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Background Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. Objective This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. Design This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Setting Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Participants Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Intervention Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. Main outcome measures The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of Results We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data. Limitations Delays to the study prevented the use of alternative recruitment strategies and the planned 12-month follow-up could not be completed. Conclusions Recruitment was not feasible, but other feasibility outcomes were more positive. Future work Evaluating befriending for people with intellectual disability could be explored through alternative study designs, such as observational studies. Trial registration Current Controlled Trials ISRCTN63779614. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.

BACKGROUND People with intellectual disability (ID) are more likely to experience chronic depression compared with the general population, which may be compounded by loneliness and lower levels of social support. Befriending aims to provide social support and promote engagement in community activities. No randomised controlled trials have examined whether befriending improves symptoms of depression and social outcomes in people with ID. The aim of this pilot trial was to assess the feasibility and acceptability of a future larger trial of one-to-one befriending by volunteers in people with ID and depressive symptoms. METHODS Participants were adults with mild or moderate ID with a score of 5 or more on the Glasgow Depression Scale for People with Learning Disabilities (GDS-LD). They were randomised to the intervention arm (matched to a volunteer befriender for 6 months) or the control arm (usual care). Volunteers received training and supervision provided by two community befriending schemes. The main outcomes were feasibility of recruitment (minimum target n = 35), retention rate of participants, adherence (minimum 10 meetings), acceptability of the intervention, changes in depressive symptoms (assessed at baseline and 6 months) and feasibility of collecting data for a health economic analysis. RESULTS Recruitment was challenging, and only 16 participants with ID and 10 volunteers were recruited. Six participants were matched with a volunteer and no participants dropped out (except for two volunteers). Four participants completed 10 meetings (mean 11.8). Befriending was thought to be acceptable, but modifications were suggested. An exploratory analysis suggested that GDS-LD score was lower in the intervention group compared with the control group after adjusting for baseline scores, but not significant (adjusted mean difference: -4.0; 95% confidence interval: -11.2 to 3.2). CONCLUSIONS A large trial would not be feasible based on the recruitment strategies employed in this study. A further feasibility study addressing these challenges or the use of other study designs should be considered.

Background Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities. Methods This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30–59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation. Discussion Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities. Trial registration number Clinicaltrials.gov, NCT03086876. Registered 22nd March 2017, https://clinicaltrials.gov/ct2/show/NCT03086876.

BackgroundThe Alpha variant (B.1.1.7 lineage) of SARS-CoV-2 emerged and became the dominant circulating variant in the UK in late 2020. Current literature is unclear on whether the Alpha variant is associated with increased severity. We linked clinical data with viral genome sequence data to compare admitted cases between SARS-CoV-2 waves in London and to investigate the association between the Alpha variant and the severity of disease.MethodsClinical, demographic, laboratory and viral sequence data from electronic health record systems were collected for all cases with a positive SARS-CoV-2 RNA test between 13 March 2020 and 17 February 2021 in a multisite London healthcare institution. Multivariate analysis using logistic regression assessed risk factors for severity as defined by hypoxia at admission.ResultsThere were 5810 SARS-CoV-2 RNA-positive cases of which 2341 were admitted (838 in wave 1 and 1503 in wave 2). Both waves had a temporally aligned rise in nosocomial cases (96 in wave 1 and 137 in wave 2). The Alpha variant was first identified on 15 November 2020 and increased rapidly to comprise 400/472 (85%) of sequenced isolates from admitted cases in wave 2. A multivariate analysis identified risk factors for severity on admission, such as age (OR 1.02, 95% CI 1.01 to 1.03, for every year older; pConclusionsOur analysis is the first in hospitalised cohorts to show increased severity of disease associated with the Alpha variant. The number of nosocomial cases was similar in both waves despite the introduction of many infection control interventions before wave 2.

Background An unplanned hospital admission of a nursing home resident distresses the person, their family and nursing home staff, and is costly to the NHS. Improving health care in care homes, including early detection of residents’ health changes, may reduce hospital admissions. Previously, we identified four conditions associated with avoidable hospital admissions. We noted promising ‘within-home’ complex interventions including care pathways, knowledge and skills enhancement, and implementation support. Objectives Develop a complex intervention with implementation support [the Better Health in Residents in Care Homes with Nursing (BHiRCH-NH)] to improve early detection, assessment and treatment for the four conditions. Determine its impact on hospital admissions, test study procedures and acceptability of the intervention and implementation support, and indicate if a definitive trial was warranted. Design A Carer Reference Panel advised on the intervention, implementation support and study documentation, and engaged in data analysis and interpretation. In workstream 1, we developed a complex intervention to reduce rates of hospitalisation from nursing homes using mixed methods, including a rapid research review, semistructured interviews and consensus workshops. The complex intervention comprised care pathways, approaches to enhance staff knowledge and skills, implementation support and clarity regarding the role of family carers. In workstream 2, we tested the complex intervention and implementation support via two work packages. In work package 1, we conducted a feasibility study of the intervention, implementation support and study procedures in two nursing homes and refined the complex intervention to comprise the Stop and Watch Early Warning Tool (S&W), condition-specific care pathways and a structured framework for nurses to communicate with primary care. The final implementation support included identifying two Practice Development Champions (PDCs) in each intervention home, and supporting them with a training workshop, practice development support group, monthly coaching calls, handbooks and web-based resources. In work package 2, we undertook a cluster randomised controlled trial to pilot test the complex intervention for acceptability and a preliminary estimate of effect. Setting Fourteen nursing homes allocated to intervention and implementation support (n = 7) or treatment as usual (n = 7). Participants We recruited sufficient numbers of nursing homes (n = 14), staff (n = 148), family carers (n = 95) and residents (n = 245). Two nursing homes withdrew prior to the intervention starting. Intervention This ran from February to July 2018. Data sources Individual-level data on nursing home residents, their family carers and staff; system-level data using nursing home records; and process-level data comprising how the intervention was implemented. Data were collected on recruitment rates, consent and the numbers of family carers who wished to be involved in the residents’ care. Completeness of outcome measures and data collection and the return rate of questionnaires were assessed. Results The pilot trial showed no effects on hospitalisations or secondary outcomes. No home implemented the intervention tools as expected. Most staff endorsed the importance of early detection, assessment and treatment. Many reported that they ‘were already doing it’, using an early-warning tool; a detailed nursing assessment; or the situation, background, assessment, recommendation communication protocol. Three homes never used the S&W and four never used care pathways. Only 16 S&W forms and eight care pathways were completed. Care records revealed little use of the intervention principles. PDCs from five of six intervention homes attended the training workshop, following which they had variable engagement with implementation support. Progression criteria regarding recruitment and data collection were met: 70% of homes were retained, the proportion of missing data was Limitations The study homes may already have had effective approaches to early detection, assessment and treatment for acute health changes; consistent with government policy emphasising the need for enhanced health care in homes. Alternatively, the implementation support may not have been sufficiently potent. Conclusion A definitive trial is feasible, but the intervention is unlikely to be effective. Participant recruitment, retention, data collection and engagement with family carers can guide subsequent studies, including service evaluation and quality improvement methodologies. Future work Intervention research should be conducted in homes which need to enhance early detection, assessment and treatment. Interventions to reduce avoidable hospital admissions may be beneficial in residential care homes, as they are not required to employ nurses. Trial registration Current Controlled Trials ISRCTN74109734 and ISRCTN86811077. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 2. See the NIHR Journals Library website for further project information.

ObjectivesTo pilot a complex intervention to support healthcare and improve early detection and treatment for common health conditions experienced by nursing home (NH) residents.DesignPilot cluster randomised controlled trial.Setting14 NHs (7 intervention, 7 control) in London and West Yorkshire.ParticipantsNH residents, their family carers and staff.InterventionComplex intervention to support healthcare and improve early detection and treatment of urinary tract and respiratory infections, chronic heart failure and dehydration, comprising: (1) ‘Stop and Watch (S&W)’ early warning tool for changes in physical health, (2) condition-specific care pathway and (3) Situation, Background, Assessment and Recommendation tool to enhance communication with primary care. Implementation was supported by Practice Development Champions, a Practice Development Support Group and regular telephone coaching with external facilitators.Outcome measuresData on NH (quality ratings, size, ownership), residents, family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits, and unscheduled general practitioner visits monthly for 6 months during intervention. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed recruitment and retention, and whether a full trial was warranted.ResultsWe recruited 14 NHs, 148 staff, 95 family carers and 245 residents. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions. We were able to collect sufficient questionnaire data (all over 96% complete). No NH implemented intervention tools as planned. Only 16 S&W forms and 8 care pathways were completed. There was no evidence of harm.ConclusionsRecruitment, retention and data collection processes were effective but the intervention not implemented. A full trial is not warranted.Trial registration numberISRCTN74109734 (https://doi.org/10.1186/ISRCTN74109734).Original protocolBMJ Open. 2019;9(5):e026510. doi:10.1136/bmjopen-2018-026510.

Objectives:To develop a staff training intervention for agitation in people with severe dementia, reaching end-of-life, residing in nursing homes (NHs), test feasibility, acceptability, and whether a trial is warranted.Design:Feasibility study with pre- and post-intervention data collection, qualitative interviews, and focus groups.Setting:Three NHs in South East England with dementia units, diverse in terms of size, ownership status, and location.Participants:Residents with a dementia diagnosis or scoring ≥2 on the Noticeable Problems Checklist, rated as “severe” on Clinical Dementia Rating Scale, family carers, and staff (healthcare assistants and nurses).Intervention:Manualized training, delivered by nonclinical psychology graduates focusing on agitation in severe dementia, underpinned by a palliative care framework.Measurements:Main outcomes were feasibility of recruitment, data collection, follow-up, and intervention acceptability. We collected resident, family carer, and staff demographics. Staff provided data on resident’s agitation, pain, quality of life, and service receipt. Staff reported their sense of competence in dementia care. Family carers reported on satisfaction with end-of-life care. In qualitative interviews, we explored staff and family carers’ views on the intervention.Results:The target three NHs participated: 28 (49%) residents, 53 (74%) staff, and 11 (85%) family carers who were eligible to participate consented. Eight-four percent of staff attended ≥3 sessions, and we achieved 93% follow-up. We were able to complete quantitative interviews. Staff and family carers reported the intervention and delivery were acceptable and helpful.Conclusions:The intervention was feasible and acceptable indicating a larger trial for effectiveness may be warranted.

IntroductionPeople with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with an active control group.Methods and analysisThe trial aims to recruit 40 participants with ID. Participants in the intervention arm will receive weekly visits from a volunteer over 6 months. Community befriending schemes will recruit, train, supervise volunteers and match them to individuals with ID. Both groups will receive a booklet about local activities and have access to usual care. Health and social outcomes will be measured at the end of the intervention and 6 months’ follow-up. The following outcomes will be assessed: (1) recruitment and retention of individuals with ID and volunteers in the trial, (2) adverse events related to the intervention, (3) the acceptability of the intervention, (4) whether the intervention is delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis in a full trial. Qualitative data from participants, volunteers, staff and carers will identify barriers and facilitators of a future full trial.Ethics and disseminationThe study has been approved by the London City and East Research Ethics Committee (reference 18/LO/2188). The findings will be presented at conferences and published in a peer-reviewed journal and in the National Institute of Health Research journals library. A public engagement seminar will be held at the end of the study aimed at key stakeholders.Trial registration numberNCT63779614.

Background: Nursing home residents are often frail and most have complex healthcare needs. Hospitalisation is distressing to the person, their family and nursing home staff and costly for health services. Early detection of changes in residents’ health may reduce admissions. Our aim was to pilot a complex intervention with implementation support to improve early detection and treatment for four common Ambulatory Care Sensitive Conditions (ACSCs); urinary tract and respiratory infections, chronic heart failure and dehydration. Methods: Pilot cluster randomised controlled trial in 14 nursing homes (7 intervention, 7 control). The intervention involved 1) “stop and watch (S&W)” early warning tool for changes in physical health, 2) condition- specific care pathways and 3) Situation, Background, Assessment and Recommendation (SBAR) to structure communication with primary care. of Intervention implementation was supported by Practice Development Champions (PDCs) in the care home, a Practice Development Support Group (PDSG) and regular telephone coaching with external facilitators. We collected data on nursing homes (quality ratings, size, ownership), residents, their family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits and unscheduled GP visits monthly for 6 months during the intervention period. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed participant recruitment and retention and whether a full trial was warranted. Results: We recruited 14 nursing homes, 148 staff, 95 family carers and 245 residents. One nursing home closed prior to the intervention starting and another withdrew during the data collection phase. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions during follow-up. We were able to collect sufficient data on study questionnaires (all were over 96% complete). No home implemented intervention tools as planned. Only 16 S&W forms and 8 Care Pathways were completed. There was no evidence that the intervention was harmful.Conclusions: Study recruitment, retention, data collection and processes were effective but the intervention was not implemented in practice, therefore a full trial is not warranted. Trial registration: ISRCTN74109734 (registered 6/11/2017) https://doi.org/10.1186/ISRCTN74109734

BackgroundThe annual health check (AHC) programme, as part of a Directed Enhanced Service, offers an incentive to general practitioners in England to conduct health checks for people with intellectual disabilities (IDs). The aim of this analysis was to estimate the impact on health care costs of AHCs in primary care to the National Health Service in England by comparing adults with ID who did or did not have AHCs using data obtained from The Health Improvement Network.MethodsTwo hundred eight records of people with ID from The Health Improvement Network database were analysed. Baseline health care resource use was captured at the time the first AHC was recorded (i.e. index date), or the earliest date after 1 April 2008 for those without an AHC. We examined the volume of resource use and associated costs that occurred at the time AHCs were performed, as well as before and after the index date. We then estimated the impact of AHCs on health care costs.ResultsThe average cost of AHC was estimated at £142.57 (95%CI £135.41 to £149.74). Primary, community and secondary health care costs increased significantly after the index date in the no AHC group owing to higher increase in resource utilisation. Regression analysis showed that the expected health care cost for those who have an AHC is 56% higher than for those who did not have an AHC. Age and gender were also associated with increase in expected health care cost.ConclusionThe level of resource utilisation increased in both (AHC and no AHC) groups after the index date. Although the level of resource use before index date was lower in the no AHC group, it increased after the index date up to almost reaching the level of resource utilisation in the AHC group. Further research is needed to explore if the AHCs are effective in reducing health inequalities.

Evidence shows that surgery for severe obesity in adults improves health and psychological functioning, and is cost-effective. Data on bariatric surgery for adolescents with severe obesity are extremely limited, with no evidence on cost-effectiveness. We evaluated the lifetime cost-effectiveness of bariatric surgery compared with no surgery in adolescents with severe obesity from the UK's National Health Service perspective. Eighteen adolescents with body mass index ≥40 kg m-2 who underwent bariatric surgery (laparoscopic Roux en Y Gastric Bypass [RYGB] [N = 9], and laparoscopic Sleeve Gastrectomy [SG] [N = 9]) at University College London Hospitals between January 2008 and December 2013 were included. We used a Markov cohort model to compare the lifetime expected costs and quality-adjusted life years (QALYs) between bariatric surgery and no surgery. Mean cost of RYGB and SG procedures were £7100 and £7312, respectively. For RYGB vs. no surgery, the incremental cost/QALY was £2018 (95% CI £1942 - £2042) for males and £2005 (95% CI £1974 - £2031) for females. For SG vs. no surgery, the incremental cost/QALY was £1978 (95% CI £1954 - £2002) for males and £1941 (95% CI £1915 - £1969) for females. Bariatric surgery in adolescents with severe obesity is cost-effective; it is more costly than no surgery however it markedly improved quality of life.

Summary Background Many people with dementia living in care homes have distressing and costly agitation symptoms. Interventions should be efficacious, scalable, and feasible. Methods We did a parallel-group, cluster-randomised controlled trial in 20 care homes across England. Care homes were eligible if they had 17 residents or more with dementia, agreed to mandatory training for all eligible staff and the implementation of plans, and more than 60% of eligible staff agreed to participate. Staff were eligible if they worked during the day providing face-to-face care for residents with dementia. Residents were eligible if they had a known dementia diagnosis or scored positive on screening with the Noticeable Problems Checklist. A statistician independent of the study randomised care homes (1:1) to the Managing Agitation and Raising Quality of Life (MARQUE) intervention or treatment as usual (TAU) using computer-generated randomisation in blocks of two, stratified by type of home (residential or nursing). Care home staff were not masked to the intervention but were asked not to inform assessors. Residents with dementia, family carers, outcome assessors, statisticians, and health economists were masked to allocation until the data were analysed. MARQUE is an evidence-based manualised intervention, delivered by supervised graduate psychologists to staff in six interactive sessions. The primary outcome was agitation score at 8 months, measured using the Cohen-Mansfield Agitation Inventory (CMAI). Analysis of the primary outcome was done in the modified intention-to-treat population, which included all randomly assigned residents for whom CMAI data was available at 8 months. Mortality was assessed in all randomly assigned residents. This study is registered with the ISRCTN registry, number ISRCTN96745365. Findings Between June 14, 2016, and July 4, 2017, we randomised ten care homes (189 residents) to the MARQUE intervention and ten care homes (215 residents) to TAU. At 8 months, primary outcome data were available for 155 residents in the MARQUE group and 163 residents in the TAU group. At 8 months, no significant differences in mean CMAI scores were identified between the MARQUE and TAU groups (adjusted difference −0·40 [95% CI −3·89 to 3·09; p=0·8226]). In the intervention care homes, 84% of all eligible staff completed all sessions. The mean difference in cost between the MARQUE and TAU groups was £204 (−215 to 623; p=0·320) and mean difference in quality-adjusted life-years was 0·015 (95% CI −0·004 to 0·034; p=0·127). At 8 months, 27 (14%) of 189 residents in the MARQUE group and 41 (19%) of 215 residents in the TAU group had died. The prescription of antipsychotic drugs was not significantly different between the MARQUE group and the TAU group (odds ratio 0·66; 95% CI 0·26 to 1·69, p=0·3880). Interpretation The MARQUE intervention was not efficacious for agitation although feasible and cost-effective in terms of quality of life. Addressing agitation in care homes might require resourcing for delivery by professional staff of a more intensive intervention, implementing social and activity times, and a longer time to implement change. Funding UK Economic and Social Research Council and the National Institute of Health Research.

OBJECTIVE To assess clinical outcomes and cost-effectiveness of using continuous positive airway pressure (CPAP) to manage obstructive sleep apnea (OSA) in patients with type 2 diabetes (T2D) from the perspective of the U.K.’s National Health Service (NHS). RESEARCH DESIGN AND METHODS Using a case-control design, 150 CPAP-treated patients with OSA and T2D were randomly selected from The Health Improvement Network (THIN) database (a nationally representative database of patients registered with general practitioners in the U.K.) and matched with 150 OSA and T2D patients from the same database who were not treated with CPAP. The total NHS cost and outcomes of patient management in both groups over 5 years and the cost-effectiveness of CPAP compared with no CPAP treatment were estimated. RESULTS Using CPAP was associated with significantly lower blood pressure at 5 years and increasingly lower HbA1c levels over 5 consecutive years compared with untreated OSA patients. At 5 years, the HbA1c level in the CPAP-treated group was 8.2% (66.0 mmol/mol) vs. 12.1% (108.4 mmol/mol) in the control group (P < 0.03). Use of CPAP significantly increased patients’ health status by 0.27 quality-adjusted life years (QALYs) per patient over 5 years (P < 0.001) and NHS management costs by £4,141 per patient over 5 years; the cost per QALY gained with CPAP was £15,337. CONCLUSIONS Initiating treatment with CPAP in OSA patients with T2D leads to significantly lower blood pressure and better controlled diabetes and affords a cost-effective use of NHS resources. These observations have the potential for treatment modification if confirmed in a prospective study.

The objective of this study was to assess the cost-effectiveness of Polyheal compared with surgery in treating chronic wounds with exposed bones and/or tendons (EB&T) due to trauma in France, Germany and the UK, from the perspective of the payers. Decision models were constructed depicting the management of chronic wounds with EB&T and spanned the period up to healing or up to 1 year. The models considered the decision by a plastic surgeon to treat these wounds with Polyheal or surgery and was used to estimate the relative cost-effectiveness of Polyheal at 2010/2011 prices. Using Polyheal instead of surgery is expected to increase the probability of healing from 0·93 to 0·98 and lead to a total health-care cost of €7984, €7517 and €8860 per patient in France, Germany and the UK, respectively. Management with surgery is expected to lead to a total health-care cost of €12 300, €18 137 and €11 330 per patient in France, Germany and the UK, respectively. Hence, initial treatment with Polyheal instead of surgery is expected to lead to a 5% improvement in the probability of healing and a substantial decrease in health-care costs of 35%, 59% and 22% in France, Germany and the UK, respectively. Within the models' limitations, Polyheal potentially affords the public health-care system in France, Germany and the UK a cost-effective treatment for chronic wounds with EB&T due to trauma, when compared with surgery. However, this will be dependent on Polyheal's healing rate in clinical practice when it becomes routinely available.

Objective: To estimate the clinical effectiveness and cost effectiveness of using a sodium carboxymethylcellulose dressing (CMC [Aquacel]) and four superabsorbent dressings (DryMax Extra [DM], Flivasorb [F], Kerramax [K] and sachet S [S]) in the treatment of highly exuding chronic venous leg ulcers (VLUs) in the UK, from the perspective of the National Health Service (NHS). Method: A decision model was constructed depicting the patient pathways and associated management of a cohort of 439 patients with highly exuding chronic VLUs of ≥ 3 months of age. The model was based on the case records of a cohort of matched patients from The Health Improvement Network (THIN) database (a nationally representative database of patients registered with general practitioners (GPs) in the UK) who were treated with one of the five dressings. The model estimated the costs and outcomes of patient management over 6 months and the relative cost-effectiveness of using each dressing. Results: Patients' mean age was 73.1 years, and 46% were female. Between 39% and 56% of VLUs healed by 6 months. CMC-treated wounds that remained unhealed increased in size by 43% over the study period, whereas unhealed wounds treated with the other dressings decreased in size by a mean 34%. Consequently, CMC was excluded from the cost-effectiveness analysis. The 6-monthly NHS cost of managing a VLU with S was £3700 per patient, which was 15–28% lower than the cost of managing patients with the other three superabsorbents. Additonally, use of S improved patients' health status to a greater extent than the other three superabsorbents, since S-treated patients accrued 0.3–3% more QALYs. Starting treatment with S was the preferred strategy followed by DM, K and F in that order. Conclusion: Within the limitations of the data set, S affords the NHS a cost-effective treatment for managing highly exuding chronic VLUs of ≥3 months of age, compared with DM, F, K and CMC. Declaration of interest: This study was funded with an unrestricted research grant from Sorbion GmbH & Co. KG, Senden, Germany, manufacturers of sachet S. However, Sorbion did not have any control of the methodology, conduct, results or conclusion of this study, or editorial involvement in this manuscript. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript, which remains their sole responsibility

To cite this article: Taylor RR, Sladkevicius E, Panca M, Lack G, Guest JF. Cost-effectiveness of using an extensively hydrolysed formula compared to an amino acid formula as first-line treatment for cow milk allergy in the UK. Pediatric Allergy Immunology 2012: 23: 240–249. Abstract Objective: To estimate the cost-effectiveness of using an extensively hydrolysed formula (eHF; Nutramigen) compared with an amino acid formula (AAF; Neocate) as first-line treatment for cow milk allergy (CMA) in the UK, from the perspective of the National Health Service (NHS). Method: A decision model was constructed depicting the treatment paths and associated resource use attributable to first-line management of CMA with the two formulae. The model was based on the case records of 145 AAF-treated infants and 150 matched eHF-treated patients from The Health Improvement Network (THIN) database [a nationally representative database of patients registered with general practitioners (GPs) in the UK]. The model estimated the costs and consequences of patient management over 12 months following their initial GP visit for CMA. Results: Patients presenting with a combination of gastrointestinal symptoms and eczema accounted for 44% of all patients in both groups. Those with gastrointestinal symptoms alone and eczema alone accounted for up to a further 39% and 13%, respectively. Those with urticaria and faltering growth accounted for

summary Background & aims: To examine the effect of malnutrition on clinical outcomes and healthcare resource use from initial diagnosis by a general practitioner (GP) in the UK. Methods: 1000 records of malnourished patients were randomly selected from The Health Improvement Network database and matched with a sample of 996 patients’ records with no previous history of malnutrition. Patients’ outcomes and resource use were quantified for six months following diagnosis. Results: Malnourished patients utilised significantly more healthcare resources (e.g. 18.90 versus 9.12 GP consultations; p < 0.001, and 13% versus 5% were hospitalised; p < 0.05). The six-monthly cost of managing the malnourished and non-malnourished group was £1753 and £750 per patient respectively, generating an incremental cost of care following a diagnosis of malnutrition of £1003 per patient. Thirteen percent and 2% of patients died in the malnourished and non-malnourished group respectively (p < 0.001). Independent predictors of mortality were: malnutrition (OR: 7.70); age (per 10 years) (OR: 10.46); and the Charlson Comorbidity Index Score (per unit score) (OR: 1.24). Conclusion: The healthcare cost of managing malnourished patients was more than twice that of managing non-malnourished patients, due to increased use of healthcare resources. After adjusting for age and comorbidity, malnutrition remained an independent predictor of mortality.

ObjectiveTo undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care.DesignCost-utility analysis alongside a randomised controlled trial.SettingCommunity settings in Greater London, England.Participants174 young people with obesity aged 12–19 years.InterventionsIntervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice.Main outcome measuresMean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC).ResultsMean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI −0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained.ConclusionsWe did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective.Trial registration numberISRCTN99840111.

Objective To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) containing the probiotic Lactobacillus rhamnosus GG, (eHCF + LGG; Nutramigen LGG) as first-line management for cow’s milk allergy (CMA) compared with eHCF alone, soy-based formulae (SBF), hydrolyzed rice formulae (HRF), and amino acid formulae (AAF) in Italy, from the perspective of the Italian National Health Service (INHS) and parents. Methods Decision modeling was used to estimate the probability of infants developing tolerance to cow’s milk by 18 months, based on an observational study dataset. The model also estimated the cost (at 2012/2013 prices) of health care resource use funded by the INHS and formulae paid for by parents over 18 months after starting a formula, as well as the relative cost-effectiveness of each of the formulae. Results The probability of developing tolerance to cow’s milk by 18 months was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were fed eHCF + LGG compared to those fed one of the other formulae. The total health care cost of initially feeding infants with eHCF + LGG was less than that of feeding infants with one of the other formulae. Hence, eHCF + LGG affords the greatest value for money to both the INHS and parents of infants with either IgE-mediated or non-IgE-mediated CMA. Conclusion Using eHCF + LGG instead of eHCF, SBF, HRF, or an AAF for first-line management of newly diagnosed infants with CMA in Italy affords a cost-effective use of publicly funded resources, and is cost-effective from the parents’ perspective, since it improves outcome for less cost. A randomized controlled study showing faster tolerance development in children receiving a probiotic-containing formula is required before this conclusion can be confirmed.

BackgroundChildhood overweight and obesity have health and economic impacts on individuals and the wider society. Families participating in weight management programmes may foresee or experience monetary and other costs which deter them from signing up to or completing programmes. This is recognised in the health economics literature, though within this sparse body of work, costs to families are often narrowly defined and not fully accounted for. A societal perspective incorporating a broader array of costs may provide a more accurate picture. This paper brings together a review of the health economics literature on the costs to families attending child weight management programmes with qualitative data from families participating in a programme to manage child overweight and obesity.MethodsA search identified economic evaluation studies of lifestyle interventions in childhood obesity. The qualitative work drew on interviews with families who attended a weight management intervention in three UK regions.ResultsWe identified four cost-effectiveness analyses that include information on costs to families. These were categorised as direct (e.g. monetary) and indirect (e.g. time) costs. Our analysis of qualitative data demonstrated that, for families who attended the programme, costs were associated both with participation on the scheme and with maintaining a healthy lifestyle afterwards. Respondents reported three kinds of cost: time-related, social/emotionaland monetary.ConclusionSocietal approaches to measuring cost-effectiveness provide a framework for assessing the monetary and non-monetary costs borne by participants attending treatment programmes. From this perspective, all costs should be considered in any analysis of cost-effectiveness. Our data suggest that family costs are important, and may act as a barrier to the uptake, completion and maintenance of behaviours to reduce child obesity. These findings have implications for the development and implementation of child weight initiatives in particular, in relation to reducing inequalities in health.

Background. Doxorubicin/ifosfamide is a first-line systemic chemotherapy for the majority of advanced soft tissue sarcoma (ASTS) subtypes. Trabectedin is indicated for the treatment of ASTS after failure of anthracyclines and/or ifosfamide; however it is being increasingly used off-label as a first-line treatment. This study estimated the cost effectiveness of these two treatments in the first-line management of ASTS in Italy, Spain, and Sweden.Methods. A Markov model was constructed to estimate the cost effectiveness of doxorubicin/ifosfamide compared to trabectedin monotherapy, defined as the cost per QALY gained, in each country.Results. First-line treatment with doxorubicin/ifosfamide resulted in lower two-year healthcare costs and more QALYs than first-line treatment with trabectedin monotherapy in all three countries. Probabilistic sensitivity analysis showed that at a cost per QALY threshold of €35,000, >90% of a cohort would be cost effectively treated with doxorubicin/ifosfamide compared to trabectedin monotherapy in all three countries.Conclusion. Within the model’s limitations, first-line treatment of patients with ASTS with doxorubicin/ifosfamide instead of trabectedin monotherapy affords a cost-effective use of publicly funded healthcare resources in Italy, Spain, and Sweden and is therefore the preferred treatment in all three countries. These findings support the recommendation that trabectedin should remain a second-line treatment.

The objective of this study was to assess the cost‐effectiveness of Polyheal compared with surgery in treating chronic wounds with exposed bones and/or tendons (EB&T) due to trauma in France, Germany and the UK, from the perspective of the payers. Decision models were constructed depicting the management of chronic wounds with EB&T and spanned the period up to healing or up to 1 year. The models considered the decision by a plastic surgeon to treat these wounds with Polyheal or surgery and was used to estimate the relative cost‐effectiveness of Polyheal at 2010/2011 prices. Using Polyheal instead of surgery is expected to increase the probability of healing from 0·93 to 0·98 and lead to a total health‐care cost of €7984, €7517 and €8860 per patient in France, Germany and the UK, respectively. Management with surgery is expected to lead to a total health‐care cost of €12 300, €18 137 and €11 330 per patient in France, Germany and the UK, respectively. Hence, initial treatment with Polyheal instead of surgery is expected to lead to a 5% improvement in the probability of healing and a substantial decrease in health‐care costs of 35%, 59% and 22% in France, Germany and the UK, respectively. Within the models' limitations, Polyheal potentially affords the public health‐care system in France, Germany and the UK a cost‐effective treatment for chronic wounds with EB&T due to trauma, when compared with surgery. However, this will be dependent on Polyheal's healing rate in clinical practice when it becomes routinely available.

To estimate the cost-effectiveness of using an extensively hydrolysed formula (eHF; Nutramigen) compared with an amino acid formula (AAF; Neocate) as first-line treatment for cow milk allergy (CMA) in the UK, from the perspective of the National Health Service (NHS). A decision model was constructed depicting the treatment paths and associated resource use attributable to first-line management of CMA with the two formulae. The model was based on the case records of 145 AAF-treated infants and 150 matched eHF-treated patients from The Health Improvement Network (THIN) database [a nationally representative database of patients registered with general practitioners (GPs) in the UK]. The model estimated the costs and consequences of patient management over 12 months following their initial GP visit for CMA. Patients presenting with a combination of gastrointestinal symptoms and eczema accounted for 44% of all patients in both groups. Those with gastrointestinal symptoms alone and eczema alone accounted for up to a further 39% and 13%, respectively. Those with urticaria and faltering growth accounted for5% and ≤6% of all patients, respectively. Patients' age and weight at presentation was a mean 2.6-2.8 months and 4.4 kg, respectively. It took a mean 2.2 months to start a formula after initially seeing a GP. Time to symptom resolution following the start of treatment was 1.2 months in both groups; hence, the mean number of symptom-free months during the 12 months following the initial GP visit was estimated to be 8.6 months in both groups. Patients treated with an eHF had a mean 13.1 GP visits over the 12 months compared to 17.5 visits made by AAF-treated patients (p 0.001). The NHS cost of managing a CMA infant over the first 12 months following initial presentation to a GP was estimated to be £1853 and £3161 for an eHF-treated and AAF-treated patient, respectively. Starting treatment for CMA with an eHF was the cost-effective option, as there were no significant differences in clinical outcomes between the two groups. A prospective, randomized controlled trial would allow a definitive confirmation of these findings.

Julian F Guest,1,2 Monica Panca,1 Olga Ovcinnikova,1 Rita Nocerino3 1CATALYST Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King's College, London, UK; 3Department of Translational Medical Science, Pediatric Section, University of Naples 'Federico II', Naples, Italy Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) containing the probiotic Lactobacillus rhamnosus GG, (eHCF + LGG; Nutramigen LGG) as first-line management for cow's milk allergy (CMA) compared with eHCF alone, soy-based formulae (SBF), hydrolyzed rice formulae (HRF), and amino acid formulae (AAF) in Italy, from the perspective of the Italian National Health Service (INHS) and parents. Methods: Decision modeling was used to estimate the probability of infants developing tolerance to cow's milk by 18 months, based on an observational study dataset. The model also estimated the cost (at 2012/2013 prices) of health care resource use funded by the INHS and formulae paid for by parents over 18 months after starting a formula, as well as the relative cost-effectiveness of each of the formulae. Results: The probability of developing tolerance to cow's milk by 18 months was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were fed eHCF + LGG compared to those fed one of the other formulae. The total health care cost of initially feeding infants with eHCF + LGG was less than that of feeding infants with one of the other formulae. Hence, eHCF + LGG affords the greatest value for money to both the INHS and parents of infants with either IgE-mediated or non-IgE-mediated CMA. Conclusion: Using eHCF + LGG instead of eHCF, SBF, HRF, or an AAF for first-line management of newly diagnosed infants with CMA in Italy affords a cost-effective use of publicly funded resources, and is cost-effective from the parents' perspective, since it improves outcome for less cost. A randomized controlled study showing faster tolerance development in children receiving a probiotic-containing formula is required before this conclusion can be confirmed. Keywords: amino acid formula, extensively hydrolyzed formula, soy-based formulae, hydrolyzed rice formulae