Department of Pediatrics, Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Department of Pediatrics, Division of Hematology/Oncology/Bone Marrow Transplant, Children's Mercy Hospital, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Pediatr Blood Cancer. 2022 Nov;69(11):e29937. doi: 10.1002/pbc.29937. Epub 2022 Sep 9.
Infections cause substantial morbidity for children with acute lymphoblastic leukemia (ALL). Therefore, accurate characterization of infectious adverse events (AEs) reported on clinical trials is imperative to defining, comparing, and managing safety and toxicity. Here, we describe key processes implemented to improve reporting of infectious AEs on two active phase III Children's Oncology Group (COG) ALL trials. Processes include: (a) identifying infections as a targeted toxicity, (b) incorporation of infection-specific case report form questions, and (c) physician review of AEs with real-time data cleaning. Preliminary assessment of these processes suggests improved reporting, as well as opportunities for further improvement.
感染会给患有急性淋巴细胞白血病（ALL）的儿童带来严重的发病率。因此，准确描述临床试验报告的感染不良事件（AE）对于定义、比较和管理安全性和毒性至关重要。在这里，我们描述了为改进两项正在进行的儿童肿瘤学组（COG）ALL 试验中感染性 AE 的报告而实施的关键流程。这些流程包括：（a）将感染确定为靶向毒性，（b）纳入感染特异性病例报告表问题，以及（c）医生实时数据清理 AE。这些流程的初步评估表明报告得到了改善，并且还有进一步改进的机会。
