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A structured interview guide for global impressions: increasing reliability and scoring accuracy for CNS trials.

Steven D Targum1, Celine Houser, Joanne Northcutt

  • 1Clintara LLC, 505 Tremont Street, Boston, MA, 02116, USA. sdtargum@yahoo.com.

Annals of General Psychiatry
|February 2, 2013
PubMed
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A new structured interview guide for global impressions (SIGGI) improved the reliability and accuracy of the Clinical Global Impression of Severity (CGI-S) scale in CNS trials. This tool enhances data quality for psychiatric research.

Area of Science:

  • Clinical Psychology
  • Psychiatric Research
  • Neuroscience Clinical Trials

Background:

  • The Clinical Global Impression of Severity (CGI-S) scale is vital for assessing illness severity in Central Nervous System (CNS) trials.
  • Current CGI-S scoring lacks standardized documentation, potentially impacting inter-rater reliability and data accuracy.
  • This limitation hinders consistent assessment across different raters and trials.

Purpose of the Study:

  • To develop and evaluate a Structured Interview Guide for Global Impressions (SIGGI).
  • To assess if SIGGI improves the inter-rater reliability and scoring precision of the CGI-S scale.
  • To determine the applicability of SIGGI in CNS clinical trials, specifically for Major Depressive Disorder (MDD) and schizophrenia.

Main Methods:

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  • Developed the SIGGI, a structured interview guide designed to standardize CGI-S scoring.
  • Conducted a 2-visit study with ambulatory patients diagnosed with MDD or schizophrenia.
  • Employed blinded, site-independent raters to evaluate audio-recorded SIGGI interviews administered by site-based raters, comparing their CGI-S scores.

    • Main Results:

    • SIGGI demonstrated significant intraclass correlations for CGI-S scores between site-based raters and between site-based and site-independent raters (r = 0.768, 0.748, 0.706).
    • High agreement rates were observed between site-independent raters and site-based raters, with identical scores given to 67.6%-77.1% of subjects.
    • SIGGI-derived CGI-S scores showed significant correlations with established measures like MADRS for MDD and PANSS for schizophrenia.

    Conclusions:

    • The SIGGI shows promise in enhancing the inter-rater reliability and scoring precision of the CGI-S scale.
    • The structured format of SIGGI can improve the quality and consistency of data in CNS clinical trials.
    • SIGGI may have broad applicability across various psychiatric conditions assessed in clinical research.