Kidney stones (nephrolithiasis), including the diagnosis of current kidney stones and recurrence within 12 months after treatment among patients who achieve a stone-free status or have no clearly detectable residual renal stones.
Conditions
Interventions
Gold Standard:The reference standard is the result of routine diagnostic imaging performed during clinical care. Participants with unilateral or bilateral renal stones identified by ultrasonography or
Index test:A kidney stone diagnostic prediction model based on routinely collected clinical characteristics and laboratory test results. The prespecified primary model is multivariable logistic regres
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older, with no sex restriction. 2.Receiving routine care at Shanghai General Hospital because of suspected kidney stones or a clinical need to rule out kidney stones, including flank or abdominal pain, renal colic, hematuria, hydronephrosis, urinary tract obstruction, a history of stone-related symptoms, or other relevant clinical indications. 3.Completion of routine imaging capable of determining the presence or absence of kidney stones before stone-related treatment or any procedure that may alter stone status. 4.Availability of the core routine laboratory measurements and baseline clinical data required for the diagnostic model. 5.For the retrospective cohort, hospitalization at Shanghai General Hospital within the prespecified data period. If a patient has multiple eligible hospitalizations, only the first eligible hospitalization will be included in the primary analysis. 6.For the prospective cohort, the participant must understand the study, provide written informed consent, and agree to the collection of data generated during routine clinical care. 7.Participants included in the recurrence prediction analysis must have imaging-confirmed kidney stones, achieve a stone-free status or have no clearly detectable residual renal stones after routine treatment, have the required baseline clinical, laboratory, and imaging data, and have available 12-month outcome data or agree to 12 months of follow-up.
Exclusion criteria
Exclusion criteria: 1.Age younger than 18 years. 2.No imaging examination capable of definitively determining kidney stone status, or an indeterminate imaging result that prevents reliable classification. 3.The first valid imaging examination was performed only after stone-related surgery, lithotripsy, stone removal, catheter or stent placement, or another treatment that may alter stone status. 4.Ureteral or bladder stones without imaging evidence of kidney stones. 5.Renal or urinary tract malignancy, genitourinary tuberculosis, kidney transplantation, or a severe congenital anatomical abnormality of the urinary system. 6.Pregnancy or breastfeeding. 7.Missing primary outcome information or extensive missingness of core predictors that remains insufficient for analysis after data verification. 8.Refusal to provide written informed consent for participation in the prospective cohort. 9.Any other condition considered by the investigator to make the individual unsuitable for the primary analysis. 10.For the recurrence prediction analysis, inability to determine the index stone status, baseline treatment status, or the starting point of recurrence risk. 11.For the retrospective cohort, absence of follow-up visits, rehospitalization records, imaging results, or other records sufficient to determine the 12-month outcome. 12.For the prospective cohort, refusal to continue 12-month follow-up or an anticipated inability to complete the required follow-up. 13.Inability to determine recurrence reliably from clinical records, imaging data, or standardized follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnosis of kidney stones;Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public Contactwenjunxiang
Shanghai General Hospital
Outcome results
None listed