Validation of the Wisconsin Stone-QOL
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology, Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | June 2018 |
| Contact: | Kristina L Penniston, PhD |
| Email: | penn@urology.wisc.edu |
| Phone: | 608-265-9797 |
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?"
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.
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.
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
We found this trial at
1
site
Madison, Wisconsin 53705
Phone: 608-265-9797
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