Validation of the Wisconsin Stone-QOL

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188108
• Other study ID #: 2014-0062
• Secondary ID: UW QOLA539998SMP
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3299
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Urinary Calculi
• Urolithiasis

Intervention

Other:
• Wisconsin 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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh	Madison	Wisconsin

Sponsors (16)

Lead Sponsor

Collaborator

University of Wisconsin, Madison

Dartmouth College, McGill University, Penn State University, The Cleveland Clinic, Université de Montréal, University of British Columbia, University of California, Davis, University of California, Irvine, University of California, San Diego, University of California, San Francisco, University of Florida, University of North Carolina, University of Pittsburgh, University of Texas, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ahmad TR, Tzou DT, Usawachintachit M, Reliford-Titus S, Wu C, Goodman J, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Chi T. Low Income and Nonwhite Race are Strongly Associated with Worse Quality of Life in Patients with Nephrolithiasis. J Urol. 2019 Jul;202(1):119-124. doi: 10.1097/JU.0000000000000233. Epub 2019 Jun 7. — View Citation

Atalay HA, Ulker V, Canat L, Ozer M, Can O, Penniston KL. Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. Turk J Urol. 2018 Mar 16;45(2):118-123. doi: 10.5152/tud.2018.35305. Print 2019 Mar. — View Citation

Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23. — View Citation

Penniston KL, Nakada SY. Development of an instrument to assess the health related quality of life of kidney stone formers. J Urol. 2013 Mar;189(3):921-30. doi: 10.1016/j.juro.2012.08.247. Epub 2012 Sep 24. — View Citation

Penniston KL, Nakada SY. Health related quality of life differs between male and female stone formers. J Urol. 2007 Dec;178(6):2435-40; discussion 2440. doi: 10.1016/j.juro.2007.08.009. Epub 2007 Oct 15. — View Citation

Raffin EP, Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Bird VG, Chew BH, Sivalingam S, Sur RL, Nakada SY, Pais VM Jr. The Effect of Thiazide and Potassium Citrate Use on the Health Related Quality of Life of Patients with Urolithiasis. J Urol. 2018 Dec;200(6):1290-1294. doi: 10.1016/j.juro.2018.06.023. Epub 2018 Jun 18. — View Citation

Stern KL, Gao T, Antonelli JA, Viprakasit DP, Averch TD, Chi T, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Sivalingam S. Association of Patient Age and Gender with Kidney Stone Related Quality of Life. J Urol. 2019 Aug;202(2):309-313. doi: 10.1097/JU.0000000000000291. Epub 2019 Jul 8. — View Citation

Streeper NM, Wertheim ML, Nakada SY, Penniston KL. Cystine Stone Formers Have Impaired Health-Related Quality of Life Compared with Noncystine Stone Formers: A Case-Referent Study Piloting the Wisconsin Stone Quality of Life Questionnaire Among Patients with Cystine Stones. J Endourol. 2017 Apr;31(S1):S48-S53. doi: 10.1089/end.2016.0564. Epub 2016 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' self-reported quality of life		12 months
Other	Patients' self-reported quality of life		24 months
Other	Patients' self-reported quality of life		36 months
Primary	Patients' self-reported health-related quality of life (HRQOL)	Change in HRQOL from baseline to follow-up time points will be assessed	Enrollment
Secondary	Patients' self-reported quality of life		3 months