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Biomedical subjects

M Sculpher

Publications and source records attributed to M Sculpher.

At least 19 recordsLinked to original sources

A cost-utility analysis of patients undergoing orthognathic treatment for the management of dentofacial disharmony.

INTRODUCTION: Management of dentofacial discrepancies using orthognathic treatment is now a common procedure in the United Kingdom. Although the benefits of orthognathic intervention are often considered, the cost implications have not been investigated to our knowledge. This study is a cost-utility analysis of orthognathic treatment. PATIENTS AND METHODS: Twenty-one patients were interviewed five times during treatment using the time trade-off (TTO) method to establish utility values. Quality adjusted life years (QALYs) gained as a result of treatment were calculated and discounted. The resource use was calculated for each of the 21 patients individually and the costs subjected to both a sensitivity analysis and discounting. The incremental mean cost per additional QALY was calculated (as compared with a 'no treatment' approach). RESULTS: The incremental cost for each additional QALY was 561 pounds sterling for the groups combined, based on mean additional costs and QALYs (546 pounds sterling for the bimaxillary group and 617 pounds sterling for the single jaw group). DISCUSSION: Orthognathic treatment seems to provide good outcomes at relatively low cost. Even allowing for the uncertainty in mean costs and QALYs, there is a high probability of treatment being cost-effective. Cost-utility analysis is still a relatively new technique in dentistry and further studies should be encouraged.

Adult↗

Decision-making by healthcare payers.

Healthcare payers are faced with the need to allocate finite resources to maximize population health. To assist in decision-making, healthcare payers are increasingly using health outcomes information and economic analyses. Healthcare payers are often under pressure to make early decisions (around the time of product launch), when the evidence available is imperfect. They must also consider the equitable distribution of resources between therapeutic areas. Tools to help healthcare payers reach transparent and objective decisions include cost-utility analysis and decision modelling. In practice, healthcare payers in different countries (for example, Ireland, France and Canada) vary in the approaches taken to reimbursement and formulary listing decisions. The key to decision-making among healthcare payers is the provision of appropriate evidence, comparing any new treatment approach to current best practice, in situations corresponding to real life. When data assumptions have to be made, these should be clearly stated with consideration of the impact of varying the assumptions. The impact on budgets should also be considered.

Attitude of Health Personnel↗

Coronary angioplasty versus medical therapy for angina. Health service costs based on the second Randomized Intervention Treatment of Angina (RITA-2) trial.

AIMS: The second Randomized Intervention Treatment of Angina (RITA-2) trial compares an initial strategy of PTCA with continued medical management in patients with arteriographically proven coronary artery disease. This paper employs resource use data collected in the trial to compare the health service costs of the two strategies over 3 years follow-up. METHODS AND RESULTS: 1018 patients were randomized, 504 to PTCA and 514 to continued medical management. Health service resource use data were collected prospectively on all patients. Hospital unit costs were estimated in collaboration with five U.K. centres. PTCA patients underwent more subsequent coronary arteriograms, but subsequent (non-randomized) PTCAs were more common in patients randomized to medical management (118 procedures in 102 patients) compared to those randomized to PTCA (73 procedures in 62 patients). The likelihood of undergoing CABG was similar in the two groups. The use of antianginal medications was higher in patients randomized to an initial strategy of medical management. There was an overall mean additional cost per patient over 3 years in patients randomized to PTCA of pound 2685 (95% CI pound 2074- pound 3322). CONCLUSIONS: In RITA-2, the cost of an initial strategy of PTCA exceeded the cost of an initial strategy of medical management by 74% over 3 years.

Angina Pectoris↗

Screening for Down's syndrome: effects, safety, and cost effectiveness of first and second trimester strategies.

OBJECTIVE: To compare the effects, safety, and cost effectiveness of antenatal screening strategies for Down's syndrome. DESIGN: Analysis of incremental cost effectiveness. SETTING: United Kingdom. MAIN OUTCOME MEASURES: Number of liveborn babies with Down's syndrome, miscarriages due to chorionic villus sampling or amniocentesis, health care costs of screening programme, and additional costs and additional miscarriages per additional affected live birth prevented by adopting a more effective strategy. RESULTS: Compared with no screening, the additional cost per additional liveborn baby with Down's syndrome prevented was 22 000 pound sterling for measurement of nuchal translucency. The cost of the integrated test was 51 000 pound sterling compared with measurement of nuchal translucency. All other strategies were more costly and less effective, or cost more per additional affected baby prevented. Depending on the cost of the screening test, the first trimester combined test and the quadruple test would also be cost effective options. CONCLUSIONS: The choice of screening strategy should be between the integrated test, first trimester combined test, quadruple test, or nuchal translucency measurement depending on how much service providers are willing to pay, the total budget available, and values on safety. Screening based on maternal age, the second trimester double test, and the first trimester serum test was less effective, less safe, and more costly than these four options.

Abortion, Spontaneous↗

Recognizing diversity in public preferences: the use of preference sub-groups in cost-effectiveness analysis.

Public preferences are typically incorporated into cost-effectiveness analyses (CEA) on the basis of the average health state utilities of a sample of individuals drawn from the general public. The cost-effectiveness of a programme is then assessed on an 'all-or-nothing' basis: the programme is declared either cost-effective or not for all patients in clinically homogeneous sub-groups. However, this approach fails to recognize variability between individuals in their preferences. In this paper, we consider how diversity in the preferences of individuals can be handled within CEA when the public's preferences are considered appropriate for defining benefit, with the objective of increasing the efficiency of health care delivery. The concept of preference sub-group analysis is described and some of its implications are assessed. These include the methods that could be used to identify sub-groups from amongst public raters, the appropriate approach to eliciting preferences and the possible implications of preference sub-group analysis for clinical decision making.

Consumer Behavior↗

Representing uncertainty: the role of cost-effectiveness acceptability curves.

Decision-making in health care is inevitably undertaken in a context of uncertainty concerning the effectiveness and costs of health care interventions and programmes. One method that has been suggested to represent this uncertainty is the cost-effectiveness acceptability curve. This technique, which directly addresses the decision-making problem, has advantages over confidence interval estimation for incremental cost-effectiveness ratios. However, despite these advantages, cost-effectiveness acceptability curves have yet to be widely adopted within the field of economic evaluation of health care technologies. In this paper we consider the relationship between cost-effectiveness acceptability curves and decision-making in health care, suggest the introduction of a new concept more relevant to decision-making, that of the cost-effectiveness frontier, and clarify the use of these techniques when considering decisions involving multiple interventions. We hope that as a result we can encourage the greater use of these techniques.

Confidence Intervals↗

Using economic evaluations to reduce the burden of asthma and chronic obstructive pulmonary disease.

There is increasing interest in the use of economic evaluations in healthcare, because of the need to maximise health benefits from limited resources. The focus of most economic evaluations is on efficiency, though they may also consider the issue of equity. In an economic evaluation, it is important to consider all the relevant costs, not just the acquisition cost of the treatment. Likewise, it is important to include all the benefits in the economic appraisal, although the outcomes of relevance to decision-makers may differ according to their perspective. If an intervention costs less but delivers fewer benefits than the comparator or, more commonly, a new intervention increases benefits compared with standard therapy but at increased cost, decision-makers must consider whether the extra cost is worth the extra benefit. This depends on the opportunity cost of introducing the new intervention - i.e. the benefit forgone by doing less of something else to fund it. In other words, decision-makers need to decide on the maximum amount they are willing to pay for an additional unit of health benefit. The result of an economic evaluation will be strongly influenced by the information used in the analysis. Currently, clinical trials are the most common source of data for economic evaluations. Yet there are a number of limitations in the information generated by clinical trials, which are primarily designed for regulatory approval. Consequently, decision analytical models are being increasingly used to synthesise data from various sources and to manage uncertainty in input parameters. When using economic evaluations, decision-makers may be unwilling to take a broad perspective on costs, focusing instead on their narrow budgetary concerns. Incentives may be required within healthcare systems to ensure that decision-makers adhere more strictly to the results of formal analysis.

Asthma↗

Evaluating the cost-effectiveness of interventions designed to increase the utilization of evidence-based guidelines.

Evidence-based medicine has highlighted examples of where clinicians' treatment decisions do not accord with 'best practice' defined by high-quality research. This has resulted in the development of implementation interventions which attempt to change professional practice, such as educational programmes and audit with feedback. As these behavioural interventions themselves require a share of the health service's finite resources, it is important to evaluate their cost-effectiveness in terms of their effect on health care and hence on health outcomes. This paper considers the economic characteristics of implementation interventions and introduces methods by which their cost-effectiveness can be estimated in advance of significant investment. The paper emphasizes that implementation interventions cannot be good value for money unless the 'good practice' for which increased utilization is considered important is itself cost-effective. Furthermore, the likelihood that an implementation strategy will be cost-effective will depend on a number of factors including its cost, its effectiveness in terms of increasing utilization of 'good practice' and the costs and benefits of 'good practice' relative to an appropriate comparator.

Cost-Benefit Analysis↗

A cost effectiveness analysis of goserelin compared with danazol as endometrial thinning agents.

OBJECTIVE: To analyse the cost, effectiveness and cost effectiveness of two endometrial thinning agents prior to laser ablation for dysfunctional uterine bleeding: danazol and goserelin. SETTING: A district general hospital. DESIGN: A retrospective cost effectiveness analysis, from the perspective of the health service, based on data from an open, randomised, parallel group comparative study of 160 pre-menopausal women with dysfunctional uterine bleeding. METHODS: Within the trial, length of operation and duration of hospital stay was recorded for each woman. Resource use due to complications of surgery and adverse drug events was evaluated by one of the authors (R.G.). Additional surgery after completion of the study was collected using a postal questionnaire which was distributed to every woman who had undergone surgery. Resource use was costed using detailed unit costs from a specific NHS trust and from published sources. A cost effectiveness analysis was undertaken relating differential cost to differential rates of amenorrhoea at women's last point of follow up. RESULTS: Information on amenorrhoea was available from 138 women, of whom 111 had completed the questionnaire to indicate longer term follow up. Women who did not complete the clinical trial were not included in this economic evaluation. On average, women randomised to goserelin spent less time in theatre and on the ward. Based on longer term follow up, rates of retreatment were similar in the two groups. The mean (SD) health service cost of women in the goserelin group was pound sterling 323.84 (pound sterling 309.94), compared with pound sterling 243.45 (pound sterling 265.23) in the danazol group; median (range) costs were pound sterling 220.29 (pound sterling 191-pound sterling 2127) and pound sterling 159.76 (pound sterling 140-pound sterling 1426) in the two groups, respectively. These costs were significantly higher for goserelin (P = 0.0001). The goserelin group also had a higher rate of amenorrhoea (38.8% vs 28.6%, P = 0.23). Based on mean differences in cost, the incremental cost of goserelin per additional woman with amenorrhoea was pound sterling 788; based on median differences in cost the ratio was pound sterling 590. CONCLUSIONS: The shorter duration in theatre and stay in hospital provided a modest offset of the higher acquisition cost of goserelin, but the overall cost of management remained significantly higher than managing women with danazol. The rates of amenorrhoea indicated that goserelin was more effective at 24 weeks and approximately two years after surgery, although statistical significance was only achieved at 24 weeks. The economic impact of women withdrawn from treatment was not considered, but sensitivity analysis indicates that these women may have had a large effect on the overall result of this study. Purchasers will need to decide whether the additional cost of management with goserelin is justified by the increased rates of amenorrhoea and the reduced withdrawals from treatment.

Adult↗

Costs incurred by patients undergoing advanced colorectal cancer therapy. A comparison of raltitrexed and fluorouracil plus folinic acid.

BACKGROUND: To assess the cost effectiveness of healthcare interventions from a societal perspective, it is necessary to include costs such as patients' travel costs and the opportunity cost of patients' time spent consuming healthcare. OBJECTIVE: To analyse patients' travel and time costs associated with 2 alternative drug therapies for advanced colorectal cancer: raltitrexed and fluorouracil plus folinic acid (leucovorin) [5FU + FA]. DESIGN AND SETTING: The analysis is based on a prospective substudy within a multinational randomised controlled trial of raltitrexed versus 5FU + FA. PATIENTS AND PARTICIPANTS: 495 patients with advanced colorectal cancer were enrolled in the trial, 270 of whom completed the questionnaire on costs. METHODS: Data were collected within the trial to estimate the numbers of journeys made to and from hospital by patients and the time lost from usual activities over the period of therapy. A subset of patients were asked to complete a questionnaire to provide the information necessary to value time and travel costs in monetary terms. These data, together with UK transport costs and forgone time values, were used to value the transport and opportunity costs of time of all patients in the trial. RESULTS: The total travel cost per patient was statistically significantly higher in the 5FU + FA group (p < 0.001; median of 31.50 Pounds with raltitrexed, 96.00 Pounds with 5FU + FA; 1997 prices). Overall time cost per patient was also higher in the 5FU + FA group (p = 0.005; median of 168.80 Pounds with raltitrexed, 224.04 Pounds with 5FU + FA). Adding the two gives a median total cost per patient of 206.08 Pounds [interquartile range (IQR) 108 Pounds to 482 Pounds] among patients randomised to raltitrexed and 342.25 Pounds (IQR 214 Pounds to 555 Pounds) for those in the 5FU + FA group (p < 0.001). The sensitivity analysis showed that, even under extreme assumptions, raltitrexed imposed fewer time and travel costs on patients. These cost differences are likely, in part, to reflect the longer treatment times for 5FU + FA patients (median 16.9 vs 12.7 weeks). CONCLUSIONS: Different chemotherapy regimens for advanced colorectal cancer can impose different travel and time costs on patients. Over the period of treatment in a randomised controlled trial of 495 patients, those randomised to 5FU + FA were found to have a median travel plus time cost 136 Pounds per patient higher than those randomised to raltitrexed.

Antimetabolites, Antineoplastic↗

Assessing quality in decision analytic cost-effectiveness models. A suggested framework and example of application.

Despite the growing use of decision analytic modelling in cost-effectiveness analysis, there is a relatively small literature on what constitutes good practice in decision analysis. The aim of this paper is to consider the concept of 'validity' and 'quality' in this area of evaluation, and to suggest a framework by which quality can be demonstrated on the part of the analyst and assessed by the reviewer and user. The paper begins by considering the purpose of cost-effectiveness models and argues that the their role is to identify optimum treatment decisions in the context of uncertainty about future states of the world. The issue of whether such models can be defined as 'scientific' is considered. The notion that decision analysis undertaken at time t can only be considered scientific if its outputs closely predict the results of a trial undertaken at time t + 1 is rejected as this ignores the need to make decisions on the basis of currently available evidence. Rather, the scientific characteristic of decision models is based on the fact that, in principle at least, such analyses can be falsified by comparison of two states of the world, one where resource allocation decisions are based on formal decision analysis and the other where such decisions are not. This section of the paper also rejects the idea of exact codification of scientific method in general, and of decision analysis in particular, as this risks rejecting potentially valuable models, may discourage the development of novel methods and can distort research priorities. However, the paper argues that it is both possible and necessary to develop a framework for assessing quality in decision models. Building on earlier work, various dimensions of quality in decision modelling are considered: model structure (disease states, options, time horizon and cycle length); data (identification, incorporation, handling uncertainty); and consistency (internal and external). Within this taxonomy a (nonexhaustive) list of questions about quality is suggested which are illustrated by their application to a specific published model. The paper argues that such a framework can never be prescriptive about every aspect of decision modelling. Rather, it should encourage the analyst to provide an explicit and comprehensive justification of their methods, and allow the user of the model to make an informed judgment about the relevance, coherence and usefulness of the analysis.

Clinical Trials as Topic↗

The "Let's Get Alarmed!" initiative: a smoke alarm giveaway programme.

OBJECTIVES: To reduce fires and fire related injuries by increasing the prevalence of functioning smoke alarms in high risk households. SETTING: The programme was delivered in an inner London area with above average material deprivation and below average smoke alarm ownership. The target population included low income and rental households and households with elderly persons or young children. METHODS: Forty wards, averaging 4000 households each, were randomised to intervention or control status. Free smoke alarms and fire safety information were distributed in intervention wards by community groups and workers as part of routine activities and by paid workers who visited target neighbourhoods. Recipients provided data on household age distribution and housing tenure. Programme costs were documented from a societal perspective. Data are being collected on smoke alarm ownership and function, and on fires and related injuries and their costs. RESULTS: Community and paid workers distributed 20,050 smoke alarms, potentially sufficient to increase smoke alarm ownership by 50% in intervention wards. Compared with the total study population, recipients included greater proportions of low income and rental households and households including children under 5 years or adults aged 65 and older. Total programme costs were 145,087 Pounds. CONCLUSIONS: It is possible to implement a large scale smoke alarm giveaway programme targeted to high risk households in a densely populated, multicultural, materially deprived community. The programme's effects on the prevalence of installed and functioning alarms and the incidence of fires and fire related injuries, and its cost effectiveness, are being evaluated as a randomized controlled trial.

Adolescent↗

Benefit valuation in economic evaluation of cancer therapies. A systematic review of the published literature.

Generic measures of benefit which employ individuals' preferences, such as the quality-adjusted life-year (QALY), are, in principle, the most appropriate outcome measure to use in the economic evaluation of cancer therapies. They can reflect the trade-offs between health-related quality of life (HR-QOL) and length of life, between different dimensions of HR-QOL and between the process (e.g. convenience) and outcome characteristics of treatments. This paper reviews the methods literature on preference-based measures of benefit in economic evaluation, with the aim of establishing good practice for applied studies using these methods. A systematic review of applied economic evaluations of cancer therapies which have used these types of benefit measure was performed with the aim of establishing whether studies in this area adhere to good practice. In total, 29 studies were reviewed, and the results showed that, in general, good methods are not being adopted. This may be due, in part, to authors not having the space in journals to detail their methods fully, but it is likely also to reflect the fact that good methods for the use of preference-based measures of benefit in economic evaluation have not been adequately disseminated.

Cost-Benefit Analysis↗

The cost-effectiveness of preference-based treatment allocation: the case of hysterectomy versus endometrial resection in the treatment of menorrhagia.

Typically, economic evaluation compares the costs and benefits of two or more interventions and seeks to identify the single superior option on the basis of relative cost-effectiveness. It is then anticipated that all patients will receive the more or most cost-effective option. This 'all or nothing' approach can be departed from when sub-groups of patient exist, defined on the basis of clinical or demographic characteristics which are considered to influence benefit, for whom an option is cost-effective whilst not being so for the population of patients as a whole. However, patients' preferences concerning the different process characteristics and outcomes of an intervention will also influence the benefit they derive from health care. This paper explores the concept of preference-based sub-group analysis in economic evaluation to assess the potential cost-effectiveness of using patients' preferences to determine treatment allocation. The clinical example used to explore these methods is the comparison of abdominal hysterectomy (AH) and transcervical resection of the endometrial (TCRE) for the treatment of menorrhagia.

Catheter Ablation↗