Intravenous immunoglobulin for severe sepsis and septic shock: clinical effectiveness, cost-effectiveness and value of a further randomised controlled trial
| Autor: | A E Ades, Kathryn M Rowan, Sheila Harvey, Manu Shankar-Hari, David A Harrison, Jason Madan, Stephen Palmer, Nicky J Welton, Marta Soares, Piia Peura |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Cost effectiveness Cost-Benefit Analysis Critical Care and Intensive Care Medicine law.invention Decision Support Techniques Case mix index Randomized controlled trial law Intensive care Sepsis medicine Humans Intensive care medicine Aged Randomized Controlled Trials as Topic Cost–benefit analysis business.industry Research Immunoglobulins Intravenous Middle Aged Shock Septic Clinical trial Survival Rate Study heterogeneity Systematic review Treatment Outcome Female business RC |
| Zdroj: | Critical Care |
| ISSN: | 1466-609X 1530-0293 |
| Popis: | Introduction\ud \ud 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.\ud \ud Methods \ud \ud 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.\ud \ud Results\ud \ud 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.\ud \ud Conclusions\ud \ud 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink