Comparison of Increasingly Detailed Elicitation Methods for the Assessment of Adverse Events in Pediatric Psychopharmacology.
GREENHILL, LAURENCE L M.D.; VITIELLO, BENEDETTO M.D.; FISHER, PRUDENCE PH.D.; LEVINE, JEROME M.D.; DAVIES, MARK M.P.H.; ABIKOFF, HOWARD PH.D.; CHRISMAN, ALLAN K M.D.; CHUANG, SHIRLEY M.S.; FINDLING, ROBERT L M.D.; MARCH, JOHN M.D.; SCAHILL, LAWRENCE M.S.N., PH.D.; WALKUP, JOHN M.D.; RIDDLE, MARK A M.D.
Journal of the American Academy of Child & Adolescent Psychiatry.
43(12):1488-1496, December 2004.
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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.
Copyright 2004 (C) American Academy of Child and Adolescent Psychiatry