Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology.

Published

Journal Article

OBJECTIVE: To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods. METHOD: Trained clinicians administered the Safety Monitoring Uniform Report Form (SMURF) to 59 parents and outpatients (mean age +/- SD = 11.9 +/- 3.2 years) in treatment, with 36% on stimulants, 29% on selective serotonin reuptake inhibitor drugs, 10% on both, and 25% on other drug combinations. The SMURF included a brief general inquiry, a drug-specific inquiry, and a comprehensive body system review (BSR). RESULTS: SMURF administration took 24.6 +/- 13.9 minutes (median, 21). The BSR took 15.5 +/- 8.1 minutes (median, 14) longer (p < .0001) than the general inquiry (4.3 +/- 5.4 minutes) and the drug-specific inquiry (4.2 +/- 2.9 minutes). The general inquiry elicited 48 AEs, the drug-specific inquiry elicited 16 additional AEs, and the BSR 129 additional AEs. Of all the clinically relevant AEs elicited by the SMURF (n = 36), 19 (53%) were elicited by the BSR. The BSR length and detail were acceptable to parents but not to clinicians. CONCLUSIONS: The BSR elicited additional clinically significant AEs that had been missed with less detailed methods. Parents, but not clinicians, rated satisfaction and acceptability of the BSR as good.

Full Text

Duke Authors

Cited Authors

  • Greenhill, LL; Vitiello, B; Fisher, P; Levine, J; Davies, M; Abikoff, H; Chrisman, AK; Chuang, S; Findling, RL; March, J; Scahill, L; Walkup, J; Riddle, MA

Published Date

  • December 2004

Published In

Volume / Issue

  • 43 / 12

Start / End Page

  • 1488 - 1496

PubMed ID

  • 15564818

Pubmed Central ID

  • 15564818

International Standard Serial Number (ISSN)

  • 0890-8567

Digital Object Identifier (DOI)

  • 10.1097/01.chi.0000142668.29191.13

Language

  • eng

Conference Location

  • United States