"Despite the desirability of re-certification, few studies ever recertify raters. The simple requirement for additional tapes with gold standard rating is not particularly challenging. More significant obstacles include the expense of reassembling the raters in a central location or coordinating rater schedules with those of a visiting monitor. Additionally, there is a risk that failure of a single rater to recertify may cripple a site in the midst of study operations.
"There is thus a need for a re-certification process that is more convenient and better integrated into the conduct of clinical trials."
As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "In one aspect, the present invention provides a computerized system and method for training, monitoring, certification or re-certification of clinical raters by presenting to a rater one or more segments of a simulated or recorded patient interview, obtaining from the rater one or more scores in response to the presented interview segment or segments, and comparing the one or more rater scores with one or more reference ratings for the presented interview segment or segments. In one embodiment, the reference rating is an expert rating or a consensus rating by a plurality of experts. In another embodiment, the reference rating is a consensus score of a plurality of raters, for example a rating determined by intra-class correlation of scores entered by a plurality of raters. The invention is suitable for training, monitoring, certifying or recertifying raters at a plurality of distinct locations or at a plurality of times and advantageously provides different raters with individually paced training, monitoring or certification sessions. The invention facilitates the provision of individual sessions at a plurality of places and/or times to suit the convenience of individual raters.
"In a second aspect, the invention provides a computerized system and method for evaluating or quantifying the severity of a condition (including a previously diagnosed condition such as a psychiatric or other illness) through a automated interview that may be termed an interactive computer interview (ICI). The system elicits information from the subject in response to prompts comprising an interactive interview and determines a computerized symptom severity rating or score for the subject in accordance with a clinical rating scale. During the interactive computer interview, the system preferably uses branching logic whereby a question or prompt is selected for presentation to the subject from a variety of alternative question or prompts, based on the subject's response to a prior question or prompt (e.g. the immediately preceding question or prompt). This process of selection can be iteratively performed for any desired number of cycles. Preferably, the interview is automatically terminated when sufficient information has been gathered, according to previously determined criteria. The interactive computer interview is thus tailored for the subject, without the need to present all possible questions or prompts to the subject and/or without the need to present a predetermined number of questions or prompts to the subject.
"In a third aspect, the invention provides a system and method for monitoring, certifying, recertifying or improving the performance of clinical raters, on a continuing basis if desired. This advantageously assists diverging raters to reduce the variance of their symptom severity scores or ratings from reference ratings (which may be consensus standard or expert ratings obtained by conducting one or more human clinical interviews, or ratings determined by one more interactive computer interviews). The system compares one or more scores by the rater with one or more reference ratings to determine whether the score(s) of a given rater show a variance from the reference rating(s) that exceeds a given threshold. Based on the results of the comparison, the frequency of computerized rating may be adjusted. If the difference between the computerized rating and the score determined by the human rater exceeds a defined threshold (e.g. a predetermined limit), the system can optionally suggest or initiate remediation to improve the human rater's performance. The remedial plan may be implemented by a rating instructor (e.g. the system can generate a script for a telephone call), or by providing the deviating rater with electronic access to stored conventions explaining how those items should be scored.
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