- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01492244
Validation of an Online Knee Pain Map and Questionnaire: A Probabilistic Diagnostic Tool
March 26, 2012 updated by: Brock Foster
Alidation of an Online Knee Pain Map and Questionnaire: A Probabilistic Diagnostic Tool
"Blank" has designed a medical diagnostic system in the form of an unvalidated online questionnaire and drawing tool used to describe and identify the location of knee pain, respectively.
A component of the survey includes the patient inputting their diagnosis as the etiology of their knee pain.
Dr. Ivo Dinov's team has used the data from 100,000 patient surveys to construct a probabilistic model to diagnose those who fill out the questionnaire and knee pain map but do not have a diagnosis.
However, the validity of the online survey and the accuracy of the probabilistic model has not been confirmed in patients with known diagnoses.
Therefore, the purpose of this study will be to recruit patients with knee pain at UCLA orthopedic clinics to complete the online survey which will then be applied to the probabilistic model to output possible diagnoses.
The results will be compared to the actual diagnosis assigned to that patient in the clinic.
If validated, the online survey may serve as a tool for diagnostic and research purposes.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients older than 18 years old with knee pain that contains a known diagnosis for their pain.
Description
Inclusion Criteria:
- patients with knee pain and a known diagnosis for their pain
- patients older than 18 years old
Exclusion Criteria:
- patients that are unable or unwilling to complete the online survey.
- patients who do not have a diagnosis for their knee pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with knee pain and a known diagnosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ability of the UCLA modeling software to predict diagnosis based on questionnaire answers
Time Frame: One year
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UCLA has developed modeling software that may be accurate at predicting diagnoses depending on the answers given by patients to an online questionnaire and knee pain drawing map.
The accuracy of the software has not been tested or validated.
This study will determine the accuracy of this software by comparing UCLA orthopedic surgeon input diagnosis to that output by the modeling software following completion of the questionnaire by study participants.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of patient input diagnosis compared to orthopedic surgeon diagnosis
Time Frame: One Year
|
Patients may inaccurately input "known diagnoses" into the online questionnaire because they were diagnosed inaccurately by their doctor, input the wrong diagnosis into the questionnaire by accident, or were never diagnosed with a condition but they input a diagnosis.
Therefore, because the modeling software is contingent on accurate patient input diagnoses, determining if patients accurately input their diagnoses into the questionnaire by comparing surgeon input diagnosis to patient input diagnosis may be helpful in elucidating modeling inaccuracy.
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Study Registration Dates
First Submitted
December 6, 2011
First Submitted That Met QC Criteria
December 12, 2011
First Posted (Estimate)
December 14, 2011
Study Record Updates
Last Update Posted (Estimate)
March 27, 2012
Last Update Submitted That Met QC Criteria
March 26, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-003024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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