1. Development of a neonatal adverse event severity scale through a Delphi consensus approach
- Author
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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, Allen, Marilee, Allen, Albert, Freimane, Dina Apele, Aschner, Judy, Ballard, Roberta, Belew, Yodit, Bax, Ralph, Bellflower, Bobby, Bhatt-Mehta, Varsha, Blum, Mike, Bonardi, Chiara, Bondurant, Patti, Boylan, Geraldine, Buracchio, Teresa, Burckart, Gilbert, Burnett, Amber, Burnham, Janelle, Carlson, Cheryl, Chen, Alice, Clay, Bob, Cohen, Alan, Connolly, Eamonn, Connor, Edward, Darsey, Edress, De Lisa, Roberto, Degl, Jennifer, Dempsey, Eugene, Diacovo, Tom, Dionne, Janis, Duchon, Jennifer, Eklund, Wakako, Fabbri, Laura, Fielder, Alistair, Freilich, Emily, Furst-Recktenwald, Sabine, Graham, Tamorah, Green, Dionna, Grogan, Cristal, Heiselman, Darell, Hellstrom, Ann, Herold, Ralf, Hibbs, Anna Maria, Hirschfeld, Steven, Brown, Mary Hise, Holberton, Jim, Iveli, Pablo, Jobe, Alan, Kayton, Allyson, Kenner, Carole, Kraft, Walter, Kusuda, Satoshi, Lacaze, Thierry, Lewis, Tamorah, Lui, Kei, Lutsar, Irja, Mangili, Alexandra, Mangum, Barry, McCune, Susan, McDonald, Karen, McGuire, Courtney, McPherson, Christopher, Miller, Thomas, Ming, Jeffrey, Mitzner, Alison, Modi, Neena, Morrison, Maya, Morsing, Eva, Mulugeta, Lily, Nakamura, Hide, Nelson, Skip, Noel, Gary, Olshansky, Miki, Oschman, Alex, Ozsahin, Hulya, Padula, Mike, Peiris, Vasum, Koplowitz, Luana Pesco, Pham, Josh, Pilon, Aprile, Portman, Ron, Pressler, Ronit, Rabe, Heike, Raju, Tonse, Roepke, Douglas Andrew, Savani, Rashmin, Schnell, Patrick, Segal, Robert, Senterre, Thibault, Shah, Prakesh, Sheridan, Philip, Sherwin, Catherine, Singh, Rajendra, Soll, Roger, Soul, Janet, Spence, Kaye, Storari, Linda, Taminiau, Jan, Tseng, Brian, Van Den Anker, John, Varga, Judy, Venkataraman, Preeti, Vivas, Norma, Walker, Karen, Wilson, Janice, Zajicek, Anne, Zaloga, Gary, Zeldis, Stav, and Pediatrics
- Subjects
medicine.medical_specialty ,Consensus ,severity grading ,drug safety ,Delphi Technique ,Endpoint Determination ,Delphi method ,adverse event ,Severity grading ,macromolecular substances ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,030225 pediatrics ,Medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,computer.programming_language ,Clinical Trials as Topic ,business.industry ,Infant, Newborn ,Age appropriate ,Clinical trial ,Scale (social sciences) ,Pediatrics, Perinatology and Child Health ,Emergency medicine ,Severity Criteria ,Original Article ,neonate ,business ,computer ,Delphi - Abstract
BackgroundAssessment 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.MethodsA 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.ResultsNeonatal 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.DiscussionThe 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.
- Published
- 2019