Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.

The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia (n = 24), caregivers (n = 12), and professional peer support specialists (n = 12) to elicit their views about the definition and importance of functional independence, the importance of the functional domains assessed by the VRFCAT (meal planning, using transportation, handling money, shopping), and the relevance of the VRFCAT tasks to these domains. Qualitative thematic analyses revealed consistent themes across groups in defining functional independence, including performing instrumental self-care, financial, and social tasks; making decisions autonomously; and not depending on others to carry out daily activities. There were, however, notable differences in their views regarding the importance of and barriers to functional independence. All groups viewed the VRFCAT as assessing skill domains that are central to independent functioning and, with some minor differences, the VRFCAT tasks were viewed as relevant and meaningful examples of the domains. These qualitative results provide converging evidence that key stakeholders view the VRFCAT as a content-valid measure.

Insight in cognitive impairment assessed with the Cognitive Assessment Interview in a large sample of patients with schizophrenia.

The Cognitive Assessment Interview (CAI) is an interview-based scale measuring cognitive impairment and its impact on functioning in subjects with schizophrenia (SCZ). The present study aimed at assessing, in a large sample of SCZ (n = 601), the agreement between patients and their informants on CAI ratings, to explore patients' insight in their cognitive deficits and its relationships with clinical and functional indices. Agreement between patient- and informant-based ratings was assessed by the Gwet's agreement coefficient. Predictors of insight in cognitive deficits were explored by stepwise multiple regression analyses. Patients reported lower severity of cognitive impairment vs. informants. A substantial to almost perfect agreement was observed between patients' and informants' ratings. Lower insight in cognitive deficits was associated to greater severity of neurocognitive impairment and positive symptoms, lower severity of depressive symptoms, and older age. Worse real-life functioning was associated to lower insight in cognitive deficit, worse neurocognitive performance, and worse functional capacity. Our findings indicate that the CAI is a valid co-primary measure with the interview to patients providing a reliable assessment of their cognitive deficits. In the absence of informants with good knowledge of the subject, the interview to the patient may represent a valid alternative.

The Cognitive Assessment Interview (CAI): Association with neuropsychological scores and real-life functioning in a large sample of Italian subjects with schizophrenia.

INTRODUCTION: The Cognitive Assessment Interview (CAI) is an interview-based scale developed to measure cognitive impairment and its impact on functioning in subjects with schizophrenia (SCZ). Previous studies demonstrated good psychometric properties of the CAI. However, only relatively small samples of SCZ were investigated. This study aimed to determine in a large sample of SCZ (N = 580) the relationships of the Italian Version of the CAI with measures of cognitive performance and functional capacity and real-life functioning, using state-of-the-art instruments. METHODS: Intraclass correlation coefficients (ICCs) and Cronbach's alpha were calculated to examine the CAI's inter-rater reliability and internal consistency. Pearson's correlation coefficients were used to evaluate relationships between CAI global and domain composite scores with neurocognition, social cognition, functional capacity, and functioning. RESULTS: The inter-rater reliability and internal consistency were good to excellent. The CAI global composite score showed a strong correlation with the MATRICS Consensus Cognitive Battery (MCCB) composite score (r = -0.50) and moderate/strong associations with measures of functional capacity (-0.46 < r < -0.52) and real-life functioning (-0.30 < r < -0.51). Finally, CAI composite social cognition score correlated moderately with the Facial Emotion Identification Test (r = -0.31) and two subscales of the Awareness of Social Inference Test (-0.32 < r < -0.34). CONCLUSIONS: The study suggests that CAI is a valid co-primary measure for clinical trials and a suitable instrument to screen impairment in neurocognitive and social cognitive domains and its impact on functioning in SCZ in everyday clinical practice.

Associations between daily living skills, cognition, and real-world functioning across stages of schizophrenia; a study with the Schizophrenia Cognition Rating Scale Japanese version.

Cognitive function is impaired in patients with schizophrenia-spectrum disorders, even in their prodromal stages. Specifically, the assessment of cognitive abilities related to daily-living functioning, or functional capacity, is important to predict long-term outcome. In this study, we sought to determine the validity of the Schizophrenia Cognition Rating Scale (SCoRS) Japanese version, an interview-based measure of cognition relevant to functional capacity (i.e. co-primary measure). For this purpose, we examined the relationship of SCoRS scores with performance on the Brief Assessment of Cognition in Schizophrenia (BACS) Japanese version, a standard neuropsychological test battery, and the Social and Occupational Functioning Assessment Scale (SOFAS), an interview-based social function scale. Subjects for this study (n = 294) included 38 patients with first episode schizophrenia (FES), 135 with chronic schizophrenia (CS), 102 with at-risk mental state (ARMS) and 19 with other psychiatric disorders with psychosis. SCoRS scores showed a significant relationship with SOFAS scores for the entire subjects. Also, performance on the BACS was significantly correlated with SCoRS scores. These associations were also noted within each diagnosis (FES, CS, ARMS). These results indicate the utility of SCoRS as a measure of functional capacity that is associated both with cognitive function and real-world functional outcome in subjects with schizophrenia-spectrum disorders.

Utility of the UCSD Performance-based Skills Assessment-Brief Japanese version: discriminative ability and relation to neurocognition.

The UCSD Performance-based Skills Assessment Brief (the UPSA-B) has been widely used for evaluating functional capacity in patients with schizophrenia. The utility of the battery in a wide range of cultural contexts has been of concern among developers. The current study investigated the validity of the Japanese version of the UPSA-B as a measure of functional capacity and as a co-primary for neurocognion. Sixty-four Japanese patients with schizophrenia and 83 healthy adults entered the study. The Japanese version of the UPSA-B (UPSA-B Japanese version) and the MATRICS Cognitive Consensus Battery Japanese version (MCCB Japanese version) were administered. Normal controls performed significantly better than patients, with large effect sizes for the Total and the subscale scores of the UPSA-B. Receiver Operating Characteristic (ROC) curve analysis revealed that the optimal cut-off point for the UPSA-B Total score was estimated at around 80. The UPSA-B Total score was significantly correlated with the MCCB Composite score and several domain scores, indicating the relationship between this co-primary measure and overall cognitive functioning in Japanese patients with schizophrenia. The results obtained here suggest that the UPSA-B Japanese version is an effective tool for evaluating disturbances of daily-living skills linked to cognitive functioning in schizophrenia, providing an identifiable cut-off point and relationships to neurocognition. Further research is warranted to evaluate the psychometrical properties and response to treatment of the Japanese version of the UPSA-B.