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Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers
The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are: 1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?" 2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"
The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed specifically for patients with kidney stones. Its development has been published. Internal and other validity tests on the instrument have been conducted and reported. Further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones. Upon enrollment at each site, patients will be asked to complete a medical history form and the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3 months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys will usually be mailed to patients to the addresses they provide. Alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. At each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh
Madison, Wisconsin, United States
Start Date
July 1, 2014
Primary Completion Date
May 31, 2022
Completion Date
June 30, 2023
Last Updated
July 3, 2023
3,299
ACTUAL participants
Wisconsin Stone-QOL survey
OTHER
Lead Sponsor
University of Wisconsin, Madison
Collaborators
NCT07055282
NCT07174479
NCT07275879
Data Source & Attribution
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