Abstract
We derived outlier-response pattern checks to flag possible careless PANSS (Positive and Negative Syndrome Scale) administrations based on analysis of 122,000 administrations from 29 registration trials of antipsychotics from NEWMEDS data repository. Flags identify outlier administrations based on frequency of endorsing a given response value, use of even or odd values, consecutive use of same value, variability of values, responses per specific item, and values on multiple items. Outlier flags were compared to published expert derived scoring inconsistency flags and tested in Monte Carlo simulated data, with known inconsistency, and appear to be useful at identifying administrations that require review.
Original language | English |
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Article number | 114114 |
Journal | Psychiatry Research |
Volume | 303 |
DOIs | |
State | Published - Sep 2021 |
Bibliographical note
Funding Information:Jonathan Rabinowitz has received research grant(s) support and/or travel support and/or speaker fees and/or consultant fees from Janssen (J&J), Eli Lilly, Pfizer, Lundbeck, Roche, Abraham Pharmaceuticals, Pierre Fabre, Intra-cellular Therapies, Minerva, Takeda and Amgen.
Publisher Copyright:
© 2021 Elsevier B.V.
Keywords
- Data surveillance
- PANNS flags
- Reliability
- Risk-based monitoring