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List of abbreviations

All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices, in which case the abbreviation is defined in the figure legend or in the notes at the end of the table.

NIHR Health Technology Assessment programme

The Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.

Acknowledgements

We acknowledge both the time and input from our Expert Group members: Maureen Dalziel (service user representative); Carrock Sewell (Consultant Immunologist, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust and Visiting Professor of Immunology, University of Lincoln, UK); Mervyn Singer (Professor of Intensive Care Medicine, University College London, UK); Richard Beale (Head of Perioperative, Critical Care and Pain Services and Consultant Intensivist, Guy's and St Thomas' NHS Foundation Trust, London, UK); and Graham Ramsay (Chief Executive, Mid Essex Hospital Services NHS Trust, Chelmsford, UK). We also acknowledge Phil Restarick who co-ordinated the survey and Expert Group meetings.

Conclusions

Our meta-analysis, the first to simultaneously allow for type of IVIG (IVIG or IVIGAM), choice of control (no treatment or albumin), study quality/publication bias and other potential covariates, indicated that the treatment effect of IVIG on mortality for patients with severe sepsis is borderline significant with a large degree of heterogeneity in treatment effect between individual studies. Based on the results of combining the available evidence, and until further evidence becomes available, the immediate implications for health care are as per current policy and practice for off-label use of IVIG in severe sepsis (i.e. colour-coded black as treatment not recommended).

Introduction

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Sepsis, severe sepsis and septic shock are generic terms and do not represent a single homogeneous disease; rather they are terms for a common syndrome.

Value of information analysis - analytic methods and results

In the previous chapter, the expected cost-effectiveness of IVIG in adults with severe sepsis and septic shock was assessed given the existing evidence available. Evidence on a number of key inputs and assumptions was demonstrated to be uncertain, and there is a need to identify whether or not further research would be potentially worthwhile and to help prioritise areas where this research would appear to be most valuable in terms of informing decision-making in the NHS concerning the appropriate use of IVIG. An analysis of EVI is presented to help to inform and prioritise potential areas where further research is needed.

Executive summary

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Estimates of severe sepsis (sepsis associated with acute organ dysfunction) in UK adult critical-care units from the Intensive Care National Audit & Research Centre Case Mix Programme Database indicate an increasing incidence of severe sepsis in critical care (rising from 50 to 70 cases per 100,000 population per year over the last decade). This now represents approximately 31,000 patient episodes and 15,000 in-hospital deaths per year.

Survey of the management of severe sepsis in UK critical-care units

To describe current practice in the management of adult patients severely ill with sepsis (severe sepsis or septic shock) in the UK.

Health Technology Assessment programme

Director, Professor Tom Walley, CBE, Director, NIHR HTA programme, Professor of Clinical Pharmacology, University of Liverpool

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