Validation of the Wisconsin Stone-QOL

Study Overview
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Brief Summary
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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: 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? 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?

Detailed Description
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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.

Official Title
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Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers

Conditions
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Urolithiasis, Nephrolithiasis, Kidney Stones

Intervention / Treatment
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* Other: Wisconsin Stone-QOL survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of kidney stones, either in the past or currently 18 years of age or older Exclusion Criteria: Under 18 years of age No previous or current diagnosis of kidney stones

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Survey<br>Wisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months. | Other: Wisconsin Stone-QOL survey<br>* Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' self-reported health-related quality of life (HRQOL) | Change in HRQOL from baseline to follow-up time points will be assessed | Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' self-reported quality of life |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, QOL, urolithiasis, nephrolithiasis, kidney stones, patient-reported outcomes