A Comprehensive Analysis of Single-Incision Laparoscopic Cholecystectomy: Trends, Challenges, and Future Directions.

Single-incision laparoscopic cholecystectomy (SILC) is a minimally invasive surgical technique introduced as an advancement to laparoscopic cholecystectomy (LC). This narrative review delves into the emergence of SILC, emphasizing its distinct advantages such as improved cosmesis, reduced postoperative pain, and potentially faster recovery compared to traditional LC. The study meticulously examines current trends and challenges in SILC, including variations in techniques and their impact on patient outcomes. Furthermore, the article sheds light on the technical intricacies and longer operative times associated with SILC. It aims to contribute valuable insights to the medical community by synthesizing existing literature and recent research findings, fostering a deeper understanding of SILC, and guiding future advancements in minimally invasive surgical approaches. The discussion extends to the learning curve, complications, and a comparative analysis between SILC and traditional LC, offering a nuanced understanding of their respective strengths and limitations. The article concludes with a forward-looking perspective, exploring future directions and innovations in SILC, including advancements in surgical techniques and the integration of innovative technologies, such as robotic assistance and in vivo robots, to enhance precision and efficacy. The call for continued research into the long-term outcomes, safety, and refined patient selection criteria emphasizes the evolving landscape of SILC and its potential to shape the future of minimally invasive abdominal surgeries.

A qualitative study exploring nurses' experiences of supporting South Asian people with dementia and their family carers.

AIMS: To explore nurses' experiences of providing support to South Asian (SA) people with dementia and their family carers and to identify barriers and enablers of good transcultural care. DESIGN: A qualitative, phenomenological design was used. METHODS: Fifteen registered community and in-patient nurses were recruited via one NHS Mental Health Foundation Trust. Nurses were from diverse backgrounds (Black, Ghanaian, Irish, Mauritian and White), 13 females and 2 males, and had been qualified from between 2 and 49 years. One-to-one semi-structured interviews were conducted between July and October 2019. RESULTS: A thematic analysis identified three themes. 'Communication challenges' highlighted the impact of language barriers and the consequences of misunderstandings due to a dissonance in cultural values between nurses and interpreters. 'The bi-directional impact of culture' identified the two-way dynamics of transcultural work, the process of countering mutual stigma, and revealed an original perspective on how 'cultural desire' grows through practice experiences rather than being a prior motivation for learning. 'Learning experiences' showed that most learning was informal, experiential and prolonged, with nurses feeling they had unmet learning needs. CONCLUSION: Nurses have minimal training opportunities and are under-supported in their transcultural work, potentially perpetuating the disadvantages that SA people with dementia and their families face in relation to healthcare. Enhanced cultural understanding of self and others and application of specific communication strategies could support nurses, together with interpreters, to build rapport and effective working relationships with each other and service users. IMPACT: Transcultural nursing is a key competency, but nurses experience difficulties with providing care which is recognized as effective by SA family carers. The development of more acceptable and effective services requires improved mutual cultural understanding between nurses, interpreters and families, underpinned by joint brief training interventions, leading to more effective professional communication, better care outcomes and improved satisfaction with services.

Beyond Information Provision: Analysis of the Roles of Structure and Agency in COVID-19 Vaccine Confidence in Ethnic Minority Communities.

People from Black and Asian backgrounds are more likely to die from COVID-19 but less likely to be vaccinated, threatening to exacerbate health inequalities already experienced by ethnic minority groups. The literature suggests that mistrust rooted in structural inequality (including socioeconomic position and experience of racism) may be a key barrier to COVID-19 vaccine uptake. Understanding and addressing structural inequality is likely to lead to longer-term impacts than information alone. The aim of this study is to draw on health and sociological theories of structure and agency to inform our understanding of how structural factors influence vaccine confidence. We conducted qualitative interviews and focus groups with 22 people from London and the surrounding areas from December 2021 to March 2022. Fourteen participants were members of the public from ethnic minority backgrounds, and seven were professionals working with the public to address concerns and encourage vaccine uptake. Our findings suggest that people from ethnic minority backgrounds make decisions regarding COVID-19 vaccination based on a combination of how they experience external social structures (including lack of credibility and clarity from political authority, neglect by health services, and structural racism) and internal processes (weighing up COVID-19 vaccine harms and benefits and concerns about vaccine development and deployment). We may be able to support knowledge accumulation through the provision of reliable and accessible information, particularly through primary and community care, but we recommend a number of changes to research, policy and practice that address structural inequalities. These include working with communities to improve ethnicity data collection, increasing funding allocation to health conditions where ethnic minority communities experience poorer outcomes, greater transparency and public engagement in the vaccine development process, and culturally adapted research recruitment processes.

The Agile Co-production and Evaluation framework for developing public health interventions, messaging and guidance.

A lesson identified from the COVID-19 pandemic is that we need to extend existing best practice for intervention development. In particular, we need to integrate (a) state-of-the-art methods of rapidly coproducing public health interventions and messaging to support all population groups to protect themselves and their communities with (b) methods of rapidly evaluating co-produced interventions to determine which are acceptable and effective. This paper describes the Agile Co-production and Evaluation (ACE) framework, which is intended to provide a focus for investigating new ways of rapidly developing effective interventions and messaging by combining co-production methods with large-scale testing and/or real-world evaluation. We briefly review some of the participatory, qualitative and quantitative methods that could potentially be combined and propose a research agenda to further develop, refine and validate packages of methods in a variety of public health contexts to determine which combinations are feasible, cost-effective and achieve the goal of improving health and reducing health inequalities.

Development and testing of a bespoke cultural intervention to support healthcare professionals with patients from a diverse background.

OBJECTIVE: Development and test of a culturally sensitive intervention for rheumatology healthcare professionals (HCPs). METHODS: Using a before and after study design, fifteen HCPs were recruited to undertake the bespoke intervention from four NHS sites across England, in areas serving a diverse population. The intervention was evaluated using the validated outcomes: [1] Patient Reported Physician Cultural Competency (PRPCC); and [2] Patient Enablement Instrument (PEI), measuring patients' perceptions of their overall healthcare delivery. Additionally, HCPs completed the Capability COM-B questionnaire (C), Opportunity (O) and Motivation (M) to perform Behaviour (B), measuring behaviour change. RESULTS: 200 patients were recruited before HCPs undertook the intervention (cohort 1), and 200 were recruited after (cohort 2) from fifteen HCPs, after exclusions 178 patients remained in cohort 1 and 186 in cohort 2. Patients identifying as White in both recruited cohorts were 60% compared with 29% and 33% of patients (cohorts 1 and 2 respectively) who identified as of South Asian origin. After the intervention, the COM-B scores indicated HCPs felt more skilled and equipped for consultations. No significant differences were noted in the average overall cultural competency score between the two cohorts in White patients (57.3 vs 56.8, p= 0.8), however, in the South Asian cohort, there was a statistically significant improvement in mean scores (64.1 vs 56.7, p= 0.014). Overall, the enablement score also showed a statistically significant improvement following intervention (7.3 vs 4.3, p< 0.001) in the White patients; and in the South Asian patients (8.0 vs 2.2, p< 0.001). CONCLUSION: This novel study provides evidence for improving cultural competency and patient enablement in rheumatology settings.

A Systematic Review of Behaviour Change Techniques within Interventions to Increase Vaccine Uptake among Ethnic Minority Populations.

COVID-19 caused significant morbidity and mortality amongst ethnic minority groups, but vaccine uptake remained lower than non-minoritised groups. Interventions to increase vaccine uptake among ethnic minority communities are crucial. This systematic review synthesises and evaluates behaviour change techniques (BCTs) in interventions to increase vaccination uptake in ethnic minority populations. We searched five databases and grey literature sources. From 7637 records identified, 23 studies were included in the review. Interventions were categorised using the Behaviour Change Wheel (BCW) and Behaviour Change Taxonomy v1. Vaccines included influenza, pertussis, tetanus, diphtheria, meningitis and hepatitis. Interventions were primarily delivered in health centres/clinics and community settings. Six BCW intervention functions and policy categories and 26 BCTs were identified. The main intervention functions used were education, persuasion and enablement. Overall, effective interventions had multi-components and were tailored to specific populations. No strong evidence was observed to recommend specific interventions, but raising awareness and involvement of community organisations was associated with positive effects. Several strategies are used to increase vaccine uptake among ethnic minority communities; however, these do not address all issues related to low vaccine acceptance. There is a strong need for an increased understanding of addressing vaccine hesitancy among ethnic minority groups.

Understanding a constellation of eight COVID-19 disease prevention behaviours using the COM-B model and the theoretical domains framework: a qualitative study using the behaviour change wheel.

Background: The use of behavioural science and behaviour change within local authorities and public health has supported healthful change; as evidenced by its importance and contribution to reducing harm during the COVID-19 pandemic. It can provide valuable information to enable the creation of evidence-based intervention strategies, co-created with the people they are aimed at, in an effective and efficient manner. Aim: This study aimed to use the COM-B model to understand the Capability, Opportunity and Motivation of performing a constellation of eight COVID-19 disease prevention behaviours related to the slogans of 'Hands, Face, Space, Fresh Air'; 'Find, Isolate, Test, (FIT), and Vaccinate' in those employed in workplaces identified as high risk for transmission of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) to support intervention development. Methods: This qualitative study recruited twenty-three participants (16 female, 7 male), who were interviewed from three environments (schools, care homes, warehouses) across three local authorities. Semi-structured interviews were analysed using thematic analysis. Findings: Ten core themes were identified inductively; (1) knowledge and skills, (2) regulating the behaviour, (3) willingness to act, (4) necessity and concerns, (5) emotional impact, (6) conducive environment, (7) societal influence, (8) no longer united against COVID-19, (9) credible leadership, and (10) inconsistent adherence to COVID-19 prevention behaviours. Themes were then deductively mapped to the COM-B model of behaviour change and the theoretical domains framework and a logic model using the behaviour change wheel (BCW) was produced to inform intervention design. Conclusion: This study offers a novel approach to analysis that has included eight behaviours within a single thematic analysis and COM-B diagnosis. This will enable local authorities to direct limited resources to overarching priorities. Of key importance, was the need for supportive and credible leadership, alongside developing interventions collaboratively with the target audience. COVID-19 has had an emotional toll on those interviewed, however, promoting the value of disease prevention behaviours, over and above their costs, can facilitate behaviour. Developing knowledge and skills, through education, training, marketing and modelling can further facilitate behaviour. This supports guidance produced by the British Psychological Society COVID-19 behavioural science and disease prevention taskforce.

Areas of enduring COVID-19 prevalence: drivers of prevalence and mitigating strategies.

BACKGROUND: UK local authorities that experienced sustained high levels of COVID-19 between 1st March 2020 and 28th February 2021 were described by the UK Scientific Advisory Group for Emergencies as areas of enduring prevalence. This research was carried out in order to examine the views of local authority Directors of Public Health, who played a crucial role in the local response to COVID-19, on reasons for sustained high levels of prevalence in some areas, alongside an investigation of the mitigation strategies that they implemented during the course of the pandemic. METHODS: Interviews were conducted with Directors of Public Health in 19 local authority areas across England, between July and November 2021. This included nine areas identified as areas of enduring prevalence and ten 'comparison' areas. RESULTS: The outcomes of this study suggests that the geographical differences in prevalence rates are strongly influenced by health inequalities. Structural factors including deprivation, employment, and housing, due to their disproportionate impact on specific groups, converged with demographic factors, including ethnicity and age, and vaccination rates, and were identified as the main drivers of enduring prevalence. There are key differences in these drivers both within and, to a lesser extent, between local authorities. Other than these structural barriers, no major differences in facilitators or barriers to COVID-19 mitigation were identified between areas of varying prevalence. The main features of successful mitigation strategies were a locally tailored approach and partnership working involving local authority departments working with local health, community, voluntary and business organisations. CONCLUSIONS: This study is the first to add the voices of Directors of Public Health, who played a crucial role in the local COVID-19 response. Areas of enduring prevalence existed during the pandemic which were caused by a complex mix of structural factors related to inequalities. Participants advised that more research is needed on the effectiveness of mitigation strategies and other measures to reduce the impact of structural inequalities, to better understand the factors that drive prevalence. This would include an assessment of how these factors combine to predict transmission and how this varies between different areas.

Attitudes towards coronavirus (COVID-19) vaccine and sources of information across diverse ethnic groups in the UK: a qualitative study from June to October 2020.

OBJECTIVES: Across diverse ethnic groups in the UK, explore attitudes and intentions towards COVID-19 vaccination and sources of COVID-19 information. DESIGN: Remote qualitative interviews and focus groups (FGs) conducted June-October 2020 before UK COVID-19 vaccine approval. Data were transcribed and analysed through inductive thematic analysis and mapped to the Theoretical Domains Framework. SETTING: England and Wales. PARTICIPANTS: 100 participants from 19 self-identified ethnic groups. RESULTS: Mistrust and doubt were reported across ethnic groups. Many participants shared concerns about perceived lack of information about COVID-19 vaccine safety and efficacy. There were differences within each ethnic group, with factors such as occupation and perceived health status influencing intention to accept a vaccine once made available. Across ethnic groups, participants believed that public contact occupations, older adults and vulnerable groups should be prioritised for vaccination. Perceived risk, social influences, occupation, age, comorbidities and engagement with healthcare influenced participants' intentions to accept vaccination once available. All Jewish FG participants intended to accept, while all Traveller FG participants indicated they probably would not.Facilitators to COVID-19 vaccine uptake across ethnic groups included: desire to return to normality and protect health and well-being; perceived higher risk of infection; evidence of vaccine safety and efficacy; vaccine availability and accessibility.COVID-19 information sources were influenced by social factors and included: friends and family; media and news outlets; research literature; and culture and religion. Participants across most different ethnic groups were concerned about misinformation or had negative attitudes towards the media. CONCLUSIONS: During vaccination rollout, including boosters, commissioners and providers should provide accurate information, authentic community outreach and use appropriate channels to disseminate information and counter misinformation. Adopting a context-specific approach to vaccine resources, interventions and policies and empowering communities has potential to increase trust in the programme.

Public views of and reactions to the COVID-19 pandemic in England: a qualitative study with diverse ethnicities.

OBJECTIVES: To explore public reactions to the COVID-19 pandemic across diverse ethnic groups. DESIGN: Remote qualitative interviews and focus groups in English or Punjabi. Data were transcribed and analysed through inductive thematic analysis. SETTING: England and Wales, June to October 2020. PARTICIPANTS: 100 participants from 19 diverse 'self-identified' ethnic groups. RESULTS: Dismay, frustration and altruism were reported across all ethnic groups during the first 6-9 months of the COVID-19 pandemic. Dismay was caused by participants' reported individual, family and community risks, and loss of support networks. Frustration was caused by reported lack of recognition of the efforts of ethnic minority groups (EMGs), inaction by government to address COVID-19 and inequalities, rule breaking by government advisors, changing government rules around: border controls, personal protective equipment, social distancing, eating out, and perceived poor communication around COVID-19 and the Public Health England COVID-19 disparities report (leading to reported increased racism and social isolation). Altruism was felt by all, in the resilience of National Health Service (NHS) staff and their communities and families pulling together. Data, participants' suggested actions and the behaviour change wheel informed suggested interventions and policies to help control COVID-19. CONCLUSION: To improve trust and compliance future reports or guidance should clearly explain any stated differences in health outcomes by ethnicity or other risk group, including specific messages for these groups and concrete actions to minimise any risks. Messaging should reflect the uncertainty in data or advice and how guidance may change going forward as new evidence becomes available. A contingency plan is needed to mitigate the impact of COVID-19 across all communities including EMGs, the vulnerable and socially disadvantaged individuals, in preparation for any rise in cases and for future pandemics. Equality across ethnicities for healthcare is essential, and the NHS and local communities will need to be supported to attain this.

Interventions to promote physical distancing behaviour during infectious disease pandemics or epidemics: A systematic review.

OBJECTIVES: Physical distancing, defined as keeping 1-2m apart when co-located, can prevent cases of droplet or aerosol transmitted infectious diseases such as SARS-CoV2. During the COVID-19 pandemic, distancing was a recommendation or a requirement in many countries. This systematic review aimed to determine which interventions and behavior change techniques (BCTs) are effective in promoting adherence to distancing and through which potential mechanisms of action (MOAs). METHODS: Six databases were searched. The review included studies that were (a) conducted on humans, (b) reported physical distancing interventions, (c) included any comparator (e.g., pre-intervention versus post-intervention; randomized controlled trial), and (d) reported actual distancing or predictors of distancing behavior. Risk of bias was assessed using the Mixed Methods Appraisal Tool. BCTs and potential MoAs were identified in each intervention. RESULTS: Six articles (with seven studies and 19 comparisons) indicated that distancing interventions could successfully change MoAs and behavior. Successful BCTs (MoAs) included feedback on behavior (e.g., motivation); information about health consequences, salience of health consequences (e.g., beliefs about consequences), demonstration (e.g., beliefs about capabilities), and restructuring the physical environment (e.g., environmental context and resources). The most promising interventions were proximity buzzers, directional systems, and posters with loss-framed messages that demonstrated the behaviors. CONCLUSIONS: The evidence indicates several BCTs and potential MoAs that should be targeted in interventions and highlights gaps that should be the focus of future research.

Template for Rapid Iterative Consensus of Experts (TRICE).

BACKGROUND: Public health emergencies require rapid responses from experts. Differing viewpoints are common in science, however, "mixed messaging" of varied perspectives can undermine credibility of experts; reduce trust in guidance; and act as a barrier to changing public health behaviours. Collation of a unified voice for effective knowledge creation and translation can be challenging. This work aimed to create a method for rapid psychologically-informed expert guidance during the COVID-19 response. METHOD: TRICE (Template for Rapid Iterative Consensus of Experts) brings structure, peer-review and consensus to the rapid generation of expert advice. It was developed and trialled with 15 core members of the British Psychological Society COVID-19 Behavioural Science and Disease Prevention Taskforce. RESULTS: Using TRICE; we have produced 18 peer-reviewed COVID-19 guidance documents; based on rapid systematic reviews; co-created by experts in behavioural science and public health; taking 4-156 days to produce; with approximately 18 experts and a median of 7 drafts per output. We provide worked-examples and key considerations; including a shared ethos and theoretical/methodological framework; in this case; the Behaviour Change Wheel and COM-B. CONCLUSION: TRICE extends existing consensus methodologies and has supported public health collaboration; co-creation of guidance and translation of behavioural science to practice through explicit processes in generating expert advice for public health emergencies.

A Rapid Systematic Review of Factors Influencing COVID-19 Vaccination Uptake in Minority Ethnic Groups in the UK.

COVID-19 has disproportionately affected minority ethnic groups in the United Kingdom. To maximise the effectiveness of the vaccination programme, it is important to understand and address disparities in vaccine uptake. The aim of this review was to identify factors influencing COVID-19 vaccination uptake between minority ethnic groups in the UK. A search was undertaken in peer-reviewed databases, polling websites and grey literature from January 2020-May 2021. Studies were included if they reported data on vaccine uptake or the reasons for or against accepting the COVID-19 vaccination for minority ethnic groups in the UK. Twenty-one papers met the inclusion criteria, all of which were rated as either good or moderate quality. Ethnic minority status was associated with higher vaccine hesitancy and lower vaccine uptake compared with White British groups. Barriers included pre-existing mistrust of formal services, lack of information about the vaccine's safety, misinformation, inaccessible communications, and logistical issues. Facilitators included inclusive communications which address vaccine concerns via trusted communicators and increased visibility of minority ethnic groups in the media. Community engagement to address the concerns and informational needs of minority ethnic groups using trusted and collaborative community and healthcare networks is likely to increase vaccine equity and uptake.

Behavioural responses to Covid-19 health certification: a rapid review.

BACKGROUND: Covid-status certification - certificates for those who test negative for the SARS-CoV-2 virus, test positive for antibodies, or who have been vaccinated against SARS-CoV-2 - has been proposed to enable safer access to a range of activities. Realising these benefits will depend in part upon the behavioural and social impacts of certification. The aim of this rapid review was to describe public attitudes towards certification, and its possible impact on uptake of testing and vaccination, protective behaviours, and crime. METHOD: A search was undertaken in peer-reviewed databases, pre-print databases, and the grey literature, from 2000 to December 2020. Studies were included if they measured attitudes towards or behavioural consequences of health certificates based on one of three indices of Covid-19 status: test-negative result for current infectiousness, test-positive for antibodies conferring natural immunity, or vaccination(s) conferring immunity. RESULTS: Thirty-three papers met the inclusion criteria, only three of which were rated as low risk of bias. Public attitudes were generally favourable towards the use of immunity certificates for international travel, but unfavourable towards their use for access to work and other activities. A significant minority was strongly opposed to the use of certificates of immunity for any purpose. The limited evidence suggested that intention to get vaccinated varied with the activity enabled by certification or vaccination (e.g., international travel). Where vaccination is seen as compulsory this could lead to unwillingness to accept a subsequent vaccination. There was some evidence that restricting access to settings and activities to those with antibody test certificates may lead to deliberate exposure to infection in a minority. Behaviours that reduce transmission may decrease upon health certificates based on any of the three indices of Covid-19 status, including physical distancing and handwashing. CONCLUSIONS: The limited evidence suggests that health certification in relation to COVID-19 - outside of the context of international travel - has the potential for harm as well as benefit. Realising the benefits while minimising the harms will require real-time evaluations allowing modifications to maximise the potential contribution of certification to enable safer access to a range of activities.

Systematic review and meta-synthesis of coping with retinitis pigmentosa: implications for improving quality of life.

BACKGROUND: Retinitis pigmentosa (RP) are a group of incurable and inherited eye conditions, and the leading cause of inherited blindness in people under the age of 60. The aim of this systematic review and meta-synthesis was to present a comprehensive overview of qualitative papers on experiences and coping strategies of adults living with RP, and how these influence quality of life. METHODS: A pre-registered search strategy was applied in nine databases and 12 articles met eligibility criteria. Studies included were from Australia, Brazil, Ireland, Netherlands, Republic of Korea, United Kingdom, and USA. The overall sample was based on 126 people with RP (ages ranging from 18 to 85; at least 65 female). Principles of meta-ethnography were used to synthesise the articles revealing five higher-level meta-themes. RESULTS: The five higher-level meta-themes were, 1) managing identity: making sense of RP, managing autonomy and independence; 2) living with RP: practical and emotional issues; 3) experiences with healthcare professionals and other social support; 4) adaptive and maladaptive coping strategies; and 5) impact of RP on work and career. A conceptual model was developed by grouping higher-level meta-themes as intra- and inter-individual factors and how they may be implicated with coping strategies and quality of life. CONCLUSIONS: This review established factors that can be explored as potential psychosocial influences in the relationship between coping strategies and quality of life in people with RP. Further understanding of these factors and mechanisms can help inform intervention development to support adaptive coping in living with RP and positively impact quality of life.

The lived experience of chronic headache: a systematic review and synthesis of the qualitative literature.

OBJECTIVE: To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder. BACKGROUND: Chronic headaches affect 3%-4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache. METHODS: We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach. RESULTS: We identified 3586 unique citations; full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: 'headache as a driver of behaviour' (directly and indirectly), 'the spectre of headache' and 'strained relationships'. CONCLUSION: This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people's lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders.

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.

BACKGROUND: Effective 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. OBJECTIVE: The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). DESIGN: The 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. SETTING: Three sites in the West Midlands, England, UK. PARTICIPANTS: Children 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. INTERVENTIONS: Families 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 MEASURES: Joint 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. RESULTS: The 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. CONCLUSIONS: Families 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 REGISTRATION: Current Controlled Trials ISRCTN45032201. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.

Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

OBJECTIVE: Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). DESIGN: Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. SETTING: Three National Health Service Primary Care Trusts in West Midlands, England. PARTICIPANTS: Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. INTERVENTIONS: FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. MAIN OUTCOME MEASURES: Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. RESULTS: 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. CONCLUSIONS: FFH was neither effective nor cost-effective for the management of obesity compared with UC. TRIAL REGISTRATION NUMBER: ISRCTN45032201.