TY - JOUR
T1 - Changing the paradigm of defining, detecting, and diagnosing NEC
T2 - Perspectives on Bell's stages and biomarkers for NEC
AU - Gephart, Sheila M.
AU - Gordon, Phillip V.
AU - Penn, Alexander H.
AU - Gregory, Katherine E.
AU - Swanson, Jonathan R.
AU - Maheshwari, Akhil
AU - Sylvester, Karl
N1 - Funding Information:
Dr. Gephart acknowledges support from the Robert Wood Johnson Foundation Nurse Faculty Scholars Program (72114) and the Agency for Healthcare Research and Quality (K08HS022908). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality or Robert Wood Johnson Foundation. The Necrotizing Enterocolitis Symposium: A Transdisciplinary Approach to Improved NEC Outcomes was supported by a Eugene Washington PCORI Engagement Award by the Patient-Centered Outcomes Research Institute (PCORI) and the University of California Davis. PCORI is an independent, non-profit organization authorized by Congress in 2010 to fund comparative effectiveness research that will provide patients, their caregivers, and clinicians with the evidence needed to make better-informed health and healthcare decisions. PCORI is committed to seeking input from a broad range of stakeholders to guide its work. Dr. Maheshwari is supported by the NIH awards HL124078 and HL133022. We thank Dr. Robert Christensen for his contributions to the workgroup on defining NEC.
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/2
Y1 - 2018/2
N2 - Better means to diagnose and define necrotizing enterocolitis are needed to guide clinical practice and research. Adequacy of Bell's staging system for clinical practice and clarity of cases used in NEC clinical datasets has been a topic of controversy for some time. This article provides reasons why a better global definition for NEC is needed and offers a simple alternative bedside definition for preterm NEC called the “Two out of Three” rule. Some argue that biomarkers may fill knowledge gaps and provide greater precision in defining relevant features of a clinical disease like NEC. NEC biomarkers include markers of inflammation, intestinal dysfunction, hematologic changes, and clinical features. Development and reporting of NEC biomarkers should be guided by the FDA's BEST Consensus resource, “Biomarkers, EndpointS, & other Tools” and consistently report metrics so that studies can be compared and results pooled. Current practice in the NICU would be enhanced by clinical tools that effectively inform the clinical team that a baby is at increasing risk of NEC. Ideally, these tools will incorporate both clinical information about the baby as well as molecular signals that are indicative of NEC. While meaningful biomarkers for NEC and clinical tools exist, translation into practice is mediocre.
AB - Better means to diagnose and define necrotizing enterocolitis are needed to guide clinical practice and research. Adequacy of Bell's staging system for clinical practice and clarity of cases used in NEC clinical datasets has been a topic of controversy for some time. This article provides reasons why a better global definition for NEC is needed and offers a simple alternative bedside definition for preterm NEC called the “Two out of Three” rule. Some argue that biomarkers may fill knowledge gaps and provide greater precision in defining relevant features of a clinical disease like NEC. NEC biomarkers include markers of inflammation, intestinal dysfunction, hematologic changes, and clinical features. Development and reporting of NEC biomarkers should be guided by the FDA's BEST Consensus resource, “Biomarkers, EndpointS, & other Tools” and consistently report metrics so that studies can be compared and results pooled. Current practice in the NICU would be enhanced by clinical tools that effectively inform the clinical team that a baby is at increasing risk of NEC. Ideally, these tools will incorporate both clinical information about the baby as well as molecular signals that are indicative of NEC. While meaningful biomarkers for NEC and clinical tools exist, translation into practice is mediocre.
KW - Bell's stages
KW - Biomarkers
KW - Clinical definition
KW - Clinical predictors
KW - Necrotizing enterocolitis
KW - Spontaneous intestinal perforation
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U2 - 10.1053/j.sempedsurg.2017.11.002
DO - 10.1053/j.sempedsurg.2017.11.002
M3 - Article
C2 - 29275814
AN - SCOPUS:85034830223
SN - 1055-8586
VL - 27
SP - 3
EP - 10
JO - Seminars in Pediatric Surgery
JF - Seminars in Pediatric Surgery
IS - 1
ER -