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Biomedical subjects

F F Rutten

Publications and source records attributed to F F Rutten.

At least 19 recordsLinked to original sources

Analysis of costs and cost-effectiveness in multinational trials.

OBJECTIVES: the number of economic evaluations alongside multinational trials is increasing. Pooling of health effects of patients from different countries may be possible, but simply pooling costs does not give valid results and may not address national health policy issues properly. How should costs be handled in multinational economic evaluations? METHODS: a range of factors is discussed, that determine the (un)comparability of medical consumption and costs between countries; patient characteristics, epidemiology, patterns of medical practice, absolute and relative prices of medical services and cost estimation procedures. RESULTS: as an empirical example we investigated a clinical trial on breast cancer therapy in three European countries, focusing on the relationship between differences in medical practice and hospital medical consumption and costs. Correcting for differences in patient mix a multivariate analysis showed that differences in the number of laboratory procedures, day care treatments and outpatient visits between countries appear to be related to differences in medical practice. We calculated the costs of medical consumption as if all patients were treated in one country, correcting for these differences in medical practice. CONCLUSIONS: although the extent of the correction in this particular example was not very substantial, this approach seems a sensible way of analysis in order to investigate cost differences between countries in multinational trials. This provisional approach should be further developed and compared with alternative methods of correcting medical consumption and costs.

Breast Neoplasms↗

Quality of life and clinical outcome in psoriasis patients using intermittent cyclosporin.

BACKGROUND: Psoriasis causes considerable patient morbidity and can seriously affect a patient's quality of life (QoL). OBJECTIVES: To investigate the relationships between changes in QoL and measures of severity and extent of disease, and itch, in patients with chronic plaque psoriasis receiving intermittent short courses of cyclosporin (Neoral). METHODS: This study was performed as part of an international trial investigating the safety, efficacy and total costs of intermittent short courses of cyclosporin (the PISCES study). All patients received cyclosporin until clearance and were then followed up until relapse. On relapsing, patients received another course. Patients were followed up for a minimum of 1 year during which they could receive as many courses of treatment as necessary. In a subgroup (n = 255) of patients in the trial, the Dermatology Life Quality Index (DLQI) was used to assess the impact of psoriasis and its treatment on the patients' health status at the beginning and end of each treatment period. At the beginning and end of each treatment period, as well as at 2-weekly visits, the extent and severity of disease, together calculated into a modified Psoriasis Area and Severity Index (PASI), and itch were recorded. Data were analysed using the Wilcoxon matched pairs test, multivariate Hotelling's T2 tests, and Spearman's rank correlation coefficients (rs). RESULTS: During treatment, a clear impact on the overall DLQI scores and in the scores in all six DLQI headings was found (i.e. an improvement in QoL; P < 0.001 in all scores). Also, significant decreases in PASI and itch scores were found (P < 0.001). Multivariate analyses confirmed that a decrease in PASI and itch scores was accompanied by an impact on the DLQI scores during and between the two treatment periods (P < 0.0001). Statistically significant but weak correlations were found between changes in QoL and changes in PASI (rs = 0.40 and 0.24 for the first and second treatment periods, respectively) and itch scores (rs = 0.31 and 0.42, respectively). CONCLUSIONS: Intermittent short courses of cyclosporin clearly improve the QoL of the patients and decrease the extent and severity of disease and itch. Changes in clinical outcome scores are accompanied by changes in QoL. The weak correlations between changes in QoL and clinical measures may suggest that no clear relationship between QoL and clinical outcomes exists. However, due to the inclusion and exclusion criteria of the study, both QoL and clinical outcome measures do not show much variation among this homogeneous group of patients. As long as the relationship between clinical outcome parameters and measures of QoL is not completely clear, both measures of health should be considered in adequate, patient-orientated clinical decision making.

Adult↗

Lower urinary tract symptoms suggestive of benign prostatic obstruction--Triumph: health-economical analysis.

Given the ageing of western populations, the cost burden associated with the treatment of LUTS suggestive of BPO will increase substantially over the next few decades. Therefore, from the economic perspective, the primary objective of the Triumph project is the assessment of the cost-effectiveness of treatment options for lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO), formerly referred to as symptomtic benign prostatic hyperplasia (BPH), in medical practice in initially six European countries. All modalities of LUTS treatment used in these countries will be considered. The effectiveness and costs associated with these treatments will be assessed in each country. Data will be gathered from observed medical practice rather than in the setting of a trial. Country-specific aspects will be studied and the outcome of country-specific policies can be predicted. Patient quality of life will also be measured using the I-PSS score as a basis. A number of treatment scenarios will be assessed in terms of both their costs and long-term effects, using a computer simulation. These economic analyses will provide greatly improved insight into the most cost-effective treatments for LUTS suggestive of BPO.

Cost-Benefit Analysis↗

Healthcare resource utilisation and costs of treating NSAID-associated gastrointestinal toxicity. A multinational perspective.

OBJECTIVE: The aim of the study was to perform an economic analysis of a new therapy in 11 countries (Australia, Belgium, Finland, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and the UK) to assess the cost of treating the gastrointestinal (GI) events associated with the use of nonsteroidal anti-inflammatory drugs in patients with osteoarthritis and rheumatoid arthritis. METHODS: Estimates of GI event-related costs were based on the results of resource utilisation questionnaires. Resources required for the treatment and follow-up of GI events were identified and converted into costs from society and payer perspectives. RESULTS: From the perspective of society, the total per-event cost of managing GI-related events varies from $US51 to $US772 for GI discomfort, from $US108 to $US1100 for anaemia, from $US145 to $US1200 for ulcer and from $US1923 to $US5473 for serious GI events requiring hospitalisation. From the payer perspective, the total per-event cost varies from $US47 to $US680 for GI discomfort, from $US144 to $US762 for anaemia, from $US229 to $US795 for ulcer and from $US1787 to $US6729 for serious GI events requiring hospitalisation. The total cost is driven by hospital expenses for those events requiring hospital admission. For GI discomfort, physician consultations are generally the cost driver, whereas for ulcer and anaemia, cost is primarily driven by the rate of endoscopy. CONCLUSIONS: Costs associated with nonsteroidal anti-inflammatory drug-related GI events differ significantly across countries as a result of variations in resources consumed and price/tariff policies.

Anti-Inflammatory Agents, Non-Steroidal↗

The cost of treatment of Alzheimer's disease in The Netherlands: a regression-based simulation model.

OBJECTIVE: To examine the potential economic impact of treatment of Alzheimer's disease. DESIGN: Regression-based simulation estimation of the long term costs of Alzheimer's disease under a number of treatment scenarios. Data from an epidemiological study conducted in Rotterdam, The Netherlands, was used to simulate disease progression. Comparison of the costs and effectiveness experienced by the patients were used to measure the impact of treatment. PATIENTS AND INTERVENTION: 2 theoretical cohorts of patients with Alzheimer's disease, one of which receives standard treatment, while the other receives a treatment which slows cognitive decline as measured by the Mini-Mental State Examination (MMSE). MAIN OUTCOME MEASURES AND RESULTS: Under one of the scenarios examined, the baseline cost of Alzheimer's disease was 97,866 euro (EUR; 1996 values) per patient over 10 years' follow-up; the cost was almost EUR100,000 under all scenarios. Life expectancy following onset was about 4.5 years and MMSE decline was approximately 2 points per year for a typical prevalent (existing) patient and almost twice as much for incident (newly diagnosed) patients (1.82 vs 3.42 points per year, respectively). Slowing the rate of cognitive decline results in a slightly increased life expectancy, with more time being spent at home and less in a nursing home. Total costs (excluding those of therapy) will decrease, but savings will be modest and may well be less than the cost of therapy. Under the same scenario, total savings were EUR1,571 per patient which corresponds to an annual break-even cost of just EUR453. Decisions regarding the initiation or termination of therapy will affect both the number of patients treated and the costs and potential savings of treatment. CONCLUSIONS: The savings made in treating Alzheimer's disease will almost certainly be small in comparison with total costs and may well be offset by the cost of the treatment itself. Simulation models can be used to estimate the effect of therapy on the costs of care and can be useful tools in clinical decision-making and allocation of resources. These results show the need for further research into the costs and effects of treatment of Alzheimer's disease.

Aged↗

Cost effectiveness of continuous terbinafine compared with intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis: an analysis of based on results from the L.I.ON. study. Lamisil versus Itraconazole in Onychomycosis.

OBJECTIVE: To compare the costs and effectiveness of 2 oral antifungal treatment regimens in patients with dermatophyte toenail onychomycosis. DESIGN AND METHODS: A cost-effectiveness analysis using a model based on data from the Lamisil versus Itraconazole in Onychomycosis (L.I.ON.) study, a randomised controlled trial comparing continuous terbinafine with intermittent itraconazole. The trial included 4 treatment arms: terbinafine 250 mg/day for 12 or 16 weeks (T12, T16) and itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (I3, I4). Cost calculations for 6 countries (Finland, Germany, Iceland, Italy, The Netherlands, UK) included costs for medication, physician visits, laboratory tests, management of adverse events and management of relapse. Effectiveness was based on complete cure rates (mycological cure plus 100% toenail clearing). Costs per complete cure were determined and both average and incremental cost-effectiveness ratios were calculated. PERSPECTIVE: Healthcare system. MAIN OUTCOME MEASURES AND RESULTS: In the L.I.ON. study, terbinafine was seen to be more effective than itraconazole (cure rates, 45.8 vs 23.4%). In most comparisons (5 of the 6 countries), the costs of T12 were statistically significantly lower than those of I3 [range: -37 to -173 euros (EUR); 1998 values; 1.172 US dollars = EUR1], indicating that T12 was the dominant strategy (i.e. less expensive and more effective). One exception (Finland) showed an incremental cost-effectiveness ratio of EUR524 per additional cure. In the other 5 countries, T16 and 14 were essentially equal in cost, but the greater effectiveness of T16 (cure rates, 55.1 vs 25.9%) resulted in a situation of extended dominance. CONCLUSION: From a healthcare system perspective, continuous terbinafine is less costly and more effective than intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis.

Antifungal Agents↗

The cost effectiveness of tapered versus abrupt discontinuation of oral cyclosporin microemulsion for the treatment of psoriasis.

OBJECTIVE: To assess the cost effectiveness of tapered versus abrupt discontinuation of a microemulsion formulation of cyclosporin in patients with chronic plaque psoriasis. METHODS: A cost-effectiveness analysis was performed in parallel with a non-blind, multicentre, international clinical trial of the safety and efficacy of intermittent short courses of cyclosporin. Direct and indirect costs were considered within a 1-year period following randomisation. PATIENTS: Patients with chronic plaque psoriasis inadequately controlled with topical treatment. STUDY PERSPECTIVE: The study was conducted from a societal perspective and was performed using data from Canada, Spain, Turkey and the UK. MAIN OUTCOMES MEASURES: The health outcome used was the total number of systemic therapy-free days (STFDs) over the first year. The mean incremental cost-effectiveness ratio (ICER) was determined by dividing the differences in average cost per patient by the differences in average STFDs per patient. RESULTS: The overall ICER was dominant because tapered discontinuation was associated with both lower costs and improved efficacy in comparison with abrupt discontinuation. Further analyses showed that tapered discontinuation was a cost-effective alternative to abrupt discontinuation therapy, even when a conservative definition for cost effectiveness was adopted. CONCLUSION: This cost-effectiveness analysis demonstrated that tapering cyclosporin was more cost effective than abruptly stopping cyclosporin in patients with chronic plaque psoriasis.

Administration, Oral↗

[Roaming through methodology. XIX. Cost-effectiveness ratios].

A number of aspects must be kept in mind when interpreting cost-effectiveness ratios; it is important to realise, for example, that a cost-effectiveness ratio is a relative and not an absolute measure of efficiency. A cost-effectiveness ratio always involves a comparison of two interventions; therefore, the choice of the competing alternative has great impact on the reported, 'incremental', cost-effectiveness ratio and requires careful study. Furthermore, a cost-effectiveness ratio is meant to support a choice or decision. A check must be done to see whether the study context and the resulting cost-effectiveness ratio are appropriate for the choice or decision under consideration.

Cost-Benefit Analysis↗

Cost utility analysis of sildenafil compared with papaverine-phentolamine injections.

OBJECTIVE: To compare the cost effectiveness of sildenafil and papaverine-phentolamine injections for treating erectile dysfunction. DESIGN: Cost utility analysis comparing treatment with sildenafil (allowing a switch to injection therapy) and treatment with papaverine-phentolamine (no switch allowed). Costs and effects were estimated from the societal perspective. Using time trade-off, a sample of the general public (n=169) valued health states relating to erectile dysfunction. These values were used to estimated health related quality of life by converting the clinical outcomes of a trial into quality adjusted life years (QALYs). PARTICIPANTS: 169 residents of Rotterdam. MAIN OUTCOME MEASURES: Cost per quality adjusted life year. RESULTS: Participants thought that erectile dysfunction limits quality of life considerably: the mean utility gain attributable to sildenafil is 0.11. Overall, treatment with sildenafil gained more QALYs, but the total costs were higher. The incremental cost effectiveness ratio for the introduction of sildenafil was pound sterling 3639 in the first year and fell in following years. Doubling the frequency of use of sildenafil almost doubled the cost per additional QALY. CONCLUSIONS: Treatment with sildenafil is cost effective. When considering funding sildenafil, healthcare systems should take into account that the frequency of use affects cost effectiveness.

Adolescent↗

Intrauterine insemination or in-vitro fertilisation in idiopathic subfertility and male subfertility: a randomised trial and cost-effectiveness analysis.

BACKGROUND: Couples affected by idiopathic subfertility or male subfertility have an estimated spontaneous conception rate of about 2% per cycle. Although various infertility treatments are available, counselling of a couple in their choice of treatment is difficult because of the lack of consistent data from good-quality comparative studies. We compared the results of treatment with intrauterine insemination (IUI) with those of in-vitro fertilisation (IVF), and did a cost-effectiveness analysis. METHODS: In a prospective, randomised, parallel trial, 258 couples with idiopathic subfertility or male subfertility were treated for a maximum of six cycles of either IUI in the spontaneous cycle (IUI alone), IUI after mild ovarian hyperstimulation, or IVF. The primary endpoint was a pregnancy resulting in at least one livebirth after treatment. Cost-effectiveness based on real costs was studied by Markov chain analysis. FINDINGS: 86 couples were assigned IUI alone, 85 IUI plus ovarian hyperstimulation, and 87 IVF. Ten couples dropped out before treatment began. Although the pregnancy rate per cycle was higher in the IVF group than in the IUI groups (12.2% vs 7.4% and 8.7%, respectively; p=0.09), the cumulative pregnancy rate for IVF was not significantly better than that for IUI. Couples in the IVF group were more likely than those in the IUI groups to give up treatment before their maximum of six attempts (37 [42%] drop-outs vs 13 [15%] and 14 [16%], respectively; p<0.01). The woman's age was the only factor that influenced a couple's chance of success. IUI was a more cost-effective treatment than IVF (costs per pregnancy resulting in at least one livebirth 8423-10661 Dutch guilders [US$4511-5710] for IUI vs 27409 Dutch guilders [US$14679] for IVF). INTERPRETATION: Couples with idiopathic or male subfertility should be counselled that IUI offers the same likelihood of successful pregnancy as IVF, and is a more cost-effective approach. IUI in the spontaneous cycle carries fewer health risks than does IUI after mild hormonal stimulation and is therefore the first-choice treatment.

Adult↗

The evidence-based approach in health policy and health care delivery.

Evidence-based approaches are prominent on the national and international agendas for health policy and health research. It is unclear what the implications of this approach are for the production and distribution of health in populations, given the notion of multiple determinants in health. It is equally unclear what kind of barriers there are to the adoption of evidence-based approaches in health care practice. This paper sketches some developments in the way in which health policy is informed by the results from health research. It summarises evidence-based approaches in health at three impact levels: intersectoral assessment, national health care policy, and evidence-based medicine in everyday practice. Consensus is growing on the role of broad and specific health determinants, including health care, as well as on priority setting based on the burden of diseases. In spite of methodological constraints, there is a demand for intersectoral assessments, especially in health sector reform. Initiators of policy changes in other sectors may be held responsible for providing the evidence related to health. There are limited possibilities for priority setting at the national health care policy level. Hence, there is a decentralisation of responsibilities for resource use. Health care providers are encouraged to assume agency roles for both patients and society and asked to promote and deliver effective and efficient health care. Governments will have to design a national framework to facilitate their organisation and legal framework to enhance evidence-based health policy. Treatment guidelines supported by evidence on effectiveness and efficiency will be one essential element in this process. With the increasing number of advocates for the enhancement of population health in the policy arenas, evidence-based approaches provide the information and some of the tools to help with priority setting.

Cost-Benefit Analysis↗

Cost-effectiveness of neonatal surgery: a review.

BACKGROUND/PURPOSE: Technological developments have revolutionized both diagnosis and treatment in neonatal surgery. However, it has been increasingly recognized that financial resources might become insufficient to provide all the medical care that is technically feasible or that patients and families might desire. The purpose of this study is to apply the theory of health economics to neonatal surgery and to explore the extent and the kind of economic evaluation done in neonatal surgery. METHODS: To explore the work done so far, the authors undertook a literature search aimed at costs and effects of surgical interventions in newborns with Ravitch' surgical index diagnoses of congenital anomalies. Common keywords in cost-effectiveness analysis were used to search Medline. RESULTS: Evidence about the cost effectiveness of neonatal surgery is largely lacking. This is probably because of difficulties in long-term tracking of the patients and to the problem that most generic quality-of-life measures are not applicable in children yet. CONCLUSIONS: Further cost-effectiveness research in neonatal surgery is warranted to settle priority discussions in health care when neonatal surgery is part of such discussions. Methodology for generic quality-of-life measurement in children is badly needed.

Congenital Abnormalities↗

Cost of illness in adult patients with hypopituitarism.

OBJECTIVE: To compare the healthcare costs of patients with hypopituitarism with those of individuals from the general population. DESIGN: A retrospective study of costs over 1 year. Estimates of direct and indirect health-related costs were calculated for patients from the general population using existing databases, and for patients with hypopituitarism using records of all patients eligible to participate on 31 December 1989 who could be traced, were willing to participate and had not been treated for acromegaly or Cushing's disease. SETTING: The catchment area of the Endocrine Unit, Sahlgrenska Hospital, Gothenburg. The study was conducted from the societal perspective. Reference data were collected from official regional and national registries. PATIENTS: 199 patients with adult-onset hypopituitarism in whom replacement therapy was given to maintain the adrenal, thyroid and gonadal (but not the somatotropic) axes. MAIN OUTCOME MEASURES AND RESULTS: Direct and indirect costs incurred by patients with hypopituitarism were higher than those incurred by individuals from the general population. The total direct costs per patient were Swedish Crowns (SEK)22,920 vs SEK12,080 (p < 0.003) in the general population, and the highest costs were related to inpatient care. Of the patients aged 16 to 64 years, 22% had drawn a disability pension versus the expected 11.3% (p < 0.003) in the general population, and the patients had a mean sick leave of 38.4 days vs 23.5 (p < 0.001). Total excess costs for all patients with hypopituitarism were SEK 35,768 per patient (p < 0.007). CONCLUSIONS: Patients with hypopituitarism incur more health-related costs than individuals from the general population. They also take more sick leave days and are more likely to claim a disability pension than members of the general population. Further cost analyses are needed to determine whether improvements in diagnostic and surgical procedures, and hormone replacement therapy, can reduce the healthcare costs of patients with hypopituitarism.

Adult↗

Differences in attitudes, knowledge and use of economic evaluations in decision-making in The Netherlands. The Dutch results from the EUROMET Project.

OBJECTIVE: To investigate differences in attitudes, knowledge and actual use of economic evaluations in different groups of decision-makers, and to compare the results from the Netherlands with the overall European results of the European Network on Methodology and Application of Economic Evaluation Techniques (EUROMET) project. DESIGN AND SETTING: Members of the EUROMET group conducted interviews and surveys with politicians, regulators, hospital pharmacists and physicians in The Netherlands. Three approaches of investigation could be adopted: (i) a postal questionnaire survey, (ii) semi-structured interviews, and (iii) a focus-group approach. MAIN OUTCOME MEASURES AND RESULTS: In the Netherlands, decision-makers generally have a positive attitude towards economic evaluations. Nevertheless, their actual use and knowledge of economic evaluations are still limited. Hospital pharmacists and regulators are more objective than physicians and politicians, who also base their judgements on other societal values. Hospital pharmacists and regulators have a greater knowledge of economic evaluations, and they use them more often than the other groups. Most decision-makers do not want to base their decisions strictly on a cost-effectiveness ranking alone. Our findings were similar to the findings in other European countries. CONCLUSIONS: Decision-makers prefer to make their own broad comparisons of advantages and disadvantages, and do not base their decisions solely on a single summary measure.

Attitude↗

[Conditions for introduction and financing of new technologies].

Introduction and application of new technologies in the Dutch health care system will be less straightforward in the future than they were in the past. The pressure to contain health care expenditure has increased, also because of European agreements about adequate financing of collective spending. This will make initiators and producers of new technologies more critical towards technologies currently in development and urge them to specifically introduce technologies with a relatively favourable cost effectiveness profile. Whether new technologies will be used to a large extent will increasingly depend on the parties in health care at the regional and practice levels, who will assume a more important role in resource allocation in health care. On the other hand, they will be made more accountable for their decisions and will have to demonstrate their contribution to efficiency in health care.

Cost-Benefit Analysis↗

Productivity losses without absence: measurement validation and empirical evidence.

Productivity losses without absence are scarcely discussed in the literature. In this paper, the construct validity of three different measurement instruments for productivity losses without absence is investigated. The data were collected under employees of a Dutch trade firm, not in specific patient groups. On an average day, over 7% of the respondents were working with health problems, indicating that productivity losses without absence is quite a common problem. The amount of production losses related to these health problems are relatively small. However, for specific patient groups, the costs related to these productivity losses may be substantial.

Commerce↗