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Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials
CJ. Henry, G. Semova, E. Barnes, I. Cotter, T. Devers, A. Rafaee, A. Slavescu, NO. Cathain, D. McCollum, E. Roche, D. Mockler, J. Allen, J. Meehan, C. Klingenberg, JM. Latour, A. van den Hoogen, T. Strunk, E. Giannoni, LJ. Schlapbach, M....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu systematický přehled, práce podpořená grantem
Grantová podpora
MR/N008405/1
Medical Research Council - United Kingdom
NLK
Free Medical Journals
od 1967 do Před 1 rokem
ProQuest Central
od 2016-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2016-01-01 do Před 1 rokem
Public Health Database (ProQuest)
od 2016-01-01 do Před 1 rokem
- MeSH
- delfská metoda MeSH
- hodnocení výsledků zdravotní péče MeSH
- lidé MeSH
- novorozenec MeSH
- novorozenecká sepse * diagnóza terapie MeSH
- randomizované kontrolované studie jako téma MeSH
- výsledek terapie MeSH
- výzkumný projekt * MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- práce podpořená grantem MeSH
- systematický přehled MeSH
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. IMPACT: 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.
Department of Neonatology CHI at Crumlin Dublin Ireland
Department of Neonatology Pirogov Russian National Research Medical University Moscow Russia
Department of Paediatrics Coombe Women's and Infant's University Hospital Dublin Ireland
Department of Paediatrics Tergooi Hospital Blaricum The Netherlands
Department of Paediatrics University of Florida Gainesville FL USA
Department of Pathology Immunology and Laboratory Medicine University of Florida Gainesville FY USA
Department of Pediatrics and Adolescence Medicine University Hospital of North Norway Tromsø Norway
Department of Pediatrics Bern University Hospital University of Bern Bern Switzerland
Division of Neonatology Edward Doisy Research Center Saint Louis University St Louis MO USA
John Stearne Medical Library Trinity College Dublin St James' Hospital Dublin Ireland
Karolinska University Hospital and Karolinska Institutet Stockholm Sweden
Neonatal Directorate King Edward Memorial Hospital for Women Perth WA Australia
Neonatal Health and Development Telethon Kids Institute Perth WA Australia
Paediatric Intensive Care Unit Queensland Children's Hospital Brisbane QLD Australia
School of Nursing and Midwifery Faculty of Health University of Plymouth Plymouth UK
Trinity Research in Childhood Centre Trinity College Dublin Dublin Ireland
Trinity Translational Medicine Institute St James Hospital Dublin Ireland
Citace poskytuje Crossref.org
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- $a BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. IMPACT: 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.
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