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 P. Reese , Charles D. Scales , Gregory E. Tasian , NIDDK Urinary Stone Disease Research Network
{"title":"水合预防尿路结石试验中对症状性结石复发的自我报告的判断。","authors":"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 P. Reese , Charles D. Scales , Gregory E. Tasian , NIDDK Urinary Stone Disease Research Network","doi":"10.1016/j.urology.2024.08.026","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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 (eg, 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.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Clinical Trials Registration</h3><div>NCT03244189</div></div>","PeriodicalId":23415,"journal":{"name":"Urology","volume":"194 ","pages":"Pages 27-35"},"PeriodicalIF":2.3000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial\",\"authors\":\"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 P. Reese , Charles D. Scales , Gregory E. Tasian , NIDDK Urinary Stone Disease Research Network\",\"doi\":\"10.1016/j.urology.2024.08.026\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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 (eg, 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.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Clinical Trials Registration</h3><div>NCT03244189</div></div>\",\"PeriodicalId\":23415,\"journal\":{\"name\":\"Urology\",\"volume\":\"194 \",\"pages\":\"Pages 27-35\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0090429524007052\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Urology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0090429524007052","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/4 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial
Objective
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.
Methods
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 (eg, 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.
Results
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).
Conclusion
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.
期刊介绍：
Urology is a monthly, peer–reviewed journal primarily for urologists, residents, interns, nephrologists, and other specialists interested in urology
The mission of Urology®, the "Gold Journal," is to provide practical, timely, and relevant clinical and basic science information to physicians and researchers practicing the art of urology worldwide. Urology® publishes original articles relating to adult and pediatric clinical urology as well as to clinical and basic science research. Topics in Urology® include pediatrics, surgical oncology, radiology, pathology, erectile dysfunction, infertility, incontinence, transplantation, endourology, andrology, female urology, reconstructive surgery, and medical oncology, as well as relevant basic science issues. Special features include rapid communication of important timely issues, surgeon''s workshops, interesting case reports, surgical techniques, clinical and basic science review articles, guest editorials, letters to the editor, book reviews, and historical articles in urology.
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