Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group.

Autor: Elgarten CW; Department of Pediatrics, Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA., Thompson JC; Department of Pediatrics, Division of Hematology/Oncology/Bone Marrow Transplant, Children's Mercy Hospital, University of Missouri-Kansas City, Kansas City, Missouri, USA., Angiolillo A; Center for Cancer and Blood Disorders, Children's National Medical Center, Washington, District of Columbia, USA., Chen Z; Department of Biostatistics, University of Florida, Gainesville, Florida, USA., Conway S; Department of Biostatistics, University of Florida, Gainesville, Florida, USA., Devidas M; St. Jude Children's Research Hospital, Memphis, Tennessee, USA., Gupta S; Department of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada., Kairalla JA; Department of Biostatistics, University of Florida, Gainesville, Florida, USA., McNeer JL; University of Chicago Comer Children's Hospital, Chicago, Illinois, USA., O'Brien MM; Cincinnati Children's Hospital Medical Center, Pediatric Hematology/Oncology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Rabin KR; Pediatric Hematology/Oncology, Baylor College of Medicine, Houston, Texas, USA., Rau RE; Pediatric Hematology/Oncology, Baylor College of Medicine, Houston, Texas, USA., Rheingold SR; Department of Pediatrics, Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA., Wang C; Department of Biostatistics, University of Florida, Gainesville, Florida, USA., Wood C; Department of Biostatistics, University of Florida, Gainesville, Florida, USA., Raetz EA; Laura and Isaac Perlmutter Cancer Center, NYU Langone, New York, New York, USA., Loh ML; Division of Hematology, Oncology, Bone Marrow Transplant, and Cellular Therapies, Seattle Children's Hospital and the Ben Towne Center for Childhood Cancer Research, University of Washington, Seattle, Washington, USA., Alexander S; Department of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada., Miller TP; Pediatric Hematology/Oncology, Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, USA.
Jazyk: angličtina
Zdroj: Pediatric blood & cancer [Pediatr Blood Cancer] 2022 Nov; Vol. 69 (11), pp. e29937. Date of Electronic Publication: 2022 Sep 09.
DOI: 10.1002/pbc.29937
Abstrakt: 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.
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Databáze: MEDLINE
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