Literature DB >> 32894576

A novel way to quantify schizophrenia symptoms in clinical trials.

Oleg N Medvedev1,2, Michael Berk3, Olivia M Dean3, Ellie Brown3, Margaret H Sandham2, Joanna F Dipnall3,4, Robert K McNamara5, Alexander Sumich2,6, Christian U Krägeloh2, Ajit Narayanan2, Richard J Siegert2.   

Abstract

BACKGROUND: A major problem in quantifying symptoms of schizophrenia is establishing a reliable distinction between enduring and dynamic aspects of psychopathology. This is critical for accurate diagnosis, monitoring and evaluating treatment effects in both clinical practice and trials.
MATERIALS AND METHODS: We applied Generalizability Theory, a robust novel method to distinguish between dynamic and stable aspects of schizophrenia symptoms in the widely used Positive and Negative Symptom Scale (PANSS) using a longitudinal measurement design. The sample included 107 patients with chronic schizophrenia assessed using the PANSS at five time points over a 24-week period during a multi-site clinical trial of N-Acetylcysteine as an add-on to maintenance medication for the treatment of chronic schizophrenia.
RESULTS: The original PANSS and its three subscales demonstrated good reliability and generalizability of scores (G = 0.77-0.93) across sample population and occasions making them suitable for assessment of psychosis risks and long-lasting change following a treatment, while subscales of the five-factor models appeared less reliable. The most enduring symptoms represented by the PANSS were poor attention, delusions, blunted affect and poor rapport. More dynamic symptoms with 40%-50% of variance explained by patient transient state including grandiosity, preoccupation, somatic concerns, guilt feeling and hallucinatory behaviour.
CONCLUSIONS: Identified dynamic symptoms are more amendable to change and should be the primary target of interventions aiming at effectively treating schizophrenia. Separating out the dynamic symptoms would increase assay sensitivity in trials, reduce the signal to noise ratio and increase the potential to detect the effects of novel therapies in clinical trials.
© 2020 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.

Entities:  

Keywords:  clinical trial; generalizability theory; measurement; positive and negative syndrome scale; schizophrenia

Year:  2020        PMID: 32894576     DOI: 10.1111/eci.13398

Source DB:  PubMed          Journal:  Eur J Clin Invest        ISSN: 0014-2972            Impact factor:   4.686


  2 in total

1.  Strengthening Community End-of-Life Care through Implementing Measurement-Based Palliative Care.

Authors:  Margaret H Sandham; Emma Hedgecock; Mevhibe Hocaoglu; Celia Palmer; Rebecca J Jarden; Ajit Narayanan; Richard J Siegert
Journal:  Int J Environ Res Public Health       Date:  2022-06-24       Impact factor: 4.614

2.  Cross-cultural validation of the stroke riskometer using generalizability theory.

Authors:  Oleg Medvedev; Quoc Cuong Truong; Alexander Merkin; Robert Borotkanics; Rita Krishnamurthi; Valery Feigin
Journal:  Sci Rep       Date:  2021-09-24       Impact factor: 4.379

  2 in total

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