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   Table of Contents - Current issue
January-March 2021
Volume 12 | Issue 1
Page Nos. 1-61

Online since Tuesday, January 19, 2021

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Artificial intelligence in managing clinical trial design and conduct: Man and machine still on the learning curve? p. 1
Arun Bhatt
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Sodium-glucose co-transporter-2 inhibitors: A cardiovascular outcome trial analysis p. 4
Viraj Ramesh Suvarna
Cardiovascular outcome trials (CVOTs) have to be done by sponsors who wish to launch new antidiabetic drugs in the US, since the December 2008 US Food and Drug Administration ruling, which was subsequently accepted by the European Medicines (Evaluation) Agency (EMA) in 2012. However, the medical community asks the question, “So What?” as they are not convinced of the clinical relevance of CVOTs. The patients selected in CVOTs are necessarily high risk, so that they develop major adverse cardiovascular events quickly, but then, the results are extrapolatable to only a certain percentage of patients seen in the clinical practice. Doctors believe that these trials only serve a regulatory need. At the same time, these trials do provide a lot of good data, but it needs to be interpreted well, and extrapolated appropriately to patients in practice as there are differences between what happens in a randomized control trial and in the real world. Hence, the need for this article which serves to dissect the CVOTs of sodium-glucose co-transporter-2 inhibitors, so that doctors are able to better read this evidence. However, the question of which gliflozin is the best cannot be answered by these trials as these are not head to head trials. All the more reason why one needs to look at the data holistically and be empowered to make the right decision for individual patients, hoping to match the best patient for the best drug, rather than determine which drug is better.
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A retrospective study to assess the risk of bladder cancer in type-2 diabetic patients treated with pioglitazone Highly accessed article p. 9
Prabhat Agrawal, Apoorva Jain, Ashish Gautam, Ashwini Kumar Nigam, Nikhil Pursnani, Maaz Farooqui
Introduction: Pioglitazone has been a cornerstone of oral hypoglycemic therapy. Concerns have been raised about its association with urinary bladder cancer. Considering the wide usage of this drug, concrete and multiple population-based studies are needed to establish the safety of this drug. The present retrospective study is aimed to assess the association of pioglitazone with urinary bladder cancer. Materials and Methods: Clinical records of 4170 patients (2085 pioglitazone users and similar number of nonpioglitazone users) attending the diabetes clinic at a tertiary level teaching hospital were accessed, and the patients were subjected to symptom-directed questionnaire, urine examination, and cystoscopy and bladder biopsy (whenever clinically indicated). The risk of bladder cancer was also assessed with respect to cumulative dose and duration of pioglitazone. Results: We did not observe any increased risk of bladder malignancy with pioglitazone exposure; furthermore, there was no association with cumulative dose and duration of pioglitazone therapy. Pioglitazone was found to be effective and safe in managing glycemic control in diabetic patients.
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Cost-saving medication therapy management for outpatients Highly accessed article p. 14
K Priya, Mary Sreshta, Sonin Philip
Objective: Medication costs comprise the majority of health system budgets and continue to increase faster than other health-care expenditures. The objective of this study is to evaluate the causes and monetary value of cost-saving prescription interventions made by clinical pharmacists in outpatient pharmacy. Materials and Methods: Outpatient prescriptions were randomly audited for a period of 11 months (August 2017–June 2018) using a customized outpatient prescription audit tool integrated with computerized physician order entry. Drug-related problems were communicated to respective prescribers, and their response to each intervention was documented in accordance with PCNE classification. Both unit dose cost and anticipated dose cost savings were calculated to evaluate the monetary benefit for patients. Results: Unit dose cost of INR 4875.73 and anticipated dose cost of INR 26890.8 were saved from outpatients. Majority of the prescribing errors were associated with therapeutic duplication (43.4%) and drug interaction (25.7%) that account for anticipated dose cost savings of INR 17812.65 for patients. Major contributory drug classes that reduced the cost of therapy were antibiotics (24.23%), proton-pump inhibitors (13.27%), and analgesics (12.34%). Prescribers' response to pharmacist intervention varied, 53% responded to stop the drug, 21% responded to change the brand, and 20% changed the frequency of administration. Necessary instructions were verbally given to patients without making any modification in the prescription for 3.2% (n = 10) of cost-saving interventions. Discussion and Conclusion: As clinical pharmacist has the expertise to detect, resolve, and prevent medication errors, the development of clinical pharmacy practice in a hospital outpatient pharmacy will have a significant impact on reducing prescription errors and health-care cost also.
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An evaluation of medication appropriateness in pregnant women with coexisting illness in a tertiary care hospital p. 21
Htet Wai Moe, Sushil Sharma, AK Sharma
Aim: Prescribing drugs during pregnancy needs careful consideration of benefit to the mother and risk to the fetus. Therefore, this study was conducted to evaluate the appropriateness of medications among pregnant women with coexisting illness in a tertiary care hospital, Western India. Materials and Methods: It was a hospital-based cross-sectional study conducted in the obstetrics and gynecology department of a tertiary care hospital. The study was conducted over a period of 12 months wherein data from 800 pregnant women suffering from any co-existing illness and being prescribed any medication apart from routine supplementation were analyzed. The Medication Appropriateness Index (MAI) was used to assess the appropriateness of medications. Higher MAI scores indicate more inappropriate prescribing. Results: Drugs which were most inappropriately prescribed with the highest average MAI scores were albendazole, itraconazole, injection amikacin, oxcarbazepine, warfarin, domperidone, propylthiouracil, and combiflam (ibuprofen + paracetamol). Diseases with the highest average MAI scores were anemia, Grave's disease, umbilical hernia, urinary tract infection, urticaria, allergic rhinitis, and preeclampsia. The MAI criteria which had the highest percentage of inappropriately prescribed medications were “cost of drugs,” “duration of therapy,” and “indication.” Conclusion: Potentially inappropriate prescribing was seen in the study with some of the common coexisting illness being treated with drugs which fared poorly on the MAI. The study has also highlighted areas in drug prescribing where scope for improvement exists. Further, it can act as a benchmark for comparison of future studies to evaluate medication appropriateness in pregnant women.
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Analyzability of newly developed/commercially promoted drugs among young medical and dental doctors p. 27
Sonu Gupta, Ravinder Nath Bansal
Introduction: The development of a new chemical entity into a drug is of indispensable importance for the progression of health care. As physicians play the main and important part of any clinical trial, it is necessary to know about their awareness about clinical research, drug development, good clinical practices, and regulatory authorities. Objective: This study was designed to assess and compare the knowledge and awareness toward drug development process among medical interns, dental interns, and postgraduates (PGs). Methodology: This was a cross-sectional study enrolling 186 professionals of medical college and 110 professionals of dental college in Punjab who were given a prevalidated questionnaire that included 27 questions related to knowledge regarding drug development process. Data were analyzed for percentage correct responses, mean values, and intergroup comparison by applying t-test using SPSS version 20, IBM SPSS Statistics for Windows, Version 20.0. IBM Corp., Armonk, NY, USA. Results: It was found that medical and dental college professionals had a very poor awareness and knowledge about drug development process to the tune of 33%. Professionals of dental college had 53.7% knowledge of clinical research in comparison to 43.2% of medical college. A statistically significant (P < 0.05) difference for sections on drug development, clinical research, and regulatory authority among interns and PGs was found with interns possessing better knowledge. Conclusion: It is concluded that regulatory authorities such as Board of Studies of various medical universities, Dental Council of India, and Medical Council of India must take necessary steps to increase the knowledge of drug development process among dental and medical professionals. Incorporation of this topic in educational curriculum in the initial stages of graduation and postgraduation would be beneficial.
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An evaluation of trigger tool method for adverse drug reaction monitoring at a tertiary care teaching hospital p. 33
Urmila Menat, Chetna K Desai, Jigar R Panchal, Asha N Shah
Objectives: The objective of this study is to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs) at Civil Hospital Ahmedabad, India. Materials and Methods: A prospective, single-center, observational cum intervention study was conducted in two phases in the Department of Medicine over 15 months. In phase I, preliminary trigger tool list (PTTL) comprising 55 triggers was evaluated by pharmacologist in terms of detection of ADR in 400 patients and then, modified trigger tool list (MTTL) was prepared. In Phase II, the TTM using MTTL was compared with the spontaneous method of ADR monitoring after educational interventions in resident doctors of the two units of medicine department. Results: Of the 55 triggers in PTTL, 34 triggers were observed in 327 patients, of which 19 triggers lead to the detection of 66 ADRs. The rate of ADEs was 16.5%/100 patients. Positive predictive value (PPV) of each trigger ranged from 0% to 100%. PPV for drug trigger, laboratory trigger , and PT was 14.4%, 4.5%, and 23.3%, respectively. Overall, PPV of PTTL was 19.27%. Sensitivity and specificity were 100% and 21.66%, respectively. MTTL consists of these 19 triggers. In Phase II, resident doctors reported 16 ADRs, using spontaneous method and 23 ADRs using MTTL. The rate of ADEs per 100 patients was 1.63 and 2.13, respectively, with these methods. A total of 105 ADRs were reported during both phases. Conclusion: TTM is an effective method of ADR reporting if it is utilized by a trained person. This method could be used as add-on method to spontaneous method to improve ADR reporting.
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Treatment outcome of different antiretroviral drug regimens in HIV-positive pregnant women p. 40
Nidhi Chauhan, Mira Desai, Samidh Shah, Asha Shah, Rajendra Gadhavi
Objective: The objective of the study was to compare the maternal and fetal outcomes of currently preferred tenofovir-based regimen with previous zidovudine-based regimen and also to determine whether the time of starting antiretroviral therapy (ART), whether it can affect the pregnancy and fetal outcome. Materials and Methods: Pregnant patients prescribed any of the above regimens were followed up every month till delivery and newborns for initial 6 months. Maternal endpoints were body weight, hemoglobin, and CD4 count, whereas fetal endpoints were birth weight, Apgar score, body weight, and HIV status at 6 months. Data were analyzed using ANOVA and unpaired t-test.P <0.05 was considered statistically significant. Results: A significant increase in CD4 count was observed in patients treated with both the regimens at 12 months as compared to baseline (P < 0.001 and 0.05). Moreover, a significant increase in CD4 count was observed at 12 months as compared to baseline, whether treatment was started before or after the diagnosis of pregnancy (P < 0.05 and 0.001). A significant difference in mean body weight at the end of 9 months was observed in patients wherein ART was started before or after the diagnosis of pregnancy (P < 0.005). Majority of patients had a favorable maternal outcome, while fetal birth weight, Apgar score, body weight, and HIV status were comparable at 6 months irrespective of treatment and time of starting ART. Conclusion: All ART regimens are equally effective in terms of increase in CD4 count, gestational gain in body weight, and pregnancy and fetal outcome. Furthermore, there is no significant difference in efficacy, pregnancy, and fetal outcome in women who were already on ART when diagnosed pregnancy or who were started ART later in antenatal period.
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Current status of clinical research using artificial intelligence techniques: A registry-based audit p. 48
Sonali Rajiv Karekar, Arzan Khurshed Vazifdar
Background and Objectives: Artificial intelligence (AI) as a field has recently gained a lot of importance and is expected to revolutionize the health-care scenario in the near future. There have been no studies done worldwide to review the status of research with respect to the use of AI in health care. Hence, we conceptualized this study to get an overview of the clinical studies being conducted in the field of AI, by analyzing those registered on the Food and Drug Administration trial registry website. Methodology: All the clinical studies conducted in the field of AI registered on the ClinicalTrials.gov website up to September 2019 were reviewed and analyzed. The variables such as geographical distribution, study design, status of study whether ongoing or completed, therapy area, type of intervention tested, type of funding, and year of initiation of study were recorded. The data were analyzed using descriptive statistics using SPSS for Windows, Version 16.0 (SPSS Inc. Chicago, IL, USA). Results: Out of all the studies registered, 156 were related to AI. Of these 156 studies, 84 were interventional and 72 were observational. The most common therapy area under study was oncology with 26.3% studies, followed by cardiology, ophthalmology, psychiatry, and neurology. Devices comprised the most common intervention being studied, accounting to 34% of studies, followed by diagnostics which included 28% of studies. In the first 8 months of 2019 itself, 65 studies had been registered. Conclusion: The study revealed an increasing trend in the studies being conducted using AI techniques, with majority being conducted in the area of oncology, with medical devices being the most common intervention being tested.
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Study designs: Part 9 – Meta-analysis (II) p. 53
Priya Ranganathan, Rakesh Aggarwal
The previous two articles in this series gave an overview of the methodology of systematic reviews and meta-analysis. In this third and concluding article, we look at the different types of biases that can confound the results of a meta-analysis and briefly describe some special types of meta-analysis.
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Hydroxychloroquine in the prophylaxis of COVID 19: A survey of safety on the healthcare workers in India p. 58
Sandip Mukhopadhyay, Suhrita Paul, Basabdatta Samanta
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Declaration of conflict of interest for reviewers in time of COVID-19 should be mandatory p. 60
Francesco Chirico, Nicola Luigi Bragazzi
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