Protocol for economic evaluation alongside the SHINE (Supporting Healthy Image, Nutrition and Exercise) cluster randomised controlled trial

IntroductionLimited evidence exists on the cost-effectiveness of interventions to prevent obesity and promote healthy body image in adolescents. The SHINE (Supporting Healthy Image, Nutrition and Exercise) study is a cluster randomised control trial (cRCT) aiming to deliver universal education about healthy nutrition and physical activity to adolescents, as well as targeted advice to young people with body image concerns who are at risk of developing disordered eating behaviours. This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.Methods and analysisA public payer perspective will be adopted, with intervention costs collected prospectively. Within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will quantify the incremental costs and health gains of the intervention as compared with usual practice (ie, teacher-delivered curriculum). CEA will present results as cost per body mass index unit saved. CUA will present results as cost per quality-adjusted life year gained. A modelled CUA will extend the target population, time horizon and decision context to provide valuable information to policymakers on the potential for incremental cost offsets attributable to disease prevention arising from intervention. Intervention costs and effects will be extrapolated to the population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort’s lifetime. Modelled CUA results will be presented as health-adjusted life years saved and healthcare cost-savings of diseases averted. Incremental cost-effectiveness ratios will be calculated as the difference in costs between the intervention and comparator divided by the difference in benefit. Semi-structured interviews with key intervention stakeholders will explore the potential impact of scalability on cost-effectiveness. These data will be thematically analysed to inform sensitivity analysis of the base case economic evaluation, such that cost-effectiveness evidence is reflective of the potential for scalability.Ethics and disseminationEthics approval was obtained from the Deakin University Human Research Ethics Committee (#2017–269) and the Victorian Department of Education and Training (#2018_003630). Study findings will be disseminated through peer-reviewed academic papers and participating schools will receive annual reports over the 3 years of data collection.Trial registration numberACTRN 12618000330246; Pre-results.

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Cost-effectiveness of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

Journal of Medical Screening ◽

10.1177/0969141317704679 ◽

2017 ◽

Vol 25 (2) ◽

pp. 99-109 ◽

Cited By ~ 5

Author(s):

Apostolos Tsiachristas ◽

Matthew Gittins ◽

Henry Kitchener ◽

Alastair Gray

Keyword(s):

Cost Effectiveness ◽

Incremental Cost ◽

Cervical Screening ◽

Cost Effective ◽

Sensitivity Analyses ◽

Screening Uptake ◽

Life Years ◽

Nurse Navigator ◽

Lifetime Costs ◽

Intervention Costs

Objective To assess the cost-effectiveness of strategies to increase cervical cancer screening uptake at first invitation (STRATEGIC trial). Methods We performed an economic analysis alongside the STRATEGIC trial, comparing each of seven novel interventions for improving cervical screening uptake with control general practices in Greater Manchester and Grampian (United Kingdom). A template was developed to measure the intervention costs. Trial estimates of screening uptake were combined with data from the literature to estimate healthcare costs of each intervention. The added lifetime costs and quality adjusted life years (QALYs) of attending cervical screening were estimated by a systematic literature review, with relevant results pooled and weighted by study quality. Trial results and estimated lifetime costs and benefits of screening were then combined in a decision analytic model, giving an incremental cost per QALY gained for each intervention. Uncertainty was addressed in probabilistic and univariate sensitivity analyses. Results Intervention costs per screening round per woman attending varied from about £1.20 (2014 UK) for the nurse navigator intervention to £62 for the unrequested HPV self-sampler kit. The meta-analysis revealed a lifetime discounted benefit from screening of 0.043 QALYs per woman attending, at an additional lifetime discounted cost of £234. The incremental cost per QALY gained in all interventions was below £13,000. Probabilistic sensitivity analyses suggested that only unrequested self-sampling and timed appointments have a high probability of being cost-effective. Conclusions Unrequested self-sampling and timed appointments are likely to be cost-effective interventions. Further research is required on the duration of effects and on implementing combinations of interventions.

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Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women’s health and infant’s health and development in Vietnam

BMJ Open ◽

10.1136/bmjopen-2019-031721 ◽

2019 ◽

Vol 9 (12) ◽

pp. e031721

Author(s):

Trang Nguyen ◽

Kim Sweeny ◽

Thach Tran ◽

Stanley Luchters ◽

David B Hipgrave ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Economic Evaluations ◽

Cluster Randomised ◽

Life Years ◽

Randomised Controlled ◽

The Impact

IntroductionEconomic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available.Methods and analysisAlthough significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant’s development, infant’s health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit–cost ratios.Ethics and disseminationThe trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016–0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations.Trial registration numberACTRN12617000442303.

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Point-of-care testing and treatment of sexually transmitted and genital infections during pregnancy in Papua New Guinea (WANTAIM trial): protocol for an economic evaluation alongside a cluster-randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-046308 ◽

2021 ◽

Vol 11 (8) ◽

pp. e046308

Author(s):

Neha Batura ◽

Olga PM Saweri ◽

Andrew Vallely ◽

William Pomat ◽

Caroline Homer ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Antenatal Care ◽

Medical Research ◽

Papua New Guinea ◽

Point Of Care ◽

Ethics Committee ◽

Sexually Transmitted ◽

Cluster Randomised ◽

Life Years

IntroductionLeft untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rates. Diagnosis and treatment of these STIs in PNG rely on syndromic management. Advances in STI diagnostics through point-of-care (PoC) testing using GeneXpert technology hold promise for resource-constrained countries such as PNG. This paper describes the planned economic evaluation of a cluster-randomised cross-over trial comparing antenatal PoC testing and immediate treatment of curable STIs with standard antenatal care in two provinces in PNG.Methods and analysisCost-effectiveness of the PoC intervention compared with standard antenatal care will be assessed prospectively over the trial period (2017–2021) from societal and provider perspectives. Incremental cost-effectiveness ratios will be calculated for the primary health outcome, a composite measure of the proportion of either preterm birth and/or low birth weight; for life years saved; for disability-adjusted life years averted; and for non-health benefits (financial risk protection and improved health equity). Scenario analyses will be conducted to identify scale-up options, and budget impact analysis will be undertaken to understand short-term financial impacts of intervention adoption on the national budget. Deterministic and probabilistic sensitivity analysis will be conducted to account for uncertainty in key model inputs.Ethics and disseminationThis study has ethical approval from the Institutional Review Board of the PNG Institute of Medical Research; the Medical Research Advisory Committee of the PNG National Department of Health; the Human Research Ethics Committee of the University of New South Wales; and the Research Ethics Committee of the London School of Hygiene and Tropical Medicine. Findings will be disseminated through national stakeholder meetings, conferences, peer-reviewed publications and policy briefs.Trial registration numberISRCTN37134032.

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REDUCING POTENTIALLY INAPPROPRIATE PRESCRIBING FOR OLDER PEOPLE IN PRIMARY CARE: COST-EFFECTIVENESS OF THE OPTI-SCRIPT INTERVENTION

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317000782 ◽

2017 ◽

Vol 33 (4) ◽

pp. 494-503 ◽

Cited By ~ 4

Author(s):

Paddy Gillespie ◽

Barbara Clyne ◽

Adam Raymakers ◽

Tom Fahey ◽

Carmel M. Hughes ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Incremental Cost ◽

Controlled Trial ◽

Inappropriate Prescribing ◽

Potentially Inappropriate Prescribing ◽

Multilevel Regression ◽

Usual Practice ◽

Economic Implications ◽

Life Years

Objectives: This study examines the cost-effectiveness of the OPTI-SCRIPT intervention on potentially inappropriate prescribing in primary care.Methods: Economic evaluation, using incremental cost-effectiveness and cost utility analyses, conducted alongside a cluster randomized controlled trial of twenty-one general practices and 196 patients, to compare a multifaceted intervention with usual practice in primary care in Ireland. Potentially inappropriate prescriptions (PIPs) were determined by a pharmacist. Incremental costs, PIPs, and quality-adjusted life-years (QALYs) at 12-month follow-up were estimated using multilevel regression. Uncertainty was explored using cost-effectiveness acceptability curves.Results: The intervention was associated with a nonsignificant mean cost increase of €407 (95 percent CIs, −357–1170), a significant mean reduction in PIPs of 0.379 (95 percent CI, 0.092–0.666), and a nonsignificant mean increase in QALYs of 0.013 (95 percent CIs, −0.016–0.042). The incremental cost per PIP avoided was €1,269 (95 percent CI, −1400–6302) and the incremental cost per QALY gained was €30,535 (95 percent CI, −334,846–289,498). The probability of the intervention being cost-effective was 0.602 at a threshold value of €45,000 per QALY gained and was at least 0.845 at threshold values of €2,500 per PIP avoided and higher.Conclusions: While the OPTI-SCRIPT intervention was effective in reducing potentially inappropriate prescribing in primary care in Ireland, our findings highlight the uncertainty with respect to its cost-effectiveness. Further studies are required to explore the health and economic implications of interventions targeting potentially inappropriate prescribing.

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Cost-Effectiveness of an Exercise Programme that Provided Group or Individual Training to Reduce the Fall Risk in Healthy Community-Dwelling People Aged 65–80: A Secondary Data Analysis

Healthcare ◽

10.3390/healthcare9060714 ◽

2021 ◽

Vol 9 (6) ◽

pp. 714

Author(s):

Isaac Aranda-Reneo ◽

Laura Albornos-Muñoz ◽

Manuel Rich-Ruiz ◽

María Ángeles Cidoncha-Moreno ◽

Ángeles Pastor-López ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Older People ◽

Incremental Cost ◽

Fall Risk ◽

Community Dwelling ◽

Effective Measure ◽

The Individual ◽

The Cost ◽

Individual Training

Research has demonstrated that some exercise programs are effective for reducing fall rates in community-dwelling older people; however, the literature is limited in providing clear recommendations of individual or group training as a result of economic evaluation. The objective of this study was to assess the cost-effectiveness of the Otago Exercise Program (OEP) for reducing the fall risk in healthy, non-institutionalized older people. An economic evaluation of a multicenter, blinded, randomized, non-inferiority clinical trial was performed on 498 patients aged over 65 in primary care. Participants were randomly allocated to the treatment or control arms, and group or individual training. The program was delivered in primary healthcare settings and comprised five initial sessions, ongoing encouragement and support to exercise at home, and a reinforcement session after six months. Our hypothesis was that the patients who received the intervention would achieve better health outcomes and therefore need lower healthcare resources during the follow-up, thus, lower healthcare costs. The primary outcome was the incremental cost-effectiveness ratio, which used the timed up and go test results as an effective measure for preventing falls. The secondary outcomes included differently validated tools that assessed the fall risk. The cost per patient was USD 51.28 lower for the group than the individual sessions in the control group, and the fall risk was 10% lower when exercises had a group delivery. The OEP program delivered in a group manner was superior to the individual method. We observed slight differences in the incremental cost estimations when using different tools to assess the risk of fall, but all of them indicated the dominance of the intervention group. The OEP group sessions were more cost-effective than the individual sessions, and the fall risk was 10% lower.

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The cost-effectiveness of one-time opportunistic screening for atrial fibrillation in different age cohorts of inhabitants in Denmark aged 65 years and above: a Markov modelled analysis

European Heart Journal - Quality of Care and Clinical Outcomes ◽

10.1093/ehjqcco/qcaa092 ◽

2020 ◽

Author(s):

Lucca Katrine Sciera ◽

Lars Frost ◽

Lars Dybro ◽

Peter Bo Poulsen

Keyword(s):

Atrial Fibrillation ◽

General Practice ◽

Cost Effectiveness ◽

Incremental Cost ◽

Population Data ◽

National Registry ◽

Opportunistic Screening ◽

Age Cohorts ◽

Life Years ◽

The Cost

Abstract Aims The objective was to evaluate the cost-effectiveness of one-time opportunistic screening for atrial fibrillation (AF) in general practice in citizens aged ≥65 years in Denmark compared to a no-screening alternative following current Danish practice. Methods and results A decision tree and a Markov model were designed to simulate costs and quality-adjusted life years (QALYs) in a hypothetical cohort of citizens aged ≥65 years equivalent to the Danish population (1 M citizens) over the course of 19 years, using a healthcare and societal perspective. Share of detected AF patients following opportunistic screening was retrieved from a recent Danish screening study, whereas the risk stroke and bleedings in AF patients were based on population data from national registries and their associated costs was obtained from published national registry studies. The present study showed that one-time opportunistic screening for AF was more costly, but also more effective compared to a no-screening alternative. The analysis predicts that one-time opportunistic screening of all Danes aged ≥65 years potentially can identify an additional 10 300 AF patients and prevent 856 strokes in the period considered. The incremental cost of such a screening programme is €56.4 M, with a total gain of 6000 QALYs, resulting in an incremental cost-effectiveness ratio of €9400 per QALY gained. Conclusion Opportunistic screening in general practice in citizens aged ≥65 years in Denmark is cost-effective compared to a willingness-to-pay threshold of €22 000. The study and its findings support a potential implementation of opportunistic screening for AF at the general practitioner level in Denmark.

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COST-EFFECTIVENESS ANALYSIS OF IVABRADINE IN TREATMENT OF PATIENTS WITH HEART FAILURE IN IRAN

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318003598 ◽

2018 ◽

Vol 34 (6) ◽

pp. 576-583 ◽

Cited By ~ 2

Author(s):

Saeed Taheri ◽

Elham Heidari ◽

Mohammad Ali Aivazi ◽

Mehran Shams-Beyranvand ◽

Mehdi Varmaghani

Keyword(s):

Heart Failure ◽

Sensitivity Analysis ◽

Cost Effectiveness ◽

Incremental Cost ◽

Transition Probabilities ◽

Drug Acquisition ◽

Sensitivity Analyses ◽

Baseline Heart Rate ◽

Life Years ◽

The Cost

Objectives:This study aimed to assess the cost-effectiveness of ivabradine plus standard of care (SoC) in comparison with current SoC alone from the Iranian payer perspective.Methods:A cohort-based Markov model was developed to assess the incremental cost-effectiveness ratio (ICER) over a 10-year time horizon in a cohort of 1,000 patients. The baseline transition probabilities between New York Heart Association (NYHA), mortality rate, and hospitalization rate were extracted from the literature. The effect of ivabradine on mortality, hospitalization, and NYHA improvement or worsening were retrieved from the SHIFT study. The effectiveness was measured as quality-adjusted life-years (QALYs) using the utility values derived from Iranian Heart Failure Quality of Life study. Direct medical costs were obtained from hospital records and national tariffs. Deterministic and probabilistic sensitivity analyses were conducted to show the robustness of the model.Results:Ivabradine therapy was associated with an incremental cost per QALY of USD $5,437 (incremental cost of USD $2,207 and QALYs gained 0.41) versus SoC. The probabilistic sensitivity analysis showed that ivabradine is expected to have a 60 percent chance of being cost-effective accepting a threshold of USD $6,550 per QALY. Furthermore, deterministic sensitivity analysis indicated that the model is sensitive to the ivabradine drug acquisition cost.Conclusions:The cost-effectiveness model suggested that the addition of ivabradine to SoC therapy was associated with improved clinical outcomes along with increased costs. The analysis indicates that the clinical benefit of ivabradine can be achieved at a reasonable cost in eligible heart failure patients with sinus rhythm and a baseline heart rate ≥ 75 beats per minute (bpm).

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Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial

BMJ Open ◽

10.1136/bmjopen-2016-014849 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014849 ◽

Cited By ~ 1

Author(s):

Zahidul Quayyum ◽

Andrew Briggs ◽

Jose Robles-Zurita ◽

Keith Oldroyd ◽

Uwe Zeymer ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Cardiogenic Shock ◽

Controlled Trial ◽

Culprit Lesion ◽

Link Type ◽

Trial Analysis ◽

Life Years ◽

Randomised Controlled

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

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Economic Evaluation of Posaconazole Versus Standard Azole Therapy as Prophylaxis against Invasive Fungal Infections in Patients with Prolonged Neutropenia in Canada

Canadian Journal of Infectious Diseases and Medical Microbiology ◽

10.1155/2012/583630 ◽

2012 ◽

Vol 23 (2) ◽

pp. 59-64 ◽

Cited By ~ 8

Author(s):

Amir A Tahami Monfared ◽

Amy K O’Sullivan ◽

Coleman Rotstein ◽

George Papadopoulos

Keyword(s):

Cost Effectiveness ◽

High Risk ◽

Cost Saving ◽

Incremental Cost ◽

Incremental Cost Effectiveness Ratio ◽

Cost Effectiveness Ratio ◽

Lifetime Horizon ◽

System Perspective ◽

Life Years ◽

Neutropenic Patients

INTRODUCTION: Posaconazole prophylaxis in high-risk neutropenic patients prevents invasive fungal infection (IFI). An economic model was used to assess the cost effectiveness of posaconazole from a Canadian health care system perspective.METHODS: A decision-analytic model was developed based on data from a randomized trial comparing posaconazole with standard azole (fluconazole or itraconazole) therapy. The model was extrapolated to a lifetime horizon using one-month Markov cycles; lifetime survival was specific to the underlying disease. Drug and treatment costs associated with IFI were estimated using published literature. The model was used to estimate total costs, IFIs avoided, life-years gained and the incremental cost-effectiveness ratio of posaconazole versus standard azole therapy, in 2007 Canadian dollars.RESULTS: Based on the clinical trial data, posaconazole was associated with fewer cases of IFI (0.05 versus 0.11; P=0.003), increased life-years (2.52 years versus 2.43 years) and slightly lower costs ($6,601 versus $7,045) per patient relative to standard azole therapy over a lifetime horizon. Higher acquisition costs for posaconazole were offset by IFI-associated inpatient costs for those prophylaxed with standard azoles. Probabilistic sensitivity analysis indicated a 59% probability that posaconazole was cost-saving versus standard azole therapy and a 96% probability that the incremental cost-effectiveness ratio for posaconazole was at or below the $50,000 per life-year saved threshold.DISCUSSION: In Canada, posaconazole appears to be cost-saving relative to standard azole therapy in IFI prevention among high-risk neutropenic patients.

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Abstract 3774: Cost Effectiveness Of Enoxaparin In Patients With ST-elevation Myocardial Infarction: Results From EXTRACT-TIMI 25

Circulation ◽

10.1161/circ.116.suppl_16.ii_858-b ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Zefeng Zhang ◽

Paul Kolm ◽

Wei Zhang ◽

Edward Ewen ◽

Claudine Jurkovitz ◽

...

Keyword(s):

Myocardial Infarction ◽

Cost Effectiveness ◽

Unfractionated Heparin ◽

Cost Effective ◽

St Elevation Myocardial Infarction ◽

Published Data ◽

Outpatient Procedures ◽

Life Years ◽

St Elevation ◽

The Difference

Background: The efficacy of enoxaparin versus unfractionated heparin in the setting of ST-elevation myocardial infarction (STEMI) has been demonstrated in EXTRACT-TIMI 25, with 17% reductions in relative risk in the primary endpoint of death or nonfatal recurrent myocardial infarction (MI) (p<0.0001). This study considers the cost effectiveness of enoxaparin versus unfractionated heparin with fibrinolysis based on EXTRACT-TIMI 25. Methods: The ITT population of 20,479 patients from 48 countries were monitored for clinical and adverse events during the index hospitalization and through 30 days. Trial-wide resource utilization from all participating countries was used in the analysis while all costs were based on 2004 US costs. Medicare Fee Schedule was used for outpatient procedures and DRGs were applied for index and subsequent hospitalizations costs. Lost life years associated with 30-day in-trial events (death, MI and stroke) were estimated from published data from Framingham. Results: Overall, costs of index hospitalizations and outpatient procedures were lower, while costs for the subsequent hospitalization were higher for the enoxaparin patients. Total 30 days’ costs remained lower for enoxaparin, although the difference did not reach significance. Life years lost were significantly less with enoxaparin. For lifetime, when costs beyond the trial period were considered, the costs of enoxaparin in patients with STEMI were $506 higher, and the incremental cost-effectiveness ratio of enoxaparin compared to UFH was $4,369 per life year gained, with 99.9% of estimates falling below the $50,000 per life year gained threshold. Conclusions: Enoxaparin is effective in reducing mortality or nonfatal MI, and is highly cost-effective strategy in the US settings for the treatment of STEMI patients.

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