Audio-digital recordings used for independent confirmation of site-based MADRS interview scores
Autor: | Mahnaz Asgharnejad, J. Cara Pendergrass, Chelsea Toner, Steven D. Targum, Daniel Burch |
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Jazyk: | angličtina |
Předmět: |
medicine.medical_specialty
Monoamine Oxidase Inhibitors Psychometrics Major Depressive Disorder Placebo-controlled study Clinical Neurology Predictive value Site-independent ratings Copying Processes Interviews as Topic Depressive Disorder Treatment-Resistant Double-Blind Method Heterocyclic Compounds Rating scale medicine Humans Pharmacology (medical) Reliability (statistics) Biological Psychiatry Randomized Controlled Trials as Topic Psychiatric Status Rating Scales Pharmacology Ratings precision business.industry Reproducibility of Results Audio-digital recording Antidepressive Agents Clinical trial Inter-rater reliability Psychiatry and Mental health Neurology Physical therapy Neurology (clinical) Metric (unit) business Psychology Quality assurance Kappa Clinical psychology |
Zdroj: | European Neuropsychopharmacology. (11):1760-1766 |
ISSN: | 0924-977X |
DOI: | 10.1016/j.euroneuro.2014.08.016 |
Popis: | Signal detection requires ratings reliability throughout a clinical trial. The confirmation of site-based rater scores by a second, independent and blinded rater is a reasonable metric of ratings reliability. We used audio-digital pens to record site-based interviews of the Montgomery-Asberg Depression Rating Scale (MADRS) in a double-blind, placebo controlled trial of a novel antidepressant in treatment resistant depressed patients. Blinded, site-independent raters generated “dual” scores that revealed high correlations between site-based and site-independent raters (r=0.940 for all ratings) and high sensitivity, specificity, predictive values, and kappa coefficients for treatment response and non-response outcomes using the site-based rater scores as the standard. The blinded raters achieved an 89.4% overall accuracy and 0.786 kappa for matching the treatment response or non-response outcomes of the site-based raters. A limitation of this method is that independent ratings depend on the quality of site-based interviews and patient responses to the site-based interviewers. Nonetheless, this quality assurance strategy may have broad applicability for studies that use subjective measures and wherever ratings reliability is a concern. “Dual” scoring of recorded site-based ratings can be a relatively unobtrusive surveillance strategy to confirm scores and to identify and remediate rater “outliers” during a study. |
Databáze: | OpenAIRE |
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