Jan Breckwoldt, Adrian P Marty, Daniel Stricker, Raphael Stolz, Reto Thomasin, Niels Seeholzer, Joana Berger-Estilita, Robert Greif, Sören Huwendiek, Marco P Zalunardo
Bottom-up feedback to improve clinical teaching: validation of the Swiss System for Evaluation of Teaching Qualities (SwissSETQ)
Swiss medical weekly
rare severe adverse events occur children inflammatory bowel disease ibd relationship disease drug treatment often uncertain aimed establish method reporting adverse events interest children ibd allowing estimates incidence rates comparison different regions possible compare published data rates adverse events children overall analysis used data paediatric inflammatory bowel disease network safety efficacy treatment quality improvement care pibdsetquality safety registry collects data multiple rare severe adverse events children younger 19 years ibd overall registry collected data ten prespecified rare severe adverse events children ibd established panel paediatric ibd experts via reports paediatric gastroenterologists participating hospitals nov 1 2016 march 31 2023 reporting physicians could paediatric gastroenterologists ibd nurses reporting behalf paediatric gastroenterologists recruited invitations sent national international ibd networks conferences per month participating paediatric gastroenterologists received email anonymous unique link online survey asking report whether ten rare severe adverse events occurred patient paediatricibd population previous month prevalent retrospective rare severe adverse events excluded events occurring children unconfirmed diagnosis ibd inflammatory colitis part monogenic immunodeficiency disorder duplicates events meet definitions criteria excluded physicians could also report noncategorised adverse events considered rare severe case response two reminders sent permonth survey annual denominator data surveys sent obtain total number personyears estimation incidence rates calculated via poisson regression models responses gathered 220 paediatric gastroenterologists 167 centres 121 centres europe 23 centres north america 17 centres asia six centres oceania combined total population paediatric ibd consisted estimated 30 193 children 114 528 personyears followup 451 adverse events initially reported excluding reorganising adverse events 402 eligible 261 65 categorised 141 35 noncategorised frequently reported adverse events venousthromboembolic events n66 renal failure n43 opportunistic infections n42 cancer n33 haemophagocytic lymphohistiocytosis n4 liver failure n3 least frequently reported adverse events incidence rates per 10 000 personyears 550 95 ci 425697 venousthromboembolic events 375 274499 renal failure 367 267489 opportunistic infection 288 201398 cancer 66 venousthromboembolic events 31 47 involved cerebral venous sinus thrombosis incidence rate 271 95 ci 186377 pibdsetquality safety registry enabled us identify incidence rates rare severe adverse events children ibd findings guide physicians enhance awareness incidence adverse events children ibd considered rare eu horizon 2020 research innovation programme