TY - JOUR AU - Trojan, Andreas AU - Leuthold, Nicolas AU - Thomssen, Christoph AU - Rody, Achim AU - Winder, Thomas AU - Jakob, Andreas AU - Egger, Claudine AU - Held, Ulrike AU - Jackisch, Christian PY - 2021 DA - 2021/8/5 TI -接受全身治疗的癌症患者电子报告结果协同评价对患者和临床报告毒性一致性的影响:前瞻性、多中心、观察性临床试验JO - J Med Internet Res SP - e29271 VL - 23 IS - 8 KW - cancer KW - consilium KW - app KW - eHealth KW - ePRO KW - CTCAE KW -一致性KW -患者报告的KW -症状AB -背景:电子患者报告的结果(ePRO)是一种相对较新的数据形式，具有改善癌症患者临床实践的潜力。在这项前瞻性、多中心、观察性临床试验中，我们努力证明患者报告症状的可靠性。目的:本研究的主要目的是通过共享评估过程来评估医生和患者症状评分之间的一致性κ水平，以确定自我报告的电子症状监测的未来可靠性和实用性。方法:在90天的观察期内，在(新)辅助或非治疗意图环境中接受全身治疗的患者捕获了52种症状的ePRO。每隔3周，根据不良事件通用术语标准(CTCAE)对患者和医生之间随机选择的症状进行评估，以确定不良事件分级的严重程度是否一致。通过科恩κ (Cohen kappa， κ)评估患者-医生对症状评价的认同程度，并通过其计算解释者信度。卡方检验用于确定患者报告的结果在症状、癌症类型、人口统计学和医生经验之间是否存在差异。结果:181例患者中，女性158例，男性23例;中位年龄54.4岁)，评分一致(κ=0.24; 95% CI 0.16-0.33) for symptoms that were entered 2 to 4 weeks before the intended review (first rating) and a moderate agreement (κ=0.41; 95% CI 0.34-0.48) for symptoms that were entered within 1 week of the intended review (second rating). However, the level of agreement increased from moderate (first rating, κ=0.43) to substantial (second rating, κ=0.68) for common symptoms of pain, fever, diarrhea, obstipation, nausea, vomiting, and stomatitis. Similar congruency levels of ratings were found for the most frequently entered symptoms (first rating: κ=0.42; second rating: κ=0.65). The symptom with the lowest agreement was hair loss (κ=–0.05). With regard to the latency of symptom entry into the review, hardly any difference was demonstrated between symptoms that were entered from days 1 to 3 and from days 4 to 7 before the intended review (κ=0.40 vs κ=0.39, respectively). In contrast, for symptoms that were entered 15 to 21 days before the intended review, no congruency was demonstrated (κ=–0.15). Congruency levels seemed to be unrelated to the type of cancer, demographics, and physicians’ review experience. Conclusions: The shared monitoring and review of symptoms between patients and clinicians has the potential to improve the understanding of patient self-reporting. Our data indicate that the integration of ePRO into oncological clinical research and continuous clinical practice provides reliable information for self-empowerment and the timely intervention of symptoms. Trial Registration: ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731 SN - 1438-8871 UR - //www.mybigtv.com/2021/8/e29271 UR - https://doi.org/10.2196/29271 UR - http://www.ncbi.nlm.nih.gov/pubmed/34383675 DO - 10.2196/29271 ID - info:doi/10.2196/29271 ER -