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Intravenous immunoglobulin for severe sepsis and septic shock : clinical effectiveness, cost-effectiveness and value of a further randomised controlled trial
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Soares, Marta O., Welton, Nicky J., Harrison, David A., Peura, Piia, Shankar-Hari, Manu, Harvey, Sheila E, Madan, Jason, Ades, Anthony E., Rowan, Kathryn M. and Palmer, Stephen J. (2014) Intravenous immunoglobulin for severe sepsis and septic shock : clinical effectiveness, cost-effectiveness and value of a further randomised controlled trial. Critical Care Medicine, 18 (6). 649. doi:10.1186/s13054-014-0649-z
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WRAP-intravenous-immunoglobulin-for-severe-septic-shock-Madan-2014.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1638Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13054-014-0649-z
Abstract
Introduction
Prior to investing in a large, multicentre randomised controlled trial (RCT), the National Institute for Health Research in the UK called for an evaluation of the feasibility and value for money of undertaking a trial on intravenous immunoglobulin (IVIG) as an adjuvant therapy for severe sepsis/septic shock.
Methods
In response to this call, this study assessed the clinical and cost-effectiveness of IVIG (using a decision model), and evaluated the value of conducting an RCT (using expected value of information (EVI) analysis). The evidence informing such assessments was obtained through a series of systematic reviews and meta-analyses. Further primary data analyses were also undertaken using the Intensive Care National Audit & Research Centre Case Mix Programme Database, and a Scottish Intensive Care Society research study.
Results
We found a large degree of statistical heterogeneity in the clinical evidence on treatment effect, and the source of such heterogeneity was unclear. The incremental cost-effectiveness ratio of IVIG is within the borderline region of estimates considered to represent value for money, but results appear highly sensitive to the choice of model used for clinical effectiveness. This was also the case with EVI estimates, with maximum payoffs from conducting a further clinical trial between £137 and £1,011 million.
Conclusions
Our analyses suggest that there is a need for a further RCT. Results on the value of conducting such research, however, were sensitive to the clinical effectiveness model used, reflecting the high level of heterogeneity in the evidence base.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Septicemia -- Treatment -- Cost effectiveness, Septic shock -- Treatment -- Cost effectiveness, Clinical trials, Injections, Intravenous, Immunoglobulins | ||||||
| Journal or Publication Title: | Critical Care Medicine | ||||||
| Publisher: | Lippincott Williams & Wilkins | ||||||
| ISSN: | 1530-0293 | ||||||
| Official Date: | 1 December 2014 | ||||||
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| Volume: | 18 | ||||||
| Number: | 6 | ||||||
| Article Number: | 649 | ||||||
| DOI: | 10.1186/s13054-014-0649-z | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access | ||||||
| RIOXX Funder/Project Grant: |
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