Decreasing variability in psychiatric outcome measures augments statistical power, reduces sample size requirements for clinical trials, and reduces the likelihood of failed trials. Concordant Rater Systems (CRS) has developed a suite of computer-based rater tools, including Interactive Computer Interviews (ICI). Results from these patient self-report tools, which utilize a set of proprietary algorithms to administer and score the Young Mania Rating Scale or other measures, can be used to monitor the performance of human clinical raters. In Phase I, we assess the construct validity of the ICI as well as its acceptability to ethnic minority populations, industry study sponsors, and psychiatric patients. We also conduct a pilot study to assess the effect of the ICI on rater sensitivity to symptoms, obtain feedback from raters on its acceptability, and establish effect size estimates needed for design of multi-center clinical trials to be conducted in Phase II. Statistical analyses and market research suggest that the ability to improve rater concordance will be valuable to pharmaceutical companies or clinical research organizations that conduct clinical trials in psychiatry. As a company combining significant expertise in rater training with delivery of internet-based educational content, CRS is well positioned to develop and implement these innovative technologies.
Thesaurus Terms: computer data analysis, computer system design /evaluation, diagnosis design /evaluation, diagnosis quality /standard, interview, outcomes research, psychometrics, statistics /biometry bipolar depression, racial /ethnic difference clinical research, human subject
