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IVIg
An evaluation of the feasibility, cost and value of information of a multicentre randomised controlled trial of intravenous immunoglobulin for sepsis (severe sepsis and septic shock)

Aim:

To evaluate the feasibility, cost and value of information of a multicentre randomised controlled trial of intravenous immunoglobulin for sepsis (severe sepsis and septic shock)

 

Objectives:

The sequential objectives are:

  • To define the appropriate decision problem and to develop a provisional decision analytic model structure consistent with this and relevant to an NHS setting.
  • To define the requirements of the subsequent phases of work. 
  • To obtain appropriate inputs for the decision model parameters based on evidence synthesis approaches employing meta-analysis, primary data analysis and other published evidence. 
  • To establish current NHS practice based on a national survey and re-analysis of existing audit data, and also to reflect potential anticipated changes to current practice.  
  • To determine the cost-effectiveness of IVIg and to estimate the value of additional primary research. 
  • To develop a draft protocol outlining the optimal design, sample size, potential costs and value of commissioning a substantive trial using expected value of sample information approaches.

Funder:  NIHR Health Technology and Assessment
Grant:  HTA/08/70/01
Award:  £126,799
Duration:  April 2009 – July 2010

 

Chief Investigator:

Prof Kathryn Rowan

 

Co-Investigators:

Prof Anthony Ades, University of Bristol
Dr Richard Beale, St Thomas’ Hospital
Dr David Harrison, ICNARC
Dr Stephen Palmer, University of York
Prof Graham Ramsay, Hemel Hempstead Hospital
Prof Carrock Sewell, Scunthorpe General Hospital
Prof Mervyn Singer, University College London
Dr Nicky Welton, University of Bristol

Steering Group (Investigators above, plus):

Mrs Maureen Dalziel
Marta Soares
Dr Sheila Harvey
Dr Manu Shankar-Hari

 

Study Team:

Prof Kathy Rowan 
Dr David Harrison
Dr Sheila Harvey
Dr Manu Shankar-Hari
Phil Restarick
Stephen Palmer
Marta Soares
Nicky Welton

Publications
Shankar-Hari M, Spencer J, Sewell WA, Rowan KM, Singer M. Bench-to-bedside review: Immunoglobulin therapy for sepsis - biological plausibility from a critical care perspective. Critical Care. 2012;16(2):206.
(PubMed citation) | (Journal website)
 
Soares MO, Welton NJ, Harrison DA, Peura P, Shankar-Hari M, Harvey SE, Madan JJ, Ades AE, Palmer SJ, Rowan KM. An evaluation of the feasibility, cost and value of information of a multicentre randomised controlled trial of intravenous immunoglobulin for sepsis: incorporating a systematic review, meta-analysis and value of information analysis. Health Technology Assessment. 2012;16(7):1-186.
(PubMed citation) | (Journal website)