an observational prospective cohort study to compare stone clearance and
patient experiences for surgical treatments to remove kidney stones: ureteroscopy
(URS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL).
The study additionally seeks to compare re-treatment, and unplanned healthcare
encounters across these treatments within three months after surgery.
The study is an example of partner-based research. Its design relies on the input from a variety of perspectives that come together to develop the overall project design and implement the study. Through this model, the voices of clinicians, patients, and caregivers join to create comprehensive insight into important research questions and methods of generating evaluable information.
This study’s clinical data collection, including the selection of patient reported outcome (PRO) measures used to evaluate patient experience, were developed in collaboration with PKIDS Patient and Family Partners.
in the study are enrolled at all clinical centers in the PKIDS Care Improvement
Network according to the below eligibility criteria.
1. Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the removal of at least one kidney and/or ureteral stone.
2. Parental/guardian or participant (if ≥ 18 years old) permission (informed consent), and if appropriate, child assent
- Individuals who are not
able to provide consent/assent (whether ≥18 or < 18 years) and/or not
willing or able to complete questionnaires are eligible for participation for
the stone clearance assessment and Electronic Health Record (EHR) surveillance
if the legal guardian consents for study participation.
- Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
1. Patients for whom conducting informed consent and baseline study procedures would confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency surgery) and delay necessary immediate clinical care.
2. Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures