Costs and Cost-Effectiveness of Targeted, Personalized Risk Information to Increase Appropriate Screening by First-Degree Relatives of People With Colorectal Cancer

2019 ◽  
Vol 46 (5) ◽  
pp. 798-808 ◽  
Author(s):  
Penny Reeves ◽  
Christopher Doran ◽  
Mariko Carey ◽  
Emilie Cameron ◽  
Robert Sanson-Fisher ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Health Care ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Economic Evaluations ◽  
Screening Guidelines ◽  
First Degree Relatives ◽  
Life Years ◽  
Significant Difference ◽  
Quality Adjusted Life

Background. Economic evaluations are less commonly applied to implementation interventions compared to clinical interventions. The efficacy of an implementation strategy to improve adherence to screening guidelines among first-degree relatives of people with colorectal cancer was recently evaluated in a randomized-controlled trial. Using these trial data, we examined the costs and cost-effectiveness of the intervention from societal and health care funder perspectives. Method. In this prospective, trial-based evaluation, mean costs, and outcomes were calculated. The primary outcome of the trial was the proportion of participants who had screening tests in the year following the intervention commensurate with their risk category. Quality-adjusted life years were included as secondary outcomes. Intervention costs were determined from trial records. Standard Australian unit costs for 2016/2017 were applied. Cost-effectiveness was assessed using the net benefit framework. Nonparametric bootstrapping was used to calculate uncertainty intervals (UIs) around the costs and the incremental net monetary benefit statistic. Results. Compared with usual care, mean health sector costs were $17 (95% UI [$14, $24]) higher for those receiving the intervention. The incremental cost-effectiveness ratio for the primary trial outcome was calculated to be $258 (95% UI [$184, $441]) per additional person appropriately screened. The significant difference in adherence to screening guidelines between the usual care and intervention groups did not translate into a mean quality-adjusted life year difference. Discussion. Providing information on both the costs and outcomes of implementation interventions is important to inform public health care investment decisions. Challenges in the application of cost–utility analysis hampered the interpretation of results and potentially underestimated the value of the intervention. Further research in the form of a modeled extrapolation of the intermediate increased adherence effect and distributional cost-effectiveness to include equity requirements is warranted.

A Systematic Review of Cost-Effectiveness Analyses Alongside Randomised Controlled Trials of Acupuncture

2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Economic Evaluations ◽  
Controlled Trials ◽  
German Studies ◽  
Life Years ◽  
Randomised Controlled ◽  
The Cost

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.

Cost-of-illness and economic evaluations in axial spondyloarthritis

2016 ◽  
Author(s):  
Annelies Boonen
Keyword(s):  
Cost Effectiveness ◽  
Cost Of Illness ◽  
Axial Spondyloarthritis ◽  
Economic Evaluations ◽  
Low Back ◽  
Quality Adjusted Life Years ◽  
Life Years ◽  
Methodological Principles ◽  
The Cost ◽  
Quality Adjusted Life

Consideration of costs and budgets plays an increasingly important role in decisions on access to innovative technologies. When clinicians want to influence such decisions, it is essential to understand the information on the burden of the disease and the evidence on cost-effectiveness of technologies. This chapter provides guidance to understanding the key methodological principles of economic evaluations, and describes available evidence on these issues in axial spondyloarthritis (axSpA). In the prebiologics era, the cost-of-illness for society of ankylosing spondylitis was slightly lower than for rheumatoid arthritis, and substantially lower than chronic low back pain. Cost of sick leave and work disability accounted for up to 75% of total cost-of-illness. Treatment with biologics increased cost-of-illness substantially, but the important gain in quality-adjusted life years resulted in acceptable cost-effectiveness in patients with active disease. There remains a gap in knowledge about the cost-effectiveness of diagnosing and treating axSpA earlier.

scholarly journals Evaluation of an Extended Stroke Rehabilitation Service (EXTRAS)

Stroke ◽  
2019 ◽  
Vol 50 (12) ◽  
pp. 3561-3568 ◽  
Author(s):  
Helen Rodgers ◽  
Denise Howel ◽  
Nawaraj Bhattarai ◽  
Robin Cant ◽  
Avril Drummond ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Resource Utilization ◽  
Daily Living ◽  
Stroke Rehabilitation ◽  
Rehabilitation Service ◽  
Quality Adjusted Life Years ◽  
Early Supported Discharge ◽  
Life Years ◽  
Quality Adjusted Life

Background and Purpose— There is limited evidence to guide rehabilitation to meet the longer term needs of stroke survivors. The clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS) provided following early supported discharge were determined. Methods— EXTRAS was a pragmatic parallel-group observer-blind randomized controlled trial involving 19 UK centers. Patients with stroke were individually randomized to receive EXTRAS or usual care at discharge from early supported discharge. Five EXTRAS reviews were provided by an early supported discharge team member between one and 18 months, usually by telephone. Reviews consisted of a semi-structured interview assessing progress, rehabilitation needs, and service provision, with goal setting and action planning. The primary outcome was performance in extended activities of daily living (Nottingham EADL Scale) at 24 months post-randomization. The Nottingham EADL Scale is scored 0 to 66, with higher scores indicating better performance in these activities. Cost-effectiveness was estimated using resource utilization costs and Quality Adjusted Life Years. Analyses were intention to treat. Results— Between January 9, 2013 and October 26, 2015, 573 participants were randomized (EXTRAS, n=285; usual care, n=288). Mean 24 month Nottingham EADL Scale scores were EXTRAS (n=219) 40.0 (SD 18.1) and usual care (n=231) 37.2 (SD 18.5) giving an adjusted mean difference of 1.8 (95% CI, –0.7 to 4.2). 1155/1338 (86%) of expected EXTRAS reviews were undertaken. Over 24 months, the mean cost of resource utilization was lower in the intervention group: –£311 (–$450 [95% CI, −£3292 to £2787; −$4764 to $4033]). EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]). At current conventional thresholds of willingness to pay (£20 000 [$28 940] per Quality Adjusted Life Years), there was a 90% chance that EXTRAS could be considered cost-effective. Conclusions— EXTRAS did not significantly improve stroke survivors’ performance in extended activities of daily living. However, given the impact on costs and Quality Adjusted Life Years, EXTRAS may be an affordable addition to improve stroke care. Clinical Trial Registration— URL: www.isrctn.com . Unique identifier: ISRCTN45203373.

Cost-effectiveness of genotype-guided aspirin use for colorectal cancer prevention.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18318-e18318
Author(s):  
Eman Biltaji ◽  
Trang H. Au ◽  
Brandon Walker ◽  
Jennifer Ose ◽  
Cornelia M Ulrich ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Genetic Testing ◽  
Cost Effectiveness ◽  
Adverse Events ◽  
Bleeding Complications ◽  
Average Risk ◽  
Risk Population ◽  
Life Years ◽  
Quality Adjusted Life ◽  
Testing Costs

e18318 Background: Colonoscopy is the “gold standard” for colorectal cancer (CRC) screening. However, adherence rates are low and detection is not optimal. Concomitant aspirin chemoprevention is recommended by US Preventive Task Force, but bleeding complications can be limiting. Variant genotypes in aspirin metabolism can modify CRC and adenoma risk. Genotype guided aspirin (ggASA) use will identify a targeted average-risk population for maximal aspirin benefit while minimizing adverse events rates compared to the general population. We conducted a cost-effectiveness analysis (CEA) of primary chemoprevention in CRC using ggASA compared to no intervention, and colonoscopy ±general aspirin in healthy average-risk individuals. Methods: Our Markov decision analytical model consisted of 5 possible health states: no CRC/polyps, adenoma, pre-clinical CRC, CRC, and death. Model probabilities for CRC and its prevalence were estimated using SEER database and published literature. A microsimulation of 10,000 individuals aged 50-64 years was used to estimate cost-effectiveness from US payer perspective over lifetime. One way and probabilistic sensitivity analyses and model validation results will be reported in the final poster. Results: Our results suggest that compared to colonoscopy and no intervention, ggASA was associated with fewer CRC cases, and CRC-related deaths and MI cases. Compared to colonoscopy + general aspirin, ggASA was associated with fewer bleeding events, similar rates of CRC and CRC-related deaths, and fewer MI cases prevented. From a cost-effectiveness standpoint, ggASA use over a lifetime had the lowest costs and highest quality adjusted life years gained compared to other strategies, if testing costs were ignored. Once genetic testing costs exceeds $63, colonoscopy + general aspirin becomes the most cost effective strategy. Between genetic testing cost of $63-283, the costs of using ggASA per quality adjusted life year gained is below $100,000. Conclusions: Genotype-guided aspirin use precisely identifies an average-risk population, and lowers adverse events rates compared to general aspirin. The economic value of genotype-guided aspirin is dependent on the genetic testing costs.

Cost-Effectiveness and Budget Impact of Emicizumab Prophylaxis in Haemophilia A Patients with Inhibitors

2019 ◽  
Vol 120 (02) ◽  
pp. 216-228 ◽  
Author(s):  
Paolo Angelo Cortesi ◽  
Giancarlo Castaman ◽  
Gianluca Trifirò ◽  
Simona Serao Creazzola ◽  
Giovanni Improta ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Cost Saving ◽  
Budget Impact ◽  
Economic Evaluations ◽  
Extensive Literature ◽  
Haemophilia A ◽  
Old Patients ◽  
Life Years ◽  
The Cost

AbstractRecent evidence demonstrated that weekly prophylaxis with subcutaneous bispecific antibody (emicizumab) has shown higher efficacy in adolescent and adults patients affected by haemophilia A (HA) with inhibitor, compared with patients treated on demand or on prophylaxis with bypassing agents (BPAs). However, no economic evaluations assessing the value and sustainability of emicizumab prophylaxis have been performed in Europe. This study assessed the cost-effectiveness of emicizumab prophylaxis compared with BPA prophylaxis and its possible budget impact from the Italian National Health Service (NHS) perspective. A Markov model and a budget impact model were developed to estimate the cost-effectiveness and budget impact of emicizumab prophylaxis in HA patients with inhibitors. The model was populated using treatment efficacy from clinical trials and key clinical, cost and epidemiological data retrieved through an extensive literature review. Compared with BPAs prophylaxis, emicizumab prophylaxis was found to be more effective (0.94 quality adjusted life-years) and cost saving (–€19.4/–€24.4 million per patient lifetime) in a cohort of 4-year-old patients with HA and inhibitors who failed immune tolerance induction. In the probabilistic sensitivity analysis, emicizumab prophylaxis had always 100% probability of being cost-effective at any threshold. Further, the use of emicizumab prophylaxis was associated to an overall budget reduction of €45.4 million in the next 3 years. In conclusion, the clinically effective emicizumab prophylaxis can be considered a cost-saving treatment for HA with inhibitor patients. Furthermore, emicizumab treatment is also associated to a significant reduction of the health care budget, making this new treatment a sustainable and convenient health care option for Italian NHS.

scholarly journals Economic evaluation of a combined screening and stepped-care treatment program targeting psychological distress in patients with metastatic colorectal cancer: A cluster randomized controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 934-945 ◽  
Author(s):  
Mohamed El Alili ◽  
Claudia S.E.W Schuurhuizen ◽  
Annemarie M.J. Braamse ◽  
Aartjan T.F. Beekman ◽  
Mecheline H. van der Linden ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Psychological Distress ◽  
Cost Effectiveness ◽  
Confidence Interval ◽  
Depression Scale ◽  
Anxiety And Depression ◽  
Quality Adjusted Life Years ◽  
Hospital Anxiety ◽  
Life Years ◽  
Quality Adjusted Life

Background: Psychological distress is highly prevalent among patients with metastatic colorectal cancer. Aims: To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care. Design: Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included. Setting: Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands. Methods: Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results. Results: Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: –0.058; 95% confidence interval: –0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: –0.015 to 0.099), and societal costs (mean difference: –1152; 95% confidence interval: –5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. Conclusion: The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.

scholarly journals Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis

2021 ◽  
Author(s):  
Farzin Fakhry ◽  
Ellen V. Rouwet ◽  
Reinier Spillenaar Bilgen ◽  
Lijckle van der Laan ◽  
Jan J. Wever ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Combination Therapy ◽  
Intermittent Claudication ◽  
Societal Perspective ◽  
Supervised Exercise ◽  
Endovascular Revascularization ◽  
Life Years ◽  
The Cost ◽  
Quality Adjusted Life

Background: The ERASE (Endovascular Revascularization and Supervised Exercise) study showed that a combination therapy of endovascular revascularization followed by supervised exercise resulted in greater improvement in walking ability and quality of life as compared with supervised exercise only (standard care) in patients with intermittent claudication. The cost-effectiveness of the combination therapy as compared with supervised exercise is not well defined. In this report, the cost-effectiveness analysis of the ERASE study is presented. Methods: Two hundred twelve patients were randomly assigned to the combination therapy (n=106) or supervised exercise only (n=106) and were followed for 12 months. Cumulative costs per patient were collected using the in-hospital resource utilization data and cost-questionnaires. Quality-adjusted life years were estimated using the EuroQol-5D questionnaire. Incremental cost-effectiveness ratios were calculated from both the health care and societal perspective. The associated uncertainty was determined using bootstrap techniques and acceptability curves. Results: As compared with supervised exercise only, the combination therapy cost an additional €1.462 (99% CI, 388 to 3862) from the health care perspective and €161 (99% CI, −2286 to 3106) from the societal perspective. Accumulated quality-adjusted life- years during 1 year follow-up were 0.042 (99% CI, −0.009 to 0.118) higher in the combination therapy group. The incremental cost-effectiveness ratio was €34.810 from the health care perspective and €3.833 from the societal perspective. Compared with supervised exercise, at a willingness-to-pay threshold of €80.000 per quality-adjusted life-year, the combination therapy had a probability of 87% and 95% of being cost-effective from the health care and societal perspective, respectively. Conclusions: Combination therapy of endovascular revascularization followed by supervised exercise is clinically and economically a more attractive approach than supervised exercise only for intermittent claudication up to 12-month follow-up. Yet, the long-term cost- and clinical effectiveness of both strategies for specific patient groups remains to be defined. REGISTRATION: URL: https://www.trialregister.nl ; Unique identifier: NTR2249.

PD05 Influence Of Economic Data In The Incorporation Of Medicines In Brazil

2018 ◽  
Vol 34 (S1) ◽  
pp. 134-134
Author(s):  
André Santos ◽  
André Ribeiro ◽  
Cristina Ruas
Keyword(s):  
Logistic Regression ◽  
Cost Effectiveness ◽  
Budget Impact ◽  
Binary Logistic Regression ◽  
Poor Quality ◽  
National Commission ◽  
Economic Evaluations ◽  
Binary Logistic Regression Analysis ◽  
Life Years ◽  
Significant Difference

Introduction:Since 2011, the process of incorporation of technologies into the Brazilian public health system (SUS) has been assisted by the National Commission for the Incorporation of Technologies in SUS (Conitec). The present work collected data of effectiveness, safety, cost-effectiveness, budget impact and other criteria from Conitec's reports to determine the influence of economic evaluations on issued recommendations.Methods:Data was collected from drug recommendation reports published by Conitec between 2012 and 2016 and organized in a Microsoft Excel® spreadsheet. The association of the incremental cost-effectiveness ratio (ICER) and the chance of incorporation was assessed through a binary logistic regression in R®.Results:Two hundred and sixty-six reports were issued by Conitec between 2012 and 2016. Data were collected from 169 reports evaluating requisitions of incorporation of new medicines. Of these, there were ninety-nine which recommended the incorporation. The most common ATC classes analyzed were immunosuppressants (34 drugs), other antineoplastic agents (16 drugs) and direct-acting antivirals (15 drugs). Of the seventy negative recommendations, thirty-five were due to cost-effectiveness, thirty-one due to efficacy, twenty-nine due to safety, forty due to the budget impact, and thirty-two due to other reasons. In general, the reports were considered to be of poor quality. Only 21.9 percent of the reports had ICERs. The binary logistic regression analysis did not present a statistically significant difference for the influence of the ICER on the recommendation decision with outcomes reported in life years gained (OR = 0.9999732; 95% Confidence Interval [CI] = 0.9999304 to 1.000016) or quality-adjusted life years (OR = 0.9999789; 95% CI = 0.9999321 to 1.000026).Conclusions:Economic evaluations appear to be a secondary criterion for Conitec's recommendations. Despite this, they are commonly used to justify non-incorporation of drugs into the public system.

Community or patient preferences for cost-effectiveness of cardiac rehabilitation: does it matter?

2008 ◽  
Vol 15 (5) ◽  
pp. 608-615 ◽  
Author(s):  
Neil Oldridge ◽  
William Furlong ◽  
Anthony Perkins ◽  
David Feeny ◽  
George W. Torrance
Keyword(s):  
Cost Effectiveness ◽  
Cardiac Rehabilitation ◽  
Incremental Cost ◽  
Usual Care ◽  
Randomized Trial ◽  
Patient Preferences ◽  
Secondary Analysis ◽  
Cost Effective ◽  
Economic Evaluations ◽  
Life Years

Background Few healthcare economic evaluations, and none in cardiac rehabilitation, report results based on both community and patient preferences for health outcomes. We published the results of a randomized trial of cardiac rehabilitation after myocardial infarction in 1994 in which preferences were measured using both perspectives but only patient preferences were reported. This secondary analysis uses both types of preference measurements. Methods We collected community Quality of Well-Being (QWB) and patient Time Trade-off (TTO) preference scores from 188 patients (rehabilitation, n = 93; usual care, n = 95) on entry into the trial, at 2 months (end of the intervention) and again at 4, 8, and 12 months. Mean preference scores over the 12-month follow-up study period, estimates of quality-adjusted life years (QALYs) gained per patient, incremental cost-effectiveness ratios [costs inflated to 2006 US dollars] and probabilities of the cost-effectiveness of rehabilitation for costs per QALY up to US$100 000 are reported. Results Mean QWB preference scores were lower ( P < 0.01) than the corresponding mean TTO preference scores at each assessment point. The 12-month changes in mean QWB and TTO preference scores were large and positive ( P < 0.001) with rehabilitation patients gaining a mean of 0.011 (95% confidence interval, –0.030 to +0.052) more QWB-derived QALYs, and 0.040 (–0.026, 0.107) more TTO-derived QALYs, per patient than usual care patients. The incremental cost-effectiveness ratio for QWB-derived QALYs was estimated at $60270/QALY (about €50 600/QALY) and at $16580/QALY (about €13 900/QALY) with TTO-derived QALYs. With a willingness to spend $100 000/QALY, the probability of rehabilitation being cost-effective is 0.58 for QWB-derived QALYs and 0.83 for TTO-derived QALYs. Conclusion This secondary analysis of data from a randomized trial indicates that cardiac rehabilitation is cost-effective from a community perspective and highly cost-effective from the perspective of patients.

scholarly journals The cost-effectiveness of early goaldirected therapy: an economic evaluation alongside the ARISE trial

2021 ◽  
Vol 23 (3) ◽  
pp. 329-336
Author(s):  
Alisa M Higgins ◽  
◽  
Sandra L Peake ◽  
Rinaldo Bellomo AO ◽  
D Jamie Cooper AO ◽  
...  
Keyword(s):  
Health Care ◽  
Septic Shock ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Resource Use ◽  
Cost Effective ◽  
Evaluation Study ◽  
Life Years ◽  
The Cost

OBJECTIVE: To determine the cost-effectiveness of early goal-directed therapy (EGDT) for patients with early septic shock. DESIGN: Within-trial cost-effectiveness evaluation. SETTING: Nineteen hospitals in Australia and New Zealand. PARTICIPANTS AND INTERVENTIONS: Patients with early septic shock enrolled in the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial were randomly assigned to EGDT versus usual care. A subgroup of patients participated in a nested economic evaluation study in which detailed resource use data were collected until 12 months after randomisation. OUTCOME MEASURES: Clinical outcomes included lives saved, life-years gained and quality-adjusted life-years (QALYs), with mortality collected until 12 months and health-related quality of life assessed at baseline, 6 and 12 months using the 3-level EuroQol five dimensions questionnaire (EQ-5D-3L). Economic outcomes included health care resource use, costs and cost-effectiveness from the Australian health care payer perspective. RESULTS: A total of 205 patients (100 EGDT, 105 usual care) participated in the nested economic evaluation study, of which 203 had complete resource use data. Unadjusted mean health care costs to 12 months were $67 223 (standard deviation [SD], $72 397) in the EGDT group and $54 179 (SD, $61 980) in the usual care group, with a mean difference of $13 044 (95% CI, −$5791 to $31 878). There was no difference between groups with regards to lives saved (EGDT, 69.4% v usual care, 68.6%; P = 1.0), life-years gained (mean EGDT, 0.746 [SD, 0.406] v usual care, 0.725 [SD, 0.417]; P = 0.72) or QALYs (mean EGDT, 0.318 [SD, 0.291] v usual care, 0.367 [SD, 0.295]; P = 0.24). EGDT was dominated (higher costs, lower effectiveness) by usual care in 80.4% of bootstrap replications. For a willingness-to-pay threshold of $50 000 per QALY, the probability of EGDT being cost-effective was only 6.4%. CONCLUSIONS: In patients presenting to the emergency department with early septic shock, EGDT compared with usual care was not cost-effective. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT00975793.

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