Housing is a social determinant of health, comprising multiple interrelated attributes; the current study was developed to examine whether differences in mental wellbeing across housing tenure types might relate to individual, living, or neighbourhood circumstances. To achieve this aim, an exploratory cross-sectional analysis was conducted using secondary data from a county-wide resident survey undertaken by Cornwall Council in 2017. The survey included questions about individual, living, or neighbourhood circumstances, as well as mental wellbeing (Short WarwickEdinburgh Mental Wellbeing Scale). A random sample of 30,152 households in Cornwall were sent the survey, from whom 11,247 valid responses were received (38% response), but only 4085 (13.5%) provided complete data for this study. Stratified stepwise models were estimated to generate hypotheses about inequalities in mental wellbeing related to housing tenure. Health, life satisfaction, and social connectedness were found to be universal determinants of mental wellbeing, whereas issues related to living circumstances (quality of housing, fuel poverty) were only found to be related to wellbeing among residents of privately owned and rented properties. Sense of safety and belonging (neighbourhood circumstances) were also found to be related to wellbeing, which together suggests that whole system place-based home and people/community-centred approaches are needed to reduce inequalities.

Improving child and adolescent mental health requires the careful development and rigorous testing of interventions and delivery methods. This includes universal school-based mindfulness training, evaluated in the My Resilience in Adolescence (MYRIAD) trial reported in this special edition. While discovering effective interventions through randomised controlled trials is our ultimate aim, null or negative results can and should play an important role in progressing our understanding of what works. Unfortunately, alongside publication bias there can be a tendency to ignore, spin or unfairly undermine disappointing findings. This creates research waste that can increase risk and reduce benefits for future service users. We advocate several practices to help optimise learning from all trials, whatever the results: stronger intervention design reduces the likelihood of foreseeable null or negative results; an evidence-informed conceptual map of the subject area assists with understanding how results contribute to the knowledge base; mixed methods trial designs aid explanation of outcome results; various open science practices support the dispassionate analysis of data and transparent reporting of trial findings; and preparation for null or negative results helps to temper stakeholder expectations and increase understanding of why we conduct trials in the first place. To embed these practices, research funders must be willing to pay for pilot studies and 'thicker' trials, and publishers should judge trials according to their conduct and not their outcome. MYRIAD is an exemplar of how to design, conduct and report a trial to optimise learning, with important implications for practice.

Background: Access to affordable, appropriate housing is one of the key social determinants of health, affecting well-being across the lifecourse. However, beyond a recognition that housing quality is linked to place of death, little is known about the ways in which housing status impacts social, emotional, and practical aspects of dying and bereavement. Method: the Checking Out project is a qualitative study aiming to explore the ways in which socio-economic status impacts people’s experiences of, and attitudes towards, death, dying, and bereavement in the United Kingdom. Qualitative interviews were carried out with 14 bereaved individuals with experience of poverty at end of life or in bereavement, and 15 professionals supporting individuals in low-income communities. Interviews were conducted via phone/video call, and data include experiences of end of life and bereavement both before and during the pandemic. Transcripts were examined using thematic analysis. Results: Housing emerged as an important factor affecting people’s experiences, with 7 of the 14 bereaved individuals and all except 1 of the professionals discussing housing-related issues. Participants described ways in which unsuitable housing and housing insecurity impacted practical aspects of dying but also emotional and social well-being at end of life. Housing-related issues affected both patients and their families, though families found it difficult to air these concerns when their relative was dying. Conclusion: the paper demonstrates how trusted professionals are able to advocate or address the issues faced by bereaved individuals and suggests implications for policy and practice. A greater awareness of the potential impact of housing status across public services, including healthcare practitioners, welfare support, and housing providers, could better support patients and practitioners to address these issues proactively. Housing providers and policy-makers should be included as key partners in collaborative public health approaches to palliative care.

There can be a tendency for investigators to disregard or explain away null or negative results in prevention science trials. Examples include not publicizing findings, conducting spurious subgroup analyses, or attributing the outcome post hoc to real or perceived weaknesses in trial design or intervention implementation. This is unhelpful for several reasons, not least that it skews the evidence base, contributes to research "waste", undermines respect for science, and stifles creativity in intervention development. In this paper, we identify possible policy and practice responses when interventions have null (ineffective) or negative (harmful) results, and argue that these are influenced by: the intervention itself (e.g. stage of gestation, perceived importance); trial design, conduct, and results (e.g. pattern of null/negative effects, internal and external validity); context (e.g. wider evidence base, state of policy); and individual perspectives and interests (e.g. stake in the intervention). We advance several strategies to promote more informative null or negative effect trials and enable learning from such results, focusing on changes to culture, process, intervention design, trial design, and environment.

Summary
. This study sought to understand the current challenges mainstream secondary schools in England face in creating a health promoting school culture for diet and physical activity behaviours. An in-depth qualitative case study of two purposely selected state-funded schools, including interviews with teachers, observations of school activities including meal breaks and a qualitative survey with parents was done. Inductive thematic analysis was used to explore emerging themes. Additional interviews with the leadership team from four further schools were used to develop and refine emerging themes. Four main themes emerged from the data: competing pressures, school environment, personnel and policy. Results demonstrate that schools recognize they have role to play in promoting healthy lifestyle behaviours to pupils; however, several significant barriers were identified such as lack of government support and regulation, school structures and organization, focus on core subjects, business-run canteens and lack of family and community engagement. Given the importance of maintaining a healthy weight throughout the life course, schools have an important role to play in creating healthy environments in which students can easily make a healthy choice. Future school promotion initiatives need to consider addressing the barriers that schools face by working with them and the communities in which they are embedded.

AbstractBackgroundInvolving patients, service users, carers and members of the public in research has been part of health policy and practice in the UK for the last 15 years. However, low‐income communities tend to remain marginalized from the co‐design and delivery of mental health research, perpetuating the potential for health inequalities. Greater understanding is therefore needed on how to meaningfully engage low‐income communities in mental health research.ObjectivesTo explore and articulate whether and how an engaged research approach facilitated knowledge coproduction relating to poverty and mental distress.SettingA reflective evaluation of community and researcher engagement in the DeStress study that took place in two low‐income areas of South‐west England.DesignReflective evaluation by the authors through on‐going feedback, a focus group and first‐person writing and discussion on experiences of working with the DeStress project, and how knowledge coproduction was influenced by an engaged research approach.ResultsAn engaged research approach influenced the process and delivery of the DeStress project, creating a space where community partners felt empowered to coproduce knowledge relating to poverty‐related mental distress, treatment and the training of health professionals that would otherwise have been missed. We examine motivations for involvement, factors sustaining engagement, how coproduction influenced research analysis, findings and dissemination of outputs, and what involvement meant for different stakeholders.ConclusionEngaged research supported the coproduction of knowledge in mental health research with low‐income communities which led to multiple impacts.

BACKGROUND: Research and policy have identified social cohesion as a potentially modifiable determinant of health and wellbeing that could contribute to more sustainable development. However, the function of social cohesion appears to vary between communities. The aim of this study was to analyse the levels of, and associations, between social cohesion, mental wellbeing, and physical and mental health-related quality of life among a cohort of social housing residents from low socioeconomic status communities in Cornwall, UK. Social housing is below market-rate rental accommodation made available to those in certain health or economic circumstances. These circumstances may impact on the form and function of social cohesion. METHODS: During recruitment, participants in the Smartline project completed the Short Warwick-Edinburgh Mental Wellbeing Scale, SF-12v2 and an eight item social cohesion scale. Cross sectional regression analyses of these data adjusted for gender, age, national identity, area socioeconomic status, rurality, education, employment, and household size were undertaken to address the study aim. RESULTS: Complete data were available from 305 (92.7%) participants in the Smartline project. Univariable analyses identified a significant association between social cohesion, mental wellbeing and mental health-related quality of life. Within fully adjusted multivariable models, social cohesion only remained significantly associated with mental wellbeing. Sensitivity analyses additionally adjusting for ethnicity and duration of residence, where there was greater missing data, did not alter the findings. CONCLUSIONS: Among a relatively homogeneous cohort, the reported level of social cohesion was only found to be significantly associated with higher mental wellbeing, not physical or mental health-related quality of life. The efforts made by social housing providers to offer social opportunities to all their residents regardless of individual physical or mental health state may support the development of a certain degree of social cohesion. Sense of control or safety in communities may be more critical to health than social cohesion. Additional observational research is needed before attempts are made to alter social cohesion to improve health.

Objective: This paper uses a qualitative approach to explore the factors that influence diet and physical activity choices of 11–13-year-olds with a particular focus on the impact of the school environment. Design: Qualitative focus groups. Setting: Three purposively sampled secondary schools in Devon, UK. Method: a total of 53 students, aged 11–13, took part in six focus groups. Thematic, framework analysis was used to analyse the data. Result: Four overarching themes emerged: (1) health now and in the future; (2) the role of others; (3) provision, temptation and addiction; and (4) boundaries, strategies and support. Participants demonstrated good knowledge of what constitutes a healthy lifestyle and its importance for future health, although it was not necessarily seen as a priority at this stage of life. Key influences on their choices were their peers and family, although participants also identified that the school environment influences the food choices they make while there. Conclusion: in this study, 11–13-year-olds identified that schools could do more to support them to make healthier food choices. However, future research needs to understand the constraints schools face in terms of food provision in order to highlight possible opportunities for intervention.

This paper examines the impact of increased welfare conditionality on people with mental health issues claiming benefits in the UK. Drawing on data from the DeStress study, this paper explores the lived experience of welfare claimants in low-income communities, and the perspectives of GPs seeking to support them. Particular focus is placed on people’s experience of the Work Capability Assessment, the tool used to determine welfare claimants’ entitlement to sickness benefit, and how the narratives and culture surrounding welfare reform and the actual assessment itself can have a negative impact on mental health and wellbeing.

BACKGROUND: Physical activity guidelines state that children should achieve at least 60 minutes of moderate to vigorous physical activity (MVPA) on each day of the week. Accurate assessment of adherence to these guidelines should, ideally, include measurement over 7 days. When less than 7 days of data are available, researchers often report the average minutes of MVPA per day as a proxy for 7-day measurement. The aim of this study was to compare prevalence estimates generated by average MVPA per day versus MVPA assessed over 7 days. METHODS: Data were collected as part of the Healthy Lifestyles Programme. One class from each school was randomized to wear a GENEActiv accelerometer for 8 days. The percentages of children achieving an average of ≥60 minutes of MVPA per day and those achieving ≥60 minutes of MVPA on each of 7 days were calculated. RESULTS: a total of 807 children provided 7 days of data. When the average MVPA per day was calculated, 30.6% (n = 247) of children accumulated ≥60 minutes of MVPA per day. Only 3.2% (n = 26) accumulated ≥60 minutes of MVPA on every day of the week. CONCLUSION: Previous studies utilizing average MVPA per day are likely to have overestimated the percentage of children meeting recommendations.

Purpose: the purpose of this study was to assess children's compliance with wrist-worn accelerometry during a randomized controlled trial and to examine whether compliance differed by allocated condition or gender. Methods: a total of 886 children within the Healthy Lifestyles Programme trial were randomly allocated to wear a GENEActiv accelerometer at baseline and 18-month follow-up. Compliance with minimum wear-time criteria (=10 h for 3 weekdays and 1 weekend day) was obtained for both time points. Chi-square tests were used to determine associations between compliance, group allocation, and gender. Results: at baseline, 851 children had usable data, 830 (97.5%) met the minimum wear-time criteria, and 631 (74.1%) had data for 7 days at 24 hours per day. At follow-up, 789 children had usable data, 745 (94.4%) met the minimum wear-time criteria, and 528 (67%) had complete data. Compliance did not differ by gender (baseline: ?2 = 1.66, P =. 2; follow-up: ?2 = 0.76, P =. 4) or by group at follow-up (?2 = 2.35, P =. 13). Conclusion: the use of wrist-worn accelerometers and robust trial procedures resulted in high compliance at 2 time points regardless of group allocation, demonstrating the feasibility of using precise physical activity monitors to measure intervention effectiveness.

BackgroundApproximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.ObjectiveTo determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.DesignA cluster randomised controlled trial with an economic and process evaluation.SettingThirty-two primary schools in south-west England.ParticipantsChildren in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.InterventionThe Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.Main outcome measuresThe primary outcome measure was body mass index (BMI) standard deviation score (SDS) at 24 months post baseline measures (12 months post intervention). The secondary outcomes comprised waist circumference SDS, percentage body fat SDS, proportion of children overweight and obese at 18 and 24 months, accelerometer-assessed physical activity and food intake at 18 months, and cost-effectiveness.ResultsWe recruited 32 schools and 1324 children. We had a rate of 94% follow-up for the primary outcome. No difference in BMI SDS was found at 24 months [mean difference –0.02, 95% confidence interval (CI) –0.09 to 0.05] or at 18 months (mean difference –0.02, 95% CI –0.08 to 0.05) between children in the intervention schools and children in the control schools. No difference was found between the intervention and control groups in waist circumference SDS, percentage body fat SDS or physical activity levels. Self-reported dietary behaviours showed that, at 18 months, children in the intervention schools consumed fewer energy-dense snacks and had fewer negative food markers than children in the control schools. The intervention effect on negative food markers was fully mediated by ‘knowledge’ and three composite variables: ‘confidence and motivation’, ‘family approval/behaviours and child attitudes’ and ‘behaviours and strategies’. The intervention effect on energy-dense snacks was partially mediated by ‘knowledge’ and the same composite variables apart from ‘behaviours and strategies’. The cost of implementing the intervention was approximately £210 per child. The intervention was not cost-effective compared with control. The programme was delivered with high fidelity, and it engaged children, schools and families across the socioeconomic spectrum.LimitationsThe rate of response to the parent questionnaire in the process evaluation was low. Although the schools in the HeLP study included a range of levels of socioeconomic deprivation, class sizes and rural and urban settings, the number of children for whom English was an additional language was considerably lower than the national average.ConclusionsHeLP is not effective or cost-effective in preventing overweight or obesity in children aged 9–10 years.Future workOur very high levels of follow-up and fidelity of intervention delivery lead us to conclude that it is unlikely that school-based programmes targeting a single age group can ever be sufficiently intense to affect weight status. New approaches are needed that affect the school, the family and the wider environment to prevent childhood obesity.Trial registrationCurrent Controlled Trials ISRCTN15811706.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 6, No. 1. See the NIHR Journals Library website for further project information.

Background Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months. Methods This pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (

Despite extraordinary advances in biomedicine and associated gains in human health and well-being, a growing number of health and well-being related challenges have remained or emerged in recent years. These challenges are often ‘more than biomedical’ in complexion, being social, cultural and environmental in terms of their key drivers and determinants, and underline the necessity of a concerted policy focus on generating healthy societies. Despite the apparent agreement on this diagnosis, the means to produce change are seldom clear, even when the turn to health and well-being requires sizable shifts in our understandings of public health and research practices. This paper sets out a platform from which research approaches, methods and translational pathways for enabling health and well-being can be built. The term ‘healthy publics’ allows us to shift the focus of public health away from ‘the public’ or individuals as targets for intervention, and away from the view that culture acts as a barrier to efficient biomedical intervention, towards a greater recognition of the public struggles that are involved in raising health issues, questioning what counts as healthy and unhealthy and assembling the evidence and experience to change practices and outcomes. Creating the conditions for health and well-being, we argue, requires an engaged research process in which public experiments in building and repairing social and material relations are staged and sustained even if, and especially when, the fates of those publics remain fragile and buffeted by competing and often more powerful public formations.

Associations between mental health and poverty are increasingly well established. Yet in neoliberally oriented contexts in which distress engendered through the everyday hardships of poverty is increasingly pathologised and medicalised, important questions are raised over the assumptions inherent within mental health policy and its implementation. Using the UK as a focus, this paper reviews and maps out key questions that require investigation in order to better understand the complex inter-relations between poverty and distress; explores how current paradigms might influence notions of individual responsibility and agency as well as health seeking behaviours; and examines the role of, and cultural and systemic expectations and constraints placed upon GPs as they respond to distress amongst patients from low-income communities. In so doing, we argue for recognition of the moral narratives that underpin both mental health care and processes of welfare reform, and call for an expansion of conventional notions of evidence-based healthcare to incorporate the understandings, experiences and priorities of people from low-income groups. We call for more detailed questioning and analysis of the interactions that lead to mental health diagnosis and treatment and better understanding of the relevance and effectiveness of current treatment options. As a central tenet of this, we argue for more flexible and nuanced healthcare responses that better reflect the dynamic and multi-faceted nature of poverty-related distress.

BACKGROUND: the Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS: all 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION: ISRCTN15811706.

BACKGROUND: Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventions focus on programme content rather than the building of supportive relationships with all participants and tend to employ specific standalone strategies, such as incentives, to improve retention. We believe that actively involving stakeholders in both intervention and trial design improves recruitment and retention and increases the chances of creating an effective intervention. METHODS: the Healthy Lifestyles Programme, HeLP (an obesity prevention programme for children 9-10 years old) was developed using intervention mapping and involved extensive stakeholder involvement in both the design of the trial and the intervention to ensure that: (i) delivery methods were suitably engaging, (ii) deliverers had the necessary skills and qualities to build relationships and (iii) the intervention dovetailed with the National Curriculum. HeLP was a year-long intervention consisting of 4 multi-component phases using a range of delivery methods. We recruited 1324 children from 32 schools from the South West of England to a cluster-randomised controlled trial to determine the effectiveness of HeLP in preventing obesity. The primary outcome was change in body mass index standard deviation score (BMI SDS) at 24 months post randomisation. Secondary outcomes included additional anthropometric and behavioural (physical activity and diet) measures at 18 and 24 months. RESULTS: Anthropometric and behavioural measures were taken in 99%, 96% and 94% of children at baseline, 18 and 24 months, respectively, with no differential follow up between the control and intervention groups at each time point. All children participated in the programme and 92% of children and 77% of parents across the socio-economic spectrum were considered to have actively engaged with HeLP. CONCLUSIONS: We attribute our excellent retention and engagement results to the high level of stakeholder involvement in both trial and intervention design, the building of relationships using appropriate personnel and creative delivery methods that are accessible to children and their families across the social spectrum. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Register, ISRCTN15811706. Registered on 1 May 2012.

BACKGROUND: Healthcare professionals throughout the developed world report higher levels of sickness absence, dissatisfaction, distress, and "burnout" at work than staff in other sectors. There is a growing call for the 'triple aim' of healthcare delivery (improving patient experience and outcomes and reducing costs; to include a fourth aim: improving healthcare staff experience of healthcare delivery. A systematic review commissioned by the United Kingdom's (UK) Department of Health reviewed a large number of international healthy workplace interventions and recommended five whole-system changes to improve healthcare staff health and wellbeing: identification and response to local need, engagement of staff at all levels, and the involvement, visible leadership from, and up-skilling of, management and board-level staff. OBJECTIVES: This systematic review aims to identify whole-system healthy workplace interventions in healthcare settings that incorporate (combinations of) these recommendations and determine whether they improve staff health and wellbeing. METHODS: a comprehensive and systematic search of medical, education, exercise science, and social science databases was undertaken. Studies were included if they reported the results of interventions that included all healthcare staff within a healthcare setting (e.g. whole hospital; whole unit, e.g. ward) in collective activities to improve physical or mental health or promote healthy behaviours. RESULTS: Eleven studies were identified which incorporated at least one of the whole-system recommendations. Interventions that incorporated recommendations to address local need and engage the whole workforce fell in to four broad types: 1) pre-determined (one-size-fits-all) and no choice of activities (two studies); or 2) pre-determined and some choice of activities (one study); 3) a wide choice of a range of activities and some adaptation to local needs (five studies); or, 3) a participatory approach to creating programmes responsive and adaptive to local staff needs that have extensive choice of activities to participate in (three studies). Only five of the interventions included substantial involvement and engagement of leadership and efforts aimed at up-skilling the leadership of staff to support staff health and wellbeing. Incorporation of more of the recommendations did not appear to be related to effectiveness. The heterogeneity of study designs, populations and outcomes excluded a meta-analysis. All studies were deemed by their authors to be at least partly effective. Two studies reported statistically significant improvement in objectively measured physical health (BMI) and eight in subjective mental health. Six studies reported statistically significant positive changes in subjectively assessed health behaviours. CONCLUSIONS: This systematic review identified 11 studies which incorporate at least one of the Boorman recommendations and provides evidence that whole-system healthy workplace interventions can improve health and wellbeing and promote healthier behaviours in healthcare staff.

BACKGROUND: the Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. METHODS AND DESIGN: the HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706. Registered on 1 May 2012.

Schools are common sites for obesity prevention interventions. Although many theories suggest that the school context influences weight status, there has been little empirical research. The objective of this study was to explore whether features of the school context were consistently and meaningfully associated with pupil weight status (overweight or obese). Exploratory factor analysis of routinely collected data on 319 primary schools in Devon, England, was used to identify possible school-based contextual factors. Repeated cross-sectional multilevel analysis of five years (2006/07-2010/11) of data from the National Child Measurement Programme was then used to test for consistent and meaningful associations. Four school-based contextual factors were derived which ranked schools according to deprivation, location, resource and prioritisation of physical activity. None of which were meaningfully and consistently associated with pupil weight status, across the five years. The lack of consistent associations between the factors and pupil weight status suggests that the school context is not inherently obesogenic. In contrast, incorporating findings from education research indicates that schools may be equalising weight status, and obesity prevention research, policy and practice might need to address what is happening outside schools and particularly during the school holidays.

BACKGROUND: Schools have long been viewed as a good setting in which to encourage healthy lifestyles amongst children, and schools in many countries aspire to more comprehensive, integrated approaches to health promotion. Recent reviews have identified evidence of the effects of school health promotion on children's and young people's health. However, understanding of how such programmes can be implemented in schools is more limited. METHODS: We conducted a realist review to identify the conditions and actions which lead to the successful implementation of health promotion programmes in schools. We used the international literature to develop programme theories which were then tested using evaluations of school health promotion programmes conducted in the United Kingdom (UK). Iterative searching and screening was conducted to identify sources and clear criteria applied for appraisal of included sources. A review advisory group comprising educational and public health practitioners, commissioners, and academics was established at the outset. RESULTS: in consultation with the review advisory group, we developed four programme theories (preparing for implementation, initial implementation, embedding into routine practice, adaptation and evolution); these were then refined using the UK evaluations in the review. This enabled us to identify transferable mechanisms and enabling and constraining contexts and investigate how the operation of mechanisms differed in different contexts. We also identified steps that should be taken at a senior level in relation to preparing for implementation (which revolved around negotiation about programme delivery) and initial implementation (which centred on facilitation, support, and reciprocity-the latter for both programme deliverers and pupils). However, the depth and rigour of evidence concerning embedding into routine practice and adaptation and evolution was limited. CONCLUSIONS: Our findings provide guidance for the design, implementation, and evaluation of health promotion in schools and identify the areas where further research is needed.

Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of
healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the
scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance
of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting
that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity
theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains
(system characteristics) that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW) framework is
responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by
capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace,
a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy
workplace interventions that create workplaces conducive to healthy behaviour change.

Despite the rise in childhood obesity, there remains a paucity of evidence for effective interventions that engage children and parents sufficiently to make and sustain lifestyle behaviour change. The Healthy Lifestyles Programme (HeLP) is a school-located obesity prevention programme, which has been developed with teachers, families and healthcare professionals. The underpinning assumption in the development of HeLP was to take a relational approach to changing behaviour, building relationships with the schools, children and their families to create supportive environments for healthy lifestyle choices. Thus, HeLP was conceptualised as a complex intervention within a complex system and developed as a dynamic, evolving set of processes to support and motivate children towards healthy behaviours. The delivery methods used are highly interactive and encourage identification with and ownership of the healthy lifestyle messages so that the children are motivated to take them home to their parents and effect change within the family. We have good evidence that HeLP engages schools and children such that they want to participate in the Programme. Results from an exploratory trial showed that the Programme is feasible and acceptable and has the potential to change behaviours and affect weight status. This paper presents an overview of and recommendations arising from the conceptualization; development and evaluation of the Healthy Lifestyles Programme as part of a special issue focusing on novel approaches to the global problem of childhood obesity.

The workplace is an important setting for promoting health and well-being. We sought to understand how successful workplace health and well-being programs were developed and implemented to inform the development of a program for a National Health Service (NHS) hospital. Case studies of successful healthy workplace programs with 34 semi-structured employee interviews informed 12 interviews with NHS staff. Interviews were thematically analyzed using Nvivo. Themes were fed back to participants for further clarification and validation. Healthy workplace programs were characterized by senior management endorsement; collective sense of ownership; presence of visible "quick wins"; and a sense that participation was easy and fun, not mandated. Programs evolved organically, allowing trust to be built and activities to be developed with employees. Interviews with NHS staff suggested a lack of belief in the possibility of change in their workplace due to time and workload pressures, and a sense of an "us and them" relationship with management, as well as environmental barriers. A consistent pattern of how the conditions for a healthy workplace can be created, which map onto the results from the NHS ward staff, suggest that without creating an enabling environment for health-promoting behaviors, workplace programs will have poor uptake and retention.

BACKGROUND: Much has been written about public involvement (PI) in health and social care research, but underpinning values are rarely made explicit despite the potential for these to have significant influence on the practice and assessment of PI. OBJECTIVE: the narrative review reported here is part of a larger MRC-funded study which is producing a framework and related guidance on assessing the impact of PI in health and social care research. The review aimed to identify and characterize the range of values associated with PI that are central elements of the framework. METHODS: We undertook a review and narrative synthesis of diverse literatures of PI in health and social care research, including twenty existing reviews and twenty-four chapters in sixteen textbooks. RESULTS: Three overarching value systems were identified, each containing five value clusters. (i) a system concerned with ethical and/or political issues including value clusters associated with empowerment; change/action; accountability/transparency; rights; and ethics (normative values). (ii). A system concerned with the consequences of public involvement in research including value clusters associated with effectiveness; quality/relevance; validity/reliability; representativeness/objectivity/generalizability; and evidence (substantive values). (iii) a system concerned with the conduct of public involvement in including value clusters associated with Partnership/equality; respect/trust; openness and honesty; independence; and clarity (process values). CONCLUSION: Our review identified three systems associated with PI in health and social care research focused on normative, substantive and process values. The findings suggest that research teams should consider and make explicit the values they attach to PI in research and discuss ways in which potential tensions may be managed in order to maximize the benefits of PI for researchers, lay experts and the research.

OBJECTIVE: the aim of this study is to examine whether there is a differential impact of primary schools upon children's weight status. METHODS: a repeated cross-sectional study was undertaken using five years (2006/07-2010/11) of National Child Measurement Programme data, comprising 57,976 children (aged 4-5 (Reception) and 10-11 (Year 6) years) from 300 primary schools across Devon, England. Examining each year separately, the schools were ranked according to their observed and residual (having accounted for school and neighbourhood clustering and pupil ethnicity and socioeconomic status) school mean body mass index standard deviation score (BMI-SDS). Subtracting the Reception from the Year 6 mean residuals gave 'value-added' scores for each school which were also ranked. The rankings were compared within and across the years to assess consistency. RESULTS: Although pupil BMI-SDS was high, >97% of the variation in BMI-SDS was attributable to environments other than the school. The 'value-added' by each school was only poorly correlated with the observed and residual pupil BMI-SDS; but none of the rankings were consistent across the five years. CONCLUSION: the inconsistency of the rankings and the small variation in BMI-SDS at the level of the school suggests that there is no systematic differential impact of primary schools upon pupil weight status.

OBJECTIVES: to determine the effectiveness of enzyme replacement therapy (ERT) for adults with late-onset Pompe disease. DESIGN: a longitudinal cohort study including prospective and retrospective clinical outcome data. Age- and gender-adjusted treatment effects were estimated using generalised linear mixed models. Treated patients contributed data before and during treatment. Untreated patients contributed natural history data. PARTICIPANTS: Consenting adults (N = 62) with a diagnosis of late-onset Pompe disease who attended a specialist treatment centre in England. This cohort represented 83 % of all patients in the UK with a confirmed diagnosis of this rare condition. At study entry, all but three patients were receiving ERT (range of treatment duration, 0 to 3.1 years). OUTCOME MEASURES: Percent predicted forced vital capacity (%FVC); ventilation dependency; mobility; 6 min walk test (6MWT); muscle strength and body mass index (BMI). RESULTS: an association was found between time on ERT and significant increases in the distance walked in the 6MWT (p 

Objective: There is growing interest in the potential benefits of public involvement (PI) in health and social care research. However, there has been little examination of values underpinning PI or how these values might differ for different groups with an interest in PI in the research process. We aimed to explore areas of consensus and conflict around normative, substantive and process-related values underpinning PI. Design: Mixed method, three-phase, modified Delphi study, conducted as part of a larger multiphase project. Setting: the UK health and social care research community. Participants: Stakeholders in PI in research, defined as: clinical and non-clinical academics, members of the public, research managers, commissioners and funders; identified via research networks, online searches and a literature review. Results: We identified high levels of consensus for many normative, substantive and process-related issues. However, there were also areas of conflict in relation to issues of bias and representativeness, and around whether the purpose of PI in health and social care research is to bring about service change or generate new knowledge. There were large differences by group in the percentages endorsing the ethical justification for PI and the argument that PI equalises power imbalances. With regard to practical implementation of PI, research support infrastructures were reported as lacking. Participants reported shortcomings in the uptake and practice of PI. Embedding PI practice and evaluation in research study designs was seen as fundamental to strengthening the evidence base. Conclusions: Our findings highlight the extent to which PI is already embedded in research. However, they also highlight a need for 'best practice' standards to assist research teams to understand, implement and evaluate PI. These findings have been used in developing a Public Involvement Impact Assessment Framework (PiiAF), which offers guidance to researchers and members of the public involved in the PI process.

Objective: to explore areas of consensus and conflict in relation to perceived public involvement (PI) barriers and drivers, perceived impacts of PI and ways of evaluating PI approaches in health and social care research. Background: Internationally and within the UK the recognition of potential benefits of PI in health and social care research is gathering momentum and PI is increasingly identified by organisations as a prerequisite for funding. However, there is relatively little examination of the impacts of PI and how those impacts might be measured. Design: Mixed method, three-phase, modified Delphi technique, conducted as part of a larger MRC multiphase project. Sample: Clinical and non-clinical academics, members of the public, research managers, commissioners and funders. Findings: This study found high levels of consensus about the most important barriers and drivers to PI. There was acknowledgement that tokenism was common in relation to PI; and strong support for the view that demonstrating the impacts and value of PI was made more difficult by tokenistic practice. PI was seen as having intrinsic value; nonetheless, there was clear support for the importance of evaluating its impact. Research team cohesion and appropriate resources were considered essential to effective PI implementation. Panellists agreed that PI can be challenging, but can be facilitated by clear guidance, together with models of good practice and measurable standards. Conclusions: This study is the first to present empirical evidence of the opinions voiced by key stakeholders on areas of consensus and conflict in relation to perceived PI barriers and drivers, perceived impacts of PI and the need to evaluate PI. As such it further contributes to debate around best practice in PI, the potential for tokenism and how best to evaluate the impacts of PI. These findings have been used in the development of the Public Involvement Impact Assessment Framework (PiiAF), an online resource which offers guidance to researchers and members of the public involved in the PI process.

OBJECTIVES: to determine the effectiveness of enzyme replacement therapy (ERT) for adults and children with Fabry disease. DESIGN: Cohort study including prospective and retrospective clinical data. Age- and gender-adjusted treatment effects were estimated using generalised linear mixed models. Treated patients contributed data before and during treatment and untreated patients contributed natural history data. PARTICIPANTS: Consenting adults (N = 289) and children (N = 22) with a confirmed diagnosis of Fabry disease attending a specialist Lysosomal Storage Disorder treatment centre in England. At recruitment 211 adults and seven children were on ERT (range of treatment duration, 0 to 9.7 and 0 to 4.2 years respectively). OUTCOME MEASURES: Clinical outcomes chosen to reflect disease progression included left ventricular mass index (LVMI); proteinuria; estimated glomerular filtration rate (eGFR); pain; hearing and transient ischaemic attacks (TIA)/stroke. RESULTS: We found evidence of a statistically significant association between time on ERT and a small linear decrease in LVMI (p = 0.01); a reduction in the risk of proteinuria after adjusting for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (p 

OBJECTIVES: to determine the effectiveness of enzyme replacement therapies (ERT) for adults with Gaucher disease (GD). DESIGN: a longitudinal, multi-centre cohort study, including prospective and retrospective clinical data. Age- and gender-adjusted treatment effects were estimated using generalised linear mixed models. Treated patients contributed data before and during treatment. Untreated patients contributed natural history data. PARTICIPANTS: Consenting adults (N = 150, aged 16 to 83 years) with a diagnosis of GD who attended a specialist treatment centre in England. At recruitment, 131 patients were receiving ERT (mean treatment duration, 10.8 years; range 0-18 years). OUTCOME MEASURES: Clinical outcomes chosen to reflect disease progression, included platelet count; haemoglobin; absence/presence of bone pain; spleen and liver volumes and AST levels. RESULTS: One hundred and fifty adults were recruited. Duration of ERT was associated with statistically significant improvements in platelet count (p 

OBJECTIVES: to determine the effectiveness of enzyme replacement therapies (ERT) for children with Gaucher disease (GD). DESIGN: a longitudinal cohort study including prospective and retrospective clinical data. Age- and gender-adjusted treatment effects were estimated using generalised linear mixed models. Children on treatment contributed data before and during treatment. Children not on treatment contributed natural history data. PARTICIPANTS: Consenting children (N = 25, aged 1.1 to 15.6 years) with a diagnosis of GD (14 with GD1 and 11 with GD3) who attended a specialist treatment centre in England. At recruitment, 24 patients were receiving ERT (mean treatment duration, 5.57 years; range 0-13.7 years). OUTCOME MEASURES: Clinical outcomes chosen to reflect disease progression, included platelet count; haemoglobin and absence/presence of bone pain. RESULTS: Duration of ERT was associated with statistically significant improvements in platelet count (p 

Objective: to describe the use of, and attitudes toward, complementary therapy (CT) by parents of children with moderate to severe cerebral palsy. Methods: Parents of 32 children with cerebral palsy (age 5-12 years) enrolled in a randomized trial of cranial osteopathy prospectively participated in semi-structured interviews in the home to explore the use of CT and views regarding access to and expectations of these therapies. Interview transcripts were analyzed thematically, and content analysis was used to determine the frequency of use of different therapies. Results: Sixteen children (50%) had received one or more types of CT, although only three were currently receiving any CT. The primary reasons for trying CT were to reduce children's pain and improve physical function. Parents had limited knowledge of the range of, and possible indications for, CT and expressed concerns about CT safety and effectiveness. Practical considerations of time and cost were also identified. Some parents had strong beliefs about the benefits, and, overall, parents indicated a high level of commitment to finding any treatments, conventional or CT, to help their children. Conclusion: Parents of children with cerebral palsy want to help their child, but they need information, guidance, and practical support to facilitate their decision-making regarding the use of CT. A clearer understanding of factors predictive of optimal outcomes will enable resources to be targeted effectively. © Copyright 2014, Mary Ann Liebert, Inc. 2014.

Background: Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours. Methods. A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis. Results: Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change. Conclusion: the process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial. © 2014 Lloyd and Wyatt; licensee BioMed Central Ltd.

BACKGROUND: Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours. METHODS: a process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis. RESULTS: Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change. CONCLUSION: the process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial.

Lysosomal storage disorders (LSDs) comprise more than 50 extremely rare, inherited metabolic diseases resulting from a deficiency of specific lysosomal enzymes required for normal macromolecular metabolism. The National Collaborative Study for Lysosomal Storage Disorders (NCS-LSD), was a longitudinal cohort study which collected prospective and retrospective clinical data, and patient-reported data from adults and children with a confirmed diagnosis of Gaucher disease, Fabry disease, mucopolysaccharidosis type I (MPS I), mucopolysaccharidosis type II (MPS II), Pompe disease and Niemann Pick disease type C (NPC) in the UK. The study aimed to determine the natural history of these conditions and estimate the effectiveness and cost of therapies. Clinical outcomes were chosen to reflect disease progression. Age- and gender-adjusted treatment effects were estimated using generalised linear mixed models. Treated patients contributed data before and during treatment while untreated patients contributed natural history data. A total of 711 adults and children were recruited to this study from the seven LSD treatment centres in England. Data was collected from 2008 to 2011. This paper describes the methods used to collect and analyse clinical data for this study. The clinical findings are reported separately in a series of condition-specific articles in this issue.

The standard, deficit-based, approach to health promotion tends to focus on health problems, designing services which are meant to solve these problems, of which members of communities are made the passive recipients. An alternative approach recognises that health problems are complex, having many causal pathways and as a result will require locally tailored interventions, involving multiple service providers working with local communities. Using empirical research from the development of two transformational community-led partnerships, an experiential learning programme was developed, Connecting Communities (C2). Complexity science is the underpinning theoretical framework for C2, which seeks to create the conditions to transform the health and well-being of disadvantaged communities. C2 focuses specifically on the nature of the relations between the agents in the system and their interactions with the social environment which determine the system's behaviour. This is because a key tenet of complexity science is that systemic change cannot be externally directed, but occurs as a result of the self-organising interactions and relationships within the system. C2 takes an explicit asset-based community development approach, seeking to facilitate and support the development of local neighbourhood partnerships which focus on the strengths and aspirations of the community, rather than perceived deficits. This paper reports on the development of C2, its delivery, presents a case study of one of the first groups to undertake the Programme, and assesses its subsequent impacts on the participants' ways of working, and in the local community. © 2013 Copyright Taylor and Francis Group, LLC.

BACKGROUND: over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children. METHODS/DESIGN: We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ≥19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme. DISCUSSION: the results of the trial will provide evidence on the effectiveness and cost effectiveness of the Healthy Lifestyles Programme in affecting the weight status of children. TRIAL REGISTRATION: ISRCTN15811706.

This systematic review considers current literature on the association between childhood overweight and obesity and the primary school built environment. Bibliographic databases from the fields of medicine, social science, exercise science and education were systematically searched. The following elements of the built environment were found to have been investigated: playground availability and adequacy; gymnasium availability and adequacy; school field, showers and covered playground availability. One intervention study was identified which utilized the built environment as an adjunct to a behavior change intervention. This systematic review identified minimal research upon the association between the school built environment and weight status and the current results are inconclusive.

OBJECTIVES: to assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme. DESIGN: Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme. SETTING: Four city primary schools (two control and two intervention) in the South West of England. PARTICIPANTS: 202 children aged 9-10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class. INTERVENTION: Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6. PRIMARY AND SECONDARY OUTCOMES: Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months. RESULTS: at 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less 'negative food markers', more 'positive food markers', lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures. CONCLUSIONS: Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.

BACKGROUND: School-based interventions and campaigns are used to promote health and address a wide variety of public health problems. Schools are considered to be key sites for the implementation of health promotion programmes for their potential to reach the whole population in particular age-groups and instil healthy patterns of behavior early in life. However, evidence for the effectiveness of school-based health promotion interventions is highly variable. Systematic reviews of the evidence of school-based interventions tend to be highly problem- or intervention- specific, thereby missing potential generic insights into implementation and effectiveness of such programmes across problems. METHODS/DESIGN: a realist systematic review will be undertaken to explain how, why and in what circumstances schools can provide feasible settings for effective health promotion programmes in the United Kingdom (UK). The review will be conducted in two phases. Phase 1 will identify programme theories about implementation (ideas about what enables or inhibits effective health promotion to be delivered in a school setting). Phase 2 will test the programme theories so that they can be challenged, endorsed and/or refined. A Review Advisory Group of education and health professionals will be convened to help identify and choose potential programme theories, provide a 'reality check' on the clarity and explanatory strength of the mechanisms to be tested, and help shape the presentation of findings to be usable by practitioners and decision-makers. Review findings will be disseminated through liaison with decision-makers, and voluntary and professional groups in the fields of education and health.

BACKGROUND: Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs). OBJECTIVE: to demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP). DESIGN: Semi-structured interviews were carried out with 20 parents of children with CP and other neurological conditions, asking them to choose between four different trial designs, to talk about noticeable changes in their child's condition and their views about payment for trial treatment. SETTING AND PARTICIPANTS: the parents interviewed were all members of Cerebra, a charity for 'brain-injured' children and young people. All interviews were carried out at the parents' homes. RESULTS: Parents had mixed views about possible trial designs; however, a waitlist design which allowed all children eventually to receive the treatment emerged as a clear favourite. Parents did not focus on isolated outcomes, but suggested a range of factors relevant to their child's quality of life. They expressed a clear preference for the costs of treatment to be funded by the trial. CONCLUSIONS: Involvement of parents helped design a trial which was acceptable to families and addressed outcomes that mattered to them. By consulting parents about the design of the research, the subsequent trial achieved excellent recruitment and retention rates.

OBJECTIVES: to estimate the effect of cranial osteopathy on the general health and wellbeing, including physical functioning, of children with cerebral palsy. DESIGN: Pragmatic randomised controlled trial. PARTICIPANTS: 142 children from Greater London and the South West of England, aged 5-12 years with cerebral palsy. INTERVENTION: Participants were randomised to six sessions of cranial osteopathy with a registered osteopath or a waiting list with partial attention control (parents invited to participate in two semistructured interviews). PRIMARY OUTCOME MEASURES: Blind assessment of motor function by physiotherapists using the Gross Motor Function Measure-66 (GMFM-66) and quality of life using the Child Health Questionnaire (CHQ) PF50 at 6 months. SECONDARY OUTCOME MEASURES: Parents' assessment of global health and sleep at 6 months, pain and sleep diaries at 10 weeks and 6 months, CHQ PF50 at 10 weeks and quality of life of main carer (Short Form 36) at 10 weeks and 6 months. RESULTS: Compared with children in the control group, children in the osteopathy group demonstrated no statistically significant differences in GMFM-66 (mean difference 4.9, 95% CI -4.4 to 14.1), CHQ Physical Summary Score (mean difference 2.2, 95% CI -3.5 to 8.0) or CHQ Psychological Summary Score (mean difference 3.4, 95% CI -0.8 to 7.7). There were no significant differences between groups with respect to pain; sleep (either 'time asleep' or 'time to sleep'); or main carer's quality of life. Compared with children in the control group, carers of children receiving cranial osteopathy were nearly twice as likely to report that their child's global health had 'improved' at 6 months rather than 'decreased' or 'remained the same' (38% vs 18%; odds ratio 2.8, 95% CI 1.1 to 6.9). CONCLUSIONS: This trial found no statistically significant evidence that cranial osteopathy leads to sustained improvement in motor function, pain, sleep or quality of life in children aged 5-12 years with cerebral palsy nor in quality of life of their carers.

BACKGROUND: Only limited data are available on the development and feasibility piloting of school-based interventions to prevent and reduce obesity in children. Clear documentation of the rationale, process of development and content of such interventions is essential to enable other researchers to understand why interventions succeed or fail. METHODS: This paper describes the development of the Healthy Lifestyles Programme (HeLP), a school-based intervention to prevent obesity in children, through the first 4 steps of the Intervention Mapping protocol (IM). The intervention focuses on the following health behaviours, i) reduction of the consumption of sweetened fizzy drinks, ii) increase in the proportion of healthy snacks consumed and iii) reduction of TV viewing and other screen-based activities, within the context of a wider attempt to improve diet and increase physical activity. RESULTS: Two phases of pilot work demonstrated that the intervention was acceptable and feasible for schools, children and their families and suggested areas for further refinement. Feedback from the first pilot phase suggested that the 9-10 year olds were both receptive to the messages and more able and willing to translate them into possible behaviour changes than older or younger children and engaged their families to the greatest extent. Performance objectives were mapped onto 3 three broad domains of behaviour change objectives--establish motivation, take action and stay motivated--in order to create an intervention that supports and enables behaviour change. Activities include whole school assemblies, parents evenings, sport/dance workshops, classroom based education lessons, interactive drama workshops and goal setting and runs over three school terms. CONCLUSION: the Intervention Mapping protocol was a useful tool in developing a feasible, theory based intervention aimed at motivating children and their families to make small sustainable changes to their eating and activity behaviours. Although the process was time consuming, this systematic approach ensures that the behaviour change techniques and delivery methods link directly to the Programme's performance objectives and their associated determinants. This in turn provides a clear framework for process analysis and increases the potential of the intervention to realise the desired outcome of preventing and reducing obesity in children.

Overweight and obesity in pre-school children are an increasing problem, with poor diet and exercise habits laying the foundation for serious health risks in later life. Yet most research into childhood obesity has focused on school-age children. Two previous systematic reviews of pre-school children have included uncontrolled designs and self-report outcomes potentially biasing the results in favour of the interventions. We have conducted a systematic review of the effectiveness and cost-effectiveness of weight management schemes for the under fives restricting the inclusion criteria to controlled trials with objective measures. We found four effectiveness randomized controlled trials of prevention. No treatment or cost-effectiveness studies were found. Only one study in a Latino community showed a statistically significant advantage from the intervention in a slower rate of increase in body mass index. However, trends in decrease in body mass index and weight loss favoured the intervention groups in other studies. From the studies characteristics we hypothesize that important features to include in future interventions may be; cultural sensitivity, sustained moderate to vigorous exercise, active engagement of the parents in the programme and as role models of healthy living and active engagement of the children in nutrition education. Further randomized controlled trials are needed in this population.

BACKGROUND: Obesity in pregnancy is increasing. It carries significant risks for the mother and her baby, and has considerable implications for the family and maternity services. Specific guidelines have been developed for the identification and management of the associated clinical risks, but there is little evidence of an optimum dietary intervention for these mothers who are at high risk of developing them. AIM: This study assessed the feasibility of recruiting individuals to a proposed dietary intervention project aimed at reducingthe incidence of excessive weight gain during pregnancy for mothers with a raised body mass index (BMI) in early pregnancy. METHOD: Women in early pregnancy (8-10 weeks) with a BMI greater than 30 kg/m2 were identified and offered the opportunity to participate in aproject that delivered specific dietary advice and ongoing motivational support at the time of the routine antenatal appointments that took place throughout their pregnancy. RESULTS AND DISCUSSION: over a four month period, 25 women out of a potential 172 were recruited into the study; a recruitment rate of 14.5%. Midwives were crucial to the recruitment strategy, but cited personal and professional reasons for their reluctance to address directly the issue of obesityin pregnancy with pregnant women. CONCLUSION: Recruitment for this study and any future obesity intervention study is problematic due to the perceived sensitivity surrounding obesity in pregnancy and the subsequent discomfort that professionals feel about raising the issue.

Transition onto haemodialysis is a time of increased psychosocial difficulty, yet, many renal patients exhibit personal resilience in continuing to lead productive lives. Using a positive psychological methodology, this qualitative study aims to identify factors identified by patients as helpful in the transition onto haemodialysis. Semi-structured interviews were undertaken with 10 patients within six months of starting haemodialysis. Interpretive content analysis identified three main themes (each with subthemes) in patients' accounts-preparation, cognitive style and social support. Limited differences arose between patients who underwent a gradual versus acute transition onto haemodialysis. Themes are discussed with reference to implications for practice development.

Background: This is a substantive update of a previous review. Severe premenstrual syndrome (PMS) affects between 3% to 5% of women of reproductive age. Severe PMS is classified under the Diagnostic and Statistical Manual of Mental Disorders as premenstrual dysphoric disorder (PMDD). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as front-line therapy for PMS. A systematic review was undertaken on the efficacy of SSRIs in the management of severe PMS, or PMDD, to assess the evidence for this treatment option. Objectives: the objective of this review was to evaluate the effectiveness of SSRIs in reducing premenstrual syndrome symptoms in women diagnosed with severe premenstrual syndrome. Search strategy: Electronic searches for relevant randomised controlled trials were undertaken in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycInfo, and CINAHL (March 2008). Where insufficient data were presented in a report the original authors were contacted for further details. Selection criteria: all trials were considered in which women with a prospective diagnosis of PMS, PMDD or late luteal phase dysphoric disorder (LPDD) were randomised to receive SSRIs or placebo for the treatment of premenstrual syndrome in a blinded trial. Data collection and analysis: Forty randomised controlled trials were identified which reported the use of SSRIs in the management of PMS. Fifty-six trials were excluded. The review authors extracted the data independently and estimated standardised mean differences for continuous outcomes. Main results: Due to heterogeneity, analyses were subgrouped into change and absolute scores. The primary analysis of reduction in overall symptomatology included data on 2294 women with premenstrual syndrome. SSRIs were found to be highly effective in treating the premenstrual symptoms (SMD -0.53, 95% CI 0.68 to -0.39; P < 0.00001). Secondary analysis showed that they were effective in treating physical (SMD -0.34, 95% CI -0.45 to -0.22; P < 0.00001), functional (SMD -0.30, 95% CI -0.43 to -0.17; P < 0.00001), and behavioural symptoms (SMD-0.41, 95%CI -0.53 to -0.29; P < 0.00001). Luteal phase only and continuous administration were both effective and there was no influence of a placebo run-in period on reduction in symptoms. All SSRIs (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and clomipramine) were effective in reducing premenstrual symptoms. Withdrawals due to side effects were twice as likely to occur in the treatment group (OR 2.18, 95% CI 1.62 to 2.92; P < 0.00001). Authors' conclusions: the evidence supports the use of selective serotonin reuptake inhibitors in the management of severe premenstrual syndrome. Copyright © 2009 the Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND: This is a substantive update of a previous review. Severe premenstrual syndrome (PMS) affects between 3% to 5% of women of reproductive age. Severe PMS is classified under the Diagnostic and Statistical Manual of Mental Disorders as premenstrual dysphoric disorder (PMDD). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as front-line therapy for PMS. A systematic review was undertaken on the efficacy of SSRIs in the management of severe PMS, or PMDD, to assess the evidence for this treatment option. OBJECTIVES: the objective of this review was to evaluate the effectiveness of SSRIs in reducing premenstrual syndrome symptoms in women diagnosed with severe premenstrual syndrome. SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials were undertaken in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycInfo, and CINAHL (March 2008). Where insufficient data were presented in a report the original authors were contacted for further details. SELECTION CRITERIA: all trials were considered in which women with a prospective diagnosis of PMS, PMDD or late luteal phase dysphoric disorder (LPDD) were randomised to receive SSRIs or placebo for the treatment of premenstrual syndrome in a blinded trial. DATA COLLECTION AND ANALYSIS: Forty randomised controlled trials were identified which reported the use of SSRIs in the management of PMS. Fifty-six trials were excluded. The review authors extracted the data independently and estimated standardised mean differences for continuous outcomes. MAIN RESULTS: Due to heterogeneity, analyses were subgrouped into change and absolute scores. The primary analysis of reduction in overall symptomatology included data on 2294 women with premenstrual syndrome. SSRIs were found to be highly effective in treating the premenstrual symptoms (SMD -0.53, 95% CI 0.68 to -0.39; P < 0.00001). Secondary analysis showed that they were effective in treating physical (SMD -0.34, 95% CI -0.45 to -0.22; P < 0.00001), functional (SMD -0.30, 95% CI -0.43 to -0.17; P < 0.00001), and behavioural symptoms (SMD -0.41, 95% CI -0.53 to -0.29; P < 0.00001). Luteal phase only and continuous administration were both effective and there was no influence of a placebo run-in period on reduction in symptoms. All SSRIs (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and clomipramine) were effective in reducing premenstrual symptoms. Withdrawals due to side effects were twice as likely to occur in the treatment group (OR 2.18, 95% CI 1.62 to 2.92; P < 0.00001). AUTHORS' CONCLUSIONS: the evidence supports the use of selective serotonin reuptake inhibitors in the management of severe premenstrual syndrome.

To search for, review and synthesise studies of the effectiveness and cost-effectiveness of weight management schemes for the under fives.

BACKGROUND: the value of consumer involvement in health services research is widely recognized. While there is a growing body of evidence about the principles of good consumer involvement, there is little research about the effect that involvement can have on the research. This evaluation assessed the level and impact of consumer involvement in the London Primary Care Studies Programme (LPCSP), all of whose individual projects had to demonstrate substantial involvement as a condition of funding. OBJECTIVE: to evaluate consumer involvement in the LPSCP and understand what impact consumers had on the research process and outcomes. METHODS: a multi-method case study approach was undertaken, using survey techniques, interviews, focus groups, observation and scrutiny of written documents. The overall data set comprised 61 questionnaires, 44 semi-structured interviews, 2 focus groups and 15 hours of observation of meetings. Eleven primary care-based research projects which together made up the LPCSP. RESULTS: an in-depth description of consumer involvement in the Programme was produced. Nine projects had consumers as co-applicants, four projects had been completed before the evaluation began and one was still ongoing at the time of the evaluation. of the eight projects which have produced final reports, all met their aims and objectives. Consumers had had an additional impact in the research, in the initial design of the study, in recruitment of the research subjects, in developing data collection tools, in collecting the data, in analysis and disseminating the findings. CONCLUSIONS: Consumer involvement in National Health Service research is a relatively recent policy development and while there is an increasing amount of literature about how and why consumers should be involved in research, there is less evidence about the impact of such involvement. This evaluation provides evidence about the impact that consumers have not only on the research process but also on the outcomes of the research.

BACKGROUND AND OBJECTIVE: There is increasing regulation and concern about the use of material from patients' records. Studies on patients' views have focused on primary care and on use of material for research. This study investigated patients' preferences about whether and how doctors should seek permission for use of specified items of anonymised information from their hospital records for clinical audit, teaching, national data collection and research. METHOD: a specially designed questionnaire sent to recently discharged patients under the care of medical and surgical specialists. RESULTS: 166/316 (53%) patients completed the questionnaires. The percentage of respondents who "definitely wanted" or "preferred" to be asked for permission for use of anonymised information was highest for medical history (21%) and reasons for treatment (20%). The purpose for which information was requested (eg, research, audit) made little difference to the overall percentages (range 10-12%). 21 (13%) patients "definitely wanted" to be asked for permission for use of some item or proposed use of information--most had no preference or preferred not to be asked. The most popular method for asking permission was signing a form while in hospital, rather than by specific requests later. CONCLUSIONS: Most hospital patients have no preference or prefer not to be asked permission for doctors to use information from their records. About 1 in 8 patients would like to be asked for permission, some even for clinical audit of outcomes--although a minority, this could compromise thorough clinical audit. Systems for obtaining permission when patients are admitted to hospital need to be considered. Resolution of uncertainties surrounding legislation on the use of information would be helpful to clinicians.

This paper addresses the debate concerning the 'added value' of complexity theory for health care research. In particular, it considers the way in which complexity theory can enable researchers to understand the relation between whole system processes and individual, and community, health outcomes. It presents a case study of a process of sustained regeneration which took place on a severely deprived estate in West Cornwall, UK. In so doing, it seeks to add to the stock of new empirical research, upon which debates about the value of complexity theory for health care research need to be founded. It also seeks to determine whether complexity theory can facilitate the transferability of successful regeneration processes from one place, or community, to another.

OBJECTIVE: to compare the effectiveness of two second generation endometrial ablation techniques (microwave and thermal balloon endometrial ablation) with first generation techniques of endometrial ablation to treat heavy menstrual bleeding in women. SEARCH STRATEGY: We searched the Cochrane Library (issue 3, 2002), the National Research Register, MEDLINE (1966 to August 2002), Embase (1980 to August 2002) and Web of Science Proceedings (all years). We also searched reference lists and contacted experts and manufacturers in the field. SELECTION CRITERIA: Randomised controlled trials and controlled trials of microwave endometrial ablation and thermal balloon endometrial ablation versus transcervical resection and rollerball ablation, alone or in combination, to treat heavy menstrual bleeding were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies for inclusion and extracted data. As there was considerable clinical and methodological heterogeneity among the studies, meta-analysis was not undertaken and results are presented descriptively. RESULTS: Two randomised controlled trials of microwave endometrial ablation and eight trials (six randomised controlled trials) of thermal balloon endometrial ablation were included in the review. No significant differences were found between first and second generation techniques in terms of amenorrhoea, bleeding patterns, pre-menstrual symptoms, patient satisfaction or quality of life. Microwave endometrial ablation and thermal balloon endometrial ablation had significantly shorter operating and theatre times than first generation techniques. Adverse effects were few with all techniques, but there were fewer peri-operative adverse effects with second generation techniques. CONCLUSION: Microwave endometrial ablation and thermal balloon endometrial ablation are alternatives to first generation techniques for treating heavy menstrual bleeding. No head-to-head trials of microwave endometrial ablation and thermal balloon endometrial ablation have been undertaken and there is not yet enough evidence of differences in clinical effectiveness between these two techniques.

OBJECTIVE: to assess the cost effectiveness of the second-generation surgical treatments for heavy menstrual bleeding (microwave and thermal balloon endometrial ablation) compared with existing endometrial ablation techniques (transcervical resection and rollerball, alone or in combination) and hysterectomy. DESIGN: a state transition (Markov) cost-utility economic model. POPULATION: Women with heavy menstrual bleeding. METHODS: a Markov model was developed using spreadsheet software. Transition probabilities, costs and quality of life data were obtained from a systematic review of effectiveness undertaken by the authors, from published sources, and expert opinion. Cost data were obtained from the literature and from a NHS trust hospital. Indirect comparison of thermal balloon endometrial ablation versus microwave endometrial ablation or either second-generation endometrial ablation method versus hysterectomy, and comparison of second-generation versus first-generation techniques were carried out from the perspective of health service payers. The effects of uncertainty were explored through extensive one-way sensitivity analyses and Monte Carlo simulation. MAIN OUTCOME MEASURES: Incremental cost effectiveness ratios based on cost per quality adjusted life year (QALY) gained, and cost effectiveness acceptability curves. RESULTS: Compared with first-generation techniques, both microwave and thermal balloon endometrial ablation cost less and accrued more QALYs. Hysterectomy was more expensive, but accrued more QALYs than all endometrial ablation methods. Baseline results showed that differences between microwave endometrial ablation and thermal balloon endometrial ablation were slight. Sensitivity analyses showed that small changes in values may have a marked effect on cost effectiveness. Probabilistic simulation highlighted the uncertainty in comparisons between different endometrial ablation options, particularly between second-generation techniques. CONCLUSIONS: Despite limitations in available data, the analysis suggests that second-generation techniques are likely to be more cost effective than first-generation techniques in most cases. Hysterectomy, where a woman finds this option acceptable, continues to be a very cost effective procedure compared with all endometrial ablation methods.

Context. Non-executive directors in the South West Region. Objectives. To evaluate the effectiveness of a one-day training programme for non-executive directors in critically appraising board clinical governance reports. Design. The evaluation included delegate perceptions of their skills, knowledge and confidence, as well as the views of their Board chief executive officers (CEOs)/chairs regarding the ability of the non-executive directors to bring these attributes to board meetings, before and after the workshop. Subjects. In total, 86 non-executive directors attended the workshops. All eight healthcare communities in the south west were represented and most participants were drawn from primary care, health authorities, and acute and community trusts. Results. Results showed that delegates' knowledge, skills, attitudes and confidence had improved significantly immediately after the workshop. In particular, delegates' knowledge and understanding of the critical appraisal aspects of clinical governance seemed to have been the most affected. The evaluation strategy also tested whether these skills and knowledge were retained after three months. Results showed that the gains made by the workshop had been sustained in all cases. In some areas, such as skills and confidence in their experience as working as non-executive/lay representatives, their ratings of performance had continued to improve beyond the experience of the workshop. Findings also showed that CEOs/chairs noticed an increase in delegates' confidence in carrying out their tasks as non-executive/lay members. Ratings of their contribution to the board meetings improved but not significantly. Conclusions. Overall, the workshop was shown to be an effective mechanism for raising the performance of non-executive/lay members in being fit for the role for critically appraising clinical governance reports. © 2004 Radcliffe Medical Press.

OBJECTIVES: to estimate the clinical effectiveness and cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA) for heavy menstrual bleeding (HMB), compared with the existing (first-generation) endometrial ablation (EA) techniques of transcervical resection (TCRE) and rollerball (RB) ablation, and hysterectomy. DATA SOURCES: Electronic databases, bibliographies of articles, and also experts in the field and relevant industry bodies were asked to provide information. REVIEW METHODS: a detailed search strategy was carried out to identify systematic reviews and controlled trials of MEA and TBEA versus first-generation techniques for EA. In addition to electronic database searching, reference lists were hand-searched and information sought from manufacturers of EA devices and by experts in the field. A deterministic Markov model was developed to assess cost-effectiveness. Data for the model were taken from a range of sources. RESULTS: the systematic review of first-generation EA techniques versus hysterectomy found that EA offered an alternative to hysterectomy for HMB, with fewer complications and a shorter recovery period. Satisfaction and effectiveness were high for both MEA and TBEA. Costs were lower with EA although the difference narrows over time. Second-generation EA techniques are an alternative treatment to first-generation techniques for HMB, and first-generation techniques are known to offer an alternative to hysterectomy. Although no trials of second-generation techniques and hysterectomy have been undertaken, it seems reasonable to assume that second-generation techniques also offer an alternative surgical treatment. Using the model to assess cost-effectiveness, costs were very slightly higher for MEA when compared to TBEA, and differences in quality-adjusted life-years (QALYs) were negligible. For MEA compared with transcervical resection of the endometrium (TCRE) and RB ablation, costs were slightly lower with MEA and MEA accrued very slightly more QALYs. Compared with hysterectomy, MEA costs less and accrues slightly fewer QALYs. For TBEA compared with TCRE and RB ablation, costs were lower with TBEA and TBEA accrued slightly more QALYs. Compared with hysterectomy, TBEA costs moderately less and accrues moderately fewer QALYs. CONCLUSIONS: Overall, there were few significant differences between the outcomes of first- and second-generation techniques including bleeding, satisfaction and QoL measures and repeat surgery rates. Second-generation techniques had significantly shorter operating and theatre times and there appear to be fewer serious perioperative adverse effects with second-generation techniques and postoperative effects are similar. Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalisation and faster return to work. Hysterectomy results in more adverse effects and is more expensive, although the need for retreatment leads this difference to decrease over time. Satisfaction with hysterectomy is initially higher, but there is no significant difference after 2 years. The economic model suggests that second-generation techniques are more cost-effective than first-generation techniques of EA for HMB. Both TBEA and MEA appear to be less costly than hysterectomy, although the latter results in more QALYs. Further research is suggested to make direct comparisons of the cost-effectiveness of second-generation EA techniques, to carry out longer term follow-up for all methods of EA in RCTs, and to develop more sophisticated modelling studies. Further research is also recommended into HMB to establish health-state utility values, its surgical treatment, convalescence, complications of treatment, symptoms and patient satisfaction.

OBJECTIVE: to determine the effectiveness of gonadotrophin-releasing hormone analogues (GnRHa) with and without hormonal add-back therapy in the management of premenstrual syndrome. DESIGN: Randomised controlled trials were identified by searching multiple databases. SETTING: Exeter and North Devon Research and Development Support Unit and Keele University Academic Unit of Obstetrics and Gynaecology. POPULATION: Women with pre-diagnosed premenstrual syndrome and/or premenstrual dysphoric disorder. METHODS: a meta-analysis of published randomised placebo-controlled trials assessing the use of GnRHa in the management of premenstrual syndrome. The standardised mean difference for each individual study and subsequently an overall standardised mean difference were calculated after demonstrating the consistency or homogeneity of the study results. MAIN OUTCOME MEASURES: Overall improvement in premenstrual symptomatology and effectiveness of GnRHa with additional hormonal add-back therapy were the main outcome measures assessed in this analysis. A secondary analysis was performed to assess the effectiveness of GnRHa in treating physical and emotional symptoms. RESULTS: Overall standardised mean difference for all trials that assessed the efficacy of GnRHa was -1.19 (95% confidence interval [CI] -1.88 to -0.51). The equivalent odds ratio was 8.66 (95% CI 2.52 to 30.26) in favour of GnRHa. GnRHa were more efficacious for physical than behavioural symptoms, although the difference was not statistically significant. The addition of hormonal add-back therapy to GnRHa did not appear to reduce the efficacy of GnRHa alone; standardised mean difference 0.12 (95% CI -0.35 to 0.58). CONCLUSIONS: GnRHa appear to be an effective treatment in the management of premenstrual syndrome. The addition of hormonal add-back therapy to reduce side effects does not reduce efficacy.

OBJECTIVE: to validate a menstrual symptometrics device that can quantify menstrual blood loss, dysmenorrhea, and the premenstrual syndrome against traditional methods of collecting data on symptoms. DESIGN: Validation study. SETTING: Academic research clinic for menstrual cycle disorders. PARTICIPANT(S): Women 18-50 years of age who presented with menstrual cycle disorders. Controls were recruited from lists of patients requesting sterilization and from hospital staff. INTERVENTION(S): Participants were asked to complete the menstrual symptometrics device and to record pain, blood loss, and premenstrual symptoms by using traditional methods (paper-based scales and the alkaline hematin method) for two cycles. MAIN OUTCOME MEASURE(S): Agreement between traditional methods of quantifying menstrual cycle disorders and data obtained from the menstrual symptometrics device, and acceptability of the latter technique to patients. RESULT(S): a high level of agreement was observed between the traditional methods and the menstrual symptometrics device in quantifying and diagnosing menorrhagia, dysmenorrhea, and the premenstrual syndrome. Most patients preferred the menstrual symptometrics device as a data collection tool. CONCLUSION(S): the menstrual symptometrics device is a rapid and accurate method of quantifying blood loss, pain, and premenstrual symptoms. It has a high level of patient acceptability and can provide instant pictorial feedback on symptoms for patients and clinicians.

BACKGROUND: over 300 therapies have been proposed for premenstrual syndrome. To date there has been only one survey conducted in the UK of PMS treatments prescribed by GPs, a questionnaire-based study by the National Association of Premenstrual Syndrome in 1989. Since then, selective serotonin re-uptake inhibitors have been licensed for severe PMS/PMDD, and governmental recommendations to reduce the dosage of vitamin B6 (the first choice over-the-counter treatment for many women with PMS) have been made. This study investigates the annual rates of diagnoses and prescribing patterns for premenstrual syndrome (1993-1998) within a computerised general practitioner database. METHODS: Retrospective survey of prescribing data for premenstrual syndrome between 1993-1998 using the General Practice Research Database for the West Midlands Region which contains information on 282,600 female patients RESULTS: Overall the proportion of women with a prescription-linked diagnosis of premenstrual syndrome has halved over the five years. Progestogens including progesterone were the most commonly recorded treatment for premenstrual syndrome during the whole study period accounting for over 40% of all prescriptions. Selective serotonin-reuptake inhibitors accounted for only 2% of the prescriptions in 1993 but rose to over 16% by 1998, becoming the second most commonly recorded treatment. Vitamin B6 accounted for 22% of the prescriptions in 1993 but dropped markedly between 1997 and 1998 to 11%. CONCLUSIONS: This study shows a yearly decrease in the number of prescriptions linked to diagnoses for premenstrual syndrome. Progestogens including progesterone, is the most widely prescribed treatment for premenstrual syndrome despite the lack of evidence demonstrating their efficacy.

OBJECTIVE: to develop and validate a simple method of measuring total menstrual blood loss using a pictorial representation of blood loss, the menstrual pictogram. DESIGN: a prospective evaluation of total menstrual blood loss measurement by the menstrual pictogram compared to the alkaline hematin technique. SETTING: Academic menorrhagia research clinic. PATIENT(S): One hundred twenty-one women; 62 women complaining of heavy menstrual blood loss, 59 women who considered their menstrual blood loss to be normal. INTERVENTION(S): Participants were asked to complete the menstrual pictogram through the period and collect their feminine hygiene products for an alkaline hematin assessment. MAIN OUTCOME MEASURE(S): Percentage agreement between blood loss measured by the gold standard alkaline hematin method and the menstrual pictogram. Extraneous blood loss was measured using a semiquantitative pictorial method. RESULT(S): the menstrual pictogram had a high level of agreement for blood collected on feminine hygiene products compared with the alkaline hematin method. Some women also lose a significantly large amount of extraneous blood, which is not proportional to the alkaline hematin blood loss assessment. CONCLUSION(S): the menstrual pictogram provides a simple means of measuring menstrual blood loss. It is no longer appropriate to ignore extraneous blood loss, particularly as there is no correlation between extraneous blood loss and that measured on feminine hygiene products.

OBJECTIVE: to evaluate the efficacy of progesterone and progestogens in the management of premenstrual syndrome. DESIGN: Systematic review of published randomised, placebo controlled trials. STUDIES REVIEWED: 10 trials of progesterone therapy (531 women) and four trials of progestogen therapy (378 women). MAIN OUTCOME MEASURES: Proportion of women whose symptoms showed improvement with progesterone preparations (suppositories and oral micronised). Proportion of women whose symptoms showed improvement with progestogens. Secondary analysis of efficacy of progesterone and progestogens in managing physical and behavioural symptoms. RESULTS: Overall standardised mean difference for all trials that assessed efficacy of progesterone (by both routes of administration) was -0.028 (95% confidence interval -0.017 to -0.040). The odds ratio was 1.05 (1.03 to 1.08) in favour of progesterone, indicating no clinically important difference between progesterone and placebo. For progestogens the overall standardised mean was -0.036 (-0.014 to -0.060), which corresponds to an odds ratio of 1.07 (1.03 to 1.11) showing a statistically, but not clinically, significant improvement for women taking progestogens. CONCLUSION: the evidence from these meta-analyses does not support the use of progesterone or progestogens in the management of premenstrual syndrome.

BACKGROUND: Selective serotonin-reuptake inhibitors (SSRIs) are increasingly being used as first-line therapy for severe premenstrual syndrome (PMS). We undertook a meta-analysis on the efficacy of SSRIs in this disorder. METHODS: We searched medical and scientific databases, approached pharmaceutical companies, and reviewed citations of relevant articles to identify 29 studies of the use of SSRIs in PMS. 14 were excluded (no placebo group, preliminary report of included trial, or low quality). 15 randomised placebo-controlled trials were included. Information on study design, participants, drugs used and dosing regimens, outcome measures, side-effects, and sources of funding was extracted. Standardised mean differences between treatment and placebo groups were calculated to obtain an overall estimate of efficacy. The primary outcome measure was a reduction in overall PMS symptoms. FINDINGS: the primary analysis included data on 904 women (570 assigned active treatment and 435 assigned placebo, including 101 in crossover trials). The overall standardised mean difference was -1.066 (95% CI -1.381 to -0.750), which corresponds to an odds ratio of 6.91 (3.90 to 12.2) in favour of SSRIs. SSRIs were effective in treating physical and behavioural symptoms. There was no significant difference in symptom reduction between continuous and intermittent dosing or between trials funded by pharmaceutical companies and those independently funded. Withdrawal due to side-effects was 2.5 times more likely in the active-treatment group than in the placebo group. INTERPRETATION: SSRIs are an effective first-line therapy for severe PMS. The safety of these drugs has been demonstrated in trials of affective disorder, and the side-effects at low doses are generally acceptable.

OBJECTIVE: to evaluate the efficacy of vitamin B-6 in the treatment of premenstrual syndrome. DESIGN: Systematic review of published and unpublished randomised placebo controlled trials of the effectiveness of vitamin B-6 in the management of premenstrual syndrome. SUBJECTS: Nine published trials representing 940 patients with premenstrual syndrome. MAIN OUTCOME MEASURES: Proportion of women whose overall premenstrual symptoms showed an improvement over placebo. A secondary analysis was performed on the proportion of women whose premenstrual depressive symptoms showed an improvement over placebo. RESULTS: Odds ratio relative to placebo for an improvement in overall premenstrual symptoms was 2.32 (95% confidence interval 1.95 to 2.54). Odds ratio relative to placebo for an improvement in depressive symptoms was 1.69 (1.39 to 2.06) from four trials representing 541 patients. CONCLUSION: Conclusions are limited by the low quality of most of the trials included. Results suggest that doses of vitamin B-6 up to 100 mg/day are likely to be of benefit in treating premenstrual symptoms and premenstrual depression.