Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials.

Details

Serval ID
serval:BIB_C65B9B3BEFF3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials.
Journal
Pediatric research
Author(s)
Henry C.J., Semova G., Barnes E., Cotter I., Devers T., Rafaee A., Slavescu A., Cathain N.O., McCollum D., Roche E., Mockler D., Allen J., Meehan J., Klingenberg C., Latour J.M., van den Hoogen A., Strunk T., Giannoni E., Schlapbach L.J., Degtyareva M., Plötz F.B., de Boode W.P., Naver L., Wynn J.L., Küster H., Janota J., Keij F.M., Reiss IKM, Bliss J.M., Polin R., Koenig J.M., Turner M.A., Gale C., Molloy E.J.
Working group(s)
Infection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)
ISSN
1530-0447 (Electronic)
ISSN-L
0031-3998
Publication state
Published
Issued date
03/2022
Peer-reviewed
Oui
Volume
91
Number
4
Pages
735-742
Language
english
Notes
Publication types: Systematic Review ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.
A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.
Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.
This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.
This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
Keywords
Delphi Technique, Humans, Infant, Newborn, Neonatal Sepsis/diagnosis, Neonatal Sepsis/therapy, Outcome Assessment, Health Care, Randomized Controlled Trials as Topic, Research Design, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
14/01/2022 19:41
Last modification date
28/05/2022 6:34
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