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. Food-allergic patients were enrolled into the study and in all cases diagnosis was confirmed through a standardized DBPCFC. Data were collected through a self-administered survey on all aspects of health and social care resource use, costs of living, and costs of leisure activities. Costs were measured before and 6 months after the DBPCFC and reported in international dollars with 2007 as the benchmark year. Results: Forty-two patients were enrolled. Twenty-one patients had a negative DBPCFC and the suspected food was reintroduced into their diet. Comparing total direct costs before and after the DBPCFC, the reactive group spent a significantly higher amount (median increase of $813.1 over baseline), while the tolerant group’s spending decreased by a median of $87.3 (P=.031). The amount of money spent on food 6 months after diagnosis was also significantly higher in the reactive group (P=.040). Finally, a larger, but not statistically significant, decrease in total indirect costs was observed in the tolerant group compared with the reactive group ($538.3 vs $32.3). Conclusion: DBPCFC has an impact on indirect and direct costs of living. The main contribution to this increase was money spent on food (AU)

Introducción: La provocación oral doble ciego controlada con placebo (PODCCP) es prueba diagnóstica "gold standard" en alergia a alimentos. Objetivo: El objetivo de este estudio es investigar el efecto del diagnóstico en los costes socioeconómicos de la alergia a alimentos (AA). Métodos: Estudio prospectivo longitudinal de análisis de costes llevado a cabo en España y Polonia en el contexto de proyecto EuroPrevall. Se seleccionaron pacientes con AA y en todos los casos el diagnóstico fue estandarizado a través de una PODCCP estandarizada. Se utilizaron cuestionarios autoadministrados para recoger datos del uso de recursos sociosanitarios, coste de vida y coste de actividades de ocio. Los costes se midieron en dos puntos, antes y 6 meses después de PODCCP, expresados en dólares internacionales (nivel de costes 2007). Resultados: Se incluyeron 42 pacientes. 21 pacientes tuvieron una PODCCP negativa y se reintrodujo el alimento. Comparando los costes directos antes y después de PODCCP, el gasto en el grupo de pacientes reactivos fue significativamente mayor (mediana de incremento $813,1 a los 6 meses), mientras que en el grupo de pacientes tolerantes disminuyó una mediana de $87,3 (p=0,031). Los pacientes con una provocación positiva gastaron también más dinero en comida a los 6 meses del diagnóstico (p=0,040). Por último, los costes indirectos disminuyeron, aunque de forma no estadísticamente significativa, en el grupo de pacientes tolerantes comparado con los reactivos ($ 538,3 versus $32,3). Conclusión: La PODCCP tiene un impacto en los costes directos e indirectos, en su mayor parte debido al dinero gastado en comida (AU)

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. Food-allergic patients were enrolled into the study and in all cases diagnosis was confirmed through a standardized DBPCFC. Data were collected through a self-administered survey on all aspects of health and social care resource use, costs of living, and costs of leisure activities. Costs were measured before and 6 months after the DBPCFC and reported in international dollars with 2007 as the benchmark year. RESULTS: Forty-two patients were enrolled. Twenty-one patients had a negative DBPCFC and the suspected food was reintroduced into their diet. Comparing total direct costs before and after the DBPCFC, the reactive group spent a significantly higher amount (median increase of $813.1 over baseline), while the tolerant group's spending decreased by a median of $87.3 (P = .031). The amount of money spent on food 6 months after diagnosis was also significantly higher in the reactive group (P = .040). Finally, a larger, but not statistically significant, decrease in total indirect costs was observed in the tolerant group compared with the reactive group ($538.3 vs $32.3). CONCLUSION: DBPCFC has an impact on indirect and direct costs of living. The main contribution to this increase was money spent on food.

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. PARTICIPANTS: Patients aged 18-65 years with severe, but potentially reversible, respiratory failure, defined as a Murray lung injury score > or = 3.0, or uncompensated hypercapnoea with a pH < 7.20 despite optimal conventional treatment. INTERVENTIONS: Participants were randomised to conventional management (CM) or to consideration of ECMO. MAIN OUTCOME MEASURES: The primary outcome measure was death or severe disability at 6 months. Secondary outcomes included a range of hospital indices: duration of ventilation, use of high frequency/oscillation/jet ventilation, use of nitric oxide, prone positioning, use of steroids, length of intensive care unit stay, and length of hospital stay - and (for ECMO patients only) mode (venovenous/veno-arterial), duration of ECMO, blood flow and sweep flow. RESULTS: A total of 180 patients (90 in each arm) were randomised from 68 centres. Three patients in the conventional arm did not give permission to be followed up. Of the 90 patients randomised to the ECMO arm, 68 received that treatment. ECMO was not given to three patients who died prior to transfer, two who died in transit, 16 who improved with conventional treatment given by the ECMO team and one who required amputation and could not therefore be heparinised. Ninety patients entered the CM (control) arm, three patients later withdrew and refused follow-up (meaning that they were alive), leaving 87 patients for whom primary outcome measures were available. CM consisted of any treatment deemed appropriate by the patient's intensivist with the exception of extracorporeal gas exchange. No CM patients received ECMO, although one received a form of experimental extracorporeal arteriovenous carbon dioxide removal support (a clear protocol violation). Fewer patients in the ECMO arm than in the CM arm had died or were severely disabled 6 months after randomisation, [33/90 (36.7%) versus 46/87 (52.9%) respectively]. This equated to one extra survivor for every six patients treated. Only one patient (in the CM arm) was known to be severely disabled at 6 months. Patients allocated to ECMO incurred average total costs of 73,979 pounds compared with 33,435 pounds for those undergoing CM (UK prices, 2005). A lifetime model predicted the cost per quality-adjusted life-year (QALY) of ECMO to be 19,252 pounds (95% confidence interval 7622 pounds to 59,200 pounds) at a discount rate of 3.5%. Lifetime QALYs gained were 10.75 for the ECMO group compared with 7.31 for the conventional group. Costs to patients and their relatives, including out of pocket and time costs, were higher for patients allocated to ECMO. CONCLUSIONS: Compared with CM, transferring adult patients with severe but potentially reversible respiratory failure to a single centre specialising in the treatment of severe respiratory failure for consideration of ECMO significantly increased survival without severe disability. Use of ECMO in this way is likely to be cost-effective when compared with other technologies currently competing for health resources. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47279827.

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. METHOD: Seventy-seven participants were recruited from secondary mental health teams after presenting with a history of unemployment and poor social outcome. The cognitive behavioural intervention was delivered over a 9-month period with a mean of 12 sessions. The primary outcomes were weekly hours spent in constructive economic and structured activity. A range of secondary and tertiary outcomes were also assessed. RESULTS: Intention-to-treat analysis on the combined affective and non-affective psychosis sample showed no significant impact of treatment on primary or secondary outcomes. However, analysis of interactions by diagnostic subgroup was significant for secondary symptomatic outcomes on the Positive and Negative Syndrome Scale (PANSS) [F(1, 69)=3.99, p=0.05]. Subsequent exploratory analyses within diagnostic subgroups revealed clinically important and significant improvements in weekly hours in constructive and structured activity and PANSS scores among people with non-affective psychosis. CONCLUSIONS: The primary study comparison provided no clear evidence for the benefit of CBT in a combined sample of patients. However, planned analyses with diagnostic subgroups showed important benefits for CBT among people with non-affective psychosis who have social recovery problems. These promising results need to be independently replicated in a larger, multi-centre RCT.

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. METHODS: This study described and compared the experience of integrating children's services in all 35 children's trust pathfinders, covering 20% of children in England. It had a prospective mixed-methods design. Over 3 years we interviewed 147 managers and professionals working in the children's trusts, including 172 semi-structured interviews, carried out two questionnaire surveys of the 35 children's trusts and analysed official documents. RESULTS: In most areas different agencies jointly commissioned children's services, especially for mental health, disabilities and multi-purpose children's centres, and increasingly pooled finances. Provision of multi-agency and multi-professional services was increasing. Professionals generally supported these changes but found them stressful. All children's trusts appointed directors of children's services and established boards representing multiple agencies. Systems for sharing information about individual children were mostly in place but were still underused. Health services were generally less involved in joint work than were local authorities' education and social care services, with notable exceptions. Areas where local authorities and health authorities shared geographical boundaries made most progress. Some children's trusts made few changes beyond their statutory obligations. CONCLUSION: Children's trusts enabled major changes to services in areas where local actors and organizations were motivated and empowered. In other areas the remit of children's trusts was often too broad and vague to overcome entrenched organizational and professional divisions and interests. Policymakers need to balance facilitation of change in areas with dynamic change agents with methods for ensuring that dormant areas and agencies are not left behind.

Does befriending by trained lay workers improve psychological well-being and quality of life for carers of people with dementia, and at what cost? A randomised controlled trial.

OBJECTIVES: To determine whether a social support intervention (access to an employed befriending facilitator in addition to usual care) is effective compared with usual care alone. Also to document direct and indirect costs, and establish incremental cost-effectiveness. DESIGN: The Befriending and Costs of Caring (BECCA) trial was a cost-effectiveness randomised controlled trial. Data on well-being and resource use were collected through interviews with participants at baseline and at 6, 15 and 24 months. SETTING: This research was carried out in the English counties of Norfolk and Suffolk, and the London Borough of Havering. It was a community-based study. PARTICIPANTS: Participants were family carers who were cohabiting with, or providing at least 20 hours' care per week for, a community-dwelling relative with a primary progressive dementia. INTERVENTIONS: The intervention was 'access to a befriender facilitator' (BF). BFs, based with charitable/voluntary-sector organisations, were responsible for local befriending schemes, including recruitment, screening, training and ongoing support of befriending volunteers, and for matching carers with befrienders. The role of befrienders was to provide emotional support for carers. The target duration for befriending relationships was 6 months or more. MAIN OUTCOME MEASURES: Depression was measured by the Hospital Anxiety and Depression Scale (HADS) at 15 months postrandomisation. The health-related quality of life scale EQ-5D (EuroQol 5 Dimensions) was used to derive utilities for the calculation of quality-adjusted life-years (QALYs). RESULTS: A total of 236 carers were randomised into the trial (116 intervention; 120 control). At final follow-up, 190 carers (93 intervention; 97 control) were still involved in the trial (19% attrition). There was no evidence of effectiveness or cost-effectiveness from the primary analyses on the intention-to-treat population. The mean incremental cost per incremental QALY gained was in excess of 100,000 pounds, with only a 42.2% probability of being below 30,000 pounds per QALY gained. Where care-recipient QALYs were included, mean incremental cost per incremental QALY gained was 26,848 pounds, with a 51.4% probability of being below 30,000 pounds per QALY gained. Only 60 carers (52%) took up the offer of being matched with a trained lay befriender, and of these only 37 (32%) were befriended for 6 months or more. A subgroup analysis of controls versus those befriended for 6 months or more found a reduction in HADS-depression scores that approached statistical significance (95% CI -0.09 to 2.84). CONCLUSIONS: 'Access to a befriender facilitator' is neither an effective nor a cost-effective intervention in the support of carers of people with dementia, although there is a suggestion of cost-effectiveness for the care dyad (carer and care recipient). In common with many services for carers of people with dementia, uptake of befriending services was not high. However, the small number of carers who engaged with befrienders for 6 months or more reported a reduction in scores on HADS depression that approached statistical significance compared with controls (95% CI -0.09 to 2.84). While providing only weak evidence of any beneficial effect, further research into befriending interventions for carers is warranted.

Exploring the cost effectiveness of an immunization programme for rotavirus gastroenteritis in the United Kingdom.

Rotavirus is the most common cause of gastroenteritis in children aged <5 years old, two new vaccines have recently been developed which can prevent associated morbidity and mortality. While apparently safe and efficacious, it is also important to establish whether rotavirus immunization is cost effective. A decision analytical model which employs data from a review of published evidence is used to determine the cost effectiveness of a rotavirus vaccine. The results suggest that some of the health sector costs, and all of the societal costs, of rotavirus gastroenteritis in children can be avoided by an immunization programme. The additional cost to the health sector may be considered worthwhile if there is a sufficient improvement in the quality-of-life of children and parents affected by gastroenteritis; this study did not find any evidence of research which has measured the utility gains from vaccination.

Infantile gastroenteritis in the community: a cost-of-illness study.

Rotavirus infections are the main cause of gastroenteritis in infants and children and it is expected that by the age of 5 years, nearly every child will have experienced at least one episode of rotavirus gastroenteritis. While severe cases are hospitalized, milder disease is either treated at home or by the GP, and as such the true prevalence of rotavirus infection in the community, and the burden of disease, is unknown. This paper reports the results of a cost-of-illness study which was conducted alongside a structured community surveillance study. Forty-eight percent of our sample was found to have rotavirus acute gastroenteritis; and the average total cost of a child presenting with rotavirus gastroenteritis ranged between pound sterling 59 and pound sterling 143 per episode, depending on the perspective. Given the prevalence and severity of the disease, the estimated burden of rotavirus gastroenteritis to society is pound sterling 11.5 million per year.

Structured surveillance of infantile gastroenteritis in East Anglia, UK: incidence of infection with common viral gastroenteric pathogens.

The aim of this study was to investigate the burden of disease associated with gastroenteric viruses (rotavirus, norovirus, sapovirus, astrovirus and enteric adenovirus) using structured surveillance of children aged <6 years in the community. Faecal samples were collected between 2000 and 2003 from 685 children with symptoms of gastroenteritis. The children comprised three groups; 223 in the structured surveillance cohort, 203 in a community cohort and 259 in a cohort of hospitalized children. All samples were tested for the presence of viral pathogens using molecular methods. Questionnaires were sent to the parents/carers of the children recruited to the structured surveillance cohort in order to collect data that would allow an estimation of the severity of illness by means of the Vesikari score, and of the cost associated with gastrointestinal disease in this age group. A viral aetiological agent was detected in 53.5% of samples tested. Rotavirus was the most common pathogen found in all three cohorts followed by norovirus and enteric adenoviruses. Multiple viruses were found in 8% of the samples, and commonly involved rotavirus and any other virus. G1P[8] was the most commonly detected rotavirus strain and there was no significant difference in the distribution of rotavirus genotypes among the three cohorts. Analysis of the questionnaires indicated that rotavirus infections were likely to be more severe than any other virus infection, and children from whom a viral pathogen was identified were more likely to require rehydration therapy.

Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of bone morphogenetic protein (BMP) for the treatment of spinal fusions and the healing of fractures compared with the current standards of care. DATA SOURCES: Electronic databases, related journals and references from identified studies were searched in January 2006, with an updated search only for randomised controlled trials (RCTs) in November 2006. REVIEW METHODS: A systematic review of available data was conducted. The data from selected studies were then analysed and graded according to quality and processed to give a value to the efficacy of BMP. Existing models were modified or updated to evaluate the cost-effectiveness of BMP for open tibial fractures and spinal fusion. RESULTS: All selected trials were found to have several methodological weaknesses. Insufficient sample size in most trials, meant that patient baseline comparability between trial arms was not achieved and the statistical power to detect a moderate effect was low. Data did indicate that BMP increased fracture union among patients with acute tibial fractures and found that high-dose BMP is more effective than a lower dose for open tibial fractures. The healing rate in the BMP group was not found to be statistically significantly different from that in the autogenous bone grafting group for patients with tibial non-union fractures, but BMP reduced the number of secondary interventions in patients with acute tibial fractures compared with controls. There was very limited evidence that BMP in scaphoid non-union was safe and may help to accelerate non-union healing when used in conjunction with either autograft or allograft. There was evidence that BMP-2 is more effective than autogenous bone graft for radiographic fusion in patients with single-level degenerative disc disease. No significant difference was found when BMP-7 was compared with autograft for degenerative spondylolisthesis with spinal stenosis and spondylolysis. The use of BMP was associated with a reduced operating time, improvement in clinical outcomes and a shorter hospital stay as compared with autograft. The proportion of secondary interventions tended to be lower in the BMP group than the control, but not of statistical significance. Trial data on time to return to work postoperatively were sometimes difficult to interpret because of unclear or inappropriate data analysis methods. The incremental cost of BMP for open tibial fractures was estimated to be about 3.5 million pounds per year in the UK. The estimated incremental cost per quality-adjusted life-year (QALY) gained is 32,603 pounds. The probability that cost per QALY gained is less than 30,000 pounds for open tibial fracture is 35.5%. The cost-effectiveness ratio is sensitive to the price of BMP and the severity of open tibial fractures. The use of recombinant human bone morphogenetic protein for spinal fusion surgery may increase the cost to the UK NHS by about 1.3 million pounds per year. The estimated incremental cost per QALY gained was about 120,390 pounds. The probability that BMP is cost-effective (i.e. cost/QALY less than 30,000 pounds) was only 6.4%. From the societal perspective, the estimated total cost of using BMP for spinal fusion is about 4.2 million pounds per year in the UK. CONCLUSIONS: Additional BMP treatment plus conventional intervention is more effective than conventional intervention alone for union of acute open tibial fractures. The cost-effectiveness of additional BMP may be improved if the price of BMP is reduced or if BMP is mainly used in severe cases. BMP may eliminate the need for autogenous bone grafting so that costs and complications related to harvesting autograft can be avoided. In non-unions, there is no evidence that BMP is more or less effective than bone graft; however, it is currently used when bone graft and other treatments have failed. The use of BMP-2 in spinal fusion surgery seems to be more effective than autogenous bone graft in terms of radiographic spinal fusion among patients with single-level degenerative disc disease. There is a lack of evidence about the effectiveness of BMP for other spinal disorders including spondylolisthesis and spinal stenosis. There was limited evidence showing that BMP is associated with greater improvement in clinical outcomes. According to the results of economic evaluation, the use of BMP for spinal fusion is unlikely to be cost-effective. The following areas would benefit from further research: clinical trials of BMP that include formal economic evaluation, a multicentre RCT of fracture non-union and of interbody and/or posterolateral spinal fusion, trials of non-tibial acute long bone fractures, and RCTs comparing BMP-2, BMP-7 and controls.

Out-of-home day care for families living in a disadvantaged area of London: economic evaluation alongside a RCT.

BACKGROUND: Children born into poverty have lifelong disadvantages compared with those more fortunate; social interventions seek to break this cycle of poverty and deprivation. Early Years Centres are one such intervention. These were established in deprived areas in the UK to provide high quality out-of-home day care. This paper reports the results of an economic evaluation conducted alongside a randomized controlled trial of one of these centres in the Borough of Hackney, London. METHODS: Participants were randomized to receive either high quality day care as provided by the centre or to other child care that they secured for themselves where they chose to do so. Information on resource use (early years education and care, as well as health and social care) was collected over an 18-month period; this was valued using appropriate unit costs. The cost of education, social and health care together with the value of productivity gains and out-of-pocket costs were then compared with the effectiveness of the intervention, increased labour force participant in mothers. RESULTS: From the societal perspective, the value of employment outweighs the costs of health and social services used, and in both groups there are cost savings. These are greater in the intervention group, therefore Early Years day care is an efficient use of resources. However, there is a net cost to the public sector of providing the intervention. The cost of achieving an additional mother in the labour force at 18 months is pound38 550 (85% CI of -pound1273, pound416 172). CONCLUSION: From the societal perspective, over an 18-month period, all child care is cost saving, but high quality day care provided by the Early Years Centre is a cost-effective alternative to day care provided by other local services in Hackney. The public sector, however, incurs added expense from this intervention.

What are children's trusts? Early findings from a national survey.

BACKGROUND: The Children Act 2004 and National Service Framework for Children, Young People and Maternity Services require fuller integration of health, education and social services for children and young people in England and Wales. The UK government supported the establishment of 35 experimental children's trust pathfinders (henceforth called children's trusts) in England. METHODS: A questionnaire was completed by managers in all 35 children's trusts a year after their start. Children's trust documents were examined. Census and performance indicators were compared between children's trust areas and the rest of England. RESULTS: Children's trust areas had demographic and social characteristics typical of England. All children's trusts aimed to improve health, education and social services by greater managerial and service integration. All had boards representing the three sectors; other agencies' representation varied. Two-thirds of children's trusts had moved towards pooling budgets in at least some service areas. At this stage in their development, some had prioritized joint procurement or provision of services, with formal managerial structures, while others favoured an informal strategic planning, co-ordination and information sharing approach. The commonest priorities for services development were for disabled children (16 children's trusts), followed by early intervention (11) and mental health services (8). CONCLUSIONS: The diverse strategies adopted by these 35 children's trusts during their first year is due to their own characteristics and to the way government strategy developed during this period. Whilst some prioritized organizational development, joint financing and commissioning, and information sharing, others laid more emphasis on mechanisms for bringing front-line professionals closer together. Their experiences are of value to others deciding how best to integrate children's services.

The Coping with Asthma Study: a randomised controlled trial of a home based, nurse led psychoeducational intervention for adults at risk of adverse asthma outcomes.

BACKGROUND: Morbidity and mortality associated with severe asthma might be reduced by interventions that address psychosocial factors contributing to adverse outcomes. A study was undertaken to assess the effectiveness of a 6 month home based psychoeducational intervention delivered by a respiratory nurse specialist for adults at risk of adverse asthma outcomes. METHODS: A pragmatic randomised controlled trial was performed in 92 adults registered with hospital or primary care asthma clinics. All had previous hospital admissions and/or were on British Thoracic Society step 4-5 treatment and had failed to attend clinic appointments or were considered to have poor adherence to other aspects of their agreed management. Patients were visited in their homes for assessment and, where appropriate, intervention. The main outcomes measured were symptom control, asthma specific quality of life, and generic health status. RESULTS: At the 6 month primary time point there were no significant differences between usual care and intervention groups in mean symptom control, physical functioning, or mental health scores (differences (with 95% CI) -0.35 (-1.83 to 1.13), 3.10 (-11.42 to 17.63), 0.42 (-10.22 to 11.07), respectively). Small effects on asthma specific quality of life up to 12 months (e.g. adjusted difference at 12 months 0.13 (95% CI 0.02 to 0.25)) and short term effects on generic health status, which mirrored improvements in aspects of self-care observed at the end of the intensive phase of the intervention, were apparent only from fully adjusted analyses. CONCLUSIONS: A home based intervention provided by a nurse receiving psychological supervision may have effects on quality of life but is overall of limited long term benefit to adults at risk of adverse asthma outcomes.

A framework for measuring costs to society of IgE-mediated food allergy.

Both immunoglobulin E (IgE)-mediated food allergy and food intolerance can lead to many changes in personal behaviour and health care resource use which have important economic consequences. These costs will impact directly, indirectly and intangibly on both individuals and society in general. It is important to measure the cost of illness (COI) of food allergy as a first step in developing and evaluating measures to reduce and control the burden of illness. This paper outlines a framework for assessing COI of food allergy from different viewpoints. It offers a structure for identifying the different cost impacts on allergic and nonallergic consumers, food producers and society as a whole, and for scoping, measurement and valuation of relevant costs. Within this structure, the existing literature is reviewed. This review illustrates the lack of information and clear methodology for assessing costs of food allergy. The paper concludes that there is a need for a more structured research programme to generate data essential for future evaluations of procedures and technologies for the diagnosis, treatment and management of food allergy.

A systematic review to examine the impact of psycho-educational interventions on health outcomes and costs in adults and children with difficult asthma.

OBJECTIVES: Prior research has highlighted the importance of psychosocial factors in 'difficult' asthma. This study aimed to review the content, effectiveness and cost-effectiveness of psycho-educational interventions designed to address these factors in patients with severe and difficult asthma. DATA SOURCES: Thirty-two electronic databases and other sources were searched for studies of educational, self-management, psychosocial and multifaceted interventions. REVIEW METHODS: Abstracts were screened in duplicate, against prior definitions, to identify eligible interventions targeted to patients with forms of or risk factors for difficult asthma. Studies were classified by patient group (child, adult) and graded along two dimensions related to study design and relevance in terms of the degree to which they were judged to have targeted difficult asthma. Detailed data were extracted from studies meeting a minimum design and relevance threshold. Characteristics of studies were tabulated and results qualitatively synthesised. Where sufficiently similar studies reported adequate data about comparable outcomes, quantitative syntheses of results were undertaken using a random effects approach to calculate pooled relative risks (RR) or standardised mean differences (SMD), with 95% confidence intervals (CI). RESULTS: Searches identified over 23,000 citations. After initial screening and removal of duplicates, 4240 possibly relevant abstracts were assessed. Papers associated with 188 studies were initially obtained and classified. Fifty-seven studies including control groups and those that were judged to have at least 'possible' targeting of difficult asthma (35 in children, 21 in adults, 1 in both) were selected for in-depth review. The delivery, setting, timing and content of interventions varied considerably even within broad types. Reporting of interventions and methodological quality was often poor, but studies demonstrated some success in targeting and following up at-risk patients. Studies reporting data suitable for calculation of summary statistics were of higher quality than those that did not. There was evidence from these that, compared to usual or non-psycho-educational care, psycho-educational interventions reduced admissions when data from the latest follow-ups reported were pooled across nine studies in children (RR = 0.64, CI = 0.46-0.89) and six studies with possible targeting of difficult asthma in adults (RR = 0.57, CI = 0.34-0.93). In children, the greatest and only significant effects were confined to individual studies with limited targeting of difficult asthma and no long-term follow-up. Limited data in adults also suggested effects may not extend to those most at risk. There was no evidence of pooled effects of psycho-educational interventions on emergency attendances from eight studies in children (RR = 0.97, CI = 0.78-1.21) and four in adults (RR = 1.03, CI = 0.82-1.29). There were overall significant reductions in symptoms, similar in different sub-groups of difficult asthma, across four paediatric studies that could be combined (SMD = -0.45, CI = -0.68 to -0.22), but mixed results across individual adult studies. A few individual studies in children showed mainly positive effects on measures of self-care behaviour, but with respect to all other outcomes in adults and children, studies showed mixed results or suggested limited effectiveness of psycho-educational interventions. No studies of psychosocial interventions were included in any quantitative syntheses and it was not possible to draw clear conclusions regarding the relative effectiveness of educational, self-management and multifaceted programmes. Data on costs were very limited. Of the two well-designed economic evaluations identified, both of multifaceted interventions, one in children suggested an additional cost of achieving health gain in terms of symptom-free days. Provisional data from the other study suggested that in adults the significantly increased costs of providing an intervention were not offset by any short-term savings in use of healthcare resources or associated with improvements in health outcomes. CONCLUSIONS: There was some evidence of overall positive effects of psycho-educational interventions on hospital admissions in adults and children, and on symptoms in children, but limited evidence of effects on other outcomes. The majority of research and greatest effects, especially in adults, were confined to patients with severe disease but who lacked other characteristics indicative of difficult asthma or likely to put them at risk. A lack of good-quality research limited conclusions about cost-effectiveness. Although psycho-educational interventions may be of some benefit to patients with severe disease, there is currently a lack of evidence to warrant significant changes in clinical practice with regard to the care of patients with more difficult asthma. Further research is needed to: (1) standardise reporting of complex interventions; (2) extend and update this review; (3) improve identification of patients at risk from their asthma; (4) develop and test appropriate outcome measures for this group; and (5) design and evaluate, via the conduct of high-quality pragmatic RCTs, more powerful psycho-educational interventions that are conceptualised in terms of the ways in which psychosocial factors and asthma interact.

Postnatal support for mothers living in disadvantaged inner city areas: a randomised controlled trial.

STUDY OBJECTIVE: To evaluate the effect of two forms of postnatal social support for disadvantaged inner city mothers on maternal and child health outcomes. DESIGN: Randomised controlled trial with economic and process evaluations and follow up at 12 and 18 months. The two intervention groups received either the offer of a year of monthly supportive listening home visits by a support health visitor (SHV), or a year of support from community groups providing drop in sessions, home visiting and/or telephone support (CGS). Each was compared with a control group that received standard health visitor services. SETTING: Two disadvantaged boroughs of London, United Kingdom. PARTICIPANTS: 731 women from culturally diverse backgrounds with infants. MAIN RESULTS: At 12 and 18 months, there was little impact for either intervention on the main outcomes: child injury (SHV: relative risk 0.99; 95% confidence intervals 0.68 to 1.45, CGS: 0.91; 0.61 to1.36), maternal smoking (SHV: 0.86; 0.62 to 1.19, CGS: 0.97; 0.72 to 1.33) or maternal depression (SHV: 0.86; 0.62 to1.19, CGS: 0.93; 0.69 to 1.27). SHV women had different patterns of health service use (with fewer taking their children to the GP) and had less anxious experiences of motherhood than control women. User satisfaction with the SHV intervention was high. Uptake of the CGS intervention was low: 19%, compared with 94% for the SHV intervention. CONCLUSIONS: There was no evidence of impact on the primary outcomes of either intervention among this culturally diverse population. The SHV intervention was associated with improvement in some of the secondary outcomes.

Randomised controlled trial and cost consequences study comparing initial physiotherapy assessment and management with routine practice for selected patients in an accident and emergency department of an acute hospital.

OBJECTIVE: The Department of Health is reviewing the effectiveness of accident and emergency (A&E) departments. This study aimed to compare health and economic effects of physiotherapy initial assessment and management with routine practice in an A&E department. METHODS: Randomised controlled trial and cost and consequences study. Patients presenting at A&E were eligible if suspected at triage to have soft tissue injury without fracture. The efficacy end point was "days to return to usual activities". Secondary end points included patient satisfaction with their care and further health outcomes and cost data. RESULTS: 766 of 844 (915) patients were randomised. The median days before return to usual activities (available for 73% of those randomised) was greater in the physiotherapist group (41 days compared with 28.5 days; hazard ratio 0.85 p = 0.071). The physiotherapy group expressed greater satisfaction with their A&E care (on a scale of 1 to 5, median was 4.2 compared with 4.0, p<0.001), were more likely to be given advice and reassurance, and more likely to be provided with aids and appliances. Costs were the same between the two arms. CONCLUSION: There is evidence that physiotherapy leads to a prolonged time before patients return to usual activities. This study shows no clear danger from physiotherapy intervention and long term outcomes may be different but given these findings, a best estimate is that introducing physiotherapist assessment will increase costs to the health service and society. Routine care should continue be provided unless there is some reason why it is not feasible to do so and an alternative must be found.

The impact of day care on socially disadvantaged families: an example of the use of process evaluation within a randomized controlled trial.

AIM: This paper describes a process evaluation that was conducted alongside a randomized controlled trial of out-of-home pre-school day care. The evaluation aimed to: (1) describe the intervention; (2) document the day care received by participating families; (3) describe the social context of the trial; and (4) provide data to assist in the interpretation of trial outcomes. METHODS: The setting for the trial was an out-of-home day care Centre in Hackney, East London. Process data were collected through the use of questionnaires, interviews, and researcher field-notes. Data from questionnaires were collected from 120 mothers and included data on 143 children. Interviews were undertaken with 21 participating mothers. Staff also completed questionnaires and the Head of the Centre was interviewed. The quality of care provided was assessed using the Early Childhood Environment Rating Scale. RESULTS: Process data collected during the trial suggest that the day care provided was education-led, flexible in catering to families' needs, and was of a very high quality. The social context of the trial resulted in financial pressures, which may well have influenced the intervention provided. Data collected through in-depth interviews suggested that it may be the flexibility of day care that is particularly important in allowing women to return to paid employment, but that the loss of benefits when starting work may have meant no increase in household income. CONCLUSION: The paper illustrates the value of conducting a process evaluation alongside a randomized trial, particularly where complex interventions are involved. In this case, where the intervention was not provided by the research team, the evaluation allowed an insight into the content of a multifaceted intervention, which is useful in interpreting the trial's results, and in explaining the possible effects of the social context on the intervention.

The Social Support and Family Health Study: a randomised controlled trial and economic evaluation of two alternative forms of postnatal support for mothers living in disadvantaged inner-city areas.

OBJECTIVES: To determine whether increased postnatal support could influence maternal and child health outcomes. DESIGN: This was a randomised controlled trial comparing maternal and child health outcomes for women offered either of the support interventions with those for control women receiving standard services only. Outcome data were collected through questionnaires distributed 12 and 18 months postrandomisation. Process data were also collected. There was also an integral economic evaluation. SETTING AND PARTICIPANTS: Women living in deprived enumeration districts in selected London boroughs were eligible for the trial if they gave birth between 1 January and 30 September 1999. RESULTS: The 731 participants were found to be well matched in terms of socio-economic characteristics and health and support variables (14% of the participants were non-English speaking). Response rates at the two follow-up points were 90% and 82%. At both points there were no differences that could not be attributed to chance on the primary outcomes of maternal depression, child injury or maternal smoking. At the first follow-up, there was reduced use of general practitioners by support health visitor (SHV) children, but increased use of NHS health visitors and social workers by mothers. At the second follow-up, both community group support (CGS) and SHV mothers had less use of midwifery services (fewer were pregnant), and SHV mothers were less worried about their child's health and development. Uptake of the CGS intervention was low: 19%, compared with 94% for the SHV intervention. Satisfaction with the intervention among women in the SHV group was high. Based on the assumptions and conditions of the costing methods, the economic evaluation found no net economic cost or benefit of choosing either of the two interventions. CONCLUSIONS: There was no evidence of impact on the primary outcomes of either intervention. The SHV intervention was popular with women, and was associated with improvement in some of the secondary outcomes. This suggests that greater emphasis on the social support role of health visitors could improve some measures of family well-being. Possible areas for future research include a systematic review of social support and its effect on health; developing and testing other postnatal models of support that match more closely the age of the baby and the changing patterns of mothers' needs; evaluating other strategies for mobilising 'non-professional' support; developing and testing more culturally specific support interventions; developing more culturally appropriate standardised measures of health outcomes; providing longer term follow-up of social support interventions; and exploring the role of social support on the delay in subsequent pregnancy.