Kelsey Leonard Grabeel, Jennifer Russomanno, Sandy Oelschlegel, Emily Tester, Robert Eric Heidel
Computerized versus hand-scored health literacy tools: a comparison of Simple Measure of Gobbledygook (SMOG) and Flesch-Kincaid in printed patient education materials
Journal of the Medical Library Association : JMLA
pharmacovigilance studies adverse event ae data tumour necrosis factor alpha tnf inhibitors south korea analysed aes induced adalimumab infliximab etanercept methods used data korea institute drug safety risk managementkorea adverse events reporting system database kidskd collected 2005 2016 used three different signal detection methods proportional reporting ratio prr reporting odds ratio ror information component ic drug compared drug labels usa korea logistic regression analysis identified aes likely occur drug use 5594 aes identified 350 452 71 related adalimumab infliximab etanercept respectively identified seven new signals listed drug labels either korea usa aes associated study drugs two adalimumab medication error drug failure two infliximab palpitation temperature sensation change three etanercept hyperkeratosis acne thyroid neoplasm malignant injection site pain 614 95 ci 1153274 alopecia 454 95 ci 1161777 adalimumab chest pain 601 95 ci 1352677 infliximab uveitis 1011 95 ci 1139077 etanercept likely reported patients tnf inhibitor without respectively seven new signals included current label identified tnf inhibitors updated monitoredkey points largescale spontaneous ae reporting data data mining techniques useful detecting signals rare aes well common aes induced drugs drug labels updated reflect signals newly discovered continuous monitoring