Results of the Economic Evaluation of the FIRST Study:<i>A Multinational Prospective Economic Evaluation</i>

Schulman, Kevin A.; Buxton, Martin; Glick, Henry A.; Sculpher, Mark; Guzmán, Gladys; Kong, Janet; Backhouse, Martin E.; Mauskopf, Jo; Bell, Larry; Eisenberg, John M.

doi:10.1017/s0266462300010989

Cited by 47 publications

(35 citation statements)

References 12 publications

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“…53,77,84 Furthermore, it has been argued that, in multinational trials, unit costs should be taken from all or a sample of centres within each country as applying unit costs from single centres in a multinational economic evaluation may reflect neither the average unit costs within a country nor the true variation in unit costs. 34 In a recent simulation exercise, it was confirmed that there is a significant difference in overall cost results between using unit costs averaged across centres and centre-specific costs to value all the resource use measured in the trial. 119 Frequently, unit costs may not be available for some sites in a study.…”

Section: Unit Costsmentioning

confidence: 96%

“…A random effects model was used to account for institutional variation in overall clinical results. In another multinational trial, Schulman and colleagues 34,77 attempted to quantify resource utilisation and quality of life in a population with severe congestive heart failure and to explain the variation among patients receiving epoprostenol therapy versus best usual care alone in 14 countries. The study concluded that the validity of estimates of the costs and their differences may be limited, because they were determined within the environment of a Phase III trial and because the application of a single set of unit cost data would not demonstrate the true variation in unit cost estimates between locations.…”

Section: Studies Looking At International Variationmentioning

confidence: 99%

“…At a fundamental level, several authors have argued for the development of a standardised cost framework which includes the production of a checklist of common cost categories across countries, a standardised approach to service use data collection and agreed principles for estimating the unit costs of service use. 34,47,65 It is common for unit costs from one country in the multinational trial to be used to proxy those in other countries and applied to pooled resource use data collected in all studies. For example, Jonsson and colleagues assumed that Swedish costs could be generalised to four other Scandinavian/Nordic countries in the 4S.…”

Section: Unit Costsmentioning

confidence: 99%

“…34,86,179,[182][183][184][185][186][187][188][189][190][191] The next most popular method (four studies) was to calculate several different unit cost vectors for different countries, and to apply each of these to all resource use data in the trial. 78,173,192,193 In effect, this amounts to a series of sensitivity analyses based on different countries' unit costs.…”

Section: Multinational Trialsmentioning

confidence: 99%

See 3 more Smart Citations

Generalisability in economic evaluation studies in healthcare: a review and case studies

Sculpher

Fs²,

Manca³

et al. 2004

Health Technol Assess

318

297

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of £100 for each volume (normally comprising 30-40 titles). The commercial subscription rate is £300 per volume. Please see our website for details. Subscriptions can only be purchased for the current or forthcoming volume. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK.We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. HTA NHS R&D HTA ProgrammeT he research findings from the NHS R&D Health Technology Assessment (HTA) Programme directly influence key decision-making bodies such as the National Institute for Clinical Excellence (NICE) and the National Screening Committee (NSC) who rely on HTA outputs to help raise standards of care. HTA findings also help to improve the quality of the service in the NHS indirectly in that they form a key component of the 'National Knowledge Service' that is being developed to improve the evidence of clinical practice throughout the NHS.The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care.The HTA programme commissions research only on topics where it has identified key gaps in the evidence needed by the NHS. Suggestions for topics are actively sought from people working in the NHS, the public,...

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Section: Unit Costsmentioning

confidence: 96%

Section: Studies Looking At International Variationmentioning

confidence: 99%

Section: Unit Costsmentioning

confidence: 99%

Section: Multinational Trialsmentioning

confidence: 99%

See 2 more Smart Citations

Generalisability in economic evaluation studies in healthcare: a review and case studies

Sculpher

Fs²,

Manca³

et al. 2004

Health Technol Assess

318

297

View full text Add to dashboard Cite

show abstract

“…As recently reported, 23 this method adjusts for differential right-censoring by reweighting the observed costs and quality-adjusted life-months (QALMs) of patients followed in the later study period and predicting the costs and QALMs of study participants as if they had all been available for the full 13 months of follow-up.…”

Section: Discussionmentioning

confidence: 99%

Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin’s and non-Hodgkin’s lymphoma

Dorsainvil

Yabroff

et al. 1998

Bone Marrow Transplant

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Summary:Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79 892 (95% CI $69 343 to $90 544) for patients receiving GM-CSF alone and $89 651 (95% CI $79 769 to $102 114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective.

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A 75-Year-Old Man With Congestive Heart Failure

Guyatt

1999

JAMA

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A 75-year-old man sought medical assistance due to hemoptysis and general malaise. The patient presented dyspnea triggered by moderate exertion at the end of April. A week after the symptom onset, the dyspnea increased and started to be triggered by mild exertion. He also suffered a syncopal episode, which prompted him to seek emergency medical attention. Two weeks later he sought medical assistance at Instituto do Coracao (InCor-The Heart Institute) due to worsening of the dyspnea and a sensation of suffocation in the chest. The physical examination (May 10, 2008) showed a heart rate (HR) of 88 bpm and blood pressure (BP) of 90/60 mm Hg. The lung examination disclosed pulmonary rales. The remainder of the examination did not reveal any other alterations. The electrocardiogram (May 10, 2008) showed sinus rhythm; HR at 88 bpm; PR interval of 203 ms; QRS duration of 68 ms; low-voltage QRS complex in the frontal plane; extensive anterior and inferior-wall areas that were electrically inactive; and ST-segment elevation from V 1 to V 6 and in I aVL, with positive T waves from V 1 to V 6 (Figure 1). The laboratory assessment (May 10, 2008) showed glycemia of 94 mg/dl; urea of 43 mg/dl; creatinine of 1.07 mg/dl; sodium of 137 mEq/l; potassium of 4.5 mEq/l; hemoglobin of 12.6 g/dl; leukocytes at 6,500/mm³; platelets at 286,000/m³; INR of 1.1; APTT (patient/control ratio) of 1.12; CKMB of 6.46 ng/ml and troponin of 6.27 ng/ml. The chest X-ray (05. 10. 2008) showed cardiomegaly at the expense of the left ventricle (LV). The echocardiogram (05. 14. 2008) showed an enlarged left atrium (45 mm). The left ventricular ejection fraction (LVEF) was 20%. Akinesis of the LV septal and anterior segments and signs suggestive of intracavitary thrombi in the apical region, one measuring 2.4 x 5 mm, fixed, and a mobile one in middle septal segment measuring 1.0 x 0.7 mm, were diagnosed. There was slight pericardial effusion. The pulmonary artery pressure was estimated at 30 mmHg. The coronary angiography (May 14, 2008) identified occlusion of the anterior interventricular branch of the left coronary artery, a 90% lesion at the emergence of the first diagonal branch and a 70% in the left marginal branch; there were also irregularities in the right coronary artery. An angioplasty of the anterior interventricular branch was attempted; however, the guidewire did not surpass the lesion and an angioplasty in the first diagonal branch was performed with a balloon-catheter. The patient was discharged from the hospital (May 20, 2008) with a daily prescription of 100 mg ASA, 12.5 mg carvedilol, 10 mg enalapril, 25 mg spironolactone, 20 mg simvastatin and 5 mg warfarin. The patient developed dyspnea triggered by moderate exertion and three days later, stated to present dyspnea even at rest. On the morning of the following day, he presented an episode of precordial discomfort, followed by intense sudoresis and nausea that lasted for 30 minutes. He sought medical attention at InCor seven hours after the pain onset. At physical examination (May 24, ...

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Results of the Economic Evaluation of the FIRST Study:A Multinational Prospective Economic Evaluation

Cited by 47 publications

References 12 publications

Generalisability in economic evaluation studies in healthcare: a review and case studies

Generalisability in economic evaluation studies in healthcare: a review and case studies

Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin’s and non-Hodgkin’s lymphoma

A 75-Year-Old Man With Congestive Heart Failure

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