In the era of evidence-based medicine, real-world evidence (RWE) studies have opened avenues to utilize real-world data (RWD) effectively for improving clinical decision-making. However, the transformation of RWD into a meaningful RWE can only be achieved when the researcher asks the right clinical question, selects the right RWD source for variables of interest, uses the right study design, and applies the right statistical analysis. The generated RWE needs to have internal as well as external validity to be actionable.
View Article and Find Full Text PDFBackground: Venous thromboembolism is a significant source of morbidity and mortality following total hip replacement and total knee replacement. Apixaban has been proven to be efficacious without increased risk of bleeding in phase-III trials in patients undergoing total knee replacement and total hip replacement. Due to paucity of data on safety of apixaban in Indian patients, this phase-IV study was conducted to evaluate safety of apixaban in patients undergoing total knee replacement and total hip replacement.
View Article and Find Full Text PDFIndian J Med Ethics
December 2015
This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using “research ethics committees” (MeSH] and “India” (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14).
View Article and Find Full Text PDFObjectives: Reliability and usefulness of various adverse drug reaction (ADR) causality assessment scales have not been fully explored. There is no universally accepted method for causality grading of ADRs. In the present study we assessed agreement between the two widely used causality assessment scales, that is, the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria and the Naranjo algorithm.
View Article and Find Full Text PDFBackground: Therapeutic drug monitoring (TDM) is an important adjunct to the treatment of epilepsy. However, few studies have actually correlated plasma levels of antiepileptic drugs (AEDs) with treatment response. The present audit aimed to study (i) the association between seizure control and number of AEDs, plasma AED concentration, and concomitant use of antitubercular drugs; (ii) the pattern of indications for TDM requisitions; and (iii) the association between referral for toxicity and plasma AED concentration.
View Article and Find Full Text PDFBackground: Genetic polymorphisms of CYP2C9 can lead to wide inter-individual variations in drug metabolism. Decreased metabolism leads to higher plasma levels, causing adverse drug reactions (ADRs). Polymorphic alleles CYP2C9 FNx01 2 and CYP2C9 FNx01 3 occur in the Indian population and this may serve as the basis for using genotyping as a tool to predict phenytoin toxicity.
View Article and Find Full Text PDFA study was carried out to determine the extent to which ECs comply with format requirements given in guidelines and regulations. ECs were sent a written communication requesting them to permit investigators to study their approval letter for compliance with the ICMR Guidelines and Schedule Y using a pre-designed proforma. Of the 60 ECs approached, only 20 agreed to participate.
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