Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Cancer. 2020 Jan 1;126(1):140-147. doi: 10.1002/cncr.32525. Epub 2019 Sep 25.
Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO-CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO-CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials.
Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO-CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO-CTCAE response patterns, and the authors examined how clinical context influenced grade assignment.
A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa = 0.73; 95% CI, 0.66-0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement.
The current study provides a framework for integrating child self-reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.
尽管症状性不良反应（AE）具有主观性，但临床医生仍然是肿瘤试验中不良事件报告的标准来源。作者设计了一种用于症状性 AE 的儿科患者报告结局（PRO）工具，以支持美国国家癌症研究所的不良事件通用术语标准（CTCAE）（儿科 PRO-CTCAE）。目前的研究开发了一种标准化算法，将所有可能的儿科 PRO-CTCAE 反应模式映射到推荐的 CTCAE 等级，以提高儿科肿瘤试验中 AE 报告的准确性。
在 9 家儿童医院，对经验丰富的癌症临床医生进行了两轮调查。在第一轮中，儿科肿瘤学家为所有 101 种可能的儿科 PRO-CTCAE 反应模式分配了 CTCAE 等级。作者评估了临床医生对不同反应模式下 CTCAE 等级的一致性，并将每种反应模式分为高一致性或低一致性。在第二轮中，向更大的临床医生群体发送了一份调查，以检查一组选定的儿科 PRO-CTCAE 反应模式之间的临床医生一致性，并检查临床背景如何影响等级分配。
共有 10 名儿科肿瘤学家参加了第一轮。在 101 种可能的模式中，有 89 种（88%）具有高度一致性。10 名肿瘤学家的平均 Light kappa 值为 0.73（95%CI，0.66-0.81）。共有 139 名临床医生参加了第二轮。对于大多数通用反应模式，临床医生仍然具有高度一致性，而且临床背景通常不会改变等级，而是提高了一致性。
目前的研究为将儿童自我报告的症状数据直接纳入肿瘤试验中的强制性 AE 报告提供了框架。将儿科 PRO-CTCAE 反应转化为具有临床意义的指标将指导未来的癌症护理和毒性分级。
