Health sector costs of self-reported food allergy in Europe: a patient-based cost of illness study.

INTRODUCTION: Food allergy is a recognized health problem, but little has been reported on its cost for health services. The EuroPrevall project was a European study investigating the patterns, prevalence and socio-economic cost of food allergy. AIMS: To investigate the health service cost for food-allergic Europeans and the relationship between severity and cost of illness. METHODS: Participants recruited through EuroPrevall studies in a case-control study in four countries, and cases only in five countries, completed a validated economics questionnaire. Individuals with possible food allergy were identified by clinical history, and those with food-specific immunoglobulin E were defined as having probable allergy. Data on resource use were used to estimate total health care costs of illness. Mean costs were compared in the case-control cohorts. Regression analysis was conducted on cases from all 9 countries to assess impact of country, severity and age group. RESULTS: Food-allergic individuals had higher health care costs than controls. The mean annual cost of health care was international dollars (I$)2016 for food-allergic adults and I$1089 for controls, a difference of I$927 (95% confidence interval I$324-I$1530). A similar result was found for adults in each country, and for children, and was not sensitive to baseline demographic differences. Cost was significantly related to severity of illness in cases in nine countries. CONCLUSIONS: Food allergy is associated with higher health care costs. Severity of allergic symptoms is a key explanatory factor.

Methods used to identify and measure resource use in economic evaluations: a systematic review of questionnaires for older people.

This paper presents the findings of a systematic review of full or partial economic evaluations that included questions to service users or their carers to elicit information on the types, amounts or costs of community-based formal social care support provided to people 65 years and older. We have found that studies seldom report use of published validated questions for eliciting information from older people in the UK about their use of formal social care services. Given the political prominence of the debate over funding social care for older people, there remains a need for analysis of policy options. This requires reliable data on the receipt and payment for care. We recommend the development of improved questions on care that are clear, robust and up-to-date with developments in policy and practice.

Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial.

BACKGROUND: Severe acute respiratory failure in adults causes high mortality despite improvements in ventilation techniques and other treatments (eg, steroids, prone positioning, bronchoscopy, and inhaled nitric oxide). We aimed to delineate the safety, clinical efficacy, and cost-effectiveness of extracorporeal membrane oxygenation (ECMO) compared with conventional ventilation support. METHODS: In this UK-based multicentre trial, we used an independent central randomisation service to randomly assign 180 adults in a 1:1 ratio to receive continued conventional management or referral to consideration for treatment by ECMO. Eligible patients were aged 18-65 years and had severe (Murray score >3.0 or pH <7.20) but potentially reversible respiratory failure. Exclusion criteria were: high pressure (>30 cm H(2)O of peak inspiratory pressure) or high FiO(2) (>0.8) ventilation for more than 7 days; intracranial bleeding; any other contraindication to limited heparinisation; or any contraindication to continuation of active treatment. The primary outcome was death or severe disability at 6 months after randomisation or before discharge from hospital. Primary analysis was by intention to treat. Only researchers who did the 6-month follow-up were masked to treatment assignment. Data about resource use and economic outcomes (quality-adjusted life-years) were collected. Studies of the key cost generating events were undertaken, and we did analyses of cost-utility at 6 months after randomisation and modelled lifetime cost-utility. This study is registered, number ISRCTN47279827. FINDINGS: 766 patients were screened; 180 were enrolled and randomly allocated to consideration for treatment by ECMO (n=90 patients) or to receive conventional management (n=90). 68 (75%) patients actually received ECMO; 63% (57/90) of patients allocated to consideration for treatment by ECMO survived to 6 months without disability compared with 47% (41/87) of those allocated to conventional management (relative risk 0.69; 95% CI 0.05-0.97, p=0.03). Referral to consideration for treatment by ECMO led to a gain of 0.03 quality-adjusted life-years (QALYs) at 6-month follow-up [corrected]. A lifetime model predicted the cost per QALY of ECMO to be pound19 252 (95% CI 7622-59 200) at a discount rate of 3.5%. INTERPRETATION: We recommend transferring of adult patients with severe but potentially reversible respiratory failure, whose Murray score exceeds 3.0 or who have a pH of less than 7.20 on optimum conventional management, to a centre with an ECMO-based management protocol to significantly improve survival without severe disability. This strategy is also likely to be cost effective in settings with similar services to those in the UK. FUNDING: UK NHS Health Technology Assessment, English National Specialist Commissioning Advisory Group, Scottish Department of Health, and Welsh Department of Health.

Can choices between alternative hip prostheses be evidence based? a review of the economic evaluation literature.

BACKGROUND: Total hip replacement surgery places a considerable financial burden on health services and society. Given the large number of hip prostheses available to surgeons, reliable economic evidence is crucial to inform resource allocation decisions. This review summarises published economic evidence on alternative hip prostheses to examine the potential for the literature to inform resource allocation decisions in the UK. METHODS: We searched nine medical and economics electronic databases. 3,270 studies were initially identified, 17 studies were included in the review. Studies were critically appraised using three separate guidelines. RESULTS: Several methodological problems were identified including a lack of observed long term prosthesis survival data, limited up-to-date and UK based evidence and exclusion of patient and societal perspectives. CONCLUSIONS: More clinical trials including long term follow-up and economic evaluation are needed. These should compare the cost-effectiveness of different prostheses with longer-term follow-up and including a wider perspective.

Bone morphogenetic protein (BMP) for fracture healing in adults.

BACKGROUND: Delay in fracture healing is a complex clinical and economic issue for patients and health services. OBJECTIVES: To assess the incremental effectiveness and costs of bone morphogenetic protein (BMP) on fracture healing in acute fractures and nonunions compared with standards of care. SEARCH STRATEGY: We searched The Cochrane Library (2008, Issue 4), MEDLINE, and other major health and health economics databases (to October 2008). SELECTION CRITERIA: Randomised controlled trials (RCTs) and full or partial economic evaluations of BMP for fracture healing in skeletally mature adults. DATA COLLECTION AND ANALYSIS: All clinical and economic data were extracted by one author and checked by another. MAIN RESULTS: Eleven RCTs, all at high risk of bias, and four economic evaluations were included. Apart from one study, the times to fracture healing were comparable between the BMP and control groups. There was some evidence for increased healing rates, without requiring a secondary procedure, of BMP compared with usual care control in acute, mainly open, tibial fractures (risk ratio (RR) 1.19, 95% CI 0.99 to 1.43). The pooled RR for achieving union for nonunited fractures was 1.02 (95% CI 0.90 to 1.15). One study found no difference in union for patients who had corrective osteotomy for radial malunions. Data from three RCTs indicated that fewer secondary procedures were required for acute fracture patients treated with BMP versus controls (RR 0.65, 95% CI 0.50 to 0.83). Adverse events experienced were infection, hardware failure, pain, donor site morbidity, heterotopic bone formation and immunogenic reactions. The evidence on costs for BMP-2 for acute open tibia fractures is from one large RCT. This indicates that the direct medical costs associated with BMP would generally be higher than treatment with standard care, but this cost difference may decrease as fracture severity increases. Limited evidence suggests that the direct medical costs associated with BMP could be offset by faster healing and reduced time off work for patients with the most severe open tibia fractures. AUTHORS' CONCLUSIONS: This review highlights a paucity of data on the use of BMP in fracture healing as well as considerable industry involvement in currently available evidence. There is limited evidence to suggest that BMP may be more effective than controls for acute tibial fracture healing, however, the use of BMP for treating nonunion remains unclear. The limited available economic evidence indicates that BMP treatment for acute open tibial fractures may be more favourable economically when used in patients with the most severe fractures.

Measuring the benefits of treatment for psychosis: validity and responsiveness of the EQ-5D.

BACKGROUND: The UK National Institute for Health and Clinical Excellence (NICE) has recommended that cost-effectiveness analysis includes the EQ-5D; however, this is often not implemented in the area of mental health. AIMS: To assess the appropriateness of using the EQ-5D to measure improvements in mental health. METHOD: Seventy-seven participants with psychosis were rated according to the EQ-5D and seven measures of mental health at both pre- and post-intervention. To assess construct validity we compared the (pre-intervention) mean EQ-5D scores for those with milder and more severe scores, according to each of the seven measures. To assess responsiveness we estimated the mean EQ-5D change score for those who improved (post-intervention), according to each of the measures. RESULTS: The mean EQ-5D score was more favourable for both those with milder scores (mean difference: 0.044 to 0.301) and for those who improved post-intervention (mean change: 0.029 to 0.117). CONCLUSIONS: This suggests the EQ-5D should be considered for use in future cost-effectiveness studies in the area of mental health.

Befriending carers of people with dementia: a cost utility analysis.

OBJECTIVE: There is very little evidence on the cost-effectiveness of social care interventions for people with dementia or their carers. The BEfriending and Costs of CAring trial (BECCA, ISRCTN08130075) aimed to establish whether a structured befriending service improved the quality of life of carers of people with dementia, and at what cost. METHODS: We performed an economic evaluation alongside a single blind, randomised controlled trial in a community setting of 236 carers of people with a primary progressive dementia. The intervention was contact with a Befriender Facilitator (BF), and offer of match with a trained lay volunteer befriender compared with no BF contact. Main outcome measures were health and social care, voluntary sector, and family care costs and quality adjusted life years (QALYs) in carers over 15 months. RESULTS: Mean QALYs per carer over 15 months were 0.017 higher in the intervention group compared with control (95%CI: -0.051, 0.083). Mean costs from a societal perspective were pound 1,813 higher (- pound 11,312, pound 14,984). The point estimate Incremental Cost Effectiveness Ratio (ICER) is thus pound 105,954 per incremental QALY gained. Probabilistic sensitivity analysis suggests a 42.2% probability that the ICER is below pound 30,000 per QALY. Inclusion of dementia patient QALYs reduces the ICER to pound 28,848 (51.4% probability below pound 30,000). CONCLUSIONS: Befriending leads to a non-significant trend towards improved carer quality of life, and there is a non-significant trend towards higher costs for all sectors. It is unlikely that befriending is a cost-effective intervention from the point of view of society.

Is it feasible to pool funds for local children's services in England? Evidence from the national evaluation of children's trust pathfinders.

OBJECTIVES: To describe how funds were pooled or otherwise jointly managed by National Health Service (NHS) primary care trusts and local authorities in England. To compare expenditure on local children's services by health, education and social services. METHODS: We conducted a questionnaire survey of all 35 children's trust pathfinders, six months after they were launched, with a follow-up at 2.5 years. We also undertook an in-depth analysis of local authorities and primary care trusts, within eight pathfinder areas and three non-pathfinder areas, whereby we compared expenditure on children's services, interviewed managers and professionals and examined financial documents. RESULTS: Local authorities and NHS trusts coordinated expenditure in various ways, most commonly through informal agreements and aligning budgets but also by formally pooling budgets. The latter were usually for selected services such as child and adolescent mental health services, though four children's trusts pathfinders pooled (or aligned) their budgets for all children's services. Total expenditure per child was greatest for education, lowest for social services and intermediate for health. However, it was difficult to quantify education expenditure on children with health and social care needs, and health care expenditure on children. CONCLUSIONS: Sharing money for local children's services requires shared objectives, trust, and legal and accounting expertise. Several different mechanisms are permitted and many are feasible but programme budgeting for children's services could make them more effective.

Economic implications of newborn screening for cystic fibrosis: a cost of illness retrospective cohort study.

BACKGROUND: Newborn screening for cystic fibrosis might not be introduced if implementation and running costs are perceived as prohibitive. Compared with clinical diagnosis, newborn screening is associated with clinical benefit and reduced treatment needs. We estimate the potential savings in treatment costs attributable to newborn screening. METHODS: Using the UK Cystic Fibrosis Database, we used a prevalence strategy to undertake a cost of illness retrospective snapshot cohort study. We estimated yearly costs of long-term therapies and intravenous antibiotics for 184 patients who were diagnosed as a result of screening as newborn babies, and 950 patients who were clinically diagnosed aged 1-9 years in 2002. Costs of adding cystic fibrosis screening to an established newborn screening service in Scotland were adjusted to 2002 prices and applied to the UK as a whole. Costs were recalculated in US$. FINDINGS: Cost of therapy for patients diagnosed by newborn screening was significantly lower than equivalent therapies for clinically diagnosed patients: mean ($7228 vs $12 008, 95% CI of difference -6736 to -2028, p<0.0001) and median ($352 vs $2442, -1916 to -180, p<0.0001). When we limited the clinically diagnosed group to only those diagnosable with a 31 cystic fibrosis transmembrane regulator mutation assay and assumed similar disease progression in the clinically diagnosed group as in the newborn screening group, we showed that mean ($3,397,344) or median ($947,032) drug cost savings could have offset the estimated cost of adding cystic fibrosis to a UK national newborn screening service ($2,971,551). INTERPRETATION: Including indirect costs savings, newborn screening for cystic fibrosis might have even greater financial benefits to society than our estimate shows. Clinical, social, and now economic evidence suggests that universal newborn screening programmes for cystic fibrosis should be adopted internationally.

Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants.

BACKGROUND: Neonatal extracorporeal membrane oxygenation (ECMO) is a complex procedure of life support used in severe but potentially reversible respiratory failure in term infants. Although the number of babies eligible for ECMO is small and the use of ECMO invasive and potentially expensive, its benefits may be high. OBJECTIVES: To determine whether ECMO used for neonatal infants with severe respiratory failure is clinically and cost effective compared to conventional ventilatory support. SEARCH STRATEGY: The Cochrane Neonatal Group Specialised Register, the Cochrane Controlled Trials Register, and MEDLINE were searched for 1974 to 2007. SELECTION CRITERIA: All randomised trials comparing neonatal ECMO to conventional ventilatory support. DATA COLLECTION AND ANALYSIS: The authors independently evaluated the trials for methodological quality and appropriateness for inclusion in the Review (without consideration of their results) and independently extracted the data. MAIN RESULTS: The four trials (three USA and one UK) recruited clinically similar groups of babies. Two trials excluded infants with congenital diaphragmatic hernias. In two trials, transfer for ECMO implied transport over long distances. Two trials had follow-up information. One study included economic evaluation. The three USA trials had very small numbers of patients. Two trials used conventional randomisation with low potential for bias. Two used less usual designs, which led to difficulties in their interpretation. All four trials showed strong benefit of ECMO on mortality (typical RR 0.44; 95% CI 0.31 to 0.61), especially for babies without congenital diaphragmatic hernia (typical RR 0.33, 95% CI 0.21 to 0.53). The UK trial provided follow up information about death or severe disability, and cost-effectiveness, and showed benefit of ECMO at one year (RR 0.56, 95% CI 0.40 to 0.78), four years (RR 0.62, 95% CI 0.45 to 0.86), and seven years (RR 0.64, 95% CI 0.47 to 0.86). Overall nearly half of the children recruited had died or were severely disabled by seven years of age, reflecting the severity of their underlying conditions. A policy of ECMO is as cost-effective as other intensive care technologies in common use. AUTHORS' CONCLUSIONS: A policy of using ECMO in mature infants with severe but potentially reversible respiratory failure results in significantly improved survival without increased risk of severe disability. The benefit of ECMO for babies with diaphragmatic hernia is unclear. Further studies are needed to consider the optimal timing for introducing ECMO; to identify which infants are most likely to benefit; and to address the implications of neonatal ECMO during later childhood and adult life.

Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR).

BACKGROUND: Extracorporeal Membrane Oxygenation (ECMO) is a technology used in treatment of patients with severe but potentially reversible respiratory failure. A multi-centre randomised controlled trial (CESAR) was funded in the UK to compare care including ECMO with conventional intensive care management. The protocol and funding for the CESAR trial included plans for economic data collection and analysis. Given the high cost of treatment, ECMO is considered an expensive technology for many funding systems. However, conventional treatment for severe respiratory failure is also one of the more costly forms of care in any health system. METHODS/DESIGN: The objectives of the economic evaluation are to compare the costs of a policy of referral for ECMO with those of conventional treatment; to assess cost-effectiveness and the cost-utility at 6 months follow-up; and to assess the cost-utility over a predicted lifetime. Resources used by patients in the trial are identified. Resource use data are collected from clinical report forms and through follow up interviews with patients. Unit costs of hospital intensive care resources are based on parallel research on cost functions in UK NHS intensive care units. Other unit costs are based on published NHS tariffs. Cost effectiveness analysis uses the outcome: survival without severe disability. Cost utility analysis is based on quality adjusted life years gained based on the Euroqol EQ-5D at 6 months. Sensitivity analysis is planned to vary assumptions about transport costs and method of costing intensive care. Uncertainty will also be expressed in analysis of individual patient data. Probabilities of cost effectiveness given different funding thresholds will be estimated. DISCUSSION: In our view it is important to record our methods in detail and present them before publication of the results of the trial so that a record of detail not normally found in the final trial reports can be made available in the public domain. TRIAL REGISTRATIONS: The CESAR trial registration number is ISRCTN47279827.

Genetic screening for cystic fibrosis: an overview of the science and the economics.

The aim of this paper is to provide an overview of the current scientific and economic thinking on the use of genetic technologies for cystic fibrosis (CF) screening. The paper takes a public health genetics viewpoint and gives an overview of the genetics behind CF, then describes current practices in screening for the disease. We then discuss the current literature on the economic evaluations of screening for CF. As the "wet" science improves, there are direct implications for health service. Therefore, it is important to keep examining both clinical practice and economics behind the technologies.

A systematic review of economic evaluation literature in Thailand: are the data good enough to be used by policy-makers?

In many countries, including Thailand, there is an increasing impetus to use economic evaluation to allow more explicit and transparent healthcare priority setting. However, an important question for policy makers in low- and middle-income countries is whether it is appropriate and feasible to introduce economic evaluation data into healthcare priority-setting decisions. In addition to ethical, social and political issues, information supply challenges need to be addressed. This paper systematically reviewed the literature on economic evaluation of health technology in Thailand published between 1982 and 2005. Its aim was to analyse the quantity, quality and targeting of economic evaluation studies that can provide a framework for those conducting similar reviews in other settings. The review revealed that, although the number of publications reporting economic evaluations has increased significantly in recent years, serious attention needs to be given to the quality of reporting and analysis. Furthermore, there is an absence of economic evaluation publications for 15 of the top 20 major health problems in Thailand, indicating a poor distribution of research resources towards the determination of cost-effective interventions for diminishing the disease burden of certain major health problems. If economic evaluation is only useful for policy makers when performed correctly and reported accurately, these findings depict information barriers to using economic evaluation to assist health decision-making processes in Thailand.

Economic evaluation of treatment administration strategies of ganciclovir for cytomegalovirus retinitis in HIV/AIDS patients in Thailand: a simulation study.

BACKGROUND: There are many effective interventions, via various routes (intravenous [IV], oral [OR], intravitreal injection [IVT] and intraocular implantation [IMP]), for treating cytomegalovirus retinitis (CMVR) that have become available. There are large variations in treating CMVR in clinical practice in Thailand. OBJECTIVE: To evaluate the incremental cost-effectiveness ratio (ICER) of providing (i) IVT, (ii) IV/OR and (iii) IMP ganciclovir to patients with HIV/AIDS and CMVR versus providing no treatment. DESIGN: A simulation study for which the input parameters were derived from a systematic review of the literature, a hospital-based survey and patient interviews. SETTING: The analysis assumed a Thai healthcare system perspective. However, the model was run using both societal and healthcare provider perspectives. RESULTS: Our results suggest that IVT ganciclovir was cost effective and the best option for treating patients with CMVR irrespective of whether patients received antiretroviral treatment (ART). In patients receiving ART, moving from IVT to IV/OR ganciclovir was also likely to be a cost-effective option. Offering IMP ganciclovir was not likely to be cost effective. Providing treatments for patients with bilateral CMVR was more cost effective than providing treatments for those with unilateral CMVR, and offering treatments for patients receiving ART was better value for money than treating patients without ART. CONCLUSIONS: Our models suggest that IV/OR ganciclovir should be recommended for the treatment of unilateral and bilateral CMVR for patients receiving ART in the Thai healthcare system. IVT ganciclovir may also have a role in the treatment of CMVR patients not receiving ART.

Methods for analyzing cost effectiveness data from cluster randomized trials.

BACKGROUND: Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. METHODS: We used data from a cluster randomized trial to demonstrate five appropriate analytic methods: 1) joint modeling of costs and effects with two-stage non-parametric bootstrap sampling of clusters then individuals, 2) joint modeling of costs and effects with Bayesian hierarchical models and 3) linear regression of net benefits at different willingness to pay levels using a) least squares regression with Huber-White robust adjustment of errors, b) a least squares hierarchical model and c) a Bayesian hierarchical model. RESULTS: All five methods produced similar results, with greater uncertainty than if cluster randomization was not accounted for. CONCLUSION: Cost effectiveness analyses alongside cluster randomized trials need to account for study design. Several theoretically coherent methods can be implemented with common statistical software.

Economics methods in Cochrane systematic reviews of health promotion and public health related interventions.

BACKGROUND: Provision of evidence on costs alongside evidence on the effects of interventions can enhance the relevance of systematic reviews to decision-making. However, patterns of use of economics methods alongside systematic review remain unclear. Reviews of evidence on the effects of interventions are published by both the Cochrane and Campbell Collaborations. Although it is not a requirement that Cochrane or Campbell Reviews should consider economic aspects of interventions, many do. This study aims to explore and describe approaches to incorporating economics methods in a selection of Cochrane systematic reviews in the area of health promotion and public health, to help inform development of methodological guidance on economics for reviewers. METHODS: The Cochrane Database of Systematic Reviews was searched using a search strategy for potential economic evaluation studies. We included current Cochrane reviews and review protocols retrieved using the search that are also identified as relevant to health promotion or public health topics. A reviewer extracted data which describe the economics components of included reviews. Extracted data were summarised in tables and analysed qualitatively. RESULTS: Twenty-one completed Cochrane reviews and seven review protocols met inclusion criteria. None incorporate formal economic evaluation methods. Ten completed reviews explicitly aim to incorporate economics studies and data. There is a lack of transparent reporting of methods underpinning the incorporation of economics studies and data. Some reviews are likely to exclude useful economics studies and data due to a failure to incorporate search strategies tailored to the retrieval of such data or use of key specialist databases, and application of inclusion criteria designed for effectiveness studies. CONCLUSION: There is a need for consistency and transparency in the reporting and conduct of the economics components of Cochrane reviews, as well as regular dialogue between Cochrane reviewers and economists to develop increased capacity for economic analyses alongside such reviews. Use of applicable economics methods in Cochrane reviews can help provide the international context within which economics data can be interpreted and assessed as a preliminary to full economic evaluation.

Cost effectiveness of prevention and treatment of neonatal respiratory distress (RDS) with exogenous surfactant: what has changed in the last three decades?

In 1993, exogenous surfactant products were emerging as licensed treatments for respiratory distress syndrome (RDS), a leading cause of death in preterm newborn babies. Models of cost-effectiveness of alternative treatments showed surfactant to be an expensive but effective and also cost effective treatment. However the most efficient policy for use of surfactant depended on other parallel 'technologies' such as giving antenatal corticosteroids where preterm delivery is anticipated. Following introduction into clinical practice, questions changed from whether to use surfactant, to when, and which product to use. The early models of cost effectiveness were dependent on the neonatal technology in use, and on the costs of neonatal care and prices of surfactant at the time. Little information was available about long term outcomes. The aims of this paper are to summarise the role of surfactant in the economics of newborn care since the late 1980s; to observe the value of studies published in the early 1990s for current decisions; and to comment on recent and possible future economic studies of neonatal surfactant.

CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure.

BACKGROUND: An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising. METHODS/DESIGN: The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR) is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress') by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18-65 years) with severe, but potentially reversible, respiratory failure (Murray score >/= 3.0 or hypercapnea with pH < 7.2) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital, Leicester or continuing conventional care in a centre providing a high standard of conventional treatment. The central randomisation service will minimise by type of conventional treatment centre, age, duration of high pressure ventilation, hypoxia/hypercapnea, diagnosis and number of organs failed, to ensure balance in key prognostic variables. Extracorporeal membrane oxygenation will not be available for patients meeting entry criteria outside the trial. 180 patients will be recruited to have 80% power to be able to detect a one third reduction in the primary outcome from 65% at 5% level of statistical significance (2-sided test). Secondary outcomes include patient morbidity and health status at 6 months. DISCUSSION: Analysis will be based on intention to treat. A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments.

Genetic health technology and economic evaluation: a critical review.

The aim of the review is to establish whether, on the basis of previous published evidence, current accepted guidance for health economic evaluation needs to be adapted to evaluate healthcare based on use of genetic information. Online literature search strategies were designed (using PubMed and the NHS Economic Evaluation Database [NHS EED], among others) to gather papers carrying out or discussing economic evaluation and genetics. Papers meeting the inclusion criteria were obtained and reviewed. The papers purporting to be economic analyses were classified using the criteria of the NHS EED and the British Medical Journal (BMJ) working party on peer review of health economic literature. Of 120 English-language papers that met the criteria for review, only 37 were economic evaluations according to the criteria set out by the NHS EED and BMJ working party on economic evaluations. Of these 37, only 33 papers discussed economic evaluation methodologies in the genetics context. The economic evaluation papers did not seem to tackle any of the problems discussed in the methodological papers. Economic evaluation methods offer a structured approach for evaluation of changes but may need to change in order to assess the new technologies. We have found that such studies have not been widely reported, and that those that have been reported do not depart from current economic methods. We have identified a need for better skills and guidance in health economics within this growing area of research.

Visiting adult patients in intensive care: the importance of relatives' travel and time costs.

UNLABELLED: Families of critically ill patients consistently rate visiting and being near their relative as very important. However, the costs incurred by families whilst visiting have received little attention. This study investigated the personal costs to informal caregivers (families, relatives and friends) visiting critically ill patients in an intensive care unit (ICU). The purpose of the study was (1) to test the feasibility of collecting data from informal caregivers visiting critically ill relatives and (2) to estimate the personal costs incurred by them. Data were collected by self-completed questionnaires over a 2-week period on out-of-pocket expenses and time foregone. RESULTS: One hundred and seven informal caregivers were invited to participate in the study. Fifty-four completed the questionnaire (response 50%). Forty-eight percent of respondents were male and 52% female. Fifty-nine percent of participants were in paid employment, and of these 16% lost wages as a result of the visit. The mean cost of time foregone was 46.21 pounds sterlings /visit (66.92 US dollars) and mean out-of-pocket expenses 29.30 pounds sterlings (42.43 US dollars). CONCLUSION: It is feasible to collect data on expenses and time foregone from informal caregivers visiting the ICU. The main out-of-pocket expense was that related to travel. More empirical work is needed across different settings to obtain more generalisable estimates of out-of-pocket expenses and time foregone.