Role of multiparametric MRI in predicting muscle invasiveness in urinary bladder neoplasms with pathological correlations.

Urinary bladder cancer (BC) is one of the most frequent malignancies and the ninth most common malignancy worldwide. The objective of this study is to assess the role of multiparametric magnetic resonance imaging (mp-MRI) in predicting the invasiveness of urinary bladder space occupying lesions. Thirty-five patients diagnosed with bladder masses underwent an mp-MRI study. The results of three image sets were analysed and compared with the histopathological results as a reference standard: T2-weighted image (T2WI) plus dynamic contrast-enhanced (DCE), T2WI plus diffusion-weighted images (DWI), and mp-MRI, including T2WI plus DWI and DCE. The diagnostic accuracy of mp-MRI was evaluated using receiver operating characteristic curve analysis. We discovered a highly significant correlation between muscle invasiveness as staged by HPE (Histopathological examination) and mp-MRI utilising a VI-RADS score >3 (p 0.001) with a sensitivity of 100% and a specificity of 85.7%. With a diagnostic accuracy of 77.14%, a sensitivity of 92.31%, a specificity of 72.72%, a positive predictive value of 66.67%, and a negative predictive value of 94.11%, In terms of muscle invasiveness, there is good concordance between HPE staging and mp-MRI utilising the VI-RADS score. The mean apparent diffusion coefficient (ADC) values were higher in low grades than in high grades. The ROC curve study revealed a very strong correlation between HPE grade and ADC (p = 0.045). In 77.14% of patients, Mp-MRI correctly identified the local T stage. Mp-MRI is imaging biomarker for invasiveness and grade of tumour. The tumours with high grade are more invasive. However, the diagnostic accuracy of mp-MRI in determining muscle invasiveness is not very high and it overstages the disease in some cases (33.3%). Its clinical usefulness in determining muscle invasiveness before TURBT and histopathological examination can be questioned.

An Observational Study showing Dipeptidyl Peptidase-4 (DPP-4) Activity and Gene Expression Variation in Chronic Liver Disease (CLD) Patients from a Tertiary Care Hospital of Eastern India.

Introduction: The studies in animal models of cirrhosis suggest that dipeptidyl peptidase type 4 (DPP-4) enzymes play a crucial role in disease pathogenesis. In this clinical observational study, activity of DPP-4 and related gene expression were analysed in chronic liver disease patients. Objectives: To understand the DPP-4 enzyme activity variation in the common types of chronic liver disease by assessing plasma and peripheral blood mononuclear cell (PBMC) DPP-4 activity and comparing with healthy controls and to explore DPP-4 gene expression in PBMC. Methods: We recruited 130 study subjects in four cohorts-46 nonalcoholic fatty liver disease (NAFLD), 23 non-alcoholic cirrhosis (NAC) excluding viral aetiology, 21 alcoholic liver disease (ALC), and 40 control subjects. Blood samples were analysed for relevant biochemical parameters and plasma DPP-4 activity. PBMC fraction was used for the DPP-4 activity assay and gene expression analysis. Results: We found that lower plasma DPP-4 activity among patient cohorts but this was not statistically significant. The PBMC DPP-4 activity was significantly lower in NAFLD cohort. In the same cohort, DPP-4 gene expression in PBMC fraction was significantly increased (P < 0.05). There was significant correlation between plasma DPP-4 activity and liver injury marker alanine aminotransferase (ALT) among NAFLD (rho = 0.459, P < 0.01), NAC (rho = 0.475, P < 0.05), and ALC (rho = -0.572, P < 0.01) patients. Plasma DPP-4 activity modestly predicted ALT plasma level (beta coefficient = 0.489, P < 0.01). Conclusions: The PBMC DPP-4 activity and DPP-4 gene expression gets significantly altered in NAFLD patients. Plasma DPP-4 activity also shows correlation with ALT levels in CLD patients. The role of DPP-4 in disease pathology in NAFLD and other forms of CLD needs to be explored.

Information adequacy of medicine package inserts in India: A critical evaluation.

OBJECTIVES: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. MATERIALS AND METHODS: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. RESULTS: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15-19). Deficiencies were observed under important headings. For example, "references" were mentioned in only 6.67% and "date of last updating" in only 19.26% of PIs. Other notable shortcomings were in "disposal" (not mentioned in 92.59%), "effects on ability to drive and use machines" (76.30%), "pharmaceutical incompatibilities" (66.67%), "shelf life" (62.96%), "excipients" (60.00%), and "overdose" (17.78%) information. Information on "generic name," "composition," and "indications" were however provided by all (100%) PIs. CONCLUSIONS: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information.

Inadequate diversity of information resources searched in US-affiliated systematic reviews and meta-analyses: 2005-2016.

OBJECTIVE: Systematic reviews and meta-analyses (SRMAs) rely upon comprehensive searches into diverse resources that catalog primary studies. However, since what constitutes a comprehensive search is unclear, we examined trends in databases searched from 2005-2016, surrounding the publication of search guidelines in 2013, and associations between resources searched and evidence of publication bias in SRMAs involving human subjects. STUDY DESIGN: To ensure comparability of included SRMAs over the 12 years in the face of a near 100-fold increase of international SRMAs (mainly genetic studies from China) during this period, we focused on USA-affiliated SRMAs, manually reviewing 100 randomly selected SRMAs from those published in each year. After excluding articles (mainly for inadequate detail or out-of-scope methods), we identified factors associated with the databases searched, used network analysis to see which resources were simultaneously searched, and used logistic regression to link information sources searched with a lower chance of finding publication bias. RESULTS: Among 817 SRMA articles studied, the common resources used were Medline (95%), EMBASE (44%), and Cochrane (41%). Methods journal SRMAs were most likely to use registries and grey literature resources. We found substantial co-searching of resources with only published materials, and not complemented by searches of registries and the grey literature. The 2013 guideline did not substantially increase searching of registries and grey literature resources to retrieve primary studies for the SRMAs. When used to augment Medline, Scopus (in all SRMAs) and ClinicalTrials.gov (in SRMAs with safety outcomes) were negatively associated with publication bias. CONCLUSIONS: Even SRMAs that search multiple sources tend to search similar resources. Our study supports searching Scopus and CTG in addition to Medline to reduce the chance of publication bias.