The impact of living in a bio-secure bubble on mental health: An examination in elite cricket.

The COVID-19 pandemic has had a profound impact on many people's lives, including the use of bio-secure environments to facilitate the continuation of professional sport. Although it is well documented that the pandemic has negatively impacted mental health, the impact of bio-bubbles on mental health is yet to be investigated. In the present study we sought to identify the impact of bio-bubbles on the mental health of those residing within, and then to explore the underlying mechanism of any such impact. Individuals (n = 68) who resided in England and Wales Cricket Board (ECB) created bio-bubbles between March 2020 and April 2021 provided data, regarding their time inside and outside of bio-bubbles, on measures of mental health and basic psychological need satisfaction and frustration. Analysis revealed that bio-bubbles increased anxiety and depression and reduced wellbeing. Additionally, MEMORE mediation analyses revealed that autonomy frustration mediated the relationship between bubble status and all mental health markers. Furthermore, compared to men, women were more likely to experience elevated levels of anxiety and depression inside the bubble. The findings suggest that bio-bubbles negatively impact mental health and further suggest that satisfaction and frustration of basic psychological needs is a contributing factor. Findings suggest organizations tasked with creating bio-bubbles would do well to tailor their environment with an awareness of the importance of basic psychological needs and sex differences in relation to mental health. To the best of our knowledge, this research represents the first investigation of the impact of bio-bubbles on mental health.

Noncontact Injury Distribution and Relationship With Preseason Training Load and Nonmodifiable Risk Factors in Rugby Union Players Across Multiple Seasons.

ABSTRACT: Evans, SL, Whittaker, G, Elphinstone Davis, E, Jones, ES, Hardy, J, and Owen, JA. Noncontact injury distribution and relationship with preseason training load and non-modifiable risk factors in Rugby Union players across multiple seasons. J Strength Cond Res 37(7): 1456-1462, 2023-This study examined the distribution of noncontact injury during phases of the competitive season and the association between preseason training load (TL) and nonmodifiable risk factors on injury risk during these phases. Injury data were recorded from 1 senior academy team over 3 seasons (2017-2020) and analyzed across early-season, midseason, and late-season phases. A generalized estimating equation was used to model risk factors with noncontact injury for selected phases. The highest noncontact injury incidence occurred in the late-season phase (22.2 per 1,000 hours) compared with early (13.7 per 1,000 hours, p < 0.001) and midseason phases (15.5 per 1,000 hours, p = 0.001). Low preseason TL (8,949-12,589 arbitrary units; odds ratio [OR], 95% confidence interval [CI] = 4.7, 1.0-21.6; p = 0.04) and low preseason TL combined with high early-season TL and injury in the early-season phase (OR, 95% CI = 6.5, 1.1-35.5; p = 0.03) were associated with greater midseason noncontact injury risk. In addition, low preseason TL combined with previous injury was associated with increased risk of noncontact injury risk in the late season (OR, 95% CI = 12.2, 0.9-15.6, p = 0.05). Our results suggest players are at a greater injury risk during the late-season phase, with low preseason cumulative loads combined with a history of previous injury associated with increased in-season injury risk. Strength and conditioning coaches should therefore monitor cumulative preseason TL alongside screening for previous injury history to identify athletes at greater risk of noncontact injury risk during the competitive season.

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum.

OBJECTIVE: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. METHODS: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. INTERVENTIONS: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. RESULTS: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was -0.02 (95% CI -0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. CONCLUSIONS: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25260464.

Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.

Importance: Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited. Objective: To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents. Design, Setting, and Participants: Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018. Interventions: Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year. Main Outcomes and Measures: The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year. Results: Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group. Conclusions and Relevance: Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting. Trial Registration: ISRCTN Identifier:16392920.

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

BACKGROUND: Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. METHODS: We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. FINDINGS: Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. INTERPRETATION: Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. FUNDING: Department of Health Policy Research Programme.

Interventions to provide culturally-appropriate maternity care services: factors affecting implementation.

BACKGROUND: The World Health Organization recently made a recommendation supporting 'culturally-appropriate' maternity care services to improve maternal and newborn health. This recommendation results, in part, from a systematic review we conducted, which showed that interventions to provide culturally-appropriate maternity care have largely improved women's use of skilled maternity care. Factors relating to the implementation of these interventions can have implications for their success. This paper examines stakeholders' perspectives and experiences of these interventions, and facilitators and barriers to implementation; and concludes with how they relate to the effects of the interventions on care-seeking outcomes. METHODS: We based our analysis on 15 papers included in the systematic review. To extract, collate and organise data on the context and conditions from each paper, we adapted the SURE (Supporting the Use of Research Evidence) framework that lists categories of factors that could influence implementation. We considered information from the background and discussion sections of papers included in the systematic review, as well as cost data and qualitative data when included. RESULTS: Women's and other stakeholders' perspectives on the interventions were generally positive. Four key themes emerged in our analysis of facilitators and barriers to implementation. Firstly, interventions must consider broader economic, geographical and social factors that affect ethnic minority groups' access to services, alongside providing culturally-appropriate care. Secondly, community participation is important in understanding problems with existing services and potential solutions from the community perspective, and in the development and implementation of interventions. Thirdly, respectful, person-centred care should be at the core of these interventions. Finally, cohesiveness is essential between the culturally-appropriate service and other health care providers encountered by women and their families along the continuum of care through pregnancy until after birth. CONCLUSION: Several important factors should be considered and addressed when implementing interventions to provide culturally-appropriate care. These factors reflect more general goals on the international agenda of improving access to skilled maternity care; providing high-quality, respectful care; and community participation.

Food production and service in UK hospitals.

PURPOSE: The purpose of this paper is to apply value stream mapping holistically to hospital food production/service systems focused on high-quality food. DESIGN/METHODOLOGY/APPROACH: Multiple embedded case study of three (two private-sector and one public-sector) hospitals in the UK. FINDINGS: The results indicated various issues affecting hospital food production including: the menu and nutritional considerations; food procurement; food production; foodservice; patient perceptions/expectations. RESEARCH LIMITATIONS/IMPLICATIONS: Value stream mapping is a new approach for food production systems in UK hospitals whether private or public hospitals. PRACTICAL IMPLICATIONS: The paper identifies opportunities for enhancing hospital food production systems. ORIGINALITY/VALUE: The paper provides a theoretical basis for process enhancement of hospital food production and the provision of high-quality hospital food.

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy.

BACKGROUND: Approximately 1 in 5 pregnant women in the United Kingdom are obese. In addition to being associated generally with poor health, obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity.This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women's Body Mass Index at 12 months following birth. METHODS/DESIGN: The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales. The units will be randomised, 10 to the intervention group and 10 to the control group. 570 pregnant women aged 18 years or over, with a Body Mass Index of +/=30 (kg/m2) and between 12 and 20 weeks gestation will be recruited. Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity. In addition to their usual care and the leaflets, women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group, which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives, until 6 weeks postpartum.Participants will be followed up at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum is the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. A cost effectiveness analysis and process evaluation will also be conducted. DISCUSSION: This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women. If successful the intervention will equip women with the necessary knowledge and skills to enable them to make healthier choices for themselves and their unborn child. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN25260464 Date of registration: 16th April 2010.

Targeting the Complexity of In Vitro Skin Models: A Review of Cutting-Edge Developments.

Skin in vitro models offer much promise for research, testing drugs, cosmetics, and medical devices, reducing animal testing and extensive clinical trials. There are several in vitro approaches to mimicking human skin behavior, ranging from simple cell monolayer to complex organotypic and bioengineered 3-dimensional models. Some have been approved for preclinical studies in cosmetics, pharmaceuticals, and chemicals. However, development of physiologically reliable in vitro human skin models remains in its infancy. This review reports on advances in in vitro complex skin models to study skin homeostasis, aging, and skin disease.

Statistical analysis plan for the SOLUTIONS randomised controlled trial with internal pilot: Solution Focused Brief Therapy (SFBT) in 10-17-year-olds presenting at policy custody.

BACKGROUND: Within England, children and young people entering police custody are referred to Liaison and Diversion (L&D) teams. These teams liaise with healthcare and other support services aiming to divert children and young people away from the criminal justice system. Although targeted psychological interventions are not typically offered to children and young people by L&D teams, evidence suggests that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems. METHODS: A two-arm individually randomised controlled trial (RCT) with internal pilot and process evaluation will be conducted with approximately 448 children and young people aged 10-17 years presenting at police custody suites who are referred to the L&D team or recruited via online routes if they have previously presented at any police custody suite in England. The primary outcome is the Self-Report Delinquency Measure (SRDM) at 6 months post-randomisation. Analyses will be performed using intention-to-treat. RESULTS: The statistical analysis plan (SAP) for the trial is described. The plan details of analyses to be undertaken which will be reported in the primary and any secondary publications. The plan was developed and published prior to locking our database and unblinding to treatment allocation. DISCUSSION: This RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites including testing of moderating factors and sensitivity of the primary analyses. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023.

The effectiveness and cost-effectiveness of the Family Nurse Partnership home visiting programme for first time teenage mothers in England: a protocol for the Building Blocks randomised controlled trial.

BACKGROUND: The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children. METHODS / DESIGN: This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child's second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth. DISCUSSION: This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child's second birthday. TRIAL REGISTRATION: Trial registration number: ISRCTN23019866.

Regulation of human trophoblast gene expression by endogenous retroviruses.

The placenta is a fast-evolving organ with large morphological and histological differences across eutherians, but the genetic changes driving placental evolution have not been fully elucidated. Transposable elements, through their capacity to quickly generate genetic variation and affect host gene regulation, may have helped to define species-specific trophoblast gene expression programs. Here we assess the contribution of transposable elements to human trophoblast gene expression as enhancers or promoters. Using epigenomic data from primary human trophoblast and trophoblast stem-cell lines, we identified multiple endogenous retrovirus families with regulatory potential that lie close to genes with preferential expression in trophoblast. These largely primate-specific elements are associated with inter-species gene expression differences and are bound by transcription factors with key roles in placental development. Using genetic editing, we demonstrate that several elements act as transcriptional enhancers of important placental genes, such as CSF1R and PSG5. We also identify an LTR10A element that regulates ENG expression, affecting secretion of soluble endoglin, with potential implications for preeclampsia. Our data show that transposons have made important contributions to human trophoblast gene regulation, and suggest that their activity may affect pregnancy outcomes.

Gut microbiology of UK care home residents: a cross-sectional analysis from a randomised controlled trial.

OBJECTIVE: To describe the prevalence of potentially clinically relevant gut pathogens and associations with the carriage of resistant organisms in UK care home residents. METHODS: Stool samples were collected pre-randomisation from care home residents participating in a randomised placebo-controlled trial. Cultivable clinically relevant bacteria were analysed. Antimicrobial susceptibility testing was performed by agar dilution (amoxicillin, co-amoxiclav, gentamicin, trimethoprim, nitrofurantoin, and ciprofloxacin). We also aimed to detect resistance to third-generation cephalosporins, carbapenems, and vancomycin. RESULTS: Stool samples were available for 159/310 residents participating in the trial (51%) from 23 care homes between 2016 and 2018. In total, 402 bacterial isolates were cultured from 158 stool samples and 29 different species were cultured. The five most common species were Escherichia coli (155/158, 98%), Pseudomonas aeruginosa (40/158, 25%), Enterococcus faecalis (35/158, 22%), Enterococcus faecium (30/158, 19%), and Proteus mirabilis (25/158, 16%). Enterobacterales isolates were cultured from 157 samples (99%), and resistance to at least one of the tested antimicrobials was found in 119 of these (76%). There were high levels of variation in outcomes by care home. DISCUSSION: We demonstrated that care home residents harbour significant levels of antimicrobial-resistant organisms in their stool. This work emphasises the importance of both enhanced infection control practices and antimicrobial stewardship programmes to support the appropriate use of antimicrobials in this setting.

Match and training injury risk in semi-professional rugby union: A four-year study.

OBJECTIVES: Describe medical-attention and time-loss injuries during matches and training in a Welsh Premiership Rugby Union team. DESIGN: Prospective cohort observational study. METHODS: Injury incidence, severity, burden, location, type, and cause were determined in sixty-nine players from one semi-professional Rugby Union team. RESULTS: Medical-attention and time-loss injury incidence was greater for matches (incidence, 95% confidence interval = 122.8, 108.9-138.4 and 99.8, 87.3-114.0) than training (incidence, 95% confidence interval = 2.2, 1.8-2.6 and 1.7, 1.4-2.1) per 1000 player-hours. Injury severity was similar for matches (time-loss ± standard deviation = 24.9 ± 30.8 days) and training (time-loss ± SD = 22.4 ± 29.1 days), with injury burden greater for matches (burden, 95% confidence interval = 3148.8, 3019.8-6479.2) than training (burden, 95% confidence interval = 49.7, 36.7-129.6). Lower-limb time-loss injuries were most common during matches (incidence, 95% confidence interval = 46.0, 37.9-55.9) and training (incidence, 95% confidence interval = 1.3, 1.0-1.7) per 1000 player-hours, whilst upper-limb injuries were most severe in matches (time-loss, 95% confidence interval = 38.8, 28.3-44.4 days) and training (time-loss, 95% confidence interval = 45.9, 17.5-52.7 days). The prevalent cause of contact-injury was tackling (31%) with running (11%) the common cause of non-contact injury. CONCLUSIONS: Time-loss match-injury incidence, severity, and burden were similar to data reported in the professional tier, with similar patterns of injuries for location, type, and inciting event. These figures are greater than previously reported for semi-professional Rugby Union, warranting further investigation at this level of play.

Psychosocial and Physiological Factors Affecting Selection to Regional Age-Grade Rugby Union Squads: A Machine Learning Approach.

Talent selection programmes choose athletes for talent development pathways. Currently, the set of psychosocial variables that determine talent selection in youth Rugby Union are unknown, with the literature almost exclusively focusing on physiological variables. The purpose of this study was to use a novel machine learning approach to identify the physiological and psychosocial models that predict selection to a regional age-grade rugby union team. Age-grade club rugby players (n = 104; age, 15.47 ± 0.80; U16, n = 62; U18, n = 42) were assessed for physiological and psychosocial factors during regional talent selection days. Predictive models (selected vs. non-selected) were created for forwards, backs, and across all players using Bayesian machine learning. The generated physiological models correctly classified 67.55% of all players, 70.09% of forwards, and 62.50% of backs. Greater hand-grip strength, faster 10 m and 40 m sprint, and power were common features for selection. The generated psychosocial models correctly classified 62.26% of all players, 73.66% of forwards, and 60.42% of backs. Reduced burnout, reduced emotional exhaustion, and lower reduced sense of accomplishment, were common features for selection. Selection appears to be predominantly based on greater strength, speed, and power, as well as lower athlete burnout.

Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage.

OBJECTIVES: Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs. DESIGN: Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage. PARTICIPANTS: 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone. OUTCOME MEASURES: Primary outcome: state-verified child-in-need status recorded at any time during follow-up. SECONDARY OUTCOMES: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs. RESULTS: Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs. CONCLUSIONS: FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1. TRIAL REGISTRATION NUMBER: ISRCTN23019866.

Evaluating the family nurse partnership in England: the Building Blocks trial.

The Family Nurse Partnership (FNP) Programme is a structured intensive home visiting programme delivered by trained family nurses to nulliparous teenagers throughout pregnancy and until their child is two years old. Currently FNP is provided in over 60 primary healthcare sites in England with a planned capacity increase to 13,000 concurrent clients by 2015. Researchers from the South East Wales Trials Unit at Cardiff University are testing the effectiveness of FNP in England in the Building Blocks study--a randomised controlled trial funded by the Department of Health (DH). The trial team includes collaborators from the Universities of York, Bristol and Glamorgan.

Relationships Between Age, Frailty, Length of Care Home Residence and Biomarkers of Immunity and Inflammation in Older Care Home Residents in the United Kingdom.

Aging is associated with changes to the immune system, collectively termed immunosenescence and inflammageing. However, the relationships among age, frailty, and immune parameters in older people resident in care homes are not well described. We assessed immune and inflammatory parameters in 184 United Kingdom care home residents aged over 65 years and how they relate to age, frailty index, and length of care home residence. Linear regression was used to identify the independent contribution of age, frailty, and length of care home residence to the various immune parameters as dependent variables. Participants had a mean age (±SD) of 85.3 ± 7.5 years, had been residing in the care home for a mean (±SD) of 1.9 ± 2.2 years at the time of study commencement, and 40.7% were severely frail. Length of care home residence and frailty index were correlated but age and frailty index and age and length of care home residence were not significantly correlated. All components of the full blood count, apart from total lymphocytes, were within the reference range; 31% of participants had blood lymphocyte numbers below the lower value of the reference range. Among the components of the full blood count, platelet numbers were positively associated with frailty index. Amongst plasma inflammatory markers, C-reactive protein (CRP), interleukin-1 receptor antagonist (IL-1ra), soluble E-selectin and interferon gamma-induced protein 10 (IP-10) were positively associated with frailty. Plasma soluble vascular cell adhesion molecule 1 (sVCAM-1), IP-10 and tumor necrosis factor receptor II (TNFRII) were positively associated with age. Plasma monocyte chemoattractant protein 1 was positively associated with length of care home residence. Frailty was an independent predictor of platelet numbers, plasma CRP, IL-1ra, IP-10, and sE-selectin. Age was an independent predictor of activated monocytes and plasma IP-10, TNFRII and sVCAM-1. Length of care home residence was an independent predictor of plasma MCP-1. This study concludes that there are independent links between increased frailty and inflammation and between increased age and inflammation amongst older people resident in care homes in the United Kingdom. Since, inflammation is known to contribute to morbidity and mortality in older people, the causes and consequences of inflammation in this population should be further explored.

Combination of the Probiotics Lacticaseibacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis, BB-12 Has Limited Effect on Biomarkers of Immunity and Inflammation in Older People Resident in Care Homes: Results From the Probiotics to Reduce Infections iN CarE home reSidentS Randomized, Controlled Trial.

Aging is associated with a decline in many components of the immune system (immunosenescence). Probiotics may improve the immune response in older people. The objective was to determine the effect of the combination of two probiotic organisms [Lacticaseibacillus (previously known as Lactobacillus) rhamnosus GG (LGG) and Bifidobacterium animalis subsp. lactis, BB-12 (BB-12)] on a range of immune biomarkers measured in the blood of older people resident in care homes in the UK. In a randomized controlled trial, older people [aged 67-97 (mean 86) years] resident in care homes received the combination of LGG+BB-12 (1.3-1.6 × 109 CFU per day) or placebo for up to 12 months. Full blood count, blood immune cell phenotypes, plasma immune mediator concentrations, phagocytosis, and blood culture responses to immune stimulation were all measured. Response to seasonal influenza vaccination was measured in a subset of participants. Paired samples (i.e., before and after intervention) were available for 30 participants per group. LGG and BB-12 were more likely to be present in feces in the probiotic group and were present at higher numbers. There was no significant effect of the probiotics on components of the full blood count, blood immune cell phenotypes, plasma immune mediator concentrations, phagocytosis by neutrophils and monocytes, and blood culture responses to immune stimulation. There was an indication that the probiotics improved the response to seasonal influenza vaccination with significantly (p = 0.04) higher seroconversion to the A/Michigan/2015 vaccine strain in the probiotic group than in the placebo group (47 vs. 15%).