced drowsiness, hyper-salivation, weight
METHODS: Multiple articles were referred to from peer
gain, mental state, and global functioning.
reviewed journals as well as our own experience in
designing our poster with illustrations. METHODS: Design: Randomized, parallel-group, single-
centre, participant, investigator, observer and data-entry-
RESULTS: We will elucidate the advantages of RCTs including
blinded trial conducted between October 2007 and October
its efficiency in postulating and testing clinical hypothesis,
2008. Offsite computer-generated, variable-block-size
use of analysis based on statistical theory, allocation
randomization and pharmacist-dispensed, pre-packed,
concealment and patient and assessor blinding thereby
serially numbered, containers ensured allocation
reducing bias. The disadvantages of RCTs include its cost,
concealment.
difficulty in organising, obtaining informed consent and
ethical approval made difficult by the nature of the study Participants: Consenting adults with a diagnosis of
and also failure to report negative results. schizophrenia or schizoaffective disorder (DSM IV) in
remission, with troublesome drowsiness or hyper-
We will also review the advantages of OSs including its low
salivation, with/without weight gain, without unstable
cost, easy access to ethical approval, informed consent
medical conditions, and on stable doses of clozapine for at
which is frequently unnecessary, use of statistical methods
least 4 weeks.
like propensity and multivariate analysis with tests for
interaction. It also benefits from retrieving data from large Intervention and comparator: Modafinil 100mg/day for first
number of patient groups in a short amount of time from week and 200mg/day for 8 weeks or identical placebo once
databases. One of the main disadvantages include bias from daily for 9 weeks.
unknown confounders as well as treatment allocation bias
which can be offset to an extent by the use of propensity Estimated Sample size: 35 in each arm (80% power; 5% alpha
analysis. error)

While RCTs have pride of place in studies of efficacy, OSs Outcomes: Primary: Proportion without daytime sleepiness
have been limited to safety or adverse events data analysis. and hyper-salivation, scores on Epworth Sleepiness Scale
(ESS) and Nocturnal Hyper-salivation rating scale (NHRS).
CONCLUSIONS: After reading this poster, one should be able Secondary: change in weight, pulse rate, systolic and
to identify the key methodological issues involved in diastolic blood pressures; scores on Positive and Negative
analytical studies. Although some would consider RCTs as Symptom Scale (PANSS); Clinical Global Impression (CGI)
the ‘gold standard’ in analytical studies, it is important to for alertness, hyper-salivation and overall improvement;
understand that there is no perfect methodology to answer Indian Disability Evaluation Assessment Scale (IDEAS) and
clinical questions. Clinicians will need to take account of adverse events check list. Assessment: End of weeks 1, 5 and
the published data, decide which of the studies are best 9. Analysis; by intention to treat.
designed to answer their questions and also consider the
generalisability and reproducibility of the intervention and RESULTS: A pre-planned interim analysis (if more than 5%
come to a conclusion based not only on the published developed adverse events necessitating discontinuation)
evidence but also rely on their medical experience and was done after 34 people (Modafinil 16, placebo 18) were
judgement. 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

56
exponentially, online trials have a significant role to play
(9/16 (56%) vs. 7/18 (44%); OR 2.6, 95% CI 0.6 to 10.8; P=
in shaping up the future of the health care industry.
0.7). Modafinil did not differ from placebo on the NHRS or
ESS scores but significantly reduced duration of sleep by Aim: To carry out a systematic search for the areas in which
week 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05). internet trials have been carried out till date and to analyze
No significant differences were noted in PANNS or IDEAS the advantages and limitations of using internet as a
scores, CGI overall improvement, weight, pulse rate, blood medium to conduct clinical trials.
pressure or other adverse effects in both groups.
Methods: The online U.S NIH database
CONCLUSION: This trial was stopped early due to pre- (www.clinicaltrials.gov), was searched for internet based
determined stopping rules and was insufficiently powered trials. Both active and closed trials were included.Relevant
to draw firm conclusions. Modafinil may have the potential results were categorized under separate subject headings
to significantly improve hyper-salivation and drowsiness based on the health condition/category the trial was
due to Clozapine. Further trials, particularly at lower does, addressing. Both interventional and observational trials
may be warranted, but any potential benefits must be were included in the categorization. PubMed literature
weighed against the risk of worsening of psychosis or anxiety search was performed to study the advantages and
and the cost of Modafinil. limitations of online trials separately.
TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI) Results: Of the 432 search results obtained using the keyword
identification number: CTRI/2007/091/000020, 04-10-2007 “ internet”, 383 were appropriate. These trials were
categorized into subject headings as described. A wide
FUNDING: Fluid Research Fund of CMC Vellore; Modafinil
variety of health conditions such as alcoholism, diabetes,
and placebo supplied by Sun Pharmaceuticals (who had no
psychiatric conditions, smoking cessation, weight control,
other role in the study)
hypertension etc. were addressed in these trials*. A majority
AUTHOR AFFILIATIONS: of these trials have been carried out in the USA and Europe.
Surprisingly, Asian countries have carried out only a
1
Dr. Sebind Kumar: Former Tutor in Psychiatry, negligible number of such trials(~2%).
Department of Psychiatry, Christian Medical College,
Vellore 632002, Tamil Nadu; email: sebind@gmail.com Conclusion**: Online trials have many advantages.
However, multiple log-ins, remuneration, internet spamming
2
Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV Moses and internet squatting are a few limitations. We propose a
Centre for Clinical Trials and Evidence Based Medicine, solution to these problems, which could be an interesting
Christian Medical College, Vellore 632002, Tamil Nadu. area for future research.
3
Dr. Naveen Thomas, Assistant Professor in Psychiatry, (* Involves numerical data that cannot be condensed)
Christian Medical College, Vellore 632002, Tamil Nadu.
(**Not elaborated due to word limit restriction)
4
Dr. Clive Adams, Professor of Psychiatry and Chair of
Mental Health Services Research, Division of Psychiatry, Presenting Author and Author for Correspondence:
University of Nottingham, Nottingham, NG7 2TU, UK.
Siddhartha Devarakonda
Internet based clinical trials: An Expanding Horizon “Premabandham”, Near Birla Mandir
5-9-22/38 G Adarshnagar
Authors: Siddhartha D, Lalith Chandra K, Hyderabad 500063, AP
Gandhi Medical College, Secunderabad India
email- siddarth.dt@gmail.com
BACKGROUND: Internet is being widely utilized in medical
research. It offers many benefits when used as a medium BODY MASS INDEX AND EXOCRINE PANCREATIC INSUFFI-
for carrying out clinical trials. Being able to reach a wide CIENCY ARE PREDICTORS OF PANCREATIC OSTEODYSTRO-
population, participant privacy, easier blinding and PHY IN SUBJECTS WITH FIBROCALCIFIC PANCREATITIS WITH
randomization, studying geographically scattered DIABETES.
populations are a few such benefits. Online trials so far,
have mostly been focusing on educational, preventive, Presenting author: Sudeep.K
rehabilitative and follow up issues which can have a
Co-Authors: Selvakumar R, Chacko A, George B, Kavitha M,
beneficial impact on patient health, health service quality,
Paul T, Seshadri MS, Thomas N
health service availability and finances. In a society where
the utilization of Information Technology seems to be rising Department; Department of Endocrinology, Department of
Biochemistry, Gastroenterology.

57
Institution: Christian Medical College, Vellore. Phone deaths per year (1 every 90 seconds) of the total 1.3 million
(0416)-2282528,2282491.Fax-416-4205844 worldwide (25.5% or one in four deaths). Mortality rate due
to TB is 28/100000 population per year in India.
Address for correspondence: Dr .Nihal Thomas, Professor,
Department of Endocrinology, Diabetes and Metabolism, AIM: To investigate whether INH prophylaxis for cases with
Christian Medical College, Vellore. India. latent tuberculosis infection can be incorporated in the
Email ID: nihal_thomas@yahoo.com. routine health care system in Indian scenario.
Email ID: drsudeepmd@rediffmail.com
METHODS: An evidence based search is conducted to find
BACKGROUND: Chronic pancreatitis with exocrine effectiveness of INH prophylaxis in cases with latent
insufficiency, inflammation, diabetes, low body weight and tuberculosis infection with or without associated medical
undernutrition alter bone metabolism leading to a relatively conditions. Search was conducted in electronic medical
novel entity entitled pancreatic osteodystrophy. resources to find the related studies performing Meta
analysis and randomized control trials comparing Isoniazid
AIMS: To determine the relationship between bone mineral and placebo/other anti tubercular drugs in different
content and pancreatic exocrine and endocrine dysfunction population groups. Appropriate statistical methodology was
in subjects with chronic non-alcoholic pancreatitis. adopted to analyse the results (Numbers needed to treat,
MATERIALS AND METHODS: A prospective study of relative risk reduction) and formulate the policy.
consecutive eligible males aged between 20 and 60 years. RESULTS: The study best suited to answer our question for
BMD was measured using Hologic DXA machine. Vitamin D Non HIV general population was a Meta analysis done by
was measured using radioimmuno-assay. Stool fat Smieja Marek et al., titled “Isoniazid for preventing
excretion rate was measured in a 72 hour stool collection. tuberculosis in non HIV infected persons” (1999) available
Statistical analysis was done applying Pearsons at Cochrane database. The risk ratio (RR) of the persons on
correlation, independent t-test and nonparametric tests. INH prophylaxis was 0.40 (95%CI 0.31 to 0.52) with a P
RESULTS: Thirty-one males with a mean BMI of 18.46 (± value of <<.01. Numbers needed to treat (NNT) is 35. The
2.86) Kg/m2 and radiologically documented pancreatitis study we used for HIV children was “Effect of Isoniazid
were studied.The mean 72 hour stool fat was 25.30 (± prophylaxis on mortality and incidence of tuberculosis in
children with HIV: randomised controlled trial” by Heather
18.09)gms and the mean VitaminD was 18.44 (± 10.97) ng/
J Zar et al, available at PUBMED. Numbers needed to treat is
ml. Nineteen (61%) subjects had an abnormal T score.There
16 for preventing Incidence of one case and 12 for preventing
was a significant positive correlation between BMC and
one death.
BMI (r = 0.426 ; P = 0.017) and a significant negative
correlation BMC and 72 hour stool fat (r = minus 0.468;P = CONCLUSION: Although a definite reduction of risk is seen
0.028). Twenty one (68%) inclusive of eleven FCPD subjects in groups on INH prophylaxis, INH prophylaxis cannot be
had diabetes.Subjects with diabetes had a lower BMI (17.7 instituted in cases with all latent TB infection in India
±2.4 vs 20.0 ± 3.31 Kg/ m2 ;P = 0.087) and lower VitaminD because the incidence of latent TB is very high and following
(16.01 ± 9.03 vs 26.03 ± 13.9 ng/ml P= 0.056) than those up them all is impossible. However, it can be administered
without diabetes. A significant linear correlation (r = 0.448; in high risk groups like HIV positives, health care workers
P= 0.041) between BMC and BMI was seen only in subjects and people in prisons and army barracks.
with diabetes.
AUTHORS:
CONCLUSIONS: In subjects with chronic pancreatitis and
diabetes a linear correlation exists between BMC and BMI 1. Dr. T.Shyam, School of medical science and technology,
presumably due to severe undernutrition. Subjects with IIT Kharagpur.
steatorrhea had a significantly reduced BMC which could
not be accounted for by differences in BMI or diabetes or 2. Dr. Bikas Kumar Arya, School of medical science and
vitamin D deficiency. Pancreatic osteodystrophy in chronic technology, IIT Kharagpur.
pancreatitis is an underrecognized co-morbidty requiring
Presenting Author:
a more extensive evaluation.
Dr. T.Shyam, B – 002,
Evidence based policy formulation on Isoniazid prophylaxis Gokhale hall of residence,
for Latent Tuberculosis infection in Indian context. Indian Institute of Technology, Kharagpur,
BACKGROUND: India has the highest burden of tuberculosis West Bengal. PIN: 721302
cases for any country in the world. It has an Incidence rate Email: tshyamiitkgp@gmail.com
of 168 cases per 100000 population. It reported 331,268

58
Nature, prevalence, explanatory models and correlates of CONCLUSION: We suggest the need to include effective
sexual dysfunction among men attending primary health management of sexual dysfunction in the existing primary
setting in south India health system. Future longitudinal studies to evaluate
incidence and correlates of sexual dysfunction are desired.
Dr. P. Thangadurai, MBBS, DPM, DNB,
Assistant professor, The impact of family attachment programme in
Department of Psychiatry, Christian Medical College, undergraduate curriculum to appreciate the concept of
Vellore - 632002, India.Email ID: thanga@cmcvellore.ac.in evidence informed public health.

BACKGROUND: Sexual dysfunction is common in all health BACKGROUND: Evidence based public health is the
care settings. However, this remains under-reported, under- integration of science based intervention with community
recognized and under-treated, leading to significant preference to develop the health of the public. The latter
morbidity and reduction in quality of life. stages of this process of evidence based public health
involve vigilant decision making in order to address specific
AIMS: We aimed to determine the nature, prevalence, public health problems, where the adaptation of the
explanatory models and correlates of sexual dysfunction research knowledge to the local context prior to the
among men attending primary health setting. implementation of the adapted evidence in to practice or
policy development is of crucial value. This adaptation is
METHODS: We conducted a cross-sectional study
mainly based on the recognition and analysis of needs/
investigating 270 consecutive consenting men aged 16 and
preferences specific to the community under consideration.
above attending the department of community health, CMCH.
Those with severe language, hearing or cognitive impairment AIM/OBJECTIVE: To describe the importance of family
were excluded. We screened for sexual dysfunction using attachment programme in undergraduate curriculum to
Sexual History Questionnaire. Those who screened positive appreciate the concept of evidence informed public health.
were further evaluated using the International Index of
Erectile Function-5 (IIEF5) and the Chinese Index of METHOD/ACTIVITY: Medical students of the Faculty of
Premature Ejaculation-5 (CIPE5). Explanatory models of Medical Sciences, University of Sri Jayewardenepura, Sri
sexual dysfunction were assessed using the modified Short Lanka were allocated in to groups of three students and
Explanatory Model Interview (SEMI). We employed Tamil assigned a household in the university project area for a
version of Clinical Interview Schedule- Revised (CISR) to period of two months during their final year training.
diagnose common mental disorders.
Weekly seminars were held to discuss the health related
RESULTS: 75.9% men (95% CI 70.9-81.1) were tested positive issues faced by each family and possible interventions that
for sexual dysfunction. The most common disorder was could be made to overcome them. The students then
premature ejaculation followed by erectile dysfunction and undertook a practical approach in to decision making and
their co morbidity. Poverty, advancing age, less education, implementing the necessary interventions under supervised
history of diabetes, hypertension and presence of a common guidance from the departments of Community Medicine,
mental disorder were significantly associated with sexual Family Medicine, Paediatrics, Psychiatry and public health
dysfunction (P<0.05). Primary health care physicians under- staff from the university project area.
diagnosed sexual dysfunction and documented poor inter
rater reliability when compared with diagnoses by a The students were assessed by a Viva Voce examination as
psychiatric professional (Kappa=0.01). part of their final MBBS examination.

DISCUSSION: Sexual dysfunction is widely prevalent but Conclusions and Recommendations


under diagnosed among men attending primary health
Conventionally the undergraduate training is hospital
clinics. Strengths of this study include adequate sample
centred and mainly focused on relieving physical infirmity.
size, minimal refusal rates, use of standardized instruments
But through this innovative programme the students got the
and eliciting explanatory models. We acknowledge the
opportunity to explore the possible interventions while
limitations such as absence of consensus on normal
considering the individuals, family and community as a
ejaculatory latency, varying diagnostic cut off scores of
whole. Thus enabling them to understand how to adapt the
IIEF-5 and CIPE-5, debatable cross cultural validity and the
research knowledge to the local context by recognizing the
possibility of high false positive rates due to poor positive
needs/preferences specific to that community, thereby
predictive values. We minimized selection and reporting
achieving better decision making in the process of evidence
bias by consecutive sampling and by interviews conducted
informed public health. Therefore,including this innovative
by a single investigator well versed in local culture and
programme in the undergraduate public health training is
language.
highly recommended.

59
Using evidence to inform policy making & to strengthen implementation of law. Increased awareness
implementation: A case of tobacco control in Karnataka among students, teachers and community in general.

Dr. Upendra Bhojani URINARY METANEPHRINES IN THE DIAGNOSIS OF


Faculty, PHEOCHROMOCYTOMA
Institute of Public Health
250, Master’s cottage, 2 C Main, 2 C Cross, Girinagar 1st Vasanthi K*, Kanakamani J*, Rajaratnam S*, Gracy V$,
Phase, Bangalore 560085 Fleming J$,
(080) 26421929, 09342349121 *Departments of Endocrinology, Diabetes and Metabolism
upendra@iphindia.org & $Clinical Biochemistry
Christian Medical College, Vellore.
BACKGROUND: India was among the earlier countries to
ratify the WHO’s Framework Convention on Tobacco Control BACKGROUND: Though pheochromocytomas are rare
(FCTC). In fact India enacted a national legislation, ‘The tumors, they need to be considered in a large number of
Cigarettes and Other Tobacco Products Act (COTPA) 2003’ patients with hypertension because they are dangerous and
even before FCTC came in force. Though, not free of lacuna, are potentially curable. Measurement of plasma or urinary
COTPA provided good framework with inclusion of evidence- metanephrines are said to be diagnostically superior than
based strategies including 1) prohibition on smoking in measurement of catecholamines or vanillyl mandelic acid.
public spaces 2) prohibition on tobacco advertising 3) OBJECTIVE: The objective was to study the diagnostic value
prohibition of sale of tobacco products to minors and near of urinary total metanephrines in the diagnosis of
educational institutions and 4) mandatory display of pheochromocytomas.
picture warnings on tobacco products including others.
However, framing of rules and their notifications to METHODS: Outcomes of patients tested in our center for
implement COTPA presented complex challenges for public pheochromocytomas from June 2008 to June 2009 were
health community as it became evident from repeated delays retrospectively studied. Urinary total metanephrines (uMN)
and dilutions of the original provisions of the Act. and normetanephrines (uNMN) were measured by enzyme
immunoassay. The upper limit of the laboratory reference
AIM: To describe how needed evidences to strengthen range was used to calculate the diagnostic accuracy
tobacco control policies and its implementation were parameters.
generated and were disseminated using innovative tools
and channels to relevant stakeholders by Institute of Public RESULTS: There were 66 patients (49 males and 17 females).
Health (IPH) in Karnataka. Fifteen patients had histopathologically proven
pheochromocytomas. 11 of them were adrenal tumors and
METHOD: Situational and stakeholder analysis helped to 4 were paragangliomas. 45 patients had hypertension in
identify issues and influential stakeholders in context of whom secondary causes were not found. Six had adrenal
tobacco control in India. Discourses regarding employment masses of other origin, proven by biopsy. The median uMN
of tobacco industry workers, effectiveness and acceptance in the pheochromocytoma group was 363 (59 – 5640) mg/
of suggested warnings, impact of tobacco control measures day and uNMN 4000 (329 – 10400) mg/day and that of non-
on general economy surfaced by tobacco industry, media, pheochromocytoma group was 168 (43-638) mg/day and
and at times politicians created negative environment for 734 (85-2763) mg/day. The sensitivity and specificity of
effective and undiluted implementation of proposed Act. uMN was 53.3% & 90.2% respectively and that of uNMN
In this context, through short studies and surveys IPH was 86.6% & 21.57%. Area under the receiver operating
generated relevant evidences and used innovative tools characteristic curve was 0.737 (95% CI: 0.566-0.909) for
and to disseminate it to media (Media tool kit, Sensitization uMN and 0.851(95% CI: 0.693-1.009) for uNMN.If both uMN
meetings, Provision of relevant information), law makers and uNMN were combined together, negative predictive
(Stories in local and national newspapers, Advocacy kit on value is 100% but positive predictive value is only 26%.
pictorial warnings, memoranda, and campaigns), law Conclusion: Urinary total metanephrines is a valuable test
enforcers (news stories on legal violations, Complaints to to exclude pheochromocytoma in a population who need to
various departments, PIL in Karnataka high court) and be screened for the tumor. However with a low pretest
community (Awareness campaigns, painting competitions probability, it cannot be used to confirm a diagnosis of
and fact sheets for schools). pheochromocytoma.
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
Affiliation address:
A Randomized Double Blind Comparative trial of
Antidepressant Augmentation by High and Low Dosage * Assistant Professor, Department of Psychiatry, PSG
Folic Acid in Depressive Disorder Institute of Medical Sciences and Research,
Coimbatore-641004
ABSTRACT
** Professor of Psychiatry, National Institute of Mental
BACKGROUND: Several studies show elevated incidence of
Health and Neurosciences, Hosur Road, Bangalore-
folate deficiency in patients suffering from depression.
560029
Systematic-reviews suggest that folate may have a potential
role as supplement to antidepressants but have called for *** Junior Resident, Department of Psychiatry, PSG Institute
further trials. Few trials have shown that in females than in of Medical Sciences and Research, Coimbatore-641004
males; administering folic acid with antidepressants
augments the antidepressant response. Presenting author:

OBJECTIVE: In this study we compared the add on effect of Dr. R. Venkatasubramanian, MD


high (5mg) versus low dose (1.5mg) folic acid to fluoxetine Assistant Professor,
(20 mg) in female patients suffering from moderate/severe Department of Psychiatry,
depressive episode (either first episode or recurrent PSG Institute of Medical Science and Research,
depressive disorder) Coimbatore- 641004.
Tamilnadu, India.
METHODOLOGY: 42 drug naïve female outpatients clinically Phone number: +91-9791802486; + 91-9944059997
diagnosed to have moderate or severe depressive episode Fax number: +91 422 2594400
(ICD-10 criteria) were randomized into two groups 1 and 2. E-mail: rvs.1947@gmail.com
Both groups received fluoxetine 20 mg. In addition, group 1 psychiatry.venkat@hotmail.com
received folic acid 1.5 mg/day, while group 2 received 5
mg/day of folic acid in a double blind fashion. Out come Study of Depression among Diabetics in a General
measures were Hamilton Depression Rating Scale (17 item hospital: Consequences in Diabetes Management &
version) and Beck Depression Inventory administered every Quality of Life
week for a period of 6 weeks. Appropriate statistics was
used to analyze the data BACKGROUND: Recent studies quote high prevalence of
depressive episodes in diabetics, which leads to increased
RESULTS: Both groups were comparable at baseline in terms risk for various complications of the metabolic disorder.
of socio-demographic and illness variables (p>0.05). There Yet depression is often unrecognized and untreated in
was no significant difference across two groups with approximately two thirds of patients with diabetes.
respect to baseline HDRS and BDI scores (p>0.05). Within Underdiagnosis of co-morbid depression may reflect a
both the groups there was a significant decline in mean perception among clinicians that psychological issues are
depression scores on both HDRS, BDI (p=0.00). Across the less important than medical concerns in patients with
two groups, the decline in BDI scores was statistically diabetes. To maximize overall patient outcome, this needs
significant which was more in group 2 (p = 0.04). The to be addressed adequately.
decline in HDRS scores was not statistically significant
across the two groups (p > 0.05). 66% of patients in group 2 OBJECTIVE: To estimate the prevalence of depression among
and 33 % in group 1 showed a 50% decline from the baseline the diabetics in the study population. To ascertain and
score in both scales. compare the level of diabetes self care management and
the health-related quality of life between the depressed and
CONCLUSION AND LIMITATION: Hence supplementing 5 mg non-depressed.
folic acid to fluoxetine in the treatment algorithm in women
with depressive episode, produces a better add on effect METHODOLOGY: 50 consecutive diabetic out-patients of
than 1.5 mg of folic acid. The results could have been better either sex, after informed consent were administered
substantiated with a laboratory measurement of serum folic Hamilton Depression Rating Scale (HAM-D), Summary of
acid and homocysteine levels. Diabetes Self Care Activities (SDSCA), and Rand 36 Health
status inventory. Based on the HAM-D scores, patients were
Authors: initially grouped as depressed and non-depressed.
Depressed were further sub-grouped into mild, moderate,
1) Dr. R. Venkatasubramanian*, MD severe and very severe. Comparison of the level of diabetes
management self care and Quality of Life between the
2) Dr. Ravi Shankara Pandey***, MD
depressed and non-depressed was done using the mean
3) Dr. Venkateshwaran.R**, MBBS

61
scores of SDSCA, Rand 36 inventory. Appropriate statistics
Assessment of the reporting quality of non-inferiority and
was used to analyze the data.
equivalence trials in cancer post CONSORT, using a
RESULTS: The proportion of depression among the study modified CONSORT checklist
population was 46% and of them 50% was mildly depressed.
AUTHORS: Vikram Gota1, Sadhana Kannan1, Priya
All components of SDSCA scores were lower among
Ranganathan2, Nithya Gogtay3, Sandeep Bavdekar3, CS
depressed compared to normal population (p<0.01). There
Pramesh2
is a decline in the all the components of SDSCA scores as
the severity of depressive symptoms increases, with severe 1
ACTREC, Tata Memorial Centre, Sector-22, Kharghar, Navi
& very severely depressed having the least score. Rand 36 Mumbai 410 210, India
inventory items were also significantly different between
2
depressed and non-depressed (<0.05). The mean scores of Tata Memorial Hospital, Parel, Mumbai 400 012, India
SDSCA, RAND 36 also show a statistically significant decline 3
as the severity of depression increases. Seth GS Medical College and KEM Hospital Parel,
Mumbai 400 012, India
CONCLUSION: Results substantiate that prevalence of
depression among diabetics is higher than in the general BACKGROUND: The revised CONSORT was published in 2006
population which is in the range of 7.8% to 17%. Identifying to improve the reporting of RCTs. Non-inferiority (NI) and
depression among the diabetics at an earlier stage would equivalence (Eq) trials are a subset of RCTs that differ
improve the Physical & Mental domain of Health Related methodologically from superiority trials. An extension to
Quality of Life and breaking the vicious cycle of depression the CONSORT checklist was published in 2006 for reporting
and diabetes. Eclectic interventions need to be planned for NI/Eq trials. This checklist provides a framework for
each individual. However rater-blind studies are required minimum reporting standards, but leaves several points
for further validation of our findings. open to interpretation. Studies that evaluated the impact of
the extended CONSORT statement on the quality of reporting
AUTHORS: of NI/Eq trials in AIDS and ophthalmology concluded that
reviewers and editors need to reinforce their standards for
1. Dr. Venkateswaran. R*, MBBS acceptance of NI/Eq RCTs.
2. Dr. Mario Victor Newton. L**, MBBS AIM:
3. Dr. Venkatasubramanian. R***, MD 1) Assess the impact of the CONSORT statement, on the
quality of reporting of NI/Eq trials in oncology.
Affiliation address:
2) Validate a modified CONSORT checklist for NI/EQ trials
* Junior Resident, Department of Psychiatry, PSG
by checking the intraclass correlation coefficient (ICC)
Institute of Medical Sciences and Research,
between three sets of raters.
Coimbatore-641004
METHODS: All RCTs in cancer with NI/Eq design published
** Under-graduate Student, PSG Institute of Medical
post CONSORT till November 2008 were selected from
Sciences and Research, Coimbatore-641004
PUBMED. A modified CONSORT checklist was developed
*** Assistant Professor, Department of Psychiatry, PSG that included all 22 items of the extended CONSORT for NI/
Institute of Medical Sciences and Research, Eq trials. Additional items considered important from a NI/
Coimbatore-641004 Eq trial perspective were also included. Each of the 22 items
was further subcategorized to render objectivity to the
Presenting author: checklist. Three groups of reviewers scored the checklist
independently for all post CONSORT trials. After scoring,
Dr. R. Venkateswaran, MBBS the reviewers got together to arrive at a composite score
Junior Resident, based on consensus. The interrater agreement was assessed
Department of Psychiatry, using ICC. Compliance of each article to CONSORT was also
PSG Institute of Medical Science and Research, assessed.
Coimbatore- 641004.
Tamilnadu, India. RESULTS: Twenty six studies were identified. The overall
Phone number: +91-9994474538; + 91-9655590526 interrater agreement for the modified checklist was 71%.
Fax number: +91 422 2594400 The agreement was greatest for the ‘results section’ (77%)
E-mail: drwaran005@gmail.com 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

62
areas that require improved reporting include specifying Results: In India, in 2008 a full text article was downloaded
a) NI margin b) rationale for choice of delta c) methods from Wiley InterScience every 7 minutes. For India this
used to implement random allocation. No difference was represents an increase in usage of The Cochrane Library of
found in the reporting quality of industry sponsored and 648% from Year 2006 to Year 2007 and 14% from Year 2007
investigator initiated trials (P=0.80). to Year 2008 and by August 2009, the total full text download
is already 68% of the total Year 2008 figures. Data taken
CONCLUSION: Compliance to CONSORT statement for NI/Eq from all websites of The Cochrane Library show that during
trials in cancer is poor. We have attempted to validate a 2008: A search of The Cochrane Library took place every 2
modified CONSORT checklist for NI/Eq trials. seconds; A Cochrane abstract was viewed every 3 seconds;
A full text article was downloaded every 4 seconds. The
Presenting author (Also contact author)
total full text download for Cochrane Library in India in
Dr. Vikram Gota Year 2008 is 70,090; making India as one of the top 10
Assistant Professor countries from Asia that visited Cochrane Library worldwide
Clinical Pharmacology
Conclusions: In summary, usage of The Cochrane Library in
Advanced Centre for Treatment Research & Education in
2008 has increased considerably in comparison to 2007.
Cancer (ACTREC)
Over half the world’s population now have access to The
Tata Memorial Centre
Cochrane Library via one-click access (no login required),
Kharghar
and it is clear that worldwide usage of The Cochrane Library
Navi Mumbai
is increasing as a consequence. Usage in India, since the
Tel: 022 2740 5130
national license was provided, access nationally has grown
vgota@actrec.gov.in
significantly and the usage levels now surpass many other
Who is using The Cochrane Library? developed countries with established national access
schemes including Norway, Ireland and Poland establishing
Usage statistics of Wiley InterScience for India and India as one of the top countries visiting and using The
Worldwide. Cochrane Library.
Jaslyn Tan, Piyush Gupta, Ashish Sood, Laura Sampson; EVIDENCE BASED MEDICINE: A NEW APPROACH TO TEACH
Wiley InterScience MEDICINE
BACKGROUND: The dissemination of high quality, timely Authors:
evidence is a priority for The Cochrane Collaboration and
for the ICMR who fund a national access licence for India. Yeshwant*, Elakkiya*, Prarthana Saraswathi*, Surapaneni
By monitoring usage, exploring user activity, and identifying Krishna Mohan**
trends we can build on our understanding of how people
Affiliation:
use The Cochrane Library, where they come from, and which
reviews they access. We can use these data to help us *II MBBS Student, Saveetha Medical College & Hospital,
identify ways of increasing access to and usage of The Saveetha University, Saveetha Nagar, Thandalam, CHENNAI
Cochrane Library in India and worldwide. – 602 105, T.N, INDIA.
METHODS: For the worldwide data the periods of 1st **Assistant Professor, Department of Biochemistry,
January 2008 to 31st December 2008, the number of unique Saveetha Medical College & Hospital, Saveetha University,
visits to www.thecochranelibrary.com, number of visits by Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.
country, and most accessed Cochrane reviews on Wiley
InterScience were taken from the Wiley InterScience Data BACKGROUND: No clinician would consider entering
Warehouse, an analysis tool that stores and tracks usage clinical practice without knowing the rudiments of history-
data. Another set of usage data was obtained from all other taking and physical examination, nor would clinicians
licensed providers of The Cochrane Library, showing the consider independent practice without a basic
number of abstracts and full text articles that were accessed understanding of how the drugs they prescribe act on their
during 2008 from Wiley InterScience, EBSCO, OVID, La patients. Yet, traditionally, clinicians have started practice
Biblioteca Cochrane, BIREME and www.cochrane.org. For without an ability to understand evidence about how they
the India usage data the periods calendar year 2006, 2007, should interpret what they find on history and physical
2008 and Jan – August 2009 were considered, so as to help examination, or the magnitude of the effects they might
investigate the impact of introducing national access, using expect when they offer patients medication. Evidence-based
the IP ranges for India to identify India usage activity as medicine (EBM) provides a remedy for this problem.
registered from Wiley InterScience Data Warehouse.

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

Prof. BV Moses and ICMR Centre for Research and AUTHOR


Training in Evidence-Informed Healthcare Dr. Anna Mathew M. D. (Pharm),

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