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Biomedical subjects

M Sculpher

Publications and source records attributed to M Sculpher.

At least 37 records · Page 2Linked to original sources

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↗

A cost-utility analysis of abdominal hysterectomy versus transcervical endometrial resection for the surgical treatment of menorrhagia.

Menorrhagia, or heavy regular menstrual bleeding, represents a major health burden to women. Trials comparing abdominal hysterectomy (AH) with transcervical resection of the endometrium (TCRE) for the condition have shown that, although the duration and severity of convalescence is less with TCRE, AH produces a permanent solution to heavy bleeding while TCRE fails in a proportion of women by 2 years. However, by 2 years, TCRE costs only 71% that of AH. This paper presents a cost-utility analysis to assess which procedure is more cost-effective overall. Under most plausible parameter values and on the basis of health state values elicited from a sample of women with menorrhagia, AH is likely to be considered more cost-effective than TCRE if purchasers are willing to pay an additional cost of at least 6,500 Pounds per extra quality-adjusted life-year generated by AH.

Adult↗

An introduction to Markov modelling for economic evaluation.

Markov models are often employed to represent stochastic processes, that is, random processes that evolve over time. In a healthcare context, Markov models are particularly suited to modelling chronic disease. In this article, we describe the use of Markov models for economic evaluation of healthcare interventions. The intuitive way in which Markov models can handle both costs and outcomes make them a powerful tool for economic evaluation modelling. The time component of Markov models can offer advantages of standard decision tree models, particularly with respect to discounting. This paper gives a comprehensive description of Markov modelling for economic evaluation, including a discussion of the assumptions on which the type of model is based, most notably the memoryless quality of Markov models often termed the 'Markovian assumption'. A hypothetical example of a drug intervention to slow the progression of a chronic disease is employed to demonstrate the modelling technique and the possible methods of analysing Markov models are explored. Analysts should be aware of the limitations of Markov models, particularly the Markovian assumption, although the adept modeller will often find ways around this problem.

Economics, Pharmaceutical↗

The iterative use of economic evaluation as part of the process of health technology assessment.

The economic evaluation of health care technologies has a key role within the new National Health Service health technology assessment process. There has, however, been little discussion of the best way of combining economic and clinical research. Economic evaluation should be iterative, generating progressively firmer estimates of cost-effectiveness and helping to maximise the efficiency of health care R&D. Here, four stages of economic analysis are suggested, starting with stage I when the basic clinical science is complete, and finishing with stage IV analysis to generalise the results of earlier studies to routine clinical practice.

Clinical Trials as Topic↗

The economic evaluation of the FIRST study: design of a prospective analysis alongside a multinational phase III clinical trial. Flolan International Randomized Survival Trial.

Prospective economic assessments of new pharmaceutical therapies are increasingly being incorporated into phase III clinical trials. We report on the design of an economic evaluation integrated into the Flolan International Randomized Survival Trial (FIRST). Economic evaluation was considered a critical component of the assessment of this therapy given the resources required to administer epoprostenol (Flolan), a therapy that would require lifelong continuous intravenous infusion. Economic secondary endpoints were incorporated in the clinical trial. The economic evaluation of the treatment was integrated into all aspects of study development, including study design, implementation, and monitoring. Since this was a multinational trial, special care was required to ensure that the protocol design was appropriate for all study countries. The economic assessment required the development of several methodologic components: a set of background economic concepts to guide protocol development, a set of resource items to be recorded when required for study participants; a set of data collection instruments for assessment of health-related quality of life for study patients; and a protocol for a resource costing exercise for the study. We report the data elements included in the study design, as well as a discussion of some of the issues faced in developing the economic evaluation for this trial.

Antihypertensive Agents↗

A cost-utility analysis of laser-assisted angioplasty for peripheral arterial occlusions.

Despite the perception of many people that lasers represent the cutting edge of high-technology medicine, this form of medical technology has been subject to relatively little rigorous evaluation. This dearth of research relates particularly to economic evaluation, where there have been few attempts to justify the high cost of laser equipment. This paper details an economic evaluation of the use of laser technology as a secondary adjunct to angioplasty to treat peripheral arterial occlusions. Using data from a range of sources, including a published randomized trial, a cost-utility model is developed to estimate the costs and benefits of the laser, relative to standard angioplasty. The best available data indicate a cost-effective role for the laser, but important areas of uncertainty exist, including the laser's secondary recanalization rate, which has been estimated on the basis of limited numbers of patients. This uncertainty suggests that further research is required before widespread diffusion of the laser for use in this clinical context.

Adult↗