scholarly journals Components, impacts and costs of dementia home support: a research programme including the DESCANT RCT

2021 ◽  
Vol 9 (6) ◽  
pp. 1-132
Author(s):  
Paul Clarkson ◽  
David Challis ◽  
Jane Hughes ◽  
Brenda Roe ◽  
Linda Davies ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Observational Study ◽  
Outcome Measures ◽  
Daily Living ◽  
Early Stage ◽  
Evidence Synthesis ◽  
Cost Effective ◽  
Home Support ◽  
Basic Care ◽  
People With Dementia

Background Over half of people with dementia live at home. We know little about what home support could be clinically effective or cost-effective in enabling them to live well. Objectives We aimed to (1) review evidence for components of home support, identify their presence in the literature and in services in England, and develop an appropriate economic model; (2) develop and test a practical memory support package in early-stage dementia, test the clinical effectiveness and cost-effectiveness of routine home support in later-stage dementia and design a toolkit based on this evidence; and (3) elicit the preferences of staff, carers and people with dementia for home support inputs and packages, and evaluate the cost-effectiveness of these approaches in early- and later-stage dementia. Design We undertook (1) an evidence synthesis, national surveys on the NHS and social care and an economic review; (2) a multicentre pragmatic randomised trial [Dementia Early Stage Cognitive Aids New Trial (DESCANT)] to estimate the clinical effectiveness and cost-effectiveness of providing memory aids and guidance to people with early-stage dementia (the DESCANT intervention), alongside process evaluation and qualitative analysis, an observational study of existing care packages in later-stage dementia along with qualitative analysis, and toolkit development to summarise this evidence; and (3) consultation with experts, staff and carers to explore the balance between informal and paid home support using case vignettes, discrete choice experiments to explore the preferences of people with dementia and carers between home support packages in early- and later-stage dementia, and cost–utility analysis building on trial and observational study. Setting The national surveys described Community Mental Health Teams, memory clinics and social care services across England. Recruitment to the trial was through memory services in nine NHS trusts in England and one health board in Wales. Recruitment to the observational study was through social services in 17 local authorities in England. Recruitment for the vignette and preference studies was through memory services, community centres and carers’ organisations. Participants People aged > 50 years with dementia within 1 year of first attendance at a memory clinic were eligible for the trial. People aged > 60 years with later-stage dementia within 3 months of a review of care needs were eligible for the observational study. We recruited staff, carers and people with dementia for the vignette and preference studies. All participants had to give written informed consent. Main outcome measures The trial and observational study used the Bristol Activities of Daily Living Scale as the primary outcome and also measured quality of life, capability, cognition, general psychological health and carers’ sense of competence. Methods Owing to the heterogeneity of interventions, methods and outcome measures, our evidence and economic reviews both used narrative synthesis. The main source of economic studies was the NHS Economic Evaluation Database. We analysed the trial and observational study by linear mixed models. We analysed the trial by ‘treatment allocated’ and used propensity scores to minimise confounding in the observational study. Results Our reviews and surveys identified several home support approaches of potential benefit. In early-stage dementia, the DESCANT trial had 468 randomised participants (234 intervention participants and 234 control participants), with 347 participants analysed. We found no significant effect at the primary end point of 6 months of the DESCANT intervention on any of several participant outcome measures. The primary outcome was the Bristol Activities of Daily Living Scale, for which scores range from 0 to 60, with higher scores showing greater dependence. After adjustment for differences at baseline, the mean difference was 0.38, slightly but not significantly favouring the comparator group receiving treatment as usual. The 95% confidence interval ran from –0.89 to 1.65 (p = 0.56). There was no evidence that more intensive care packages in later-stage dementia were more effective than basic care. However, formal home care appeared to help keep people at home. Staff recommended informal care that cost 88% of formal care, but for informal carers this ratio was only 62%. People with dementia preferred social and recreational activities, and carers preferred respite care and regular home care. The DESCANT intervention is probably not cost-effective in early-stage dementia, and intensive care packages are probably not cost-effective in later-stage dementia. From the perspective of the third sector, intermediate intensity packages were cheaper but less effective. Certain elements may be driving these results, notably reduced use of carers’ groups. Limitations Our chosen outcome measures may not reflect subtle outcomes valued by people with dementia. Conclusions Several approaches preferred by people with dementia and their carers have potential. However, memory aids aiming to affect daily living activities in early-stage dementia or intensive packages compared with basic care in later-stage dementia were not clinically effective or cost-effective. Future work Further work needs to identify what people with dementia and their carers prefer and develop more sensitive outcome measures. Study registration Current Controlled Trials ISRCTN12591717. The evidence synthesis is registered as PROSPERO CRD42014008890. 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. 6. See the NIHR Journals Library website for further project information.

scholarly journals A Systematic Review of Methods, Study Quality, and Results of Economic Evaluation for Childhood and Adolescent Obesity Intervention

2019 ◽  
Vol 16 (3) ◽  
pp. 485 ◽  
Author(s):  
Mandana Zanganeh ◽  
Peymane Adab ◽  
Bai Li ◽  
Emma Frew
Keyword(s):  
Systematic Review ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Evidence Synthesis ◽  
Evaluation Studies ◽  
Cost Effective ◽  
Adolescent Obesity ◽  
Economic Evaluations ◽  
Full Economic Evaluation ◽  
Childhood And Adolescent Obesity

Many suggested policy interventions for childhood and adolescent obesity have costs and effects that fall outside the health care sector. These cross-sectorial costs and consequences have implications for how economic evaluation is applied and although previous systematic reviews have provided a summary of cost-effectiveness, very few have conducted a review of methods applied. We undertook this comprehensive review of economic evaluations, appraising the methods used, assessing the quality of the economic evaluations, and summarising cost-effectiveness. Nine electronic databases were searched for full-economic evaluation studies published between January 2001 and April 2017 with no language or country restrictions. 39 economic evaluation studies were reviewed and quality assessed. Almost all the studies were from Western countries and methods were found to vary by country, setting and type of intervention. The majority, particularly “behavioural and policy” preventive interventions, were cost-effective, even cost-saving. Only four interventions were not cost effective. This systematic review suggests that economic evaluation of obesity interventions is an expanding area of research. However, methodological heterogeneity makes evidence synthesis challenging. Whilst upstream interventions show promise, an expanded and consistent approach to evaluate cost-effectiveness is needed to capture health and non-health costs and consequences.

scholarly journals Contextualization of cost-effectiveness evidence from literature for 382 health interventions for the Ethiopian essential health services package revision

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Alemayehu Hailu ◽  
Getachew Teshome Eregata ◽  
Amanuel Yigezu ◽  
Melanie Y. Bertram ◽  
Kjell Arne Johansson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Services ◽  
Evidence Synthesis ◽  
Cost Effective ◽  
Evaluation Study ◽  
Quality Adjusted Life Year ◽  
Health Interventions ◽  
Hepatitis B Vaccination ◽  
Economic Evaluations ◽  
Life Years

Abstract Background Cost-effectiveness of interventions was a criterion decided to guide priority setting in the latest revision of Ethiopia’s essential health services package (EHSP) in 2019. However, conducting an economic evaluation study for a broad set of health interventions simultaneously is challenging in terms of cost, timeliness, input data demanded, and analytic competency. Therefore, this study aimed to synthesize and contextualize cost-effectiveness evidence for the Ethiopian EHSP interventions from the literature. Methods The evidence synthesis was conducted in five key steps: search, screen, evaluate, extract, and contextualize. We searched MEDLINE and EMBASE research databases for peer-reviewed published articles to identify average cost-effectiveness ratios (ACERs). Only studies reporting cost per disability-adjusted life year (DALY), quality-adjusted life year (QALY), or life years gained (LYG) were included. All the articles were evaluated using the Drummond checklist for quality, and those with a score of at least 7 out of 10 were included. Information on cost, effectiveness, and ACER was extracted. All the ACERs were converted into 2019 US dollars using appropriate exchange rates and the GDP deflator. Results In this study, we synthesized ACERs for 382 interventions from seven major program areas, ranging from US$3 per DALY averted (for the provision of hepatitis B vaccination at birth) to US$242,880 per DALY averted (for late-stage liver cancer treatment). Overall, 56% of the interventions have an ACER of less than US$1000 per DALY, and 80% of the interventions have an ACER of less than US$10,000 per DALY. Conclusion We conclude that it is possible to identify relevant economic evaluations using evidence from the literature, even if transferability remains a challenge. The present study identified several cost-effective candidate interventions that could, if scaled up, substantially reduce Ethiopia’s disease burden.

scholarly journals Estimated Implementation Costs of DNA-informed Breeding in a Peach Breeding Program

2020 ◽  
Vol 30 (3) ◽  
pp. 356-364 ◽  
Author(s):  
Seth D. Wannemuehler ◽  
Chengyan Yue ◽  
William W. Shane ◽  
R. Karina Gallardo ◽  
Vicki McCracken
Keyword(s):  
Cost Effectiveness ◽  
Prunus Persica ◽  
Early Stage ◽  
Cost Effective ◽  
Breeding Program ◽  
Breeding Cycle ◽  
Breeding Programs ◽  
Implementation Costs ◽  
Peach Breeding ◽  
Additional Costs

Marker-assisted selection (MAS) use in breeding programs allows for examination of seedlings at an early stage before accumulation of high field costs. However, introducing MAS into a breeding program implies additional costs and uncertainties about effective incorporation. Previous simulations in apple (Malus ×domestica) have shown cost-effective applications of MAS. To further evaluate MAS cost-effectiveness in perennial crops, we conducted a cost-effectiveness analysis examining MAS in an upper midwestern U.S. peach (Prunus persica) breeding program. Breeding program procedures and associated costs were collected and used as input into spreadsheet-based simulations of the breeding program. Simulations compared a conventional breeding program to MAS with varying cull rates of low, medium, and high at multiple stages in the breeding cycle. Cost-effective MAS implementation was identified at the end of seedling trials with a break-even cull rate of 4%. These results inform breeders of cost-effectiveness of MAS use in a peach breeding program.

scholarly journals Cost-effectiveness Analysis of Sentinel Lymph Node Biopsy in the Treatment of Early-Stage Vulvar Cancer

2014 ◽  
Vol 24 (8) ◽  
pp. 1480-1485 ◽  
Author(s):  
Britt K. Erickson ◽  
Laura M. Divine ◽  
Charles A. Leath ◽  
J. Michael Straughn
Keyword(s):  
Lymph Node ◽  
Cost Effectiveness ◽  
Sentinel Lymph Node ◽  
Sentinel Lymph Node Biopsy ◽  
Vulvar Cancer ◽  
Early Stage ◽  
Cost Effective ◽  
The United States ◽  
Lymph Node Biopsy ◽  
Node Biopsy

ObjectiveThe objective of this study was to determine the costs and outcomes of inguinal-femoral lymph node dissection (IF-LND) versus sentinel lymph node biopsy (SLNB) for the management of early-stage vulvar cancer.MethodsA cost-effectiveness model compared 2 different strategies for the management of early-stage vulvar cancer: (1) vulvectomy and SLNB and (2) vulvectomy and IF-LND. Probabilities of inguinal-femoral node metastases and recurrence rates associated with each strategy were estimated from published data. Actual payer costs of surgery and radiation therapy were obtained using 2012 CPT codes and Medicare payment information. Rates and costs of postoperative complications including lymphedema, lymphocyst formation, and infection were estimated and included in a separate model. Cost-effectiveness ratios were determined for each strategy. Sensitivity analyses were performed to evaluate pertinent uncertainties in the models.ResultsFor the estimated 3000 women diagnosed annually with early-stage vulvar cancer in the United States, the annual cost of the SLNB strategy is $65.2 million compared with $76.8 million for the IF-LND strategy. Three-year inguinal-femoral recurrence-free survival was similar between groups (96.9% vs 97.3%). This translates into a lower cost-effectiveness ratio for the SLNB strategy ($22,416), compared with the IF-LND strategy ($26,344). When adding complication costs to the model, cost-effectiveness ratios further favor the SLNB strategy ($23,711 vs $31,198). Sensitivity analysis revealed that the SLNB strategy remained cost-effective until the recurrence rate after a negative sentinel lymph node approaches 9%.ConclusionsSentinel lymph node biopsy is the most cost-effective strategy for the management of patients with early-stage vulvar cancer due to lower treatment costs and lower costs due to complications.

scholarly journals Evaluating the effectiveness of different approaches to home support for people in later stage dementia: a protocol for an observational study

2017 ◽  
Vol 29 (7) ◽  
pp. 1213-1221 ◽  
Author(s):  
Helen Chester ◽  
Paul Clarkson ◽  
Jane Hughes ◽  
Ian Russell ◽  
Joan Beresford ◽  
...  
Keyword(s):  
Observational Study ◽  
Service Providers ◽  
Geographical Area ◽  
National Study ◽  
Structured Interviews ◽  
Major Health Problem ◽  
Home Support ◽  
People With Dementia ◽  
Health And Social Care ◽  
Person With Dementia

ABSTRACTBackground:Dementia is a major health problem with a growing number of people affected by the condition, both directly and indirectly through caring for someone with dementia. Many live at home but little is known about the range and intensity of the support they receive. Previous studies have mainly reported on discrete services within a single geographical area. This paper presents a protocol for study of different services across several sites in England. The aim is to explore the presence, effects, and cost-effectiveness of approaches to home support for people in later stage dementia and their carers.Methods:This is a prospective observational study employing mixed methods. At least 300 participants (people with dementia and their carers) from geographical areas with demonstrably different ranges of services available for people with dementia will be selected. Within each area, participants will be recruited from a range of services. Participants will be interviewed on two occasions and data will be collected on their characteristics and circumstances, quality of life, carer health and burden, and informal and formal support for the person with dementia. The structured interviews will also collect qualitative data to explore the perceptions of older people and carers.Conclusions:This national study will explore the components of appropriate and effective home support for people with late stage dementia and their carers. It aims to inform commissioners and service providers across health and social care.

A review of stroke outcome measures valid and reliable for administration by postal survey

2010 ◽  
Vol 20 (4) ◽  
pp. 338-353 ◽  
Author(s):  
Elizabeth A Teale ◽  
John B Young
Keyword(s):  
Psychometric Properties ◽  
Outcome Measures ◽  
Daily Living ◽  
Cost Effective ◽  
Outcome Data ◽  
Postal Survey ◽  
Stroke Outcome ◽  
Stroke Research ◽  
Questionnaire Administration ◽  
Cost Effective Alternative

SummaryCollecting outcome measures by patient or proxy-completed postal survey in stroke research offers a pragmatic and cost-effective alternative to interview-based assessments. The psychometric properties of outcome measures cannot be assumed to be equivalent across methods of questionnaire administration. Many stroke outcome measures have variable or unproven psychometric properties when administered by post. The validity of stroke research that uses postal surveys may be improved through the adoption of questionnaires with acceptable postal psychometric properties. This review identifies 60 reports of quantitative stroke studies using one or more of 36 instruments to collect stroke outcome data by postal survey. Three of these instruments have acceptable psychometric properties for postal administration in stroke populations (the Frenchay Activities Index (FAI), Subjective Index of Physical and Social Outcome (SIPSO) and the EuroQoL (EQ5D)). Two further instruments lack evidence to support proxy reliability (Nottingham Extended Activities of Daily Living and London Handicap Score), but have otherwise acceptable properties.

scholarly journals A cost-effectiveness analysis of front-line treatment strategies in early stage follicular lymphoma

2021 ◽  
Author(s):  
Joshua W.D. Tobin ◽  
Anna Crothers ◽  
Ti Eric Ma ◽  
Peter Mollee ◽  
Maher K. Gandhi ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Follicular Lymphoma ◽  
Early Stage ◽  
Combined Modality Therapy ◽  
Treatment Strategies ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Effectiveness Analysis ◽  
Life Years ◽  
Minimal Improvement

AbstractRecent data suggests the use of radiotherapy alone (RT) in Early-Stage Follicular Lymphoma is declining. Cost-effectiveness analysis of treatments has not been performed. We constructed a partitioning model (15-year horizon) to compare RT, combined-modality therapy (CMT) and immunochemotherapy with rituximab maintenance (ICT+RM) from a PET-staged cohort from the Australian Lymphoma Alliance. Lifetime direct health care costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. AUD $75,000 was defined as the willingness-to-pay threshold (WTP). The direct healthcare costs were: RT $12,791, CMT $29,391 and ICT+RM $42,644. Compared with RT, CMT demonstrated minimal improvement in QALYs (+0.01) and an ICER well above the WTP threshold ($1,535,488). Compared with RT, ICT+RM demonstrated an improvement in QALYs (+0.41) with an ICER of $73,319. Modelling a 25% cost reduction with a rituximab biosimilar led to further ICER reductions with ICT+RM ($52,476). ICT+RM is cost-effective in early stage FL from the Australian taxpayer perspective.

scholarly journals Are Novel Therapies Worth the Cost for Young Patients?: A Cost-Effectiveness Analysis of Frontline Therapies with or without Radiation for Early-Stage Unfavourable Hodgkin Lymphoma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 662-662
Author(s):  
Abi Vijenthira ◽  
David C. Hodgson ◽  
Matthew Cheung ◽  
Michael Crump ◽  
Anca Prica
Keyword(s):  
Breast Cancer ◽  
Heart Failure ◽  
Cost Effectiveness ◽  
Hodgkin Lymphoma ◽  
Early Stage ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Health State ◽  
Effective Regimen

Abstract Background: A variety of frontline treatment regimens exist for early-stage unfavourable Hodgkin lymphoma (HL), offering personalization of risk versus benefit in this primarily young population of patients. While radiation therapy has been a mainstay of treatment due to improved progression-free survival (PFS), recent studies have challenged this paradigm, using a PET-driven approach (HD17) or incorporating novel agents (nivolumab-AVD (N-AVD), brentuximab-AVD (A-AVD)). Long term risks of radiation and chemotherapy include secondary breast and other cancers, and heart failure; however novel regimens are more costly with uncertainty surrounding long-term efficacy. Methods: A cost-effectiveness and cost-utility analysis was conducted to compare five published frontline approaches for early-stage unfavourable HL: HD17, two H10 approaches, N-AVD, and A-AVD without radiation (Table 1). A Markov model was constructed with a lifetime horizon using TreeAge Pro 2021 (Figure 1). The base case was a 20-year-old female with a mediastinal mass who would require chest field radiation. Baseline estimates in the model were derived from the literature, including risk of relapse after each line of therapy, risk of late complications (breast cancer, secondary cancer, and/or heart failure), risk of death (from complications, lymphoma, and background mortality), and health state utilities. A Canadian public health care payer's perspective was taken, and costs are estimated in 2021 Canadian dollars. Global discounting of 3% was used. Results: Probabilistic sensitivity analyses were performed (10,000 simulations). First, we evaluated the uncertainty of long-term PFS using novel regimens (N-AVD or A-AVD); at a willingness-to-pay of $50,000/QALY, N-AVD was the most cost-effective regimen when 5-year PFS was at least 92% (Table 2). If 5-year PFS with N-AVD was <92%, HD17 became the most cost-effective approach. There was no PFS threshold at which A-AVD was the most cost-effective regimen. Holding the 5-year PFS of novel regimens at 92%, the model remained robust to multiple deterministic sensitivity analyses testing key variables including health state utilities (of relapse post-transplant, breast cancer, second malignancy, heart failure), costs (of radiation, autologous stem cell transplant, breast cancer, second malignancy, heart failure), and risks (of breast cancer after radiation, cardiovascular disease after radiation and/or chemotherapy,). However, if the risk of developing second cancer was less than 2% after 5 years with HD17 approach (current estimates 1% at 48 months in HD17 to 2% at 43 months in HD14 (which used a similar regimen)), or if the median overall survival after secondary cancer was over 9 years, HD17 became the most cost-effective regimen. The threshold cost for brentuximab to make A-AVD the most cost-effective regimen was <$5000 per dose (current price $14,520 CAD). Conclusions: If the long term PFS of nivolumab-AVD is greater than 92%, it could be the most cost-effective regimen when treating a young female patient with early-stage unfavourable Hodgkin lymphoma. This model accounts for increased costs with nivolumab added to chemotherapy, due to potential reduced incidence of late effects. However, there remain uncertainties in efficacy and risk regarding novel therapies as only non-randomized Phase II studies with short follow-up durations have been published; further trials of these approaches are being planned. HD17 remains the most cost-effective approach among published Phase III regimens. Long term follow-up of HD17 will also be meaningful to understand the risk of second cancer with this approach, which may impact its cost-effectiveness. Figure 1 Figure 1. Disclosures Crump: Epizyme: Research Funding; Kyte/Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Roche: Research Funding. Prica: Astra-Zeneca: Honoraria; Kite Gilead: Honoraria.

scholarly journals Randomised controlled trial evaluating the effectiveness and cost-effectiveness of ‘Families for Health’, a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years

2017 ◽  
Vol 21 (1) ◽  
pp. 1-180 ◽  
Author(s):  
Wendy Robertson ◽  
Joanna Fleming ◽  
Atiya Kamal ◽  
Thomas Hamborg ◽  
Kamran A Khan ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Process Evaluation ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Cost Effective ◽  
Z Score ◽  
Clinically Significant ◽  
Family Based ◽  
Randomised Controlled

BackgroundEffective programmes to help children manage their weight are required. ‘Families for Health’ focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project.ObjectiveThe aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT).DesignThe trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families.SettingThree sites in the West Midlands, England, UK.ParticipantsChildren aged 6–11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral.InterventionsFamilies for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality.Main outcome measuresJoint primary outcome measures were change in children’s BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months’ follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods.ResultsThe study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the ‘usual-care’ control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) –0.001 to 0.229;p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI –0.203 to –0.034;p = 0.007), but not in the Families for Health arm (–0.005, 95% CI –0.085 to 0.078;p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548;p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators’, parents’ and children’s experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome.ConclusionsFamilies for Health was neither effective nor cost-effective for the management of obesity in children aged 6–11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment.Trial registrationCurrent Controlled Trials ISRCTN45032201.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.

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