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Psych Congress  

Development of a Self-reported Schizophrenia Relapse Risk Factor Screener

Charles Ruetsch, PhD
Dawn Velligan, PhD
William T. Carpenter, Jr., MD
Heidi C. Waters, MS, MBA
Susan N. Legacy, MD, MS
Otsuka America Pharmaceutical, Inc.

There is a need for clinicians to easily identify patients with schizophrenia at an increased risk for relapse. Currently, few instruments exist for use in clinical settings that quantify current relapse status based on patient self-report. The purpose of this study was to develop a screener that predicts relapse among patients with schizophrenia. Methods: An expert panel in schizophrenia treatment research was convened to evaluate existing tools, identify their strengths, weaknesses, and gaps, and develop a new tool. First, they defined the measurement constructs (11). Next, items (both from existing questionnaires and newly generated items) were organized into a list by measurement construct (item pool). Of the 62 items in the item pool, 22 items were selected for the draft survey based on relevance to relapse and item difficulty. Results: The first draft of the questionnaire included 20 dichotomous and 2 continuous items and was pilot tested with N=6 patients with schizophrenia. The pilot included a cognitive debrief to ascertain: 1) time to complete and participant burden 2) meaning of each item, 3) where patient understanding deviated from item intent, 4) when wording was unclear, rephrasing questions for better clarity. Based on the pilot results, the panel made final adjustments and prepared the tool for field testing and psychometric analysis. Conclusion: Next steps include psychometric testing (e.g., reliability, predicative validity), item refinement and implementation. The final brief screener will aid in clinician assessment of relapse potential with enough information to adjust treatment.

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