Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data.
Journal
Journal of perinatology : official journal of the California Perinatal Association
ISSN: 1476-5543
Titre abrégé: J Perinatol
Pays: United States
ID NLM: 8501884
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
received:
28
12
2020
accepted:
13
07
2021
revised:
09
06
2021
pubmed:
16
9
2021
medline:
19
2
2022
entrez:
15
9
2021
Statut:
ppublish
Résumé
The Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool. Retrospective validation study assessing the inter-rater reliability (IRR) of the NAESS. Reviewers used real-world AE data from a neonatal trial. Intra-class correlation (ICC) statistical analysis was performed. Sixty AEs were randomly assigned to twelve reviewers for a total of 240 severity scores. Generic and AE-specific NAESS tables were assessed. The ICC was 0.63 (95% confidence interval 0.51 to 0.73). Percent variation due to reviewer and residual error was 0.03 and 0.34, respectively. In this first study of the NAESS tool, an ICC of 0.63 indicates moderate reliability. Results highlight the need for improved data collection on neonatal AE forms, augmented training on the NAESS tool, and will inform the prospective validation studies.
Identifiants
pubmed: 34521975
doi: 10.1038/s41372-021-01164-w
pii: 10.1038/s41372-021-01164-w
pmc: PMC8752442
mid: NIHMS1724332
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
2813-2819Subventions
Organisme : NICHD NIH HHS
ID : K23 HD091362
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002544
Pays : United States
Informations de copyright
© 2021. The Author(s).
Références
Gipson DS, Kirkendall ES, Gumbs-Petty B, Quinn T, Steen A, Hicks A, et al. Development of a pediatric adverse events terminology. Pediatrics 2017;139:e20160985.
doi: 10.1542/peds.2016-0985
Miller TP, Fisher BT, Getz KD, Sack L, Razzaghi H, Seif AE, et al. Unintended consequences of evolution of the common terminology criteria for adverse events. Pediatr Blood Cancer. 2019;66:e27747.
doi: 10.1002/pbc.27747
Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, et al. Development of a neonatal adverse event severity scale through a Delphi consensus approach. Arch Dis Child. 2019;104:1167–73.
doi: 10.1136/archdischild-2019-317399
Davis JM, Pilon AL, Shenberger J, Breeze JL, Terrin N, Mazela J, et al. The role of recombinant human CC10 in the prevention of chronic pulmonary insufficiency of prematurity. Pediatr Res. 2019;86:254–60.
doi: 10.1038/s41390-019-0419-3
Bates D, Mächler M, Bolker B, Walker S. Fitting linear mixed-effects models using lme4. J Stat Softw. 2015;67:48.
Gamer M, Lemon J, Singh P. Various coefficients of interrater reliability and agreement 2019. Available from: https://CRAN.R-project.org/package=irr .
Intraclass Correlation - Statistics How To 2016. Available from: https://www.statisticshowto.com/intraclass-correlation/ .
Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, et al. Reliability of adverse symptom event reporting by clinicians. Qual Life Res. 2012;21:1159–64.
doi: 10.1007/s11136-011-0031-4
Rampersaud YR, Anderson PA, Dimar JR 2nd, Fisher CG. Spinal adverse events severity system, version 2 (SAVES-V2): inter- and intraobserver reliability assessment. J Neurosurg Spine. 2016;25:256–63.
doi: 10.3171/2016.1.SPINE14808
Kahn MG, Bailey LC, Forrest CB, Padula MA, Hirschfeld S. Building a common pediatric research terminology for accelerating child health research. Pediatrics 2014;133:516–25.
doi: 10.1542/peds.2013-1504
Webbe JWH, Duffy JMN, Afonso E, Al-Muzaffar I, Brunton G, Greenough A, et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2020;105:425–31.
doi: 10.1136/archdischild-2019-317501
Miller TP, Li Y, Kavcic M, Troxel AB, Huang YS, Sung L, et al. Accuracy of adverse event ascertainment in clinical trials for pediatric acute myeloid leukemia. J Clin Oncol. 2016;34:1537–43.
doi: 10.1200/JCO.2015.65.5860