Study protocol for an evaluation of the effectiveness of ‘care bundles’ as a means of improving hospital care and reducing hospital readmission for patients with chronic obstructive pulmonary disease (COPD)

BACKGROUND: Chronic Obstructive Pulmonary Disease is one of the commonest respiratory diseases in the United Kingdom, accounting for 10 % of unplanned hospital admissions each year. Nearly a third of these admitted patients are re-admitted to hospital within 28 days of discharge. Whilst there is a move within the NHS to ensure that people with long-term conditions receive more co-ordinated care, there is little research evidence to support an optimum approach to this in COPD. This study aims to evaluate the effectiveness of introducing standardised packages of care i.e. care bundles, for patients with acute exacerbations of COPD as a means of improving hospital care and reducing re-admissions. METHODS / DESIGN: This mixed-methods evaluation will use a controlled before-and-after design to examine the effect of, and costs associated with, implementing care bundles for patients admitted to hospital with an acute exacerbation of COPD, compared with usual care. It will quantitatively measure a range of patient and organisational outcomes for two groups of hospitals - those who deliver care using COPD care bundles, and those who deliver care without the use of COPD care bundles. These care bundles may be provided for patients with COPD following admission, prior to discharge or at both points in the care pathway. The primary outcome will be re-admission to hospital within 28 days of discharge, although the study will additionally investigate a number of secondary outcomes including length of stay, total bed days, in-hospital mortality, costs of care and patient / carer experience. A series of nested qualitative case studies will explore in detail the context and process of care as well as the impact of COPD bundles on staff, patients and carers. DISCUSSION: The results of the study will provide information about the effectiveness of care bundles as a way of managing in-hospital care for patients with an acute exacerbation of COPD. Given the number of unplanned hospital admissions for this patient group and their rate of subsequent re-admission, it is hoped that this evaluation will make a timely contribution to the evidence on care provision, to the benefit of patients, clinicians, managers and policy-makers. TRIAL REGISTRATION: International Standard Randomised Controlled Trials – ISRCTN13022442 - 11 February 201

Pilot trial and process evaluation of a multilevel smoking prevention intervention in further education settings

Background: Preventing smoking uptake among young people is a public health priority. Further education (FE) settings provide access to the majority of 16- to 18-year-olds, but few evaluations of smoking prevention interventions have been reported in this context to date. Objectives: To evaluate the feasibility and acceptability of implementing and trialling a new multilevel smoking prevention intervention in FE settings. Design: Pilot cluster randomised controlled trial and process evaluation. Setting: Six UK FE institutions. Participants: FE students aged 16–18 years. Intervention: ‘The Filter FE’ intervention. Staff working on Action on Smoking and Health Wales’ ‘The Filter’ youth project applied existing staff training, social media and youth work resources in three intervention settings, compared with three control sites with usual practice. The intervention aimed to prevent smoking uptake by restricting the sale of tobacco to under-18s in local shops, implementing tobacco-free campus policies, training FE staff to deliver smoke-free messages, publicising The Filter youth project’s online advice and support services, and providing educational youth work activities. Main outcome measures: (1) The primary outcome assessed was the feasibility and acceptability of delivering and trialling the intervention. (2) Qualitative process data were analysed to explore student, staff and intervention team experiences of implementing and trialling the intervention. (3) Primary, secondary and intermediate (process) outcomes and economic evaluation methods were piloted. Data sources: New students at participating FE settings were surveyed in September 2014 and followed up in September 2015. Qualitative process data were collected via interviews with FE college managers (n = 5) and the intervention team (n = 6); focus groups with students (n = 11) and staff (n = 5); and observations of intervention settings. Other data sources were semistructured observations of intervention delivery, intervention team records, ‘mystery shopper’ audits of local shops and college policy documents. Results: The intervention was not delivered as planned at any of the three intervention settings, with no implementation of some community- and college-level components, and low fidelity of the social media component across sites. Staff training reached 28 staff and youth work activities were attended by 190 students across the three sites (< 10% of all eligible staff and students), with low levels of acceptability reported. Implementation was limited by various factors, such as uncertainty about the value of smoking prevention activities in FE colleges, intervention management weaknesses and high turnover of intervention staff. It was feasible to recruit, randomise and retain FE settings. Prevalence of weekly smoking at baseline was 20.6% and was 17.2% at follow-up, with low levels of missing data for all pilot outcomes. Limitations: Only 17% of eligible students participated in baseline and follow-up surveys; the representativeness of student and staff focus groups is uncertain. Conclusions: In this study, FE settings were not a supportive environment for smoking prevention activities because of their non-interventionist institutional cultures promoting personal responsibility. Weaknesses in intervention management and staff turnover also limited implementation. Managers accept randomisation but methodological work is required to improve student recruitment and retention rates if trials are to be conducted in FE settings. Trial registration: Current Controlled Trials ISRCTN19563136. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 5, No. 8. See the NIHR Journals Library website for further project information. It was also funded by the Big Lottery Fund

NAP SACC UK:protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in 2-4 year olds

Introduction: Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial. Methods and analysis: A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8–10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staff's review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants. Ethics and dissemination: Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data will be available from the University of Bristol Research Data Repository

Observational cost-effectiveness analysis using routine data: Admission and discharge care bundles for patients with chronic obstructive pulmonary disease

Background: Chronic obstructive pulmonary disease (COPD) is a prevalent respiratory disease, and accounts for a substantial proportion of unplanned hospital admissions. Care bundles for COPD are a set of standardised, evidence-based interventions that may improve outcomes in hospitalised COPD patients. We estimated the cost effectiveness of care bundles for acute exacerbations of COPD using routinely collected observational data. Methods: Data were collected from implementation (n = 7) and comparator (n = 7) acute hospitals located in England and Wales. We conducted a difference-in-difference cost-effectiveness analysis using a secondary care (i.e. hospital) perspective to examine the effect on National Health Service (NHS) costs and 90-day mortality of implementing care bundles compared with usual care for patients admitted to hospital with an acute exacerbation of COPD. Adjusted models included as covariates patient age, sex, deprivation, ethnicity and seasonal effects and mixed effects for site. Results: Outcomes and baseline characteristics of up to 12,532 patients were analysed using both complete case and multiply imputed models. Implementation of bundles varied. COPD care bundles were associated with slightly lower secondary care costs, but there was no evidence that they improved outcomes once adjustments were made for site and baseline covariates. Care bundles were unlikely to be cost effective for the NHS with an estimated net monetary benefit per 90-day death avoided from an adjusted multiply imputed model of −£1231 (95% confidence interval − £2428 to − £35) at a high cost-effectiveness threshold of £50,000 per 90-day death avoided. Conclusion and Recommendations: Care bundles for COPD did not appear to be cost effective, although this finding may have been influenced by unmeasured variations in bundle implementation and other potential confounding factors

Percutaneous vertebral compression fracture management with polyethylene mesh-contained morcelized allograft bone

Study design    A comprehensive systematic review of the literature. Objectives To assess the modern literature on the use of polyethylene mesh-contained morcelized allograft (PMCMA) bone for spinal fusion and vertebral compression fracture management. Summary of background data    There are presently no systematic reviews of PMCMA. Methods    A systematic literature review was performed within three databases (OVID, PubMed, and Google Scholar) using the following keyword search terms: vertebroplasty, kyphoplasty, vertebral compression fracture, percutaneous, polyethylene mesh, and osteoporosis. Results    The initial search identified 764 items, from which two pertinent technique-based articles were identified. There were no published scientific peer-reviewed or case series reporting the clinical results of this technique. The use of PMCMA in the management of vertebral compression fractures (VCFs) is similar to vertebroplasty and kyphoplasty. This novel, percutaneous system uses the properties of granular mechanics to establish a conforming, semirigid graft that is purportedly capable of withstanding physiologic loads. Discussion    PMCMA is a novel percutaneous technology for the management of VCF and possibly for use as a conforming interbody graft. The available published literature lacks outcome data of the use of PMCMA. Careful, independent research is needed to assess the viability of this technology and its long-term results

A physical activity, nutrition and oral health intervention in nursery settings:Process evaluation of the NAP SACC UK feasibility cluster RCT

Background The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable? Methods Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators. Results Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors’ capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents. Conclusions Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted

A Reappraisal of Children’s ‘Potential’

What does it mean for a child to fulfil his or her potential? This article explores the contexts and implications of the much-used concept of potential in educational discourses. We claim that many of the popular, political and educational uses of the term in relation to childhood have a problematic blind spot: interpersonality, and the necessary coexistence for the concept to be receivable of all children’s ‘potentials’. Rather than advocating abandoning the term—a futile gesture given its emotive force—we argue that the concept of children’s potential must be profoundly rethought to be workable as a philosophical notion in education. In an era marked by the unspoken assumption that ‘unlimited potential’ is always a good thing, we argue that it might be necessary to think about the limitations of the notion of individual potential; namely, the moment when it comes into contact with other people’s projects. We propose a conceptualisation of potential as the negotiated, situated, ever-changing creation of a group of individuals, in a process marked by conflict, and which remains essentially difficult.This is the final version of the article. It first appeared from Springer via http://dx.doi.org/10.1007/s11217-016-9508-