Major lower limb amputation, defined as an amputation above the level of the ankle joint, is a substantial cause of morbidity and mortality. Limited data exist on the burden, aetiology and outcomes of major lower limb amputations in sub-Saharan Africa (SSA). This is despite increasing rates of diabetes, peripheral arterial disease and trauma, with further projected increases in these conditions, which often precede major lower limb amputation. The Regional Assessment of Amputations in sub-Saharan Africa (RAMPs) study aims to address this knowledge gap by performing a multicentre, prospective study of major lower limb amputations across the region.

We describe a prospective, multicentre observational cohort study enrolling patients undergoing major lower limb amputation at hospitals in SSA over a consecutive 6-month period. Consecutive patients will be included, and data will be collected from medical records until discharge, death or 30 days postoperatively, whichever is sooner. The primary outcome is in-hospital or 30-day mortality. Secondary outcomes include the aetiology of amputations and in-hospital complications. We will also examine systems and processes using a facility survey of each participating centre. The study will collect system-level, patient-level and outcome-level data. Our sample size calculation suggests 904 patients need to be recruited.

The RAMPs study will provide a snapshot of the current outcomes and aetiology of major lower limb amputation in SSA. It will show if variation in outcomes and aetiology in patients in the region exists and provide information on the healthcare processes and systems in those who may be at risk of lower limb amputation. Ethical approval has been granted by the University of Birmingham (Science, Technology, Engineering and Mathematics Committee reference: ERN_2929-Jan2025) and the College of Surgeons of East, Central and Southern Africa (COSECSA Institutional review board reference COSECSA/REC/2025/07). Findings will be disseminated throughout the region at local, national and international conferences and through at least one peer-reviewed manuscript.

Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.

A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.

Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.

EudraCT 2022-003589-19.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147

Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.

The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.

The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.

ClinicalTrials.gov ID: NCT05681962. Registered January 2023.

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.

Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.

BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.

This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.

NCT05779631.

Tuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services.

We will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events.

The study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications.

NCT06214910. Date and version: 3.0, 30 July 2024.

Adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are at high risk of harmful sexual and reproductive health (SRH) practices due to limited knowledge, low availability or acceptability of modern contraceptives, gender inequality and cultural practices like child marriage. Preventive and educational interventions by lay health workers or through technological means are a cost-effective and scalable solution. Unfortunately, too little is currently known about the scope, content and conditions of the effectiveness and sustainability of these approaches and synthetic evidence on this topic is scarce. To help fill this knowledge gap and to identify where further research is needed, we will conduct a scoping review of technology-based or lay health-worker delivered preventive and educational SRH interventions targeting AYAs in LMICs. This information is valuable to both policymakers and researchers as it provides a synthesis of existing interventions, highlights best practices for their implementation and identifies potential avenues for future research.

This review will include studies on SRH preventive and educational interventions targeting AYAs aged 10–24 years in LMICs. It encompasses interventions delivered by lay health workers or via technological means, assessing various outcomes including but not limited to SRH literacy, sexual risk behaviours, pregnancies, sexually transmitted infections and gender-based violence. Key databases, including PubMed via MEDLINE and Embase, will be searched from 1 January 2000 up to 23 January 2024, using a comprehensive search strategy. Screening will be conducted using Covidence software. Data extraction will cover study details, methods, intervention strategies, outcomes and findings. A narrative synthesis will be conducted following synthesis without meta-analysis guidelines.

The scope of this scoping review is limited to publicly accessible databases that do not require prior ethical approval for access. The findings will be disseminated through peer-reviewed journal publications, as well as presentations at national and international conferences and stakeholder meetings in LMICs.

The final protocol is prospectively registered with the Open Science Framework on 7 May 2024 (osf.io/vna2z).

To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.

Triangulation to integrate quantitative and qualitative data.

Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.

A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.

To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.

Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.

There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.

ISRCTN66682918.

Traditional peoples and communities (TPCs), such as indigenous peoples and quilombolas (communities descended from escaped African slaves), face challenges related to food security and the impact of the food environment on their health. Changes in food systems, urbanisation and loss of territorial rights have contributed to less healthy eating patterns, with increased consumption of ultra-processed foods and a higher prevalence of chronic non-communicable diseases. Despite this, there are gaps in knowledge about how the food environments of these communities are investigated, especially in relation to the physical, economic, political and sociocultural dimensions.

This scoping review will be conducted following the methodological framework developed by the Joanna Briggs Institute for scoping reviews, and its reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews checklist. A systematic search will be carried out in the following databases: PubMed, SciELO, Web of Science, Embase and EBSCO, using terms related to traditional populations and food environments. The studies to be included will be selected according to the inclusion and exclusion criteria defined based on the population, concept and context technique. The study population will include TPCs, such as indigenous peoples and quilombolas; the concept will address the food environment in its physical, economic, political and sociocultural dimensions; and the context will encompass studies conducted at a global level, without any restrictions on geographic location. The study type will include original articles and grey literature. The screening of studies will involve independent reviewers and predefined inclusion and exclusion criteria. Data synthesis will be presented in tables, including information on focus, geographic scope and methodology of the selected studies. The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies of Exposure tool.

As the study does not involve the collection of primary data or human participants, it does not require ethical approval. The results will be submitted to peer-reviewed journals and presented at public health and nutrition conferences, contributing to the advancement of knowledge on food environments of TPCs.

Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.

We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.

The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).

ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).

While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.

A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.

TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.

NCT06245135.

Post-traumatic stress disorder (PTSD) constitutes a significant anxiety disorder that exerts substantial societal and familial impacts, while concurrently imposing an additional as well as a substantial burden on the healthcare system. Beyond the direct expenses incurred in its treatment, PTSD also gives rise to broader economic costs. The details of these costs in the UK are currently, we believe, unknown.

Our methodology was developed collaboratively with a collaborative advisory group of clinicians, patients, carers and other stakeholders. A comprehensive search strategy was devised to identify articles, including systematic reviews evaluating the economic costs linked to PTSD. We adhered to the National Institute for Health and Care Excellence checklist for economic evaluations. After applying our search strategy, the selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD.

PubMed, PsycInfo, PTSDpubs, EMBASE and Google Scholar were searched from January 1990 until January 2023; the search was revised and re-run in September 2024.

The articles must have been published originally in English and include a detailed evaluation of costs related to PTSD.

Two independent reviewers used standardised methods to search, screen and code included papers. After applying our search strategy, selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD. Detailed information on per-contact and per-session costs of healthcare variables was obtained at 2020/2021 prices. Additionally, with the advisory group, we ensured the validity of frequencies and unit cost figures associated with variables linked to PTSD. Further, indirect socio-economic costs arising from PTSD were computed.

By extrapolating from cost components identified, our findings indicate an average annual cost exceeding £14 780 per person. Given current 2020/2021 prevalence rates, this translates to an annual societal burden of £40 billion, a figure that does not encompass the many additional financial burdens stemming from PTSD, such as poor or inconsistent employment. This figure does not include the myriad intangible costs ranging from reduced quality of life to suicidality and countless other issues a person may suffer from as a result of PTSD. Finally, this number does not capture the breadth of impact, as it is difficult to quantify how the families, communities and social systems are adversely affected (both financially and otherwise) by the condition.

The economic and societal burden of PTSD in the UK is far greater than what extant research and common understanding indicate, as there is minimal awareness and information relating to indirect costs or ancillary effects such as discrimination, joblessness, substance use and other comorbidities. Ultimately, we found that there exists, conservatively, an annual excess societal burden of £40 billion, or approximately £14 780 per person. We demonstrated that PTSD is a significantly larger burden on society and individuals than estimated and that we are gravely underquantifying the cost of this increasingly prevalent condition.

Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic.

In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis.

Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.

Maintaining a healthy workforce is crucial for safe, high-quality care. To enhance well-being and engagement in Dutch university medical centres (UMCs), an overview of staff well-being and job perceptions is needed first. Surveys are widely used to improve working conditions, but varying questionnaires hinder a comprehensive view. This study aimed to evaluate the content of employee surveys currently used in UMCs in the Netherlands from a well-being perspective and to analyse the survey results at a national level.

All seven UMCs were approached to participate in the study and share employee survey data. The primary outcome of interest is work experience; a secondary analysis was conducted. Items were categorised following the Job Demands-Resources model. Descriptive statistics were presented as percentages, means and medians with IQRs.

Two UMCs participated and 31 862 completed surveys were included. Variation in survey items (eg, 15–18 subcategories, 21–33 question items), response options (eg, 1–5, 1–10), frequency (1–3 times per year) and timing were found. Scores on the following outcomes are presented: work overload, coworker support, job control, organisational justice, participation in decision-making, performance feedback, possibilities for learning and development, recognition, task variety, team atmosphere, team effectiveness, trust in leadership, other job resources, connecting/inspiring leadership, self-efficacy, goal-directiveness, boredom, burnout, job satisfaction, work engagement, other employee well-being, commitment organisation/team and work ability. Results should be interpreted with caution, and solely found for hospital A, for certain job control items, median scores of 2 or 3 were observed, whereas the majority of other question items revealed a median score of 4.

There is a significant lack of cohesion across employee surveys. As it stands, employee surveys in Dutch UMCs are not effective tools for monitoring the work experience or well-being of the healthcare workforce. While these surveys may support management decisions, this support is not reflected in interventions related to work and the work environment.

Sarcopenia, osteoporosis and osteosarcopenia are conditions prevalent in ageing that impair muscle strength and bone density, increasing the risks of fractures, falls, disability and mortality. Recent studies highlight the benefits of milk protein supplementation (MPS) combined with exercises to improve musculoskeletal health in the older population. This systematic review protocol will enable the production of a compilation of evidence that will elucidate the effects of MPS combined with aerobic exercise, resistance exercise or both on the musculoskeletal function of older individuals with these three conditions.

Studies will be selected from electronic databases, including PubMed/MEDLINE, EMBASE, Scopus, Web of Science and the Cochrane Library, without restrictions on language or publication date. The outcomes evaluated will include muscle mass, muscle strength, BMD and physical performance after combined interventions of MPS and physical exercise of any type. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to classify the certainty of the evidence into four levels: high, moderate, low and very low. Meta-analysis will be performed given the homogeneity of the studies, using random effects methods in the face of the expected heterogeneity. The standardised mean difference (SMD) will be used for continuous data, and the I² index will assess heterogeneity (I² > 50%). Sensitivity analysis, ‘leave one out’ and a strategy for dealing with missing data will be carried out. Statistical analysis will be conducted using the STATA 18 software with a 95% CI and p

Formal ethical approval will not be required as primary data collection will not be performed. The results will be disseminated through peer-reviewed publications and presentations at conferences dedicated to the relevant field of study.

CRD42024555933.

Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public.

To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages.

The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums.

The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.