title: Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales.
abstract: BACKGROUND
  While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored.
  
  
  METHODS
  Data from four randomized, placebo- and haloperidol-controlled ziprasidone trials were analyzed to examine the relationship between spontaneously reported EPS-AEs with the Simpson Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS). Categorical summaries were created for each treatment group to show the frequencies of subjects with EPS-AEs in each of the SAS and BARS categories at weeks 1, 3, and 6, and agreement between ratings was quantified by means of weighted kappa (κ).
  
  
  RESULTS
  In general, we found greater frequencies of EPS-AEs with increasing severity of the SAS and BARS scores. The EPS-AEs reported with a "none" SAS score ranged from 0 to 22.2%, with a "mild" SAS score from 3.3 to 29.0%, and with a "moderate" SAS score from 0 to 100%. No subjects in any treatment group reported "severe" SAS scores or corresponding EPS-AEs. Agreement between SAS scores and EPS-AEs was poor for ziprasidone and placebo (κ < 0.2) and only slightly better for haloperidol. The EPS-AEs reported with "non questionable" BARS scores ranged from 1.9 to 9.8%, with "mild moderate" BARS scores from 12.8 to 54.6%, and with "marked severe" scores from 0 to 100%. Agreement was modest for ziprasidone and placebo (κ < 0.4) and moderate for haloperidol (κ < 0.6).
  
  
  CONCLUSIONS
  These findings may reflect either underreporting of AEs by investigators and subjects or erroneous rating scale evaluations.
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg). christian.widschwendter@i-med.ac.at.
authors.forename: Christian G
authors.initials: CG
authors.lastname: Widschwendter
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg).
authors.forename: Onur N
authors.initials: ON
authors.lastname: Karayal
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg).
authors.forename: Sheela
authors.initials: S
authors.lastname: Kolluri
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg).
authors.forename: Douglas
authors.initials: D
authors.lastname: Vanderburg
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg).
authors.forename: Georg
authors.initials: G
authors.lastname: Kemmler
authors.affiliation: Department of Psychiatry and Psychotherapy, Biological Psychiatry Division, Medical University of Innsbruck, Austria (Drs Widschwendter, Kemmler, and Fleischhacker);Pfizer Inc., New York, NY (Drs Karayal, Kolluri, and Vanderburg).
authors.forename: W Wolfgang
authors.initials: WW
authors.lastname: Fleischhacker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017109:Akathisia, Drug-Induced / Q000175:diagnosis*; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D006220:Haloperidol / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy; D012720:Severity of Illness Index; D013844:Thiazoles / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone; D006220:Haloperidol
keywords: Barnes Akathisia Rating Scale; Simpson Angus Scale; extrapyramidal adverse events; movement disorder rating scales; schizophrenia