Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Issue 4 (26th June 2018)

• Record Type: Journal Article
• Authors: Targum, Steven D.; Pendergrass, J. Cara; Lee, Sang; Loebel, Antony
• Is Part Of: International journal of methods in psychiatric research. Volume 27:Issue 4(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2018-06-26
• Subjects: audio‐digital recordings -- interview length -- MADRS -- mixed depression -- ratings reliability -- subthreshold hypomania -- symptom severity -- YMRS; Psychiatry -- Research -- Methodology -- Periodicals; Psychiatry -- Periodicals; 616.890072
• DOI: 10.1002/mpr.1729
• Languages: English
• ISSNs: 1049-8931

Abstract

Abstract: Objectives: Site‐independent ratings surveillance assessed ratings reliability in a clinical trial. Methods: Inter‐rater reliability was assessed at the screen visit in a 6‐week, double‐blind, placebo‐controlled study of lurasidone for the treatment of major depressive disorder (MDD) with subthreshold hypomanic ("mixed") symptoms (clinicaltrials.gov NCT01421134). Site‐based Montgomery‐Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) interviews were paired with 184 site‐independent ratings derived from audio‐digital recordings. Results: The paired MADRS and YMRS scores were highly correlated ( r = 0.708 and 0.885, respectively) and generated minimal scoring discordance. The surveillance program identified 14 MADRS scores (7.6% of this sample) that were below the study entry criterion (MADRS ≥26) and resulted in screen failure. When present, paired scoring discordance was associated with symptom severity, interview length, interview quality, and the level of patient cooperation. Higher severity scores (MADRS ≥40 and YMRS ≥15) were associated with greater paired scoring discordance. Further, MADRS scores <30 and short MADRS interviews conducted in ≤12 min revealed significantly more pairs of discordant outliers ( p = 0.04 and 0.009, respectively). Conclusions: The findings suggest that MDD patients with mixed features can be reliably assessed, that paired site‐based and site‐independent assessments were generally concordant, and that ratings surveillance may reinforce ratings precision.