Ľuboslav Šiška, Peter Mačura, Andrej Hubinák, Peter Krška, Jaromír Sedláček, Anna Blahutová, Martin Zvonař, Katarína Kohútová, Lovro Štefan
Basic motor competencies in Slovak children from the 3rd and 4th grade elementary age group
Frontiers in pediatrics
disproportionality analyses using reports suspected adverse drug reactions commonly used quantitative methods detecting safety signals pharmacovigilance however methods results generally poorly reported published articles existing guidelines capture specific features disproportionality analyses describe development guideline reporting disproportionality analysis drug safety signal detection using individual case safety reports pharmacovigilance readuspv reporting results disproportionality analyses articles abstracts established group 34 international experts universities pharmaceutical industry regulatory agencies expertise pharmacovigilance disproportionality analyses assessment safety signals followed threestep process develop checklist 1 opentext survey generate first list items 2 online delphi method select rephrase important items 3 final online consensus meeting among panel members 33 experts responded round 1 30 round 2 delphi 25 participated consensus meeting overall 60 recommendations main body manuscript 13 recommendations abstracts retained participants delphi method merging items together online consensus meeting readuspv guidelines comprise checklist 32 recommendations 14 items reporting disproportionality analyses main body text four items comprising 12 recommendations abstracts readuspv guidelines support authors editors peerreviewers users disproportionality analyses using individual case safety report databases adopting guidelines lead transparent comprehensive accurate reporting interpretation disproportionality analyses facilitating integration sources evidence