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   2012| July-September  | Volume 3 | Issue 3  
    Online since September 5, 2012

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What to use to express the variability of data: Standard deviation or standard error of mean?
Mohini P Barde, Prajakt J Barde
July-September 2012, 3(3):113-116
DOI:10.4103/2229-3485.100662  PMID:23125963
Statistics plays a vital role in biomedical research. It helps present data precisely and draws the meaningful conclusions. While presenting data, one should be aware of using adequate statistical measures. In biomedical journals, Standard Error of Mean (SEM) and Standard Deviation (SD) are used interchangeably to express the variability; though they measure different parameters. SEM quantifies uncertainty in estimate of the mean whereas SD indicates dispersion of the data from mean. As readers are generally interested in knowing the variability within sample, descriptive data should be precisely summarized with SD. Use of SEM should be limited to compute CI which measures the precision of population estimate. Journals can avoid such errors by requiring authors to adhere to their guidelines.
  32,237 9,801 91
Protocol deviation and violation
Arun Bhatt
July-September 2012, 3(3):117-117
DOI:10.4103/2229-3485.100663  PMID:23125964
  7,154 1,818 12
Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting
Mala Kharkar, Suresh Bowalekar
July-September 2012, 3(3):90-94
DOI:10.4103/2229-3485.100651  PMID:23125959
Objective: The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. Materials and Methods: A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. Results: 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. Conclusion: The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right perception toward ADR reporting. However, as far as practice of ADR reporting is concerned it is discouraging.
  6,370 1,257 13
Diabetes mellitus: Exploring the challenges in the drug development process
Julius A Vaz, Ashis Patnaik
July-September 2012, 3(3):109-112
DOI:10.4103/2229-3485.100660  PMID:23125962
Diabetes mellitus has reached epidemic proportions and continues to be a major burden on society globally. The International Diabetes Federation (IDF) estimated the global burden of diabetes to be 366 million in 2011 and predicted that by 2030 this will have risen to 552 million. In spite of newer and effective treatment options, newer delivery and diagnostic devices, stricter glycaemic targets, better treatment guidelines and increased awareness of the disease, baseline glycosylated hemoglobin remains relatively high in subjects diagnosed and treated with type 2 diabetes. The search continues for an ideal anti diabetic drug that will not only normalize blood glucose but also provide beta cell rest and possibly restoration of beta cell function. The development of anti diabetic drugs is riddled with fundamental challenges. The concept of beta cell rest and restoration is yet to be completely understood and proven on a long term. The ideal therapeutic approach to treating type 2 diabetes is not yet determined. Our understanding of drug safety in early clinical development is primarily limited to "Type A" reactions. Until marketing authorization most drugs are approved based on the principle of confirming non-inferiority with an existing gold standard or determining superiority to a placebo. The need to obtain robust pharmaco-economic data prior to marketing authorization in order to determine appropriate pricing of a new drug remains a major challenge. The present review outlines some of the challenges in drug development of anti-diabetic drugs citing examples of pulmonary insulin, insulin analogues, thiazolidinediones and the GLP1 analogues.
  4,510 633 9
Management of third stage of labor with misoprostol: A comparison of three routes of administration
Sukhwinder Kaur Bajwa, Sukhminder Jit Singh Bajwa, Harpreet Kaur, S. P. S. Goraya, Anita Singh, Harpreet KaurIshar
July-September 2012, 3(3):102-108
DOI:10.4103/2229-3485.100666  PMID:23125961
Background and Context: Misoprostol is a versatile drug with an effective uterotonic effect on the postpartum uterine tissue and is used through various routes during the third stage of labor. Aims and Objectives: A randomized prospective study was carried out to analyze the most effective route for misoprostol administration, with an emphasis on parturients' acceptability and compliance, a possible shortening of the duration of the third stage of labor, minimization of blood loss and possibly reducing the incidence of potential side effects. Materials and Methods: The study groups comprised of 300 healthy parturients, divided randomly into three groups of 100 parturients each, who were administered misoprostol 400 mg through the oral (O), rectal (R), and sublingual (S) routes, respectively, during the third stage of labor. Estimation of blood loss was measured in terms of fall in hemoglobin, hematocrit, and packed cell volume (PCV) levels, and duration of the third stage of labor was also compared. Results: The mean duration for the third stage of labor was significantly shorter in group S (3.62 minutes) as compared to R (4.12 minutes), and O (4.94 minutes) ( P = 0.02). The average blood loss was observed to be the least in the group S (210 ml) as compared to group R (230 ml), and group O. The incidence of shivering and fever was observed to be significantly higher (25 and 15%) in the parturients of group S ( P < 0.05). Conclusions: All routes were equally effective in managing the third stage of labor, but administration of misoprostol through the rectal route evoked better acceptability, comparable efficacy, and had an incidence of minimal side effects.
  4,519 565 4
Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs) in selected hospitals in Nigeria
Kenneth Anene Agu, Azuka Cyriacus Oparah, Uche M Ochei
July-September 2012, 3(3):95-101
DOI:10.4103/2229-3485.100657  PMID:23125960
Purpose: The study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following routine patient counseling and education in selected hospitals in Nigeria. Materials and Methods: From 36,459 HIV-infected patients on ART in the 36 selected hospitals, a study-specific instrument was administered to 3,650 patients in a cross-sectional study. Patients were provided counseling and education on ADRs before and after commencing ART. Factor analysis was performed using principal components extraction. Item score means above midpoint (3.7) on a 5-point scale were regarded as positive attitudes and below as negative attitudes. A chi-square test was used for inferential statistics; P<0.05 was used to determine statistical significance. Results: The mean questionnaire return rate was 47.5%. Data from 2329 (63.8%) participants were analyzed, 63.1% females and 34.4% aged 25-34 years old. A total of 80.1% participants accepted to have been counseled on ADRs; 65.8% knew that all medicines cause some kind of adverse effects; 55.1% knew the adverse effects of their medicines; 60.8% knew what to do when they suspect ADRs and it included mainly reporting to the healthcare provider (88.1%). However, only 31.9% had experienced ADRs previously. The knowledge of ADRs was associated with gender and educational and employment status of the patients (P<0.05). A total of 95.6% reported self-efficacy to ART. Majority of the rated attitude score means were >3.7 which denotes positive attitudes to ADRs. Three extracted factors accounted for 73.1% of cumulative variability. All attitude items had very significant loadings of ≥0.5. Conclusion: Overall, participants reported good knowledge and positive attitudes to adverse effects of their medicines compared to what was reported previously. The patient counseling and education on drug therapy provided to patients may have contributed to these findings and are highly recommended.
  4,475 490 1
Government's role in shaping public perceptions about clinical research
Arun Bhatt
July-September 2012, 3(3):87-89
DOI:10.4103/2229-3485.100643  PMID:23125958
  3,309 397 1
Safety reporting - making it safely effective or effectively safe?
Viraj Rajadhyaksha
July-September 2012, 3(3):85-86
DOI:10.4103/2229-3485.100640  PMID:23125957
  2,397 423 -
From the World of Clinical Research
Arun Bhatt
July-September 2012, 3(3):118-118
  2,151 298 -