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Soares MO, Welton NJ, Harrison DA, et al. 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): Incorporating a Systematic Review, Meta-Analysis and Value of Information Analysis. Southampton (UK): NIHR Evaluation, Trials and Studies Coordinating Center (UK); 2012 Feb. (Health Technology Assessment, No. 16.7.)

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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): Incorporating a Systematic Review, Meta-Analysis and Value of Information Analysis.

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Appendix 3Quality assessment of published cost-effectiveness evidence for intravenous immunoglobulin

ItemQuestionResponseComment
1Was a well-defined question posed in answerable form?YesThe aim was to compare the cost-effectiveness of Pentaglobin with standard therapy in adult patients treated for sepsis and septic shock in Germany
2Was a comprehensive description of the competing alternatives given (i.e. can you tell who did what to whom, where and how often)?NoThe approach of standard care for sepsis patients was not described
3Was the effectiveness of the programme or services established?YesA previously published review was updated. The results of the nine identified RCTs were pooled with meta-analysis
4Were all the important and relevant costs and consequences for each alternative identified?NoThe study was conducted from the hospital perspective and considered only the costs and consequences of the critical-care unit stay. However, episode of severe sepsis is likely to impact patient's health and resource use after the initial critical-care unit stay
5Were costs and consequences measured accurately in appropriate physical units (e.g. hours of nursing time, number of physician visits, lost work-days, gained life-years)??Critical-care unit resource use (measured in length of stay) was multiplied by mean daily unit costs of critical care (basic critical care + hotel costs + personnel). The cost of ‘block’ therapies (sepsis, blood, ventilation, renal) was added to the critical care costs. The costs were weighted averages of surgical and nonsurgical patients. The length of stay and unit costs were assumed to be different for survivors and non-survivors
6Were the cost and consequences valued credibly?YesThe critical-care unit resource use and unit cost were based on a German severe sepsis costing study
7Were costs and consequences adjusted for differential timing?NoThe time horizon was the critical-care unit inpatient episode. Since time horizon was <1 year, discounting was not needed
8Was an incremental analysis of costs and consequences of alternatives performed?YesCost-effectiveness was measured in incremental cost per life saved
9Was allowance made for uncertainty in the estimates of costs and consequences?YesParameter uncertainty was addressed using univariate sensitivity analysis and probabilistic sensitivity analysis
10Did the presentation and discussion of study results include all issues of concern to users?NoThe ICER was compared with cost-effectiveness of various health-care interventions in Germany

The generalisability of the results to other settings or patient groups was not discussed

The study did not discuss the feasibility of Pentaglobin in the treatment of severe sepsis in Germany

?, unclear.

© 2012, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK97453
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