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ERIC Number: EJ696732
Record Type: Journal
Publication Date: 2004-Dec-1
Pages: 9
Abstractor: Author
ISBN: N/A
ISSN: ISSN-0890-8567
EISSN: N/A
Comparison of Increasingly Detailed Elicitation Methods for the Assessment of Adverse Events in Pediatric Psychopharmacology.
Greenhill, Laurence L.; Vitiello, Benedetto; Fisher, Prudence; Levine, Jerome; Davies, Mark; Abikoff, Howard; Chrisman, Allan K.; Chuang, Shirley; Findling, Robert L.; March, John; Scahill, Lawrence; Walkup, John; Riddle, Mark A.
Journal of the American Academy of Child and Adolescent Psychiatry, v43 n12 p1488 Dec 2004
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 [+ or -] SD = 11.9 [+ or -] 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 [+ or -] 13.9 minutes (median, 21). The BSR took 15.5 [+ or -] 8.1 minutes (median, 14) longer (p < .0001) than the general inquiry (4.3 [+ or -] 5.4 minutes) and the drug-specific inquiry (4.2 [+ or -] 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. J. Am. Acad. Child Adolesc. Psychiatry, 2004;43(12):1488-1496. Key Words: psychopharmacology, safety, adverse events, methodology.
Lippincott Williams & Wilkins, P.O. Box 1620, Hagerstown, MD 21741. Tel: 800-638-3030 (Toll Free); Fax: 301-223-2400.
Publication Type: Journal Articles
Education Level: N/A
Audience: N/A
Language: N/A
Sponsor: N/A
Authoring Institution: N/A
Grant or Contract Numbers: N/A