Development of a neonatal adverse event severity scale through a Delphi consensus approach. Issue 12 (19th September 2019)

• Record Type: Journal Article
• Authors: Salaets, Thomas; Turner, Mark A; Short, Mary; Ward, Robert M; Hokuto, Isamu; Ariagno, Ronald L; Klein, Agnes; Beauman, Sandra; Wade, Kelly; Thomson, Merran; Roberts, Eve; Harrison, Judy; Quinn, Theresa; Baer, Gerri; Davis, Jonathan; Allegaert, Karel
• Other Names: author non-byline.; Allen Marilee author non-byline.; Allen Albert author non-byline.; Freimane Dina Apele author non-byline.; Aschner Judy author non-byline.; Ballard Roberta author non-byline.; Belew Yodit author non-byline.; Bax Ralph author non-byline.; Bellflower Bobby author non-byline.; Bhatt-Mehta Varsha author non-byline.; Blum Mike author non-byline.; Bonardi Chiara author non-byline.; Bondurant Patti author non-byline.; Boylan Geraldine author non-byline.; Buracchio Teresa author non-byline.; Burckart Gilbert author non-byline.; Burnett Amber author non-byline.; Burnham Janelle author non-byline.; Carlson Cheryl author non-byline.; Chen Alice author non-byline.; Clay Bob author non-byline.; Cohen Alan author non-byline.; Connolly Eamonn author non-byline.; Connor Edward author non-byline.; Darsey Edress author non-byline.; Lisa Roberto De author non-byline.; Degl Jennifer author non-byline.; Dempsey Eugene author non-byline.; Diacovo Tom author non-byline.; Dionne Janis author non-byline.; Duchon Jennifer author non-byline.; Eklund Wakako author non-byline.; Fabbri Laura author non-byline.; Fielder Alistair author non-byline.; Freilich Emily author non-byline.; Fürst-Recktenwald Sabine author non-byline.; Graham Tamorah author non-byline.; Green Dionna author non-byline.; Grogan Cristal author non-byline.; Heiselman Darell author non-byline.; Hellström Ann author non-byline.; Herold Ralf author non-byline.; Hibbs Anna Maria author non-byline.; Hirschfeld Steven author non-byline.; Brown Mary Hise author non-byline.; Holberton Jim author non-byline.; Iveli Pablo author non-byline.; Jobe Alan author non-byline.; Kayton Allyson author non-byline.; Kenner Carole author non-byline.; Kraft Walter author non-byline.; Kusuda Satoshi author non-byline.; Lacaze Thierry author non-byline.; Lewis Tamorah author non-byline.; Lui Kei author non-byline.; Lutsar Irja author non-byline.; Mangili Alexandra author non-byline.; Mangum Barry author non-byline.; McCune Susan author non-byline.; McDonald Karen author non-byline.; McGuire Courtney author non-byline.; McPherson Christopher author non-byline.; Miller Washington UniversityThomas author non-byline.; Ming Jeffrey author non-byline.; Mitzner Alison author non-byline.; Modi Neena author non-byline.; Morrison Maya author non-byline.; Morsing Eva author non-byline.; Mulugeta Lily author non-byline.; Nakamura Hide author non-byline.; Nelson Skip author non-byline.; Noel Gary author non-byline.; Olshansky Miki author non-byline.; Oschman Alex author non-byline.; Ozsahin Hulya author non-byline.; Padula Mike author non-byline.; Peiris Vasum author non-byline.; Koplowitz Luana Pesco author non-byline.; Pham Josh author non-byline.; Pilon Aprile author non-byline.; Portman Ron author non-byline.; Pressler Ronit author non-byline.; Rabe Heike author non-byline.; Raju Tonse author non-byline.; Roepke Douglas Andrew author non-byline.; Savani Rashmin author non-byline.; Schnell Patrick author non-byline.; Segal Robert author non-byline.; Senterre Thibault author non-byline.; Shah Prakesh author non-byline.; Sheridan Philip author non-byline.; Sherwin Catherine author non-byline.; Singh Rajendra author non-byline.; Soll Roger author non-byline.; Soul Janet author non-byline.; Spence Kaye author non-byline.; Storari Linda author non-byline.; Taminiau Jan author non-byline.; Tseng Brian author non-byline.; Anker John Van Den author non-byline.; Varga Judy author non-byline.; Venkataraman Preeti author non-byline.; Vivas Norma author non-byline.; Walker Karen author non-byline.; Wilson Janice author non-byline.; Zajicek Anne author non-byline.; Zaloga Gary author non-byline.; Zeldis Stav author non-byline.;
• Is Part Of: Archives of disease in childhood. Volume 104:Issue 12(2019)
• Page Start: 1167
• Page End: 1173
• Publication Date: 2019-09-19
• Subjects: adverse event -- severity grading -- drug safety -- neonate; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/archdischild-2019-317399
• Languages: English
• ISSNs: 0003-9888

Abstract

Abstract : Background: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. Methods: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. Results: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. Discussion: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.