Tamara P Miller, Melissa Z Marx1, Christopher Henchen2, Nicholas P DeGroote3, Sally Jones4, Jenny Weiland5, Beth Fisher3, Adam J Esbenshade6, Richard Aplenc, Christopher C Dvorak7, Brian T Fisher. 1. University of Chicago, Chicago, Illinois. 2. Medical College of Wisconsin, Milwaukee, Wisconsin. 3. From the Aflac Cancer & Blood Disorders Center, Children's Healthcare of Atlanta. 4. Washington University School of Medicine, St Louis, Missouri. 5. University of Wisconsin, Madison, Wisconsin. 6. Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, Tennessee. 7. Division of Pediatric Allergy, Immunology, and Blood and Marrow Transplantation, University of California at San Francisco, San Francisco, California.
Abstract
OBJECTIVE: Adverse event (AE) reporting is crucial for determining safety of trials. Adverse events are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to understand AE reporting training, processes, and institution-level differences to improve AE capture. METHODS: A 26-item questionnaire regarding AE reporting training, identification, tracking, and challenges was distributed to all Children's Oncology Group (COG) CRAs and RNs from February 15 to March 11, 2019, regardless of if they report AEs based on limitations of COG rosters. Results were tabulated. Institutions were grouped by self-reported full-time equivalents and compared using χ2 tests. RESULTS: Of 1315 CRAs and 2703 RNs surveyed, 509 (12.7%) responded. Of those, 369 (64.9%) representing 71.8% of COG institutions report AEs. Only data from respondents who report AEs were collected and analyzed. There was a range in AE training; COG training modules were most common (79.7%). There was wide variability in AE ascertainment; only 51.2% use standardized approaches at their site. There was no standard AE tracking method; larger sites more commonly use spreadsheets (P = 0.002) and smaller sites more commonly use paper (P = 0.028). The greatest AE reporting challenges were differences between protocols (70%) and between AE definitions and documentation (53%). Half of the respondents endorsed 6 of 13 proposed tools for improving reporting including online AE reporting modules (75.3%), tip sheets for interpreting Common Terminology Criteria for Adverse Events definitions (67.5%), and standardized AE tracking forms (66.9%). Only half of the respondents reported that all colleagues at their site followed the same AE reporting practices, and there was no dominant AE tracking approach across the respondents. DISCUSSION: There is wide variability in AE reporting training and practices. Numerous challenges exist, including differences between trials, challenges in interpreting AE definitions, and engaging clinicians. CONCLUSIONS: Respondents are eager for additional central resources. These results provide a roadmap for areas of potential improvement.
OBJECTIVE: Adverse event (AE) reporting is crucial for determining safety of trials. Adverse events are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to understand AE reporting training, processes, and institution-level differences to improve AE capture. METHODS: A 26-item questionnaire regarding AE reporting training, identification, tracking, and challenges was distributed to all Children's Oncology Group (COG) CRAs and RNs from February 15 to March 11, 2019, regardless of if they report AEs based on limitations of COG rosters. Results were tabulated. Institutions were grouped by self-reported full-time equivalents and compared using χ2 tests. RESULTS: Of 1315 CRAs and 2703 RNs surveyed, 509 (12.7%) responded. Of those, 369 (64.9%) representing 71.8% of COG institutions report AEs. Only data from respondents who report AEs were collected and analyzed. There was a range in AE training; COG training modules were most common (79.7%). There was wide variability in AE ascertainment; only 51.2% use standardized approaches at their site. There was no standard AE tracking method; larger sites more commonly use spreadsheets (P = 0.002) and smaller sites more commonly use paper (P = 0.028). The greatest AE reporting challenges were differences between protocols (70%) and between AE definitions and documentation (53%). Half of the respondents endorsed 6 of 13 proposed tools for improving reporting including online AE reporting modules (75.3%), tip sheets for interpreting Common Terminology Criteria for Adverse Events definitions (67.5%), and standardized AE tracking forms (66.9%). Only half of the respondents reported that all colleagues at their site followed the same AE reporting practices, and there was no dominant AE tracking approach across the respondents. DISCUSSION: There is wide variability in AE reporting training and practices. Numerous challenges exist, including differences between trials, challenges in interpreting AE definitions, and engaging clinicians. CONCLUSIONS: Respondents are eager for additional central resources. These results provide a roadmap for areas of potential improvement.
Authors: Tamara P Miller; Brian T Fisher; Kelly D Getz; Leah Sack; Hanieh Razzaghi; Alix E Seif; Rochelle Bagatell; Peter C Adamson; Richard Aplenc Journal: Pediatr Blood Cancer Date: 2019-04-09 Impact factor: 3.167
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Authors: Anne L Angiolillo; Reuven J Schore; John A Kairalla; Meenakshi Devidas; Karen R Rabin; Patrick Zweidler-McKay; Michael J Borowitz; Brent Wood; Andrew J Carroll; Nyla A Heerema; Mary V Relling; Johann Hitzler; Ashley R Lane; Kelly W Maloney; Cindy Wang; Mylène Bassal; William L Carroll; Naomi J Winick; Elizabeth A Raetz; Mignon L Loh; Stephen P Hunger Journal: J Clin Oncol Date: 2021-01-07 Impact factor: 44.544
Authors: Tamara P Miller; Kelly D Getz; Yimei Li; Biniyam G Demissei; Peter C Adamson; Todd A Alonzo; Evanette Burrows; Lusha Cao; Sharon M Castellino; Marla H Daves; Brian T Fisher; Robert Gerbing; Robert W Grundmeier; Edward M Krause; Judy Lee; Philip J Lupo; Karen R Rabin; Mark Ramos; Michael E Scheurer; Jennifer J Wilkes; Lena E Winestone; Douglas S Hawkins; M Monica Gramatges; Richard Aplenc Journal: Lancet Haematol Date: 2022-07-20 Impact factor: 30.153
Authors: Caitlin W Elgarten; Joel C Thompson; Anne Angiolillo; Zhiguo Chen; Susan Conway; Meenakshi Devidas; Sumit Gupta; John A Kairalla; Jennifer L McNeer; Maureen M O'Brien; Karen R Rabin; Rachel E Rau; Susan R Rheingold; Cindy Wang; Charlotte Wood; Elizabeth A Raetz; Mignon L Loh; Sarah Alexander; Tamara P Miller Journal: Pediatr Blood Cancer Date: 2022-09-09 Impact factor: 3.838