TY - JOUR
T1 - Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology
AU - Greenhill, Laurence L.
AU - Vitiello, Benedetto
AU - Fisher, Prudence
AU - Levine, Jerome
AU - Davies, Mark
AU - Abikoff, Howard
AU - Chrisman, Allan K.
AU - Chuang, Shirley
AU - Findling, Robert L.
AU - March, John
AU - Scahill, Lawrence
AU - Walkup, John
AU - Riddle, Mark A.
PY - 2004/12
Y1 - 2004/12
N2 - 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.
AB - 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.
KW - Adverse events
KW - Methodology
KW - Psychopharmacology
KW - Safety
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U2 - 10.1097/01.chi.0000142668.29191.13
DO - 10.1097/01.chi.0000142668.29191.13
M3 - Article
C2 - 15564818
AN - SCOPUS:20144387542
SN - 0890-8567
VL - 43
SP - 1488
EP - 1496
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 12
ER -