Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data.

Creator(s)

Tamorah R. Lewis, Children's Mercy HospitalFollow
Norma Terrin
Jonathan Davis
Kurt Michels
Thomas Salaets
Kelly Wade
International Neonatal Consortium

Document Type

Article

Publication Date

12-2021

Identifier

DOI: 10.1038/s41372-021-01164-w

Abstract

OBJECTIVE: 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.

STUDY DESIGN: 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.

RESULT: 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.

CONCLUSION: 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.

Journal Title

Journal of perinatology : official journal of the California Perinatal Association

Volume

41

Issue

12

First Page

2813

Last Page

2819

Comments

Grant support

• K23 HD091362/HD/NICHD NIH HHS/United States
• 76230/Robert Wood Johnson Foundation (RWJF)
• K23 HD091362-03/U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Publisher's Link: https://www.nature.com/articles/s41372-021-01164-w

Recommended Citation

Lewis T, Terrin N, Davis J, et al. Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data. J Perinatol. 2021;41(12):2813-2819. doi:10.1038/s41372-021-01164-w