Enhancing Pragmatic Language skills for Young children with Social communication difficulties (E-PLAYS-2) trial: study protocol for a cluster-randomised controlled trial evaluating a computerised intervention to promote communicative development and collaborative skills in young children.

BACKGROUND: A number of children experience difficulties with social communication and this has long-term deleterious effects on their mental health, social development and education. The E-PLAYS-2 study will test an intervention ('E-PLAYS') aimed at supporting such children. E-PLAYS uses a dyadic computer game to develop collaborative and communication skills. Preliminary studies by the authors show that E-PLAYS can produce improvements in children with social communication difficulties on communication test scores and observed collaborative behaviours. The study described here is a definitive trial to test the effectiveness and cost-effectiveness of E-PLAYS delivered by teaching assistants in schools. METHODS: The aim of the E-PLAYS-2 trial is to establish the effectiveness and cost-effectiveness of care as usual plus the E-PLAYS programme, delivered in primary schools, compared to care as usual. Cluster-randomisation will take place at school level to avoid contamination. The E-PLAYS intervention will be delivered by schools' teaching assistants. Teachers will select suitable children (ages 5-7 years old) from their schools using guidelines provided by the research team. Assessments will include blinded language measures and observations (conducted by the research team), non-blinded teacher-reported measures of peer relations and classroom behaviour and parent-reported use of resources and quality of life. A process evaluation will also include interviews with parents, children and teaching assistants, observations of intervention delivery and a survey of care as usual. The primary analysis will compare pragmatic language scores for children who received the E-PLAYS intervention versus those who did not at 40 weeks post-randomisation. Secondary analyses will assess cost-effectiveness and a mixed methods process evaluation will provide richer data on the delivery of E-PLAYS. DISCUSSION: The aim of this study is to undertake a final, definitive test of the effectiveness of E-PLAYS when delivered by teaching assistants within schools. The use of technology in game form is a novel approach in an area where there are currently few available interventions. Should E-PLAYS prove to be effective at the end of this trial, we believe it is likely to be welcomed by schools, parents and children. TRIAL REGISTRATION: ISRCTN 17561417, registration date 19th December 2022. PROTOCOL VERSION: v1.1 19th June 2023.

The impact of COVID-19 (Coronavirus) on children and young people with Down syndrome in the United Kingdom.

The COVID-19 pandemic had a profound impact across the globe. Evidence suggests children with Special Educational Needs and Disabilities and their families experienced impacts on well-being and disruptions in support from education and health services. This study investigated the impact of measures associated with the COVID-19 pandemic on children and young people (CYP) with Down syndrome in the United Kingdom, specifically changes in speech, language and communication abilities, behavior, social, emotional and mental health and access to education and healthcare services. Forty-six parents/carers of CYP with Down Syndrome (aged 2-25 years) completed an online survey between June and September 2020. Parents/carers frequently reported deterioration in speech, language and communication, literacy and attention skills since the onset of the pandemic. Deterioration in social and emotional wellbeing and behavior, including greater reliance on adults were also reported for some CYP with Down syndrome. Parents reported challenges with home-schooling and reductions in support from education and community services. Preferences for support during COVID-19 were for professional support or from other parents. These findings have implications for the support that is now needed for CYP with Down syndrome and their families and for periods of social restrictions in the future.

The Sign 4 Big Feelings Intervention to Improve Early Years Outcomes in Preschool Children: Outcome Evaluation.

BACKGROUND: Any delays in language development may affect learning, profoundly influencing personal, social, and professional trajectories. The effectiveness of the Sign 4 Big Feelings (S4BF) intervention was investigated by measuring changes in early years outcomes (EYOs) after a 3-month period. OBJECTIVE: This study aims to determine whether children's well-being and EYOs significantly improve (beyond typical, expected development) after the S4BF intervention period and whether there are differences between boys and girls in progress achieved. METHODS: An evaluation of the S4BF intervention was conducted with 111 preschool-age children in early years settings in Luton, United Kingdom. Listening, speaking, understanding, and managing feelings and behavior, in addition to the Leuven well-being scale, were assessed in a quasi-experimental study design to measure pre- and postintervention outcomes. RESULTS: Statistically and clinically significant differences were found for each of the 7 pre- and postmeasures evaluated: words understood and spoken, well-being scores, and the 4 EYO domains. Gender differences were negligible in all analyses. CONCLUSIONS: Children of all abilities may benefit considerably from S4BF, but a language-based intervention of this nature may be transformational for children who are behind developmentally, with English as an additional language, or of lower socioeconomic status. TRIAL REGISTRATION: ISRCTN Registry ISRCTN42025531; https://doi.org/10.1186/ISRCTN42025531.

The CARESSES Randomised Controlled Trial: Exploring the Health-Related Impact of Culturally Competent Artificial Intelligence Embedded Into Socially Assistive Robots and Tested in Older Adult Care Homes.

This trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp 2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp 2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.

The Sign 4 Little Talkers Intervention to Improve Listening, Understanding, Speaking, and Behavior in Hearing Preschool Children: Outcome Evaluation.

BACKGROUND: Gaining age-appropriate proficiency in speech and language in the early years is crucial to later life chances; however, a significant proportion of children fail to meet the expected standards in these early years outcomes when they start school. Factors influencing the development of language and communication include low income, gender, and having English as an additional language (EAL). OBJECTIVE: This study aimed to determine whether the Sign 4 Little Talkers (S4LT) program improves key developmental outcomes in hearing preschool children. S4LT was developed to address gaps in the attainment of vocabulary and communication skills in preschool children, identified through routine monitoring of outcomes in early years. Signs were adapted and incorporated into storybooks to improve vocabulary, communication, and behavior in hearing children. METHODS: An evaluation of S4LT was conducted to measure key outcomes pre- and postintervention in 8 early years settings in Luton, United Kingdom. A total of 118 preschool children were tested in 4 early years outcomes domains-listening, speaking, understanding, and managing feelings and behavior-as well as Leuven well-being scales and the number of key words understood and spoken. RESULTS: Statistically significant results were found for all measures tested: words spoken (P<.001) and understood (P<.001), speaking (P<.001), managing feelings and behavior (P<.001), understanding (P<.001), listening and attention (P<.001), and well-being (P<.001). Approximately two-thirds of the children made expected or good progress, often progressing multiple steps in educational attainment after being assessed as developmentally behind at baseline. CONCLUSIONS: The findings reported here suggest that S4LT may help children to catch up with their peers at a crucial stage in development and become school ready by improving their command of language and communication as well as learning social skills. Our analysis also highlights specific groups of children who are not responding as well as expected, namely boys with EAL, and who require additional, tailored support.

The CARESSES study protocol: testing and evaluating culturally competent socially assistive robots among older adults residing in long term care homes through a controlled experimental trial.

BACKGROUND: This article describes the design of an intervention study that focuses on whether and to what degree culturally competent social robots can improve health and well-being related outcomes among older adults residing long-term care homes. The trial forms the final stage of the international, multidisciplinary CARESSES project aimed at designing, developing and evaluating culturally competent robots that can assist older people according to the culture of the individual they are supporting. The importance of cultural competence has been demonstrated in previous nursing literature to be key towards improving health outcomes among patients. METHOD: This study employed a mixed-method, single-blind, parallel-group controlled before-and-after experimental trial design that took place in England and Japan. It aimed to recruit 45 residents of long-term care homes aged ≥65 years, possess sufficient cognitive and physical health and who self-identify with the English, Indian or Japanese culture (n = 15 each). Participants were allocated to either the experimental group, control group 1 or control group 2 (all n = 15). Those allocated to the experimental group or control group 1 received a Pepper robot programmed with the CARESSES culturally competent artificial intelligence (experimental group) or a limited version of this software (control group 1) for 18 h across 2 weeks. Participants in control group 2 did not receive a robot and continued to receive care as usual. Participants could also nominate their informal carer(s) to participate. Quantitative data collection occurred at baseline, after 1 week of use, and after 2 weeks of use with the latter time-point also including qualitative semi-structured interviews that explored their experience and perceptions further. Quantitative outcomes of interest included perceptions of robotic cultural competence, health-related quality of life, loneliness, user satisfaction, attitudes towards robots and caregiver burden. DISCUSSION: This trial adds to the current preliminary and limited pool of evidence regarding the benefits of socially assistive robots for older adults which to date indicates considerable potential for improving outcomes. It is the first to assess whether and to what extent cultural competence carries importance in generating improvements to well-being. TRIAL REGISTRATION: Name of the registry: ClinicalTrials.govTrial registration number: NCT03756194.Date of registration: 28 November 2018. URL of trial registry record.

How the Integration of Telehealth and Coordinated Care Approaches Impact Health Care Service Organization Structure and Ethos: Mixed Methods Study.

BACKGROUND: Coordinated care and telehealth services have the potential to deliver quality care to chronically ill patients. They can both reduce the economic burden of chronic care and maximize the delivery of clinical services. Such services require new behaviors, routines, and ways of working to improve health outcomes, administrative efficiency, cost-effectiveness, and user (patient and health professional) experience. OBJECTIVE: The aim of this study was to assess how health care organization setup influences the perceptions and experience of service managers and frontline staff during the development and deployment of integrated care with and without telehealth. METHODS: As part of a multinational project exploring the use of coordinated care and telehealth, questionnaires were sent to service managers and frontline practitioners. These questionnaires gathered quantitative and qualitative data related to organizational issues in the implementation of coordinated care and telehealth. Three analytical stages were followed: (1) preliminary analysis for a direct comparison of the responses of service managers and frontline staff to a range of organizational issues, (2) secondary analysis to establish statistically significant relationships between baseline and follow-up questionnaires, and (3) thematic analysis of free-text responses of service managers and frontline staff. RESULTS: Both frontline practitioners and managers highlighted that training, tailored to the needs of different professional groups and staff grades, was a crucial element in the successful implementation of new services. Frontline staff were markedly less positive than managers in their views regarding the responsiveness of their organization and the pace of change. CONCLUSIONS: The data provide evidence that the setup of health care services is positively associated with outcomes in several areas, particularly tailored staff training, rewards for good service, staff satisfaction, and patient involvement.

Identification of Complex Health Interventions Suitable for Evaluation: Development and Validation of the 8-Step Scoping Framework.

BACKGROUND: There is extensive literature on the methodology of evaluation research and the development and evaluation of complex interventions but little guidance on the formative stages before evaluation and how to work with partner organizations that wish to have their provision evaluated. It is important to be able to identify suitable projects for evaluation from a range of provision and describe the steps required, often with academic institutions working in partnership with external organizations, in order to set up an evaluation. However, research evaluating programs or interventions rarely discusses these stages. OBJECTIVE: This study aimed to extend work on evaluability assessment and pre-evaluation planning by proposing an 8-Step Scoping Framework to enable the appraisal of multiple programs in order to identify interventions suitable for evaluation. We aimed to add to the literature on evaluability assessment and more recent evaluation guidance by describing the processes involved in working with partner organizations. METHODS: This paper documents the steps required to identify multiple complex interventions suitable for process and outcome evaluation. The steps were developed using an iterative approach by working alongside staff in a local government organization, to build an evidence base to demonstrate which interventions improve children's outcomes. The process of identifying suitable programs for evaluation, thereby establishing the pre-evaluation steps, was tested using all Flying Start provision. RESULTS: The 8-Step Scoping Framework was described using the example of the local government organization Flying Start to illustrate how each step contributes to finding projects suitable for process and outcome evaluation: (1) formulating overarching key questions that encompass all programs offered by an organization, (2) gaining an in-depth understanding of the work and provision of an organization and engaging staff, (3) completing a data template per project/program offered, (4) assessing the robustness/validity of data across all programs, (5) deciding on projects suitable for evaluation and those requiring additional data, (6) negotiating with chosen project leads, both within and outside the organization, (7) developing individual project evaluation protocols, and (8) applying for ethical approval from the university and partner organization. CONCLUSIONS: This paper describes the processes involved in identifying suitable projects for evaluation. It adds to the existing literature on the assessment of specific programs suitable for evaluation and guidance for conducting evaluations by establishing the formative steps required to identify suitable programs from a range of provision. This scoping framework particularly relates to academic partners and organizations tasked with delivering evidence-based services designed to meet local needs. The steps identified have been described in the context of early years provision but can be applied to a range of community-based evaluations, or more generally, to cases where an academic partner is working with external stakeholders to identify projects suitable for academic evaluation.

Women's experiences of disrespect and abuse in maternity care facilities in Benue State, Nigeria.

BACKGROUND: Disrespect and abuse (D&A) of women in health facilities continues to be a prevailing public health issue in many countries. Studies have reported significantly high prevalence of D&A among women during pregnancy and childbirth in Nigeria, but little is known about women's perceptions and experiences of D&A during maternity care in the country. The aim of this study was to explore: 1) how women perceived their experiences of D&A during pregnancy, childbirth, and in the postnatal period in Benue State, Nigeria; and 2) how women viewed the impact of D&A on the future use of health facilities for maternity care. METHOD: Five focus group discussions with a sample of 32 women were conducted as part of a qualitative phenomenological study. All the women received maternity care in health facilities in Benue State, Nigeria and had experienced at least one incident of disrespect and abuse. Audio-recorded discussions were transcribed and analysed using a six-stage thematic analysis using NVivo11. RESULTS: The participants perceived incidents such as being shouted at and the use of abusive language as a common practice. Women described these incidents as devaluing and dehumanising to their sense of dignity. Some women perceived that professionals did not intend to cause harm by such behaviours. Emerged themes included: (1) 'normative' practice; (2) dehumanisation of women; (3) 'no harm intended' and (4) intentions about the use of maternity services in future. The women highlighted the importance of accessing health facilities for safe childbirth and expressed that the experiences of D&A may not impact their intended use of health facilities. However, the accounts reflected their perceptions about the inherent lack of choice and an underlying sense of helplessness. CONCLUSION: Incidents of D&A that were perceived as commonplace carry substantial implications for the provision of respectful maternity care in Nigeria and other similar settings. As a country with one of the highest rates of maternal deaths, the findings point to the need for policy and practice to address the issue urgently through implementing preventive measures, including empowering women to reinforce their right to be treated with dignity and respect, and sensitising health care professionals.

A method for studying decision-making by guideline development groups.

BACKGROUND: Multidisciplinary guideline development groups (GDGs) have considerable influence on UK healthcare policy and practice, but previous research suggests that research evidence is a variable influence on GDG recommendations. The Evidence into Recommendations (EiR) study has been set up to document social-psychological influences on GDG decision-making. In this paper we aim to evaluate the relevance of existing qualitative methodologies to the EiR study, and to develop a method best-suited to capturing influences on GDG decision-making. METHODS: A research team comprised of three postdoctoral research fellows and a multidisciplinary steering group assessed the utility of extant qualitative methodologies for coding verbatim GDG meeting transcripts and semi-structured interviews with GDG members. A unique configuration of techniques was developed to permit data reduction and analysis. RESULTS: Our method incorporates techniques from thematic analysis, grounded theory analysis, content analysis, and framework analysis. Thematic analysis of individual interviews conducted with group members at the start and end of the GDG process defines discrete problem areas to guide data extraction from GDG meeting transcripts. Data excerpts are coded both inductively and deductively, using concepts taken from theories of decision-making, social influence and group processes. These codes inform a framework analysis to describe and explain incidents within GDG meetings. We illustrate the application of the method by discussing some preliminary findings of a study of a National Institute for Health and Clinical Excellence (NICE) acute physical health GDG. CONCLUSION: This method is currently being applied to study the meetings of three of NICE GDGs. These cover topics in acute physical health, mental health and public health, and comprise a total of 45 full-day meetings. The method offers potential for application to other health care and decision-making groups.

Degradome expression profiling in human articular cartilage.

INTRODUCTION: The molecular mechanisms underlying cartilage destruction in osteoarthritis are poorly understood. Proteolysis is a key feature in the turnover and degradation of cartilage extracellular matrix where the focus of research has been on the metzincin family of metalloproteinases. However, there is strong evidence to indicate important roles for other catalytic classes of proteases, with both extracellular and intracellular activities. The aim of this study was to profile the expression of the majority of protease genes in all catalytic classes in normal human cartilage and that from patients with osteoarthritis (OA) using a quantitative method. METHODS: Human cartilage was obtained from femoral heads at joint replacement for either osteoarthritis or following fracture to the neck of femur (NOF). Total RNA was purified, and expression of genes assayed using Taqman low-density array quantitative RT-PCR. RESULTS: A total of 538 protease genes were profiled, of which 431 were expressed in cartilage. A total of 179 genes were differentially expressed in OA versus NOF cartilage: eight aspartic proteases, 44 cysteine proteases, 76 metalloproteases, 46 serine proteases and five threonine proteases. Wilcoxon ranking as well as the LogitBoost-NR machine learning approach were used to assign significance to each gene, with the most highly ranked genes broadly similar using each method. CONCLUSIONS: This study is the most complete quantitative analysis of protease gene expression in cartilage to date. The data help give direction to future research on the specific function(s) of individual proteases or protease families in cartilage and may help to refine anti-proteolytic strategies in OA.

Location, location, location: the role of experience of disadvantage in lay perceptions of area inequalities in health.

This paper examines how people see and express their experience of inequalities through place and how they understand the impact of place on health. Drawing on focus group discussions with participants from varying socio-economic backgrounds, we show, in contrast to a nascent received wisdom, how people from more deprived areas more readily discuss the adverse effects on health and well-being of structural and contextual features, whereas those with least experience of deprivation or hardship were more likely to draw on behavioural explanations of area inequalities. People living in more deprived areas also more readily accept statistics on area inequalities in health than those based in more affluent areas. We discuss these findings in the light of people's constructions of differences and distance between contiguous areas. We conclude by discussing some methodological and contextual features of our study which may explain why our findings both support and challenge those from earlier studies.

The wealthy get healthy, the poor get poorly? Lay perceptions of health inequalities.

Research repeatedly identifies an association between health and socio-economic status-richer people are healthier than poorer people. Richard Wilkinson has posited that socio-psychological mechanisms may be part of the explanation for the fact that socio-economic inequalities run right across the social spectrum in wealthy societies. He argues that polarised income distributions within countries have a negative impact on stress, self-esteem and social relations which, in turn, impact on physical well-being. How people experience and perceive inequalities is central to his thesis. However, relatively little empirical work has explored such lay perceptions. We attempt to address this gap by exploring how people see inequality, how they theorise its impact on health, and the extent to which they make personal and social comparisons, by drawing on 14 focus group discussions in Scotland and the north of England. Contrary to other research which suggests that people from more deprived backgrounds are more reluctant to acknowledge the effects of socio-economic deprivation, our findings demonstrate that, in some contexts at least, people from less favourable circumstances converse in a way to suggest that inequalities deeply affect their health and well-being. We discuss these findings in the light of the methodological challenges presented for pursuing such research.

'Radical blueprint for social change'? Media representations of New Labour's policies on public health.

For almost two decades prior to the election of the New Labour government in 1997, inequalities in health were largely absent from the political debate in Britain. New Labour sought to bring inequalities, and the role of poverty as a 'root cause' of ill-health, back on to the public agenda. This paper analyses four key documents (Green and White Papers) laying out their proposals for public health. We explore the shifting emphasis on health inequalities between the four official documents, and between the documents and their associated press release. The paper also analyses how this translated into media coverage. It identifies common themes across the press coverage - such as criticisms about lack of targets - but also shows how coverage varied (e.g. between UK 'national' and 'Scottish' press). Finally, the study highlights the crucial issue of political context and news timing, illustrating how the English White Paper was overshadowed by other health stories which formed the basis for attacks on the Labour government in general and the Health Minister in particular.