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www.cochrane-sacn.org

Date: 11th - 14th January 2010

Venue: Scudder Auditorium, CMC Campus, Bagayam, Vellore

Theme: “Evidence for Better Health”

Prof BV Moses & ICMR Centre for Advanced Research and Training in Evidence Informed Healthcare &

South Asian Cochrane Network & Centre

Organised by

Prof BV Moses & ICMR Centre for Advanced Research and Training in Evidence Informed Healthcare,South Asian Cochrane Network & Centre, II Floor, Carman Block, Christian Medical College, Bagayam, Vellore 632 002

Tel: +91 416 2284499 / 2284504 Fax: +91 416 2260085 Email: cochrane@cmcvellore.ac.inWebsite: www.cochrane-sacn.org

8th Winter Symposium3rd South Asian Regional Symposium on

Evidence Informed Healthcare

Christian Medical College, Vellore

Plenary Session Abstracts & Poster Abstracts

Supplement

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Comparison of effectiveness of allopathic treatment withherbal treatment for uncomplicated upper respiratory

tract infection in Jamunamarathur Tribal Primary HealthCare Centre of Tamil Nadu

(Dr. M.Abdul Kareem *, Dr. M. S. Subramaniam **,Dr. K. R. John***)

*Senior Program Officer, Foundation for Revitilization ofLocal Health Tradition, Bangalore,

** Department of Botany, Kongunadu Arts and ScienceCollege, Coimbatore,

***Professor, Department of Community Medicine,Chiristian Medical College, Vellore

BACKGROUND: Today it is very evident that the local healthtraditions at house hold level show that there is a declinein the usage of home remedies, traditional diets and healthcustoms. This situation demands a movement thatincorporates local resources and local knowledge forenhancing health security by promoting under a publichealth system for the wider use. Hence there is a need toresearch and promote the proper use of traditional medicineby developing and providing international standards,technical guidelines and methodologies on theeffectiveness. In this study one formulation for cough dueto upper respiratory tract infection has been selected fromthe ethno botanical documentation of the local healer.

AIM: To study the effectiveness of herbal cough syrupcompared to allopathic treatment for uncomplicated upperrespiratory tract infection.

METHODOLOGY: Randomized control clinical trial. Settings:Out patients of Jamunamarathur Primary Healthcare Centrein the Javadu hills, in Thiruvanamalai. Participants: 64participants (32 in each arm) were recruited from amongstthe patients suffering from uncomplicated upper respiratorytract infection. Intervention: One group received theallopathic treatment of benadryl syrup, paracetamol tabletsand a saline nasal drop. The other group got the herbalcough syrup, with masked tablets and nasal drops.Examined twice (3rd and 7th day), during the length of theweek long follow-up. Method: Patients were randomlyallocated to receive either the herbal cough syrup orallopathic treatment.

RESULTS: Baseline sex and age of both groups were similar.Thirty-one patients completed the follow-up in each arm.The results of the trial indicated that 20 out of 31 patients(65%) were cured with the allopathic drug and 18 out of the31 patients (58%) were cured with the herbal syrup. Therewas no report of any adverse events or side effects. Epi-Info 6.04 (CDC, Atlanta, USA) software was used for analysis.

Conclusions:

• The study drug has been found effective (58 % cure rate)for the population under condition.

• There is only 7% difference in the cure rate between theallopathic arm (65%) and the herbal arm (58%). The Pvalue= 0.602, P>.05, the difference of effectivenessbetween two arms is not significant. Hence the herbalcough syrup can be acceptable as alternative cure forcough due to URI.

• No adverse effects have been reported during the presentclinical study.

Editorial policy and the reporting of RandomizedControlled Trials in Indian Medical Journals in 2004 & 2005 compared to 2007 & 2008

Aneesh George, Richard Kirubakaran, Prathap Tharyan,Jabez Paul, Manuel Raj

Prof. BV Moses & Indian Council of Medical ResearchCenter for Advanced Research and Training in Evidence

Informed Healthcare;

South Asian Cochrane Network & Centre, ChristianMedical College, Vellore, India

Background: Editorial requirements for submission ofreports of Randomized Controlled Trials (RCTs) in 2005 andthe quality of reporting of RCTs in 2004 and 2005 in Indianmedical journals were suboptimal [1].

Objectives: To assess the changes in editorial policy formanuscript submission in 65 Indian medical journals in2008 compared to 2005 the quality of reporting of RCTspublished in these journals in 2007-2008 versus 2004-2005

Methods: We included 65 Indian medical journalsidentified from the South Asian Database of ControlledClinical Trials (www.cochrane-sadcct.org) that provideddata for the earlier survey.AG and RK independently analyzedtheir instructions to authors for endorsement of theCONSORT statement and the ICMJE requirements forreporting of RCTs.AG and RK independently evaluated reportsof all RCTs published in these journals in 2007 and 2008against 13 selected CONSORT items and the ICMJErequirements. All data were verified by PT. We comparedthe proportion of reports in 2004-2005 versus 2007-2008that endorsed selected CONSORT and ICMJE items

RESULTS: Of the 65 journals, 38 (59%) in 2005 and 37 (57%)in 2008 mentioned the ICMJE requirements in theirinstructions for authors, but only 20 (31%) in 2005 and 22(33%) in 2008 specifically required authors to submitmanuscripts 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 selectedCONSORT items were reported in > 50% of trial reports.Reporting was better for some items reflecting internalvalidity but worse or unchanged for others. Ethical issuescontinued to be poorly reported, though reporting fundingsources and conflicts of interest had significantly improved.

Adequacy of reporting was not related to endorsingCONSORT or the ICMJE requirements.

CONCLUSIONS: Editorial policy in leading Indian medicaljournals regarding manuscript submission for RCTscontinues to be suboptimal. The reporting of RCTs forCONSORT items reflecting internal validity was better in2007-2008 over 2004-2005 for random sequence generationbut continued to be suboptimal for allocation concealment,blinding and intention to treat analyses. The reporting ofconflicts of interest and funding sources had significantlyimproved in RCTS published in 2007-2008 Urgent measuresto educate Indian medical journal editors are needed andis planned.

Google Insights into The Cochrane Library usage in India: isthe national subscription being used?

Asokan GV1, Dave Sinclair2 and Prathap Tharyan3

BACKGROUND: Google Insights is a free-to-use internet toolwhich tracks the popularity of specific internet search termsover time.1 This simple tool has the potential to providereal time data on public health concerns.2

OBJECTIVE: To investigate the way health information issearched for in India via Google, and to evaluate interest insearching for The Cochrane Library since the nationalsubscription was purchased by the Indian Council forMedical Research in 2007.3

METHODS: Using “Cochrane” as the search term under thecategory of “Health”, “medical literature and resources” asthe primary subcategory, and the period 2004 to 2009 asthe time frame, we evaluated

1. The most popular search terms in India used to identifyhealth websites/portals in India

2. Variation over time and between states in India and thetop four countries of Cochrane usage.

3. The volume of Cochrane-related searches compared tosome popular Indian and International medicaljournals and health-related websites.

We also compared the Google Insights data with usagestatistics provided by Wiley-Blackwell, publishers of TheCochrane Library.

RESULTS: ‘Cochrane’ consistently scored more frequentlythan the four top-ranked Indian health portals (MedInd,

Health Library, Doctor NDTV and web health centre), overthe period studied. Interest increased dramatically sincethe provision of the national subscription with themaximum interest over time seen in Tamil Nadu,Maharashtra, Delhi and Karnataka. Interest was sustained,with peaks reflecting national Cochrane-related symposiaand activities. Australia, the UK, and Canada showed themaximum interest in ‘Cochrane’, but since 2007, India hasovertaken the US. ‘Cochrane’ also scored above Indianjournals (Indian Journal of Medical Research, NationalMedical Journal of India, Journal of the Association ofPhysicans of India, the Postgraduate Medical Journal andothers) and international journals (NEJM, The Lancet, BMJand JAMA). However, ‘PubMed’ was by far the mostcommonly-searched term in Google during these years. Datafrom Wiley-Blackwell on actual usage of The CochraneLibrary from 2006-2008 mirrors the increased interest inusage captured by Google Insights since the provision ofthe national subscription

CONCLUSION: Google Insights is a proxy to evaluate interestin Cochrane in India, and may reflect healthcare informationseeking behavior of healthcare professionals, researchers,students, consumers, etc. These results are only indicativeand restricted to trends captured by a single search enginewith this capability. They also do not reflect direct accessto health-portal, journal, or database websites thoughstored or forwarded web-links. However, they correlate withdirect data of usage statistics of The Cochrane Library. TheNational subscription has increased and sustained interestin The Cochrane Library, though high interest is limited tocertain states.

REFERENCES

1. Google Insights. Available at http://www.google.com/insights/search

2. Ginsberg J, Mohebbi MH, Patel RS, Brammer L,Smolinski MS, Brilliant L. Detecting influenzaepidemics using search engine query data. Nature.2009 Feb 19;457:1012-4.

3. Tharyan P. Access to the Cochrane library foreveryone in India. National Medical Journal of India2007; 20 (1): 49.

AUTHOR AFFILIATIONS

1Research Officer, Institute of Veterinary PreventiveMedicine, Ranipet, Vellore District, India

2Visiting Adjunct Fellow, South Asian Cochrane Network &Centre; International Health Group, Liverpool School ofTropical Medicine, UK.

3Director, South Asian Cochrane Center, Prof BV Moses andICMR Centre for Research and Training in Evidence-InformedHealthcare, CMC Vellore, India

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COMPARISON OF CEFOXITIN AND OXACILLIN DISCDIFFUSION TEST WITH OXACILLIN SCREEN AGAR FOR

DETECTION OF MRSA

AuthorsAzhar Sheikh a

Dr.Vijayshri Deotale b

a Student II MBBS| Mahatma Gandhi Institute of MedicalSciences, Sevagram | Maharashtra

b Professor of Microbiology| Mahatma Gandhi Institute ofMedical Sciences, Sevagram | Maharashtra

Correspondent Author: azhar4u27@gmail.com

INTRODUCTION: Today MRSA strains are worldwide majorcause of nasocomial infection. Mec A based detectionidentifies even the most heterogenous strains of MRSA andconsidered as gold standard. Cefoxitin surrogate markerfor for detection of mec A gene mediated methicillinresistance.

Clinical and laboratory standard institute (CLSI) guidelines2006: Cefoxitin disc diffusion test recommended fordetection of MRSA.

Why this research?:To evaluate the efficacy of cefoxitin discdiffusion test to detect MRSA and compare it with oxacillinagar screening.

METHODOLOGY: A total of 50 consecutive non-repeatisolates of MRSA isolated from clinically relevant sourcefor period of 2 month. Isolates were identified by cultureand biochemical tests and were subjected for antibioticsusceptibility testing by Kirby bauer disc diffusion method(CLSI method). All Co-agulase positive staphylococcus weretested for oxacillin susceptibility test.Inoculation of 0.5MacFarland standard was done on Mueller Hinton agarand detection for cefoxitin was done with help of disc ofcefoxitin 30 microgram applied on surface of media. OnOxacillin screen agar inoculation of 0.5 MacFarlandstandard was done. Even growth of single colony indicatedmethicillin resistance.

RESULTS: Resistogram of MRSA strains:

ANTIBIOTICS RESISTANT

Erythromycin 34(68%)Penicillin 46(92%)Ciprofloxacin 28(56%)Oxacillin 50(100%)Cefoxitin 21(42%)Linezolid 19(38%)Chloramphenicol 22(44%)

Comparison of oxacillin disc,cefoxitin disc with oxacillinscreen agar:

Oxacillin disc Oxacillin screen agar Cefoxitin disc

50(100%) 50(100%) 21(42%)

Highest isolation of MRSA isolates were from pusspecimen(42%) followed by blood (14%) and conjuctivalswabs (14%).The prevalent age group from which sampleswere obtained was 0-5 yrs age group. Maximum resistancewas for penicillin after oxacillin.On comparison withoxacillin disc with cefoxitin disc the oxacillin disc showed100% co-relation with oxacillin screen agar whereascefoxitin disc could detect only 42% isolates.

CONCLUSION: Oxacillin disc diffusion test was found betterthan cefoxitin disc diffusion test for detection of MRSAstrains.

The Cochrane Ark: are there animals studies hiding inCENTRAL?

Clive E Adams1, Samantha Roberts1, Drew Davey1, JulieMonalisa2

1Cochrane Schizophrenia Group, University of Nottingham,UK. Email: Samantha.Roberts@nottingham.ac.uk

2South Asian Cochrane Network and Centre, ChristianMedical College, Vellore, India

BACKGROUND: The Cochrane Central Register of Controlledtrials (CENTRAL) is a specialist register of electronic reportsof trials focused on living human beings.

AIMS: To investigate whether animal studies hide inCENTRAL.

METHODS: We searched CENTRAL (Issue 1, 2009) using termsfor animals in title and then the title, abstract, keywordscombined function. The results were downloaded andmanually searched twice to ascertain whether trialparticipants were indeed living human beings or animals.

RESULTS: CENTRAL positively clucks, moos, squeaks, meowsand even barks with the sound of wildlife. We initiallyretrieved 11,443 records. After screening and removingduplicates, 53 records were identified within CENTRAL asreporting trials conducted on animals, and not on humanparticipants.

Conclusions: This small number is likely to be anunderestimate of what animal trials are really in CENTRAL,because of the very strict inclusion criteria we used. Theinclusion of non-human trials [and other types of studies]in CENTRAL devalues this key product of the Collaboration.Simple measures could be adopted to clean much irrelevantdata from this important but flawed database.

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Clinical Management of Acute Undifferntiated Febrile(AUF) Illnesses with complications- Malaria duringPregancy in India: Evidence gaps in Intermittent

Preventive Treatment (IPT)

Authors:*A.George Vasanthan *Anand Manoharan **Dilip

MathaiAffliation: *Scientist (Research)

Infectious Diseases Training and Research Center (IDTRC)Dept.of Medicine Unit 1 and Infectious Diseases**Professor and HeadDepartment of Internal MedicineChief Mentor: Infectious Diseases Training and ResearchCenterProf.Benjamin Pulimood Laboratories for InfectionInflammation and Immunity (BMPLIII)ACC-CMC Trust for Infectious Diseases

Author for Correspondence:Dr.Dilip Mathai MD PhD FCAMS FICP FIDSAProfessor and HeadDept.of Internal MedicineChristian Medical CollegePO Box.No.3, 4th Floor SP ComplexIda Scudder RoadVellore 632 004Tel: +00-91-416-228-2921/2923/2804

Email:dilipmathai@hotmail.com

Clinical management of acute undifferentiated febrileillnesses in the community in India may be difficult as therewill be no single feature of any disease or common clinicalpresentation to suggest etiology of a diagnosis. In most ofcases failure of an empirical therapy provided by a privatehealth care provider or lack of an intervention may lead tosevere complications as in case of malaria or dengue.

Malaria endemic in India (estimated 70-100 million caseseach year (1.6-1.8 million reported by NVBDCP) causescomplications during pregnancy if not treated early resultingin still births, low birth weight, anemia, and maternalmortality. In remote rural areas in malaria endemic zonesof Enhanced Malaria Control Project (EMCP) states,42.79%among 12 million malaria positive pregnant women diedue to P.falciparum alone either at home or in the privatesector. This mandates further decentralization of healthcare to such areas which have been adopted by the NorwayIndia Partnership Initiative (NIPI) to prevent maternaldeaths due to malaria or other causes in line with the MDG5.Recognition of malaria in pregnancy as an importantpublic health problem in India, its delimitation,stratification, and realistic calculations for planning andinterventions is a major health care measure to meet thetarget in MDG5.

Though WHO recommends intermittent preventive treatment(IPT) as the foremost intervention for preventing thesecomplications during pregnancy, Drug Policy of India, 2008is not aligned with the evidence-based best practicesrecommended by the Roll Back Malaria (RBM) initiative.Global data (limited) suggest that artemisinins are effectiveand unlikely to be cause of foetal loss or abnormalities,when used in late pregnancy. However, none of these studieshad adequate power to rule out rare serious adverse events,even in 2nd and 3rd trimesters and there is not enoughevidence to effectively assess the risk-benefit profile ofartemisinin compounds for pregnant women particularlyfor 1st trimester exposure. Such evidence gaps in effectiveIPT in the care and management of malaria in pregnantwomen in India remains to be addressed through systematicreviews of the effects of this intervention.

Accuracy of clinical assessment of Hyperbilirubinemia inHospitalized Neonates.

AuthorsGondnale Ga,

Taksande Ab ,Vilhekar KYc

a II Year MBBS, Mahatma Gandhi Institute of MedicalSciences, Sevagram

b Associate Professor, Dept. of Pediatrics, MahatmaGandhi Institute of Medical Sciences, Sevagram.

c Professor and Head, Dept. of Pediatrics, MahatmaGandhi Institute of Medical Sciences, Sevagram

Correspondent Author: cool.goral@gmail.com.

INTRODUCTION: Jaundice, a frequently encountereddiagnostic and therapeutic problem in newborns is quitecommon affecting nearly 60% term and 80% pretermneonates during first week of life. The standard method ofserum bilirubin estimation requires blood specimen takenby heel prick or venepuncture which is painful andexpensive. Clinical evaluation of neonate through acomprehensive history and physical examination isconsidered as a cornerstone in neonatology.

Material and Methods: All newborns delivered in thehospital were enrolled on 3rd day of life after a writteninformed consent from the parents. Neonates who hadreceived exchange transfusion or phototherapy prior toinclusion were excluded. 3 independent and blindedobservers- a trained medical student, a neonatology nurseand a pediatric resident examined all the enrolled newbornsfor jaundice in the standard manner and predicted totalserum bilirubin according to the cephalocaudal extent ofjaundice. Irrespective of interpretation of the index test(clinical examination), blood was withdrawn from allnewborns immediately for estimation of total serum

39

bilirubin. The diagnostic accuracy of clinical examinationwas measured by computation of sensitivity, specificity,and positive likelihood ratios (LR+), negative likelihoodratios (LR–). The precision of these estimates will beevaluated by using 95% confidence intervals.

RESULTS: A total of 99 neonates were included in the studybetween April and May 2009. A total of 64(%) neonates hadhyperbilirubinemia above 10mg/dL and 30 (%) above 15mg/dL respectively. The sensitivity of clinical examinationfor detection of hyperbilirubinemia was poor (range 10 to70.3%). The specificity was reasonable (range 81.6 to 99.9%).The positive likelihood ratios ranged from 2.19 to 22.2 andnegative likelihood ratios from 0.43 to 0.78. In event of apositive clinical test, the chances of neonatalhyperbilirubinemia are high, however a negative clinicaltest does not rule it out.

CONCLUSION:All neonates need to be screened forhyperbilirubinemia using standard bilirubin estimationtests. Clinical assessment is likely to miss many neonateswith high bilirubin levels.

Key Words: Clinical Assessment, NeonatalHyperbilirubinemia, Accuracy, Reliability

Medicine: profession or trade?

Hari Prasad1, 2, Rishi Raj1, KR Bhagavan2, Sangeeta DasBhattacharya1

1School of Medical Science and Technology, IIT Kharagpur,India

2Department of General Surgery, KS Hegde MedicalAcademy, Deralakatte, Mangalore, India

BACKGROUND: Health information is now part of patients’rights. Although physicians frequently underestimate theimportance of patient information, there are variations inthe extent to which patients want to be involved in activedecision making. It is therefore important to find out in-advance whether some information may be unwanted, asillustrated in our case.

CASE REPORT: A 3-months-old female with Tubular colonicduplication with Recto-vaginal fistula underwent successfulright transverse colostomy along with side-to-sideanastomosis of the native and duplicated rectum aiming atinternal drainage. A few days after the surgery the surgeonlearnt that biopsy of the duplicated segment revealeddysplastic changes. The parents were informed that the childhas an additional high risk of developing malignancy ofthe duplicated segment. The new information however hada negative effect on them. They stopped being well adjustedand optimistic. Her parents believed that entire surgery hasbeen completed and she has to live rest of her life with thecolostomy in-situ. Hence they did not get the closure done

at the right time and since past 19 years she stools outthrough this colostomy.

Now prior to her marriage, they were anxious to know herfertility and made them to present her to us. We explainedher condition in detail along with a possibility of acorrective procedure. The ascending colon, which initiallyemptied into the colostomy, was anastomosed to the rectum.The patient had an uncomplicated post-operative course.

DISCUSSION: It would be in conflict with the principle ofpatient autonomy if the surgeon withheld importantinformation. But in our case, her parents already knew thatshe requires a long term follow up and hence newinformation does not imply any benefit other than a morecareful follow up. Hence the communication of theinformation in this case probably could have beenpostponed. On the other hand, her parents actually neededmore information and education regarding the type of thedefect, surgery done and the need for timely closure of thecolostomy and regular follow up.

CONCLUSION: General feeling of the public is that, “The jobof a doctor is to reassure and comfort the sick, not to frightenthem”. In our opinion, physicians need to be warned againstan attitude biased towards what “the rules say” more thantowards what the patient wants or needs. The respect enjoyedin our society imposes certain moral responsibilities onthem, one being balanced presentations of necessary factswhich neither unduly alarm nor entice patients butfacilitates decision-making.

The Cochrane Schizophrenia Group Specialised Register

Julie Monalisa1, Samantha Roberts2, Clive E Adams2

1South Asian Cochrane Network and Centre, Christian MedicalCollege, Vellore, India. Email: julie_sacn@cmcvellore.ac.in

2Cochrane Schizophrenia Group, University of Nottingham, UK

BACKGROUND: The Cochrane Schizophrenia Group (CSG)Specialised Register contains all reports of controlled trialson severe mental/psychiatric illness, psychosis,schizophrenia and related disorders with comorbiddisorders such as substance abuse, depression, personalitydisorder or problematic behaviours/adverse effects(aggression/antipsychotic-induced tardive dyskinesia). Thegroup maintains its register in a Microsoft Access database(Meerkat 1.5 http://cochrane.co.uk/en/newPage1.html).Meerkat stores references as studies (is a study-basedregister), attaches to full text of reports, stores contactaddresses of group reviewers, tracks reports sent to authorsand has the capacity to link to the datasets within existingCochrane Reviews.

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AIMS: To describe the specialized register of the CochraneSchizophrenia Group.

METHODS: Studies in the CSG register are identified from 83databases and trial registers. Many of these searches areundertaken on a regular basis (e.g. MEDLINE,Clinicaltrials.gov). Records are formatted (using Endnote)and relevant trials within the scope of the group are selectedand imported into Meerkat. Each imported study is codedfor method, participant, intervention and outcome. If arecord is identified as being part of another trial already inthe register the incoming record is merged into the existingstudy. The register can be searched by either individualreference or study using standard search terms and limitedboolean operator functions.

RESULTS: The CSG register contains both randomisedcontrolled trials (RCTs) and controlled clinical trials (CCTs).It holds 14,217 individual references (all available withfull text), which form 11,675 coded studies in the register.These references are in over 20 different languages, andonly 54% are found on PubMed or Medline.

CONCLUSIONS: The CSG register, built in free-ware software,is a formidable tool for authors of reviews. It greatlyenhances the efficiency of supply of information toreviewers, and reduces time taken to review.

Thai databases

Kamolthip Atsawawaranunt1, Clive E Adams2, SamanthaRoberts2

1Faculty of Medicine, University of Srinakharinwirot,Thailand. Email: y_rean@hotmail.com

2Cochrane Schizophrenia Group, University of Nottingham,UK

BACKGROUND: Thailand is a poor but highly literate countryof over 60m people in South-East Asia. Much biomedicalresearch is undertaken but dissemination is limited.

OBJECTIVES: To identify relevant Thai bibliographicdatabases and investigate accessibility, functionality andcontent - particularly in relation to randomised controlledtrials (RCTs) and clinical controlled trials (CCTs).

METHODS: A systematic search for institutions productiveof research, and the databases in their libraries. Use eachaccessible database and recording of functionality andcontent.

RESULTS: We found 32 different databases (29 accessiblein UK); of various sizes, coverage and functionality but manywith unique records of RCTs and CCTs (total n=781). 209 of781 trials were accessible on PubMed (27%).

CONCLUSIONS: More collaboration within Thailand wouldhelp merge databases and allow greater dissemination oflocal work. Those undertaking comprehensive searches forbiomedical literature cannot afford to ignore theconsiderable efforts of researchers in Thailand.

META ANALYSIS – Physiotherapy perspectives

Lenny Vasanthan TDept of Physiotherapy, Manipal University, Manipal.

Background: There is a wide gap existing between evidenceand practice because of large volume of literature, withwhich physiotherapy practitioners are inundated.Practitioners lack considerable time, skills to evaluate theliterature. One way of addressing this problem is to searchfor a review article. Meta-analysis is an analytical strategyused to analyse and combine the results of previous reports,which gives a precise estimate of treatment effect.

AIMS: Meta-analysis aims to identify facts more accuratelythan traditional narrative review. It delivers facts withobjectivity, helps in determining magnitude of effect andresolve differences in literature.

METHODS: Meta-analysis is a 2 stage process

1. Data extraction and calculation of summary statisticalong with confidence interval

2. Calculation of a pooled average if appropriate.

It looks at results within each study and calculates weightedaverage. QUOROM(Quality of reporting of meta-analysis)is recommended, which is an explicit and objective criteriafor inclusion or rejection of studies. Funnel plot can bedone to examine publication bias. Sensitivity analysis canbe done to explore ways in which main findings are changedby various approach to aggregation.

RESULTS: Great care has to taken to assess methodologicalquality of design and execution of study. Quality check usingappropriate check list needs to be done, Heterogeneity ofstudies should be checked as it influences the further methodof analysis. Forest plot is a pictorial representation usedto present the findings.

CONCLUSION: Helpful in determining small but clinicallysignificant effects with precise estimate of effect size, whichhelps to add to the evidence base, thereby treat patients ina better way. Pitfalls include overgeneralization, ignoringqualitative difference between studies, dealing with maineffects only. Fundamentally meta-analysis is limited byquality of underlying studies “GIGO” (garbage IN garbageOUT)

References:

1. Cochrane open learning material 2002

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2. Crombie.,EBM series 2009

3. DeCoster J.,Meta-analysis notes 2004

4. Helewa A., Critical evaluation of research in physicalrehabilitation 2000.

Ethics of inaccessibility of funded research publications

Dr.N.Isai Vani.Assistant Professor, Department of Anatomy, Sri

Venkateshwaraa Medical College & Research Centre,Pondicherry. Email: drisaivani@gmail.com

India is becoming the hub of clinical research. Incommensurate with these advances, the government fundingfor biomedical research in thrust areas is also increasing.Indian Council of Medical Research (ICMR), Department ofBiotechnology (DBT), Department of Science & Technology(DST) are some of the government organisations whichprovide financial support for various research projects.The results of the funded research projects are publishedin various international journals. Most of these journalshave an access to paid subscribers only. Hence it is unethicalto use the research grants from government (people’s tax)and not allowing the scientific community a free access tothe results of the study.

This ethical issue can be overcome by forming a body towhich every investigator who has got grants would submitthe full text of the paper published from his study and thesecan be made freely accessible to everyone in the website ofthe newly formed body.

Such an initiative – PubMed central (PMC) already exists inUSA. Every investigator getting grants from NationalInstitutes of Health has to submit the full text of the articlepublished from his study, which would be made freelyaccessible at PMC. The funding bodies in India should alsoform an initiative similar to PMC and put an end to thisunethical act.

Bedside Capillary blood glucose measurement byglucometers compared to venous blood glucose in critically

ill patients and find the Reliability Sensitivity andAccuracy of point of care glucometer in MICU.

AuthorsManish Chandra Prabhakar a

SP Kalantri b

a Student II MBBS| Mahatma Gandhi Institute ofMedical Sciences, Sevagram | Maharashtra

b Professor of Medicine | Mahatma Gandhi Institute ofMedical Sciences, Sevagram | Maharashtra

Correspondent Author: prabhakar4u07@gmail.com

BACKGROUND: Healthcare professionals routinely measureblood glucose measurement of all critically ill patients inintensive care unit. The traditional reference standard,venous blood glucose requires a venepuncture andlaboratories usually return the test results after 60 minutes.We wondered if a point of care capillary glucose measuredby glucometer could be as accurate and reliable as bloodvenous glucose.

METHODS: I studied consecutive patients admitted to anintensive care unit between 1 May and 10 May 2009. Icompared the diagnostic accuracy of two- point of careglucometers with laboratory venous glucose, the referencestandard. I used Bland- Altman plots and Clark error gridmethod to analyse the results.

RESULTS: I studied a total of 110 patients (38[34%] women;mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteenpatients (12%) were known to have diabetes. The meanglucose value (glucometer 1) was 152.9 mg/dL (SD 83.1);range= 48 to 501 mg/dL; that by glucometer 2 was 152.2mg/dL (SD 76.2); range= 30 to 458 mg/dL and by thelaboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480mg/dL. Of the 110 subjects, 2(2%) had blood glucose below70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)had blood glucose exceeding 180 mg/dL. The Bland- Altmanplot showed a bias of 4 mg% (95% confidence intervals, -9.8 to +1.1); and the limits of agreement were -63 and +54mg%. The area under the receiver operating characteristiccurve for the two glucometers was 0.92 and 0.93respectively. The error grid analysis showed that 80% (78/110) samples lay within zone A, 22(110) in zone B and 1%(1/110) in zone C.

CONCLUSIONS: Point of care glucose, measured byglucometers was in agreement with the venous glucoseestimation. Both glucometers were equally accurate andperformed uniformly well across the wide range of bloodglucose values.

KEY WORD: Capillary blood glucose, Venous blood glucose,Point of Care, Glucometer

GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS

Manusri Naredla, Keerthi Maddi.St.Peter’s institute of Pharmaceutical sciences,

vidyanagar, Hanamkonda

Users of clinical practice guidelines and otherrecommendations need to know how much confidence theycan place in the recommendations. Systematic and explicitmethods of making judgments can reduce errors andimprove clinical trials. Large scale healthcare interventionsare likely to improve the health of the public only if theevidence clearly shows that the benefits outweigh harmsand costs. Often, however, the evidence if is the other way

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the trials may fail to improve health, or may even causeharm, while costing dearly. Moreover, when a large scaleintervention is implemented careful evaluation of theevidence must and should replace wishful thinking andguesswork or else the trials may prove to be enduring butpossibly result in harmful standard of care. Suchinterventions should be implemented, therefore, only whenthe evidence shows that expected benefits outweigh harmsand costs and this can be achieved by the implementationof systematic evaluation.

Obtaining definitive evidence on the effects of large scaleinterventions can be difficult and implementation withcareful monitoring is justified but how ever acting withoutproof of net benefit is both costly and potentially damagingto health. Graded evidence follows a hierarchy of evidenceconsistent with randomized trials of high methodologicalquality, followed by randomized trials with methodologicallimitations, observational studies, and unsystematicclinical observations. Inferences are stronger when theevidence is summarized in systematic ways of representingthe evidence for better interpretation of the clinical as wellas observational trials.

EVIDENCE FOR BETTER HEALTHSURVEILLANCE ON HOSPITAL ACQUIRED INFECTIONS IN A

TERTIARY CARE SET UP

Mrs. Meenakshi Sekar,M.Sc NAssociate Professor, College of Nursing, CMC Vellore

Former Infection Control Nurse Supervisor, CMC, Vellore

Dr. Karen Jacob, D.A.P.G. Registrar, Department of Anesthesia, CMC Vellore

Former Hospital Infection Control Officer, CMC, Vellore

BACKGROUND:This surveillance of Hospital AcquiredInfections (HAI) was conducted among the inpatients ofChristian Medical College; Vellore which is a 2,572 beddedHospital located in Southern India. Surveillance of HAI inany health care facility is an important aspect of InfectionControl. The early recognition of HAI through asurveillance system is the first step to control HAIs. Thisenhances 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). Substantialmorbidity, 2) prolonged hospital stay, 3) increased indirectpatient care cost and 4) mortality. They continue to affectabout five percent of hospitalized patients. (Roy, 2004)

Steed,C,J(1999) strongly states that there is evidence thatactive hospital infection control programmes lead toreduced infection and better patient care. Wiseman, S.(2004).emphasizes that Routine surveillance can reduce

infection in the hospital by one third and improve themorbidity and mortality figures of the hospital.

AIM AND CONTENT: The aim was to assess the incidence ofHAI among the inpatients of Christian Medical College;Vellore. The surveillance was conducted in the 63-inpatientareas of the Hospital. This included the wards; the ICUs(Medical ICU, Surgical ICU, Neurosurgical ICU, Cardiothoracic ICU, Pediatric ICU& Neonatal ICU) and other Highrisk areas (Renal transplant Unit, Burns Unit and BoneMarrow Transplant Unit).

METHODOLOGY: The Surveillance included all patientsadmitted in the hospital for a period of one year (March2005 to February 2006). All Patients who developed feverafter 48 hours of hospitalization were included in the groupof “Probable HAI”. HAI was ruled out in patients whopresented with fever at the time of admission or whodeveloped fever with in 48 Hours of Hospitalization.

The Infection Control Nurse (ICN) visited all the patientsadmitted in the 63 areas of the hospital weekly twice. Ineach ward/ICU, the ICN notes down the total number ofpatients admitted and the number of patients with fever.All patients with fever are then investigated to determineif the fever originated 48 hours after hospitalization.Following the CDC guidelines these patients were tentativelydesignated as a case of HAI. The appropriatemicrobiological investigations sent for each patient wasfollowed up to confirm the presence of HAI.

Following the CDC guidelines, the incidence of HAI wascalculated using the formula given below:

Infection Rate = Number of HAI per month x 100

Number of discharges per month

RESULTS: The following table gives the incidence of HAI permonth.

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HAI and Infection Rate in CMC, Vellore (May 2005 to April2006)

MONTH DISCHARGES HAI INFECTIONRATE

March 2005 5588 14 0.25 %

April 2005 5245 23 0.44 %

May 2005 5558 22 0.44 %

June 2005 5415 18 0.33 %

July 2005 5645 18 0.32 %

Aug 2005 5852 21 0.36 %

Sept 2005 5249 20 0.38 %

Oct 2005 5249 31 0.59 %

Nov 2005 6013 34 0.57 %

Dec 2005 5760 39 0.68 %

Jan 2006 5307 53 0.99 %

Feb 2006 5147 58 1.10 %

There has been a slight increase in the Infection Rates overthe last six months. This is due to the fact that the criteriafor including patients was slightly revised. Patients whowere admitted with fever were also kept under constantobservation and any worsening of the fever or reappearanceof fever after becoming afebrile was included in hesurveillance.

CONCLUSION: The incidence of HAI for a period of one yearwas found to be less than 1.1%. Low incidence of HAI isevidence that Quality Care is being provided for the patients.Regular surveillance for HAI contributes significantly toensure quality patient care especially in tertiary carehospitals where many invasive procedures are carriedout. Abiding to the Hospital’s Infection Control Policies helpto reduce the risk of patients acquiring HAI.

REFERENCES: Roy,V.(2004). Clamp down on increasednosocomial infections ways to arrest the high level ofnosocomial infections in hospital Express Health CareManagement. Issue dtd. 16th to 30th Retrived from http://www.expresshealthcaremgmt.com/20040430/edit02.shtmon Dec 2005.

Steed,C,J.(1999). Common Infections Acquired in theHospitals. The Nursing Clinics of North America ContemporaryInfection Control For Nurses, 34,(2),pp 443- 460.

Wiseman, S. (2004). Implementing effective InfectionControl in the Hospital Environment. Nursing Times, 100,(38),pp 41-61.

Unequal Randomisation in Cancer Trials – A NewParadigm!

AUTHORS: Meghana Surlikar , Sadhana Kannan andVikram Gota.

INSTITUTION: Advanced Centre for Treatment Research andEducation in Cancer (ACTREC), Tata Memorial Centre, Sector-22, Kharghar, Navi Mumbai

BACKGROUND: Randomised Controlled Trial (RCT) withbalanced allocation of participants to the experimental andcontrol arms is a commonly practiced study design. Thedesign is simplistic and therefore very appealing. However,circumstances warrant unequal allocation of subjects tothe different arms of the study. This systematic reviewfocuses on the trends in unequal randomization (UR) incancer clinical trials and the most common reasons forresorting to this approach.

AIM: A systematic review to identify reasons for UR inoncology clinical trials published in five major cancerjournals over the last ten years.

Methods: A PUBMED search was undertaken to identify RCTsin cancer published from January 1999 to December 2008in five major cancer journals namely JCO, Annals ofOncology, BJC, Lancet Oncology and JNCI. Forty three RCTsthat reported UR of subjects to different arms were selected.Data was extracted for randomization ratio, reason for UR,phase of the trial and trial location (Single or multicentre).If the rationale for UR was not mentioned in the article, thecorresponding author was e-mailed to obtain the reason.

RESULTS: 1863 RCTs were identified. UR was employed in 43studies (2.3%). The number of studies increased over theyears (0 in 1999 to 9 in 2006). Only 13/43 gave clear reasonsfor adopting UR. Seven out of the remaining 30 authorsresponded to an email request. The reason is not clear inthe remaining 23 reports. 29/43 trials used 2:1 ratiofollowed by 2:1:1 ratio used in 11 % of the studies. Thereasons for UR in the 20 available reports are (a) to meetstatistical endpoint – 7 (b) to facilitate faster recruitment–4 (c) to get more data on new intervention – 4 (d) ethics andsafety reasons – 2 (e) Others – 3. Fourteen were single centrestudies and 29 were multicentre. In 27 reports where phaseof the study was mentioned, there were 12 phase II, 14 phaseIII and one phase IV trial.

CONCLUSION: UR appears to be an attractive alternative tobalanced allocation especially in small randomized phaseII trials. Statistical considerations and faster recruitmentare important reasons for resorting to UR.

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Aromatase inhibitors in clomiphene resistant women:A randomized double blind placebo controlled trial.

Mohan S Kamath, Aleyamma T.K, Achamma Chandy, andKorula George1

Reproductive Medicine Unit, Department of Obstetrics &Gynecology, Christian Medical College, Vellore ,Tamil Nadu,India - 632004.

BACKGROUND: Twenty five percent of anovulatory womenwith polycystic ovarian syndrome do not respond tostandard clomiphene citrate therapy and are known asclomiphene resistant. We investigated the use of letrozole,an aromatase inhibitor as an alternative ovulation inducingagent in these women.

METHODS: 36 women with clomiphene resistance wererandomized into two groups: one receiving letrozole 2.5mgdaily from day 2 to day 6 of the cycle while the other anidentical placebo. The primary outcome was the ovulationrate with analysis being intention-to-treat.

RESULTS: The ovulation rate was significantly higher in theletrozole group 6/18 (33.33%) as compared to none in theplacebo group (P= 0.015). The mean day 21 serumprogesterone was also significantly higher in the letrozolegroup (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014).One women in the letrozole group conceived and deliverednormally giving a clinical pregnancy and live birth rate of5.5%

CONCLUSION: In clomiphene resistant women, letrozole canbe used as an effective and simple alternative ovulationinducing agent. The trial is registered with clinical trialregistry of India (UTRN -017753618-3112200762223).

Clinical Trials Methods

Nailesh.T SLIMS, Villianur, Pondy605502 Email:Nailesh.reddy@gmail.com

BACKGROUND: After completing the preclinical testing of thedrug in animals, the company files an investigational newdrug (IND) application with the regulatory authority forpermission to test the drug in humans.

AIMS: To collect the safety and efficacy data for new drugs ordevices.

METHODS: Depending on the type of product and the stageof development, investigators enroll healthy volunteers and/or patients into small pilot studies followed by larger scalestudies in patients that often compare the new product withthe currently prescribed treatment. As positive safety andefficacy data are gathered, the number of patients is typicallyincreased. Clinical trials can vary in size from a single center in

one country to multicenter trials in multiple countries, trialsare conducted in 5 Phases

RESULTS: Phase 0 trials is a recent designation known ashuman micro dosing studies has no data on safety or efficacyof drug. Phase 1 trials Examines the pharmacologic actionsand safe dosage range of a drug; how it is absorbed,distributed, metabolized, and excreted; and its duration ofaction. Phase 2 trials are controlled studies in volunteers toassess the effectiveness and safety of a drug. Phase 3 trialsare testing using a greater number of volunteer patients. Thedrug is administered by practicing physicians to those sufferingfrom the condition the drug is intended to treat. These studiesmust confirm earlier efficacy studies and determine low-incidence adverse reactions. Phase 4 trials are studiesconducted after FDA approval, during general use of the drugby medical practitioners, also referred to as post marketingstudies. Fast-track approval is provided for drugs that meetunmet medical needs for patients with serious or life-threatening conditions. Labeling is information distributedabout a drug by the manufacturer, even if it is not physicallyaffixed to the product. Misbranding is “false or misleading inany particular” renders the product misbranded, making itsubject to FDA regulatory action.

Conclusion: These trials provide the tolerability,Pharmacovigilance, Pharmacokinetic, andPharmacodynamics of the drug.

Access to evidence from countries in South Asia: TheSouth Asian Database of Controlled Clinical Trials and the

South Asian Cochrane Network and Centre’s DigitalLibrary – An Update

Jabez Paul Barnabas E, Prathap Tharyan, VenkateshParthasarathy

Prof BV Moses & Indian Council of Medical Research Centrefor Advanced Research and Training in Evidence InformedHealthcare, South Asian Cochrane Centre, Christian MedicalCollege, Vellore, India

BACKGROUND: Many trials conducted in middle and lowincome countries are published in journals that are notindexed in commonly searched databases. Their exclusionfrom systematic reviews could bias conclusions, renderingthem unreliable and potentially irrelevant to health care inthese countries.

OBJECTIVES: To describe the development of the South AsianDatabase of Controlled Clinical Trials (www.cochrane-sadcct.org) and the South Asian Cochrane Network &Center’s Digital Library that aim to: provide a comprehensivesource in the public domain of all controlled clinicalinterventional trials involving humans conducted in theSouth Asian region, and published in regional journals,and contribute information about these trials to the

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Cochrane Central Register of Controlled Clinical Trials(CENTRAL) in The Cochrane Library.

METHODS: Health Science Journals published fromAfghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,Pakistan and Sri Lanka and reporting interventional trialsin humans conducted in these countries were sought frommultiple electronic and other sources and 168 journals wereidentified. Online and print issues of these journals aresearched in regular cycles. Citations and abstracts of allinterventional trials identified from online editions andhand-searching of print editions are entered into Endnote.Trials are coded as RCTs or CCTs using standard criteriaand cleaned records imported to MeerKat, with web-linksprovided to the original article, where possible. Full textarticles are indexed and stored using the Greenstone DigitalLibrary Software to create the South Asian Cochrane Network& Center’s Digital Library that can be retrieved by Titles,Author, Year, Journal and Keywords. All records are regularlytransmitted for inclusion in the Cochrane Central Registerof Controlled Clinical Trials (CENTRAL) in The CochraneLibrary.

RESULTS: The South Asian Database of Controlled ClinicalTrials, initiated in November, 2008, was launched on January1, 2009 (www.cochrne-sadcct.org) and is searchable freeof charge. It currently contains the citations, abstracts andweb-links (where possible) to 2830 records [(CCT-1350(47%); RCT-1477 (53%)] published in 65 Indian medicaljournals, and 76 Pakistan Medical Journals. Fromsubmitted records, the citations and web-links (whereavailable) to 1859 trials conducted in these South Asiancountries are now included in the Cochrane Central Registerof Controlled Trials (CENTRAL). Full text articles, indownloaded or scanned portable document format (pdf),are stored for most trials in the South Asian CochraneNetwork & Center’s Digital Library. In the ongoing secondphase, all 168 South Asian Journals (of which 101 (60%)are not indexed in Medline) and newer journals identifiedby ongoing searches will contribute trials, supplementedby searches of conference abstracts, dissertations and othersources.

CONCLUSIONS: The Cochrane Collaboration now has aresource to access all the evidence generated frominterventional trials conducted in countries in the SouthAsian Region. Many of these, hitherto unidentified, trialscan now be considered for inclusion in systematic reviewsof the effects of interventions in healthcare conditionsrelevant to people in the region; these systematic reviewshave the potential to be of greater relevance in informinghealthcare and health-policy in these countries than beforethe creation of this resource.

When ‘Evidence’ goes against the grain:Quetiapine for Bipolar depression

S. Mohan Raj,Consultant Psychiatrist, Chennai

BACKGROUND: Quetiapine is an antipsychotic medication.In the last 3 years, there are attempts to promote Quetiapineas being efficacious in Bipolar depression. Trials haveclaimed efficacy and FDA has approved the use of Quetiapinefor Bipolar depression.

But, clinicians do not find Quetiapine to be effective inBipolar depression.

AIM: To analyse the possible reasons for this disparitybetween trial results and actual clinical practice.

METHODS: Evaluation of the BOLDER II study1 (study titled‘Efficacy of Quetiapine Monotherapy in Bipolar I and IIDepression’), using the Risk of bias table of Revman 5.

RESULTS:

The biases noticed were

1) Selection bias

Exclusion criteria mention

1.1 Current episode duration more than 12 months andless than 4 weeks

(Comment: spontaneous remission is possiblearound 6 months)

1.2 History of non-response to an adequate trial (6weeks) of more than 2 classes of antidepressants(Comment: Resistant depression is excluded)

1.3 Current serious suicidal or homicidal risk as judgedby the investigator

(Comment: Severe depression is excluded)

2) Incomplete outcome data were not adequatelyaddressed.

The other problems were

1) Definition of response as > or = to 50% reductionfrom baseline score of Montgomery AsbergDepression Rating Scale (MADRS)2

2) There are 3 items on MADRS scale (decreased sleep,decreased appetite and inner tension) in whichQuetiapine can bring about 100% reduction insymptoms irrespective of its antidepressant effects.

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Another area of concern is that all the studies regardingQuetiapine in bipolar depression were prepared with‘editorial assistance’ from a medical communicationcompany called PAREXEL MMS), irrespective of the authors’institution. PAREXEL’s website3 offers to write up a scientificpaper and boast of a 92% first time journal acceptance ratein 2008.

Conclusion:

Mechanism need to be evolved to restrict approval of drugsby regulatory bodies for indications for which no effect isseen in clinical practice.

References:

1. Michael E Thase et al. Efficacy of QuetiapineMonotherapy in Bipolar I and II Depression. Adouble-blind, placebo controlled study (The BOLDERII study) J Clin Psychopharmacol 2006;26:600-609.

2. Montgomery SA and Asberg M. A new depressionscale designed to be sensitive to change. Br JPsychiatry 1979;134:382-389.

3. Parexel MedCom. http://www.parexelmms.com/

EVIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP ina medical college hospital

AUTHORS:John K R,Rakesh P S

AUTHORS AFFILIATION

1. Professor in charge of RNTCP$Head of theDepartment,Department of Community Health,CMCVellore

2 Post graduate registrar,department of CommunityHealth,CMC Vellore

CORRESPONDING AUTHOR:John K R,Professor,Departmentof Community Health,CMC,VELLOREEmail:mony@cmcvellore.ac.inPh:09443242603

BACKGROUND: The Revised National Tuberculosis ControlProgramme(RNTCP) based on Directly Observed TreatmentShort course(DOTS) strategy was launched in India as anational programme in 1997.As private sector is the firstpoint of contact for more than fifty percent TBpatients,RNTCP has collaborated with a wide range ofhealth care providers which establishes a unique model ofpublic private mix in RNTCP.

As medical colleges treat a significant number of patientswith TB and also provide care to seriously ill andcomplicated TB cases,efforts have been made to includemedical colleges into the purview of RNTCP.

The Christian Medical College,Vellore ,joined hands withRNTCP in the year 2002.

OBJECTIVES: To study the epidemiological trend oftuberculosis among patients registered in DOTS clinic,Christian Medical College,Vellore between 2002 to 2008.

METHODOLOGY: The existing quarterly RNTCP reports ofCMC DOTS Clinic from 2002 to 2008 were consolidated. Thedata was entered in Microsoft Excel and analysed.

RESULTS and CONCLUSION:The proportion of chestsymptomatics referred for sputum examination fromvarious departments in CMC were between 3 to 4% .This isabove the suggested target of at least 2%.

The sputum positivity rate is between 6.7 to 8% which liesbetween the recommended 5-15%.

Among the cases 33% were sputum positive,14% sputumnegative pulmonary and 53% were extra pulmonarytuberculosis. The maximum proportion of extrapulmonaryTB as per RNTCP guidelines is 50%.

88% of all the cases were transferred out, 35.1% of alltransfers were to ‘out of the state’, among which 43.4%were referred to northern states. Among those referred, 27%were sputum positive and 58% were extra pulmonary TB.

Among those who received care from CMC unit, sputumconversion rates were consistently above 90% except foryear 2003 when it was 86.9%.Cure rate was above 80%consistently.

The CMC data shows that most of the recommendationslaid down by RNTCP guidelines are achieved and it isfunctioning as per the guidelines of RNTCP.

Evidence Based Policy for Isoniazid Prophylaxis Therapy inHealth care workers

Authors:

Dr. Sangeeta Das Bhattacharya, Assistant Professor, Schoolof Medical Science and Technology, IIT Kharagpur.

Lt Col (Dr) Rishi Raj, School of Medical Science and Technology,IIT Kharagpur.

Dr. Hari Prasad, School of Medical Science and Technology, IITKharagpur.

Dr. T.Shyam, School of Medical Science and Technology, IITKharagpur.

Dr. Bikas K Arya, School of Medical Science and Technology,IIT Kharagpur.

BACKGROUND: India accounts for nearly one-fifth of globalburden of tuberculosis. Every year, approximately 2 million

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persons develop tuberculosis of which about 0.87 millionare new smear positive highly infectious cases and about3.3 lakh die of TB every year. There are approximately 2.5million health care workers in India (NHP 2007) providinghealth services to the population. They are not only exposedto a high number of active TB cases but also they areconstantly exposed to a high number of debilitated patientsthroughout their professional work.

AIM: To frame a policy regarding Isoniazid prophylactictherapy for health care workers in India.

METHODS: An evidence based search is conducted to findeffectiveness of INH prophylaxis in Health care workers inIndia. Search was conducted in electronic medical resourcesto find the related studies performing Meta analysis andrandomized control trials comparing Isoniazid andplacebo/other anti tubercular drugs in different populationgroups. Appropriate statistical methodology was adoptedto analyze the results and formulate the policy. The Criteriafor evaluation were Numbers needed to be treated to preventone active case of TB/ One death, number needed to harm(Hepatitis), adherence and compliance, ease ofimplementation, cost benefits analysis.

RESULTS: The best suited evidence suggesting the prevalenceof LTBI in health care workers in India is by M. Pai et al(JAMA 2005) indicating a prevalence of 40% in the healthcare workers in India. The Prevalence of Latent TB isdramatically increases from 25% for persons who have servedless than 5 years in health care profession to 62% for personsserving for 6 to 10 years and 71% for persons serving morethan 10 years. The numbers needed to treat to prevent onecase of TB in general population is 35 (Smeija et al 2004)

CONCLUSION: In India as per RNTCP recommendations noguidelines are available for prevention of TB in healthcareworkers. India’s RNTCP is the largest DOTS program in theworld. It is of paramount importance that they are given thebest possible protection from occupational health hazardsincluding TB. So we recommend incorporation of Isoniazidprophylaxis therapy among health care workers in India ifthey are found to be a case of LTBI. The therapy should bewith 300 mg Isoniazid daily for six months. The maximumeffect of Isoniazid prophylaxis is shown to be for 3 years(Debre), so it is recommended that every healthcare workershould be examined while joining health care services andthen should be reviewed every three years.

Evidence Based Surgery: knowledge, attitudes, andperceived barriers among surgical trainees

Rohin Mittal, Benjamin PerakathChristian Medical College, Vellore

BACKGROUND: Evidence Based Surgery (EBS) has been shownto improve efficiency and outcomes. It is, however, not

practiced universally among surgeons. Wider use of EBSrequires an understanding of EBS, a positive attitude, aswell as removal of perceived barriers to its practice.

AIMS: The aim of this study was to assess the knowledgeand attitude of surgical trainees towards EBS and theirperceived barriers to its practice.

METHODS: The McColl questionnaire and the BARRIERS scalewere modified and incorporated into a single questionnaire.Surgical trainees attending a Continuing Surgical Educationmeeting at the author’s institution were asked to voluntarilyfill in this questionnaire.

RESULTS: A total of 93 out of 110 (84.5%) trainees returnedthe filled in questionnaire. Attitudes towards EBS werewelcoming, although colleagues were considered lesswelcoming than self. There was high level of agreement withusefulness of EBS in everyday practice and EBS improvingpatient care. About 50 % of actual practice was consideredto be evidence based. 12.6 % (11/87) participants hadreceived formal training in EBM. 64.3 % (54/84) were awareof the Cochrane database of systemic reviews but only 35.7%(30/84) read it regularly. 67.8 % (61/90) used protocols andguidelines developed by colleagues to practice EBS. However,61.5 % (56/91) were interested in learning the skills of EBS.The terms absolute risk, relative risk and clinicaleffectiveness were understood by > 80 % of respondents,while publication bias, confidence interval andheterogeneity were poorly understood. The major perceivedbarriers to practice of EBS were inability to understandstatistical analysis, inadequate facilities forimplementation, lack of a single compiled source ofliterature, relevant literature not being readily availableand insufficient time on the job.

CONCLUSIONS: Surgical trainees have a positive attitudetowards EBS, and have some familiarity with the commonterms used in EBS. There is a need to increase awareness of,and provide access to available sources of medicalliterature. Formal training in EBS, as well as basic statisticalanalysis should form a part of the surgical curriculum tofoster an environment favorable to the practice of EBS.

CAN CLINICIANS ACTUALLY PRACTICE EBM?

Authors:Sanchaya Selvaraj*, Balaji D*, Nagamani*, Surapaneni

Krishna Mohan**

Affiliation:*II MBBS Student, Saveetha Medical College & Hospital,

Saveetha University, Saveetha Nagar, Thandalam,CHENNAI – 602 105, T.N, INDIA.

**Assistant Professor, Department of Biochemistry,Saveetha Medical College & Hospital, Saveetha University,Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.

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BACKGROUND: The term “Evidence Based Medicine” (EBM)was first used in the early 1990s to describe a frameworkfor integrating clinical epidemiology with routine clinicaldecision making. It was initially described as an“enlightened scepticism towards the application ofdiagnostic, therapeutic and prognostic technologies in theday-to-day management of patients’.

AIM: To conduct a literature survey to find out whether theclinicians actually practice EBM and to know the impact ofEBM in our country.

METHODS: Our survey mainly focuses on 3 researchquestions: First of all, do full-time clinicians really recognizeworking in these modes? Second, even if they recognize thesemodes, can they actually get at the evidence quickly enoughto consider it on a busy clinical service? Third, even if theycan get at it, can clinicians actually provide evidence-basedcare to their patients?

RESULTS: First of all, do full-time clinicians really recognizeworking in these modes? It appears so. In a survey of UKGPs, majority reported practicing at least part of their timein the “searching” mode, 72% using evidence- basedsummaries generated by others and 84% using evidence-based practice guidelines or protocols. Far fewer claimedto understand the “appraising” tools of NNTs (35%) andconfidence intervals (20%). Only 5% believed that “learningthe skills of evidence-based medicine” (all five steps) wasthe most appropriate method for “moving from opinion-based medicine to evidence-based medicine”.

Second, even if they recognize these modes, can they actuallyget at the evidence quickly enough to consider it on a busyclinical service? Again, it appears so, but examples are few.When a busy in-patient medical service brought electronicsummaries of evidence previously appraised either by teammembers (“CATs”) or by the summary journals to workingrounds, it was documented that, on average, the formercould be accessed in 10 seconds and the latter in 25seconds. When assessed from the view of the junior memberof the team caring for the patient, this evidence changed25% of their diagnostic and treatment suggestions andadded to a further 23% of them.

Third, even if they can get at it, can clinicians actuallyprovide evidence-based care to their patients? Again, itappears so from audits carried out on clinical servicesthat attempt to operate in the searching and appraisingmodes. It is documented that 82% of them were evidence-based. Out of which 53% based on systematic reviews ofrandomized trials and 29% based on convincing non-experimental evidence.

CONCLUSIONS: Similar results have been obtained fromaudits of psychiatric, surgical, pediatric and generalpractice. But in our setup usually, about developing countrythis trend is taking a snail pace.

Key Methodological Issues in Randomised ControlledStudies and Observational Studies

Santosh Philip Mathew1 MBBS student, Sonia MaryPhilip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,

MRCP, FRCR

1 Presenting Author: MBBS Student, MOSC MedicalCollege, Kolenchery, Ernakulam, Kerala- 682311

2 Queen Mary , University of London, School of Medicineand Dentistry, Mile End Road, London, UK - E1 4NS

3 Consultant Radiologist, Dorset County Hospital NHSFoundation Trust, Dorset County Hospital, WilliamsAvenue, Dorchester, UK - DT1 2JY

Presenting author email: santoshphilip@gmail.com ;Contact number: 9496334595

BACKGROUND: Analytical studies are broadly categorisedinto experimental studies including randomised controlledstudies (RCTs) and non-experimental studies which includeobservational studies (OSs). Many consider RCTs asproviding better evidence than OSs, but are not alwayspossible, appropriate or ethical to conduct.

AIMS: To identify key methodological issues relevant to RCTsand OSs.

METHODS: Multiple articles were referred to from peerreviewed journals as well as our own experience indesigning our poster with illustrations.

RESULTS: We will elucidate the advantages of RCTs includingits efficiency in postulating and testing clinical hypothesis,use of analysis based on statistical theory, allocationconcealment and patient and assessor blinding therebyreducing bias. The disadvantages of RCTs include its cost,difficulty in organising, obtaining informed consent andethical approval made difficult by the nature of the studyand also failure to report negative results.

We will also review the advantages of OSs including its lowcost, easy access to ethical approval, informed consentwhich is frequently unnecessary, use of statistical methodslike propensity and multivariate analysis with tests forinteraction. It also benefits from retrieving data from largenumber of patient groups in a short amount of time fromdatabases. One of the main disadvantages include bias fromunknown confounders as well as treatment allocation biaswhich can be offset to an extent by the use of propensityanalysis.

While RCTs have pride of place in studies of efficacy, OSshave been limited to safety or adverse events data analysis.

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CONCLUSIONS: After reading this poster, one should be ableto identify the key methodological issues involved inanalytical studies. Although some would consider RCTs asthe ‘gold standard’ in analytical studies, it is important tounderstand that there is no perfect methodology to answerclinical questions. Clinicians will need to take account ofthe published data, decide which of the studies are bestdesigned to answer their questions and also consider thegeneralisability and reproducibility of the intervention andcome to a conclusion based not only on the publishedevidence but also rely on their medical experience andjudgement.

Modafinil for clozapine induced adverse effects in peoplewith schizophrenia and schizoaffective disorder in

remission: a randomized, placebo-controlled trial stoppedearly for harms.

Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, CliveAdams4

BACKGROUND: Hyper-salivation, sedation and weight gainare common troublesome effects of Clozapine.

OBJECTIVES: To evaluate the efficacy and safety of modafinilin clozapine-induced drowsiness, hyper-salivation, weightgain, mental state, and global functioning.

METHODS: Design: Randomized, parallel-group, single-centre, participant, investigator, observer and data-entry-blinded trial conducted between October 2007 and October2008. Offsite computer-generated, variable-block-sizerandomization and pharmacist-dispensed, pre-packed,serially numbered, containers ensured allocationconcealment.

Participants: Consenting adults with a diagnosis ofschizophrenia or schizoaffective disorder (DSM IV) inremission, with troublesome drowsiness or hyper-salivation, with/without weight gain, without unstablemedical conditions, and on stable doses of clozapine for atleast 4 weeks.

Intervention and comparator: Modafinil 100mg/day for firstweek and 200mg/day for 8 weeks or identical placebo oncedaily for 9 weeks.

Estimated Sample size: 35 in each arm (80% power; 5% alphaerror)

Outcomes: Primary: Proportion without daytime sleepinessand hyper-salivation, scores on Epworth Sleepiness Scale(ESS) and Nocturnal Hyper-salivation rating scale (NHRS).Secondary: change in weight, pulse rate, systolic anddiastolic blood pressures; scores on Positive and NegativeSymptom Scale (PANSS); Clinical Global Impression (CGI)for alertness, hyper-salivation and overall improvement;Indian Disability Evaluation Assessment Scale (IDEAS) and

adverse events check list. Assessment: End of weeks 1, 5 and9. Analysis; by intention to treat.

RESULTS: A pre-planned interim analysis (if more than 5%developed adverse events necessitating discontinuation)was done after 34 people (Modafinil 16, placebo 18) wererandomized, because of marked worsening of psychosis inone and anxiety symptoms in one (both on Modafinil). Oneperson on placebo discontinued treatment due to lack ofimprovement. Groups did not differ on the baselinevariables. Modafinil significantly reduced hyper-salivationat 1 week compared to placebo (7/16 (44%) vs. 0/18; OR 1.8,95% CI 1.2 to 2.7; P= 0.002) and non-significantly by week 9(9/16 (56%) vs. 7/18 (44%); OR 2.6, 95% CI 0.6 to 10.8; P=0.7). Modafinil did not differ from placebo on the NHRS orESS scores but significantly reduced duration of sleep byweek 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05).No significant differences were noted in PANNS or IDEASscores, CGI overall improvement, weight, pulse rate, bloodpressure or other adverse effects in both groups.

CONCLUSION: This trial was stopped early due to pre-determined stopping rules and was insufficiently poweredto draw firm conclusions. Modafinil may have the potentialto significantly improve hyper-salivation and drowsinessdue to Clozapine. Further trials, particularly at lower does,may be warranted, but any potential benefits must beweighed against the risk of worsening of psychosis or anxietyand the cost of Modafinil.

TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI)identification number: CTRI/2007/091/000020, 04-10-2007

Funding: Fluid Research Fund of CMC Vellore; Modafiniland placebo supplied by Sun Pharmaceuticals (who had noother role in the study)

AUTHOR AFFILIATIONS:

1Dr. Sebind Kumar: Former Tutor in Psychiatry,Department of Psychiatry, Christian Medical College,Vellore 632002, Tamil Nadu; email: sebind@gmail.com

2Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV MosesCentre for Clinical Trials and Evidence Based Medicine,Christian Medical College, Vellore 632002, Tamil Nadu.

3Dr. Naveen Thomas, Assistant Professor in Psychiatry,Christian Medical College, Vellore 632002, Tamil Nadu.

4Dr. Clive Adams, Professor of Psychiatry and Chair ofMental Health Services Research, Division of Psychiatry,University of Nottingham, Nottingham, NG7 2TU, UK.

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Bedside Capillary blood glucose measurement byglucometers compared to venous blood glucose in

critically ill patients and find the Reliability Sensitivity andAccuracy of point of care glucometer in MICU.

AuthorsManish Chandra Prabhakar a

SP Kalantri b

a Student II MBBS| Mahatma Gandhi Institute of MedicalSciences, Sevagram | Maharashtra

b Professor of Medicine | Mahatma Gandhi Institute ofMedical Sciences, Sevagram | Maharashtra

Correspondent Author: prabhakar4u07@gmail.com

BACKGROUND: Healthcare professionals routinely measureblood glucose measurement of all critically ill patients inintensive care unit. The traditional reference standard,venous blood glucose requires a venepuncture andlaboratories usually return the test results after 60 minutes.We wondered if a point of care capillary glucose measuredby glucometer could be as accurate and reliable as bloodvenous glucose.

METHODS: I studied consecutive patients admitted to anintensive care unit between 1 May and 10 May 2009. Icompared the diagnostic accuracy of two- point of careglucometers with laboratory venous glucose, the referencestandard. I used Bland- Altman plots and Clark error gridmethod to analyse the results.

RESULTS: I studied a total of 110 patients (38[34%] women;mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteenpatients (12%) were known to have diabetes. The meanglucose value (glucometer 1) was 152.9 mg/dL (SD 83.1);range= 48 to 501 mg/dL; that by glucometer 2 was 152.2mg/dL (SD 76.2); range= 30 to 458 mg/dL and by thelaboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480mg/dL. Of the 110 subjects, 2(2%) had blood glucose below70 mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)had blood glucose exceeding 180 mg/dL. The Bland- Altmanplot showed a bias of 4 mg% (95% confidence intervals, -9.8 to +1.1); and the limits of agreement were -63 and +54mg%. The area under the receiver operating characteristiccurve for the two glucometers was 0.92 and 0.93respectively. The error grid analysis showed that 80% (78/110) samples lay within zone A, 22(110) in zone B and 1%(1/110) in zone C.

CONCLUSIONS: Point of care glucose, measured byglucometers was in agreement with the venous glucoseestimation. Both glucometers were equally accurate andperformed uniformly well across the wide range of bloodglucose values.

KEY WORD: Capillary blood glucose, Venous blood glucose,Point of Care, Glucometer

GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS

Manusri Naredla, Keerthi Maddi.St.Peter’s institute of Pharmaceutical sciences,

vidyanagar, Hanamkonda

Users of clinical practice guidelines and otherrecommendations need to know how much confidence theycan place in the recommendations. Systematic and explicitmethods of making judgments can reduce errors andimprove clinical trials. Large scale healthcare interventionsare likely to improve the health of the public only if theevidence clearly shows that the benefits outweigh harmsand costs. Often, however, the evidence if is the other waythe trials may fail to improve health, or may even causeharm, while costing dearly. Moreover, when a large scaleintervention is implemented careful evaluation of theevidence must and should replace wishful thinking andguesswork or else the trials may prove to be enduring butpossibly result in harmful standard of care. Suchinterventions should be implemented, therefore, only whenthe evidence shows that expected benefits outweigh harmsand costs and this can be achieved by the implementationof systematic evaluation.

Obtaining definitive evidence on the effects of large scaleinterventions can be difficult and implementation withcareful monitoring is justified but how ever acting withoutproof of net benefit is both costly and potentially damagingto health. Graded evidence follows a hierarchy of evidenceconsistent with randomized trials of high methodologicalquality, followed by randomized trials with methodologicallimitations, observational studies, and unsystematicclinical observations. Inferences are stronger when theevidence is summarized in systematic ways of representingthe evidence for better interpretation of the clinical as wellas observational trials.

Unequal Randomisation in Cancer Trials – A NewParadigm!

AUTHORS: Meghana Surlikar , Sadhana Kannan andVikram Gota.

INSTITUTION: Advanced Centre for Treatment Research andEducation in Cancer (ACTREC), Tata Memorial Centre, Sector-22, Kharghar, Navi Mumbai

Background: Randomised Controlled Trial (RCT) withbalanced allocation of participants to the experimental andcontrol arms is a commonly practiced study design. Thedesign is simplistic and therefore very appealing. However,circumstances warrant unequal allocation of subjects tothe different arms of the study. This systematic reviewfocuses on the trends in unequal randomization (UR) in

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cancer clinical trials and the most common reasons forresorting to this approach.

AIM: A systematic review to identify reasons for UR inoncology clinical trials published in five major cancerjournals over the last ten years.

METHODS: A PUBMED search was undertaken to identifyRCTs in cancer published from January 1999 to December2008 in five major cancer journals namely JCO, Annals ofOncology, BJC, Lancet Oncology and JNCI. Forty three RCTsthat reported UR of subjects to different arms were selected.Data was extracted for randomization ratio, reason for UR,phase of the trial and trial location (Single or multicentre).If the rationale for UR was not mentioned in the article, thecorresponding author was e-mailed to obtain the reason.

RESULTS: 1863 RCTs were identified. UR was employed in 43studies (2.3%). The number of studies increased over theyears (0 in 1999 to 9 in 2006). Only 13/43 gave clear reasonsfor adopting UR. Seven out of the remaining 30 authorsresponded to an email request. The reason is not clear inthe remaining 23 reports. 29/43 trials used 2:1 ratiofollowed by 2:1:1 ratio used in 11 % of the studies. Thereasons for UR in the 20 available reports are (a) to meetstatistical endpoint – 7 (b) to facilitate faster recruitment–4 (c) to get more data on new intervention – 4 (d) ethics andsafety reasons – 2 (e) Others – 3. Fourteen were single centrestudies and 29 were multicentre. In 27 reports where phaseof the study was mentioned, there were 12 phase II, 14 phaseIII and one phase IV trial.

CONCLUSION: UR appears to be an attractive alternative tobalanced allocation especially in small randomized phaseII trials. Statistical considerations and faster recruitmentare important reasons for resorting to UR.

Aromatase inhibitors in clomiphene resistant women: Arandomized double blind placebo controlled trial.

Mohan S Kamath, Aleyamma T.K, Achamma Chandy, andKorula George1

Reproductive Medicine Unit, Department of Obstetrics &Gynecology, Christian Medical College, Vellore ,Tamil Nadu,India - 632004.

BACKGROUND: Twenty five percent of anovulatory womenwith polycystic ovarian syndrome do not respond tostandard clomiphene citrate therapy and are known asclomiphene resistant. We investigated the use of letrozole,an aromatase inhibitor as an alternative ovulation inducingagent in these women.

METHODS: 36 women with clomiphene resistance wererandomized into two groups: one receiving letrozole 2.5mgdaily from day 2 to day 6 of the cycle while the other anidentical placebo. The primary outcome was the ovulationrate with analysis being intention-to-treat.

RESULTS: The ovulation rate was significantly higher in theletrozole group 6/18 (33.33%) as compared to none in theplacebo group (P= 0.015). The mean day 21 serumprogesterone was also significantly higher in the letrozolegroup (24.42+/- 32.17 vs 1.66+/- 0.925 nmol/l, P= 0.014).One women in the letrozole group conceived and deliverednormally giving a clinical pregnancy and live birth rate of5.5%

CONCLUSION: In clomiphene resistant women, letrozole canbe used as an effective and simple alternative ovulationinducing agent. The trial is registered with clinical trialregistry of India (UTRN -017753618-3112200762223).

Clinical Trials Methods

Nailesh.T SLIMS, Villianur, Pondy605502 Email:Nailesh.reddy@gmail.com

BACKGROUND: After completing the preclinical testing of thedrug in animals, the company files an investigational newdrug (IND) application with the regulatory authority forpermission to test the drug in humans.

AIMS: To collect the safety and efficacy data for new drugs ordevices.

METHODS: Depending on the type of product and the stageof development, investigators enroll healthy volunteers and/or patients into small pilot studies followed by larger scalestudies in patients that often compare the new product withthe currently prescribed treatment. As positive safety andefficacy data are gathered, the number of patients is typicallyincreased. Clinical trials can vary in size from a single center inone country to multicenter trials in multiple countries, trialsare conducted in 5 Phases

RESULTS: Phase 0 trials is a recent designation known ashuman micro dosing studies has no data on safety or efficacyof drug. Phase 1 trials Examines the pharmacologic actionsand safe dosage range of a drug; how it is absorbed,distributed, metabolized, and excreted; and its duration ofaction. Phase 2 trials are controlled studies in volunteers toassess the effectiveness and safety of a drug. Phase 3 trialsare testing using a greater number of volunteer patients. Thedrug is administered by practicing physicians to those sufferingfrom the condition the drug is intended to treat. These studiesmust confirm earlier efficacy studies and determine low-incidence adverse reactions. Phase 4 trials are studiesconducted after FDA approval, during general use of the drugby medical practitioners, also referred to as post marketingstudies. Fast-track approval is provided for drugs that meetunmet medical needs for patients with serious or life-threatening conditions. Labeling is information distributedabout a drug by the manufacturer, even if it is not physicallyaffixed to the product. Misbranding is “false or misleading inany particular” renders the product misbranded, making itsubject to FDA regulatory action.

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CONCLUSION: These trials provide the tolerability,Pharmacovigilance, Pharmacokinetic, andPharmacodynamics of the drug.

Access to evidence from countries in South Asia: TheSouth Asian Database of Controlled Clinical Trials and the

South Asian Cochrane Network and Centre’s DigitalLibrary – An Update

Jabez Paul Barnabas E, Prathap Tharyan, VenkateshParthasarathy

Prof BV Moses & Indian Council of Medical Research Centrefor Advanced Research and Training in Evidence InformedHealthcare, South Asian Cochrane Centre, Christian MedicalCollege, Vellore, India

BACKGROUND: Many trials conducted in middle and lowincome countries are published in journals that are notindexed in commonly searched databases. Their exclusionfrom systematic reviews could bias conclusions, renderingthem unreliable and potentially irrelevant to health care inthese countries.

OBJECTIVES: To describe the development of the South AsianDatabase of Controlled Clinical Trials (www.cochrane-sadcct.org) and the South Asian Cochrane Network &Center’s Digital Library that aim to: provide a comprehensivesource in the public domain of all controlled clinicalinterventional trials involving humans conducted in theSouth Asian region, and published in regional journals,and contribute information about these trials to theCochrane Central Register of Controlled Clinical Trials(CENTRAL) in The Cochrane Library.

METHODS: Health Science Journals published fromAfghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,Pakistan and Sri Lanka and reporting interventional trialsin humans conducted in these countries were sought frommultiple electronic and other sources and 168 journals wereidentified. Online and print issues of these journals aresearched in regular cycles. Citations and abstracts of allinterventional trials identified from online editions andhand-searching of print editions are entered into Endnote.Trials are coded as RCTs or CCTs using standard criteriaand cleaned records imported to MeerKat, with web-linksprovided to the original article, where possible. Full textarticles are indexed and stored using the Greenstone DigitalLibrary Software to create the South Asian Cochrane Network& Center’s Digital Library that can be retrieved by Titles,Author, Year, Journal and Keywords. All records are regularlytransmitted for inclusion in the Cochrane Central Registerof Controlled Clinical Trials (CENTRAL) in The CochraneLibrary.

RESULTS: The South Asian Database of Controlled ClinicalTrials, initiated in November, 2008, was launched on January1, 2009 (www.cochrne-sadcct.org) and is searchable free

of charge. It currently contains the citations, abstracts andweb-links (where possible) to 2830 records [(CCT-1350(47%); RCT-1477 (53%)] published in 65 Indian medicaljournals, and 76 Pakistan Medical Journals. Fromsubmitted records, the citations and web-links (whereavailable) to 1859 trials conducted in these South Asiancountries are now included in the Cochrane Central Registerof Controlled Trials (CENTRAL). Full text articles, indownloaded or scanned portable document format (pdf),are stored for most trials in the South Asian CochraneNetwork & Center’s Digital Library. In the ongoing secondphase, all 168 South Asian Journals (of which 101 (60%)are not indexed in Medline) and newer journals identifiedby ongoing searches will contribute trials, supplementedby searches of conference abstracts, dissertations and othersources.

CONCLUSIONS: The Cochrane Collaboration now has aresource to access all the evidence generated frominterventional trials conducted in countries in the SouthAsian Region. Many of these, hitherto unidentified, trialscan now be considered for inclusion in systematic reviewsof the effects of interventions in healthcare conditionsrelevant to people in the region; these systematic reviewshave the potential to be of greater relevance in informinghealthcare and health-policy in these countries than beforethe creation of this resource.

When ‘Evidence’ goes against the grain:Quetiapine for Bipolar depression

S. Mohan Raj,Consultant Psychiatrist, Chennai

BACKGROUND: Quetiapine is an antipsychotic medication.In the last 3 years, there are attempts to promote Quetiapineas being efficacious in Bipolar depression. Trials haveclaimed efficacy and FDA has approved the use of Quetiapinefor Bipolar depression.

But, clinicians do not find Quetiapine to be effective inBipolar depression.

AIM: To analyse the possible reasons for this disparitybetween trial results and actual clinical practice.

METHODS: Evaluation of the BOLDER II study1 (study titled‘Efficacy of Quetiapine Monotherapy in Bipolar I and IIDepression’), using the Risk of bias table of Revman 5.

RESULTS:

The biases noticed were

1) Selection bias

Exclusion criteria mention

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1.1 Current episode duration more than 12 months andless than 4 weeks

(Comment: spontaneous remission is possiblearound 6 months)

1.2 History of non-response to an adequate trial (6weeks) of more than 2 classes of antidepressants(Comment: Resistant depression is excluded)

1.3 Current serious suicidal or homicidal risk as judgedby the investigator

(Comment: Severe depression is excluded)

2) Incomplete outcome data were not adequatelyaddressed.

The other problems were

1) Definition of response as > or = to 50% reductionfrom baseline score of Montgomery AsbergDepression Rating Scale (MADRS)2

2) There are 3 items on MADRS scale (decreased sleep,decreased appetite and inner tension) in whichQuetiapine can bring about 100% reduction insymptoms irrespective of its antidepressant effects.

Another area of concern is that all the studies regardingQuetiapine in bipolar depression were prepared with‘editorial assistance’ from a medical communicationcompany called PAREXEL MMS), irrespective of the authors’institution. PAREXEL’s website3 offers to write up a scientificpaper and boast of a 92% first time journal acceptance ratein 2008.

CONCLUSION: Mechanism need to be evolved to restrictapproval of drugs by regulatory bodies for indications forwhich no effect is seen in clinical practice.

REFERENCES:

1. Michael E Thase et al. Efficacy of QuetiapineMonotherapy in Bipolar I and II Depression. Adouble-blind, placebo controlled study (The BOLDERII study) J Clin Psychopharmacol 2006;26:600-609.

2. Montgomery SA and Asberg M. A new depressionscale designed to be sensitive to change. Br JPsychiatry 1979;134:382-389.

3. Parexel MedCom. http://www.parexelmms.com/

VIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP ina medical college hospital

AUTHORS: John K R,Rakesh P S

AUTHORS AFFILIATION

1. Professor in charge of RNTCP$Head of theDepartment,Department of Community Health,CMCVellore

2 Post graduate registrar,department of CommunityHealth,CMC Vellore

CORRESPONDING AUTHOR:John K R,Professor,Departmentof Community Health,CMC,VELLOREEmail:mony@cmcvellore.ac.inPh:09443242603

BACKGROUND: The Revised National Tuberculosis ControlProgramme (RNTCP) based on Directly Observed TreatmentShort course(DOTS) strategy was launched in India as anational programme in 1997.As private sector is the firstpoint of contact for more than fifty percent TBpatients,RNTCP has collaborated with a wide range ofhealth care providers which establishes a unique model ofpublic private mix in RNTCP.

As medical colleges treat a significant number of patientswith TB and also provide care to seriously ill andcomplicated TB cases,efforts have been made to includemedical colleges into the purview of RNTCP.

The Christian Medical College,Vellore ,joined hands withRNTCP in the year 2002.

OBJECTIVES: To study the epidemiological trend oftuberculosis among patients registered in DOTS clinic,Christian Medical College,Vellore between 2002 to 2008.

METHODOLOGY: The existing quarterly RNTCP reports ofCMC DOTS Clinic from 2002 to 2008 were consolidated. Thedata was entered in Microsoft Excel and analysed.

RESULTS and CONCLUSION: The proportion of chestsymptomatics referred for sputum examination fromvarious departments in CMC were between 3 to 4% .This isabove the suggested target of at least 2%.

The sputum positivity rate is between 6.7 to 8% which liesbetween the recommended 5-15%.

Among the cases 33% were sputum positive,14% sputumnegative pulmonary and 53% were extra pulmonarytuberculosis. The maximum proportion of extrapulmonaryTB as per RNTCP guidelines is 50%.

88% of all the cases were transferred out, 35.1% of alltransfers were to ‘out of the state’, among which 43.4%

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were referred to northern states. Among those referred, 27%were sputum positive and 58% were extra pulmonary TB.

Among those who received care from CMC unit, sputumconversion rates were consistently above 90% except foryear 2003 when it was 86.9%.Cure rate was above 80%consistently.

The CMC data shows that most of the recommendationslaid down by RNTCP guidelines are achieved and it isfunctioning as per the guidelines of RNTCP.

Evidence Based Policy for Isoniazid Prophylaxis Therapy inHealth care workers

Authors:Dr. Sangeeta Das Bhattacharya, Assistant Professor, School

of Medical Science and Technology, IIT Kharagpur.

Lt Col (Dr) Rishi Raj, School of Medical Science andTechnology, IIT Kharagpur.

Dr. Hari Prasad, School of Medical Science and Technology,IIT Kharagpur.

Dr. T.Shyam, School of Medical Science and Technology, IITKharagpur.

Dr. Bikas K Arya, School of Medical Science and Technology,IIT Kharagpur.

BACKGROUND: India accounts for nearly one-fifth of globalburden of tuberculosis. Every year, approximately 2 millionpersons develop tuberculosis of which about 0.87 millionare new smear positive highly infectious cases and about3.3 lakh die of TB every year. There are approximately 2.5million health care workers in India (NHP 2007) providinghealth services to the population. They are not only exposedto a high number of active TB cases but also they areconstantly exposed to a high number of debilitated patientsthroughout their professional work.

AIM: To frame a policy regarding Isoniazid prophylactictherapy for health care workers in India.

METHODS: An evidence based search is conducted to findeffectiveness of INH prophylaxis in Health care workers inIndia. Search was conducted in electronic medical resourcesto find the related studies performing Meta analysis andrandomized control trials comparing Isoniazid andplacebo/other anti tubercular drugs in different populationgroups. Appropriate statistical methodology was adoptedto analyze the results and formulate the policy. The Criteriafor evaluation were Numbers needed to be treated to preventone active case of TB/ One death, number needed to harm(Hepatitis), adherence and compliance, ease ofimplementation, cost benefits analysis.

RESULTS: The best suited evidence suggesting the prevalenceof LTBI in health care workers in India is by M. Pai et al(JAMA 2005) indicating a prevalence of 40% in the healthcare workers in India. The Prevalence of Latent TB isdramatically increases from 25% for persons who have servedless than 5 years in health care profession to 62% for personsserving for 6 to 10 years and 71% for persons serving morethan 10 years. The numbers needed to treat to prevent onecase of TB in general population is 35 (Smeija et al 2004)

CONCLUSION: In India as per RNTCP recommendations noguidelines are available for prevention of TB in healthcareworkers. India’s RNTCP is the largest DOTS program in theworld. It is of paramount importance that they are given thebest possible protection from occupational health hazardsincluding TB. So we recommend incorporation of Isoniazidprophylaxis therapy among health care workers in India ifthey are found to be a case of LTBI. The therapy should bewith 300 mg Isoniazid daily for six months. The maximumeffect of Isoniazid prophylaxis is shown to be for 3 years(Debre), so it is recommended that every healthcare workershould be examined while joining health care services andthen should be reviewed every three years.

Evidence Based Surgery: knowledge, attitudes, andperceived barriers among surgical trainees

Dr. Rohin Mittal (Presenting author)Assistant Professor

Department of Surgery Unit 5Christian Medical College, Vellore

rohinmittal@gmail.com

Dr. Benjamin PerakathProfessor

Department of Surgery Unit 5Christian Medical College, Vellore

benjamin@cmcvellore.ac.in

BACKGROUND: Evidence Based Surgery (EBS) has beenshown to improve efficiency and outcomes. It is, however,not practiced universally among surgeons. Wider use ofEBS requires an understanding of EBS, a positive attitude,as well as removal of perceived barriers to its practice.

AIMS: The aim of this study was to assess the knowledgeand attitude of surgical trainees towards EBS and theirperceived barriers to its practice.

METHODS: The McColl questionnaire and the BARRIERS scalewere modified and incorporated into a single questionnaire.Surgical trainees attending a Continuing Surgical Educationmeeting at the author’s institution were asked to voluntarilyfill in this questionnaire.

RESULTS: A total of 93 out of 110 (84.5%) trainees returnedthe filled in questionnaire. Attitudes towards EBS were

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welcoming, although colleagues were considered lesswelcoming than self. There was high level of agreement withusefulness of EBS in everyday practice and EBS improvingpatient care. About 50 % of actual practice was consideredto be evidence based. 12.6 % (11/87) participants hadreceived formal training in EBM. 64.3 % (54/84) were awareof the Cochrane database of systemic reviews but only 35.7%(30/84) read it regularly. 67.8 % (61/90) used protocols andguidelines developed by colleagues to practice EBS. However,61.5 % (56/91) were interested in learning the skills of EBS.The terms absolute risk, relative risk and clinicaleffectiveness were understood by > 80 % of respondents,while publication bias, confidence interval andheterogeneity were poorly understood. The major perceivedbarriers to practice of EBS were inability to understandstatistical analysis, inadequate facilities forimplementation, lack of a single compiled source ofliterature, relevant literature not being readily availableand insufficient time on the job.

CONCLUSIONS: Surgical trainees have a positive attitudetowards EBS, and have some familiarity with the commonterms used in EBS. There is a need to increase awareness of,and provide access to available sources of medicalliterature. Formal training in EBS, as well as basic statisticalanalysis should form a part of the surgical curriculum tofoster an environment favorable to the practice of EBS.

CAN CLINICIANS ACTUALLY PRACTICE EBM?

Sanchaya Selvaraj*, Balaji D*, Nagamani*, SurapaneniKrishna Mohan**

AFFILIATION:

*II MBBS Student, Saveetha Medical College & Hospital,Saveetha University, Saveetha Nagar, Thandalam, CHENNAI– 602 105, T.N, INDIA.

**Assistant Professor, Department of Biochemistry,Saveetha Medical College & Hospital, Saveetha University,Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.

BACKGROUND: The term “Evidence Based Medicine” (EBM)was first used in the early 1990s to describe a frameworkfor integrating clinical epidemiology with routine clinicaldecision making. It was initially described as an“enlightened scepticism towards the application ofdiagnostic, therapeutic and prognostic technologies in theday-to-day management of patients’.

AIM: To conduct a literature survey to find out whether theclinicians actually practice EBM and to know the impact ofEBM in our country.

METHODS: Our survey mainly focuses on 3 researchquestions: First of all, do full-time clinicians really recognizeworking in these modes? Second, even if they recognize these

modes, can they actually get at the evidence quickly enoughto consider it on a busy clinical service? Third, even if theycan get at it, can clinicians actually provide evidence-basedcare to their patients?

RESULTS: First of all, do full-time clinicians really recognizeworking in these modes? It appears so. In a survey of UKGPs, majority reported practicing at least part of their timein the “searching” mode, 72% using evidence- basedsummaries generated by others and 84% using evidence-based practice guidelines or protocols. Far fewer claimedto understand the “appraising” tools of NNTs (35%) andconfidence intervals (20%). Only 5% believed that “learningthe skills of evidence-based medicine” (all five steps) wasthe most appropriate method for “moving from opinion-based medicine to evidence-based medicine”.

Second, even if they recognize these modes, can they actuallyget at the evidence quickly enough to consider it on a busyclinical service? Again, it appears so, but examples are few.When a busy in-patient medical service brought electronicsummaries of evidence previously appraised either by teammembers (“CATs”) or by the summary journals to workingrounds, it was documented that, on average, the formercould be accessed in 10 seconds and the latter in 25seconds. When assessed from the view of the junior memberof the team caring for the patient, this evidence changed25% of their diagnostic and treatment suggestions andadded to a further 23% of them.

Third, even if they can get at it, can clinicians actuallyprovide evidence-based care to their patients? Again, itappears so from audits carried out on clinical servicesthat attempt to operate in the searching and appraisingmodes. It is documented that 82% of them were evidence-based. Out of which 53% based on systematic reviews ofrandomized trials and 29% based on convincing non-experimental evidence.

CONCLUSIONS: Similar results have been obtained fromaudits of psychiatric, surgical, pediatric and generalpractice. But in our setup usually, about developing countrythis trend is taking a snail pace.

Key Methodological Issues in Randomised ControlledStudies and Observational Studies

Santosh Philip Mathew1 MBBS student, Sonia MaryPhilip2 BDS, PG Dip in Public Health, Ajay Varghese3 MBBS,MRCP, FRCR

1 Presenting Author: MBBS Student, MOSC MedicalCollege, Kolenchery, Ernakulam, Kerala- 682311

2 Queen Mary , University of London, School of Medicineand Dentistry, Mile End Road, London, UK - E1 4NS3Consultant Radiologist, Dorset County Hospital NHSFoundation Trust, Dorset County Hospital, WilliamsAvenue, Dorchester, UK - DT1 2JY

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Presenting author email: santoshphilip@gmail.com;Contact number: 9496334595

BACKGROUND: Analytical studies are broadly categorisedinto experimental studies including randomised controlledstudies (RCTs) and non-experimental studies which includeobservational studies (OSs). Many consider RCTs asproviding better evidence than OSs, but are not alwayspossible, appropriate or ethical to conduct.

AIMS: To identify key methodological issues relevant to RCTsand OSs.

METHODS: Multiple articles were referred to from peerreviewed journals as well as our own experience indesigning our poster with illustrations.

RESULTS: We will elucidate the advantages of RCTs includingits efficiency in postulating and testing clinical hypothesis,use of analysis based on statistical theory, allocationconcealment and patient and assessor blinding therebyreducing bias. The disadvantages of RCTs include its cost,difficulty in organising, obtaining informed consent andethical approval made difficult by the nature of the studyand also failure to report negative results.

We will also review the advantages of OSs including its lowcost, easy access to ethical approval, informed consentwhich is frequently unnecessary, use of statistical methodslike propensity and multivariate analysis with tests forinteraction. It also benefits from retrieving data from largenumber of patient groups in a short amount of time fromdatabases. One of the main disadvantages include bias fromunknown confounders as well as treatment allocation biaswhich can be offset to an extent by the use of propensityanalysis.

While RCTs have pride of place in studies of efficacy, OSshave been limited to safety or adverse events data analysis.

CONCLUSIONS: After reading this poster, one should be ableto identify the key methodological issues involved inanalytical studies. Although some would consider RCTs asthe ‘gold standard’ in analytical studies, it is important tounderstand that there is no perfect methodology to answerclinical questions. Clinicians will need to take account ofthe published data, decide which of the studies are bestdesigned to answer their questions and also consider thegeneralisability and reproducibility of the intervention andcome to a conclusion based not only on the publishedevidence but also rely on their medical experience andjudgement.

Modafinil for clozapine induced adverse effects in peoplewith schizophrenia and schizoaffective disorder in

remission: a randomized, placebo-controlled trial stoppedearly for harms.

Sebind Kumar1, Prathap Tharyan2, Naveen Thomas3, CliveAdams4

BACKGROUND: Hyper-salivation, sedation and weight gainare common troublesome effects of Clozapine.

OBJECTIVES: To evaluate the efficacy and safety of modafinilin clozapine-induced drowsiness, hyper-salivation, weightgain, mental state, and global functioning.

METHODS: Design: Randomized, parallel-group, single-centre, participant, investigator, observer and data-entry-blinded trial conducted between October 2007 and October2008. Offsite computer-generated, variable-block-sizerandomization and pharmacist-dispensed, pre-packed,serially numbered, containers ensured allocationconcealment.

Participants: Consenting adults with a diagnosis ofschizophrenia or schizoaffective disorder (DSM IV) inremission, with troublesome drowsiness or hyper-salivation, with/without weight gain, without unstablemedical conditions, and on stable doses of clozapine for atleast 4 weeks.

Intervention and comparator: Modafinil 100mg/day for firstweek and 200mg/day for 8 weeks or identical placebo oncedaily for 9 weeks.

Estimated Sample size: 35 in each arm (80% power; 5% alphaerror)

Outcomes: Primary: Proportion without daytime sleepinessand hyper-salivation, scores on Epworth Sleepiness Scale(ESS) and Nocturnal Hyper-salivation rating scale (NHRS).Secondary: change in weight, pulse rate, systolic anddiastolic blood pressures; scores on Positive and NegativeSymptom Scale (PANSS); Clinical Global Impression (CGI)for alertness, hyper-salivation and overall improvement;Indian Disability Evaluation Assessment Scale (IDEAS) andadverse events check list. Assessment: End of weeks 1, 5 and9. Analysis; by intention to treat.

RESULTS: A pre-planned interim analysis (if more than 5%developed adverse events necessitating discontinuation)was done after 34 people (Modafinil 16, placebo 18) wererandomized, because of marked worsening of psychosis inone and anxiety symptoms in one (both on Modafinil). Oneperson on placebo discontinued treatment due to lack ofimprovement. Groups did not differ on the baselinevariables. Modafinil significantly reduced hyper-salivationat 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

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(9/16 (56%) vs. 7/18 (44%); OR 2.6, 95% CI 0.6 to 10.8; P=0.7). Modafinil did not differ from placebo on the NHRS orESS scores but significantly reduced duration of sleep byweek 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05).No significant differences were noted in PANNS or IDEASscores, CGI overall improvement, weight, pulse rate, bloodpressure or other adverse effects in both groups.

CONCLUSION: This trial was stopped early due to pre-determined stopping rules and was insufficiently poweredto draw firm conclusions. Modafinil may have the potentialto significantly improve hyper-salivation and drowsinessdue to Clozapine. Further trials, particularly at lower does,may be warranted, but any potential benefits must beweighed against the risk of worsening of psychosis or anxietyand the cost of Modafinil.

TRIALS REGISTRATION: Clinical Trials Registry-India (CTRI)identification number: CTRI/2007/091/000020, 04-10-2007

FUNDING: Fluid Research Fund of CMC Vellore; Modafiniland placebo supplied by Sun Pharmaceuticals (who had noother role in the study)

AUTHOR AFFILIATIONS:

1Dr. Sebind Kumar: Former Tutor in Psychiatry,Department of Psychiatry, Christian Medical College,Vellore 632002, Tamil Nadu; email: sebind@gmail.com

2Dr. Prathap Tharyan, Professor of Psychiatry, Prof. BV MosesCentre for Clinical Trials and Evidence Based Medicine,Christian Medical College, Vellore 632002, Tamil Nadu.

3Dr. Naveen Thomas, Assistant Professor in Psychiatry,Christian Medical College, Vellore 632002, Tamil Nadu.

4Dr. Clive Adams, Professor of Psychiatry and Chair ofMental Health Services Research, Division of Psychiatry,University of Nottingham, Nottingham, NG7 2TU, UK.

Internet based clinical trials: An Expanding Horizon

Authors: Siddhartha D, Lalith Chandra K,Gandhi Medical College, Secunderabad

BACKGROUND: Internet is being widely utilized in medicalresearch. It offers many benefits when used as a mediumfor carrying out clinical trials. Being able to reach a widepopulation, participant privacy, easier blinding andrandomization, studying geographically scatteredpopulations are a few such benefits. Online trials so far,have mostly been focusing on educational, preventive,rehabilitative and follow up issues which can have abeneficial impact on patient health, health service quality,health service availability and finances. In a society wherethe utilization of Information Technology seems to be rising

exponentially, online trials have a significant role to playin shaping up the future of the health care industry.

Aim: To carry out a systematic search for the areas in whichinternet trials have been carried out till date and to analyzethe advantages and limitations of using internet as amedium to conduct clinical trials.

Methods: The online U.S NIH database(www.clinicaltrials.gov), was searched for internet basedtrials. Both active and closed trials were included.Relevantresults were categorized under separate subject headingsbased on the health condition/category the trial wasaddressing. Both interventional and observational trialswere included in the categorization. PubMed literaturesearch was performed to study the advantages andlimitations of online trials separately.

Results: Of the 432 search results obtained using the keyword“ internet”, 383 were appropriate. These trials werecategorized into subject headings as described. A widevariety of health conditions such as alcoholism, diabetes,psychiatric conditions, smoking cessation, weight control,hypertension etc. were addressed in these trials*. A majorityof these trials have been carried out in the USA and Europe.Surprisingly, Asian countries have carried out only anegligible number of such trials(~2%).

Conclusion**: Online trials have many advantages.However, multiple log-ins, remuneration, internet spammingand internet squatting are a few limitations. We propose asolution to these problems, which could be an interestingarea for future research.

(* Involves numerical data that cannot be condensed)

(**Not elaborated due to word limit restriction)

Presenting Author and Author for Correspondence:

Siddhartha Devarakonda“Premabandham”, Near Birla Mandir5-9-22/38 G AdarshnagarHyderabad 500063, APIndiaemail- siddarth.dt@gmail.com

BODY MASS INDEX AND EXOCRINE PANCREATIC INSUFFI-CIENCY ARE PREDICTORS OF PANCREATIC OSTEODYSTRO-

PHY IN SUBJECTS WITH FIBROCALCIFIC PANCREATITIS WITHDIABETES.

Presenting author: Sudeep.K

Co-Authors: Selvakumar R, Chacko A, George B, Kavitha M,Paul T, Seshadri MS, Thomas N

Department; Department of Endocrinology, Department ofBiochemistry, Gastroenterology.

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Institution: Christian Medical College, Vellore. Phone(0416)-2282528,2282491.Fax-416-4205844

Address for correspondence: Dr .Nihal Thomas, Professor,Department of Endocrinology, Diabetes and Metabolism,Christian Medical College, Vellore. India.Email ID: nihal_thomas@yahoo.com.Email ID: drsudeepmd@rediffmail.com

BACKGROUND: Chronic pancreatitis with exocrineinsufficiency, inflammation, diabetes, low body weight andundernutrition alter bone metabolism leading to a relativelynovel entity entitled pancreatic osteodystrophy.

AIMS: To determine the relationship between bone mineralcontent and pancreatic exocrine and endocrine dysfunctionin subjects with chronic non-alcoholic pancreatitis.

MATERIALS AND METHODS: A prospective study ofconsecutive eligible males aged between 20 and 60 years.BMD was measured using Hologic DXA machine. Vitamin Dwas measured using radioimmuno-assay. Stool fatexcretion rate was measured in a 72 hour stool collection.Statistical analysis was done applying Pearsonscorrelation, independent t-test and nonparametric tests.

RESULTS: Thirty-one males with a mean BMI of 18.46 (±2.86) Kg/m2 and radiologically documented pancreatitiswere studied.The mean 72 hour stool fat was 25.30 (±18.09)gms and the mean VitaminD was 18.44 (± 10.97) ng/ml. Nineteen (61%) subjects had an abnormal T score.Therewas a significant positive correlation between BMC andBMI (r = 0.426 ; P = 0.017) and a significant negativecorrelation BMC and 72 hour stool fat (r = minus 0.468;P =0.028). Twenty one (68%) inclusive of eleven FCPD subjectshad diabetes.Subjects with diabetes had a lower BMI (17.7±2.4 vs 20.0 ± 3.31 Kg/ m2 ;P = 0.087) and lower VitaminD(16.01 ± 9.03 vs 26.03 ± 13.9 ng/ml P= 0.056) than thosewithout diabetes. A significant linear correlation (r = 0.448;P= 0.041) between BMC and BMI was seen only in subjectswith diabetes.

CONCLUSIONS: In subjects with chronic pancreatitis anddiabetes a linear correlation exists between BMC and BMIpresumably due to severe undernutrition. Subjects withsteatorrhea had a significantly reduced BMC which couldnot be accounted for by differences in BMI or diabetes orvitamin D deficiency. Pancreatic osteodystrophy in chronicpancreatitis is an underrecognized co-morbidty requiringa more extensive evaluation.

Evidence based policy formulation on Isoniazid prophylaxisfor Latent Tuberculosis infection in Indian context.

BACKGROUND: India has the highest burden of tuberculosiscases for any country in the world. It has an Incidence rateof 168 cases per 100000 population. It reported 331,268

deaths per year (1 every 90 seconds) of the total 1.3 millionworldwide (25.5% or one in four deaths). Mortality rate dueto TB is 28/100000 population per year in India.

AIM: To investigate whether INH prophylaxis for cases withlatent tuberculosis infection can be incorporated in theroutine health care system in Indian scenario.

METHODS: An evidence based search is conducted to findeffectiveness of INH prophylaxis in cases with latenttuberculosis infection with or without associated medicalconditions. Search was conducted in electronic medicalresources to find the related studies performing Metaanalysis and randomized control trials comparing Isoniazidand placebo/other anti tubercular drugs in differentpopulation groups. Appropriate statistical methodology wasadopted to analyse the results (Numbers needed to treat,relative risk reduction) and formulate the policy.

RESULTS: The study best suited to answer our question forNon HIV general population was a Meta analysis done bySmieja Marek et al., titled “Isoniazid for preventingtuberculosis in non HIV infected persons” (1999) availableat Cochrane database. The risk ratio (RR) of the persons onINH prophylaxis was 0.40 (95%CI 0.31 to 0.52) with a Pvalue of <<.01. Numbers needed to treat (NNT) is 35. Thestudy we used for HIV children was “Effect of Isoniazidprophylaxis on mortality and incidence of tuberculosis inchildren with HIV: randomised controlled trial” by HeatherJ Zar et al, available at PUBMED. Numbers needed to treat is16 for preventing Incidence of one case and 12 for preventingone death.

CONCLUSION: Although a definite reduction of risk is seenin groups on INH prophylaxis, INH prophylaxis cannot beinstituted in cases with all latent TB infection in Indiabecause the incidence of latent TB is very high and followingup them all is impossible. However, it can be administeredin high risk groups like HIV positives, health care workersand people in prisons and army barracks.

AUTHORS:

1. Dr. T.Shyam, School of medical science and technology,IIT Kharagpur.

2. Dr. Bikas Kumar Arya, School of medical science andtechnology, IIT Kharagpur.

Presenting Author:

Dr. T.Shyam, B – 002,Gokhale hall of residence,Indian Institute of Technology, Kharagpur,West Bengal. PIN: 721302Email: tshyamiitkgp@gmail.com

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Nature, prevalence, explanatory models and correlates ofsexual dysfunction among men attending primary health

setting in south India

Dr. P. Thangadurai, MBBS, DPM, DNB,Assistant professor,

Department of Psychiatry, Christian Medical College,Vellore - 632002, India.Email ID: thanga@cmcvellore.ac.in

BACKGROUND: Sexual dysfunction is common in all healthcare settings. However, this remains under-reported, under-recognized and under-treated, leading to significantmorbidity and reduction in quality of life.

AIMS: We aimed to determine the nature, prevalence,explanatory models and correlates of sexual dysfunctionamong men attending primary health setting.

METHODS: We conducted a cross-sectional studyinvestigating 270 consecutive consenting men aged 16 andabove attending the department of community health, CMCH.Those with severe language, hearing or cognitive impairmentwere excluded. We screened for sexual dysfunction usingSexual History Questionnaire. Those who screened positivewere further evaluated using the International Index ofErectile Function-5 (IIEF5) and the Chinese Index ofPremature Ejaculation-5 (CIPE5). Explanatory models ofsexual dysfunction were assessed using the modified ShortExplanatory Model Interview (SEMI). We employed Tamilversion of Clinical Interview Schedule- Revised (CISR) todiagnose common mental disorders.

RESULTS: 75.9% men (95% CI 70.9-81.1) were tested positivefor sexual dysfunction. The most common disorder waspremature ejaculation followed by erectile dysfunction andtheir co morbidity. Poverty, advancing age, less education,history of diabetes, hypertension and presence of a commonmental disorder were significantly associated with sexualdysfunction (P<0.05). Primary health care physicians under-diagnosed sexual dysfunction and documented poor interrater reliability when compared with diagnoses by apsychiatric professional (Kappa=0.01).

DISCUSSION: Sexual dysfunction is widely prevalent butunder diagnosed among men attending primary healthclinics. Strengths of this study include adequate samplesize, minimal refusal rates, use of standardized instrumentsand eliciting explanatory models. We acknowledge thelimitations such as absence of consensus on normalejaculatory latency, varying diagnostic cut off scores ofIIEF-5 and CIPE-5, debatable cross cultural validity and thepossibility of high false positive rates due to poor positivepredictive values. We minimized selection and reportingbias by consecutive sampling and by interviews conductedby a single investigator well versed in local culture andlanguage.

CONCLUSION: We suggest the need to include effectivemanagement of sexual dysfunction in the existing primaryhealth system. Future longitudinal studies to evaluateincidence and correlates of sexual dysfunction are desired.

The impact of family attachment programme inundergraduate curriculum to appreciate the concept of

evidence informed public health.

BACKGROUND: Evidence based public health is theintegration of science based intervention with communitypreference to develop the health of the public. The latterstages of this process of evidence based public healthinvolve vigilant decision making in order to address specificpublic health problems, where the adaptation of theresearch knowledge to the local context prior to theimplementation of the adapted evidence in to practice orpolicy development is of crucial value. This adaptation ismainly based on the recognition and analysis of needs/preferences specific to the community under consideration.

AIM/OBJECTIVE: To describe the importance of familyattachment programme in undergraduate curriculum toappreciate the concept of evidence informed public health.

METHOD/ACTIVITY: Medical students of the Faculty ofMedical Sciences, University of Sri Jayewardenepura, SriLanka were allocated in to groups of three students andassigned a household in the university project area for aperiod of two months during their final year training.

Weekly seminars were held to discuss the health relatedissues faced by each family and possible interventions thatcould be made to overcome them. The students thenundertook a practical approach in to decision making andimplementing the necessary interventions under supervisedguidance from the departments of Community Medicine,Family Medicine, Paediatrics, Psychiatry and public healthstaff from the university project area.

The students were assessed by a Viva Voce examination aspart of their final MBBS examination.

Conclusions and Recommendations

Conventionally the undergraduate training is hospitalcentred and mainly focused on relieving physical infirmity.But through this innovative programme the students got theopportunity to explore the possible interventions whileconsidering the individuals, family and community as awhole. Thus enabling them to understand how to adapt theresearch knowledge to the local context by recognizing theneeds/preferences specific to that community, therebyachieving better decision making in the process of evidenceinformed public health. Therefore,including this innovativeprogramme in the undergraduate public health training ishighly recommended.

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Using evidence to inform policy making &implementation: A case of tobacco control in Karnataka

Dr. Upendra BhojaniFaculty,

Institute of Public Health250, Master’s cottage, 2 C Main, 2 C Cross, Girinagar 1st

Phase, Bangalore 560085(080) 26421929, 09342349121

upendra@iphindia.org

BACKGROUND: India was among the earlier countries toratify the WHO’s Framework Convention on Tobacco Control(FCTC). In fact India enacted a national legislation, ‘TheCigarettes and Other Tobacco Products Act (COTPA) 2003’even before FCTC came in force. Though, not free of lacuna,COTPA provided good framework with inclusion of evidence-based strategies including 1) prohibition on smoking inpublic spaces 2) prohibition on tobacco advertising 3)prohibition of sale of tobacco products to minors and neareducational institutions and 4) mandatory display ofpicture warnings on tobacco products including others.However, framing of rules and their notifications toimplement COTPA presented complex challenges for publichealth community as it became evident from repeated delaysand dilutions of the original provisions of the Act.

AIM: To describe how needed evidences to strengthentobacco control policies and its implementation weregenerated and were disseminated using innovative toolsand channels to relevant stakeholders by Institute of PublicHealth (IPH) in Karnataka.

METHOD: Situational and stakeholder analysis helped toidentify issues and influential stakeholders in context oftobacco control in India. Discourses regarding employmentof tobacco industry workers, effectiveness and acceptanceof suggested warnings, impact of tobacco control measureson general economy surfaced by tobacco industry, media,and at times politicians created negative environment foreffective and undiluted implementation of proposed Act.

In this context, through short studies and surveys IPHgenerated relevant evidences and used innovative toolsand to disseminate it to media (Media tool kit, Sensitizationmeetings, Provision of relevant information), law makers(Stories in local and national newspapers, Advocacy kit onpictorial warnings, memoranda, and campaigns), lawenforcers (news stories on legal violations, Complaints tovarious departments, PIL in Karnataka high court) andcommunity (Awareness campaigns, painting competitionsand fact sheets for schools).

RESULTS: These efforts resulted in publication of IECmaterials and more than 20 news stories in local andnational papers on periodic basis. Karnataka High Courtpassed an interim order instructing various stakeholders

to strengthen implementation of law. Increased awarenessamong students, teachers and community in general.

URINARY METANEPHRINES IN THE DIAGNOSIS OFPHEOCHROMOCYTOMA

Vasanthi K*, Kanakamani J*, Rajaratnam S*, Gracy V$,Fleming J$,

*Departments of Endocrinology, Diabetes and Metabolism& $Clinical Biochemistry

Christian Medical College, Vellore.

BACKGROUND: Though pheochromocytomas are raretumors, they need to be considered in a large number ofpatients with hypertension because they are dangerous andare potentially curable. Measurement of plasma or urinarymetanephrines are said to be diagnostically superior thanmeasurement of catecholamines or vanillyl mandelic acid.

OBJECTIVE: The objective was to study the diagnostic valueof urinary total metanephrines in the diagnosis ofpheochromocytomas.

METHODS: Outcomes of patients tested in our center forpheochromocytomas from June 2008 to June 2009 wereretrospectively studied. Urinary total metanephrines (uMN)and normetanephrines (uNMN) were measured by enzymeimmunoassay. The upper limit of the laboratory referencerange was used to calculate the diagnostic accuracyparameters.

RESULTS: There were 66 patients (49 males and 17 females).F ifteen patients had histopathologically provenpheochromocytomas. 11 of them were adrenal tumors and4 were paragangliomas. 45 patients had hypertension inwhom secondary causes were not found. Six had adrenalmasses of other origin, proven by biopsy. The median uMNin the pheochromocytoma group was 363 (59 – 5640) mg/day and uNMN 4000 (329 – 10400) mg/day and that of non-pheochromocytoma group was 168 (43-638) mg/day and734 (85-2763) mg/day. The sensitivity and specificity ofuMN was 53.3% & 90.2% respectively and that of uNMNwas 86.6% & 21.57%. Area under the receiver operatingcharacteristic curve was 0.737 (95% CI: 0.566-0.909) foruMN and 0.851(95% CI: 0.693-1.009) for uNMN.If both uMNand uNMN were combined together, negative predictivevalue is 100% but positive predictive value is only 26%.

Conclusion: Urinary total metanephrines is a valuable testto exclude pheochromocytoma in a population who need tobe screened for the tumor. However with a low pretestprobability, it cannot be used to confirm a diagnosis ofpheochromocytoma.

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A Randomized Double Blind Comparative trial ofAntidepressant Augmentation by High and Low Dosage

Folic Acid in Depressive Disorder

ABSTRACT

BACKGROUND: Several studies show elevated incidence offolate deficiency in patients suffering from depression.Systematic-reviews suggest that folate may have a potentialrole as supplement to antidepressants but have called forfurther trials. Few trials have shown that in females than inmales; administering folic acid with antidepressantsaugments the antidepressant response.

OBJECTIVE: In this study we compared the add on effect ofhigh (5mg) versus low dose (1.5mg) folic acid to fluoxetine(20 mg) in female patients suffering from moderate/severedepressive episode (either first episode or recurrentdepressive disorder)

METHODOLOGY: 42 drug naïve female outpatients clinicallydiagnosed to have moderate or severe depressive episode(ICD-10 criteria) were randomized into two groups 1 and 2.Both groups received fluoxetine 20 mg. In addition, group 1received folic acid 1.5 mg/day, while group 2 received 5mg/day of folic acid in a double blind fashion. Out comemeasures were Hamilton Depression Rating Scale (17 itemversion) and Beck Depression Inventory administered everyweek for a period of 6 weeks. Appropriate statistics wasused to analyze the data

RESULTS: Both groups were comparable at baseline in termsof socio-demographic and illness variables (p>0.05). Therewas no significant difference across two groups withrespect to baseline HDRS and BDI scores (p>0.05). Withinboth the groups there was a significant decline in meandepression scores on both HDRS, BDI (p=0.00). Across thetwo groups, the decline in BDI scores was statisticallysignificant which was more in group 2 (p = 0.04). Thedecline in HDRS scores was not statistically significantacross the two groups (p > 0.05). 66% of patients in group 2and 33 % in group 1 showed a 50% decline from the baselinescore in both scales.

CONCLUSION AND LIMITATION: Hence supplementing 5 mgfolic acid to fluoxetine in the treatment algorithm in womenwith depressive episode, produces a better add on effectthan 1.5 mg of folic acid. The results could have been bettersubstantiated with a laboratory measurement of serum folicacid and homocysteine levels.

Authors:

1) Dr. R. Venkatasubramanian*, MD

2) Dr. Ravi Shankara Pandey***, MD

3) Dr. Venkateshwaran.R**, MBBS

Affiliation address:

* Assistant Professor, Department of Psychiatry, PSGInstitute of Medical Sciences and Research,Coimbatore-641004

** Professor of Psychiatry, National Institute of MentalHealth and Neurosciences, Hosur Road, Bangalore-560029

*** Junior Resident, Department of Psychiatry, PSG Instituteof Medical Sciences and Research, Coimbatore-641004

Presenting author:

Dr. R. Venkatasubramanian, MDAssistant Professor,Department of Psychiatry,PSG Institute of Medical Science and Research,Coimbatore- 641004.Tamilnadu, India.Phone number: +91-9791802486; + 91-9944059997Fax number: +91 422 2594400E-mail: rvs.1947@gmail.compsychiatry.venkat@hotmail.com

Study of Depression among Diabetics in a Generalhospital: Consequences in Diabetes Management &

Quality of Life

BACKGROUND: Recent studies quote high prevalence ofdepressive episodes in diabetics, which leads to increasedrisk for various complications of the metabolic disorder.Yet depression is often unrecognized and untreated inapproximately two thirds of patients with diabetes.Underdiagnosis of co-morbid depression may reflect aperception among clinicians that psychological issues areless important than medical concerns in patients withdiabetes. To maximize overall patient outcome, this needsto be addressed adequately.

OBJECTIVE: To estimate the prevalence of depression amongthe diabetics in the study population. To ascertain andcompare the level of diabetes self care management andthe health-related quality of life between the depressed andnon-depressed.

METHODOLOGY: 50 consecutive diabetic out-patients ofeither sex, after informed consent were administeredHamilton Depression Rating Scale (HAM-D), Summary ofDiabetes Self Care Activities (SDSCA), and Rand 36 Healthstatus inventory. Based on the HAM-D scores, patients wereinitially grouped as depressed and non-depressed.Depressed were further sub-grouped into mild, moderate,severe and very severe. Comparison of the level of diabetesmanagement self care and Quality of Life between thedepressed and non-depressed was done using the mean

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scores of SDSCA, Rand 36 inventory. Appropriate statisticswas used to analyze the data.

RESULTS: The proportion of depression among the studypopulation was 46% and of them 50% was mildly depressed.All components of SDSCA scores were lower amongdepressed compared to normal population (p<0.01). Thereis a decline in the all the components of SDSCA scores asthe severity of depressive symptoms increases, with severe& very severely depressed having the least score. Rand 36inventory items were also significantly different betweendepressed and non-depressed (<0.05). The mean scores ofSDSCA, RAND 36 also show a statistically significant declineas the severity of depression increases.

CONCLUSION: Results substantiate that prevalence ofdepression among diabetics is higher than in the generalpopulation which is in the range of 7.8% to 17%. Identifyingdepression among the diabetics at an earlier stage wouldimprove the Physical & Mental domain of Health RelatedQuality of Life and breaking the vicious cycle of depressionand diabetes. Eclectic interventions need to be planned foreach individual. However rater-blind studies are requiredfor further validation of our findings.

AUTHORS:

1. Dr. Venkateswaran. R*, MBBS

2. Dr. Mario Victor Newton. L**, MBBS

3. Dr. Venkatasubramanian. R***, MD

Affiliation address:

* Junior Resident, Department of Psychiatry, PSGInstitute of Medical Sciences and Research,Coimbatore-641004

** Under-graduate Student, PSG Institute of MedicalSciences and Research, Coimbatore-641004

*** Assistant Professor, Department of Psychiatry, PSGInstitute of Medical Sciences and Research,Coimbatore-641004

Presenting author:

Dr. R. Venkateswaran, MBBSJunior Resident,Department of Psychiatry,PSG Institute of Medical Science and Research,Coimbatore- 641004.Tamilnadu, India.Phone number: +91-9994474538; + 91-9655590526Fax number: +91 422 2594400E-mail: drwaran005@gmail.com

Assessment of the reporting quality of non-inferiority andequivalence trials in cancer post CONSORT, using a

modified CONSORT checklist

AUTHORS: Vikram Gota1, Sadhana Kannan1, PriyaRanganathan2, Nithya Gogtay3, Sandeep Bavdekar3, CSPramesh2

1ACTREC, Tata Memorial Centre, Sector-22, Kharghar, NaviMumbai 410 210, India

2Tata Memorial Hospital, Parel, Mumbai 400 012, India

3Seth GS Medical College and KEM Hospital Parel,Mumbai 400 012, India

BACKGROUND: The revised CONSORT was published in 2006to improve the reporting of RCTs. Non-inferiority (NI) andequivalence (Eq) trials are a subset of RCTs that differmethodologically from superiority trials. An extension tothe CONSORT checklist was published in 2006 for reportingNI/Eq trials. This checklist provides a framework forminimum reporting standards, but leaves several pointsopen to interpretation. Studies that evaluated the impact ofthe extended CONSORT statement on the quality of reportingof NI/Eq trials in AIDS and ophthalmology concluded thatreviewers and editors need to reinforce their standards foracceptance of NI/Eq RCTs.

AIM:

1) Assess the impact of the CONSORT statement, on thequality of reporting of NI/Eq trials in oncology.

2) Validate a modified CONSORT checklist for NI/EQ trialsby checking the intraclass correlation coefficient (ICC)between three sets of raters.

METHODS: All RCTs in cancer with NI/Eq design publishedpost CONSORT till November 2008 were selected fromPUBMED. A modified CONSORT checklist was developedthat included all 22 items of the extended CONSORT for NI/Eq trials. Additional items considered important from a NI/Eq trial perspective were also included. Each of the 22 itemswas further subcategorized to render objectivity to thechecklist. Three groups of reviewers scored the checklistindependently for all post CONSORT trials. After scoring,the reviewers got together to arrive at a composite scorebased on consensus. The interrater agreement was assessedusing ICC. Compliance of each article to CONSORT was alsoassessed.

RESULTS: Twenty six studies were identified. The overallinterrater agreement for the modified checklist was 71%.The agreement was greatest for the ‘results section’ (77%)and least for the ‘discussion section’ (49%) of the articles.The maximum possible score was 49 points. Only 7/26studies scored above 75% of the maximum score. Major

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areas that require improved reporting include specifyinga) NI margin b) rationale for choice of delta c) methodsused to implement random allocation. No difference wasfound in the reporting quality of industry sponsored andinvestigator initiated trials (P=0.80).

CONCLUSION: Compliance to CONSORT statement for NI/Eqtrials in cancer is poor. We have attempted to validate amodified CONSORT checklist for NI/Eq trials.

Presenting author (Also contact author)

Dr. Vikram GotaAssistant ProfessorClinical PharmacologyAdvanced Centre for Treatment Research & Education inCancer (ACTREC)Tata Memorial CentreKhargharNavi MumbaiTel: 022 2740 5130vgota@actrec.gov.in

Who is using The Cochrane Library?

Usage statistics of Wiley InterScience for India andWorldwide.

Jaslyn Tan, Piyush Gupta, Ashish Sood, Laura Sampson;Wiley InterScience

BACKGROUND: The dissemination of high quality, timelyevidence is a priority for The Cochrane Collaboration andfor the ICMR who fund a national access licence for India.By monitoring usage, exploring user activity, and identifyingtrends we can build on our understanding of how peopleuse The Cochrane Library, where they come from, and whichreviews they access. We can use these data to help usidentify ways of increasing access to and usage of TheCochrane Library in India and worldwide.

METHODS: For the worldwide data the periods of 1stJanuary 2008 to 31st December 2008, the number of uniquevisits to www.thecochranelibrary.com, number of visits bycountry, and most accessed Cochrane reviews on WileyInterScience were taken from the Wiley InterScience DataWarehouse, an analysis tool that stores and tracks usagedata. Another set of usage data was obtained from all otherlicensed providers of The Cochrane Library, showing thenumber of abstracts and full text articles that were accessedduring 2008 from Wiley InterScience, EBSCO, OVID, LaBiblioteca Cochrane, BIREME and www.cochrane.org. Forthe India usage data the periods calendar year 2006, 2007,2008 and Jan – August 2009 were considered, so as to helpinvestigate the impact of introducing national access, usingthe IP ranges for India to identify India usage activity asregistered from Wiley InterScience Data Warehouse.

Results: In India, in 2008 a full text article was downloadedfrom Wiley InterScience every 7 minutes. For India thisrepresents an increase in usage of The Cochrane Library of648% from Year 2006 to Year 2007 and 14% from Year 2007to Year 2008 and by August 2009, the total full text downloadis already 68% of the total Year 2008 figures. Data takenfrom all websites of The Cochrane Library show that during2008: A search of The Cochrane Library took place every 2seconds; A Cochrane abstract was viewed every 3 seconds;A full text article was downloaded every 4 seconds. Thetotal full text download for Cochrane Library in India inYear 2008 is 70,090; making India as one of the top 10countries from Asia that visited Cochrane Library worldwide

Conclusions: In summary, usage of The Cochrane Library in2008 has increased considerably in comparison to 2007.Over half the world’s population now have access to TheCochrane Library via one-click access (no login required),and it is clear that worldwide usage of The Cochrane Libraryis increasing as a consequence. Usage in India, since thenational license was provided, access nationally has grownsignificantly and the usage levels now surpass many otherdeveloped countries with established national accessschemes including Norway, Ireland and Poland establishingIndia as one of the top countries visiting and using TheCochrane Library.

EVIDENCE BASED MEDICINE: A NEW APPROACH TO TEACHMEDICINE

Authors:

Yeshwant*, Elakkiya*, Prarthana Saraswathi*, SurapaneniKrishna Mohan**

Affiliation:

*II MBBS Student, Saveetha Medical College & Hospital,Saveetha University, Saveetha Nagar, Thandalam, CHENNAI– 602 105, T.N, INDIA.

**Assistant Professor, Department of Biochemistry,Saveetha Medical College & Hospital, Saveetha University,Saveetha Nagar, Thandalam, CHENNAI – 602 105, T.N, INDIA.

BACKGROUND: No clinician would consider enteringclinical practice without knowing the rudiments of history-taking and physical examination, nor would cliniciansconsider independent practice without a basicunderstanding of how the drugs they prescribe act on theirpatients. Yet, traditionally, clinicians have started practicewithout an ability to understand evidence about how theyshould interpret what they find on history and physicalexamination, or the magnitude of the effects they mightexpect when they offer patients medication. Evidence-basedmedicine (EBM) provides a remedy for this problem.

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AIM: Our Aim of this presentation is to introduce EBM tothe beginners.

WHAT IS EBM? Evidence-based medicine (EBM) is theintegration of best research evidence with clinical expertiseand patient values.

WHY THE INTEREST IN EBM? The EBM approach seeks toapply evidence from rigorous clinical research to the careof individual patients and has been defined as the“conscientious explicit and judicious use of current bestevidence in making decisions about the care of individualpatients”.

STEPS IN EBM PACTICE? It consists of FIVE related steps.

Step 1: ASKING focused clinical questions that arise incaring for patients.

Step 2: ACQUIRING the best available evidence throughelectronic searching.

Step 3: APPRAISING the quality of the evidence acquiredagainst explicit methodological criteria.

Step 4: APPLYING the evidence appropriately to the clinicalmanagement of individuals.

Step 5: ASSESSING performance in relation to the previousfour steps.

LIMITATIONS OF EBM: The commonly cited limitations ofEBM are as follows-1)Universal to the practice of medicine2) Shortage of coherent, consistent scientific evidence 3)Difficulties in applying evidence to the care of individualpatients 4) Barriers to the practice of high-quality medicine5) Unique to the practice of evidence-based medicine 6) Theneed to develop new skills 7) Limited time and resources 8)Paucity of evidence that evidence-based medicine “works”.

ADDRESS OF THE PRESENTING AUTHOR:

YESHWANT KUMAR N.N.T,II MBBS Student,Saveetha Medical College & Hospital,Saveetha University, Saveetha Nagar,Thandalam, CHENNAI – 602 105,Tamilnadu, INDIA.Email address: yeshwantprofo@gmail.comContact Number: +91-9962833305

EVIDENCE INFORMED PUBLIC HEALTH:

BACKGROUND: NATIONAL RURAL HEALTH MISSION (NRHM)is evidence based programme. NRHM is a national effort atensuring effective health care through a range ofinterventions at individual, household, community andmost critically at the health system.

Under NRHM programme we will study JANANI SURAKSHAYOJNA (JSY) carried out in RAJASTHAN.

AIMS:

1) Reduction in MATERNAL MORTALITY RATE (MMR)

2) Reduction in INFANT MORTALITY RATE (IMR) by 50%from existing levels in next seven years.

METHODS: Government of RAJASTHAN has appointed ASHA(Accredated Social Health Activist) in every village whoensures early registration of pregnant woman and threeinstitutional Antenatal Care check ups, two doses of TetanusToxoid vaccine and hundred tablets of Iron Folic acid toeach pregnant woman. Also she promotes InstitutionalDelivery and for doing this government provides ReferralTransport facility from the home of beneficiary to the healthcare system. ASHA also ensures five Post Natal check upsand Immunisation of the child. The financial scale ofassistance under the scheme is as follows:

RURAL AREA

Mother’s package ASHA package Total Rs.

1400/- 200+300+100=600/- 2000/-

200-ANC check up300-Referral transport

100-PNC check up

URBAN AREA

Mother’s package ASHA package Total Rs

1000/- 200/- 1200/-

RESULTS: Comparative study of Institutional Delivery in theyear 2007-08 and 2008-09 in state of RAJASTHAN.

Statement showing progress of JSY beneficiaries in stateof RAJASTHAN:

Total ANC Registration 12,78,503

Beneficiaries 2007-08 4,68,886

Beneficiaries 2008-09 598772

Percentage % 27.70

CONCLUSION: This programme has encouraged InstitutionalDelivery as a result-

1) MMR has decreased

2) IMR has decreased

PRESENTING AUTHOR: SAUMYA AGARWAL32/347 OUTSIDE SURAJPOLE ABOVE IDBI BANK ATM,UDAIPUR, RAJASTHAN.

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Plagiarism in Indian Medical Journals, a pilot studyAneesh George, Richard Kirubakaran, Prathap Tharyan

Prof. BV Moses and ICMR Centre for Research andTraining in Evidence-Informed Healthcare

BACKGROUND: Plagiarism is the reproducing of the workor ideas of others as ones own, without giving the originalauthor proper credit or acknowledgement. Plagiarism isconsidered as research misconduct. However, there arecultural differences in attitudes towards plagiarism.

OBJECTIVE: To detect plagiarism in a small sample ofindexed and non-indexed Indian Medical Journals (in 2008)and to assess guidelines on avoiding plagiarism in the‘Instructions to Authors” of these selected Journals.

METHODS: We selected 65 Indian medical journals andclassified them as indexed and non- indexed based on thecitation in Pub med. We randomly selected four journalseach, from both these categories, using a random numbertable and selected all Review articles and Original articlesin all issues for 2008. We used the free online plagiarismdetecting tool, Duplichecker, and used Google and Yahoo asour primary and secondary search engines. We checked allsections of each article and, in the absence of a standardworking definition of plagiarism, we defined plagiarism asthe detection of more than five consecutive words in asentence from another publication, without giving credit tothe original author; or more than fifteen consecutive wordswith acknowledgement but without copyright permissionfrom the original author(s) or publishers. We classifiedplagiarism as substantial if there were more than fiveinstances of the former in any article or the detection ofany instance of the latter.

RESULTS: We selected 194 articles (44 reviews (22.7%); 150original articles (77.3%)) from the 8 selected journals. Wedetected plagiarism in 70 (36%) articles (26/79 articles fromindexed journals (32.9%) and 44/115 (38%) articles fromnon indexed journals) with the highest rates in reviewarticles (70%). Google (the primary search engine in thisstudy) detected more than 80% of the plagiarized articles.Indexed and non indexed journals did not significantlydiffer with respect to plagiarism (OR=1.26 and CI=0.66-2.41).41/70 (58.6%) plagiarized articles were categorizedas ‘substantially plagiarized’ as per our working definition.

CONCLUSION: Over a third of the articles in this pilot samplehad examples of plagiarism. None of the selected journalsexcept the National Medical Journal of India had guidelineswith respect to plagiarism. Measures to develop standardworking definitions of plagiarism and to educate authorsand peer-reviewers and provide better guidance in editorialpolicy are needed.

CHANGING MEDICAL PRACTICE BY DISSEMINATINGEVIDENCE

AUTHORDr. Anna Mathew M. D. (Pharm),

Associate Professor in Pharmacology & Co-ordinator,CME Department, Christian Medical College, Vellore.

BACKGROUND: The CME department, consisting of thecoordinator and two office staff, plan and conduct CMEUpdates and prepare CME materials and media for updatingmedical practitioners with the help of the valuable expertteaching input from the committed faculty of variousdepartments in CMC.

OBJECTIVES: The objectives of the Continuing MedicalEducation (CME) department of Christian Medical College,(CMC) Vellore is to update doctors working in peripheralhospitals and rural areas and so to enable them to practiceevidence based medicine in primary and secondary carethrough relevant and need-based CME. This is important asthe Medical Council of India, now recertifies doctors everyfive years and requires thirty credit hours of CME per yearbefore recertification.

METHODS: Current Medical Issues (CMI) is a bi-monthlyjournal (ISSN 0973 4651) of the CME department, whichsummarises current issues and features Cochrane reviews,Evidence updates and Practical evidence about real lifesituations (PEARLS) to update its readership ofapproximately 1000 doctors located in various parts of thecountry both in rural and urban areas. The evidence basedmaterial provided by the Cochrane network is reviewed bya member of the faculty of CMC from the concerned specialty,who makes comments about the relevance of the update inour situation in India. These expert comments from thefaculty are included with the update in the journal.

RESULTS AND CONCLUSIONS: The Cochrane EvidenceUpdates have been well received by the readers judging bythe responses that have come back to specific questionsasked in the quality survey in each issue. The feedbackreveals that the Cochrane reviews are read and areinfluencing the practice of the doctors. The readers havesent in anecdotes about how their practice has been affectedand also ask thought-provoking questions which are thenpassed on to faculty to be answered. This has resulted in adialogue between the doctors in peripheral hospitals andthe faculty at CMC and some of these are featured in the‘Readers Write’ column of CMI.

To date 118 summaries of Cochrane reviews, EvidenceUpdates and PEARLS have been included in the CMI journaland around 60 faculty from over 20 specialties in CMC havecommented on these issues.

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As one of the doctors working in a mission hospital haswritten, “It is very difficult for busy doctors in short-staffedhospitals to keep abreast of what is happening in themedical world. Besides we cannot subscribe to journalsand do not have easy access to the internet. The Cochranenetwork has done a fine job of summarising evidence andthe CME journal. ‘Current Medical Issues’ brings us theconcise information in an easily readable format so thatwe too, working in the rural areas can practice evidencebased medicine”.

ACKNOWLEDGEMENTS: The CME department is grateful tothe faculty of CMC who are eminently competent and everwilling to share their expertise to enhance the skills ofdoctors working in peripheral hospitals.

The activities of the CME department are enhanced by thediligence and hard work of the support staff, Mr. T. SureshBabu and Mr. C. Nagarajan and their good work is herebyacknowledged.

65

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 manytrials contained several ‘Rasayana’ medicinal plants, these formulations are expected to improve quality of life apart from other actions. We have screenedAyurveda drugs with modern medicine in superiority and equivalence designs. We present results of representative trials for Rheumatoid Arthritis (RA) andOsteoarthritis (OA).

Results of RA and OA trials

Trial Design Participants Intervention (n) Outcome Result(sample size)

Plant extracts of Withaniasomnifera, Boswellia serrata,Zingiber officinale and Curcumalonga

Boswellia serrata (Salai Guggul),Trigonella foenum-graecum(Fenugreek), Linum usitatissimum(Flaxseed), Camellia sinensis(Green tea), Curcuma longa(Turmeric), Tribulus terrestris(Gokshur), and Piper nigrum(Black pepper).

1. Plant extracts of Guduchi(Tinospora cordifolia),Ashwagandha (Withaniasomnifera),Gokshur (Tribulusterrestris) and Shunthi (Zingiberofficinale)2. Bhallataka (Semecarpusanacardium)

RDBPlacebo controlled

RDBPlacebo controlled

Single blindHydroxychloroquin

Patients with active-on-chronicRA (182)

Patients with active-on-chronicRA (130)

Patients with active RA (121)

Swollen joint countSwollen joint scoreACR 20

Swollen joint countSwollen joint scoreACR 20

Swollen joint countSwollen joint scoreACR 20

Superiority overplacebo (Not Signifi-cant)

Superiority overplacebo for allefficacy measures.

Significantimprovement withrespect tophysician globalassessment

1 year of follow-upshowed significantimprovement in allefficacy variables

No significantdifference in any ofthe efficacy measuresexcept physicianglobal assessment.

RA-1

IRA-01

NMITLI/B1

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

RDBPlacebo controlled

RDB Placeboand Glucosamine

RDBEquivalence trialControl as Celecoxiband Glucosamine

Patients of symptomaticprimary OA knees with Pain VAS> 4 (90)

Patients of symptomaticprimary OA knees with Pain VAS> 4 (245)

Patients of symptomaticprimary OA knees with Pain VAS> 4 (440)

Pain VASWOMAC

Pain VASWOMAC

Pain VASWOMAC

Plant extracts of Withaniasomnifera, Boswellia serrata,Zingiber officinale and Curcumalonga

Formulations containing Shunthi(Zingiber officinale), Guduchi(Tinospora cordifolia), Amalaki(Emblica officinale), Ashwagandha(Withania somnifera) and Gokshur(Tribulus terrestris)

Formulations containing Shunthi(Zingiber officinale), Guduchi(Tinospora cordifolia)

Active group showeda significantreduction

No significantdifferences for painand WOMAC

Ayurvedic formula-tion shown equiva-lent efficacy

RA-11

NMITLI/C-01

NMITLI/C-02