OBJECTIVE: Elicitation is an essential and critical step in ascertaining adverse events (AEs). This report reviews elicitation methods used in published clinical trials of psychopharmacological agents in children. METHOD: Pediatric psychopharmacology reports were reviewed for safety methods in the Medline database. Studies were included if they were published 1980 or later, provided data on AEs, and described the ascertainment methodology used for determining them. RESULTS: A review of 196 pediatric psychopharmacology articles depicting safety assessments in clinical studies over the past 22 years revealed that there was no common method used for eliciting or reporting AE data. CONCLUSION: The current inconsistency in safety data ascertainment is a major limitation that likely impairs the ability to promptly and accurately identify drug-induced AEs. Research on how best to standardize safety methods should be considered a priority in pediatric psychopharmacology.
OBJECTIVE: Elicitation is an essential and critical step in ascertaining adverse events (AEs). This report reviews elicitation methods used in published clinical trials of psychopharmacological agents in children. METHOD: Pediatric psychopharmacology reports were reviewed for safety methods in the Medline database. Studies were included if they were published 1980 or later, provided data on AEs, and described the ascertainment methodology used for determining them. RESULTS: A review of 196 pediatric psychopharmacology articles depicting safety assessments in clinical studies over the past 22 years revealed that there was no common method used for eliciting or reporting AE data. CONCLUSION: The current inconsistency in safety data ascertainment is a major limitation that likely impairs the ability to promptly and accurately identify drug-induced AEs. Research on how best to standardize safety methods should be considered a priority in pediatric psychopharmacology.
Authors: Craig G Hartford; Kasia S Petchel; Hani Mickail; Susana Perez-Gutthann; Mary McHale; John M Grana; Paula Marquez Journal: Drug Saf Date: 2006 Impact factor: 5.606
Authors: Martine W F T Verhees; Janne Houben; Eva Ceulemans; Marian J Bakermans-Kranenburg; Marinus H van IJzendoorn; Guy Bosmans Journal: Psychopharmacology (Berl) Date: 2018-06-18 Impact factor: 4.530
Authors: Michael Aman; Mallikarjuna Rettiganti; Haikady N Nagaraja; Jill A Hollway; James McCracken; Christopher J McDougle; Elaine Tierney; Lawrence Scahill; L Eugene Arnold; Jessica Hellings; David J Posey; Naomi B Swiezy; Jaswinder Ghuman; Marco Grados; Bhavik Shah; Benedetto Vitiello Journal: J Child Adolesc Psychopharmacol Date: 2015-08 Impact factor: 2.576
Authors: Mark Shapiro; Susan G Silva; Scott Compton; Allan Chrisman; Joseph DeVeaugh-Geiss; Alfiee Breland-Noble; Douglas Kondo; Jerry Kirchner; John S March Journal: Child Adolesc Psychiatry Ment Health Date: 2009-03-25 Impact factor: 3.033