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Young people's mental health worsened during and since the coronavirus disease discovered in 2019 pandemic. School environments play a key role in young people's mental health. Learning Together for Mental Health is a whole-school intervention aiming to promote mental health in secondary schools, adapted from the previous Learning Together intervention which was found effective in reducing bullying and promoting mental health. To adapt Learning Together to increase focus on mental health so producing the Learning Together for Mental Health intervention and evaluate the appropriateness of conducting a Phase III trial of the Learning Together for Mental Health intervention regarding pre-defined progression criteria relating to the intervention and trial methods, and assessing intervention feasibility, reach and acceptability, feasibility of trial measures and procedures, potential mechanisms and possible harms. We conducted a feasibility study with baseline and follow-up surveys, process evaluation and economic-evaluation feasibility-testing. One school participated in intervention adaptation. Our feasibility study included four state, mixed-sex secondary schools in southern England (one of which dropped out after baselines and was replaced with another). We recruited 640 year-7 (age 11-12) students at baseline survey and 566 year-10 (age 14-15) students at 12-month follow-up. Baseline and follow-up participants were different groups, as the focus was assessing feasibility for the age groups to be surveyed at baseline and follow-up in a Phase III randomised controlled trial. Twenty staff, 27 year-8 (age 12-13) students and 22 year-10 students participated in qualitative research as did two trainers and one external facilitator. As part of our feasibility study, all schools received the Learning Together for Mental Health intervention for one academic school year. Pre-defined criteria for progression to a Phase III trial. The intervention was successfully adapted from the previous intervention using public involvement. The trial met all criteria for progression to Phase III. The all-staff and in-depth restorative practice training were implemented with fidelity in all schools and all schools had at least two staff trained in-depth in restorative practice. Curriculum training was delivered with fidelity in three of four schools. The response rate to the baseline (needs) survey across the three participating schools was 79%. Progression required at least two schools to have delivered the curriculum with at least 50% fidelity, which was achieved; one of the two schools which delivered the curriculum reported over 80% fidelity and the other school reported over 75% fidelity. All students and staff across all four schools who completed the action group survey and 93% of senior leadership team members who completed the senior leadership team survey reported that Learning Together for mental health was a good way to promote student Mental Health. Potential mechanisms of action involve promoting student sense of school belonging and practical reasoning and skills. No harms were reported. Trial measures and procedures were feasible and acceptable to implement. Intervention and trial refinement are suggested. Our study involved a small, purposive sample of schools and students which are not representative of those in England. With some minor amendments, Learning Together for Mental Health should be subject to a future Phase III trial of effectiveness. The intervention should be refined by making the curriculum optional and improving materials. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131594. Mental health disorders are common among young people, but there are few effective interventions provided in schools to address this that go beyond teaching about mental health in lessons. Some that do are called ‘whole-school’ interventions. They offer a practical and sustainable way of promoting mental health. We previously evaluated an intervention called ‘Learning Together’. Learning Together provided a report for schools on bullying and school experiences of students. Also, it enabled schools to form ‘action groups’, comprising students and staff who worked together to review this report and plan how the school should respond. Teachers were trained to use restorative practice to address bullying, misbehaviour or conflict. Restorative practice responds to incidents by staff facilitating meetings between those affected, identifying harms, ensuring perpetrators take responsibility and improving the relationship of those involved. Moreover, schools delivered lessons aiming to promote students’ social and emotional skills. We found that Learning Together reduced bullying and improved students’ mental health. In the present study, we adapted Learning Together to develop Learning Together Mental Health. This new intervention included a ‘menu’ of evidence-based actions for action groups to choose from to address student mental health needs. It also featured an improved social and emotional learning curriculum. This paper reports on whether the intervention and evaluation methods proved feasible and acceptable in a small study involving four secondary schools in southern England. The intervention was successfully adapted from the previous intervention. Staff training was well delivered. We had good response rates when we surveyed students before and after the intervention. Schools delivered the intervention well enough to meet the targets we set ourselves. Students and staff who were involved in intervention activities thought that it was a good way to promote mental health. With some refinements, Learning Together for Mental Health is ready to be evaluated in a larger study to assess its effectiveness.
In South Africa, men experience lower HIV care engagement and retention than women. Men who consume alcohol face greater barriers to care and may represent a population with significant unmet health needs. We investigated associations between alcohol consumption, HIV clinical outcomes, and all-cause mortality among men in rural South Africa. We analyzed data from men in a population-based health screening in KwaZulu-Natal linked to longitudinal clinical and mortality data. Our primary exposure was hazardous alcohol use, defined as an AUDIT-C score ≥4. Our primary outcomes were: living with HIV, awareness of HIV positive status, virologic suppression (<40 copies/mL), advanced HIV disease (CD4 count<200 cells/mm 3), healthcare access (clinic visit <12 months), and all-cause mortality. Poisson regression models were used for HIV outcomes and clinic follow-up; Cox proportional hazard models were used for mortality. Models were adjusted for clinical and demographic confounders. In sensitivity analyses, alcohol use was redefined as any use in the past 12 months. Among 5,771 men (median age 36.2 years, SD 18.9), 10% met criteria for hazardous alcohol use with 28% reporting any alcohol use in the past 12 months. Hazardous alcohol use was not associated with HIV prevalence (aPR 0.96 95%CI 0.83-1.12, p=0.63), awareness of HIV diagnosis (aPR 1.25, 95%CI 0.88-1.77, p=0.22), virologic suppression (aPR 0.92, 95%CI 0.82-1.03, p=0.14), or advanced HIV disease (aPR 0.71, 95%CI 0.40-1.26, p=0.24). Clinic retention was low overall (56% hazardous alcohol vs. 63% no/low-risk alcohol, p=0.092) and similar between groups in adjusted models. Over a median 3.4 years, 7.3% of men with HIV died, with no differences by hazardous alcohol use. Results were similar when considering any alcohol use as the exposure. Hazardous alcohol use among rural South Africa men was not associated with HIV prevalence, HIV clinical outcomes, retention in care, or short-term mortality. Alcohol use and hiv health outcomes among men in rural South Africa  Men in South Africa are less likely than women to engage in HIV care. Men who drink alcohol may face even greater barriers to staying healthy. This study looked at how alcohol use affects HIV status, healthcare access, and survival among men in a rural area of KwaZulu-Natal. Researchers used data from over 5,700 men who participated in a community health screening. They linked this information to long-term clinical and survival records. Hazardous alcohol use was defined as drinking patterns that could lead to health problems. The study found that hazardous drinking was common—about 10% of men met the criteria. However, hazardous alcohol use was not linked to a higher rate of HIV infection, lower rates of HIV treatment success, worse immune system health, missing clinic visits, or early death. Overall, fewer than two-thirds of men stayed connected to healthcare after screening, regardless of whether they drank alcohol. Mental health conditions like anxiety and depression, and being employed, were more strongly linked to poor health outcomes than alcohol use. These findings suggest that while alcohol use is common, it may not directly impact HIV outcomes in the era of modern treatment. Addressing broader issues, such as mental health support and easier access to care, may help improve health outcomes for men in this region.
Sibling dynamics play a crucial role in individual development, health and wellbeing. We established a national birth cohort using administrative health, education and social care data in England featuring clusters of mothers and their children (mothers and only-children, MoC; and mothers and siblings, MSib). From 13.6 million mother-baby pairs from births between April 1997 and January 2022 captured in Hospital Episode Statistics in England, we identified MoC and MSib clusters by identifying livebirths linked to the same mother. We compared only-children and children with siblings, by ethnicity, sociodemographic variables, and birth characteristics. We calculated birth intervals for children with siblings. We identified 4,086,648 MoC and 3,957,856 MSib clusters. Compared with only-children, children with siblings were more likely to be Asian, live in more deprived areas, and have younger mothers, but were less likely to be overdue births (>=42 weeks), or to have very low birth weight (<1500g). Children with siblings were also less likely to have been admitted to special neonatal care after birth compared to only-children. Among the MSib clusters, sibship sizes varied between 2 and 15, with a mean of 2.4 children per mother. The median birth interval was 3.0 years. This national cohort ECHILD-oCSib of 4.1 million MoC and 4.0 million MSib clusters in England is an important resource for investigating the effects of maternal exposures, sibling dynamics and their interplay on individual development, health and wellbeing. Potential sources of bias should be considered in analyses of these data. We derived a national cohort of 4.1 million clusters of mothers and only-children and 4.0 million clusters of mothers and siblings using administrative health, education and social care data in England.Compared with only-children, children with siblings were more likely to be Asian, live in more deprived areas, and have younger mothers, but less likely to be overdue births (>=42 weeks of gestation), or to have very low birth weight (<1500 g).Among children with siblings, sibship sizes varied between 2 and 15, with a mean of 2.4 children per mother (median = 2.0). The median birth interval was 3.0 years.The cohort is linked to longitudinal administrative data on health, education and social care use, and provides a valuable opportunity to investigate the effects of maternal factors, sibling dynamics, and their interaction on children development, health, education and wellbeing.The data can be accessed as part of ECHILD database.
Children and young people are facing increasing mental health challenges. Access to emergency mental health care for young people is under-researched and poorly understood. Police data indicates a rise in youth mental health emergency calls, but officers often feel unprepared to support young people in crisis. Mental health practitioners have the experience and training to provide helpful support to young people in crisis, although the availability of mental health services for young people can be limited during evenings and weekends, especially in rural areas. We know that children and young people can benefit when police and mental health services work together. However, we need to better understand the full range of impacts of joint responses for young people and their families and how these impacts are generated. Joint emergency response is a complex intervention, and a realist synthesis was chosen as it can make sense of such interventions. Therefore, this realist synthesis aims to develop a programme theory of the underlying generative mechanisms by which, and contexts within which, emergency responders collaborate and co-respond to support young people experiencing a mental health crisis. We will follow five steps to undertake the realist review: (1) Define the review scope, (2) develop initial programme theories, (3) conduct an evidence search, (4) select and appraise evidence, and (5) extract and synthesise data. Embase, CINAHL, Social Policy and Practice, MEDLINE, PsycINFO, and AMED databases will be searched up to June 2024, supplementing searches with citation tracking, grey literature, relevant NHS England guidance, and practitioner interpretation workshops. Data selection will be based on relevance and richness. Data will be extracted and synthesised iteratively, and causal links between contexts, mechanisms, and outcomes will be illuminated in the process. The results will be conducted and reported according to the Realist and Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) quality and publication standards. Findings will be disseminated to the research community through conference presentations and a peer-reviewed journal article. We will work with healthcare and police organisations, as well as professional and expert-by-experience stakeholder groups, including commissioners, to develop a strategy for far-reaching dissemination with impact to share findings across a range of audiences. This study will develop a programme theory regarding how emergency responders collaborate to support young people experiencing mental health crises. Findings will inform future practices, aiming to improve collaborative responses and outcomes across youth contexts. PROSPERO CRD42024542081.
Despite progress in maternal health coverage in Mexico, inequities persist, particularly in postnatal care. The COVID-19 pandemic further widened these gaps, disproportionately affecting women with similar health needs but different socioeconomic conditions. This study assesses trends in maternal healthcare coverage and inequity across nine stages of antenatal, delivery, and postnatal care, comparing pre- and post-pandemic periods. By examining horizontal inequity, we identify critical gaps and policy implications to enhance equitable maternal healthcare access. We conducted a population-based, pooled cross-sectional and retrospective analysis for the last three decades, using data from the five waves (1997, 2009, 2014, 2018, and 2023) of the Mexican National Survey of Demographic Dynamics (ENADID). Our study included 123,197 Mexican women aged 12-54 with recent live births, representing a population of 38.5 million. We estimated coverage for antenatal and postnatal care stages. We used multiple regression models to assess factors influencing the likelihood of receiving comprehensive antenatal care, skilled delivery care and postpartum care interventions, both pre-and post-COVID-19. We estimated horizontal inequity using concentration index and decomposition analysis to highlight disparities among women with similar needs and examine how these disparities have changed due to COVID-19 across nine antenatal, delivery, and postnatal care stages. Full antenatal and postnatal health care in Mexico was inadequate and inequitable. Only 73% of pregnant women received timely antenatal care and 88.3% received frequent care, despite 97.9% claiming to have received some care. Inadequate care was linked to lower education, labour market participation, low socioeconomic status, higher parity, and rural residency. The most inequitable aspects are access to skilled and institutional health care and timely post-partum care. The dismantling of a public health insurance system and focused strategies that incentivized the use of maternal health services during the pre-COVID period (January 2019 to March 2020) led to significant health coverage losses, exacerbating horizontal inequity in these areas. Although high equity was achieved in comprehensive antenatal healthcare from 2009 to 2023, since COVID, inequity has increased, particularly in antenatal indicators such as receiving four or more antenatal check-ups and check-ups in the first trimester. The pandemic intensified these inequities, and the values of these indicators have not returned to pre-pandemic levels, underscoring the seriousness of the situation. Despite efforts to improve maternal care, comprehensive antenatal services reach only 61.8% of women in Mexico. This stresses not only the need for targeted policies to enhance antenatal, delivery, and postnatal coverage at critical stages of care, but also the need to continue strengthening strategies that have rendered good results, and not to eliminate them simply for political-ideological reasons. It is imperative to prioritize reducing existing inequalities within the population, as horizontal inequity reveals significant barriers preventing equitable access to maternal health services among women with similar needs. The most pronounced disparities exist in timely healthcare access, skilled deliveries, and institutional postnatal care, where systemic issues and financial constraints are particularly impactful. Addressing these inequities is essential not only to improve overall maternal health outcomes but also to ensure that all women can benefit from the full spectrum of maternal care, particularly in situations of health crisis, such as pandemics.
The journal Health has published interdisciplinary scholarship on the social dimensions of health and illness since 1997. Despite rich thematic syntheses at milestone anniversaries, no study has systematically examined how research designs, data collection techniques, and analytic frameworks have evolved to shape the journal's empirical output. This critical scoping review maps the evolution of methodological ecosystems in the journal Health's empirical articles from 1997 to 2025, examining which research traditions have structured the journal's output, how these have changed over time, and how institutional pressures-particularly cross-sectional design bias-have shaped research temporality. A comprehensive search of the journal Health's archives identified 692 empirical articles, which were coded in MAXQDA 2024 for research design, temporal orientation, data collection methods, analytical techniques, theoretical paradigm, and reporting clarity, and then clustered using code co-occurrence networks and modularity-based community detection to identify five methodological ecosystems. Five distinct ecosystems structure the journal's research-quantitative positivism, qualitative interpretivism, ethnographic and observational inquiry, mixed-methods integration, and critical/discourse-oriented research-with cross-sectional designs dominating 78% of studies across all traditions, likely reflecting funding cycles, publication timelines, and career pressures rather than paradigmatic commitments. Over three decades, quantitative positivism declined from over half of published output in the late 1990s to under one quarter by 2025, while qualitative, ethnographic, mixed-methods, and critical approaches collectively increased from 17% to 46%, with notable inflection points including a qualitative "breakthrough" around 2012, an ethnographic resurgence after 2020, and methodological convergence across all ecosystems by 2023. The analysis theorizes these patterns as expressions of institutional cross-sectionalism, whereby structural constraints compress temporal depth even in paradigms that value process, and argues that advancing interdisciplinary health scholarship requires structural reforms in funding, publication policy, career evaluation, and methodological infrastructure to support longitudinal, immersive, and participatory inquiry.
Long-term healthcare utilisation (HCU) among mothers of infants with neonatal, invasive group B Streptococcus disease (iGBS) remains understudied; identifying these patterns could provide better support for affected families and address the iGBS public health burden. Cohort study. Population of Denmark. 1565 mothers of infants with iGBS and 44 976 matched comparators from 1997 through 2021, with follow-up until 2022, using national health and social registry data. HCU including primary, inpatient, outpatient, psychiatric and surgical care was evaluated as period prevalence ratio (PPR) and rate ratios compared across three time periods (0-6 years, 7-13 years and 14-20 years) using a modified Poisson regression model and negative binomial regression with 95% CIs. Mothers of newborns with iGBS had higher PPRs of psychiatric care contacts in the first 0-6 years and 14-20 years following iGBS compared with the comparison cohort (RR0-61.12 (95% CI 0.93 to 1.35), RR14-201.24 (95% CI 0.97 to 1.58)). Exposed mothers had similar PPRs of primary, inpatient and outpatient care use as comparators, except for a slightly higher inpatient care use 7-13 years following iGBS. Exposed mothers had higher RRs for primary, inpatient, outpatient and psychiatric care contacts than mothers in the comparison cohort. Mothers of iGBS-exposed infants had elevated psychiatric healthcare use and increased primary, and outpatient care visits compared with matched comparators, suggesting heightened healthcare needs and psychosocial burden of caregiving up to 20 years post-iGBS.
Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects. We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4. Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.
Atopic eczema may be associated with multiple health conditions. Here, we systematically explore risks across the full health spectrum based on the International Classification of Diseases, assessing associations between eczema and 2058 ICD-10 codes, 1593 phecodes, and 201 Global Burden of Disease codes. In English primary care electronic health records (1997 - 2023) we identify cohorts of people with eczema (up to 3 million) and matched (by age, sex, general practice) comparators without eczema (up to 14 million). In up to 25 years of follow-up, we capture outcomes recorded during hospital admissions. People with eczema show higher rates of several outcomes across multiple organ systems. Among those followed up from eczema diagnosis in childhood, atopic/allergic conditions and infections account for most excess diagnoses. Consistent across cohorts and analyses, large relative risk increases are seen for inflammatory bowel conditions (e.g., K50 Crohn disease, crude hazard ratio 1.70 [1.63-1.77]) and eye diseases (e.g., H16 Keratitis, crude hazard ratio 1.71 [1.57-1.86]). We provide a dashboard to explore and browse the full range of results.
To identify safety concerns reported by coroners following fentanyl patch-related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https://preventabledeathstracker.net/) to identify fentanyl patch-related deaths. Keyword searches for 'patches' were conducted, and reports were screened for eligibility in duplicate. Data were extracted and descriptively analysed, and deaths were categorized by safety events. There were 99 fentanyl patch-related deaths between 1997 and 2024, with 89 reported to NPSUM and 12 Prevention of Future Deaths reports (PFDs) from the PDT, with only two duplicates across both databases. Seventy-seven safety events were reported by coroners, with adherence and usage (34%), administration (32%) and prescribing (6%) being the most common. Compared with deaths reported to NPSUM, PFDs were more common for females (58% vs. 33%), older adults (median age: 53 vs. 45 years), occurred more in hospital (42% vs. 9%), were of accidental manner (83% vs. 22%), and were prescribed patches (100% vs. 54%). A live dashboard of PFDs was developed to continue surveillance https://preventabledeathstracker.net/case-study/fentanyl-patches/). Safety events, including poor adherence, usage and administration errors of fentanyl patches, were repeatedly identified by coroners, which mostly occurred in males aged 35-49 years. Information from coroners should be systematically monitored to inform the safety of prescribing and use of fentanyl patches, including identifying gaps in care, education and policies. https://doi.org/10.17605/OSF.IO/GMHNW.
Multimorbidity refers to the co-occurrence of multiple health conditions in a single individual. The objective of this systematic review was to synthesize and evaluate research on the prevalence of multimorbidity (including both mental and physical health conditions) for people who have experienced homelessness. MEDLINE, EMBASE, PsycINFO, Web of Science, and OpenGrey were searched for relevant studies between 1997 and 2025. Studies were included if the sample consisted of adults in high-income countries, where the exposure was current or former homelessness, and the outcome was multimorbidity including both mental and physical conditions. Random-effects meta-analyses were used to calculate pooled prevalence estimates. The studies were narratively synthesized, and quality assessed. The search retrieved 6043 papers, 30 of which were eligible for inclusion in the review. Most studies recruited participants from specialist homelessness services (n = 21). More than half of the study samples were over 75% male (N = 16). When excluding studies which applied non-probability sampling strategies, the pooled prevalence was 45% (95% CI, 25-66) for multimorbidity. There was a 34% (95% CI, 22-48) pooled prevalence for trimorbidity (co-occurring mental, physical, and substance/alcohol use conditions). High heterogeneity was observed across studies (I2 > 99%). To conclude, multimorbidity is highly prevalent for people who experience homelessness. There is a lack of research on multimorbidity for women who are or have been homeless, and for those who are not accessing specialist homelessness services. These findings demonstrate the need for the integration, collaboration, and co-ordination between services to support the multimorbid health needs of people who experience homelessness.
Globally, Down syndrome is the most common chromosomal anomaly, often co-occurring with cardiac or gastrointestinal anomalies. There is a lack of robust data on specific healthcare needs of children with Down syndrome compared to children with other major congenital anomalies. To quantify the healthcare needs of children with Down syndrome in the first year of life compared to children with major congenital anomalies in a large population-based cohort across Europe. The EUROlinkCAT study was a multicentre data linkage study between congenital anomaly registries in Europe and hospital and mortality databases. Children born between 1st January 1997 and 31st December 2014 were included. Summary statistics were used to compare differences between children (those with Down syndrome compared to all major anomalies) and regions. Random-effects meta-analysis was used to pool results related to survival, need for intensive care and ventilation support. A total of 3554 children were born with Down syndrome out of 89,081 children with major congenital anomalies. The pooled 1-year survival was 95.4%. In every region, > 80% of children with Down syndrome had a hospital admission excluding the birth admission. Hospital length of stay in the first year was higher for children with Down syndrome compared to those with all anomalies (median: 14 versus 7 days). Despite having similar need for ventilation support (9.7% vs. 8.4%), children with Down syndrome had higher rates of intensive care admission than all children with anomalies (24.8% vs. 13.0%). There is a high need for hospital care for children born with Down syndrome in the first year of life. Future work should continue to explore the long-term prognosis for children with Down syndrome to ensure their care needs are met.
Composite endpoints amalgamate multiple clinical outcomes into a single measure, offering efficiency gains in clinical trials through increased event rates and reduced sample sizes, thus accelerating clinical development and regulatory approval. However, employing composite endpoints introduces complexities into health technology assessments (HTAs), particularly in economic modeling, due to the varying clinical significance and cost implications of the components. In this paper, we explore best modeling practice for HTAs that are based on clinical trials that employ composite endpoints. We examine regulatory guidance and discuss statistical solutions for differential component impacts, before presenting a case study based on a recent dapagliflozin submission for reimbursement in heart failure. Our investigation reveals that while composite endpoints can streamline trial analyses and hasten regulatory approval, they also pose a risk of bias in HTA if treatment effects for the components are inappropriately pooled. The paper discusses HTA principles in the context of composite endpoint trials and proposes strategies to develop modeling scenarios and interpret results, especially concerning whether to combine or split out estimates of component treatment effects. A particular focus is the accurate capture of uncertainty, both in terms of the parameter inputs to the model and over the ultimate decision to reimburse. This paper serves as a potential resource for researchers, practitioners and decision-makers, offering insights into best modeling practices that can unlock the full potential of composite endpoints in the pursuit of evidence-based healthcare decision-making.
The first paper of this two-part series critically examined the role of composite endpoints in health technology assessments (HTAs) and outlined strategies for determining whether to employ the composite estimate of treatment effect or disaggregate into the component endpoints of the composite and apply separate treatment effects within a modeling framework. In this second paper, we expand the discussion beyond a pivotal trial and consider the way in which additional evidence from the same indication for different drugs in the same class, or the same drug for different indications, could be employed within HTAs. We offer a continuation of the case study of dapagliflozin for the treatment of heart failure with preserved or mildly reduced ejection fraction, where the evidence base was expanded to consider empagliflozin for the same indication, as well as both dapagliflozin and empagliflozin for heart failure with reduced ejection fraction. We conclude that, where there are multiple drugs in the same class and/or multiple indications for a class of drugs, HTAs should consider the exchangeability of the information that comes from additional evidence beyond the pivotal registration study. Further, we show how consideration of this additional evidence can support the decision concerning whether to disaggregate the components of a composite endpoint or employ the treatment effect from the composite for each endpoint.
Linkage of public law family court care proceedings (CP) data to all women giving birth in NHS hospitals in England allows calculation of the cumulative incidence of CP involvement for mothers with first children born. To assess linkage accuracy and determine the 10-year cumulative incidence of CP after a first live birth (FLB) for population subgroups. NHS England linked records for mothers in Cafcass (Children and Family Court Advisory and Support Service) involved in CP (2007-2021) to all mothers with a delivery in England using Hospital Episode Statistics (HES: 1997-21). We calculated match rates and assessed indirect evidence of potential false positive and missed links. We used survival analyses to estimate cumulative incidence of CP within 10 years overall and for five-year maternal age groups at first live birth. Of 120,937 mothers involved in CP, 6.6% (n = 8,010) were excluded due to missing postcode or date of birth, or age <15 or >50. Of the remaining 112,927 mothers, 92,891 (82.8%) were linked to a HES delivery record. Match rates were lowest for mothers with an ethnic minority background, older at first case, or residing in Greater London, but improved over time.Of 3,572,737 mothers with a FLB, 38,462 had CP involvement. The cumulative incidence of CP at 10 years from FLB was 1.31% (95% Confidence Interval [CI]; 1.29-1.32) overall and highest in mothers aged 15-19 years (6.79%, 95% CI: 6.69-6.89) and those living in the most deprived areas (2.47%, 95% CI: 2.43-2.51). One in 77 of all mothers and one in 15 aged less than 20 at first live birth were involved in CP within 10 years. Linkage error may underestimate the incidence of CP for mothers in London or with an ethnic minority background. Overall, 82.8% of women recorded as a mother in Cafcass care proceedings were linked to a hospital delivery record.Match rates were lowest for mothers with an ethnic minority background, older age at first child, or residing in Greater London.1.3% of all mothers (1 in 77) with a first birth were involved in care proceedings within 10 years and 6.8% (1 in 15) of mothers aged <20 at first live birth.
Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome-people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants' health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness. We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome. The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies. ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.
Long covid has emerged as a complex health condition for millions of people worldwide following the COVID-19 pandemic. Previously, we have categorised healthcare pathways for patients after discharge from hospital with COVID-19 across 45 UK sites. The aim of this work was to estimate the clinical and cost-effectiveness of these pathways. We examined prospectively collected data from 1013 patients at 12 months postdischarge on whether they felt fully recovered (self-report), number of newly diagnosed conditions (NDC), quality of life (EuroQoL-five dimension-five level (EQ-5D-5L) utility score compared with pre-COVID estimate) and healthcare resource costs (healthcare records). An analysis of the cost-effectiveness was performed by combining the healthcare resource cost and 1-year EQ-5D (giving a quality-adjusted life-year (QALY)) using statistical models that accounted for observed confounding. At 1 year, 29% of participants felt fully recovered, and 41% of patients had an NDC. The most comprehensive services, where all patients could potentially access assessment, rehabilitation and mental health services, were more clinically effective when compared with either no service or light touch services (mean (SE) QALY 0.789 (0.012) vs 0.725 (0.026)), with an estimated cost per QALY of £1700 (95% uncertainty interval: dominated to £24 800). Our analysis supports the need for proactive, stratified, comprehensive follow-up, particularly assessment and rehabilitation for adults after hospitalisation with COVID-19, showing these services are likely to be both clinically and cost-effective according to commonly accepted thresholds.
Midlife depression has been associated with an increased risk of dementia, but it remains unclear whether this risk is attributable to specific symptoms. We aimed to identify the midlife depressive symptoms most strongly linked to subsequent dementia and to ascertain whether these associations were independent of established dementia risk factors. In this prospective, observational cohort study based on the UK Whitehall II study, participants (aged 35-55 years at study inception [1985-88]) were eligible for analysis if they had complete depression data and successful linkage to national health records; individuals with prevalent dementia at baseline were excluded. In 1997-99, the baseline for this analysis, participants underwent a clinical examination and completed the 30-item version of the General Health Questionnaire (GHQ-30, a validated screening instrument for detecting clinically significant psychiatric distress in the general population). Threshold-level depression was defined as a GHQ-30 score of 5 or higher. The primary outcome was incident dementia, ascertained via linkage to UK National Health Service (NHS) Hospital Episode Statistics for inpatient admissions, the Mental Health Services Data Set, or the NHS Central Registry for mortality from April 24, 1997, to March 1, 2023. Analyses were conducted using a series of multivariable-adjusted Cox proportional hazards regression models. Hazard ratios (HRs) and accompanying 95% CIs were adjusted for age, sex, and ethnicity in the basic model. People with lived experience were not involved in the study design or writing process. Of 6511 participants in the Whitehall II study who completed the GHQ-30 between April 24, 1997, and Jan 8, 1999, 5811 were eligible for this analysis. The mean age of participants was 55·7 years (SD 6·0; range 45-69); 1646 (28·3%) participants were women, 4165 (71·7%) were men, 5356 (92·2%) reported their ethnicity as White, and 455 (7·8%) reported their ethnicity as non-White. During a mean follow-up of 22·6 years (SD 5·0), 586 participants (10·1%) developed dementia. Six depressive symptoms emerged as robust midlife indicators of increased dementia risk: "Losing confidence in myself" (HR 1·51, 95% CI 1·16-1·96), "Not able to face up to problems" (1·49, 1·09-2·04), "Not feeling warmth and affection for others" (1·44, 1·06-1·95), "Nervous and strung-up all the time" (1·34, 1·03-1·72), "Not satisfied with the way tasks are carried out" (1·33, 1·05-1·69), and "Difficulties concentrating" (1·29, 1·01-1·65). Associations were independent of established dementia risk factors, including APOEε4 status, cardiometabolic conditions, and lifestyle factors. In individuals younger than 60 years at baseline, the six symptoms fully accounted for the association between midlife depression and dementia risk. A distinct set of midlife depressive symptoms was associated with an increased risk of dementia, suggesting that these symptoms might be early markers of underlying neurodegenerative processes. These findings could inform earlier identification and more targeted interventions for individuals with depression who are at risk of dementia. Wellcome Trust, UK Medical Research Council, National Institute on Aging, and Research Council of Finland.
Audit and feedback (A&F) is a widely used strategy to improve professional practice. This is supported by prior Cochrane reviews and behavioural theories describing how healthcare professionals are prompted to modify their practice when given data showing that their clinical practice is inconsistent with a desirable target. Yet there remains uncertainty regarding the effects of A&F on improving healthcare practice and the characteristics of A&F that lead to a greater impact. To assess the effects of A&F on the practice of healthcare professionals and to examine factors that may explain variation in the effectiveness of A&F. With the Cochrane Effective Practice and Organisation of Care (EPOC) group information scientist, we updated our search strategy to include studies published from 2010 to June 2020. Search updates were performed on 28 February 2019 and 11 June 2020. We searched MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), the Cochrane Library, clinicaltrials.gov (all dates to June 2020), WHO ICTRP (all dates to February Week 3 2019, no information available in 2020 due to COVID-19 pandemic). An updated search and duplicate screen was completed on February 14, 2022; studies that met inclusion criteria are included in the 'Studies awaiting classification' section. Randomised trials, including cluster-trials and cross-over and factorial designs, featuring A&F (defined as measurement of clinical performance over a specified period of time (audit) and provision of the resulting data to clinicians or clinical teams (feedback)) in any trial arm that reported objectively measured health professional practice outcomes. For this updated review, we re-extracted data for each study arm, including theory-informed variables regarding how the A&F was conducted and behaviour change techniques for each intervention, as well as study-level characteristics including risk of bias. For each study, we extracted outcome data for every healthcare professional practice targeted by A&F. All data were extracted by a minimum of two independent review authors. For studies with dichotomous outcomes that included arms with and without A&F, we calculated risk differences (RDs) (absolute difference between arms in proportion of desired practice completed) and also odds ratios (ORs). We synthesised the median RDs and interquartile ranges (IQRs) across all trials. We then conducted meta-analyses, accounting for multiple outcomes from a given study and weighted by effective sample size, using reported (or imputed, when necessary) intra-cluster correlation coefficients. Next, we explored the role of baseline performance, co-interventions, targeted behaviour, and study design factors on the estimated effects of A&F. Finally, we conducted exploratory meta-regressions to test preselected variables that might be associated with A&F effect size: characteristics of the audit (number of indicators, aggregation of data); delivery of the feedback (multi-modal format, local champion, nature of comparator, repeated delivery); and components supporting action (facilitation, provision of specific plans for improvement, co-development of action plans). We included 292 studies with 678 arms; 133 (46%) had a low risk of bias, 41 (14%) unclear, and 113 (39%) had a high risk of bias. There were 26 (9%) studies conducted in low- or middle-income countries. In most studies (237, 81%), the recipients of A&F were physicians. Professional practices most commonly targeted in the studies were prescribing (138 studies, 47%) and test-ordering (103 studies, 35%). Most studies featured multifaceted interventions: the most common co-interventions were clinician education (377 study arms, 56%) and reminders (100 study arms, 15%). Forty-eight unique behaviour change techniques were identified within the study arms (mean 5.2, standard deviation 2.8, range 1 to 29). Synthesis of 558 dichotomous outcomes measuring professional practices from 177 studies testing A&F versus control revealed a median absolute improvement in desired practice of 2.7%, with an IQR of 0.0 to 8.6. Meta-analyses of these studies, accounting for multiple outcomes from the same study and weighting by effective sample size accounting for clustering, found a mean absolute increase in desired practice of 6.2% (95% confidence interval (CI) 4.1 to 8.2; moderate-certainty evidence) and an OR of 1.47 (95% CI 1.31 to 1.64; moderate-certainty evidence). Effects were similar for pre-planned subgroup analyses focused on prescribing and test-ordering outcomes. Lower baseline performance and increased number of co-interventions were both associated with larger intervention effects. Meta-regressions comparing the presence versus absence of specific A&F components to explore heterogeneity, accounting for baseline performance and number of co-interventions, suggested that A&F effects were greater with individual-recipient-level data rather than team-level data, comparing performance to top-peers or a benchmark, involving a local champion with whom the recipient had a relationship, using interactive modalities rather than just didactic or just written format, and with facilitation to support engagement, and action plans to improve performance. The meta-regressions did not find significant effects with the number of indicators in the audit, comparison to average performance of all peers, or co-development of action plans. Contrary to expectations, repeated delivery was associated with lower effect size. Direct comparisons from head-to-head trials support the use of peer-comparisons versus no comparison at all and the use of design elements in feedback that facilitate the identification and action of high-priority clinical items. A&F can be effective in improving professional practice, but effects vary in size. A&F is most often delivered along with co-interventions which can contribute additive effects. A&F may be most effective when designed to help recipients prioritise and take action on high-priority clinical issues and with the following characteristics: 1. targets important performance metrics where health professionals have substantial room for improvement (audit); 2. measures the individual recipient's practice, rather than their team or organisation (audit); 3. involves a local champion with an existing relationship with the recipient (feedback); 4. includes multiple, interactive modalities such as verbal and written (feedback); 5. compares performance to top peers or a benchmark (feedback); 6. facilitates engagement with the feedback (action); 7. features an actionable plan with specific advice for improvement (action). These conclusions require further confirmatory research; future research should focus on discerning ways to optimise the effectiveness of A&F interventions.
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