The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial.

BACKGROUND: Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. AIMS: We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. METHOD: We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). RESULTS: We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI -0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. CONCLUSIONS: There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.

Geographical variations in long term colorectal cancer outcomes in England: a contemporary population analysis revealing the north-south divide in colorectal cancer survival.

BACKGROUND: Regional variations in healthcare outcomes in England have been historically reported. This study analyses the variations in long term colorectal cancer survival across different regions in England. METHODS: Relative survival analysis of population data obtained from all cancer registries in England between 2010 and 2014. RESULTS: Totally, 167,501 patients were studied. Regions in the southern England had better outcomes with Southwest and Oxford registries having 63.5 and 62.7% 5 year relative survival. In contrast, Trent and Northwest cancer registries had 58.1% relative survival (p < 0.01). The regions in the north fared below the national average. The survival outcomes reflected socio-economic deprivation status, the best performing regions in the south having low levels of deprivation (5.3 and 6.5% having maximum deprivation in Southwest and Oxford, respectively). The regions with worst long term cancer outcomes had high levels of deprivation with 25% and 17% having high levels of deprivation in Northwest and Trent regions. CONCLUSION: There are significant variations in long term colorectal cancer survival between different regions in England, southern England had better relative survival when compared with the northern regions. Disparities in socio-economic depravation status in different regions may be associated with worse colorectal cancer outcomes.

Young-onset colorectal cancer: Insights from an English population-based study.

AIM: Young colorectal cancer (CRC) patients are reported to have more aggressive disease, an advanced stage at diagnosis and conflicting survival outcomes. The aim of this study was to analyse the demographics, clinicopathological features and prognosis of young CRC at a population-based level in England. METHOD: This is a retrospective review of all CRC patients using data from Public Health England collated from regional cancer registries in England between 2010 and 2014. Those aged 40 years and below were classified as young and those over 40 were classified as older. RESULTS: Overall, 167,501 patients had CRC. Of these, 3757 patients (2.2%) were young. Right-sided cancers were more common in younger patients (48.2% vs. 32.9%, p < 0.001). Favourable histological grade (well or moderately differentiated) was present in 83.1% and 73.5% of young and older patients, respectively. The percentage of young and older patients being diagnosed at an early stage (Stages 1 and 2) was similar at 40.6% vs. 42.9%. The 5-year age- and gender-adjusted relative survival (cancer specific) was significantly better for young patients when compared with older patients diagnosed with CRC. Additionally, overall 5-year survival was better for younger patients (71.6% and 47.2%, p < 0.001 in young and older CRC patients respectively). CONCLUSION: The increased right-sided colon cancer in young CRC patients in England warrants attention. Contrary to previous reports, they do not present at later stage. Young CRC patients have better overall and relative survival than older patients with CRC.

Preterm births in South-West England before and during the COVID-19 pandemic: an audit of retrospective data.

The COVID-19 lockdown had a series of intended and unintended consequences, including reduced infections and changes in activities and behaviours. Some of these changes may have been beneficial to perinatal outcomes; however, other factors such as reduced access to face-to-face healthcare may have contributed negatively to antenatal care. The aim of this audit was to evaluate neonatal admissions in the South-West of England during the COVID-19 pandemic in 2020 and the previous two years 2018-2019. Anonymised birth and neonatal admission rates from January to December 2020 was obtained and compared to data from 2018 to 2019. The results demonstrate a decreasing in neonatal unit admissions between 2018 and 2020, 9.48% of live births in 2018 (95% CI 9.17, 9.80) to 8.89% (95% CI 8.65, 9.13) in 2020 (p = 0.002).Conclusion: There were no significant differences across gestational groups. It is unclear without nationwide data whether our observed trends, decreased neonatal admissions over the past 3 years, are generalisable and related to the COVID-19 pandemic. Future research exploring the impact of lockdowns on behaviour change during pregnancy and support services is warranted to understand the implications of pandemics on pregnancy and preterm birth. What is Known: • The COVID-19 lockdown had a series of intended and unintended consequences; some of which may have been beneficial to perinatal outcomes. • Research suggests that preterm births have not significantly changed overall, but they have decreased in high-income countries. What is New: • In our audit, analysing retrospective data of regional birth and neonatal admission from the South-West of England, we observed a decrease in live birth rates between 2018 and 2020. • A reduction in neonatal unit admissions was observed from 2018 to 2020 with no significant differences across gestational groups. The reduction from 2019 to 2020 was smaller than that from 2018 to 2019 implying that the COVID-19 pandemic in 2020 was not necessarily implicated.

Identification of deliberate catheter motion at the left atrial posterior wall during pulmonary vein isolation: Validity of respiratory motion adjustment.

BACKGROUND: During automated radiofrequency (RF) annotation-guided pulmonary vein isolation (PVI), respiratory motion adjustment (RMA) is recommended, yet lacks in vivo validation. METHODS: Following contact force (CF) PVI (continuous RF, 30 W) using general anesthesia and automated RF annotation-guidance (VISITAG™: force-over-time 100% minimum 1 g; 2 mm position stability; ACCURESP™ RMA "off") in 25 patients, we retrospectively examined RMA settings "on" versus "off" at the left atrial posterior wall (LAPW). RESULTS: Respiratory motion detection occurred in eight, permitting offline retrospective comparison of RMA settings. Significant differences in LAPW RF auto-annotation occurred according to RMA setting, with curves displaying catheter position, CF and impedance data indicating "best-fit" for catheter motion detection using RMA "off." Comparing RMA "on" versus "off," respectively: total annotated sites, 82 versus 98; median RF duration per-site, 13.3 versus 10.6 s (p < 0.0001); median force time integral 177 versus 130 gs (p = 0.0002); mean inter-tag distance (ITD), 6.0 versus 4.8 mm (p = 0.002). Considering LAPW annotated site 1-to-2 transitions resulting from deliberate catheter movement, 3 concurrent with inadvertent 0 g CF demonstrated < 0.6 s difference in RF duration. However, 13 deliberate catheter movements during constant tissue contact (ITD range: 2.1-7.0 mm) demonstrated (mean) site-1 RF duration difference 3.7 s (range: -1.3 to 11.3 s): considering multiple measures of catheter position instability, the appropriate indication of deliberate catheter motion occurred with RMA "off" in all. CONCLUSIONS: ACCURESP™ respiratory motion adjustment importantly delayed the identification of deliberate and clinically relevant catheter motion during LAPW RF delivery, rendering auto-annotated RF display invalid. Operators seeking greater accuracy during auto-annotated RF delivery should avoid RMA use.

Insulin Resistance during normal child growth and development is associated with a distinct blood metabolic phenotype (Earlybird 72).

BACKGROUND: While insulin resistance (IR) is associated with specific metabolite signatures in adults, there have been few truly longitudinal studies in healthy children, either to confirm which abnormalities are present, or to determine whether they precede or result from IR. Therefore, we investigated the association of serum metabolites with IR in childhood in the Earlybird cohort. METHODS: The Earlybird cohort is a well-characterized cohort of healthy children with annual measurements from age 5 to 16 years. For the first time, longitudinal association analyses between individual serum metabolites and homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) have been performed taking into account the effects of age, growth, puberty, adiposity, and physical activity. RESULTS: IR was higher in girls than in boys and was associated with increasing body mass index (BMI). In longitudinal analysis IR was associated with reduced concentrations of branched-chain amino acids (BCAA), 2-ketobutyrate, citrate and 3-hydroxybutyrate, and higher concentrations of lactate and alanine. These findings demonstrate the widespread biochemical consequences of IR for intermediary metabolism, ketogenesis, and pyruvate oxidation during normal child growth and development. CONCLUSIONS: Longitudinal analysis can differentiate metabolite signatures that precede or follow the development of greater levels of IR. In healthy normal weight children, higher levels of IR are associated with reduced levels of BCAA, ketogenesis, and fuel oxidation. In contrast, elevated lactate concentrations preceded the rise in IR. These changes reveal the metabolite signature of insulin action during normal growth, and they contrast with previous findings in obese children and adults that represent the consequences of IR and obesity.

Insulin resistance is higher in prepubertal girls but switches to become higher in boys at age 16: A Cohort Study (EarlyBird 57).

BACKGROUND: The risk of type 2 diabetes is increasing in teenage girls, and is associated with their greater insulin resistance (IR). HYPOTHESIS: We hypothesized that the adverse metabolic profile of girls (compared with boys) would persist from childhood through adolescence. PATIENTS AND METHODS: Community-based longitudinal cohort of 292 children (147 boys) studied annually from 9 to 16 years. MEASURES: IR (homeostasis-model-assessment-2), high-density lipoprotein-cholesterol (HDL-C), triglycerides, % body-fat (dual-energy x-ray absorptiometry), pubertal stage (age at peak height velocity), physical activity (accelerometry). Multi-level modelling established the age-related trends in IR and lipids and the influence of covariates. RESULTS: Each year from 9 to 15 years, girls had 21% to 63% higher IR than boys (girls mean IR 0.73-1.33, boys 0.51-0.89, P < .005). At 16 years the gender difference was not significant (girls IR 0.60, boys 0.56, P = .45). Girls had lower HDL-C from 9 to 12 years, higher triglycerides from 9 to 14 years, greater adiposity throughout, and earlier puberty, but boys were more active than girls (all P < .05). After adjustment for %-fat, puberty and activity, the gender difference in IR between girls and boys aged 9 to 15 years became non-significant (IR girls 0.66-1.01, boys 0.65-1.04, P > .07). However, after adjustment at 16 years, girls' IR was 25% lower than boys' (girls 0.44, boys 0.63, P = .001), and they had 22% higher HDL-C (P < .001) and 20% lower triglycerides (P = .003). CONCLUSIONS: The higher IR of prepubertal and early pubertal girls diminishes during late puberty, and boys begin to exhibit greater metabolic risk. Despite being leaner and more active, boys at 16 years have higher IR than girls, suggesting future higher risk for diabetes, thus we reject our hypothesis.

Physical activity attenuates the mid-adolescent peak in insulin resistance but by late adolescence the effect is lost: a longitudinal study with annual measures from 9-16 years (EarlyBird 66).

AIMS/HYPOTHESIS: The aim of this work was to test whether the mid-adolescent peak in insulin resistance (IR) and trends in other metabolic markers are influenced by long-term exposure to physical activity. METHODS: Physical activity (7 day ActiGraph accelerometry), HOMA-IR and other metabolic markers (glucose, fasting insulin, HbA1c, lipids and BP) were measured annually from age 9 years to 16 years in 300 children (151 boys) from the EarlyBird study in Plymouth, UK. The activity level of each child was characterised, with 95% reliability, by averaging their eight annual physical activity measures. Age-related trends in IR and metabolic health were analysed by multi-level modelling, with physical activity as the exposure measure (categorical and continuous) and body fat percentage (assessed by dual-energy X-ray absorptiometry) and pubertal status (according to age at peak height velocity and Tanner stage) as covariates. RESULTS: The peak in IR at age 12-13 years was 17% lower (p < 0.001) in the more active adolescents independently of body fat percentage and pubertal status. However, this difference diminished progressively over the next 3 years and had disappeared completely by the age of 16 years (e.g. difference was -14% at 14 years, -8% at 15 years and +1% at 16 years; 'physical activity × age(2), interaction, p < 0.01). Triacylglycerol levels in girls (-9.7%, p = 0.05) and diastolic blood pressure in boys (-1.20 mmHg, p = 0.03) tended to be lower throughout adolescence in the more active group. CONCLUSIONS/INTERPRETATION: Our finding that physical activity attenuates IR during mid-adolescence may be clinically important. It remains to be established whether the temporary attenuation in IR during this period has implications for the development of diabetes in adolescence and for future metabolic health generally.

Mood and its association with metabolic health in adolescents: a longitudinal study, EarlyBird 65.

BACKGROUND: Mood comprises two main traits - positive and negative affect, both associated with depression and anxiety. Studies in children have linked depression with obesity, but the association with metabolic health is unclear. OBJECTIVE: To explore the relationship between mood and metabolic health in adolescents. METHODS: We studied 208 healthy children (115 boys) enrolled in the longitudinal EarlyBird Diabetes Study, and reviewed at 7 and 16 yr. Participants completed the Positive Affect and Negative Affect Schedule - Child Form (PANAS-C) at 16yr to assess positive and negative affect, together representing mood. Measures at 7 and 16 yr: body mass index (BMI), fat (%; dual energy X-ray absorptiometry), physical activity (accelerometer), metabolic risk z-score comprising homeostasis model assessment-insulin resistance (HOMA-IR), triglycerides, total cholesterol/high density lipoprotein (HDL) ratio and blood pressure. Pubertal development was determined by age at peak height velocity. RESULTS: Positive affect was higher in boys than girls, (50 vs. 46, p = 0.001), negative affect higher in girls than boys (26 vs. 22, p < 0.001). Those with lower mood were fatter (r = -0.24, p < 0.001), had higher HOMA-IR (r = -0.12, p = 0.05), higher cholesterol:HDL ratio (r = -0.14, p = 0.02), were less active (r = 0.20, p = 0.003) and had earlier pubertal development (r = 0.19, p = 0.004). Inverse associations between mood and metabolic risk z-score and change in metabolic risk z-score 7-16yr (ß = -0.26, p = 0.006, and -0.40, p = 0.004, respectively) were independent of adiposity, physical activity and puberty and sex. CONCLUSIONS: Low mood in healthy children is associated with poorer metabolic health independently of adiposity. These findings may have implications for the physical and mental health of contemporary youngsters, given their increasing obesity and cardiometabolic risk.

Metabolic risk in contemporary children is unrelated to socio-economic status: longitudinal study of a UK urban population (EarlyBird 42).

Lifestyle interventions to improve health in young children tend to target areas of relative deprivation, but the evidence for so doing is largely historical. Accordingly, we have re-examined the link between deprivation, obesity and metabolic risk in contemporary UK children. Using a postcode-based index of multiple deprivation (IMD), we assessed 269 children from the community-based EarlyBird Study, attending 53 schools representing a wide socio-economic range. Annual measures of fatness from 5 to 8 yr included body mass index (BMI), waist circumference (WC), and sum of five skinfolds (SSF). A metabolic risk score, based on blood pressure, lipids and insulin resistance, was derived from annual fasting blood samples. There were no significant associations between deprivation and any measure of adiposity in girls (all p > 0.37). In boys, there was a weak but consistently inverse relationship between deprivation and WC (r = -0.19, p = 0.03) and BMI (r = -0.14, p = 0.09) at 8 yr. Changes in adiposity over 3 yr were unrelated to deprivation in boys. In girls there was a slight but significant increase in SSF only (1 mm/yr per 20 IMD units, p = 0.001). Importantly, in both genders, metabolic risk score was unrelated to deprivation throughout (r values -0.05 to -0.13, all p > 0.12), as was change in metabolic risk (all p > 0.30). Our data do not support the assumption that obesity, metabolic disturbance and thus risk of type 2 diabetes are more prevalent among poorer children. In today's increasingly obesogenic environment, youngsters from all backgrounds appear to be vulnerable, with population-wide implications for public health spending, and the prevention of diabetes in contemporary youth.

Divergence between HbA1c and fasting glucose through childhood: implications for diagnosis of impaired fasting glucose (Early Bird 52).

OBJECTIVE: An HbA1c threshold of ≥ 6.5% has recently been adopted for the diagnosis of diabetes in adults, and of ≥ 5.7% to identify adults at risk. Little,however, is known of HbA1c's behaviour or diagnostic value in youth. Our aim was to describe the course of HbA1c during childhood, and its association with fasting glucose. RESEARCH DESIGN AND METHODS: HbA1c and glucose were measured every year in a cohort of 326 healthy children (162 boys) from 5 to 15 years. Mixed effects modelling was used to establish the determinants of HbA1c and its development over time. ROC analysis was used to determine the diagnostic value of HbA1c in the 55 individuals who showed impaired fasting glucose(IFG ­ glucose ≥ 5.6 mmol/L). RESULTS: Glucose rose progressively from 4.3 mmol/L at 5 years to 5.1 mmol/Lat 15 years, and although there were positive associations between HbA1c and glucose, from 10 to 13 years, HbA1c fell while glucose continued to rise. IFG developed in 55 children, but HbA1c exceeded 5.7% in only 16 of them. The maximum area under the ROC curve was 0.71 at the age of 14 (p<0.001), and the sensitivity and specificity were optimal at 50 and 80% respectively,corresponding to HbA1c of 5.4%. CONCLUSIONS: Although HbA1c retains a positive association with glucose throughout childhood, it is weak, and their trends diverge from 10 years,suggesting that factors other than glycaemia systematically influence the variance of HbA1c in youth. These findings therefore limit the interpretation of HbA1c for the diagnosis of IFG during childhood.

The prevalence of depression in women with pregnancy-related pelvic girdle pain: A systematic review and meta-analysis.

Background and Aims: Pregnancy-related pelvic girdle pain (PPGP) is estimated to affect between 20% and 70% of pregnant women with 10% experiencing it for more than 3 months postpartum. Women may also experience depression during this period. Understanding the prevalence of depression in women with PPGP is important to inform clinical management. This systematic review aimed to examine the prevalence of depression in women with PPGP in the antepartum and postpartum periods. Methods: A systematic review and meta-analysis. Seven databases were searched from inception until May 24, 2023, combining keywords relating to pelvic girdle pain (PGP), depression, and pregnancy. Two investigators independently screened study titles and abstracts against the eligibility criteria, extracting data characteristics of all included studies. Included articles were assessed for risk of bias. Summary estimates of the prevalence of depression were calculated with a random effects meta-analysis (stratified by antepartum and postpartum periods). Results: Eleven studies (3172 participants) were included with nine suitable for meta-analysis. The overall summary estimate of prevalence of depression among women with PPGP was 24% (95% confidence interval [CI] = 15%-37%), with significant heterogeneity between studies (I 2 = 97%, p < 0.01). Among individual studies, the estimates ranged from 18% to 48% in the antepartum PGP population and from 5% to 39% in the postpartum PGP population. The summary estimate in the antepartum group was 37% (95% CI = 19%-59%; prediction interval 8%-81%) and 15% (95% CI = 7%-30%; prediction interval 3%-56%) in the postpartum group, although time (antepartum vs. postpartum) did not have a statistically significant moderating effect (p = 0.06). Two thirds of the studies were undertaken with Scandinavian populations, limiting the generalizability of these findings. Conclusion: Summary estimates for the prevalence of depression in women with PPGP are similar to previous studies investigating depression in the general peri-natal population.

PEER CONNECT: a pragmatic feasibility randomised controlled trial of peer coaching for adults with long-term conditions.

OBJECTIVE: To test the feasibility of a targeted peer coaching intervention on the health and well-being of people with long-term health conditions and low activation attending outpatient clinics at a UK National Health Service (NHS) Trust. DESIGN: Randomised controlled feasibility trial, with embedded qualitative study. SETTING: An NHS integrated health and care organisation in the South West of England, UK, with significant areas of deprivation. PARTICIPANTS: Patients (over 18 year of age) of the Trust's rheumatology, pain or multiple sclerosis services, with a Patient Activation Measure score at level 1 or 2. INTERVENTION: Up to 14 sessions of peer coaching delivered in a stepped-down model delivered over 6 months. MAIN OUTCOMES: Primary feasibility outcomes were recruitment, retention, intervention adherence and peer, coach and staff experience.Secondary outcomes included psychological well-being, resource use, long-term condition management and disease-specific measures. RESULTS: 97 potential coaches were contacted directly. 27 (27.8%) were screened and of those 21 (77.8%) were eligible and recruited into the study. For a range of reasons, only five (23.8%) progressed through training and on to deliver peer coaching. 747 potential peers were invited to take part and 19 (2.5%) were screened. Of those screened, seven (36.8%) were eligible, recruited and randomised, all white females with median age of 50 years (range: 24-82 years). One peer in the intervention group withdrew prior to receiving the intervention, the remaining four received coaching. Peers and coaches reported a range of benefits related to their health and well-being. CONCLUSION: Coach recruitment, training and study procedures were feasible and acceptable. Due to low peer recruitment numbers, it was decided not to progress to a definitive trial. Further research is required to explore how to engage with and recruit people reporting low levels of activation and the acceptability and effectiveness of peer coaching for this group. TRIAL REGISTRATION NUMBER: ISRCTN12623577.

Evidence of early beta-cell deficiency among children who show impaired fasting glucose: 10-yr cohort study (EarlyBird 56).

OBJECTIVE: Impaired fasting glucose (IFG) is a predictor of future diabetes and is increasingly common in children, but the extent to which it results from excess insulin demand or failure of supply is unclear. Our aim was to compare the behaviour of insulin sensitivity and beta-cell function in children who developed IFG with those whose glucose levels remained within the normal range. METHODS: We examined trends in fasting glucose, insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B) in 327 healthy children annually from 5 to 15 yr, and the parents at baseline. RESULTS: Fifty-five children showed IFG, mostly after age 11 yr. Fasting glucose rose progressively and was higher throughout in those who developed IFG compared with those who did not (p < 0.001). Beta-cell function was lower from the age of 5 yr in those who developed IFG (p = 0.006), but there was no difference in BMI (p = 0.71). A difference in insulin sensitivity was revealed on adjustment for covariates (p = 0.03). Glucose was higher (p < 0.001), beta-cell function lower (p = 0.01), and insulin sensitivity the same (p = 0.86) in the mothers of children who showed IFG, compared with those who did not. CONCLUSIONS: IFG is common in contemporary children, and appears to be related to a defect in beta-cell function already present at 5 yr. Similar findings in the mothers of IFG children suggest that the beta-cell defect may be transmissible.

Echocardiography parameters used in identifying right ventricle dysfunction in preterm infants with early bronchopulmonary dysplasia: A scoping review.

Background: Bronchopulmonary Dysplasia (BPD) is a chronic condition that affects preterm infants and is associated with long-term complications. Haemodynamic effects of BPD can lead to right ventricular (RV) dysfunction. Objective: To synthesise and map the evidence of echo parameters used in identifying RV dysfunction in the first two weeks-after-birth (WAB) of preterm infants with early BPD. Information Sources: This scoping review included the databases: Medline, CINAHL, PubMed, EMBASE, Scopus, ProQuest, Web of Science, Cochrane Library, JBI Evidence-Based Practise and Gray Literature. Search Strategy: The search utilised Boolean operators and descriptors registered in Medical Subject Headings. Inclusion and exclusion criteria: Included were studies utilising echo parameters to examine RV function in preterm infants with early BPD in the first two WAB. Synthesis of results: The results are presented as a map of the extracted findings in a tabular format with a narrative summary. Results: Eight studies were included. Differences were observed in the number and timing of echo scans performed in the first two WAB and the variations in the echo parameters used to compare preterm infants with and without early BPD. Only echo scans performed at the end of the first WAB, demonstrated significant differences in the echo parameters measurements between preterm infants with and without BPD. Studies using RV Myocardial Performance Index (MPI) to identify RV-dysfunction associated with early BPD demonstrated similar findings. The Pulsed-Wave Doppler technique identified differences in RV-MPI between preterm infants with and without BPD, while Tissue-Doppler-Imaging did not demonstrate similar results. Speckle tracking can measure strain (S) and strain rate (SR) and diagnose RV-dysfunction. However, the findings of studies that utilised speckle tracking varied. Finally, two of the included studies added blood tests to their diagnostic model of early BPD, which was able to demonstrate significant differences in blood test results between BPD-affected and control preterm infants. Conclusion: BPD could adversely affect the myocardium function of the RV; these negative influences can be captured in the first two WAB. However, there are still knowledge gaps regarding the appropriate number, timing and the most suitable echo parameters to assess RV function.

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study.

BACKGROUND: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimising plantar foot pressure reduction in people with diabetes has been developed. AIM: To explore the feasibility and acceptability of testing an optimised insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy. METHODS: A double-blinded multi-centre feasibility RCT with an embedded qualitative study. Participants were randomised to either an optimised insole group (intervention) or a standard cushioned insole group (active control). Participants were assessed at baseline, 3, 6, and 12 months with clinical outcomes of foot ulceration and mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analysed using descriptive statistics (quantitative data) and thematic analysis (qualitative data). RESULTS: Screened were142 patients from which 61 were recruited; 30 participants were randomised to the intervention group and 31 to the active control group. Forty-two participants completed the study. At 12 months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. There were 17 incidences of foot ulceration occurring in 7/31 of the active control group and 10/30 in the intervention group. Mean difference in MPPP between the intervention and active control groups for all regions-of-interest combined favoured the intervention. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. CONCLUSION: The results of the feasibility RCT suggest that the optimised insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN16011830 . Registered 9th October 2017.

Enhanced analysis of somatosensory evoked potentials at 20-30 milliseconds can predict neurological outcome after cardiac arrest.

OBJECTIVE: This study attempted to test the effectiveness of an enhanced analysis of the 20-30 ms complex of somatosensory evoked potentials, in predicting the short-term outcome of comatose survivors of out of hospital cardiac arrest and compare it with the current clinical practice. METHODS: Single-centre, prospective, observational study. Median nerve SSEP recording performed at 24-36 h post-return of spontaneous circulation. Recording was analysed using amplitude measurements of P25/30 and Peak-To-Trough of 20-30 ms complex and thresholds to decide P25/30 presence. Neurological outcome was dichotomised into favourable and unfavourable. RESULTS: 89 participants were analysed. 43.8% had favourable and 56.2% unfavourable outcome. The sensitivity, specificity, positive and negative predictive values of the present SSEP and favourable outcome were calculated. P25/30 presence and size of PTT improved positive predictive value and specificity, while maintained similar negative predictive value and sensitivity, compared to the current practice. Inter-interpreter agreement was also improved. CONCLUSIONS: Enhanced analysis of the SSEP at 20-30 ms complex could improve the short-term prognostic accuracy for short-term neurological outcome in comatose survivors of cardiac arrest. SIGNIFICANCE: Peak-To-Trough analysis of the 20-30 ms SSEP waveform appears to be the best predictor of neurological outcome following out of hospital cardiac arrest. It is also the easiest and most reliable to analyse.

Exploring right ventricular function applicability in a prediction model to identify preterm infants with early bronchopulmonary dysplasia (REPORT-BPD study): a mixed-methods observational cohort feasibility study protocol.

BACKGROUND: Bronchopulmonary dysplasia (BPD) is a chronic disease that affects the immature lungs of preterm infants. Infants born before 32 weeks of gestation are at a greater risk of developing BPD due to the need for respiratory support with higher oxygen requirement. Pulmonary vascular remodelling in early BPD can impose an additional burden on the right ventricle (RV) and RV dysfunction. This protocol outlines the study design and aims to formulate a prediction model to identify early BPD through the data generated from echo scans analysis. METHODS: The mixed-methods observational cohort feasibility study, which comprises three work-packages (WPs), will be conducted at the regional neonatal unit, University Hospital Plymouth, Plymouth, UK. WP-I will recruit 40 preterm infants; each participant will have two heart scans performed in the first ten days after birth (DABs). WP-II will collect the documentation of the participating preterm infants' parents in the study neonatal unit diaries in the first 10 DABs. WP-III will involve semi-structured interviews of 10-15 parents of participating preterm infants and 10-15 health professionals who participated in WP-I. The study recruitment will be conducted over 18-months. The start date is 01 June 2022. WP-I and WP-II recruitment will occur during this period, while WP-III recruitment will occur during the second half. The results are expected to be submitted for publication by mid-2024. DISCUSSION: This paper outlines the study design. If the study successfully identifies the most sensitive echo parameter in recognising the RV dysfunction associated with early BPD, it will be an important finding in constructing an early BPD prediction model. TRIAL REGISTRATION: ClinicalTrials.gov Identifier is NCT05235399.

Protocol for a pragmatic feasibility randomised controlled trial of peer coaching for adults with long-term conditions: PEER CONNECT.

INTRODUCTION: Patients with low levels of knowledge, skills and confidence to manage their health and well-being (activation) are more likely to have unmet health needs, delay seeking healthcare and need emergency care. National Health Service England estimates that this may be applicable to 25%-40% of patients with long-term health conditions. Volunteer peer coaching may support people to increase their level of activation. This form of intervention may be particularly effective for people with low levels of activation. METHODS AND ANALYSIS: This single site, two-arm randomised controlled trial has been designed to assess the feasibility of conducting a definitive trial of volunteer peer health and well-being coaching for people with long-term health conditions (multiple sclerosis, rheumatic diseases or chronic pain) and low activation. Feasibility outcomes include recruitment and retention rates, and intervention adherence. We will measure patient activation, mental health and well-being as potential outcomes for a definitive trial. These outcomes will be summarised descriptively for each time point by allocated group and help to inform sample size calculation for the definitive trial. Criteria for progression to a full trial will be used. ETHICS AND DISSEMINATION: Ethical approval has been granted by the London - Surrey Research Ethics Committee, reference 21/LO/0715. Results from this feasibility trial will be shared directly with participants, presented at local, regional and national conferences and published in an open-access journal. TRIAL REGISTRATION NUMBER: ISRCTN12623577.

A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol.

BACKGROUND: Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. METHODS: This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. DISCUSSION: This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. TRIAL REGISTRATION: ISRCTN number 22088800.