Development of a neonatal adverse event severity scale through a Delphi consensus approach

被引：42

作者：

Salaets, Thomas ^{[1
]}

Turner, Mark A. ^{[2
]}

Short, Mary ^{[3
]}

Ward, Robert M. ^{[4
,5
]}

Hokuto, Isamu ^{[6
]}

Ariagno, Ronald L. ^{[7
]}

Klein, Agnes ^{[8
]}

Beauman, Sandra ^{[9
]}

Wade, Kelly ^{[10
]}

Thomson, Merran ^{[11
]}

Roberts, Eve ^{[2
]}

Harrison, Judy ^{[12
]}

Quinn, Theresa ^{[13
]}

Baer, Gerri ^{[14
]}

Davis, Jonathan ^{[15
,16
]}

Allegaert, Karel ^{[1
,17
]}

Allen, Marilee ^{[18
]}

Allen, Albert ^{[19
]}

Freimane, Dina Apele ^{[20
]}

Aschner, Judy ^{[21
,22
]}

Ballard, Roberta ^{[23
]}

Belew, Yodit ^{[24
]}

Bax, Ralph ^{[25
]}

Bellflower, Bobby ^{[26
]}

Bhatt-Mehta, Varsha ^{[27
]}

Blum, Mike ^{[24
]}

Bonardi, Chiara ^{[28
]}

Bondurant, Patti ^{[29
]}

Boylan, Geraldine ^{[30
,31
]}

Buracchio, Teresa ^{[24
]}

Burckart, Gilbert ^{[24
]}

Burnett, Amber ^{[32
]}

Burnham, Janelle ^{[24
]}

Carlson, Cheryl ^{[33
]}

Chen, Alice ^{[34
]}

Clay, Bob ^{[35
]}

Cohen, Alan ^{[36
]}

Connolly, Eamonn ^{[37
]}

Connor, Edward ^{[38
]}

Darsey, Edress ^{[39
]}

De Lisa, Roberto ^{[25
]}

Degl, Jennifer ^{[40
]}

Dempsey, Eugene ^{[30
,31
]}

Diacovo, Tom ^{[41
]}

Dionne, Janis ^{[42
]}

Duchon, Jennifer ^{[43
]}

Eklund, Wakako ^{[44
]}

Fabbri, Laura ^{[28
]}

Fielder, Alistair ^{[45
]}

Freilich, Emily ^{[24
]}

机构：

[1] Katholieke Univ Leuven, Dept Dev & Regenerat, Leuven, Belgium

[2] Univ Liverpool, Inst Translat Med, Liverpool, Merseyside, England

[3] Eli Lilly & Co, Indianapolis, IN 46285 USA

[4] Univ Utah, Dept Pediat, Div Neonatol, Salt Lake City, UT USA

[5] Univ Utah, Dept Pediat, Div Clin Pharmacol, Salt Lake City, UT USA

[6] St Marianna Univ, Dept Pediat, Kawasaki, Kanagawa, Japan

[7] Stanford Univ, Sch Med, Dept Pediat Neonatol, Palo Alto, CA 94304 USA

[8] Hlth Canada, Ottawa, ON, Canada

[9] Univ New Mexico, Dept Pediat, Hlth Sci Ctr, Albuquerque, NM 87131 USA

[10] Childrens Hosp Philadelphia, Div Neonatol, Philadelphia, PA 19104 USA

[11] Hillingdon Hosp NHS Fdn Trust, Uxbridge, Middx, England

[12] MedDRA, Maintenance & Support Serv Org, Mclean, VA USA

[13] NCI, Enterprise Vocabulary Serv, Bethesda, MD 20892 USA

[14] US FDA, Off Pediat Therapeut, Silver Spring, MD USA

[15] Tufts Med Ctr, Floating Hosp Children, Boston, MA 02111 USA

[16] Tufts Clin & Translat Sci Inst, Boston, MA USA

[17] Erasmus MC Sophia Kinderziekenhuis, Div Neonatol, Dept Pediat, NL-3015 Rotterdam, Netherlands

[18] Johns Hopkins, Baltimore, MD USA

[19] Eli Lilly, Indianapolis, IN USA

[20] P Stradins Clin Univ Hosp, PDCO, Riga, Latvia

[21] Hackensack Meridian Hlth Sch Med, Joseph M Sanzari Childrens Hosp, Nutley, NJ USA

[22] Albert Einstein Coll Med, The Bronx, NY USA

[23] UCSF Sch Med, San Francisco, CA USA

[24] US FDA, Rockville, MD 20857 USA

[25] EMA, London, England

[26] Univ Tennessee, Knoxville, TN 37996 USA

[27] Univ Michigan, Ann Arbor, MI 48109 USA

[28] Chiesi Pharmaceut, Parma, Italy

[29] Greenwood Solut, Greenwood, IN USA

[30] INFANT Res Ctr, Cork, Ireland

[31] Dept Paediat & Child Hlth, Cork, Ireland

[32] Baxter Int, Deerfield, IL USA

[33] UNC, Chapel Hill, NC USA

[34] NIH, Bldg 10, Bethesda, MD 20892 USA

[35] Highbury Regulatory Sci Ltd, Greater London, England

[36] Bayer, Leverkusen, Germany

[37] Infant Bacterial Therapeut, Stockholm, Sweden

[38] Inst Adv Clin Trials Children, Rockville, MD USA

[39] Pfizer Inc, New York, NY USA

[40] Speaking Moms & Babies Inc, Decatur, IL USA

[41] Childrens Hosp Pittsburgh, Pittsburgh, PA 15213 USA

[42] BC Childrens Hosp, Vancouver, BC, Canada

[43] Tufts Med Ctr, Boston, MA 02111 USA

[44] Natl Assoc Neonatal Nurses, Chicago, IL USA

[45] City Univ London, London, England

[46] Hoffmann La Roche LTD, Basel, Switzerland

[47] Quorum Hlth Corp, Brentwood, TN USA

[48] Preemie Parent Alliance, Lonedell, MO USA

[49] Univ Gothenburg, Gothenburg, Sweden

[50] Case Western Reserve Univ, Sch Med, Cleveland, OH 44106 USA

来源：

ARCHIVES OF DISEASE IN CHILDHOOD | 2019年 / 104卷 / 12期

关键词：

DRUG-REACTIONS; RELIABILITY;

D O I：

10.1136/archdischild-2019-317399

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

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 kappa=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.

引用

页码：1167 / +

页数：7

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