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Sasika's

8th Winter Symposium

Christian Medical College, Vellore 3rd South Asian Regional Symposium on Evidence Informed Healthcare Theme: “Evidence for
Christian Medical College, Vellore
3rd South Asian Regional Symposium on
Evidence Informed Healthcare
Theme: “Evidence for Better Health”
Date: 11th - 14th January 2010

Venue: Scudder Auditorium, CMC Campus, Bagayam, Vellore

Supplement

Plenary Session Abstracts & Poster Abstracts

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.in Website: www.cochrane-sacn.org

Organised by

Prof BV Moses & ICMR Centre for Advanced Research and Training in Evidence Informed Healthcare & South Asian Cochrane Network & Centre

www.cochrane-sacn.org

Comparison of effectiveness of allopathic treatment with herbal treatment for uncomplicated upper respiratory tract infection in Jamunamarathur Tribal Primary Health Care Centre of Tamil Nadu

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

*Senior Program Officer, Foundation for Revitilization of Local Health Tradition, Bangalore,

** Department of Botany, Kongunadu Arts and Science College, Coimbatore,

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

BACKGROUND: Today it is very evident that the local health traditions at house hold level show that there is a decline in the usage of home remedies, traditional diets and health customs. This situation demands a movement that incorporates local resources and local knowledge for enhancing health security by promoting under a public health system for the wider use. Hence there is a need to research and promote the proper use of traditional medicine by developing and providing international standards, technical guidelines and methodologies on the effectiveness. In this study one formulation for cough due to upper respiratory tract infection has been selected from the ethno botanical documentation of the local healer.

AIM: To study the effectiveness of herbal cough syrup compared to allopathic treatment for uncomplicated upper respiratory tract infection.

METHODOLOGY: Randomized control clinical trial. Settings:

Out patients of Jamunamarathur Primary Healthcare Centre in the Javadu hills, in Thiruvanamalai. Participants: 64 participants (32 in each arm) were recruited from amongst the patients suffering from uncomplicated upper respiratory tract infection. Intervention: One group received the allopathic treatment of benadryl syrup, paracetamol tablets and a saline nasal drop. The other group got the herbal cough syrup, with masked tablets and nasal drops. Examined twice (3rd and 7th day), during the length of the week long follow-up. Method: Patients were randomly allocated to receive either the herbal cough syrup or allopathic treatment.

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

Conclusions:

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

There is only 7% difference in the cure rate between the allopathic arm (65%) and the herbal arm (58%). The P value= 0.602, P>.05, the difference of effectiveness between two arms is not significant. Hence the herbal cough syrup can be acceptable as alternative cure for cough due to URI.

No adverse effects have been reported during the present clinical study.

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

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

Prof. BV Moses & Indian Council of Medical Research Center for Advanced Research and Training in Evidence Informed Healthcare;

South Asian Cochrane Network & Centre, Christian Medical College, Vellore, India

Background: Editorial requirements for submission of reports of Randomized Controlled Trials (RCTs) in 2005 and the quality of reporting of RCTs in 2004 and 2005 in Indian medical journals were suboptimal [1].

Objectives: To assess the changes in editorial policy for manuscript submission in 65 Indian medical journals in 2008 compared to 2005 the quality of reporting of RCTs published in these journals in 2007-2008 versus 2004-2005

Methods: We included 65 Indian medical journals identified from the South Asian Database of Controlled Clinical Trials (w ww.cochrane-sadcct.org) tha t provided data for the earlier sur vey.AG and RK independently analyzed their instructions to authors for endorsement of the CONSORT statement and the ICMJE requirements for reporting of RCTs.AG and RK independently evaluated reports of all RCTs published in these journals in 2007 and 2008 against 13 selected CONSORT items and the ICMJE requirements. All data were verified by PT. We compared the proportion of reports in 2004-2005 versus 2007-2008 that endorsed selected CONSORT and ICMJE items

RESULTS: Of the 65 journals, 38 (59%) in 2005 and 37 (57%) in 2008 mentioned the ICMJE requirements in their instructions for authors, but only 20 (31%) in 2005 and 22 (33%) in 2008 specifically required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 R CTs published in 2004-2005, and 145 R CTs

publishe d in 20 0 7-2008, only 4/13 (31%) of select ed CONSORT items were reported in > 50% of trial reports. Reporting was better for some items reflecting internal validity but worse or unchanged for others. Ethical issues continued to be poorly reported, though reporting funding sources and conflicts of interest had significantly improved.

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

CONCLUSIONS: Editorial policy in leading Indian medical journals r egar ding manuscript submission for RC Ts continues to be suboptimal. The reporting of RCTs for CONSORT items reflecting internal validity was better in 2007-2008 over 2004-2005 for random sequence generation but continued to be suboptimal for allocation concealment, blinding and intention to treat analyses. The reporting of conflicts of interest and funding sources had significantly improved in RCTS published in 2007-2008 Urgent measures to educate Indian medical journal editors are needed and is planned.

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

Asokan GV 1 , Dave Sinclair 2 and Prathap Tharyan 3 BACKGROUND: Google Insights is a free-to-use internet tool which tracks the popularity of specific internet search terms over time. 1 This simple tool has the potential to provide real time data on public health concerns. 2 OBJECTIVE: To investigate the way health information is searched for in India via Google, and to evaluate interest in searching for The Cochrane Library since the national subscription was purchased by the Indian Council for Medical Research in 2007. 3 METHODS: Using “Cochrane” as the search term under the category of “Health”, “medical literature and resources” as the primary subcategory, and the period 2004 to 2009 as the time frame, we evaluated

  • 1. The most popular search terms in India used to identify health websites/portals in India

  • 2. Variation over time and between states in India and the top four countries of Cochrane usage.

  • 3. The volume of Cochrane-related searches compared to some popular Indian and International medical journals and health-related websites.

We also compared the Google Insights data with usage statistics provided by Wiley-Blackwell, publishers of The Cochrane Library.

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

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Health Library, Doctor NDTV and web health centre), over the period studied. Interest increased dramatically since the provision of the national subscription with the maximum interest over time seen in Tamil Nadu, Maharashtra, Delhi and Karnataka. Interest was sustained, with peaks reflecting national Cochrane-related symposia and activities. Australia, the UK, and Canada showed the maximum interest in ‘Cochrane’, but since 2007, India has overtaken the US. ‘Cochrane’ also scored above Indian journals (Indian Journal of Medical Research, National Medical Journal of India, Journal of the Association of Physicans of India, the Postgraduate Medical Journal and others) and international journals (NEJM, The Lancet, BMJ and JAMA). However, ‘PubMed’ was by far the most commonly-searched term in Google during these years. Data from Wiley-Blackwell on actual usage of The Cochrane Library from 2006-2008 mirrors the increased interest in usage captured by Google Insights since the provision of the national subscription

CONCLUSION: Google Insights is a proxy to evaluate interest in Cochrane in India, and may reflect healthcare information seeking behavior of healthcare professionals, researchers, students, consumers, etc. These results are only indicative and restricted to trends captured by a single search engine with this capability. They also do not reflect direct access to health-portal, journal, or database websites though stored or forwarded web-links. However, they correlate with direct data of usage statistics of The Cochrane Library. The National subscription has increased and sustained interest in The Cochrane Library , though high interest is limited to certain states.

REFERENCES

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

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

  • 3. Tharyan P. Access to the Cochrane library for everyone in India. National Medical Journal of India 2007; 20 (1): 49.

AUTHOR AFFILIATIONS

1 Research Officer, Institute of Veterinary Preventive Medicine, Ranipet, Vellore District, India

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

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

COMPARISON OF CEFOXITIN AND OXACILLIN DISC DIFFUSION TEST WITH OXACILLIN SCREEN AGAR FOR DETECTION OF MRSA

Authors Azhar Sheikh a Dr.Vijayshri Deotale b

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

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

Correspondent Author: azhar4u27@gmail.com

INTRODUCTION: Today MRSA strains are worldwide major cause of nasocomial infection. Mec A based detection identifies even the most heterogenous strains of MRSA and considered as gold standard. Cefoxitin surrogate marker for for detection of mec A gene mediated methicillin resistance.

Clinical and laboratory standard institute (CLSI) guidelines 2006: Cefoxitin disc diffusion test recommended for detection of MRSA.

Why this research?:To evaluate the efficacy of cefoxitin disc diffusion test to detect MRSA and compare it with oxacillin agar screening.

METHODOLOGY: A total of 50 consecutive non-repeat isolates of MRSA isolated from clinically relevant source for period of 2 month. Isolates were identified by culture and biochemical tests and were subjected for antibiotic susceptibility testing by Kirby bauer disc diffusion method (CLSI method). All Co-agulase positive staphylococcus were tested for oxacillin susceptibility test.Inoculation of 0.5 MacFarland standard was done on Mueller Hinton agar and detection for cefoxitin was done with help of disc of cefoxitin 30 microgram applied on surface of media . On Oxacillin screen agar inoculation of 0.5 MacFarland standard was done. Even growth of single colony indicated methicillin resistance.

RESULTS: Resistogram of MRSA strains:

ANTIBIOTICS

RESISTANT

Erythromycin

34(68%)

Penicillin

46(92%)

Ciprofloxacin

28(56%)

Oxacillin

50(100%)

Cefoxitin

21(42%)

Linezolid

19(38%)

Chloramphenicol

22(44%)

Comparison of oxacillin disc,cefoxitin disc with oxacillin screen agar:

Oxacillin disc

Oxacillin screen agar

Cefoxitin disc

50(100%)

50(100%)

21(42%)

Highest isolation of MRSA isolates were from pus specimen(42%) followed by blood (14%) and conjuctival swabs (14%).The prevalent age group from which samples were obtained was 0-5 yrs age group. Maximum resistance was for penicillin after oxacillin.On comparison with oxacillin disc with cefoxitin disc the oxacillin disc showed 100% co-relation with oxacillin screen agar whereas cefoxitin disc could detect only 42% isolates.

CONCLUSION: Oxacillin disc diffusion test was found better than cefoxitin disc diffusion test for detection of MRSA strains.

The Cochrane Ark: are there animals studies hiding in CENTRAL?

Clive E Adams 1 , Samantha Roberts 1 , Drew Davey 1 , Julie Monalisa 2

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

2 South Asian Cochrane Network and Centre, Christian Medical College, Vellore, India

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

AIMS: To investigate whether animal studies hide in CENTRAL.

METHODS: We searched CENTRAL (Issue 1, 2009) using terms for animals in title and then the title, abstract, keywords combined function. The results were downloaded and manually searched twice to ascertain whether trial participants were indeed living human beings or animals.

RESULTS: CENTRAL positively clucks, moos, squeaks, meows and even barks with the sound of wildlife. We initially retrieved 11,443 records. After screening and removing duplicates, 53 records were identified within CENTRAL as reporting trials conducted on animals, and not on human participants.

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

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Clinical Management of Acute Undifferntiated Febrile (AUF) Illnesses with complications- Malaria during Pregancy in India: Evidence gaps in Intermittent Preventive Treatment (IPT)

 

Authors:

* A.George Vasanthan

* Anand

Manoharan

**Di lip

Mathai Affliation: *Scientist (Research)

Infectious Diseases Training and Research Center (IDTRC) Dept.of Medicine Unit 1 and Infectious Diseases **Professor and Head Department of Internal Medicine Chief Mentor: Infectious Diseases Training and Research Center Prof.Benjamin Pulimood Laboratories for Infection Inflammation and Immunity (BMPLIII) ACC-CMC Trust for Infectious Diseases

Author for Correspondence:

Dr.Dilip Mathai MD PhD FCAMS FICP FIDSA Professor and Head Dept.of Internal Medicine Christian Medical College PO Box.No.3, 4 th Floor SP Complex Ida Scudder Road Vellore 632 004 Tel: +00-91-416-228-2921/2923/2804

Email:dilipmathai@hotmail.com

Clinical management of acute undifferentiated febrile illnesses in the community in India may be difficult as there will be no single feature of any disease or common clinical presentation to suggest etiology of a diagnosis. In most of cases failure of an empirical therapy provided by a private health care provider or lack of an intervention may lead to severe complications as in case of malaria or dengue.

Malaria endemic in India (estimated 70-100 million cases each year (1.6-1.8 million reported b y NVBDCP) causes complications during pregnancy if not treated early resulting in still births, low birth weight, anemia, and maternal mortality. In remote rural areas in malaria endemic zones of Enhanced Malaria Control Project (EMCP) states,42.79% among 12 million malaria positive pregnant women die due to P.falciparum alone either at home or in the private sector. This mandates further decentralization of health care to such areas which have been adopted by the Norway India Partnership Initiative (NIPI) to prevent maternal deaths due to malaria or other causes in line with the MDG 5.Recognition of malaria in pregnancy as an important public health problem in India, its delimitation, stratification, and realistic calculations for planning and interventions is a major health care measure to meet the target in MDG5.

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

Accuracy of clinical assessment of Hyperbilirubinemia in Hospitalized Neonates.

a

b

Authors Gondnale G a , Taksande A b ,Vilhekar KY c

II Year MBBS, Mahatma Gandhi Institute of Medical Sciences, Sevagram

Associate Professor, Dept. of Pediatrics, Mahatma Gandhi Institute of Medical Sciences, Sevagram.

  • c Professor and Head, Dept. of Pediatrics, Mahatma Gandhi Institute of Medical Sciences, Sevagram

Correspondent Author: cool.goral@gmail.com.

INTRODUCTION: Jaundice, a frequently encountered diagnostic and therapeutic problem in newborns is quite common affecting nearly 60% term and 80% preterm neonates during first week of life. The standard method of serum bilirubin estimation requires blood specimen taken by heel prick or venepuncture which is painful and expensive. Clinical evaluation of neonate through a comprehensive history and physical examination is considered as a cornerstone in neonatology.

Material and Methods: All newborns delivered in the hospital were enrolled on 3rd day of life after a written informed consent from the parents. Neonates who had received exchange transfusion or phototherapy prior to inclusion were excluded. 3 independent and blinded observers- a trained medical student, a neonatology nurse and a pediatric resident examined all the enrolled newborns for jaundice in the standard manner and predicted total serum bilirubin according to the cephalocaudal extent of jaundice. Irrespective of interpretation of the index test (clinical examination), blood was withdrawn from all newborns immediately for estimation of total serum

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

RESULTS: A total of 99 neonates were included in the study between April and May 2009. A total of 64(%) neonates had hyperbilirubinemia above 10mg/dL and 30 (%) above 15 mg/dL respectively. The sensitivity of clinical examination for detection of hyperbilirubinemia was poor (range 10 to 70.3%). The specificity was reasonable (range 81.6 to 99.9%). The positive likelihood ratios ranged from 2.19 to 22.2 and negative likelihood ratios from 0.43 to 0.78. In event of a positive clinical test, the chances of neonatal hyperbilirubinemia are high, however a negative clinical test does not rule it out.

CONCLUSION: All neonates need to be screened for hyperbilirubinemia using standard bilirubin estimation tests. Clinical assessment is likely to miss many neonates with high bilirubin levels.

Key Words: Clinical Assessment, Neonatal Hyperbilirubinemia, Accuracy, Reliability

Medicine: profession or trade?

Hari Prasad 1, 2 , Rishi Raj 1 , KR Bhagavan 2 , Sangeeta Das Bhattacharya 1

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

2 Department of General Surgery, KS Hegde Medical Academy, Deralakatte, Mangalore, India

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

CASE REPORT: A 3-months-old female with Tubular colonic duplication with Recto-vaginal fistula underwent successful right transverse colostomy along with side-to-side anastomosis of the native and duplicated rectum aiming at internal drainage. A few days after the surgery the surgeon learnt that biopsy of the duplicated segment revealed dysplastic changes. The parents were informed that the child has an additional high risk of developing malignancy of the duplicated segment. The new information however had a negative effect on them. They stopped being well adjusted and optimistic. Her parents believed that entire surgery has been completed and she has to live rest of her life with the colostomy in-situ. Hence they did not get the closure done

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

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

DISCUSSION: It would be in conflict with the principle of patient autonomy if the surgeon withheld important information. But in our case, her parents already knew that she requires a long term follow up and hence new information does not imply any benefit other than a more careful follow up. Hence the communication of the information in this case probably could have been postponed. On the other hand, her parents actually needed more information and education regarding the type of the defect, surgery done and the need for timely closure of the colostomy and regular follow up.

CONCLUSION: General feeling of the public is that, “The job of a doctor is to reassure and comfort the sick, not to frighten them”. In our opinion, physicians need to be warned against an attitude biased towards what “the rules say” more than towards what the patient wants or needs. The respect enjoyed in our society imposes certain moral responsibilities on them, one being balanced presentations of necessary facts which neither unduly alarm nor entice patients but facilitates decision-making.

The Cochrane Schizophrenia Group Specialised Register

Julie Monalisa 1 , Samantha Roberts 2 , Clive E Adams 2 1 South Asian Cochrane Network and Centre, Christian Medical College, Vellore, India. Email: julie_sacn@cmcvellore.ac.in 2 Cochrane Schizophrenia Group, University of Nottingham, UK BACKGROUND: The Cochrane Schizophrenia Group (CSG) Specialised Register contains all reports of controlled trials on severe mental/psychiatric illness, psychosis, schizophrenia and related disorders with comorbid disorders such as substance abuse, depression, personality disorder or problematic behaviours/adverse effects (aggression/antipsychotic-induced tardive dyskinesia). The group maintains its register in a Microsoft Access database (Meerkat 1.5 http://cochrane.co.uk/en/newPage1.html). Meerkat stores references as studies (is a study-based register), attaches to full text of reports, stores contact addresses of group reviewers, tracks reports sent to authors and has the capacity to link to the datasets within existing Cochrane Reviews.

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AIMS: To describe the specialized register of the Cochrane Schizophrenia Group.

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

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

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

Thai databases

Kamolthip Atsawawaranunt 1 , Clive E Adams 2 , Samantha Roberts 2

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

2 Cochrane Schizophrenia Group, University of Nottingham, UK

BACKGROUND: Thailand is a poor but highly literate country of over 60m people in South-East Asia. Much biomedical research is undertaken but dissemination is limited.

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

METHODS: A systematic search for institutions productive of research, and the databases in their libraries. Use each accessible database and recording of functionality and content.

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

CONCLUSIONS: More collaboration within Thailand would help merge databases and allow greater dissemination of local work. Those undertaking comprehensive searches for biomedical literature cannot afford to ignore the considerable efforts of researchers in Thailand.

META ANALYSIS – Physiotherapy perspectives

Lenny Vasanthan T

Dept of Physiotherapy, Manipal University, Manipal.

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

AIMS: Meta-analysis aims to identify facts more accurately than traditional narrative review. It delivers facts with objectivity, helps in determining magnitude of effect and resolve differences in literature.

METHODS: Meta-analysis is a 2 stage process

  • 1. Data extraction and calculation of summary statistic along with confidence interval

  • 2. Calculation of a pooled average if appropriate.

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

RESULTS: Great care has to taken to assess methodological quality of design and execution of study. Quality check using appropriate check list needs to be done, Heterogeneity of studies should be checked as it influences the further method of analysis. Forest plot is a pictorial representation used to present the findings.

CONCLUSION: Helpful in determining small but clinically significant effects with precise estimate of effect size, which helps to add to the evidence base, thereby treat patients in a better way. Pitfalls include overgeneralization, ignoring qualitative difference between studies, dealing with main effects only. Fundamentally meta-analysis is limited by quality of underlying studies “GIGO” (garbage IN garbage OUT)

References:

  • 1. Cochrane open learning material 2002

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  • 2. Crombie.,EBM series 2009

  • 3. DeCoster J.,Meta-analysis notes 2004

  • 4. Helewa A., Critical evaluation of research in physical rehabilitation 2000.

Ethics of inaccessibility of funded research publications

Dr.N.Isai Vani.

Assistant Professor, Department of Anatomy, Sri Venkateshwaraa Medical College & Research Centre, Pondicherr y. Email: drisaivani@gmail.com

India is becoming the hub of clinical research. In commensurate with these advances, the government funding for biomedical research in thrust areas is also increasing. Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT), Department of Science & Technology (DST) are some of the government organisations which provide financial support for various research projects. The results of the funded research projects are published in various international journals. Most of these journals have an access to paid subscri bers only. Hence it is unethical to use the research grants from government (people’s tax) and not allowing the scientific community a free access to the results of the study.

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

Such an initiative – PubMed central (PMC) already exists in USA. Every investigator getting grants from National Institutes of Health has to submit the full text of the article publishe d from his s tudy, which would be made fr eely accessible at PMC. The funding bodies in India should also form an initiative similar to PMC and put an end to this unethical act.

Bedside Capillary blood glucose measurement by glucometers compared to venous blood glucose in critically ill patients and find the Reliability Sensitivity and Accuracy of point of care glucometer in MICU.

a

b

Authors Manish Chandra Prabhakar a SP Kalantri b

Student II MBBS| Mahatma Gandhi Institute of Medical Sciences, Sevagram | Maharashtra

Professor of Medicine | Mahatma Gandhi Institute of Medical Sciences, Sevagram | Maharashtra

Correspondent Author: prabhakar4u07@gmail.com

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

METHODS: I studied consecutive patients admitted to an intensive care unit between 1 May and 10 May 2009. I compared the diagnostic accuracy of two- point of care glucometers with laboratory venous glucose, the reference standard. I used Bland- Altman plots and Clark error grid method to analyse the results.

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

CONCLUSIONS: Point of care glucose, measured by glucometers was in agreement with the venous glucose estimation. Both glucometers were equally accurate and performed uniformly well across the wide range of blood glucose values.

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

GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS

Manusri Naredla, Keerthi Maddi.

St.Peter’s institute of Pharmaceutical sciences, vidyanagar, Hanamkonda

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve clinical trials. Large scale healthcare interventions are likely to improve the health of the public only if the evidence clearly shows that the benefits outweigh harms and costs. Often, however, the evidence if is the other way

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the trials may fail to improve health, or may even cause harm, while costing dearly. Moreover, when a large scale intervention is implemented careful evaluation of the evidence must and should replace wishful thinking and guesswork or else the trials may prove to be enduring but possibly result in harmful standard of care. Such interventions should be implemented, therefore, only when the evidence shows that expected benefits outweigh harms and costs and this can be achieved by the implementation of systematic evaluation.

Obtaining definitive evidence on the effects of large scale interventions can be difficult and implementation with careful monitoring is justified but how ever acting without proof of net benefit is both costly and potentially damaging to health. Graded evidence follows a hierarchy of evidence consistent with randomized trials of high methodological quality, followed by randomized trials with methodological limitations, observational studies, and unsystematic clinical observations. Inferences are stronger when the evidence is summarized in systematic ways of representing the evidence for better interpretation of the clinical as well as observational trials.

EVIDENCE FOR BETTER HEALTH SURVEILLANCE ON HOSPITAL ACQUIRED INFECTIONS IN A TERTIARY CARE SET UP

Mrs. Meenakshi Sekar,M.Sc N Associate Professor, College of Nursing, CMC Vellore Former Infection Control Nurse Supervisor, CMC, Vellore

Dr. Karen Jacob, D.A.

P.G. Registrar, Department of Anesthesia, CMC Vellore Former Hospital Infection Control Officer, CMC, Vellore

BACKGROUND: This surveillance of Hospital Acquired Infections (HAI) was conducted among the inpatients of Christian Medical College; Vellore which is a 2,572 bedded Hospital located in Southern India. Surveillance of HAI in any health care facility is an important aspect of Infection Control. The early recognition of HAI through a surveillance system is the first step to control HAIs. This enhances quality care.

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

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

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

AIM AND CONTENT: The aim was to assess the incidence of HAI among the inpatients of Christian Medical College; Vellore. The surveillance was conducted in the 63-inpatient areas of the Hospital. This included the wards; the ICUs (Medical ICU, Surgical ICU, Neurosurgical ICU, Cardio thoracic ICU, Pediatric ICU& Neonatal ICU) and other High risk areas (Renal transplant Unit, Burns Unit and Bone Marrow Transplant Unit).

METHODOLOGY: The Surveillance included all patients admitted in the hospital for a period of one year (March 2005 to February 2006). All Patients who developed fever after 48 hours of hospitalization were included in the group of “Probable HAI”. HAI was ruled out in patients who presented with fever at the time of admission or who developed fever with in 48 Hours of Hospitalization.

The Infection Control Nurse (ICN) visited all the patients admitted in the 63 areas of the hospital weekly twice. In each ward/ICU, the ICN notes down the total number of patients admitted and the number of patients with fever. All patients with fever are then investigated to determine if the fever originated 48 hours after hospitalization. Following the CDC guidelines these patients were tentatively designated as a case of HAI. The appropriate microbiological investigations sent for each patient was followed up to confirm the presence of HAI.

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

Infection Rate = Number of HAI per month x 100 Number of discharges per month

RESULTS: The following table gives the incidence of HAI per month.

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

2006)

MONTH

DISCHARGES

HAI

INFECTION

RATE

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 over the last six months. This is due to the fact that the criteria for including patients was slightly revised. Patients who were admitted with fever were also kept under constant observation and any worsening of the fever or reappearance of fever after becoming afebrile was included in he surveillance.

CONCLUSION: The incidence of HAI for a period of one year was found to be less than 1.1%. Low incidence of HAI is evidence that Quality Care is being provided for the patients. Regular surveillance for HAI contributes significantly to ensure quality patient care especially in tertiary care hospitals where many invasive procedures are carried out. Abiding to the Hospital’s Infection Control Policies help to reduce the risk of patients acquiring HAI.

REFERENCES : Roy,V.(2004). Clamp down on increased nosocomial infections ways to arrest the high level of nosocomial infections in hospital Express Health Care Management. Issue dtd. 16th to 30 th Retrived from http://

www.expresshealthcaremgmt.com/20040430/edit02.shtm

on Dec 2005.

Steed,C,J.(1999). Common

Infections Acquired in the

Hospitals. The Nursing Clinics of North America Contemporary

Infection Control For Nurses, 34,(2),pp 443- 460.

Wiseman, S. (2004). Implementing

effective Infection

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

Unequal Randomisation in Cancer Trials – A New Paradigm!

AUTHORS: Meghana Surlikar , Sadhana Kannan and Vikram Gota.

INSTITUTION: Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre, Sector-

22, Kharghar, Navi Mumbai

BACKGROUND: Randomised Controlled Trial (RC T) with

balanced allocation of participants to the experimental and control arms is a commonly practiced study design. The

design is simplis tic and therefore very appealing. However, circumstances warrant unequal allocation of subjects to

the different arms of the s tudy. This syst ematic re view focuses on the trends in unequal randomization (UR) in cancer clinical trials and the most common reasons for

resorting to this approach.

AIM: A systematic review to identify reasons for UR in oncology clinical trials published in five major cancer

journals over the last ten years.

Methods: A PUBMED search was undertaken to identify RCTs in cancer published from January 1999 to December 2008

in five major cancer journals namely JCO, Annals of Oncology, BJC, Lancet Oncology and JNCI. Forty three RCTs that reported UR of subjects to different arms were selected. Data was extracted for randomization ratio, reason for UR, phase of the trial and trial location (Single or multicentre). If the rationale for UR was not mentioned in the article, the corresponding author was e-mailed to obtain the reason.

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

CONCLUSION: UR appears to be an attractive alternative to balanced allocation especially in small randomized phase II trials. Statistical considerations and faster recruitment are important reasons for resorting to UR.

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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, and Korula George 1

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

BACKGROUND: Twenty five percent of anovulator y women with polycystic ovarian syndrome do not respond to standard clomiphene citrate therapy and are known as clomiphene resistant. We investigated the use of letrozole, an aromatase inhibitor as an alternative ovulation inducing agent in these women.

METHODS: 36 women with clomiphene resistance were randomized into two groups: one receiving letrozole 2.5mg daily from day 2 to day 6 of the cycle while the other an identical placebo. The primary outcome was the ovulation rate with analysis being intention-to-treat.

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

5.5%

CONCLUSION: In clomiphene resistant women, letrozole can be used as an effective and simple alternative ovulation inducing agent. The trial is registered with clinical trial registry of India (UTRN -017753618-3112200762223).

Clinical Trials Methods

Nailesh.T

SLIMS, Villianur, Pondy605502 Email:

Nailesh.reddy@gmail.com

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

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

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

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

RESULTS: Phase 0 trials is a recent designation known as human micro dosing studies has no data on safety or efficacy of drug. Phase 1 trials Examines the pharmacologic actions and safe dosage range of a drug; how it is absorbed, distributed, metabolized, and excreted; and its duration of action. Phase 2 trials are controlled studies in volunteers to assess the effectiveness and safety of a drug. Phase 3 trials are testing using a greater number of volunteer patients. The drug is administered by practicing physicians to those suffering from the condition the drug is intended to treat. These studies must confirm earlier efficacy studies and determine low- incidence adverse reactions. Phase 4 trials are studies conducted after FDA approval, during general use of the drug by medical practitioners, also referred to as post marketing studies. Fast-track approval is provided for drugs that meet unmet medical needs for patients with serious or life- threatening conditions. Labeling is information distributed about a drug by the manufacturer, even if it is not physically affixed to the product. Misbranding is “false or misleading in any particular” renders the product misbranded, making it subject to FDA regulatory action.

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

Access to evidence from countries in South Asia: The South Asian Database of Controlled Clinical Trials and the South Asian Cochrane Network and Centre’s Digital Library – An Update

Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh Parthasarathy

Prof BV Moses & Indian Council of Medical Research Centre for Advanced Research and Training in Evidence Informed Healthcare, South Asian Cochrane Centre, Christian Medical College, Vellore, India

BACKGROUND: Many trials conducted in middle and low income countries are published in journals that are not indexed in commonly searched databases. Their exclusion from systematic reviews could bias conclusions, rendering them unreliable and potentially irrelevant to health care in these countries.

OBJECTIVES: To describe the development of the South Asian

Database of Controlled Clinical Trials ( w w w.c ochr ane-

sadcct.org)

and the South Asian Cochrane Network &

Center’s Digital Library that aim to: provide a comprehensive

source in the public domain of all controlled clinical interventional trials involving humans conducted in the South Asian region, and published in regional journals, and contribute information about these trials to the

44

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

METHODS: Health Science Journals published from Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka and reporting interventional trials in humans conducted in these countries were sought from multiple electronic and other sources and 168 journals were identified. Online and print issues of these journals are searched in regular cycles. Citations and abstracts of all interventional trials identified from online editions and hand-searching of print editions are entered into Endnote. Trials are coded as RCTs or CCTs using standard criteria and cleaned records imported to MeerKat, with web-links provided to the original article, where possible. Full text articles are indexed and stored using the Greenstone Digital Library Software to create the South Asian Cochrane Network & Center’s Digital Library that can be retrieved by Titles, Author, Year, Journal and Keywords. All records are regularly transmitted for inclusion in the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) in The Cochrane Library.

RESULTS: The South Asian Database of Controlled Clinical Trials, initiated in November, 2008, was launched on January 1, 2009 (w ww.cochrne-sadcct.org) and is searchable free of charge. It currently contains the citations, abstracts and web-links (where possible) to 2830 records [(CCT-1350 (47%); RCT-1477 (53%)] published in 65 Indian medical journals, and 76 Pakistan Medical Journals. From submitted records, the citations and web-links (where available) to 1859 trials conducted in these South Asian countries are now included in the Cochrane Central Register of Controlled Trials (CENTRAL). Full text articles, in downloaded or scanned portable document format (pdf), are stored for most trials in the South Asian Cochrane Network & Center’s Digital Library. In the ongoing second phase, all 168 South Asian Journals (of which 101 (60%) are not indexed in Medline) and newer journals identified by ongoing searches will contribute trials, supplemented by searches of conference abstracts, dissertations and other sources.

CONCLUSIONS: The Cochrane Collaboration now has a resource to access all the evidence generated from interventional trials conducted in countries in the South Asian Region. Many of these, hitherto unidentified, trials can now be considered for inclusion in systematic reviews of the effects of interventions in healthcare conditions relevant to people in the region; these systematic reviews have the potential to be of greater relevance in informing healthcare and health-policy in these countries than before the creation of this resource.

When ‘Evidence’ goes against the grain:

Quetiapine for Bipolar depression

S. Mohan Raj,

Consultant Psychiatrist, Chennai

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

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

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

METHODS: Evaluation of the BOLDER II study 1 (study titled ‘Efficacy of Quetiapine Monotherapy in Bipolar I and II Depression’), using the Risk of bias table of Revman 5.

RESULTS:

The biases noticed were

1) Selection bias Exclusion criteria mention

  • 1.1 Current episode duration more than 12 months and less than 4 weeks (Comment: spontaneous remission is possible around 6 months)

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

  • 1.3 Current serious suicidal or homicidal risk as judged by the investigator (Comment: Severe depression is excluded)

2)

Incomplete outcome data were not adequately addressed.

The other problems were

1)

Definition of response as > or = to 50% reduction from baseline score of Montgomery Asberg Depression Rating Scale (MADRS) 2

2)

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

45

Another area of concern is that all the studies regarding Quetiapine in bipolar depression were prepared with ‘editorial assistance’ from a medical communication company called PAREXEL MMS), irrespective of the authors’ institution. PAREXEL’s website 3 offers to write up a scientific paper and boast of a 92% first time journal acceptance rate in 2008.

Conclusion:

Mechanism need to be evolved to restrict approval of drugs by regulatory bodies for indications for which no effect is seen in clinical practice.

References:

  • 1. Michael E Thase et al. Efficacy of Quetiapine Monotherapy in Bipolar I and II Depression. A double-blind, placebo controlled study (The BOLDER II study) J Clin Psychopharmacol 2006;26:600-609.

  • 2. Montgomery SA and Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-389.

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

EVIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in a medical college hospital

AUTHORS:John K R,Rakesh P S AUTHORS AFFILIATION

  • 1. Professor in charge of RNTCP$Head of the Department,Department of Community Health,CMC Vellore

    • 2 Post graduate registrar,department of Community Health,CMC Vellore

CORRESPONDING AUTHOR:John K R,Professor,Department of Community Health,CMC,VELLORE Email:mony@cmcvellore.ac.in

Ph:09443242603

BACKGROUND: The Revised National Tuberculosis Control Programme(RNTCP) based on Directly Obser ved Treatment Short course(DOTS) strategy was launched in India as a national programme in 1997.As private sector is the first point of contact for more than fifty percent TB patients,RNTCP has collaborated with a wide range of health care providers which establishes a unique model of public private mix in RNTCP.

As medical colleges treat a significant number of patients with TB and also provide care to seriously ill and complicated TB cases,efforts have been made to include medical colleges into the purview of RNTCP.

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

OBJE C TIVES : To s tudy the epidemiological trend of tuberculosis among patients registered in DOTS clinic, Christian Medical College,Vellore between 2002 to 2008.

METHODOLOGY: The exis ting quarterly RNTCP reports of CMC DOTS Clinic from 2002 to 2008 were consolidated. The data was entered in Microsoft Excel and analysed.

RESULTS and CONCL USION: The proportion of che st symptomatics referred for sputum examination from various departments in CMC were between 3 to 4% .This is above the suggested target of at least 2%.

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

Among the cases 33% were sputum positive,14% sputum negative pulmonary and 53% were extra pulmonary tuberculosis. The maximum proportion of extrapulmonary TB as per RNTCP guidelines is 50%.

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

Among those who received care from CMC unit,

sputum

conversion rates were consistently above 90% except for year 2003 when it was 86.9%.Cure rate was above 80% consiste ntly.

The CMC data shows that most of the recommendations laid down by RNTCP guidelines are achieved and it is functioning as per the guidelines of RNTCP.

Evidence Based Policy for Isoniazid Prophylaxis Therapy in Health care workers

Authors:

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

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

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

Dr. T.Shyam, School of Medical Science and Technology, IIT Kharagpur.

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

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

46

persons develop tuberculosis of which about 0.87 million are new smear positive highly infectious cases and about 3.3 lakh die of TB every year. There are approximately 2.5 million health care workers in India (NHP 2007) providing health services to the population. They are not only exposed to a high number of active TB cases but also they are constantly exposed to a high number of debilitated patients throughout their professional work.

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

METHODS: An evidence based search is conducted to find effectiveness of INH prophylaxis in Health care workers in India. Search was conducted in electronic medical resources to find the related studies performing Meta analysis and randomized control trials comparing Isoniazid and placebo/other anti tubercular drugs in different population groups. Appropriate statistical methodology was adopted to analyze the results and formulate the policy. The Criteria for evaluation were Numbers needed to be treated to prevent one active case of TB/ One death, number needed to harm (Hepatitis), adherence and compliance, ease of implementation, cost benefits analysis.

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

CONCLUSION: In India as per RNTCP recommendations no guidelines are available for prevention of TB in healthcare workers. India’s RNTCP is the largest DOTS program in the world. It is of paramount importance that they are given the best possible protection from occupational health hazards including TB. So we recommend incorporation of Isoniazid prophylaxis therapy among health care workers in India if they are found to be a case of LTBI. The therapy should be with 300 mg Isoniazid daily for six months. The maximum effect of Isoniazid prophylaxis is shown to be for 3 years (Debre), so it is recommended that every healthcare worker should be examined while joining health care services and then should be reviewed every three years.

Evidence Based Surgery: knowledge, attitudes, and perceived barriers among surgical trainees

Rohin Mittal, Benjamin Perakath

Christian Medical College, Vellore

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

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

METHODS: The McColl questionnaire and the BARRIERS scale were modified and incorporated into a single questionnaire. Surgical trainees attending a Continuing Surgical Education meeting at the author’s institution were asked to voluntarily fill in this questionnaire.

RESULTS: A total of 93 out of 110 (84.5%) trainees returned the filled in questionnaire. Attitudes towards EBS were welcoming, although colleagues were considered less welcoming than self. There was high level of agreement with usefulness of EBS in everyday practice and EBS improving patient care. About 50 % of actual practice was considered to be evidence based. 12.6 % (11/87) participants had received formal training in EBM. 64.3 % (54/84) were aware of the Cochrane database of systemic reviews but only 35.7% (30/84) read it regularly. 67.8 % (61/90) used protocols and guidelines developed by colleagues to practice EBS. However, 61.5 % (56/91) were interested in learning the skills of EBS. The terms absolute risk, relative risk and clinical effectiveness were understood by > 80 % of respondents, while publication bias, confidence interval and heterogeneity were poorly understood. The major perceived barriers to practice of EBS were inability to understand statistical analysis, inadequate facilities for implementation, lack of a single compiled source of literature, relevant literature not being readily available and insufficient time on the job.

CONCLUSIONS: Surgical trainees have a positive attitude towards EBS, and have some familiarity with the common terms used in EBS. There is a need to increase awareness of, and provide access to available sources of medical literature. Formal training in EBS, as well as basic statistical analysis should form a part of the surgical curriculum to foster an environment favorable to the practice of EBS.

CAN CLINICIANS ACTUALLY PRACTICE EBM?

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.

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

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

47

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

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

METHODS: Our survey mainly focuses on 3 research questions: First of all, do full-time clinicians really recognize working in these modes? Second, even if they recognize these modes, can they actually get at the evidence quickly enough to consider it on a busy clinical service? Third, even if they can get at it, can clinicians actually provide evidence-based care to their patients?

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

Second, even if they recognize these modes, can they actually get at the evidence quickly enough to consider it on a busy clinical service? Again, it appears so, but examples are few. When a busy in-patient medical service brought electronic summaries of evidence previously appraised either by team members (“CATs”) or by the summary journals to working rounds, it was documented that, on average, the former could be accessed in 10 seconds and the latter in 25 seconds. When assessed from the view of the junior member of the team caring for the patient, this evidence changed 25% of their diagnostic and treatment suggestions and added to a further 23% of them.

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

CONCLUSIONS: Similar results have been obtained from audits of psychiatric, surgical, pediatric and general practice. But in our setup usually, about developing country this trend is taking a snail pace.

Key Methodological Issues in Randomised Controlled Studies and Observational Studies

Santosh Philip Mathew 1 MBBS student, Sonia Mary Philip 2 BDS, PG Dip in Public Health, Ajay Varghese 3 MBBS, MRCP, FRCR

  • 1 Presenting Author: MBBS Student, MOSC Medical College, Kolenchery, Ernakulam, Kerala- 682311

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

  • 3 Consultant Radiologist, Dorset County Hospital NHS Foundation Trust, Dorset County Hospital, Williams Avenue, Dorchester, UK - DT1 2JY

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

BACKGROUND: Analytical studies are broadly categorised into experimental studies including randomised controlled studies (RCTs) and non-experimental studies which include observational studies (OSs). Many consider RCTs as providing better evidence than OSs, but are not always possible, appropriate or ethical to conduct.

AIMS: To identify key methodological issues relevant to RCTs and OSs.

METHODS: Multiple articles were referred to from peer reviewed journals as well as our own experience in designing our poster with illustrations.

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

We will also review the advantages of OSs including its low cost, easy access to ethical approval, informed consent which is frequently unnecessary, use of statistical methods like propensity and multivariate analysis with tests for interaction. It also benefits from retrieving data from large number of patient groups in a short amount of time from databases. One of the main disadvantages include bias from unknown confounders as well as treatment allocation bias which can be offset to an extent by the use of propensity analysis.

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

48

CONCLUSIONS: After reading this poster, one should be able to identify the key methodological issues involved in analytical studies. Although some would consider RCTs as the ‘gold standard’ in analytical studies, it is important to understand that there is no perfect methodology to answer clinical questions. Clinicians will need to take account of the published data, decide which of the studies are best designed to answer their questions and also consider the generalisability and reproducibility of the intervention and come to a conclusion based not only on the published evidence but also rely on their medical experience and judgement.

Modafinil for clozapine induced adverse effects in people with schizophrenia and schizoaffective disorder in remission: a randomized, placebo-controlled trial stopped early for harms.

Sebind Kumar 1 , Prathap Tharyan 2 , Naveen Thomas 3 , Clive Adams 4

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

OBJECTIVES: To evaluate the efficacy and safety of modafinil in clozapine-induced drowsiness, hyper-salivation, weight gain, mental state, and global functioning.

METHODS: Design: Randomized, parallel-group, single- centre, participant, investigator, observer and data-entry- blinded trial conducted between October 2007 and October 2008. Offsite computer-generated, variable-block-size randomization and pharmacist-dispensed, pre-packed, serially numbered, containers ensured allocation concealment.

Participants: Consenting adults with a diagnosis of schizophrenia or schizoaffective disorder (DSM IV) in remission, with troublesome drowsiness or hyper- salivation, with/without weight gain, without unstable medical conditions, and on stable doses of clozapine for at least 4 weeks.

Intervention and comparator: Modafinil 100mg/day for first week and 200mg/day for 8 weeks or identical placebo once daily for 9 weeks.

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

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

adverse events check list. Assessment: End of weeks 1, 5 and 9. Analysis; by intention to treat.

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

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

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

Funding: Fluid Research Fund of CMC Vellore; Modafinil and placebo supplied by Sun Pharmaceuticals (who had no other role in the study)

AUTHOR AFFILIATIONS:

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

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

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

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

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Bedside Capillary blood glucose measurement by glucometers compared to venous blood glucose in critically ill patients and find the Reliability Sensitivity and Accuracy of point of care glucometer in MICU.

Authors Manish Chandra Prabhakar a SP Kalantri b

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

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

Correspondent Author: prabhakar4u07@gmail.com

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

METHODS: I studied consecutive patients admitted to an intensive care unit between 1 May and 10 May 2009. I compared the diagnostic accuracy of two- point of care glucometers with laboratory venous glucose, the reference standard. I used Bland- Altman plots and Clark error grid method to analyse the results.

RESULTS: I studied a total of 110 patients (38[34%] women; mean age 52.1 years (SD, 17.3); range 14 to 85 years. Fourteen patients (12%) were known to have diabetes. The mean glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1); range= 48 to 501 mg/dL; that by glucometer 2 was 152.2 mg/dL (SD 76.2); range= 30 to 458 mg/dL and by the laboratory was 148.6 mg/dL (SD 81.5); range= 52 to 480 mg/dL. Of the 110 subjects, 2(2%) had blood glucose below

70

mg/ dL; 85(77%) between 70 and 180 mg/ dL and 23(21%)

had blood glucose exceeding 180 mg/dL. The Bland- Altman plot showed a bias of 4 mg% (95% confidence intervals, - 9.8 to +1.1); and the limits of agreement were -63 and +54

mg%. The area under the receiver operating characteristic curve for the two glucometers was 0.92 and 0.93 respectively. The error grid analysis showed that 80% (78/ 110) samples lay within zone A, 22(110) in zone B and 1% (1/110) in zone C.

CONCLUSIONS: Point of care glucose, measured by glucometers was in agreement with the venous glucose estimation. Both glucometers were equally accurate and performed uniformly well across the wide range of blood glucose values.

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

GRADED EVIDENCE HIERARCHY IN CLINICAL TRIALS

Manusri Naredla, Keerthi Maddi.

St.Peter’s institute of Pharmaceutical sciences, vidyanagar, Hanamkonda

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve clinical trials. Large scale healthcare interventions are likely to improve the health of the public only if the evidence clearly shows that the benefits outweigh harms and costs. Often, however, the evidence if is the other way the trials may fail to improve health, or may even cause harm, while costing dearly. Moreover, when a large scale intervention is implemented careful evaluation of the evidence must and should replace wishful thinking and guesswork or else the trials may prove to be enduring but possibly result in harmful standard of care. Such interventions should be implemented, therefore, only when the evidence shows that expected benefits outweigh harms and costs and this can be achieved by the implementation of systematic evaluation.

Obtaining definitive evidence on the effects of large scale interventions can be difficult and implementation with careful monitoring is justified but how ever acting without proof of net benefit is both costly and potentially damaging to health. Graded evidence follows a hierarchy of evidence consistent with randomized trials of high methodological quality, followed by randomized trials with methodological limitations, observational studies, and unsystematic clinical observations. Inferences are stronger when the evidence is summarized in systematic ways of representing the evidence for better interpretation of the clinical as well as observational trials.

Unequal Randomisation in Cancer Trials – A New Paradigm!

AUTHORS: Meghana Surlikar , Sadhana Kannan and Vikram Gota.

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

Background: Randomised Controlled Trial (RCT) with balanced allocation of participants to the experimental and control arms is a commonly practiced study design. The design is simplistic and therefore very appealing. However, circumstances warrant unequal allocation of subjects to the different arms of the study. This systematic review focuses on the trends in unequal randomization (UR) in

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

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

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

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

CONCLUSION: UR appears to be an attractive alternative to balanced allocation especially in small randomized phase II trials. Statistical considerations and faster recruitment are important reasons for resorting to UR.

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

Mohan S Kamath, Aleyamma T.K, Achamma Chandy, and Korula George 1

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

BACKGROUND: Twenty five percent of ano vulator y women with polycystic ovarian syndrome do not respond to standard clomiphene citrate therapy and are known as clomiphene resistant. We investigated the use of letrozole, an aromatase inhibitor as an alternative ovulation inducing agent in these women.

METHODS: 36 women with clomiphene resistance were randomized into two groups: one receiving letrozole 2.5mg daily from day 2 to day 6 of the cycle while the other an identical placebo. The primary outcome was the ovulation rate with analysis being intention-to-treat.

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

5.5%

CONCLUSION: In clomiphene resistant women, letrozole can be used as an effective and simple alternative ovulation inducing agent. The trial is registered with clinical trial registry of India (UTRN -017753618-3112200762223).

Clinical Trials Methods

Nailesh.T

SLIMS, Villianur, Pondy605502 Email:

Nailesh.reddy@gmail.com

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

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

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

RESULTS: Phase 0 trials is a recent designation known as human micro dosing studies has no data on safety or efficacy of drug. Phase 1 trials Examines the pharmacologic actions and safe dosage range of a drug; how it is absorbed, distributed, metabolized, and excreted; and its duration of action. Phase 2 trials are controlled studies in volunteers to assess the effectiveness and safety of a drug. Phase 3 trials are testing using a greater number of volunteer patients. The drug is administered by practicing physicians to those suffering from the condition the drug is intended to treat. These studies must confirm earlier efficacy studies and determine low- incidence adverse reactions. Phase 4 trials are studies conducted after FDA approval, during general use of the drug by medical practitioners, also referred to as post marketing studies. Fast-track approval is provided for drugs that meet unmet medical needs for patients with serious or life- threatening conditions. Labeling is information distributed about a drug by the manufacturer, even if it is not physically affixed to the product. Misbranding is “false or misleading in any particular” renders the product misbranded, making it subject to FDA regulatory action.

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

Access to evidence from countries in South Asia: The South Asian Database of Controlled Clinical Trials and the South Asian Cochrane Network and Centre’s Digital Library – An Update

Jabez Paul Barnabas E, Prathap Tharyan, Venkatesh Parthasarathy

Prof BV Moses & Indian Council of Medical Research Centre for Advanced Research and Training in Evidence Informed Healthcare, South Asian Cochrane Centre, Christian Medical College, Vellore, India

BACKGROUND: Many trials conducted in middle and low income countries are published in journals that are not indexed in commonly searched databases. Their exclusion from systematic reviews could bias conclusions, rendering them unreliable and potentially irrelevant to health care in these countries.

OBJECTIVES: To describe the development of the South Asian Database of Controlled Clinical Trials (www.cochrane-

sadcct.org)

and the South Asian Cochrane Network &

Center’s Digital Library that aim to: provide a comprehensive source in the public domain of all controlled clinical interventional trials involving humans conducted in the South Asian region, and published in regional journals, and contribute information about these trials to the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) in The Cochrane Library.

METHODS: Health Science Journals published from Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka and reporting interventional trials in humans conducted in these countries were sought from multiple electronic and other sources and 168 journals were identified. Online and print issues of these journals are searched in regular cycles. Citations and abstracts of all interventional trials identified from online editions and hand-searching of print editions are entered into Endnote. Trials are coded as RCTs or CCTs using standard criteria and cleaned records imported to MeerKat, with web-links provided to the original article, where possible. Full text articles are indexed and stored using the Greenstone Digital Library Software to create the South Asian Cochrane Network & Center’s Digital Library that can be retrieved by Titles, Author, Year, Journal and Keywords. All records are regularly transmitted for inclusion in the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) in The Cochrane Library.

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

of charge. It currently contains the citations, abstracts and web-links (where possible) to 2830 records [(CCT-1350 (47%); RCT-1477 (53%)] published in 65 Indian medical journals, and 76 Pakistan Medical Journals. From submitted records, the citations and web-links (where available) to 1859 trials conducted in these South Asian countries are now included in the Cochrane Central Register of Controlled Trials (CENTRAL). Full text articles, in downloaded or scanned portable document format (pdf), are stored for most trials in the South Asian Cochrane Network & Center’s Digital Library. In the ongoing second phase, all 168 South Asian Journals (of which 101 (60%) are not indexed in Medline) and newer journals identified by ongoing searches will contribute trials, supplemented by searches of conference abstracts, dissertations and other sources.

CONCLUSIONS: The Cochrane Collaboration now has a resource to access all the evidence generated from interventional trials conducted in countries in the South Asian Region. Many of these, hitherto unidentified, trials can now be considered for inclusion in systematic reviews of the effects of interventions in healthcare conditions relevant to people in the region; these systematic reviews have the potential to be of greater relevance in informing healthcare and health-policy in these countries than before the creation of this resource.

When ‘Evidence’ goes against the grain:

Quetiapine for Bipolar depression

S. Mohan Raj,

Consultant Psychiatrist, Chennai

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

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

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

METHODS: Evaluation of the BOLDER II study 1 (study titled ‘Efficacy of Quetiapine Monotherapy in Bipolar I and II Depression’), using the Risk of bias table of Revman 5.

RESULTS:

The biases noticed were

1) Selection bias Exclusion criteria mention

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  • 1.1 Current episode duration more than 12 months and less than 4 weeks (Comment: spontaneous remission is possible around 6 months)

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

  • 1.3 Current serious suicidal or homicidal risk as judged by the investigator (Comment: Severe depression is excluded)

2)

Incomplete outcome data were not adequately addressed.

The other problems were

1)

Definition of response as > or = to 50% reduction from baseline score of Montgomery Asberg Depression Rating Scale (MADRS) 2

2)

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

Another area of concern is that all the studies regarding Quetiapine in bipolar depression were prepared with ‘editorial assistance’ from a medical communication company called PAREXEL MMS), irrespective of the authors’ institution. PAREXEL’s website 3 offers to write up a scientific paper and boast of a 92% first time journal acceptance rate in 2008.

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

REFERENCES:

  • 1. Michael E Thase et al. Efficacy of Quetiapine Monotherapy in Bipolar I and II Depression. A double-blind, placebo controlled study (The BOLDER II study) J Clin Psychopharmacol 2006;26:600-609.

  • 2. Montgomery SA and Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-389.

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

VIDENCE OF EFFECTIVENESS OF IMPLEMENTING RNTCP in a medical college hospital

AUTHORS: John K R,Rakesh P S

AUTHORS AFFILIATION

  • 1. Professor in charge of RNTCP$Head of the Department,Department of Community Health,CMC Vellore

    • 2 Post graduate registrar,department of Community Health,CMC Vellore

CORRESPONDING AUTHOR:John K R,Professor,Department of Community Health,CMC,VELLORE Email:mony@cmcvellore.ac.in

Ph:09443242603

BACKGROUND: The Revised National Tuberculosis Control Programme (RNTCP) based on Directly Observed Treatment Short course(DOTS) strategy was launched in India as a national programme in 1997.As private sector is the first point of contact for more than fifty percent TB patients,RNTCP has collaborated with a wide range of health care providers which establishes a unique model of public private mix in RNTCP.

As medical colleges treat a significant number of patients with TB and also provide care to seriously ill and complicated TB cases,efforts have been made to include medical colleges into the purview of RNTCP.

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

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

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

RESULTS and CONCLUSION : The proportion of chest symptomatics referred for sputum examination from various departments in CMC were between 3 to 4% .This is above the suggested target of at least 2%.

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

Among the cases 33% were sputum positive,14% sputum negative pulmonary and 53% were extra pulmonary tuberculosis. The maximum proportion of extrapulmonary TB as per RNTCP guidelines is 50%.

88% of all the cases were transferred out, 35.1% of all

transfers were to ‘out of the state’,

among which 43.4%

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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,

sputum

conversion rates were consistently above 90% except for year 2003 when it was 86.9%.Cure rate was above 80% consistently.

The CMC data shows that most of the recommendations laid down by RNTCP guidelines are achieved and it is functioning as per the guidelines of RNTCP.

Evidence Based Policy for Isoniazid Prophylaxis Therapy in Health care workers

Authors:

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

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

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

Dr. T.Shyam, School of Medical Science and Technology, IIT Kharagpur.

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

BACKGROUND: India accounts for nearly one-fifth of global burden of tuberculosis. Every year, approximately 2 million persons develop tuberculosis of which about 0.87 million are new smear positive highly infectious cases and about 3.3 lakh die of TB every year. There are approximately 2.5 million health care workers in India (NHP 2007) providing health services to the population. They are not only exposed to a high number of active TB cases but also they are constantly exposed to a high number of debilitated patients throughout their professional work.

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

METHODS: An evidence based search is conducted to find effectiveness of INH prophylaxis in Health care workers in India. Search was conducted in electronic medical resources to find the related studies performing Meta analysis and randomized control trials comparing Isoniazid and placebo/other anti tubercular drugs in different population groups. Appropriate statistical methodology was adopted to analyze the results and formulate the policy. The Criteria for evaluation were Numbers needed to be treated to prevent one active case of TB/ One death, number needed to harm (Hepatitis), adherence and compliance, ease of implementation, cost benefits analysis.

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

CONCLUSION: In India as per RNTCP recommendations no guidelines are available for prevention of TB in healthcare workers. India’s RNTCP is the largest DOTS program in the world. It is of paramount importance that they are given the best possible protection from occupational health hazards including TB. So we recommend incorporation of Isoniazid prophylaxis therapy among health care workers in India if they are found to be a case of LTBI. The therapy should be with 300 mg Isoniazid daily for six months. The maximum effect of Isoniazid prophylaxis is shown to be for 3 years (Debre), so it is recommended that every healthcare worker should be examined while joining health care services and then should be reviewed every three years.

Evidence Based Surgery: knowledge, attitudes, and perceived barriers among surgical trainees

Dr. Rohin Mittal (Presenting author) Assistant Professor Department of Surgery Unit 5 Christian Medical College, Vellore rohinmittal@gmail.com

Dr. Benjamin Perakath

Professor Department of Surgery Unit 5 Christian Medical College, Vellore benjamin@cmcvellore.ac.in

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

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

METHODS: The McColl questionnaire and the BARRIERS scale were modified and incorporated into a single questionnaire. Surgical trainees attending a Continuing Surgical Education meeting at the author’s institution were asked to voluntarily fill in this questionnaire.

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

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welcoming, although colleagues were considered less welcoming than self. There was high level of agreement with usefulness of EBS in everyday practice and EBS improving patient care. About 50 % of actual practice was considered to be evidence based. 12.6 % (11/87) participants had received formal training in EBM. 64.3 % (54/84) were aware of the Cochrane database of systemic reviews but only 35.7% (30/84) read it regularly. 67.8 % (61/90) used protocols and guidelines developed by colleagues to practice EBS. However, 61.5 % (56/91) were interested in learning the skills of EBS. The terms absolute risk, relative risk and clinical effectiveness were understood by > 80 % of respondents, while publication bias, confidence interval and heterogeneity were poorly understood. The major perceived barriers to practice of EBS were inability to understand statistical analysis, inadequate facilities for implementation, lack of a single compiled source of literature, relevant literature not being readily available and insufficient time on the job.

CONCLUSIONS: Surgical trainees have a positive attitude towards EBS, and have some familiarity with the common terms used in EBS. There is a need to increase awareness of, and provide access to available sources of medical literature. Formal training in EBS, as well as basic statistical analysis should form a part of the surgical curriculum to foster an environment favorable to the practice of EBS.

CAN CLINICIANS ACTUALLY PRACTICE EBM?

Sanchaya Selvaraj*, Balaji D*, Nagamani*, Surapaneni Krishna Mohan**

AFFILIATION:

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

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

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

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

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

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

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

Second, even if they recognize these modes, can they actually get at the evidence quickly enough to consider it on a busy clinical service? Again, it appears so, but examples are few. When a busy in-patient medical service brought electronic summaries of evidence previously appraised either by team members (“CATs”) or by the summary journals to working rounds, it was documented that, on average, the former could be accessed in 10 seconds and the latter in 25 seconds. When assessed from the view of the junior member of the team caring for the patient, this evidence changed 25% of their diagnostic and treatment suggestions and added to a further 23% of them.

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

CONCLUSIONS: Similar results have been obtained from audits of psychiatric, surgical, pediatric and general practice. But in our setup usually, about developing country this trend is taking a snail pace.

Key Methodological Issues in Randomised Controlled Studies and Observational Studies

Santosh Philip Mathew 1 MBBS student, Sonia Mary Philip 2 BDS, PG Dip in Public Health, Ajay Varghese 3 MBBS, MRCP, FRCR

  • 1 Presenting Author: MBBS Student, MOSC Medical College, Kolenchery, Ernakulam, Kerala- 682311

  • 2 Queen Mary , University of London, School of Medicine and Dentistry, Mile End Road, London, UK - E1 4NS3 Consultant Radiologist, Dorset County Hospital NHS Foundation Trust, Dorset County Hospital, Williams Avenue, Dorchester, UK - DT1 2JY

55

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

BACKGROUND: Analytical studies are broadly categorised into experimental studies including randomised controlled studies (RCTs) and non-experimental studies which include observational studies (OSs). Many consider RCTs as providing better evidence than OSs, but are not always possible, appropriate or ethical to conduct.

AIMS: To identify key methodological issues relevant to RCTs and OSs.

METHODS: Multiple articles were referred to from peer reviewed journals as well as our own experience in designing our poster with illustrations.

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

We will also review the advantages of OSs including its low cost, easy access to ethical approval, informed consent which is frequently unnecessary, use of statistical methods like propensity and multivariate analysis with tests for interaction. It also benefits from retrieving data from large number of patient groups in a short amount of time from databases. One of the main disadvantages include bias from unknown confounders as well as treatment allocation bias which can be offset to an extent by the use of propensity analysis.

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

CONCLUSIONS: After reading this poster, one should be able to identify the key methodological issues involved in analytical studies. Although some would consider RCTs as the ‘gold standard’ in analytical studies, it is important to understand that there is no perfect methodology to answer clinical questions. Clinicians will need to take account of the published data, decide which of the studies are best designed to answer their questions and also consider the generalisability and reproducibility of the intervention and come to a conclusion based not only on the published evidence but also rely on their medical experience and judgement.

Modafinil for clozapine induced adverse effects in people with schizophrenia and schizoaffective disorder in remission: a randomized, placebo-controlled trial stopped early for harms.

Sebind Kumar 1 , Prathap Tharyan 2 , Naveen Thomas 3 , Clive Adams 4

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

OBJECTIVES: To evaluate the efficacy and safety of modafinil in clozapine-induced drowsiness, hyper-salivation, weight gain, mental state, and global functioning.

METHODS: Design: Randomized, parallel-group, single- centre, participant, investigator, observer and data-entry- blinded trial conducted between October 2007 and October 2008. Offsite computer-generated, variable-block-size randomization and pharmacist-dispensed, pre-packed, serially numbered, containers ensured allocation concealment.

Participants: Consenting adults with a diagnosis of schizophrenia or schizoaffective disorder (DSM IV) in remission, with troublesome drowsiness or hyper- salivation, with/without weight gain, without unstable medical conditions, and on stable doses of clozapine for at least 4 weeks.

Intervention and comparator: Modafinil 100mg/day for first week and 200mg/day for 8 weeks or identical placebo once daily for 9 weeks.

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

Outcomes: Primary: Proportion without daytime sleepiness and hyper-salivation, scores on Epworth Sleepiness Scale (ESS) and Nocturnal Hyper-salivation rating scale (NHRS). Secondary: change in weight, pulse rate, systolic and diastolic blood pressures; scores on Positive and Negative Symptom Scale (PANSS); Clinical Global Impression (CGI) for alertness, hyper-salivation and overall improvement; Indian Disability Evaluation Assessment Scale (IDEAS) and adverse events check list. Assessment: End of weeks 1, 5 and 9. Analysis; by intention to treat.

RESULTS: A pre-planned interim analysis (if more than 5% developed adverse events necessitating discontinuation) was done after 34 people (Modafinil 16, placebo 18) were randomized, because of marked worsening of psychosis in one and anxiety symptoms in one (both on Modafinil). One person on placebo discontinued treatment due to lack of improvement. Groups did not differ on the baseline variables. Modafinil significantly reduced hyper-salivation at 1 week compared to placebo (7/16 (44%) vs. 0/18; OR 1.8, 95% CI 1.2 to 2.7; P= 0.002) and non-significantly by week 9

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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 or ESS scores but significantly reduced duration of sleep by week 9 (mean (SD) 9.7 (1.5) hours vs. 10.9 (1.8) hours; P=0.05). No significant differences were noted in PANNS or IDEAS scores, CGI overall improvement, weight, pulse rate, blood pressure or other adverse effects in both groups.

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

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

FUNDING: Fluid Research Fund of CMC Vellore; Modafinil and placebo supplied by Sun Pharmaceuticals (who had no other role in the study)

AUTHOR AFFILIATIONS:

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

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

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

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

Internet based clinical trials: An Expanding Horizon

Authors: Siddhartha D, Lalith Chandra K,

Gandhi Medical College, Secunderabad

BACKGROUND: Internet is being widely utilized in medical research. It offers many benefits when used as a medium for carrying out clinical trials. Being able to reach a wide population, participant privacy, easier blinding and randomization, studying geographically scattered populations are a few such benefits. Online trials so far, have mostly been focusing on educational, preventive, rehabilitative and follow up issues which can have a beneficial impact on patient health, health service quality, health service availability and finances. In a society where the utilization of Information Technology seems to be rising

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

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

Methods: The online U.S NIH database (www.clinicaltrials.gov), was searched for internet based trials. Both active and closed trials were included.Relevant results were categorized under separate subject headings based on the health condition/category the trial was addressing. Both interventional and observational trials were included in the categorization. PubMed literature search was performed to study the advantages and limitations of online trials separately.

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

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

(* Involves numerical data that cannot be condensed) (**Not elaborated due to word limit restriction) Presenting Author and Author for Correspondence:

Siddhartha Devarakonda “Premabandham”, Near Birla Mandir 5-9-22/38 G Adarshnagar Hyderabad 500063, AP India email- siddarth.dt@gmail.com

BODY MASS INDEX AND EXOCRINE PANCREATIC INSUFFI- CIENCY ARE PREDICTORS OF PANCREATIC OSTEODYSTRO- PHY IN SUBJECTS WITH FIBROCALCIFIC PANCREATITIS WITH DIABETES.

Presenting author: Sudeep.K

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

Department; Department of Endocrinology, Department of Biochemistry, Gastroenterology.

57

Institution: Christian Medical College, Vellore. Phone

(0416)-2282528,2282491.Fax-416-4205844

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

BACKGROUND: Chronic pancreatitis with exocrine insufficiency, inflammation, diabetes, low body weight and undernutrition alter bone metabolism leading to a relatively novel entity entitled pancreatic osteodystrophy.

AIMS: To determine the relationship between bone mineral content and pancreatic exocrine and endocrine dysfunction in subjects with chronic non-alcoholic pancreatitis.

MATERIALS AND METHODS: A prospectiv e study of consecutive eligible males aged between 20 and 60 years. BMD was measured using Hologic DXA machine. Vitamin D was measured using radioimmuno-assay. Stool fat excretion rate was measured in a 72 hour stool collection. Statistical analysis was done applying Pearsons correlation, independent t-test and nonparametric tests.

RESULTS: Thirty-one males with a mean BMI of 18.46 (± 2.86) Kg/m 2 and radiologically documented pancreatitis were studied.The mean 72 hour stool fat was 25.30 (± 18.09)gms and the mean VitaminD was 18.44 (± 10.97) ng/ ml. Nineteen (61%) subjects had an abnormal T score.There was a significant positive correlation between BMC and BMI (r = 0.426 ; P = 0.017) and a significant negative correlation BMC and 72 hour stool fat (r = minus 0.468;P = 0.028). Twenty one (68%) inclusive of eleven FCPD subjects had diabetes.Subjects with diabetes had a lower BMI (17.7 ±2.4 vs 20.0 ± 3.31 Kg/ m 2 ;P = 0.087) and lower VitaminD (16.01 ± 9.03 vs 26.03 ± 13.9 ng/ml P= 0.056) than those without diabetes. A significant linear correlation (r = 0.448; P= 0.041) between BMC and BMI was seen only in subjects with diabetes.

CONCLUSIONS: In subjects with chronic pancreatitis and diabetes a linear correlation exists between BMC and BMI presumably due to severe undernutrition. Subjects with steatorrhea had a significantly reduced BMC which could

not be accounted for by differences in BMI or diabetes or vitamin D deficiency. Pancreatic osteodystrophy in chronic pancreatitis is an underrecognized co-morbidty requiring a more extensive evaluation.

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

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

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

AIM: To investigate whether INH prophylaxis for cases with latent tuberculosis infection can be incorporated in the routine health care system in Indian scenario.

METHODS: An evidence based search is conducted to find effectiveness of INH prophylaxis in cases with latent tuberculosis infection with or without associated medical conditions. Search was conducted in electronic medical resources to find the related studies performing Meta analysis and randomized control trials comparing Isoniazid and placebo/other anti tubercular drugs in different population groups. Appropriate statistical methodology was adopted to analyse the results (Numbers needed to treat, relative risk reduction) and formulate the policy.

RESULTS: The study best suited to answer our question for Non HIV general population was a Meta analysis done by Smieja Marek et al., titled “Isoniazid for preventing tuberculosis in non HIV infected persons” (1999) available at Cochrane database. The risk ratio (RR) of the persons on INH prophylaxis was 0.40 (95%CI 0.31 to 0.52) with a P value of <<.01. Numbers needed to treat (NNT) is 35. The study we used for HIV children was “Effect of Isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial” by Heather J Zar et al, available at PUBMED. Numbers needed to treat is 16 for preventing Incidence of one case and 12 for preventing one death.

CONCLUSION: Although a definite reduction of risk is seen in groups on INH prophylaxis, INH prophylaxis cannot be instituted in cases with all latent TB infection in India because the incidence of latent TB is very high and following up them all is impossible. However, it can be administered in high risk groups like HIV positives, health care workers and people in prisons and army barracks.

AUTHORS:

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

  • 2. Dr. Bi kas Kumar Ar ya, School of medical science and technology, IIT Kharagpur.

Presenting Author:

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

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Nature, prevalence, explanatory models and correlates of sexual dysfunction among men attending primary health setting in south India

Dr. P. Thangadurai, MBBS, DPM, DNB, Assistant professor, Department of Psychiatry, Christian Medical College, Vellore - 632002, India.Emai l ID: thanga@cmcvellore.ac.in

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

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

METHODS : We conducted a cross-sectional study investigating 270 consecutive consenting men aged 16 and above attending the department of community health, CMCH. Those with severe language, hearing or cognitive impairment were excluded. We screened for sexual dysfunction using Sexual History Questionnaire. Those who screened positive were further evaluated using the International Index of Erectile Function-5 (IIEF5) and the Chinese Index of Premature Ejaculation-5 (CIPE5). Explanatory models of sexual dysfunction were assessed using the modified Short Explanatory Model Inter view (SEMI). We emplo yed Tami l version of Clinical Interview Schedule- Revised (CISR) to diagnose common mental disorders.

RESULTS: 75.9% men (95% CI 70.9-81.1) were tested positive for sexual dysfunction. The most common disorder was premature ejaculation followed by erectile dysfunction and their c o morbidity. Poverty, advancing age, less education, history of diabetes, hypertension and presence of a common mental disorder were significantly associated with sexual dysfunction (P<0.05). Primary health care physicians under- diagnosed sexual dysfunction and documented poor inter rater reliability when compared with diagnoses by a psychiatric professional (Kappa=0.01).

DISCUSSION : Sexual dysfunction is widely prevalent but under diagnosed among men attending primary health clinics. Strengths of this study include adequate sample size, minimal refusal rates, use of standardized instruments and eliciting explanatory models. We acknowledge the limitations such as absence of consensus on normal ejacula tory la t ency, var ying diagnostic cut off scores of IIEF-5 and CIPE-5, debatable cross cultural validity and the possibility of high false positive rates due to poor positive predictive values. We minimized selection and reporting bias by consecutive sampling and by interviews conducted by a single investigator well versed in local culture and language.

CONCLUSION: We suggest the need to include effective management of sexual dysfunction in the existing primary health system. Future longitudinal studies to evaluate incidence and correlates of sexual dysfunction are desired.

The impact of family attachment programme in undergraduate curriculum to appreciate the concept of evidence informed public health.

BACKGROUND : Evidence based public health is the integration of science based intervention with community preference to develop the health of the public. The latter stages of this process of evidence based public health involve vigilant decision making in order to address specific public health problems, where the adaptation of the research knowledge to the local context prior to the implementation of the adapted evidence in to practice or policy development is of crucial value. This adaptation is mainly based on the recognition and analysis of needs/ preferences specific to the community under consideration.

AIM/OBJEC TIVE: To descri be the importance of f ami ly attachment programme in undergraduate curriculum to appreciate the concept of evidence informed public health.

METHOD/ACTIVITY: Medical s tudents of the Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka were allocated in to groups of three students and assigned a household in the university project area for a period of two months during their final year training.

Weekly seminars were held to discuss the health related issues faced by each family and possible interventions that could be made to overcome them. The students then undertook a practical approach in to decision making and implementing the necessary interventions under supervised guidance from the departments of Community Medicine, Family Medicine, Paediatrics, Psychiatry and public health staff from the university project area.

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

Conclusions and Recommendations

Conventionally the undergraduate training is hospital centred and mainly focused on relieving physical infirmity. But through this innovative programme the students got the opportunity to explore the possible interventions while considering the individuals, family and community as a whole. Thus enabling them to understand how to adapt the research knowledge to the local context by recognizing the needs/pr eferences specific to that community, ther eby achieving better decision making in the process of evidence informed public health. Therefore,including this innovative programme in the undergraduate public health training is highly recommended.

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

Dr. Upendra Bhojani

Faculty, Institute of Public Health 250, Master ’s cottage, 2 C Main, 2 C Cross, Girinagar 1 st Phase, Bangalore 560085 (080) 26421929, 09342349121 upendra@iphindia.org

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

AIM: To de scri be how nee ded e vidence s to str engthen tobacco control policies and its implementation were generated and were disseminated using innovative tools and channels to relevant stakeholders by Institute of Public Health (IPH) in Karnataka.

METHOD: Situational and stakeholder analysis helped to identify issues and influential stakeholders in context of tobacco control in India. Discourses regarding employment of tobacco industry workers, effectiveness and acceptance of suggested warnings, impact of tobacco control measures on general economy surfaced by tobacco industr y, media, and at times politicians created negative environment for effective and undiluted implementation of proposed Act.

In this context, through short studies and surveys IPH generated relevant evidences and used innovative tools and to disseminate it to media (Media tool kit, Sensitization meetings, Provision of relevant information), law makers (Stories in local and national newspapers, Advocacy kit on pictorial warnings, memoranda, and campaigns), law enforcers (news stories on legal violations, Complaints to various departments, PIL in Karnataka high court) and community (Awareness campaigns, painting competitions and fact sheets for schools).

RE SULTS: These e ff ort s r e sult ed in public a tion of IE C materials and more than 20 news stories in local and national papers on periodic basis. Karnataka High Court passed an interim order instructing various stakeholders

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

URINARY METANEPHRINES IN THE DIAGNOSIS OF PHEOCHROMOCYTOMA

Vasanthi K*, Kanakamani J*, Rajaratnam S*, Gracy V $ , Fleming J $ , *Departments of Endocrinology, Diabetes and Metabolism & $ Clinical Biochemistry Christian Medical College, Vellore.

BA CKGR OUND: Though pheochr omocy t oma s are r are tumors, they need to be considered in a large number of patients with hypertension because they are dangerous and are potentially curable. Measurement of plasma or urinary metanephrines are said to be diagnostically superior than measurement of catecholamines or vanillyl mandelic acid.

OBJECTIVE: The objective was to study the diagnostic value of urinary total metanephrines in the diagnosis of pheochromocytomas.

METHODS: Outcomes of patients tested in our center for pheochromocytomas from June 2008 to June 2009 were retrospectively studied. Urinary total metanephrines (uMN) and normetanephrines (uNMN) were measured by enzyme immunoassay. The upper limit of the laborator y reference range was used to calculate the diagnostic accuracy parameters.

RESULTS: There were 66 patients (49 males and 17 females). F ift een p a tient s had his to pathologic ally pr ov en pheochromocytomas. 11 of them were adrenal tumors and 4 were paragangliomas. 45 patients had hypertension in whom secondary causes were not found. Six had adrenal masses of other origin, proven by biopsy. The median uMN in the pheochromocytoma group was 363 (59 – 5640) mg/ day and uNMN 4000 (329 – 10400) mg/day and that of non- pheochromocytoma group was 168 (43-638) mg/day and 734 (85-2763) mg /day. The sensitivity and specificity of uMN was 53.3% & 90.2% respectively and that of uNMN was 86.6% & 21.57%. Area under the receiver operating characteristic curve was 0.737 (95% CI: 0.566-0.909) for uMN and 0.851(95% CI: 0.693-1.009) for uNMN.If both uMN and uNMN were combined toge ther, negative predictive value is 100% but positive predictive value is only 26%.

Conclusion: Urinary total metanephrines is a valuable test to exclude pheochromocytoma in a population who need to be scr eened for the tumor. However with a lo w pretest probability, it cannot be used to conf irm a diagnosis of pheochromocytoma.

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A Randomized Double Blind Comparative trial of Antidepressant Augmentation by High and Low Dosage Folic Acid in Depressive Disorder

ABSTRACT

BACKGROUND: Several studies show elevated incidence of folate deficiency in patients suffering from depression. Systematic-reviews suggest that folate may have a potential role as supplement to antidepressants but have called for further trials. Few trials have shown that in females than in males; administering folic acid with antidepressants augments the antidepressant response.

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

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

RESULTS: Both groups were comparable at baseline in terms of socio-demographic and illness variables (p>0.05). There was no significant difference across two groups with respect to baseline HDRS and BDI scores (p>0.05). Within both the groups there was a significant decline in mean depression scores on both HDRS, BDI (p=0.00). Across the two groups, the decline in BDI scores was statistically significant which was more in group 2 (p = 0.04). The decline in HDRS scores was not statistically significant across the two groups (p > 0.05). 66% of patients in group 2 and 33 % in group 1 showed a 50% decline from the baseline score in both scales.

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

Authors:

1) Dr. R. Venkatasubramanian*, MD 2) Dr. Ravi Shankara Pandey***, MD 3) Dr. Venkateshwaran.R**, MBBS

Affiliation address:

* Assistant Professor, Department of Psychiatry, PSG Institute of Medical Sciences and Research,

Coimbatore-641004

**

Professor of Psychiatry, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore-

560029

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

Presenting author:

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

Study of Depression among Diabetics in a General hospital: Consequences in Diabetes Management & Quality of Life

BACKGROUND: Recent studies quote high prevalence of depressive episodes in diabetics, which leads to increased risk for various complications of the metabolic disorder. Yet depression is often unrecognized and untreated in approximately two thirds of patients with diabetes. Underdiagnosis of co-morbid depression may reflect a perception among clinicians that psychological issues are less important than medical concerns in patients with diabetes. To maximize overall patient outcome, this needs to be addressed adequately.

OBJECTIVE: To estimate the prevalence of depression among the diabetics in the study population. To ascertain and compare the level of diabetes self care management and the health-related quality of life between the depressed and non-depressed.

METHODOLOGY: 50 consecutive diabetic out-patients of either sex, after informed consent were administered Hamilton Depression Rating Scale (HAM-D), Summary of Diabetes Self Care Activities (SDSCA), and Rand 36 Health status inventory. Based on the HAM-D scores, patients were initially grouped as depressed and non-depressed. Depressed were further sub-grouped into mild, moderate, severe and very severe. Comparison of the level of diabetes management self care and Quality of Life between the depressed and non-depressed was done using the mean

61

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

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

CONCLUSION: Results substantiate that prevalence of depression among diabetics is higher than in the general population which is in the range of 7.8% to 17%. Identifying depression among the diabetics at an earlier stage would improve the Physical & Mental domain of Health Related Quality of Life and breaking the vicious cycle of depression and diabetes. Eclectic interventions need to be planned for each individual. However rater-blind studies are required for further validation of our findings.

AUTHORS:

  • 1. Dr. Venkateswaran. R*, MBBS

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

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

Affiliation address:

*

Junior Resident, Department of Psychiatry, PSG Institute of Medical Sciences and Research,

Coimbatore-641004

**

Under-graduate Student, PSG Institute of Medical Sciences and Research, Coimbatore-641004

*** Assistant Professor, Department of Psychiatry, PSG Institute of Medical Sciences and Research,

Coimbatore-641004

Presenting author:

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

Assessment of the reporting quality of non-inferiority and equivalence trials in cancer post CONSORT, using a modified CONSORT checklist

AUTHORS: Vikram Gota 1 , Sadhana Kannan 1 , Priya Ranganathan 2 , Nithya Gogtay 3 , Sandeep Bavdekar 3 , CS Pramesh 2

1 ACTREC, Tata Memorial Centre, Sector-22, Kharghar, Navi Mumbai 410 210, India 2 Tata Memorial Hospital, Parel, Mumbai 400 012, India

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

BACKGROUND: The revised CONSORT was published in 2006 to improve the reporting of RCTs. Non-inferiority (NI) and equivalence (Eq) trials are a subset of RCTs that differ methodologically from superiority trials. An extension to the CONSORT checklist was published in 2006 for reporting NI/Eq trials. This checklist provides a framework for minimum reporting standards, but leaves several points open to interpretation. Studies that evaluated the impact of the extended CONSORT statement on the quality of reporting of NI/Eq trials in AIDS and ophthalmology concluded that reviewers and editors need to reinforce their standards for acceptance of NI/Eq RCTs.

AIM:

1)

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

2)

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

METHODS: All RCTs in cancer with NI/Eq design published post CONSORT till November 2008 were selected from PUBMED. A modified CONSORT checklist was developed that included all 22 items of the extended CONSORT for NI/ Eq trials. Additional items considered important from a NI/ Eq trial perspective were also included. Each of the 22 items was further subcategorized to render objectivity to the checklist. Three groups of reviewers scored the checklist independently for all post CONSORT trials. After scoring, the reviewers got together to arrive at a composite score based on consensus. The interrater agreement was assessed using ICC. Compliance of each article to CONSORT was also assessed.

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

62

areas that require improved reporting include specifying a) NI margin b) rationale for choice of delta c) methods used to implement random allocation. No difference was found in the reporting quality of industry sponsored and investigator initiated trials (P=0.80).

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

Presenting author (Also contact author)

Dr. Vikram Gota Assistant Professor Clinical Pharmacology Advanced Centre for Treatment Research & Education in Cancer (ACTREC) Tata Memorial Centre Kharghar Navi Mumbai Tel: 022 2740 5130 vgota@actrec.gov.in

Who is using The Cochrane Library?

Usage statistics of Wiley InterScience for India and Worldwide.

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

BACKGROUND: The dissemination of high quality, timely evidence is a priority for The Cochrane Collaboration and for the ICMR who fund a national access licence for India. By monitoring usage, exploring user activity, and identifying trends we can build on our understanding of how people use The Cochrane Library, where they come from, and which reviews they access. We can use these data to help us identify ways of increasing access to and usage of The Cochrane Library in India and worldwide.

METHODS: For the worldwide data the periods of 1st January 2008 to 31st December 2008, the number of unique visits to www.thecochranelibrary.com, number of visits by country, and most accessed Cochrane reviews on Wiley InterScience were taken from the Wiley InterScience Data Warehouse, an analysis tool that stores and tracks usage data. Another set of usage data was obtained from all other licensed providers of The Cochrane Library, showing the number of abstracts and full text articles that were accessed during 2008 from Wiley InterScience, EBSCO, OVID, La Biblioteca Cochrane, BIREME and www.cochrane.org. For the India usage data the periods calendar year 2006, 2007, 2008 and Jan – August 2009 were considered, so as to help investigate the impact of introducing national access, using the IP ranges for India to identify India usage activity as registered from Wiley InterScience Data Warehouse.

Results: In India, in 2008 a full text article was downloaded from Wiley InterScience every 7 minutes. For India this represents an increase in usage of The Cochrane Library of 648% from Year 2006 to Year 2007 and 14% from Year 2007 to Year 2008 and by August 2009, the total full text download is already 68% of the total Year 2008 figures. Data taken from all websites of The Cochrane Library show that during 2008: A search of The Cochrane Library took place every 2 seconds; A Cochrane abstract was viewed every 3 seconds; A full text article was downloaded every 4 seconds. The total full text download for Cochrane Library in India in Year 2008 is 70,090; making India as one of the top 10 countries from Asia that visited Cochrane Library worldwide

Conclusions: In summary, usage of The Cochrane Library in 2008 has increased considerably in comparison to 2007. Over half the world’s population now have access to The Cochrane Library via one-click access (no login required), and it is clear that worldwide usage of The Cochrane Library is increasing as a consequence. Usage in India, since the national license was provided, access nationally has grown significantly and the usage levels now surpass many other developed countries with established national access schemes including Norway, Ireland and Poland establishing India as one of the top countries visiting and using The Cochrane Library.

EVIDENCE BASED MEDICINE: A NEW APPROACH TO TEACH MEDICINE

Authors:

Yeshwant*, Elakkiya*, Prarthana Saraswathi*, Surapaneni Krishna Mohan**

Affiliation:

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

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

BACKGROUND: No clinician would consider entering clinical practice without knowing the rudiments of history- taking and physical examination, nor would clinicians consider independent practice without a basic understanding of how the drugs they prescribe act on their patients. Yet, traditionally, clinicians have started practice without an ability to understand evidence about how they should interpret what they find on history and physical examination, or the magnitude of the effects they might expect when they offer patients medication. Evidence-based medicine (EBM) provides a remedy for this problem.

63

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

WHAT IS EBM? Evidence-based medicine (EBM) is the integration of best research evidence with clinical expertise and patient values.

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

STEPS IN EBM PACTICE? It consists of FIVE related steps. Step 1: ASKING focused clinical questions that arise in caring for patients. Step 2: ACQUIRING the best available evidence through electronic searching. Step 3: APPRAISING the quality of the evidence acquired against explicit methodological criteria. Step 4: APPLYING the evidence appropriately to the clinical management of individuals. Step 5: ASSESSING performance in relation to the previous four steps.

LIMITATIONS OF EBM: The commonly cited limitations of EBM are as follows-1)Universal to the practice of medicine 2) Shortage of coherent, consistent scientific evidence 3) Difficulties in applying evidence to the care of individual patients 4) Barriers to the practice of high-quality medicine 5) Unique to the practice of evidence-based medicine 6) The need 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.com Contact Number: +91-9962833305

EVIDENCE INFORMED PUBLIC HEALTH:

BACKGROUND: NATIONAL RURAL HEALTH MISSION (NRHM) is evidence based programme. NRHM is a national effort at ensuring effective health care through a range of interventions at individual, household, community and most critically at the health system.

Under NRHM programme we will study JANANI SURAKSHA YOJNA (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 who ensures early registration of pregnant woman and three institutional Antenatal Care check ups, two doses of Tetanus Toxoid vaccine and hundred table ts of Iron Folic acid to each pregnant woman. Also she promotes Institutional Delivery and for doing this government provides Referral Transport facility from the home of beneficiar y to the health care system. ASHA also ensures five Post Natal check ups and Immunisation of the child. The financial scale of assistance under the scheme is as follows:

RURAL AREA

Mother ’s package

 

ASHA package

Total Rs.

1400/-

 

200+300+100=600/-

2000/-

200-ANC check up 300-Referral transport 100-PNC check up

URBAN AREA

Mother ’s package

ASHA package

 

Total Rs

1000/-

200/-

 

1200/-

RESULTS: Compa rative study of Institutional Deliver y in the year 2007-08 and 2008-09 in state of RAJASTHAN.

Statement showing progress of JSY beneficiaries in state of 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 Institutional Delivery as a result-

1) MMR has decreased 2) IMR has decreased

PRESENTING AUTHOR: SAUMYA AGARWAL 32/347 OUTSIDE SURAJPOLE ABOVE IDBI BANK ATM, UDAIPUR, RAJASTHAN.

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

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

BACKGROUND: Plagiarism is the reproducing of the work or ideas of others as ones own, without giving the original author proper credit or acknowledgement. Plagiarism is considered as research misconduct. However, there are cultural differences in attitudes towards plagiarism.

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

METHODS: We selected 65 Indian medical journals and classified them as indexed and non- indexed based on the citation in Pub med. We randomly selected four journals each, from both these categories, using a random number table and selected all Review articles and Original articles in all issues for 2008. We used the free online plagiarism detecting tool, Duplichecker, and used Google and Yahoo as our primary and secondary search engines. We checked all sections of each article and, in the absence of a standard working definition of plagiarism, we defined plagiarism as the detection of more than five consecutive words in a sentence from another publication, without giving credit to the original author; or more than fifteen consecutive words with acknowledgement but without copyright permission from the original author(s) or publishers. We classified plagiarism as substantial if there were more than five instances of the former in any article or the detection of any instance of the latter.

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

CONCLUSION: Over a third of the articles in this pilot sample had examples of plagiarism. None of the selected journals except the National Medical Journal of India had guidelines with respect to plagiarism. Measures to develop standard working definitions of plagiarism and to educate authors and peer-reviewers and provide better guidance in editorial policy are needed.

CHANGING MEDICAL PRACTICE BY DISSEMINATING EVIDENCE

AUTHOR

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

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

BACKGROUND: The CME department, consisting of the coordinator and two office staff, plan and conduct CME Updates and prepare CME materials and media for updating medical practitioners with the help of the valuable expert teaching input from the committed faculty of various departments in CMC.

OBJECTIVES: The objectives of the Continuing Medical Education (CME) department of Christian Medical College, (CMC) Vellore is to update doctors working in peripheral hospitals and rural areas and so to enable them to practice evidence based medicine in primary and secondary care through relevant and need-based CME. This is important as the Medical Council of India, now recertifies doctors every five years and requires thirty credit hours of CME per year before recertification.

METHODS: Current Medical Issues (CMI) is a bi-monthly journal (ISSN 0973 4651) of the CME department, which summarises current issues and features Cochrane reviews, Evidence updates and Practical evidence about real life situations (PEARLS) to update its readership of approximately 1000 doctors located in various parts of the country both in rural and urban areas. The evidence based material provided by the Cochrane network is reviewed by a member of the faculty of CMC from the concerned specialty, who makes comments about the relevance of the update in our situation in India. These expert comments from the faculty are included with the update in the journal.

RESULTS AND CONCLUSIONS: The Cochrane Evidence Updates have been well received by the readers judging by the responses that have come back to specific questions asked in the quality survey in each issue. The feedback reveals that the Cochrane reviews are read and are influencing the practice of the doctors. The readers have sent in anecdotes about how their practice has been affected and also ask thought-provoking questions which are then passed on to faculty to be answered. This has resulted in a dialogue between the doctors in peripheral hospitals and the faculty at CMC and some of these are featured in the ‘Readers Write’ column of CMI.

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

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As one of the doctors working in a mission hospital has written, “It is very difficult for busy doctors in short-staffed hospitals to keep abreast of what is happening in the medical world. Besides we cannot subscribe to journals and do not have easy access to the internet. The Cochrane network has done a fine job of summarising evidence and the CME journal. ‘Current Medical Issues’ brings us the concise information in an easily readable format so that we too, working in the rural areas can practice evidence based medicine”.

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

The activities of the CME department are enhanced by the diligence and hard work of the support staff, Mr. T. Suresh Babu and Mr. C. Nagarajan and their good work is hereby acknowledged.

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Validating Ayur veda formulations using Arthritis model – A Clinical Approach Girish Tillu 1, 2 , Manjit Saluja 1 , Sanjeev Sarmukaddam 1 , Arvind Chopra 1

Background:

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

Results of RA and OA trials

Trial

Design

Participants

Intervention (n)

Outcome

Result

(sample size)

RA-1

RDB

Patients with active-on-chronic

Plant extracts of Withania

Swollen joint count

Superiority over

Placebo controlled

RA (182)

somnifera, Boswellia serrata, Zingiber officinale and Curcuma longa

Swollen joint score ACR 20

placebo (Not Signifi- cant)

IRA-01

RDB

 

Boswellia serrata (Salai Guggul),

 

Superiority over

Placebo controlled

Patients with active-on-chronic RA (130)

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

Swollen joint count Swollen joint score ACR 20

placebo for all efficacy measures. Significant improvement with respect to physician global assessment 1 year of follow-up showed significant improvement in all efficacy variables

NMITLI/B1

Single blind

Patients with active RA (121)

  • 1. Plant extracts of Guduchi

Swollen joint count

No significant

Hydroxychloroquin

(Tinospora cordifolia),

Swollen joint score

difference in any of

Ashwagandha ( Withania somnifera),Gokshur (Tribulus terrestris) and Shunthi (Zingiber officinale)

ACR 20

the efficacy measures except physician global assessment.

  • 2. Bhallataka ( Semecarpus

anacardium)

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RA-11

RDB

Patients of symptomatic

Plant extracts of Withania

Pain VAS

Active group showed

Placebo controlled

primar y OA knees with Pain VAS > 4 (90)

somnifera, Boswellia serrata, Zingiber officinale and Curcuma longa

WOMAC

a significant reduction

NMITLI/

RDB Placebo

Patients of symptomatic

Formulations containing Shunthi

Pain VAS

No significant

C-01

and Glucosamine

primar y OA knees with Pain VAS > 4 (245)

(Zingiber officinale), Guduchi (Tinos pora cordifolia), Amalaki (Emblica officinale ), Ashwagandha (Withania somnifera) and Gokshur (Tribulus terrestris)

WOMAC

differences for pain and WOMAC

NMITLI/

RDB

Patients of symptomatic

Formulations containing Shunthi

Pain VAS

Ayurvedic formula-

C-02

Equivalence trial Control as Celecoxib and Glucosamine

primar y OA knees with Pain VAS > 4 (440)

(Zingiber officinale), Guduchi (Tinospora cordifolia)

WOMAC

tion shown equiva- lent efficacy

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

Conclusion:

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

Acknowledgement

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

  • 1. Centre for Rheumatic Diseases, Pune

  • 2. Centre for Development of Advanced Computing, Pune

Address of presenting author:

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

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