Search

Background: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial.Methods and Design: E-Freeze is a two-arm parallel-group, multi-centre, individually randomised controlled trial to determine if a policy of freezing embryos, followed by thawed frozen embryo transfer, results in a higher healthy baby rate when compared with the current policy of transferring fresh embryos. Couples undergoing their first, second or third cycle of in vitro fertilisation at fertility centres in the UK were randomised to either fresh or frozen embryo transfer. The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation. This paper describes the statistical analysis plan for the trial, including the analysis principles, definitions of outcomes, methods for primary analysis, pre-specified subgroup analysis and sensitivity analysis. This plan was finalised prior to completion of recruitment to the trial.Trial Registration: ISRCTN registry: ISRCTN61225414 . Registered on 29 December 2015. [ABSTRACT FROM AUTHOR]

Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far.Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention.Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities.Trial Registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500 . [ABSTRACT FROM AUTHOR]

Introduction: Several forces are contributing to an increase in the number of people living with and surviving colorectal cancer (CRC). However, due to the lack of available data, little is known about the implications of these forces. In recent years, the use of administrative records to inform research has been increasing. The aim of this paper is to investigate the potential contribution that administrative data could have on the health economic research of CRC. Methods: To achieve this aim, we conducted a systematic review of the health economic CRC literature published in the United Kingdom and Europe within the last decade (2009–2019). Results: Thirty‐seven relevant studies were identified and divided into economic evaluations, cost of illness studies and cost consequence analyses. Conclusions: The use of administrative data, including cancer registry, screening and hospital records, within the health economic research of CRC is commonplace. However, we found that this data often come from regional databases, which reduces the generalisability of results. Further, administrative data appear less able to contribute towards understanding the wider and indirect costs associated with the disease. We explore several ways in which various sources of administrative data could enhance future research in this area. [ABSTRACT FROM AUTHOR]

Objective: To examine the impact and cost associated with mental illness. Methods: A rapid review of the literature from Australia, New Zealand, UK and Canada was undertaken. The review included literature pertaining to the cost-of-illness and impact of mental illness as well as any modelling studies. Included studies were categorised according to impact on education, labour force engagement, earlier retirement or welfare dependency. The well-accepted Drummond 10-point economic appraisal checklist was used to assess the quality of the studies. Results: A total of 45 methodologically diverse studies were included. The studies highlight the significant burden mental illness places on all facets of society, including individuals, families, workplaces and the wider economy. Mental illness results in a greater chance of leaving school early, a lower probability of gaining full-time employment and a reduced quality of life. Research from Canada suggests that the total economic costs associated with mental illness will increase six-fold over the next 30 years with costs likely to exceed A$2.8 trillion (based on 2015 Australian dollars). Conclusions: Mental illness is associated with a high economic burden. Further research is required to develop a better understanding of the trajectory and burden of mental illness so that resources can be directed towards cost-effective interventions. What is known about the topic?: Although mental illness continues to be one of the leading contributors to the burden of disease, there is limited information on the economic impact that mental illness imposes on individuals, families, workplaces and the wider economy. What does this paper add?: This review provides a summary of the economic impact and cost of mental illness. The included literature highlights the significant burden mental illness places on individuals, families, workplaces, society and the economy in general. The review identified several areas for improvement. For example, only limited information is available on the impact of attention deficit hyperactivity disorder, anxiety, cognitive function, conduct disorder, eating disorder and psychological distress. There was also a dearth of evidence on the intangible elements of pain and suffering of people and their families with depressive disorders. More research is required to better understand the full extent of the impact of mental illness and strategies that may be implemented to minimise this harm. What are the implications for practitioners?: Knowing the current and future impact of mental illness highlights the imperative to develop an effective policy response. [ABSTRACT FROM AUTHOR]

Conduct disorder (CD) places huge costs on the individual, family and society. Parenting programmes can reduce CD symptomatology, but economic evaluations of their cost-effectiveness are rarely undertaken. The objective of this paper was to conduct the first specific systematic review of the published economic evidence of parenting programmes as a means to support families with children with or at risk of developing CD. A systematic search of 12 electronic databases was conducted. We identified 93 papers, of which six fulfilled the inclusion criteria. The search found one review article, mainly focusing upon clinical evidence with secondary focus on cost-effectiveness, one cost-effectiveness study, two partial economic evaluations and two cost studies. The costs of group parenting programme delivery ranged from £629.00 to £3839.00. Cost-effectiveness was influenced by intervention type and delivery method, i.e. individual versus group programme. The review highlights a need for a more standardized approach towards the comparison of the cost-effectiveness of parent programmes. In future studies it may be helpful to adopt a 'complex intervention approach', exploring in detail the attribution of cause and effect, the role of socio-economic setting and ripple effects, e.g. benefits to other family members. [ABSTRACT FROM AUTHOR]

Health and social care policy in the UK advocates inter-professional working (IPW) to support older people with complex and multiple needs. Whilst there is a growing understanding of what supports IPW, there is a lack of evidence linking IPW to explicit outcomes for older people living in the community. This review aimed to identify the models of IPW that provide the strongest evidence base for practice with community dwelling older people. We searched electronic databases from 1 January 1990-31 March 2008. In December 2010 we updated the findings from relevant systematic reviews identified since 2008. We selected papers describing interventions that involved IPW for community dwelling older people and randomised controlled trials (RCT) reporting user-relevant outcomes. Included studies were classified by IPW models (Case Management, Collaboration and Integrated Team) and assessed for risk of bias. We conducted a narrative synthesis of the evidence according to the type of care (interventions delivering acute, chronic, palliative and preventive care) identified within each model of IPW. We retrieved 3211 records and included 37 RCTs which were mapped onto the IPW models: Overall, there is weak evidence of effectiveness and cost-effectiveness for IPW, although well-integrated and shared care models improved processes of care and have the potential to reduce hospital or nursing/care home use. Study quality varied considerably and high quality evaluations as well as observational studies are needed to identify the key components of effective IPW in relation to user-defined outcomes. Differences in local contexts raise questions about the applicability of the findings and their implications for practice. We need more information on the outcomes of the process of IPW and evaluations of the effectiveness of different configurations of health and social care professionals for the care of community dwelling older people. [ABSTRACT FROM AUTHOR]

Abstract: Background: The rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK. Objective: This paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics. Design and methods: A multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of ‘inferiority’ of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre. Power calculations: In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of ‘inferiority’. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of ‘inferiority’, given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects. Results: The study started in July 2007 and the results are expected after July 2011. Trial registration: The International Standard Randomised Controlled Trial Number ISRCTN29803766. [Copyright &y& Elsevier]

The article presents a study which examines the effectiveness of mobile phone based self-monitoring of patients from primary care with poorly controlled asthma in Great Britain. The study has conducted a parallel group randomised controlled trial and an analysis of costs. The results of the study have revealed that the paper based model of asthma care is less expensive than the mobile phone supported model.