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Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes . Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test–retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire that loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p |
