Validation of patient centric measures in urolithiasis
Research type
Research Study
Full title
Health related Quality of life and patient preferences in urinary calculi: development and validation of patient centric measures
IRAS ID
217163
Contact name
H B Joshi
Contact email
Sponsor organisation
R&D department,Registrations and Permissions Improvement Manager
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Urinary stone disease is a common, often painful and recurrent condition that can affect kidney function and can have significant negative impact on patients' health related quality of life (HrQoL). Possible management options are conservative, medical or interventional. In many cases different treatments might achieve equivalent success rates but, involve different approaches and carry different risks.
There is limited information about the impact of stone disease on patients HrQoL as well as decision making processes and patients’ information needs. Similarly, little is known about the perception and preferences of patients and their family members of these treatment options. The decision to select one treatment option over the others in urinary stone disease is somewhat complex and current provision is considered to be suboptimal.
We have completed extensive qualitative research (first part of this study) that included semi-structured interviews of patients (n=68), focus group interviews as well collection of clinicians’ and patients’ family members’ views. The results were analysed to understand patients’ views surrounding impact of the disease, treatments and various related issues.
This work has helped to form a foundation for the development of patient centric measures. The first one of this is a long draft of the new comprehensive patient reported outcome measure (PROM); Urinary stones and Intervention (USIQol) measure that could be used in the clinical studies, audits and future research in this area. It has also provided rich data that would form a basis for the development of patient experience measure (PREM) in patients with urinary calculi and effective communication tools such as information leaflets, patient decision aids for urinary stone disease.The aims of this second part of the study are to develop and validate comprehensive set of patient centric measures for urinary calculi. This involves
1. Quantitative study to formally validate the new USIQoL measure
2. Develop a stone specific PREM using existing validated core PREM tools (e.g. Picker’s questionnaire)
3. Develop and validate, decision aids (Option Grids), which would help patients and clinicians in decision making regarding different treatments for calculi. We will follow the established techniques of developing these aids (Dr. Elwyn et al. The Dartmouth Center for Health Care Delivery Science)
4. Design a framework for development and validation of patient communication tools (information leaflets) regarding stone disease and its treatments.REC name
Wales REC 2
REC reference
17/WA/0195
Date of REC Opinion
23 Jun 2017
REC opinion
Favourable Opinion