SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

ClinicalTrials.gov: NCT05533918 and NCT05533359.

In rural areas, work-integrated learning in the form of health student placements has several potential benefits, including contributing to student learning, enhancing rural health service capacity and attracting future rural health workforce. Understanding what constitutes a high-quality rural placement experience is important for enhancing these outcomes. There is no current standardised definition of quality in the context of rural health placements, nor is there understanding of how this can be achieved across different rural contexts. This study is guided by one broad research question: what do university staff believe are the determinants of high-quality health professions student placements in regional, rural and remote Australia?

This study will adopt a convergent mixed-method design with two components. Component A will use explanatory sequential mixed methods. The first phase of component A will use a survey to explore determinants that contribute to the development of high-quality health student placements from the perspective of university staff who are not employed in University Departments of Rural Health and are involved in the delivery of health student education. The second phase will use semistructured interviews with the same stakeholder group (non-University Department of Rural Health university staff) to identify the determinants of high-quality health student placements. Component B will use a case study Employing COnceptUal schema for policy and Translation Engagement in Research mind mapping method to capture determinants that contribute to the development of high-quality health student placements from the perspective of University Department of Rural Health university staff.

The University of Melbourne Human Ethics Committee approved the study (2022-23201-33373-5). Following this, seven other Australian university human research ethics committees provided external approval to conduct the study. The results of the study will be presented in several peer-review publications and summary reports to key stakeholder groups.

The ability of digital mental health interventions (DMHIs) to reduce mental health disparities relies on the recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI research in particular has not been comprehensively reviewed.

To characterise the state of sociodemographic data reported in randomised controlled trials (RCTs) of app-based DMHIs published globally from 2007 to 2022.

A scoping review of RCTs of app-based DMHIs examined reporting frequency for 16 sociodemographic domains (eg, gender) and common category options within each domain (eg, woman). The search queried five electronic databases. 5079 records were screened and 299 articles were included.

On average, studies reported 4.64 (SD=1.79; range 0–9) of 16 sociodemographic domains. The most common were age (97%) and education (67%). The least common were housing situation (6%), residency/location (5%), veteran status (4%), number of children (3%), sexual orientation (2%), disability status (2%) and food security (

This review describes the widespread underreporting of sociodemographic information in RCTs of app-based DMHIs published from 2007 to 2022. Reporting was often incomplete (eg, % female only), unclear (eg, the conflation of gender/sex) and limited (eg, only options representing majority groups were reported). Trends suggest reporting has somewhat improved in recent years. Diverse participant populations must be welcomed and described in DMHI research to broaden learning and the generalisability of results, a prerequisite of DMHI’s potential to reduce disparities in mental healthcare.

Uncontrolled bleeding is a major cause of death for patients with major trauma. Current transfusion practices vary, and there is uncertainty about the optimal strategy. Whole blood (WB) transfusion, which contains all components in one bag, is considered potentially advantageous, particularly for resuscitating patients with major bleeding in the prehospital setting. It could potentially improve survival, reduce donor risk and simplify the processes of delivering blood transfusions outside hospitals. However, the evidence supporting the effectiveness and safety of WB compared with the standard separate blood component therapy is limited. A multicentre randomised controlled trial will be conducted, alongside an implementation study, to assess the efficacy, cost-effectiveness and implementation of prehospital WB transfusion in the prehospital environment. The implementation study will focus on evaluating the acceptability and integration of the intervention into clinical settings and on addressing broader contextual factors that may influence its success or failure.

A type 1 effectiveness–implementation hybrid design will be employed. The implementation study will use qualitative methods, encompassing comprehensive interviews and focus groups with operational staff, patients and blood donor representatives. Staff will be purposefully selected to ensure a wide range of perspectives based on their professional background and involvement in the WB pathway. The study design includes: (1) initial assessment of current practice and processes in the WB pathway; (2) qualitative interviews with up to 40 operational staff and (3) five focus groups with staff and donor representatives. Data analysis will be guided by the theoretical lenses of the Normalisation Process Theory and the Theoretical Framework of Acceptability.

The study was prospectively registered and approved by the South Central—Oxford C Research Ethics Committee and the Health Research Authority and Health and Care Research Wales. The results will be published in peer-reviewed journals and provided to all relevant stakeholders.

ISRCTN23657907; EudraCT: 2021-006876-18; IRAS Number: 300414; REC: 22/SC/0072.

Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.

This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.

The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.

ISRCTN16413728.

Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions.

A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method.

This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

To determine whether periods of disruption were associated with increased ‘avoidable’ hospital admissions and wider social inequalities in England.

Observational repeated cross-sectional study.

England (January 2019 to March 2022).

With the approval of NHS England we used individual-level electronic health records from OpenSAFELY, which covered ~40% of general practices in England (mean monthly population size 23.5 million people).

We estimated crude and directly age-standardised rates for potentially preventable unplanned hospital admissions: ambulatory care sensitive conditions and urgent emergency sensitive conditions. We considered how trends in these outcomes varied by three measures of social and spatial inequality: neighbourhood socioeconomic deprivation, ethnicity and geographical region.

There were large declines in avoidable hospitalisations during the first national lockdown (March to May 2020). Trends increased post-lockdown but never reached 2019 levels. The exception to these trends was for vaccine-preventable ambulatory care sensitive admissions which remained low throughout 2020–2021. While trends were consistent by each measure of inequality, absolute levels of inequalities narrowed across levels of neighbourhood socioeconomic deprivation, Asian ethnicity (compared with white ethnicity) and geographical region (especially in northern regions).

We found no evidence that periods of healthcare disruption from the COVID-19 pandemic resulted in more avoidable hospitalisations. Falling avoidable hospital admissions has coincided with declining inequalities most strongly by level of deprivation, but also for Asian ethnic groups and northern regions of England.

Harmful gender and social norms prescribe divergent opportunities for girls and boys and drive child marriage. This systematic review examines the scope, range and effectiveness of interventions to change social norms and delay child marriage.

We systematically assess the contributions made by interventions that work to shift norms to prevent child marriage or to limit its harmful consequences. Our analysis classifies each study’s quality in evaluation and implementation design regarding shifting norms.

We conducted a search of electronic databases (PubMed, PsycINFO, Embase, CINAHL Plus, Popline, Web of Science and Cochrane Library) and grey literature (targeted hand-searches of 15 key organisations and Google Scholar).

Included interventions sought to change norms related to child marriage, were evaluated in experimental or quasi-experimental evaluations, collected data on age at marriage and norms/attitudes, and were published in English from January 2000 to September 2021.

We used a standardised form to extract data from all eligible studies, and double-screened to validate coding and reporting. We classified the studies by low, medium and high quality for evaluation and risk of bias, and separately by the extent to which they addressed social norms.

Our assessment of the 12 eligible studies identified revealed little evidence of a systematic relationship between social norms related to marriage and changes in child marriage behaviours. We found stronger evidence of programme effect on child marriage outcomes than on social norms, though only a minority of studies found an effect for either. Studies that appeared effective in changing child marriage norms varied greatly in scale and extent of programming, and few attempted to identify the appropriate reference groups for measuring social norms.

The studies evaluated by our review provide only weak evidence on the impact of interventions on norms, and on the link between shifts in norms and marriage behaviour.

Patients diagnosed with colorectal cancer living in more deprived areas experience worse survival than those in more affluent areas. Those living in more deprived areas face barriers to accessing timely, quality healthcare. These barriers may contribute to socioeconomic inequalities in survival. We evaluated the literature for any association between socioeconomic group, hospital delay and treatments received among patients with colorectal cancer in the UK, a country with universal healthcare.

MEDLINE, EMBASE, CINAHL, CENTRAL, SCIE, AMED and PsycINFO were searched from inception to January 2023. Grey literature, including HMIC, BASE and Google Advanced Search, and forward and backward citation searches were conducted. Two reviewers independently reviewed titles, abstracts and full-text articles. Observational UK-based studies were included if they reported socioeconomic measures and an association with either hospital delay or treatments received. The QUIPS tool assessed bias risk, and a narrative synthesis was conducted. The review is reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020.

41 of the 7209 identified references were included. 12 studies evaluated 7 different hospital intervals. There was a significant association between area-level deprivation and a longer time from first presentation in primary care to diagnosis. 32 studies evaluated treatments received. There were socioeconomic inequalities in surgery and chemotherapy but not radiotherapy.

Patients with colorectal cancer face inequalities across the cancer care continuum. Further research is needed to understand why and what evidence-based actions can reduce these inequalities in treatment. Qualitative research of patients and clinicians conducted across various settings would provide a rich understanding of the complex factors that drive these inequalities. Further research should also consider using a causal approach to future studies to considerably strengthen the interpretation. Clinicians can try and mitigate some potential causes of colorectal cancer inequalities, including signposting to financial advice and patient transport schemes.

CRD42022347652.

Older surgical patients are more likely to be living with frailty and multimorbidity and experience postoperative complications. The management of these conditions in the perioperative pathway is evolving. In order to support objective decision-making for patients, services and national guidance, accurate, contemporary data are needed to describe the impact and associations between frailty, multimorbidity and healthcare processes with patient and service-level outcomes.

The study is comprised of an observational cohort study of approximately 7500 patients; an organisational survey of perioperative services and a clinician survey of the unplanned, medical workload generated from older surgical patients. The cohort will consist of patients who are 60 years and older, undergoing a surgical procedure during a 5-day recruitment period in participating UK hospitals. Participants will be assessed for baseline frailty and multimorbidity; postoperative morbidity including delirium; and quality of life. Data linkage will provide additional details about individuals, their admission and mortality.

The study’s primary outcome is length of stay, other outcome measures include incidence of postoperative morbidity and delirium; readmission, mortality and quality of life. The cohort’s incidence of frailty, multimorbidity and delirium will be estimated using 95% CIs. Their relationships with outcome measures will be examined using unadjusted and adjusted multilevel regression analyses. Choice of covariates in the adjusted models will be prespecified, based on directed acyclic graphs.

A parallel study is planned to take place in Australia in 2022.

The study has received approval from the Scotland A Research Ethics Committee and Wales Research Ethics Committee 7.

This work hopes to influence the development of services and guidelines. We will publish our findings in peer-reviewed journals and provide summary documents to our participants, sites, healthcare policy-makers and the public.

ISRCTN67043129.

Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy.

We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants’ acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework.

Online survey and remote interviews.

We recruited 400 UK respondents aged 50–70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents.

In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals.

Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.

We aim to examine the feasibility of a non-invasive monitoring tool—bowel ultrasound (BUS)—in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.

We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.

This prospective observational feasibility study will be carried out over 24 months at the Noah’s Ark Children’s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2–18 years with a modified Porto criteria diagnosis of IBD will be included.

Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.

Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.

The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and ² analysis, correlation analysis, regression analysis.

Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.

NCT05673278.

Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

NCT05078970.

Population ageing is a global phenomenon. Resultant healthcare workforce shortages are anticipated. To ensure access to comprehensive primary care, which correlates with improved health outcomes, equity and costs, data to inform workforce planning are urgently needed. We examined the medical and social characteristics of patients attached to near-retirement comprehensive primary care physicians over time and explored the early-career and mid-career workforce’s capacity to absorb these patients.

A serial cross-sectional population-based analysis using health administrative data.

Ontario, Canada, where most comprehensive primary care is delivered by family physicians (FPs) under universal insurance.

All insured Ontario residents at three time points: 2008 (12 936 360), 2013 (13 447 365) and 2019 (14 388 566) and all Ontario physicians who billed primary care services (2008: 11 566; 2013: 12 693; 2019: 15 054).

The number, proportion and health and social characteristics of patients attached to near-retirement age comprehensive FPs over time; the number, proportion and characteristics of near-retirement age comprehensive FPs over time. Secondary outcome measures: The characteristics of patients and their early-career and mid-career comprehensive FPs.

Patient attachment to comprehensive FPs increased over time. The overall FP workforce grew, but the proportion practicing comprehensiveness declined (2008: 77.2%, 2019: 70.7%). Over time, an increasing proportion of the comprehensive FP workforce was near retirement age. Correspondingly, an increasing proportion of patients were attached to near-retirement physicians. By 2019, 13.9% of comprehensive FPs were 65 years or older, corresponding to 1 695 126 (14.8%) patients. Mean patient age increased, and all physicians served markedly increasing numbers of medically and socially complex patients.

The primary care sector faces capacity challenges as both patients and physicians age and fewer physicians practice comprehensiveness. Nearly 15% (1.7 million) of Ontarians may lose their comprehensive FP to retirement between 2019 and 2025. To serve a growing, increasingly complex population, innovative solutions are needed.

There is an urgent need to support primary care organisations in implementing safe and high-quality virtual consultations. We have previously performed qualitative research to capture the views of 1600 primary care physicians across 20 countries on the main benefits and challenges of using virtual consultations. Subsequently, a prototype of a framework to guide the implementation of high-quality virtual primary care was developed.

To explore general practitioners’ perspectives on the appropriateness and relevance of each component of the framework’s prototype, to further refine it and optimise its practical use in primary care facilities.

Participants will be primary care physicians with active experience providing virtual care, recruited through convenience and snowball sampling. This study will use a systematic and iterative online Delphi research approach (eDelphi), with a minimum of three rounds. A pre-round will be used to circulate items for initial feedback and adjustment. In subsequent rounds, participants will be asked to rate the relevance of the framework’s components. Consensus will be defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a component. Data will be collected using structured online questionnaires. The primary outcome of the study will be a list of the essential components to be incorporated in the final version of the framework.

The study has received ethical approval conceded by the Imperial College London Science, Engineering and Technology Research Ethics Committee (SETREC) (reference no .6559176/2023). Anonymous results will be made available to the public, academic organisations and policymakers.