High costs of screening and diagnostic tests remain a major barrier to timely tuberculosis (TB) identification in resource-limited settings. Evidence on the cost-effectiveness of scalable screening algorithms is limited. Start4All is a research project aimed at developing and evaluating algorithmic approaches to TB screening and diagnosis, with the goal of optimising technical and allocative efficiency when expanding diagnostic coverage to primary healthcare and community settings.

Five screening and diagnostic tests will be evaluated: a capillary blood-based assay (C-reactive protein (CRP)), sputum-based rapid molecular tests (PCR; individual and pooled Xpert MTB/RIF Ultra assay (Xpert Ultra, Cepheid®, California, USA)), a lateral-flow urine-based test for lipoarabinomannan (LF-LAM), and digital chest X-rays with artificial intelligence-based computer-aided detection (CXR-CAD). A microbiological reference standard of positive culture using the mycobacteria growth indicator tube will be used to confirm TB disease.

We will compare the cost and effectiveness of concurrent and sequential positive serial combinations (screening algorithms) of CRP, CXR-CAD, LF-LAM, individual and pooled Xpert Ultra. Diagnostic performance will be estimated using sensitivity, specificity, predictive values and proportions of positive results, with Bayesian inference used to derive these estimates. The analysis will include adults (15 years and older) only and will be stratified by HIV status and level of care, including facility and community-based case finding. Effectiveness will be assessed based on the number of people with TB detected. Cost analysis will be conducted from the provider perspective, incorporating commodity and implementation costs. A decision tree model will be developed to assess the cost per number of persons with confirmed TB detected across all countries. Probabilistic sensitivity analysis will be conducted to account for uncertainty in model parameters, incorporating willingness-to-pay and willingness-to-accept thresholds.

WHO ethical review committee approval ERC.0003921. Data will be available on reasonable request to the principal investigator of the consortium.

NCT05845112.

The term ‘culture of care’ began to be used following the Francis Report in the UK in 2013. This concept involves three dimensions: personal care, leadership care and co-worker care. Personal care focuses on employees’ attitudes and behaviours. Co-worker care relates to a sense of community, and leadership care relates to how employees perceive leaders and managers as caring individuals dedicated to ensuring the well-being of others. Previous studies investigating culture assessment tools used in the healthcare system reported that although organisations are increasingly using culture assessment instruments, there is a focus on assessing safety and quality cultures rather than on caring perspectives. This scoping review aims to map existing studies related to the assessment of culture of care.

This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The search strategy will include four indexed databases (PubMed, EMBASE, Cochrane Library and Latin American and Caribbean Literature in Health Sciences) and additional sources not retrieved with the adopted search strategy. The search strategy will be constructed using the controlled vocabulary in Health Sciences Descriptors, Medical Subject Headings and Emtree. Relevant articles in all languages, without restrictions related to date of publication, will be considered eligible for inclusion. Two independent researchers will select articles based on the inclusion criteria, and a third author will be consulted to establish consensus, if necessary. Data extraction will involve a form with information on the study characteristics, methodological issues and main results from the evidence sources. The extracted data will be analysed using descriptive and content analysis.

Ethics approval is not required, as this review will use data from publicly available bibliographic sources. The results will be disseminated through publications in scientific journals and presentation of the evidence to interested parties.

The protocol was registered in the Open Science Framework (DOI: 10.17605/OSF.IO/U9Q53).

Insomnia afflicts about half of outpatients with coronary heart disease (CHD) and worsens prognosis. We aimed to simulate the potential socioeconomic savings of integrating group cognitive–behavioural therapy for insomnia (gCBT-I) into cardiac outpatient care for patients with CHD compared with usual care.

Early health technology assessment using prospective and cross-sectional cohort data.

Secondary care for outpatients with CHD in Norway in a non-university hospital setting.

A hypothetical cohort of 100 outpatients with CHD and insomnia.

Weekly sessions of gCBT-I over 5 weeks versus usual care.

Potential savings related to possible effects on revascularisations and hospitalisations due to a recurrent CHD event, and reduced sick leave. Representative data on healthcare consumption and sick leave rates were collected from the NORwegian CORonary cohort study (n=528). Costs of productivity loss were drawn from public sources and calculated using a conservative human capital approach. Estimates of therapeutic effectiveness in conveying insomnia remission by gCBT-I were informed by results from randomised trials and meta-analyses.

Rates of healthcare consumption and sick leave were higher in outpatients with CHD and insomnia compared with those without insomnia. Our model indicated that treating 100 patients with gCBT-I would cost 2406. If patients treated with gCBT-I show similar rates of revascularisations and hospitalisations as those without insomnia, there is a maximum potential saving of 117,221 per 100 patients tied to healthcare consumption. Similarly, the maximum potential savings related to reduced productivity loss from sick leave range from 53,244 to 692,172.

Treating insomnia among outpatients with CHD has the potential for substantial reduction of socioeconomic costs related to healthcare consumption and sick leave. Implementation into routine outpatient care seems relevant, but randomised controlled trials investigating the effects of gCBT-I in this population are warranted.

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.

Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.

This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.

This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.

NCT05537298.

To describe the features and rates of emergency department (ED) presentations identified as related to violence against women (VAW) and of confirmed cases of family domestic violence (FDV) inpatient admissions and to compare these across geographic locations in New South Wales (NSW) Australia.

A retrospective data linkage study.

Routinely collected public hospital data from approximately 180 designated public hospital EDs in NSW, Australia.

Cases were included if female, aged ≥15 years, presenting to any NSW ED between 2015 and 2022 and with one or more criteria indicating VAW, leading to 21 219 cases being included.

The age-standardised rate of VAW ED presentations per year and confirmed FDV inpatient admissions within metropolitan and non-metropolitan areas in NSW, Australia.

Women presenting with VAW were more likely to be aged 25–44 years (n=9705, 45.7%), with almost 20% of presentations from women who identified as Indigenous (n=4153, 19.6%). Indigenous presentations were greater in non-metropolitan areas (n=2675, 30.9%) compared with metropolitan areas (n=1478, 11.8%). Indigenous women in NSW represent only 4.2% of the estimated residential population. VAW presentation rates by age group varied over time, a gradual increase being seen in the 65–84 year-old age group who experienced 45 VAW presentations per year in 2015 to 79 presentations per year in 2022 with an annual rate of change of 7.3%.

VAW accounts for a substantial burden of ED presentations across NSW; the greatest impact on women aged 25–44 years and Indigenous women, particularly in non-metropolitan areas. Rising presentations among older women further highlight the need for strengthened ED screening and referral pathways and for targeted resource allocation to address inequities in family, domestic and sexual violence.

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Australia-wide.

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.