Audio-digital recordings for surveillance in clinical trials of major depressive disorder.

ABSTRACT: Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of paired scoring concordance and interview quality. We examined the utility of this surveillance strategy using paired site-independent scores derived from recorded site-based Montgomery-Asberg depression rating scale (MADRS) interviews obtained from patients with major depressive disorder (MDD) participating in 5 clinical trials. High correlations were noted between the 3736 paired site-based and site-independent scores across all visits. Some rater "outliers" were identified whose ratings performance improved following remediation. In 3 studi

SUBMITTER: Targum SD 

PROVIDER: S-EPMC6348193 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature