To assess accuracy of self-reported stone events in a large clinical trial by adjudication against the weight of documentation for spontaneous stone passage or surgical intervention.
Participants in the Prevention of Urinary Stones with Hydration (PUSH) trial were randomized to a multi-component behavioral intervention or control arm to increase and maintain high fluid intake. The primary endpoint was urinary stone events including symptomatic stone passage or procedural intervention. An independent adjudication committee blinded to randomization assignments reviewed all events. Confirmed clinical stone events required typical stone symptoms and documentation of stone passage (e.g., via photograph, clinical record) and/or surgical intervention. Events with typical symptoms and self-described stone passage but without objective documentation of passage were also considered as meeting the primary endpoint and classified separately as patient-reported passage. Non-events did not meet either criteria.
At time of this blinded analysis, a total of 1658 participants were randomized and had a median follow-up of 19 months. Self-reported stone events (n=217) were adjudicated by the committee as either confirmed clinical events (134; 61.8%), patient-reported passage (71; 32.7%), or non-events (12; 5.5%). Confirmed clinical events consisted of stone passage in 66/134 and procedural interventions in 68/134 (53 for symptoms and 15 without symptoms).
Rigorous adjudication revealed that self-reported stone events in the PUSH trial overwhelmingly represented clinically documented passage, surgical intervention, and patient-reported passage outside healthcare settings, with only 5.5% failing to satisfy adjudication criteria. Similar adjudication and classification processes warrant consideration for implementation in future stone trials.
NCT03244189.
Urology. 2024 Sep 04 [Epub ahead of print]
Hunter Wessells, John C Lieske, H Henry Lai, Hussein R Al-Khalidi, Alana C Desai, Jonathan D Harper, Ziya Kirkali, Naim M Maalouf, Rebecca McCune, Peter Reese, Charles D Scales, Gregory E Tasian, NIDDK Urinary Stone Disease Research Network
Department of Urology, University of Washington School of Medicine, Seattle, WA. Electronic address: ., Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN., Division of Urology, Department of Surgery, Washington University in St. Louis, St. Louis, MO., Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC., Department of Urology, University of Washington School of Medicine, Seattle, WA., National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD., Department of Internal Medicine and Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX., Children's Hospital of Philadelphia, Philadelphia, PA., Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA., Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Urology, Duke University School of Medicine, Durham, NC; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC., Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Surgery, Division of Pediatric Urology, The Children's Hospital of Philadelphia, Philadelphia, PA.