Economic Evaluation in Clinical Trials

Glick, Henry R.; Doshi, Jalpa A.; Sonnad, Seema S.; Polsky, Daniel

doi:10.1093/med/9780199685028.001.0001

Cited by 692 publications

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“…Economic evaluations are increasingly being conducted alongside phase III and phase IV randomised controlled trials of various interventions such as surgical procedures, drug treatments, diagnostic tests and behavioural interventions [1] . In the United Kingdom (UK), government agencies such as the National Institute for Health and Care Excellence (NICE) for England and Wales, the All Wales Medicines Strategy Group (AWMSG) for Wales and the Scottish Medicines Consortium (SMC) for Scotland have established decision-making processes that draw heavily upon economic evidence collected within the context of randomised controlled trials, whilst its research funding bodies such as the National Institute for Health Research (NIHR) routinely request the inclusion of economic assessment methods within large-scale clinical trials [1], [2].…”

Section: Introductionmentioning

confidence: 99%

“…In the United Kingdom (UK), government agencies such as the National Institute for Health and Care Excellence (NICE) for England and Wales, the All Wales Medicines Strategy Group (AWMSG) for Wales and the Scottish Medicines Consortium (SMC) for Scotland have established decision-making processes that draw heavily upon economic evidence collected within the context of randomised controlled trials, whilst its research funding bodies such as the National Institute for Health Research (NIHR) routinely request the inclusion of economic assessment methods within large-scale clinical trials [1], [2]. Similarly, economic evidence collected within the context of randomised trials is increasingly being used to inform the regulatory and reimbursement decisions of government agencies in other nations [3,4].…”

Section: Introductionmentioning

confidence: 99%

“…Cost-utility analyses are particularly appealing to decision makers as they permit cost-effectiveness comparisons to be made using the quality-adjusted life year (QALY) metric for different health care interventions across disparate health conditions. It is unsurprising therefore that cost-utility analysis using the QALY outcome measure (which combines length of life and health-related quality of life in a single measure of health consequence) remains the preferred evaluative method in the technology appraisal guidance of many government agencies [1], [2].…”

Section: Introductionmentioning

confidence: 99%

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Methodological Issues Surrounding the Use of Baseline Health-Related Quality of Life Data to Inform Trial-Based Economic Evaluations of Interventions Within Emergency and Critical Care Settings: A Systematic Literature Review

et al. 2017

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warwick.ac.uk/lib-publicationsOriginal citation: Dritsaki, Melina, Achana, Felix A., Mason, James and Petrou, Stavros. (2017) Methodological issues surrounding the use of baseline health-related quality of life data to inform trial-based economic evaluations of interventions within emergency and critical care settings : a systematic literature review. PharmacoEconomics. Permanent WRAP URL:http://wrap.warwick.ac.uk/85039 Copyright and reuse:The Warwick Research Archive Portal (WRAP) makes this work by researchers of the University of Warwick available open access under the following conditions. Copyright © and all moral rights to the version of the paper presented here belong to the individual author(s) and/or other copyright owners. To the extent reasonable and practicable the material made available in WRAP has been checked for eligibility before being made available.Copies of full items can be used for personal research or study, educational, or not-for profit purposes without prior permission or charge. Provided that the authors, title and full bibliographic details are credited, a hyperlink and/or URL is given for the original metadata page and the content is not changed in any way. Publisher's statement:"The final publication is available at Springer via http://dx.doi.org/10.1007/s40273-016-0485-x " A note on versions:The version presented here may differ from the published version or, version of record, if you wish to cite this item you are advised to consult the publisher's version. Please see the 'permanent WRAP url' above for details on accessing the published version and note that access may require a subscription. Results: A total of 4224 published reports were screened, 19 of which met the study inclusion criteria (mean trial size 1,670); 14 (74 %) from the UK, 4 (21%) from other European countries and 1 (5%) from India. Twelve studies (63%) were based in emergency departments and 7 (37%) in intensive care units. Only one study was able to elicit patient-reported health-related quality of life at baseline. To overcome the lack of baseline data when estimating QALYs, 8 (42%) studies assigned a fixed utility weight corresponding to either death, an unconscious health state or a country-specific norm to patients at baseline, 4 (21%) ignored baseline utilities, 3 (16%) applied values from another study, 1 (5%) generated utility values via retrospective recall and 1 (5%) elicited utilities from experts. A preliminary exploration of these methods shows that incremental QALY estimation is unlikely to be biased if balanced trial allocation is achieved and subsequent collection of health-related quality of life data occurs at the earliest possible opportunity following commencement of treatment followed by adequate number of follow-up assessments. Conclusion:Trial-based cost-utility analyses within emergency and critical illness settings have applied different methods for QALY estimation, employing disparate assumptions about the health-related quality of life of patients at baseline. Where baseline measurem...

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Methodological Issues Surrounding the Use of Baseline Health-Related Quality of Life Data to Inform Trial-Based Economic Evaluations of Interventions Within Emergency and Critical Care Settings: A Systematic Literature Review

et al. 2017

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“…Estimates were obtained using recycled predictions, which holds all covariates constant and allows brief intervention to vary. 43,44 Models were adjusted for all covariates and were clustered to account for correlation of outcomes at the facility level.…”

Section: Methodsmentioning

confidence: 99%

Association Between Receipt of Brief Alcohol Intervention and Quality of Care among Veteran Outpatients with Unhealthy Alcohol Use

Lapham

Williams

2015

J GEN INTERN MED

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“…The bootstrapped cost-effectiveness regions using 1000 samples with replacement were calculated using Stata version 11 (StataCorp LP, College Station, TX) and the userwritten program by Glick. 22,23 .…”

Section: Cost-utility Analysismentioning

confidence: 99%

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

et al. 2016

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BACKGROUND: Effective management of patients using warfarin is resource-intensive, requiring frequent inclinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly inclinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS: PST and HQACM participants were similar with regard to gender, age, and CHADS 2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per qualityadjusted life year gained with PST once weekly was $5566 (95 % CI, −$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

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Economic Evaluation in Clinical Trials

Cited by 692 publications

References 0 publications

Methodological Issues Surrounding the Use of Baseline Health-Related Quality of Life Data to Inform Trial-Based Economic Evaluations of Interventions Within Emergency and Critical Care Settings: A Systematic Literature Review

Methodological Issues Surrounding the Use of Baseline Health-Related Quality of Life Data to Inform Trial-Based Economic Evaluations of Interventions Within Emergency and Critical Care Settings: A Systematic Literature Review

Association Between Receipt of Brief Alcohol Intervention and Quality of Care among Veteran Outpatients with Unhealthy Alcohol Use

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

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