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

Laurence L. Greenhill*, Benedetto Vitiello, Prudence Fisher, Jerome Levine, Mark Davies, Howard Abikoff, Allan K. Chrisman, Shirley Chuang, Robert L. Findling, John March, Lawrence Scahill, John Walkup, Mark A. Riddle

*Corresponding author for this work

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1488-1496
Number of pages9
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume43
Issue number12
DOIs
StatePublished - Jan 1 2004

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Psychopharmacology
Pediatrics
Safety
Parents
Pharmaceutical Preparations
Serotonin Uptake Inhibitors
Drug Combinations
Drug-Related Side Effects and Adverse Reactions
Outpatients
Therapeutics

Keywords

  • Adverse events
  • Methodology
  • Psychopharmacology
  • Safety

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

Cite this

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. / Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2004 ; Vol. 43, No. 12. pp. 1488-1496.
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abstract = "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.",
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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 2004, 'Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 43, no. 12, pp. 1488-1496. https://doi.org/10.1097/01.chi.0000142668.29191.13

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.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 43, No. 12, 01.01.2004, p. 1488-1496.

Research output: Contribution to journalArticle

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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 - 2004/1/1

Y1 - 2004/1/1

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.

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KW - Adverse events

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