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Biomedical subjects

Bernie J O'Brien

Publications and source records attributed to Bernie J O'Brien.

At least 19 recordsLinked to original sources
PubMed2006

Retrospective economic evaluation of a controlled trial of indomethacin prophylaxis for patent ductus arteriosus in premature infants.

OBJECTIVE: To determine the incremental cost-effectiveness of indomethacin prophylaxis in extremely low birth weight infants enrolled in the Trial of Indomethacin Prophylaxis in Preterms (TIPP). STUDY DESIGN: Participants in this economic evaluation were 428 infants enrolled at 9 Canadian TIPP centres. The study took a third-party payer perspective. Prior to the analysis of clinical trial data, direct medical costs were derived from chart review of 89 items of resource utilization, for each day from admission to hospital discharge. Unit costs for each resource were obtained from a provincially standardized cost-accounting system. Incremental cost-effectiveness analysis was performed, with estimation of cost-effectiveness acceptability curves through non-parametric bootstrapping. RESULTS: The mean (SD) cost was $68,279 (40,317) for the placebo group and $69,629 (37,989) for the indomethacin group. Indomethacin prophylaxis cost an additional $67,500 per death or impairment averted. However, the precision of this estimate was low, such that the probability that the estimate was lower than $300,000 per death or impairment averted was only 61%. The results were similar when surgical costs were assumed to be 500% of those measured in the trial. CONCLUSIONS: This study does not provide an economic rationale for the use of indomethacin prophylaxis in ELBW infants.

Canada↗
PubMed2005

Cost-effectiveness analysis for multinational clinical trials.

Clinical trials of cost-effectiveness are often conducted in more than one country. The two most common ways of dealing with the multinational nature of the data are either to calculate a pooled estimate or to stratify results by country. Since the between-country heterogeneity in costs is potentially substantial, pooled estimates may be difficult to interpret for any one country. Policy decisions are often made at a national level, and so country-specific results are important. However, country-specific analyses will be based on fewer patients and will often fail to provide adequate precision for statistical analyses. Shrinkage estimation is a compromise between these two methods and has been used successfully in other fields. These estimates are country-specific yet less variable than those derived through a subgroup approach. Univariate and multivariate shrinkage estimators for costs and effects are proposed, then compared with one another and to the traditional methods in a simulation study. The methods are illustrated using data from a multinational trial evaluating the cost-effectiveness of three thrombolytic drug regimens in patients with acute myocardial infarction.

Clinical Trials as Topic↗
PubMed2005

Country specific cost comparisons from multinational clinical trials using empirical Bayesian shrinkage estimation: the Canadian ASSENT-3 economic analysis.

The growing number of multinational clinical trials in which patient-level health care resource data are collected have raised the issue of which is the best approach for making inference for individual countries with respect to the between-treatment difference in mean cost. We describe and discuss the relative merits of three approaches. The first uses the random effects pooled estimate from all countries to estimate the difference for any particular country. The second approach estimates the difference using only the data from the specific country in question. Using empirical Bayes estimation a third approach estimates the country-specific difference using a variance-weighted linear sum of the estimates provided by the other two approaches. The approaches are illustrated and compared using the data from the ASSENT-3 trial.

Abciximab↗
PubMed2005

Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.

Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, North Carolina, we sought to identify areas of agreement about how the primary findings of economic evaluations in multinational clinical trials should be generated and presented. In this paper, we propose a framework for classifying multinational economic evaluations according to (a) the sources of an analyst's estimates of resource use and clinical effectiveness and (b) the analyst's method of estimating costs. We review existing studies in the cardiology literature in the context of the proposed framework. We then describe important methodological and practical considerations in conducting multinational economic evaluations and summarize the advantages and disadvantages of each approach. Finally, we describe opportunities for future research. Delineation of the various approaches to multinational economic evaluation may assist researchers, peer reviewers, journal editors, and decision makers in evaluating the strengths and limitations of particular studies.

Clinical Trials as Topic↗
PubMed2005

Cost-effectiveness of physiologic pacing: results of the Canadian Health Economic Assessment of Physiologic Pacing.

OBJECTIVES: The purpose of this study was to determine the cost-effectiveness of physiologic pacemakers. BACKGROUND: The Canadian Trial of Physiologic Pacing (CTOPP) was a large randomized trial that evaluated the efficacy of physiologic pacing compared with ventricular pacing. CTOPP also included a prospective cost-effectiveness substudy. METHODS: Resource usage and costs were collected from a subset of 472 patients (of 1,094) who received a physiologic pacemaker and 586 (of 1,474) who received a ventricular pacemaker. Costs included initial pacemaker implantation and all health care follow-up costs over a follow-up of 5.2 years. Costs are reported in 2004 Canadian dollars (1 Canadian dollar = 0.76 US dollars), with adjustments for censoring. Incremental cost-effectiveness was estimated as the ratio of the difference (treatment-control) in mean cost to the difference in life expectancy (mean survival), with costs and effects discounted at 3% per year. RESULTS: Over a mean follow-up of 3.1 years, physiologic pacing was associated with a gain of 0.01 life-years. This benefit increases to 0.25 life-years in the subgroup of patients with an intrinsic (unpaced) heart rate < or =60 bpm. Physiologic pacing was more expensive than ventricular (16,833 Canadian dollars vs 13,857 US dollars), largely because of the increased cost of dual-chamber devices. Among all substudy patients, the incremental cost-effectiveness of physiologic pacing is 297,600 Canadian dollars per life-year gained; however, this value falls to 16,343 Canadian dollars in patients with an intrinsic heart rate >60. CONCLUSIONS: In the short term, a strategy of routine implantation of physiologic pacemakers is not cost-effective by currently accepted standards. The selective use of these devices in patients likely to be pacemaker dependent appears to be cost-effective. Further studies with longer follow-up and which consider the benefit of reducing nonfatal cardiac events would be valuable.

Arrhythmias, Cardiac↗
PubMed2005

The impact of reference pricing of nonsteroidal anti-inflammatory agents on the use and costs of analgesic drugs.

OBJECTIVE: To estimate the effect of reference pricing (RP) of nonsteroidal anti-inflammatory drugs (NSAIDs) on drug subsidy program and beneficiary expenditures on analgesic drugs. DATA SOURCES/STUDY SETTING: Monthly claims data from Pharmacare, the public drug subsidy program for seniors in British Columbia, Canada, over the period of February 1993 to June 2001. STUDY DESIGN: RP limits drug plan reimbursement of interchangeable medicines to a reference price, which is typically equal to the price of the lowest cost interchangeable drug; any cost above that is borne by the patient. Pharmacare introduced two different forms of RP to the NSAIDs, Type 1 in April 1994 and Type 2 in November 1995. Under Type 1 RP, generic and brand versions of the same NSAID are considered interchangeable, whereas under Type 2 RP different NSAIDs are considered interchangeable. We extrapolated average reimbursement per day of NSAID therapy over the months before RP to estimate what expenditures would have been without the policies. These counterfactual predictions were compared with actual values to estimate the impact of the policies; the estimated impacts on reimbursement rates were multiplied by the postpolicy volume of NSAIDS dispensed, which appeared unaffected by the policies, to estimate expenditure changes. PRINCIPAL FINDINGS: After Type 2 RP, program expenditures declined by $22.7 million (CAN), or $4 million (CAN), annually cutting expenditure by about half. Most savings accrued from the substitution of low-cost NSAIDs for more costly alternatives. About 20 percent of savings represented expenditures by seniors who elected to pay for partially reimbursed drugs. Type 1 RP produced one-quarter the savings of type 2 RP. CONCLUSIONS: Type 2 RP of NSAIDs achieved its goal of reducing drug expenditures and was more effective than Type 1 RP. The effects of RP on patient health and associated health care costs remain to be investigated.

Aged↗
PubMed2005

Antiviral agents for influenza: a comparison of cost-effectiveness data.

The economic burden of influenza-related illness has been estimated to be 71.3-166 billion US dollars in the US, the majority of which is attributable to indirect costs as a result of lost productivity. There are currently four antiviral drugs available for the treatment of influenza: two ion channel blockers, amantadine and rimantadine; and two neuraminidase inhibitors, zanamivir and oseltamivir. The objective of this paper was to review the studies evaluating the cost effectiveness of currently available antiviral treatment and prophylaxis management strategies for influenza. Published studies that reported both costs and effectiveness of influenza management were extracted using MEDLINE, pre-MEDLINE and EMBASE. To facilitate a broad comparison, all costs were inflated to 2003 US dollars. Fifteen studies met the inclusion criteria of the review, with 14 analyses based on decision-analytic modelling and one economic analysis performed alongside a clinical trial. Management strategies included antiviral influenza prophylaxis or vaccination, empiric treatment of suspected disease, or antiviral treatment following rapid influenza testing. Study populations included healthy adults, adults at risk of influenza-related adverse outcomes, institutionalised and non-institutionalised elderly, and children. The comparator in all studies was standard care (i.e. over-the-counter medications only), and analyses were carried out from both the societal and payer perspectives. The only dominant strategy relative to standard care was vaccination of the institutionalised elderly. All other strategies in all populations were both more costly and more effective than standard care. Depending on the population and the perspective, the incremental cost-effectiveness ratios (ICERs) for antiviral treatment strategies ranged from 5000 US dollars/QALY for amantadine in test-and-treat studies to >400,000 US dollars/QALY for zanamivir or oseltamivir treatment in children. Sensitivity analysis in all studies consistently reported a strong influence of the population prevalence or diagnostic accuracy of influenza on the cost effectiveness of all strategies. Baseline influenza prevalence varied widely between studies, ranging from 15% to 68%. There was also a wide variation in the assumption about the disutility of influenza (ranging from -0.137 to -0.983 for the elderly requiring hospitalisation), which also impacted the cost effectiveness. Given the variation in the ICERs of antiviral treatment and prophylaxis, the uncertainty around many model parameters, and the dynamic nature of influenza from year to year, one can only conclude that antiviral treatment or prophylaxis for influenza is likely to be more cost effective in specific populations at specific times during the influenza season, and during influenza seasons when the population prevalence reaches epidemic levels or there is mismatch between the vaccine and the circulating virus.

Adolescent↗
PubMed2004

Cost-effectiveness of rhythm versus rate control in atrial fibrillation.

BACKGROUND: Atrial fibrillation is the most common type of sustained cardiac arrhythmia, but recent trials have identified no clear advantage of rhythm control over rate control. Consequently, economic factors often play a role in guiding treatment selection. OBJECTIVE: To estimate the cost-effectiveness of rhythm-control versus rate-control strategies for atrial fibrillation in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM). DESIGN: Retrospective economic evaluation. Nonparametric bootstrapping was used to estimate the distribution of incremental costs and effects on the cost-effectiveness plane. DATA SOURCES: Data on survival and use of health care resources were obtained for all 4060 AFFIRM participants. Unit costs were estimated from various U.S. databases. TARGET POPULATION: Patients with atrial fibrillation who were 65 years of age or who had other risk factors for stroke or death, similar to those enrolled in AFFIRM. TIME HORIZON: Mean follow-up of 3.5 years. PERSPECTIVE: Third-party payer. INTERVENTIONS: Management of patients with atrial fibrillation with antiarrhythmic drugs (rhythm control) compared with drugs that control heart rate (rate control). OUTCOME MEASURES: Mean survival, resource use, costs, and cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: A mean survival gain of 0.08 year (P = 0.10) was observed for rate control. Patients in the rate-control group used fewer resources (hospital days, pacemaker procedures, cardioversions, and short-stay and emergency department visits). Rate control costs 5077 dollars less per person than rhythm control. RESULTS OF SENSITIVITY ANALYSIS: Cost savings ranged from 2189 dollars o 5481 dollars per person. Rhythm control was more costly and less effective than rate control in 95% of the bootstrap replicates over a wide range of cost assumptions. LIMITATIONS: Resource use was limited to key items collected in AFFIRM, and the results are generalizable only to similar patient populations with atrial fibrillation. CONCLUSION: Rate control is a cost-effective approach to the management of atrial fibrillation compared with maintenance of sinus rhythm in patients with atrial fibrillation similar to those enrolled in AFFIRM.

Anti-Arrhythmia Agents↗
PubMed2004

Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions.

Cost-effectiveness acceptability curves (CEACs) have been widely adopted as a method to quantify and graphically represent uncertainty in economic evaluation studies of health-care technologies. However, there remain some common fallacies regarding the nature and shape of CEACs that largely result from the 'textbook' illustration of the CEAC. This 'textbook' CEAC shows a smooth curve starting at probability 0, with an asymptote to 1 for higher money values of the health outcome (lambda). But this familiar 'ogive' shape which makes the 'textbook' CEAC look like a cumulative distribution function is just one special case of the CEAC. The reality is that the CEAC can take many shapes and turns because it is a graphic transformation from the cost-effectiveness plane, where the joint density of incremental costs and effects may 'straddle' quadrants with attendant discontinuities and asymptotes. In fact CEACs: (i) do not have to cut the y-axis at 0; (ii) do not have to asymptote to 1; (iii) are not always monotonically increasing in lambda; and (iv) do not represent cumulative distribution functions (cdfs). Within this paper we present a 'gallery' of CEACs in order to identify the fallacies and illustrate the facts surrounding the CEAC. The aim of the paper is to serve as a reference tool to accompany the increased use of CEACs within major medical journals.

Bayes Theorem↗
PubMed2003

Double discounting of QALYs.

Quality-adjusted life-years (QALYs) calculated from time tradeoff (TTO) based preferences have a time preference component. To impose a conventional discount rate on these implicitly discounted QALYs introduces some degree of double discounting. The purpose of this study was to determine the magnitude of the double discounting effect and the effectiveness of a suggested method for avoiding double discounting in a TTO-based QALY model. Our analysis used holistic and composite preference scores obtained with the TTO technique in a prior study of four hypothetical treatment paths in type 2 diabetes. Discounted composite preference scores were significantly discrepant from holistic preference scores. Adjusting TTO-based quality weights prior to external discounting reduced the discrepancy only slightly. Since time preference effects may vary with health state context, the double discounting effect needs further investigation.

Attitude to Health↗
PubMed2003

Stratified cost-effectiveness analysis: a framework for establishing efficient limited use criteria.

The cost-effectiveness of new health care technologies is conditional upon who receives what therapy and under what circumstances. Understanding this heterogeneity in cost-effectiveness, health care payers often limit reimbursement of therapies to a more restrictive sub-group of patients than that indicated in a product's licensing. Such limits may be based upon clinical or demographic criteria that are prognostic of costs, outcomes or both. However, there is little guidance on how to estimate and interpret stratified cost-effectiveness analysis. In this paper we present a framework for estimating the benefits from stratification that permits consideration of both the opportunity cost resulting from a lack of adherence with criteria and the efficiency loss associated with incorporating equity concerns.

Cost-Benefit Analysis↗
PubMed2003

A view from the bridge: agreement between the SF-6D utility algorithm and the Health Utilities Index.

BACKGROUND: The SF-6D is a new health state classification and utility scoring system based on 6 dimensions ('6D') of the Short Form 36, and permits a "bridging" transformation between SF-36 responses and utilities. The Health Utilities Index, mark 3 (HUI3) is a valid and reliable multi-attribute health utility scale that is widely used. We assessed within-subject agreement between SF-6D utilities and those from HUI3. METHODS: Patients at increased risk of sudden cardiac death and participating in a randomized trial of implantable defibrillator therapy completed both instruments at baseline. Score distributions were inspected by scatterplot and histogram and mean score differences compared by paired t-test. Pearson correlation was computed between instrument scores and also between dimension scores within instruments. Between-instrument agreement was by intra-class correlation coefficient (ICC). RESULTS: SF-6D and HUI3 forms were available from 246 patients. Mean scores for HUI3 and SF-6D were 0.61 (95% CI 0.60-0.63) and 0.58 (95% CI 0.54-0.62) respectively; a difference of 0.03 (p<0.03). Score intervals for HUI3 and SF-6D were (-0.21 to 1.0) and (0.30-0.95). Correlation between the instrument scores was 0.58 (95% CI 0.48-0.68) and agreement by ICC was 0.42 (95% CI 0.31-0.52). Correlations between dimensions of SF-6D were higher than for HUI3. CONCLUSIONS: Our study casts doubt on the whether utilities and QALYs estimated via SF-6D are comparable with those from HUI3. Utility differences may be due to differences in underlying concepts of health being measured, or different measurement approaches, or both. No gold standard exists for utility measurement and the SF-6D is a valuable addition that permits SF-36 data to be transformed into utilities to estimate QALYs. The challenge is developing a better understanding as to why these classification-based utility instruments differ so markedly in their distributions and point estimates of derived utilities.

Algorithms↗
PubMed2003

A systematic review of economic analyses of low-molecular-weight heparin for the treatment of venous thromboembolism.

INTRODUCTION: Public concerns about the increase in health care expenditure have prompted investigators to analyze the costs and benefits of health care interventions. We conducted a systematic review of economic analyses of venous thromboembolism treatment focusing on studies evaluating low-molecular-weight heparin. MATERIALS AND METHODS: We identified studies by a MEDLINE search and a review of bibliographies of retrieved articles. From each eligible study, we extracted data on the study characteristics, the effectiveness, and the cost of managing the venous thromboembolism with respect to treatment. We critically appraised the studies according to the framework from the Users' Guides to the Medical Literature XIII: How to Use an Article on Economic Analysis of Clinical Practice. RESULTS: Six of these eight economic analyses of venous thromboembolism treatment that met the inclusion criteria for this review showed that low-molecular-weight heparin is associated with less recurrent venous thromboembolism and is less costly than treatment with unfractionated heparin. Although discrete recurrent venous thromboembolism event rates were not included in the seventh study, these investigators concluded that the cost of low-molecular-weight heparin for the treatment of venous thromboembolism treatment was offset by the savings associated with fewer hospital admissions when low-molecular-weight heparin was used. In the eighth study, although the cost of treatment with low-molecular-weight heparin was higher than treatment with unfractionated heparin, the investigators concluded that low-molecular-weight heparin is cost-effective for inpatient management. CONCLUSIONS: Low-molecular-weight heparin treatment may confer economic advantages over unfractionated heparin therapy because it does not require anticoagulant monitoring and it facilitates outpatient therapy.

Anticoagulants↗
PubMed2003

Measures of importance for economic analysis based on decision modeling.

In probabilistic economic analysis, the uncertainty concerning input parameters is quantified, and determines the level of uncertainty over the optimal decision. Researchers from a wide range of disciplines employ mathematical models to simulate complex processes. Common through many such disciplines is the conduct of importance analysis to determine those input parameters that contribute most to the uncertainty over the optimal decision based on the results of the analysis. In this study, we compare a range of potential importance measures to see how they compare with methods used in economic analysis. Techniques were classified as variance/correlation, information, probability, entropy, or elasticity-based measures. A selection of the most commonly used measures were applied to an economic model of treatment for patients with Parkinson's disease. Techniques were evaluated in terms of their ranking of variables, complexity, and interpretation.

Cost-Benefit Analysis↗
PubMed2003

Daily cost prediction model in neonatal intensive care.

OBJECTIVES: One barrier to economic evaluation alongside neonatal randomized controlled trials is the expense of collecting detailed patient resource information. To reduce this data collection burden, we identified the key resource items that predict daily ancillary costs for extremely low birth weight infants. METHODS: Participants were 385 infants enrolled in the Trial of Indomethacin Prophylaxis for Preterms in nine tertiary level neonatal intensive care units in Canada. Information on eighty-nine nonpersonnel resource items was abstracted from the hospital chart from admission to tertiary hospital discharge. Unit costs were derived from a provincially standardized cost accounting system. Using stepwise linear regression, models correlating total daily ancillary costs with key resource items were constructed for each of five periods of admission. Models were derived in a randomly split half of the total sample of patient days and validated against the remainder. RESULTS: The 385 infants contributed resource information from 23,354 admission days. The regression model for weeks one to twelve included the covariates surfactant, chest radiograph, red blood cell transfusion, cranial ultrasound, abdominal radiograph, parenteral amino acid infusion, surgery, platelet transfusion, and echocardiogram and explained 91% of the variability in daily nonpersonnel costs (P<.0001). Models for other admission periods similarly included between four and eight covariates, were highly significant (P<.0001) and explained between 76% and 94% of daily ancillary cost variability. The regression equations showed excellent predictive power when applied to the second half of the patient data set. CONCLUSIONS: Daily nonpersonnel costs for extremely low birth weight infants are driven by a limited number of key resource variables. The ability to predict total ancillary costs with minimal data collection will facilitate inclusion of economic evaluations in neonatal trials.

Ancillary Services, Hospital↗
PubMed2003

Cost-effectiveness of the implantable cardioverter defibrillator: a review of current evidence.

INTRODUCTION: Implantable cardioverter defibrillator (ICD) therapy is indicated for patients at risk for sudden cardiac death (SCD) due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The high relative cost of therapy with the ICD versus antiarrhythmic drugs has raised questions regarding its cost-effectiveness. To address these questions, we review the literature on ICD cost-effectiveness. METHODS AND RESULTS: MEDLINE and other databases were searched for articles published since 1980 reporting original data on the cost-effectiveness of ICD versus drug therapy for patients at risk for SCD. Data on costs and life-years were abstracted and studies grouped into decision analysis models and trial-based analyses. Cost-effectiveness ratios were inflated to 2002 US dollars. Thirteen economic studies were included in this review: 6 decision-analytic models, 4 economic analysis alongside randomized controlled trials, and 1 observational study. Two additional studies evaluated the cost-effectiveness of ICDs stratified by mortality risk. Studies varied in time horizon, and in all but one study ICD therapy was more costly than drug therapy. Early models assumed larger survival benefits than were observed in subsequent trials; therefore, ICDs appeared to be more cost-effective (i.e., US dollars 28000-US dollars 60000 per life-year gained). Three large clinical trial-based studies estimated that the cost per life-year gained was between US dollars 30181 and US dollars 185000. Stratified analyses show that patients at higher risk for mortality due to structural heart disease (e.g., left ventricular ejection fraction <35%) benefit more from ICD therapy, resulting in lower cost-effectiveness ratios. CONCLUSION: ICD therapy continues to evolve with changing methods of implantation and improving technology. Current evidence suggests that ICDs may be a cost-effective option in patients at high risk for VT/VF. The cost-effectiveness of ICD therapy for primary and secondary prevention of SCD depends upon patient characteristics that influence their prior risk of mortality. Further research on patient selection criteria and the measurement of health-related quality of life is required.

Arrhythmias, Cardiac↗
PubMed2003

Economic considerations for health insurance coverage of emerging genetic tests.

Public and private health insurance plans face the question of whether to cover emerging genetic tests for cancer and other diseases. This paper outlines issues in the economic evaluation of new genetic tests, illustrating key methodological issues and policy implications with findings from a comprehensive and systematic review of the 14 full economic evaluations published over the past 5 years that have addressed both the costs and consequences of molecular genetic tests. Key questions for framing an evaluation include: whose viewpoint matters, which costs and consequences are relevant, and to which clinical alternatives should new genetic tests be compared? While economic evaluation research can inform coverage decisions about genetic tests, the coverage decision-making process must also inform economic researchers about the aims, context, and value systems within which genetic tests will be covered and practised.

Genetic Testing↗