Computer system and method for training certifying or monitoring human clinical raters
First Claim
1. A method for recertifying or monitoring performance of a clinical rater participating in a clinical trial comprising:
- receiving one or more rater inputs reflecting the rater'"'"'s clinical evaluation of a severity of a previously diagnosed condition in a subject;
performing a computerized assessment of the subject to quantify severity of the previously diagnosed condition in the subject through a computerized interview that comprises;
presenting a first question to the subject and receiving a first input from the subject in response thereto;
based on the first input, selecting a second question from a plurality of questions;
presenting the selected second question to the subject and receiving a second input from the subject in response thereto; and
based on one or more inputs received from the subject, determining in accordance with a clinical rating scale a computerized severity score for the previously diagnosed condition in the subject; and
determining, via a processor, whether the one or more rater inputs are in accordance with the computerized severity score.
19 Assignments
0 Petitions
Accused Products
Abstract
A method and system are disclosed for computerized training, monitoring, certification or re-certification of human raters in clinical trials. The invention provides an interactive computerized interview that can be compared scores obtained by human raters to monitor and train clinical raters on a continuing basis in order to reduce rater drift and variance during clinical trials. Remediation can be automatically flagged or provided to improve a deviating rater'"'"'s performance. Computerized assessment of symptom severity is provided without the need for human clinical raters. The system and method enable screening of prospective patients for inclusion or exclusion from a clinical trial by automatically obtaining computerized ratings of symptom severity.
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Citations
32 Claims
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1. A method for recertifying or monitoring performance of a clinical rater participating in a clinical trial comprising:
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receiving one or more rater inputs reflecting the rater'"'"'s clinical evaluation of a severity of a previously diagnosed condition in a subject; performing a computerized assessment of the subject to quantify severity of the previously diagnosed condition in the subject through a computerized interview that comprises; presenting a first question to the subject and receiving a first input from the subject in response thereto; based on the first input, selecting a second question from a plurality of questions; presenting the selected second question to the subject and receiving a second input from the subject in response thereto; and based on one or more inputs received from the subject, determining in accordance with a clinical rating scale a computerized severity score for the previously diagnosed condition in the subject; and determining, via a processor, whether the one or more rater inputs are in accordance with the computerized severity score. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for improving performance of a clinical rater participating or being trained to participate in a clinical trial, comprising:
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receiving one or more rater inputs reflecting the clinical rater'"'"'s clinical evaluation of a severity of a previously diagnosed condition in a subject; performing a computerized assessment of the subject to quantify severity of the previously diagnosed condition in the subject through a computerized interview that comprises; presenting a first question to the subject and receiving a first input from the subject in response thereto; based on the first input, selecting a second question from a plurality of questions; presenting the selected second question to the subject and receiving a second input from the subject in response thereto; and based on one or more inputs received from the subject, determining in accordance with a clinical rating scale a computerized severity score for the previously diagnosed condition in the subject; determining, via a processor, whether the one or more rater inputs are in accordance with the computerized severity score; and if the one or more rater inputs substantially differs from the computerized severity score, providing an indication that the clinical rater is in need of remedial training or providing remedial training to the clinical rater. - View Dependent Claims (14)
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15. A computing device comprising:
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a processing unit; and a memory having computer executable instructions stored thereon that when executed by the processor cause the processor to perform the following steps; receive one or more rater inputs reflecting the clinical rater'"'"'s clinical evaluation of a severity of a previously diagnosed condition in a subject; perform a computerized assessment of the subject to quantify severity of the previously diagnosed condition in the subject through a computerized interview that comprises; presenting a first question to the subject and receiving a first input from the subject in response thereto; based on the first input, selecting a second question from a plurality of questions; presenting the selected second question to the subject and receiving a second input from the subject in response thereto; and based on one or more inputs received from the subject, determining in accordance with a clinical rating scale a computerized severity score for the previously diagnosed condition in the subject; determine, via a processor, whether the one or more rater inputs are in accordance with the computerized severity score; and if the one or more rater inputs substantially differs from the computerized severity score, provide an indication that the clinical rater is in need of remedial training or providing remedial training to the clinical rater.
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16. A computer readable medium wherein the computer readable medium is not a transient signal having stored thereon instructions that, when executed by a processor, cause the processor to perform the following steps:
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receive one or more rater inputs reflecting the clinical rater'"'"'s clinical evaluation of a severity of a previously diagnosed condition in a subject; perform a computerized assessment of the subject to quantify severity of the previously diagnosed condition in the subject through a computerized interview that comprises; presenting a first question to the subject and receiving a first input from the subject in response thereto; based on the first input, selecting a second question from a plurality of questions; presenting the selected second question to the subject and receiving a second input from the subject in response thereto; and based on one or more inputs received from the subject, determining in accordance with a clinical rating scale a computerized severity score for the previously diagnosed condition in the subject; determine, via a processor, whether the one or more rater inputs are in accordance with the computerized severity score; and if the one or more rater inputs substantially differs from the computerized severity score, provide an indication that the clinical rater is in need of remedial training or providing remedial training to the clinical rater.
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17. A system comprising:
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an output device configured to present selected questions to a subject; an input device configured to accept inputs from the subject; and one or more computing devices configured to; present, via the output device, a first question to the subject; receive, via the input device, a first input from the subject in response to the first question; based on the first input, select a second question from a plurality of questions; present, via the output device, the selected second question to the subject; receive, via the input device, a second input from the subject in response to the second question; and determine a computerized severity score, based on the inputs received from the subject in accordance with a rating scale, wherein the computerized severity score quantifies a severity of a previously diagnosed condition in the subject.
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18. A computerized method for assisting or training a rater for clinical trials to evaluate severity of symptoms in a subject participating in a clinical trial and having a previously diagnosed medical condition, comprising:
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presenting a first output to the rater, wherein the first output to the rater conveys a first suggestion concerning a question to be posed to the subject or a clinical observation to be made concerning the subject; receiving a first input from the rater in response to the first output; based on the first input that was received in response to the first output, selecting, processor, a second output from a plurality of alternative second outputs, wherein the second output concerns a question to be posed to the subject by the rater in an interview for the clinical trial or a clinical observation to be made by the rater concerning the subject in the interview for the clinical trial; and presenting the second output to the rater. - View Dependent Claims (19, 20)
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21. A computing device configured to assist or train a rater for clinical trials to evaluate severity of symptoms in a subject participating in a clinical trial and having a previously diagnosed medical condition, the computing device comprising:
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a processing unit; and a memory having computer executable instructions stored thereon that when executed by the processor cause the processor to perform the following steps; present a first output to the rater, wherein the first output to the rater conveys a first suggestion concerning a question to be posed to the subject or a clinical observation to be made concerning the subject; receive a first input from the rater in response to the first output; based on the first input that was received in response to the first output, select, via a processor, a second output from a plurality of alternative second outputs, wherein the second output concerns a question to be posed to the subject by the rater in an interview for the clinical trial or a clinical observation to be made by the rater concerning the subject in the interview for the clinical trial; and present the second output to the rater.
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22. A computer readable medium wherein the computer readable medium is not a transient signal configured to assist or train a rater for clinical trials to evaluate severity of symptoms in a subject participating in a clinical trial and having a previously diagnosed medical condition, the computer readable medium having stored thereon instructions that, when executed by a processor, cause the processor to perform the following steps
present a first output to the rater conveying a first suggestion concerning a question to be posed to the subject or a clinical observation to be made concerning the subject; -
receive a first input from the rater in response to the first output; and based on the first input that was received in response to the first output, select a second output from a plurality of alternative second outputs concerning a question to be posed to the subject by the rater in an interview for the clinical trial or a clinical observation to be made by the rater concerning the subject in the interview for the clinical trial; and present the second output to the rater.
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23. A system configured to assist or train a rater for clinical trials to evaluate a severity of symptoms in a subject participating in a clinical trial and having a previously diagnosed medical condition, the system comprising:
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an output device configured to present outputs to the rater; an input device configured to accept inputs from the rater; and one or more computers configured to perform the following steps; present, via the output device, a first output to the rater conveying a first suggestion concerning a question to be posed to the subject or a clinical observation to be made concerning the subject; receive, via the input device, a first input from the rater in response to the first output; and based on the first input that was received in response to the first output, select a second output from a plurality of alternative second outputs concerning a question to be posed to the subject by the rater in an interview for the clinical trial or a clinical observation to be made by the rater concerning the subject in the interview for the clinical trial; and present the second output to the rater.
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24. A computerized method for implementing a clinical rating scale to evaluate a previously diagnosed condition in a subject presented with a series of questions to determine whether to include the subject in a clinical trial, the method comprising:
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establishing a bank of questions directed to measurement of an item in the clinical rating scale; presenting to the subject a first question selected from the bank of questions and receiving a first input from the subject in response to the first question; presenting to the subject a second question selected from the bank of questions based on the first input and receiving a second input from the subject in response to the second question; and based on the received first input and the received second input; generating, via a processor, a score for the item in the clinical rating scale, wherein a given response to at least one question results in different scores for the item dependent on the place of the at least one question within the series of questions; and determining whether to include or exclude the subject in the clinical trial. - View Dependent Claims (25, 26, 27, 28, 29, 30)
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31. A computer readable medium wherein the computer readable medium is not a transient signal having stored thereon instructions that, when executed by a processor, cause the processor to perform the following steps:
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establish a bank of questions directed to measurement of an item in the clinical rating scale; present to the subject a first question selected from the bank of questions and receiving a first input from the subject in response to the first question; present to the subject a second question selected from the bank of questions based on the first input and receiving a second input from the subject in response to the second question; and based on the received first input and the received second input; generate a score for the item in the clinical rating scale, wherein a given response to at least one question results in different scores for the item dependent on the place of the at least one question within the series of questions; and determine whether to include or exclude the subject from a clinical trial.
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32. A computing device comprising:
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a processing unit; and a memory having computer executable instructions stored thereon that when executed by the processor cause the processor to perform the following steps; establish a bank of questions directed to measurement of an item in the clinical rating scale; present to the subject a first question selected from the bank of questions and receiving a first input from the subject in response to the first question; present to the subject a second question selected from the bank of questions based on the first input and receiving a second input from the subject in response to the second question; and based on the received first input and the received second input; generate a score for the item in the clinical rating scale, wherein a given response to at least one question results in different scores for the item dependent on the place of the at least one question within the series of questions; and determine whether to include or exclude the subject from a clinical trial.
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Specification