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Comparison of Increasingly Detailed Elicitation Methods for the Assessment of Adverse Events in Pediatric Psychopharmacology

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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.

Section snippets

Subjects

Children of either sex, ages 6 through 18 years (inclusive) who were receiving treatment with one or more psychotropic medications (stimulants, antidepressants, antipsychotics, mood stabilizers, anxiolytics, or adrenergic agents) were recruited from the mental health outpatient clinics of five academic sites (New York State Psychiatric Institute, Johns Hopkins University, University Hospitals of Cleveland, New York University, Duke University, and Yale University). To be included, children had

RESULTS

Fifty-nine subjects, 45 boys and 14 girls, aged 11.9 ± 3.2 years, were interviewed together with their parents. The demographics and clinical characteristics of the sample are summarized in Table 2.

Administration of the entire SMURF (i.e., inclusive of GI, DSI, and BSR) took from 7 to 70 minutes (mean, 24.6 ± 3.9; median, 21). The GI took an average of 4.3 ± 5.4 minutes (range, 1–23; median, 2). The DSI took an average of 4.2 ± 2.9 minutes (range, 1–13; median, 3). The BSR took an average of

DISCUSSION

This study examined the feasibility and utility of different methods for eliciting AEs in child psychopharmacology. Three increasingly detailed assessments were administered sequentially to outpatient children receiving psychotropic medications and their parents in clinical settings. The sample (N = 59), although limited in size, reflected patient and treatment characteristics typically encountered in child and adolescent psychiatry practice. Most of the children were treated with stimulants,

REFERENCES (10)

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This research was supported by NIMH contracts N01MH60005 (Dr. Greenhill) and N01MH60016 (Dr. Riddle) and was conducted at the Departments of Psychiatry, Divisions of Child and Adolescent Psychiatry, New York State Psychiatric Institute, New York University Child Study Center, Johns Hopkins University, Yale University, University Hospitals of Cleveland, and Duke University. The authors are grateful for the technical support of Donald McMahon (Nathan Kline Institute) in preparing the study interview forms.

Article Plus (online only) materials for this article appear on the Journal's Web site: www.jaacap.com.

The opinions and assertions contained in this report are the private views of the authors and are not to be construed as official or as reflecting the views of the National Institute of Mental Health, the National Institutes of Health, or the Department of Health and Human Services.

Disclosure: Dr. Greenhill has received support (honoraria or grants to do research) from Celltech, Shire, Eli Lilly, McNeil, Alza, Janssen-Cilag, and Novartis. Dr. Abikoff has received support from McNeil, Shire, and Eli Lilly and serves as an advisor to Eli Lilly, McNeil, Shire, and Celltech. Dr. March has received research support from Pfizer (consulting fees, speaker fees, Scientific Advisor), Solvay Pharmaceuticals (speaker fee, consulting fee), Wyeth-Ayerst (research support, consulting fees), Shire (Scientific Advisor), and GSK (consulting fee). Dr. Walkup has received support for research from Pfizer (grant support and honoraria), Janssen (honoraria), and Eli Lilly (grant support and honoraria). Dr. Riddle has received support from Forest, Janssen, Eli Lilly, Pfizer, Sanofi, AstraZeneca, Shire, Mallinckrodt, and Bristol-Myers Squibb. Dr. Chrisman has received support for research from SmithKline Beecham, Wyeth-Ayerst, Somerset, Shire, Eli Lilly, Novartis, McNeil, and Noven. Dr. Findling has received support for research from Abbott, AstraZeneca, Best Practices, Bristol-Myers Squibb, Celltech-Medeva, Forest, GlaxoSmithKline, Johnson & Johnson, Layton Biosciences, Eli Lilly, Nature's Herbs, New River, Novartis, Noven, Organon, Otsuka, Pharmastar, PPD, Pfizer, Shire, Solvay Pharmaceuticals, Somerset, and Wyeth-Ayerst. The other authors have no financial relationships to disclose.

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