Ethical challenges experienced by clinical research nurses:: A qualitative study.

Background:: Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse-participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility.

Efficient Research Design: Using Value-of-Information Analysis to Estimate the Optimal Mix of Top-down and Bottom-up Costing Approaches in an Economic Evaluation alongside a Clinical Trial.

In designing economic evaluations alongside clinical trials, analysts are frequently faced with alternative methods of collecting the same data, the extremes being top-down ("gross costing") and bottom-up ("micro-costing") approaches. A priori, bottom-up approaches may be considered superior to top-down approaches but are also more expensive to collect and analyze. In this article, we use value-of-information analysis to estimate the efficient mix of observations on each method in a proposed clinical trial.

Direct health costs of inflammatory polyarthritis 10 years after disease onset: results from the Norfolk Arthritis Register.

Objectives: To explore the change in direct medical costs associated with inflammatory polyarthritis (IP) 10 to 15 years after its onset.

Methods: Patients from the Norfolk Arthritis Register who had previously participated in a health economic study in 1999 were traced 10 years later and invited to participate in a further prospective questionnaire-based study. The study was designed to identify direct medical costs and changes in health status over a 6-month period using previously validated questionnaires as the primary source of data.

The impact of double-blind placebo- controlled food challenge (DBPCFC) on the socioeconomic cost of food allergy in Europe.

Background: Double-blind placebo controlled food challenge (DBPCFC) is the gold standard diagnostic test in food allergy because it minimizes diagnostic bias.

Objective: To investigate the potential effect of diagnosis on the socioeconomic costs of food allergy.

Methods: A prospective longitudinal cost analysis study was conducted in Spain and Poland within the EuroPrevall project.

Comparing time use in individuals at different stages of psychosis and a non-clinical comparison group.

Social functioning difficulties are a common and disabling feature of psychosis and have also been identified in the prodromal phase. However, debate exists about how such difficulties should be defined and measured. Time spent in structured activity has previously been linked to increased psychological wellbeing in non-clinical samples and may provide a useful way of assessing social functioning in clinical settings.

Issues in the incorporation of economic perspectives and evidence into Cochrane reviews.

Background: Methods for systematic reviews of the effects of health interventions have focused mainly on addressing the question of 'What works?' or 'Is this intervention effective in achieving one or more specific outcomes?' Addressing the question 'Is it worth it given the resources available?' has received less attention. This latter question can be addressed by applying an economic lens to the systematic review process.This paper reflects on the value and desire for the consideration by end users for coverage of an economic perspective in a Cochrane review and outlines two potential approaches and future directions.

Costing program implementation using systematic reviews: interventions for the prevention of adolescent depression.

Systematic reviews can provide up-to-date syntheses of reliable evidence on "what works" to help policymakers, practitioners, and people who use services make well-informed decisions about social and behavioral interventions. However, systematic reviews of social and behavioral interventions do not typically include evidence on resource use and costs, critical dimensions for decision makers to consider when faced with limited resources and constrained budgets. This paper builds on existing recommendations for including evidence for resource use and costs in systematic reviews by illustrating the development and use of an instrument to code resource use and cost data from an existing systematic review on the effects of adolescent depression prevention programs and applying that instrument to 46 studies included in that review.

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.

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.

Randomised controlled trial and parallel economic evaluation of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR).

Objectives: To determine the comparative effectiveness and cost-effectiveness of conventional ventilatory support versus extracorporeal membrane oxygenation (ECMO) for severe adult respiratory failure.

Design: A multicentre, randomised controlled trial with two arms.

Setting: The ECMO centre at Glenfield Hospital, Leicester, and approved conventional treatment centres and referring hospitals throughout the UK.

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).

Evidence synthesis, economics and public policy.

Systematic reviews and syntheses of evidence are increasingly used to inform public policy decisions. Growing budgetary pressures mean that decision makers often need to consider evidence on the costs and efficiency of alternatives as well as their effects. There are a number of methodological challenges in the identification, appraisal, synthesis, interpretation and use of economic evidence.

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.

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.

Social and economic costs of food allergies in Europe: development of a questionnaire to measure costs and health utility.

Objectives: To develop a questionnaire to measure the additional social costs of food allergies (FAs). DATA SOURCE AND STUDY SETTING: People with FAs and sampled members of the general population (with and without FAs) in the Netherlands and the United Kingdom in 2006.

Study Design: (1) Literature review.

Cognitive behaviour therapy for improving social recovery in psychosis: cost-effectiveness analysis.

A randomised trial was conducted in order to estimate the clinical and cost-effectiveness of social recovery orientated cognitive behavioural therapy (SRCBT) for people diagnosed with psychosis, compared to case management alone (CMA). The mean incremental health and social care cost, and the mean incremental quality adjusted life year (QALY) gain, of SRCBT was calculated over the 9 month intervention period. The cost-effectiveness of SCRBT was in turn estimated, and considered in relation to the cost-effectiveness threshold of 20000 UK pounds per QALY.

Cognitive behaviour therapy for improving social recovery in psychosis: a report from the ISREP MRC Trial Platform Study (Improving Social Recovery in Early Psychosis).

Background: This study reports on a preliminary evaluation of a cognitive behavioural intervention to improve social recovery among young people in the early stages of psychosis showing persistent signs of poor social functioning and unemployment. The study was a single-blind randomized controlled trial (RCT) with two arms, 35 participants receiving cognitive behaviour therapy (CBT) plus treatment as usual (TAU), and 42 participants receiving TAU alone. Participants were assessed at baseline and post-treatment.

Integrating children's services in England: national evaluation of children's trusts.

Background: Poor co-ordination of services can have severe consequences for disadvantaged children with complex needs. Since 2003 national and local governments in England embarked on sweeping reforms aimed at improving and integrating local health, education and social services for children. These were to be organized locally by children's trusts and piloted by 35 children's trust pathfinders.

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.

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.

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.