Evidence map›Paper›PMID 25434816›Full record

ArticleCritical care (London, England)2014

Intravenous immunoglobulin for severe sepsis and septic shock: clinical effectiveness, cost-effectiveness and value of a further randomised controlled trial.

Marta O Soares, Nicky J Welton, David A Harrison, Piia Peura, Manu Shankar-Hari, Sheila E Harvey, Jason Madan, Anthony E Ades, Kathryn M Rowan, Stephen J Palmer

Open access · goldAbstract read
In one paragraph

Article in Critical care (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Plasma proteomics identifies molecular subtypes in sepsis.Critical care (London, England) · 2025
    Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Immune therapy in sepsis: Are we ready to try again?Journal of the Intensive Care Society · 2018
    Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Marta O SoaresCentre for Health Economics, University of York, Heslington, York, YO10 5DD, UK. marta.soares@york.ac.uk.
Nicky J WeltonSchool of Social and Community Medicine, 39 Whatley Road, University of Bristol, Bristol, BS8 2PS, UK. nicky.welton@bristol.ac.uk.
David A HarrisonIntensive Care National Audit & Research Centre, 24 High Holborn, London, WC1V 6AZ, UK. david.harrison@icnarc.org.
Piia PeuraCentre for Health Economics, University of York, Heslington, York, YO10 5DD, UK. piia.peura@fimea.fi.
Manu Shankar-HariGuy's and St Thomas' Hospital NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK. Manu.Shankar-Hari@gstt.nhs.uk.
Sheila E HarveyIntensive Care National Audit & Research Centre, 24 High Holborn, London, WC1V 6AZ, UK. sheila.harvey@icnarc.org.
Jason MadanUniversity of Warwick, Coventry, CV4 7AL, UK. J.J.Madan@warwick.ac.uk.
Anthony E AdesSchool of Social and Community Medicine, 39 Whatley Road, University of Bristol, Bristol, BS8 2PS, UK. T.Ades@bristol.ac.uk.
Kathryn M RowanIntensive Care National Audit & Research Centre, 24 High Holborn, London, WC1V 6AZ, UK. kathy.rowan@icnarc.org.
Stephen J PalmerCentre for Health Economics, University of York, Heslington, York, YO10 5DD, UK. stephen.palmer@york.ac.uk.
Intensive Care National Audit & Research Centre · GBUniversity of York · GBUniversity of Bristol · GBSt Thomas' Hospital · GBUniversity of Warwick · GB

Funding

Department of Health 08/70/01Medical Research Council G0802413Medical Research Council MC_U145079307Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

introductionPrior 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.

methodsIn 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.

resultsWe 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.

conclusionsOur 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.

Indexed as

AgedCost-Benefit AnalysisDecision Support TechniquesFemaleHumansImmunoglobulins, IntravenousMaleMiddle AgedRandomized Controlled Trials as TopicSepsisShock, SepticSurvival RateTreatment OutcomeImmunoglobulins, Intravenous

Identifiers

PMID25434816
PMCPMC4271457
OpenAlexW2035195868

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.