PMID- 34521975
OWN - NLM
STAT- MEDLINE
DCOM- 20220217
LR  - 20221030
IS  - 1476-5543 (Electronic)
IS  - 0743-8346 (Print)
IS  - 0743-8346 (Linking)
VI  - 41
IP  - 12
DP  - 2021 Dec
TI  - Inter-rater reliability of the neonatal adverse event severity scale using 
      real-world Neonatal clinical trial data.
PG  - 2813-2819
LID - 10.1038/s41372-021-01164-w [doi]
AB  - 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.
CI  - (c) 2021. The Author(s).
FAU - Lewis, Tamorah
AU  - Lewis T
AUID- ORCID: 0000-0003-2137-8339
AD  - Children's Mercy Hospital, University of Missouri Kansas City School of Medicine, 
      Department of Pediatrics, Kansas City, MO, USA. trlewis@cmh.edu.
FAU - Terrin, Norma
AU  - Terrin N
AD  - Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 
      Boston, MA, USA.
FAU - Davis, Jonathan
AU  - Davis J
AD  - Tufts Children's Hospital, Tufts University School of Medicine, Department of 
      Pediatrics, Boston, MA, USA.
FAU - Michels, Kurt
AU  - Michels K
AD  - Critical PATH Institute, Tucson, AZ, USA.
FAU - Salaets, Thomas
AU  - Salaets T
AD  - Department of Development and Regeneration, KU Leuven, Herestraat 49, Leuven, 
      Belgium.
FAU - Wade, Kelly
AU  - Wade K
AD  - Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, PA, USA.
CN  - International Neonatal Consortium
LA  - eng
GR  - K23 HD091362/HD/NICHD NIH HHS/United States
GR  - UL1 TR002544/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20210914
PL  - United States
TA  - J Perinatol
JT  - Journal of perinatology : official journal of the California Perinatal 
      Association
JID - 8501884
SB  - IM
MH  - Humans
MH  - Infant, Newborn
MH  - *Reproducibility of Results
MH  - Retrospective Studies
PMC - PMC8752442
MID - NIHMS1724332
COIS- The authors declare no competing interests.
EDAT- 2021/09/16 06:00
MHDA- 2022/02/19 06:00
PMCR- 2021/09/14
CRDT- 2021/09/15 07:02
PHST- 2020/12/28 00:00 [received]
PHST- 2021/07/13 00:00 [accepted]
PHST- 2021/06/09 00:00 [revised]
PHST- 2021/09/16 06:00 [pubmed]
PHST- 2022/02/19 06:00 [medline]
PHST- 2021/09/15 07:02 [entrez]
PHST- 2021/09/14 00:00 [pmc-release]
AID - 10.1038/s41372-021-01164-w [pii]
AID - 1164 [pii]
AID - 10.1038/s41372-021-01164-w [doi]
PST - ppublish
SO  - J Perinatol. 2021 Dec;41(12):2813-2819. doi: 10.1038/s41372-021-01164-w. Epub 
      2021 Sep 14.