Incidence of Antipsychotic-Associated Side Effects: Impact of Clinician Versus Patient Ratings and Change Versus Absolute Scores.
OBJECTIVE
This study aimed to compare (1) the detection rates of antipsychotic-associated side effects between clinician and patient ratings and (2) differences as a function of change and absolute score definitions.


METHODS
Data from phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (N = 1460) were analyzed. In this trial, 18 adverse events were systematically and concurrently assessed by clinicians and patients using a 4-point severity scale ranging from 0 (absent) to 3 (severe). The incidence of antipsychotic-associated side effects was calculated according to 2 definitions: change score (ie, higher score on the scale versus baseline) and absolute score (a score of 2 or 3 on the scale). In addition, patient and clinician concurrent detection rates were examined.


RESULTS
The differences in incidence of antipsychotic-associated side effects between clinician and patient ratings were as small as 5.7% across the 2 definitions. The incidence of all side effects across clinician and patient ratings was approximately 2 times higher when using the change versus absolute score definition. Among the side effects detected by patients, 11 side effects were identified more frequently by clinicians, with 14.3% to 30.2% differences when using the change versus absolute score definition. Conversely, there was no difference of 10% or greater in patient or clinician concurrent detection rate on any item when using the absolute versus change score definition.


CONCLUSIONS
Our findings suggest that patient ratings are in line with clinician ratings and that the change score definition may be superior for the assessment of antipsychotic-associated side effects in clinical studies.
From the *Schizophrenia Division, Centre for Addiction and Mental Health; and †Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; ‡Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan; and §Institute of Medical Science, University of Toronto; and ‖Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Hiroyoshi
H
Takeuchi
Gagan
G
Fervaha
Gary
G
Remington
D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D059026:Diagnostic Self Evaluation; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D017063:Outcome Assessment, Health Care / Q000379:methods*; D063868:Patient Outcome Assessment; D012720:Severity of Illness Index
D014150:Antipsychotic Agents