RESUMEN
Despite the functional impact of cognitive deficit in people with psychosis, objective cognitive assessment is not typically part of routine clinical care. This is partly due to the length of traditional assessments and the need for a highly trained administrator. Brief, automated computerised assessments could help to address this issue. We present data from an evaluation of PsyCog, a computerised, non-verbal, mini battery of cognitive tests. Healthy Control (HC) (N = 135), Clinical High Risk (CHR) (N = 233), and First Episode Psychosis (FEP) (N = 301) participants from a multi-centre prospective study were assessed at baseline, 6 months, and 12 months. PsyCog was used to assess cognitive performance at baseline and at up to two follow-up timepoints. Mean total testing time was 35.95 min (SD = 2.87). Relative to HCs, effect sizes of performance impairments were medium to large in FEP patients (composite score G = 1.21, subtest range = 0.52-0.88) and small to medium in CHR patients (composite score G = 0.59, subtest range = 0.18-0.49). Site effects were minimal, and test-retest reliability of the PsyCog composite was good (ICC = 0.82-0.89), though some practice effects and differences in data completion between groups were found. The present implementation of PsyCog shows it to be a useful tool for assessing cognitive function in people with psychosis. Computerised cognitive assessments have the potential to facilitate the evaluation of cognition in psychosis in both research and in clinical care, though caution should still be taken in terms of implementation and study design.
RESUMEN
With an unmet clinical need for effective interventions for cognitive and negative symptoms in patients with schizophrenia, measures of functional status (often a co-primary endpoint) remain key clinical trial outcomes. This review aims to give an overview of the different types of functional assessments commonly used in clinical trials and research involving patients with schizophrenia and highlight pertinent challenges surrounding the use of these as reliable, sensitive, and specific assessments in intervention trials. We provide examples of commonly used functional measures and highlight emerging real-time digital assessment tools. Informant- and clinician-rated functional outcome measures and functional capacity assessments are valid, commonly used measures of functional status that try to overcome the need for often overly ambitious and insensitive 'real world' milestones. The wide range of scientific and practical challenges associated with these different tools leave room for the development of improved functional outcome measures for use in clinical trials. In particular, many existing measures fail to capture small, but meaningful, functional changes that may occur over the course of typically short intervention trials. Adding passive digital data collection and short active real-time digital assessments whilst patients go about their day offers the opportunity to build a more fine-grained picture of functional improvements that, if thoughtfully developed and carefully applied, could provide the sensitivity needed to accurately evaluate functional status in intervention studies, aiding the development of desperately needed treatments.
