International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Personal and Social Performance Scale (PSP). One hundred and forty seven flags were identified, 16 flag errors in deriving the PSP decile (i.e., total) score from the four individual domain scores, 74 flag inconsistencies between domain scores relative to Positive and Negative Symptom Scale (PANSS) item ratings and 57 flag inconsistencies between PSP decile score and PANSS items ratings. The flags were applied to assessments from randomized clinical trial data of antipsychotics in schizophrenia from almost 18,000 ratings. Twenty-two flags were raised in at least 5 of 1000 ratings. Nearly 20% of the PSP ratings had at least one inconsistency flag raised. Application of flags to clinical ratings may improve the reliability of ratings and validity of trials.

Bar Ilan University Ramat Gan Israel

Janssen Research and Development LLC Titusville NJ 08560 USA

Janssen Scientific Affairs LLC 1125 Trenton Harbourton Rd Titusville NJ 08560 USA; Department of Psychiatry and Health Behavior Medical College of Georgia at Augusta University Augusta GA 30912 USA

ProPhase LLC 3 Park Avenue New York NY 10016 USA; NYU School of Medicine Dept of Psychiatry 1 Park Avenue New York NY 10016 USA

Signant Health Prague Czech Republic

SUNY Downstate Medical Center Brooklyn NY USA

Tuscaloosa VA Medical Center Tuscaloosa AL USA

UCLA Department of Psychiatry and Biobehavioral Sciences 760 Westwood Plaza Ste 28 224 Los Angeles CA 90095 USA

WCG MedAvante ProPhase 100 American Metro Boulevard Suite 201 Hamilton NJ 08619 USA

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