Management and outcomes for older women with early breast cancer treated with primary endocrine therapy (PET).

BACKGROUND: This study reports the detailed management and outcomes of women treated with Primary Endocrine Therapy (PET) in a large prospective UK cohort of older women (≥70) with breast cancer. METHODS: This was an unplanned secondary analysis of a prospective, multicentre, observational study (The Age Gap study). Data were collected at baseline and regular intervals on patient, tumour and treatment characteristics with tumour RECIST response category recorded. Direct study follow-up was 24 months with longer-term survival data obtained from the UK cancer registry. RESULTS: The Age Gap study recruited 3316 women across 56 breast units. Primary endocrine therapy (PET) was initiated for 505/3316 (15 %) women; median age was 84 (IQR 79-88) with median follow-up 41.9 months (IQR 27-60). Death occurred in 205/505(40.6 %) patients, 160/205; 78 % non- Breast Cancer related, 45/205; 21.9 % Breast Cancer related. Multivariate analysis identified older age (HR-1.055(95 % Confidence Interval: 1.029-1.084); P < 0.001) and higher Charlson Index (HR-1.166 (1.086-1.252); P < 0.001) as risk factors for all-cause mortality, but conversion to surgery (HR-0.372(0.152-0.914); P = 0.031) was protective. Grade 3 cancer (G1 vs G3 HR-0.28 (0.094-0.829); P = 0.022 & G2 vs G3 HR-0.469 (0.226-0.973); P = 0.042), axillary positivity (axilla positivity HR-2.548 (1.321-4.816); P = 0.005) and change of endocrine therapy (HR-3.010 (1.532-5.913); P = 0.001) were associated with worse breast cancer specific survival (BCSS). RECIST category was not significantly associated with either overall survival or BCSS (P > 0.05). CONCLUSION: Early disease response and change of endocrine therapy are not significantly associated with overall survival, conversion to surgery is linked to improved outcome. Prognosis is largely determined by age and comorbidity in older women treated with PET.

The Risk Factors Associated with the Prevalence of Multimorbidity of Anaemia, Malaria, and Malnutrition among Children Aged 6-59 Months in Nigeria.

In the last ten years, multimorbidity in children under the age of five years has become an emerging health issue in developing countries. The study of multimorbidity of anaemia, malaria, and malnutrition (MAMM) among children in Nigeria has not received significant attention. This study aims to investigate what risk factors are associated with the prevalence of multimorbidity among children aged 6 to 59 months in Nigeria. This study used two nationally representative cross-sectional surveys, the 2018 Nigeria Demographic and Health Survey and the 2018 National Human Development Report. A series of multilevel mixed-effect ordered logistic regression models were used to investigate the associations between child/parent/household variables (at level 1), community-related variables (at level 2) and area-related variables (at level 3), and the multimorbidity outcome (no disease, one disease only, two or more diseases). The results show that 48.3% (4917/10,184) of the sample of children aged 6-59 months display two or more of the disease outcomes. Being a female child, the maternal parent having completed higher education, the mother being anaemic, the household wealth quintile being in the richest category, the proportion of community wealth status being high, the region being in the south, and place of residence being rural were among the significant predictors of MAMM (p < 0.05). The prevalence of MAMM found in this study is unacceptably high. If suitable actions are not urgently taken, Nigeria's ability to actualise SDG-3 will be in grave danger. Therefore, suitable policies are necessary to pave the way for the creation/development of integrated care models to ameliorate this problem.

The Intersection of a Child's Demographics and Household Socioeconomic Status in the Multimorbidity of Malaria, Anaemia, and Malnutrition among Children Aged 6-59 Months in Nigeria.

Multimorbidity of malaria, anemia, and malnutrition (MAMM) is a condition in which an individual has two or more of these health conditions, and is becoming an emergent public health concern in sub-Saharan African countries. The independent associations of a child's demographic variables and household socioeconomic (HSE) disparities with a child's health outcomes have been established in the literature. However, the effects of the intersection of these factors on MAMM, while accounting for other covariates, have not been studied. Therefore, this study aimed to determine how children's sex, age, and household socioeconomic status interact to explain the variations in MAMM among children aged 6-59 months in Nigeria. Data from the 2018 Nigeria Demographic and Health Survey and the 2018 National Human Development Report (NHDR) were used. This study included weighted samples of 10,184 children aged 6-59 months in Nigeria. A three-level multilevel mixed effect ordinal logistic regression model was used, such that individual characteristics at level 1 were nested in communities at level 2 and nested in states at level 3. Subsequently, predictive probability charts and average adjusted probability tables were used to interpret the intersectional effects. Five models were created in this scenario. Model 1 is the interaction between the child's sex and household wealth status; model 2 is the interaction between the child's sex and age; model 3 is the interaction between the child's age and household wealth status; model 4 has the three two-way interactions of the child's sex, age, and household wealth status; and model 5 includes model 4 and the three-way interactions between a child's sex, age, and household wealth quintiles; while accounting for other covariates in each of the models. The prevalence of children with a 'none of the three diseases' outcome was 17.3% (1767/10,184), while 34.4% (3499/10,184) had 'only one of the diseases', and 48.3% (4918/10,184) had 'two or more' MAMMs. However, in the multivariate analyses, model 3 was the best fit compared with other models, so the two-way interaction effects of a child's age and household wealth status are significant predictors in the model. Children aged 36-47 months living in the poorest households had a probability of 0.11, 0.18, and 0.32 of existing with MAMM above the probability of children of the same age who live in the middle class, more prosperous, and richest households, respectively, while all other covariates were held constant. Thus, the variation in the prevalence of MAMM in children of different ages differs depending on the household wealth quintile. In other words, in older children, the variations in MAMM become more evident between the richer and the poorer household quintiles. Therefore, it is recommended that policies that are geared toward economic redistribution will help bridge the disparities observed in the prevalence of multiple diseases among children aged 6-59 months in Nigeria.

The effects of spatially-constrained treatment regions upon a model of wombat mange.

The use of therapeutic agents is a critical option to manage wildlife disease, but their implementation is usually spatially constrained. We seek to expand knowledge around the effectiveness of management of environmentally-transmitted Sarcoptes scabiei on a host population, by studying the effect of a spatially constrained treatment regime on disease dynamics in the bare-nosed wombat Vombatus ursinus. A host population of wombats is modelled using a system of non-linear partial differential equations, a spatially-varying treatment regime is applied to this population and the dynamics are studied over a period of several years. Treatment could result in mite decrease within the treatment region, extending to a lesser degree outside, with significant increases in wombat population. However, the benefits of targeted treatment regions within an environment are shown to be dependent on conditions at the start (endemic vs. disease free), as well as on the locations of these special regions (centre of the wombat population or against a geographical boundary). This research demonstrates the importance of understanding the state of the environment and populations before treatment commences, the effects of re-treatment schedules within the treatment region, and the transient large-scale changes in mite numbers that can be brought about by sudden changes to the environment. It also demonstrates that, with good knowledge of the host-pathogen dynamics and the spatial terrain, it is possible to achieve substantial reduction in mite numbers within the target region, with increases in wombat numbers throughout the environment.

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

BACKGROUND: Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap. METHODS: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness. DISCUSSION: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes. TRIAL REGISTRATION: ISRCTN: 10236011.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial.

INTRODUCTION: Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, 'Multiple Sclerosis International Stem Cell Transplant, MIST', showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS. METHODS AND ANALYSIS: StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve 'no evidence of disease activity' during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs. ETHICS AND DISSEMINATION: The study was approved by the Yorkshire and Humber-Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN88667898.

Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial.

BACKGROUND: Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less active than those without and face unique barriers to being physically active. Physical activity interventions for those with SMI demonstrate promise, however, there are important questions remaining about the potential feasibility and acceptability of a physical activity intervention embedded within existing NHS pathways. METHOD: This is a two-arm multi-site randomised controlled feasibility trial, assessing the feasibility and acceptability of a co-produced physical activity intervention for a full-scale trial across geographically dispersed NHS mental health trusts in England. Participants will be randomly allocated via block, 1:1 randomisation, into either the intervention arm or the usual care arm. The usual care arm will continue to receive usual care throughout the trial, whilst the intervention arm will receive usual care plus the offer of a weekly, 18-week, physical activity intervention comprising walking and indoor activity sessions and community taster sessions. Another main component of the intervention includes one-to-one support. The primary outcome is to investigate the feasibility and acceptability of the intervention and to scale it up to a full-scale trial, using a short proforma provided to all intervention participants at follow-up, qualitative interviews with approximately 15 intervention participants and 5 interventions delivery staff, and data on intervention uptake, attendance, and attrition. Usual care data will also include recruitment and follow-up retention. Secondary outcome measures include physical activity and sedentary behaviours, body mass index, depression, anxiety, health-related quality of life, healthcare resource use, and adverse events. Outcome measures will be taken at baseline, three, and six-months post randomisation. DISCUSSION: This study will determine if the physical activity intervention is feasible and acceptable to both participants receiving the intervention and NHS staff who deliver it. Results will inform the design of a larger randomised controlled trial assessing the clinical and cost effectiveness of the intervention. TRIAL REGISTRATION: ISRCTN: ISRCTN83877229. Registered on 09.09.2022.

Time trends and geographical variation in major lower limb amputation related to peripheral arterial disease in England.

BACKGROUND: Above and below knee amputation (AKA, BKA) are treatments of last resort for peripheral arterial disease (PAD). The aim was to examine amputation rates, AKA:BKA ratios, previous revascularization and minor amputation, lengths of stay in hospital, mortality following amputation, and regional variation in people with and without diabetes in England. METHODS: The study used population-based ecological and cohort study designs, 31 672 census areas, hospital admissions from 2006 to 2018 and Poisson, logistic and Cox regression. RESULTS: There were 47 249 major lower limb amputations (50.7% AKA; 48% had diabetes), giving an annual PAD-related amputation rate of 11 per 100 000 in the population aged 25+ years. Amputation rates were higher in men and substantially higher in people with diabetes. The AKA:BKA ratio was 0.63 in patients with diabetes (n = 22 702) and 1.62 in patients without diabetes (n = 24 547). Of patients having AKA, 25.3% died within 90 days of amputation compared with 11.9% for BKA. Median survival following amputation ranged from only 1.68 years following AKA in patients with diabetes to 5.72 years following BKA in patients without diabetes. Amputation rates decreased over time mainly in the population with diabetes. Short-term mortality and lengths of stay in hospital also decreased over time, while the percentage with previous revascularization generally increased. Amputation rates and AKA:BKA ratios were highest in the North. Adjustment for age, sex and deprivation did not substantially alter geographical patterns. Adjusted 90-day mortality was generally higher in the North and the Midlands but also high in London. There were also regional variations in adjusted duration from admission to amputation, duration from amputation to discharge or death in hospital, previous revascularization and previous minor amputation. CONCLUSIONS: There were large variations in amputation rates and survival following amputation in relation to diabetes status and amputation level, and regional variations which remained after adjustment for deprivation.

Socio-economic, demographic, and contextual predictors of malnutrition among children aged 6-59 months in Nigeria.

Malnutrition has remained a global public health issue, particularly in low- and middle-income countries (LMICs). Researchers have committed to studying malnutrition (especially in children under the age of five) to address the nine malnutrition targets, set by the WHO to be achieved by 2025. This study seeks to evaluate the prevalence, the individual and contextual predictors of malnutrition among children aged 6-59 months across Nigeria and its states. Two separates, independently collected, nationally representative cross-sectional surveys, the National Human Development Report (NHDR 2018) and the 2018 Nigeria Demographic and Health Survey (2018 NDHS) were linked for this study. Spatial map was used to describe the prevalence of malnutrition, a 3-level multivariate multilevel logistic regression models were fitted where children/individuals (at level 1) were nested in communities/clusters (at level 2) and nested in states (at level 3). A weighted sample of 7,770 children 6-59 months were considered in this study. The results showed that an estimated 43.6% of children aged 6-59 months are poorly nourished in Nigeria. The proportions of poorly nourished children were generally highest in the Northern Nigeria. Child's gender, age, birth size, preceding birth order, anaemia status, maternal education, work status, body weight, household wealth status, number of bedrooms were among individual/household predictors of malnutrition. On the community level, being from community with high wealth index, distance to nearest health facilities is no big problem. Regional variations and gender inequality index were the state level predictors of malnutrition among children in Nigeria. This study has shown that two-third of children aged 6-59 months in Nigeria were poorly nourished, an indication of a growing concern of double burden of malnutrition in Nigeria.

Analysing cluster randomised controlled trials using GLMM, GEE1, GEE2, and QIF: results from four case studies.

BACKGROUND: Using four case studies, we aim to provide practical guidance and recommendations for the analysis of cluster randomised controlled trials. METHODS: Four modelling approaches (Generalized Linear Mixed Models with parameters estimated by maximum likelihood/restricted maximum likelihood; Generalized Linear Models with parameters estimated by Generalized Estimating Equations (1st order or second order) and Quadratic Inference Function, for analysing correlated individual participant level outcomes in cluster randomised controlled trials were identified after we reviewed the literature. We systematically searched the online bibliography databases of MEDLINE, EMBASE, PsycINFO (via OVID), CINAHL (via EBSCO), and SCOPUS. We identified the above-mentioned four statistical analytical approaches and applied them to four case studies of cluster randomised controlled trials with the number of clusters ranging from 10 to 100, and individual participants ranging from 748 to 9,207. Results were obtained for both continuous and binary outcomes using R and SAS statistical packages. RESULTS: The intracluster correlation coefficient (ICC) estimates for the case studies were less than 0.05 and are consistent with the observed ICC values commonly reported in primary care and community-based cluster randomised controlled trials. In most cases, the four methods produced similar results. However, in a few analyses, quadratic inference function produced different results compared to the generalized linear mixed model, first-order generalized estimating equations, and second-order generalized estimating equations, especially in trials with small to moderate numbers of clusters. CONCLUSION: This paper demonstrates the analysis of cluster randomised controlled trials with four modelling approaches. The results obtained were similar in most cases, however, for trials with few clusters we do recommend that the quadratic inference function should be used with caution, and where possible a small sample correction should be used. The generalisability of our results is limited to studies with similar features to our case studies, for example, studies with a similar-sized ICC. It is important to conduct simulation studies to comprehensively evaluate the performance of the four modelling approaches.

The measurement of fatigue in clinicians within hospital settings: A systematic review of measurement properties.

Medical staff fatigue leads to accidents and mistakes and puts patient safety at risk. A measure of fatigue in the workplace may help to quantify, predict, and manage fatigue. This review aimed to evaluate instruments used to measure fatigue in medical staff within hospitals. A systematic review following the JBI methodology was undertaken. A search for articles was conducted in 2021. Included articles (all validation studies) were assessed for methodological quality using the COSMIN checklist. Measurement property data was evaluated for Quality of Evidence using GRADE methodology. Ten studies representing five instruments were reviewed: Occupational Fatigue Exertion and Recovery scale (now superseded); Occupational Fatigue Exertion and Recovery scale (15-item); Multidimensional Fatigue Inventory; Need for Recovery Scale; and the Swedish Occupational Fatigue Inventory. Four instruments show promise for measuring fatigue in hospital medical staff, however, there is limited certainty in the measure property estimates. The Quality of Evidence for measurement properties for all instruments is insufficient. Further validation studies following the COSMIN standards are needed before recommendations for use can be made.

Bracing Adolescent Idiopathic Scoliosis (BASIS) study - night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial.

Aims: Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of 'full-time bracing' versus 'night-time bracing' in adolescent idiopathic scoliosis (AIS). Methods: UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion: The primary outcome is 'treatment failure' (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or 'treatment success' (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry.

Outcomes of complex oncoplastic breast surgery in older women. Analysis of data from the Age Gap cohort study.

KEY WORDS: Breast cancer, mastectomy, breast conserving surgery, post-mastectomy reconstruction, older women, quality of life.

Socioeconomic disparities in surgery for carotid artery disease in England.

BACKGROUND: Carotid artery disease and stroke are more prevalent in socioeconomically deprived areas. The aim was to investigate socioeconomic disparities in carotid artery disease surgery rates and in outcomes following surgery. METHODS: The study used population-based ecological and cohort study designs, 31 672 census areas in England, hospital admissions from April 2006 to March 2018, the Index of Multiple Deprivation 2010 as the area-level deprivation indicator, and Poisson, logistic, and Cox regression. RESULTS: A total of 54 377 patients (67 per cent men) from a population aged 55 years and older of 14.7 million had carotid artery disease procedures (95 per cent carotid endarterectomy). Carotid endarterectomy rates were 116 per cent (95% c.i. 101 to 132) higher in men and 180 per cent (95% c.i. 155 to 207) higher in women aged 55-64 years in the most compared with the least socioeconomically deprived areas by quintile. However, this difference diminished and appeared to reverse with increasing age, with 24 per cent (95% c.i. 14 to 33) and 12 per cent (95% c.i. -3 to 24) lower carotid endarterectomy rates respectively in men and women aged 85 years and older in the most deprived areas. Patients in deprived areas having carotid endarterectomy were more likely to have been admitted as symptomatic emergency carotid artery disease admissions. Mortality, and a combined outcome of mortality or stroke-related re-admission, were both worse in patients living in more deprived areas and were only partially accounted for by the higher prevalence of co-morbidities. There was, however, no clear pattern of association between deprivation and elective waiting time for carotid endarterectomy. CONCLUSIONS: These results provide evidence of socioeconomic disparities in surgery for carotid artery disease. Clear policies are needed to address these disparities.

A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints.

BACKGROUND: Adaptive clinical trials may use conditional power (CP) to make decisions at interim analyses, requiring assumptions about the treatment effect for remaining patients. It is critical that these assumptions are understood by those using CP in decision-making, as well as timings of these decisions. METHODS: Data for 21 outcomes from 14 published clinical trials were made available for re-analysis. CP curves for accruing outcome information were calculated using and compared with a pre-specified objective criteria for original and transformed versions of the trial data using four future treatment effect assumptions: (i) observed current trend, (ii) hypothesised effect, (iii) 80% optimistic confidence limit, (iv) 90% optimistic confidence limit. RESULTS: The hypothesised effect assumption met objective criteria when the true effect was close to that planned, but not when smaller than planned. The opposite was seen using the current trend assumption. Optimistic confidence limit assumptions appeared to offer a compromise between the two, performing well against objective criteria when the end observed effect was as planned or smaller. CONCLUSION: The current trend assumption could be the preferable assumption when there is a wish to stop early for futility. Interim analyses could be undertaken as early as 30% of patients have data available. Optimistic confidence limit assumptions should be considered when using CP to make trial decisions, although later interim timings should be considered where logistically feasible.

Physical Activity in Adults with Schizophrenia and Bipolar Disorder: A Large Cross-Sectional Survey Exploring Patterns, Preferences, Barriers, and Motivating Factors.

Adults with severe mental ill health may have specific attitudes toward physical activity. To inform intervention development, we conducted a survey to assess the physical activity patterns, preferences, barriers, and motivations of adults with severe mental ill health living in the community. Data were summarised using descriptive statistics, and logistic regressions were used to explore relationships between physical activity status and participant characteristics. Five-hundred and twenty-nine participants (58% male, mean age 49.3 years) completed the survey. Large numbers were insufficiently active and excessively sedentary. Self-reported levels of physical activity below that recommended in national guidelines were associated with professional inactivity, consumption of fewer than five portions of fruit and vegetables per day, older age, and poor mental health. Participants indicated a preference for low-intensity activities and physical activity that they can do on their own, at their own time and pace, and close to home. The most commonly endorsed source of support was social support from family and friends. Common motivations included improving mental health, physical fitness, and energy levels. However, poor mental and physical health and being too tired were also common barriers. These findings can inform the development of physical activity interventions for this group of people.

Risk Factors Associated with Multimorbidity among Children Aged Under-Five Years in Sub-Saharan African Countries: A Scoping Review.

BACKGROUND/PURPOSE: Globally, the prevalence of multimorbidity (defined as the cooccurrence of two or more diseases in an individual without reference to an index disease) is greater than 33%. Consequently, childhood multimorbidity, a growing public health concern in Low- and Middle-Income-Countries (LMICs), frequently has an impact on children's health. Therefore, the aim of this scoping review was to locate and describe studies that investigate the association between socioeconomic, demographic, and environmental factors and the prevalence of multimorbidity among children aged under five years in Sub-Saharan Africa (SSA). METHODS/DESIGN: We searched MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Scopus, and Web of Science for papers written in English, and published between January 1990 and March 2022. The search included papers that focused on children aged under five years with multimorbidity from Sub-Saharan Africa and used classical regression methods in their analysis. RESULTS: A total of 261 articles were identified. Out of the 66 articles selected for full-text reading, 60 were removed for various reasons. Therefore, data from a sample of six articles were finally extracted and reported in this study. The sample size for the 6 studies included ranged from 2343 to 193,065 children under five years of age. There were six distinct disease conditions (Pneumonia, diarrhoea, malaria, being overweight, stunting, and anaemia) analysed in the included studies. One of the studies had three concurrent diseases, while the other five studies had two current diseases as their multimorbidity outcome of interest. The prevalence of multimorbidity in these six studies ranged from 1.2% to 24.8%. CONCLUSIONS: The relatively few studies found in this research area is an indication of an evidence deficit/knowledge gap yearning to be filled to help policymakers in coming up with integrated multimorbidity care for children in SSA.

Individual, household and area predictors of anaemia among children aged 6-59 months in Nigeria.

Objectives: This study aims to determine the prevalence of anaemia among children aged 6-59 months in all states of Nigeria, including the Federal Capital Territory (FCT), and to quantify the predicted probabilities by individual, household and area factors. Study design: This study is a secondary analysis of data sets from two national representative cross-sectional surveys in Nigeria: the Nigeria Demographic and Health Survey (2018 NDHS) and the National Human Development Index (2018 NHDR). The state human development index (HDI) and the state multidimensional poverty index (MPI) from the 2018 NHDR were incorporated into the 2018 NDHS. Methods: The study included a weighted sample of 10,222 children aged 6-59 months. Both univariate and bivariate analyses were computed to determine the prevalence and factors associated with anaemia status, respectively. Multiple binary logistic regression analyses with adjusted predicted probabilities (APPs) were performed to quantify the predictors' probabilities. Results: The prevalence of anaemia among children aged 6-59 months in Nigeria was 68.1% (6962/10,222). Zamfara state had the highest prevalence (84.0% [266/317]), while Kaduna state recorded the lowest (50.0% [283/572]). The APPs of being anaemic decreased from 82.9% (95% confidence interval [CI]: 80.0-85.8) for children aged 6-18 months to 60.6% (95% CI: 56.8-64.4) for children aged 43-59 months, when other predictors were held constant. The APP for a child of an anaemic mother is 10.2% points higher than the APP for a child whose mother is not anaemic. In addition, the APPs for children decreased as the age group of their mothers increased. A child from a state that is mildly deprived in the MPI has a lower APP (67.2% [95% CI: 62.2-72.2]) compared with a child from highly deprived MPI state (79.0% [95% CI: 73.4-84.5]). Conclusions: Health strategies, including supplementation programmes, should be carried out at both ante-natal and post-natal clinics to reduce the prevalence of anaemia, especially in vulnerable population groups.

The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial.

BACKGROUND: There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. METHODS: We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia (Mini-Mental State Examination score of ≥18) who lived in the community were eligible for inclusion. Patients were centrally randomly assigned (1:1) to receive the JtD intervention plus standard care (JtD group) or standard care only (standard care group). Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL) 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year (QALY) from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825. FINDINGS: Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 (41%) participants were randomly assigned: 241 (50%) to the JtD group and 239 (50%) to the standard care group. Intervention adherence was very good: 165 (68%) of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 (SD 13·0) for the JtD group and 91·9 (SD 14·6) for the control group. Difference in means was 0·9 (95% CI -1·2 to 3·0; p=0·38) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to -£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 (17%) patients in the JtD group and 35 (15%) patients in the standard care group. INTERPRETATION: In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale. FUNDING: UK National Institute of Health Research Health Technology Assessment Programme.

Symptom burden according to dialysis day of the week in three times a week haemodialysis patients.

BACKGROUND: Haemodialysis patients experience significant symptom burden and effects on health-related quality of life. Studies have shown increases in fluid overload, hospitalization and mortality immediately after the long interdialytic interval in thrice weekly in-centre haemodialysis patients, however the relationship between the dialytic interval and patient reported outcome measures (PROMs) has not been quantified and the extent to which dialysis day of PROM completion needs to be standardised is unknown. METHODS: Three times a week haemodialysis patients participating in a stepped wedge trial to increase patient participation in haemodialysis tasks completed PROMs (POS-S Renal symptom score and EQ-5D-5L) at recruitment, six, 12 and 18 months. Time from the long interdialytic interval, HD day of the week, and HD days vs non-HD days were included in mixed effects Linear Regression, estimating severity (none to overwhelming treated as 0 to 4) of 17 symptoms and EQ-5D-5L, adjusting for age, sex, time on HD, control versus intervention and Charlson Comorbidity Score. RESULTS: 517 patients completed 1659 YHS questionnaires that could be assigned HD day (510 on Mon/Tue/Sun, 549 on Wed/Thu/Tue, 308 on Fri/Sat/Thu and 269 on non-HD days). With the exception of restless legs and skin changes, there was no statistically significant change in symptom severity or EQ-5D-5L with increasing time from the long interdialytic interval. Patients who responded on non-HD days had higher severity of poor appetite, constipation, difficulty sleeping, poor mobility and depression (approximately 0.2 severity level), and lower EQ-5D-5L (-0.06, CI -0.09 to -0.03) compared to HD days. CONCLUSIONS: Measuring symptom severity and EQ-5D-5L in haemodialysis populations does not need to account for dialysis schedule, but completion either on HD or non-HD days could introduce bias that may impact evaluation of interventions. Researchers should ensure completion of these instruments are standardized on either dialysis or non-dialysis days.