- Study Dates
- 2026-06-01 - Present
- Principal Investigator
- Affiliation
- Sponsor Site
- Children's Hospital of Philadelphia
- PEDSnet Study ID
- 2026.TASG.PCORI.CHOP.881
Study to determine whether observation or upfront surgery results in less life disruption from asymptomatic kidney stones for children and adults.
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Project Description
A critical barrier to improving the health of the 40 million Americans with kidney stone disease is the weak evidence supporting the management of individuals with asymptomatic kidney stones. The options for patients with asymptomatic stones are 1) observation or 2) upfront surgical removal, both of which are safe, part of usual care, widely accessible, and covered by all types of insurance (see letter of support from Dr. Anne Docimo, Chief Medical Officer of United Healthcare). [RQ-3, RQ-5] Experts in the medical community disagree about the relative merits of observation and upfront surgery, highlighting the clinical equipoise for these alternatives.
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy.
Study Aims
The objective of the proposed OASIS trial is to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones and to identify the groups benefiting the most from each strategy. As a disease that occurs across the lifespan and affects healthy individuals as well as those with medical complexity, we will include individuals ≥6 years of age with asymptomatic, non-obstructive kidney stones between 4 to 10 mm who receive care at 30 medical centers that participate in a PCORnet clinical research network (CRN). We will exclude patients who have smaller and larger stones and those who have conditions for which observation or surgery are generally preferred, respectively.
- To compare life disruption resulting from observation versus upfront surgery of non-obstructive kidney stones.
- To determine heterogeneity of treatment effect (HTE) by patient and stone characteristics.
- To determine the preferences and values informing the choice between observation and upfront surgery.
Hypothesis
We hypothesize that observation of asymptomatic kidney stones results in less life disruption than planned surgery to remove asymptomatic kidney stones.
Study Design
A causal model recognizes that patients living with kidney stone disease face threats of disability and seek the treatment option that minimizes this risk. We apply this model in a Randomized Clinical Trial to generate the evidence for the strategy that results in the least healthcare-related life disruption due to kidney stones (Figure 3). It is also necessary to understand the preferences and values that inform the decision to choose observation or upfront surgery for asymptomatic kidney stones in order to implement the results of the OASIS trial into real-world clinical care. Accordingly, we will conduct a mixed-methods study of patients who are eligible for OASIS but refuse randomization and participants who are randomized but crossover between groups (Aim 3). The rationale for this parallel study is to elicit factors such as anxiety and coping styles that are unique to the preference for observation (e.g.,maintaining current health) or to the preference for surgery (e.g., minimizing uncertainty) and factors that influence decisions non-differentially. This knowledge will facilitate real-world implementation of trial results, including if no differences are detected between observation and surgery, and will inform the development of clinical decision aids.