DEVELOPMENT AND VALIDATION OF A NOVEL METHOD FOR CAUSALITY ASSESSMENT USING SUSPECTED ADVERSE DRUG REACTIONS TO ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2019, Vol 12, Issue 4
Abstract
Objectives: The study has been designed to develop, test reliability, and construct validity of a novel versatile causality assessment tool (VCAT) method. Methods: The study included 427 literature case reports of angiotensin-converting enzyme inhibitors with suspected adverse drug reactions from 1990 to February 25, 2016. The causality of these cases was assessed independently by 3 raters in 3 phases of the study. Kappa (k) and intra-class correlation Intraclass Correlation Coefficient (ICC) were used to test reliability and validity of the VCAT method. Results: Intra-rater reliability was high between Phase I and Phase III (k=0.84–0.93; % agreement: 92.3–96.3%). Inter-rater agreement was good in Phase I (k=0.87–0.89, % agreement: 93.7–94.1%, ICC: 0.975) and Phase III (k=0.85–0.89, % agreement: 93–94.4%, ICC: 0.973). Validity was proved by the high agreement observed between Phase I and Phase II (k=0.78–0.94; % agreement: 89.7–97.2%; p<0.001); and between Phase II and Phase III (k=0.8–0.9; % agreement: 90.2–94.8%; p<0.001). Conclusion: VCAT method is a standardized causal assessment tool that gives valid and reproducible results. It has shown good agreement with the expert judgment method. This method may overcome the limitations enthralled with existing methods of causality assessment.
Authors and Affiliations
Rupinder Kaur Sodhi
Keywords
Related Articles
- EP ID EP604706
- DOI -
- Views 101
- Downloads 0
PRELIMINARY PHYTOCHEMICAL INVESTIGATION AND EVALUATION OF HYPOGLYCEMIC ACTIVITY OF METHANOLIC EXTRACT OF MUNTINGIA CALABURA L STEM BARK AGAINST NORMAL AND STREPTOZOTOCIN-INDUCED DIABETES
Objective: This research was attributed to the investigation of preliminary phytochemical constituents and evaluation of hypoglycemic activity of the methanolic extract of Muntingia calabura L stem bark against normal an...
EFFECTIVENESS OF GLUTEAL MUSCLE STRENGTHENING ON FLAT FOOT
Objectives: To compare the effect of gluteal muscle strengthening along with conventional exercises versus conventional exercises alone on flat foot.Method: An experimental study conducted at Physiotherapy Department of...
SYNTHESIS, CHARACTERIZATION AND ANTIBACTERIAL ACTIVITIES OF CHROMIUM OXIDE NANOPARTICLES AGAINST KLEBSIELLA PNEUMONIAE
Objective: This paper consists of synthesis of chromium oxide (Cr2O3) nanoparticles by sol-gel technique, their characterization and investigation of antibacterial activity of these nanoparticles against pathogenic bacte...
SEIZURES WITH ANTI-SEIZURE DRUG
This case study is to report and explore the etiology of a case of refractory seizures due to overdosage of phenytoin tablets. A case report from the Department of Neurology generated through voluntary adverse drug react...
IN VITRO CYTOTOXIC ANTICANCER POTENTIAL OF BIOACTIVE FRACTION ISOLATED FROM INDONESIAN TIDAL SPONGE CALTHROPELLA SP.
Objective: This study was taken to examine the cytotoxicity of the bioactive fraction isolated from marine sponge Calthropella sp. as a preliminary anticancer assay and identify its bioactive compounds.Methods: The cytot...