Kidney Stones, Nephrolithiasis, Urolithiasis
Conditions
Keywords
quality of life, QOL, urolithiasis, nephrolithiasis, kidney stones, patient-reported outcomes
Brief summary
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?
Detailed description
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.
Interventions
OTHERWisconsin Stone-QOL survey
Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.
Sponsors
University of Florida
University of California, San Diego
University of North Carolina
Dartmouth College
The Cleveland Clinic
University of British Columbia
University of Texas
University of California, Davis
University of California, Irvine
University of California, San Francisco
University of Washington
Penn State University
McGill University
University of Pittsburgh
Université de Montréal
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' self-reported health-related quality of life (HRQOL) | Enrollment | Change in HRQOL from baseline to follow-up time points will be assessed |
Secondary
| Measure | Time frame |
|---|---|
| Patients' self-reported quality of life | 3 months |
Other
| Measure | Time frame |
|---|---|
| Patients' self-reported quality of life | 12 months |
Countries
United States
Outcome results
None listed