The objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS).
Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest predictor of functional impairment among people with schizophrenia because it is associated with poor response to psychosocial interventions, employment status, and social functioning. Because the subjective experience of CIAS is likely to be associated with patient burden, distress, and motivation for treatment, it is important that this experience be assessed in a reliable and valid manner and from the perspective of the patient's self report. No existing instrument to assess CIAS has been developed with patient input directly about their qualitative experience of impaired cognition during the item generation stage, in accordance with FDA guidance for patient-reported outcome (PRO) measures.
Study Type
OBSERVATIONAL
Enrollment
102
Sheppard Pratt Health System
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Rutgers University Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Richmond Behavior Associates
Staten Island, New York, United States
Cognitive Impairment Associated with Schizophrenia
Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.
Time frame: One time qualitative interivew within two weeks of screening
Assessment of Conceptual Model using Qualitative Interviews
Semi structured qualitative interviews will be conducted with adult subjects with schizophrenia. The results of the interviews will be analyzed using standard methods of inductive, iterative analysis. The results will serve as the basis for generating draft items for the PRO measure.
Time frame: One time qualitative interivew
Assess content validity and comprehension of developed PRO measure
Following generation of draft PRO items, an independent series of qualitative interviews will take place in order to evaluate the draft items and ensure they accurately reflect the patient experience of cognitive impairment associated with schizophrenia.
Time frame: One time qualitative interivew
Development and testing of a new patient reported outcome (PRO) measure
Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.
Time frame: Patients will be interviewed within 2 weeks of consent
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