Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology.
OBJECTIVE
To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods.


METHODS
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.
Greenhill
Laurence L
LL
New York State Psychiatric Institute, Columbia University, USA. greenhil@child.cpmc.columbia.edu
Vitiello
Benedetto
B
Fisher
Prudence
P
Levine
Jerome
J
Davies
Mark
M
Abikoff
Howard
H
Chrisman
Allan K
AK
Chuang
Shirley
S
Findling
Robert L
RL
March
John
J
Scahill
Lawrence
L
Walkup
John
J
Riddle
Mark A
MA
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D005240:Feasibility Studies; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy*; D011600:Psychopharmacology / Q000379:methods*; D011619:Psychotropic Drugs / Q000009:adverse effects*; D011785:Quality Assurance, Health Care / Q000379:methods*
D011619:Psychotropic Drugs