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

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.

Hypotensive unawareness in Parkinson's disease-related autonomic dysfunction.

This case demonstrates how orthostatic hypotension in the absence of typical symptoms of light-headedness/dizziness when changing posture, can contribute to the burden of falls in Parkinson's disease. At least one-third of people with severe orthostatic hypotension do not report typical symptoms, and this figure appears to be higher in patients with Parkinson's disease. This is important clinically as it can increase the difficulty in ascribing falls to orthostatic hypotension, especially given the other competing reasons in Parkinson's disease and orthostatic hypotension symptoms can act as a prompt for the patient to act to prevent falls-related injuries. There is a clinical requirement, therefore, to screen for and manage orthostatic hypotension in patients with Parkinson's disease to prevent falls, even in those who do not report typical symptoms.