Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

CRD420251011484.

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

CRD420251001413.

Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF’s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.

An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2–5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.

This study’s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.

NCT06786975.

The Osseointegration Group of Australia Accelerated Protocol-3 (OGAAP-3) presents the latest iteration of a structured, prospective, clinical-based protocol for single-stage osseointegration surgery in lower limb amputees. Building on the foundational work of OGAAP-1 and OGAAP-2, this protocol incorporates a decade of institutional experience and over 1000 cases using the Osseointegrated Prosthetic Limb system. OGAAP-3 introduces stratified rehabilitation categories—immediate, standard, slow and delayed loading—based on intraoperative findings, residual limb characteristics and patient-specific physiological factors. The surgical approach remains a single-stage procedure, with modifications described for transfemoral and transtibial levels, including primary amputation with simultaneous implant placement. The aim is to enhance safety, optimise functional outcomes and broaden access to osseointegration.

OGAAP-3 is a prospective registry-based protocol enrolling approximately 50 patients annually at the Osseointegration Group of Australia and affiliated centres, with data collection ongoing since mid-2023 and planned until 2027. Eligibility criteria include adults (aged 18 years or over) with unilateral or bilateral transfemoral or transtibial amputations, as well as primary amputees undergoing concurrent osseointegration. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values will be compared for each outcome measure, and the outcomes of the OGAAP-3 procedure will be compared with the results of the OGAAP-1 and OGAAP-2 protocol.

This study has received ethics approval by Macquarie University, Sydney, Australia. The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences with final outcome analyses planned following completion of 2-year follow-up in 2027.

India targets to eliminate lymphatic filariasis (LF) in alignment with the global goals. By 2024, 106 out of a total of 345 endemic districts have passed all three serial transmission assessment surveys (TAS) and are under post-mass drug administration (MDA) surveillance for a variable period. However, the current epidemiological situation of LF is not known in these districts. With increased mobility of population from the endemic districts currently under MDA to these post-MDA areas, resurgence of LF in these areas cannot be ruled out. Therefore, a study is planned to understand the current LF status in areas under post-MDA surveillance with the following objectives: (1) To assess the epidemiological situation of LF in terms of human and vector infection prevalence in selected evaluation units (EUs) under different durations of post-MDA phase and (2) to estimate the filarial infection (in terms of filarial antigen and microfilaria) among migrants (from endemic districts) in these EUs.

This cross-sectional study will measure the filarial infection in (1) adult population aged ≥20 years (following the WHO 2025 protocol for monitoring and evaluation of MDA) among general population (n=3150 per EU), (2) migrant population (aged 2 years and above) in the post-MDA area originating from endemic areas (n=1000 per EU) and (3) vectors (n=7500 per EU) using molecular xenomonitoring (MX) to confirm sustenance of transmission interruption or identify any potential risk of resurgence in three EUs under post-MDA phase. In one MDA-naive EU that shares borders with endemic districts, filarial infection status will be assessed in (1) school children aged 9–14 years (as per WHO mini-TAS protocol, n=480), (2) migrants (aged 2 years and above) from endemic areas (n=1000) and (3) vectors (n=7500). EU-wide prevalence of microfilaria, circulating filarial antigen and vector infection rates with 95% CIs will be estimated. Multivariate logistic regression analysis will be carried out to find factors associated with LF positivity. In addition, knowledge, attitude and practice surveys will also be conducted among the adult migrants (n=1000 per EU). Thirty in-depth interviews will be conducted among the migrants, local community and health workers (in each EU) and the results will be suitably analysed and triangulated. The study results will enable the national programme to confirm sustenance of transmission interruption or assist in taking a decision to reinitiate MDA in these areas under post-MDA surveillance. It will also enable devising specific strategies to treat migrants.

This study has been approved by the institutional ethics committee (IHEC 03-0824/N/F). A workshop will be held with all stakeholders to disseminate the study findings.

The opioid crisis remains a significant public health emergency. Key contributors to this crisis include an increasingly toxic drug supply and inadequate health policies that rely on strategies to address opioid-related harms and underutilise primary prevention and early intervention approaches. To inform comprehensive prevention and early intervention strategies, research is needed to explore pathways involving hazardous opioid use (ie, daily opioid use that results in, and may arise from, disruptions to health, relationships, work or social functioning) and the individual, social and structural factors that shape such pathways. This qualitative study aims to address this research gap by exploring the substance use journeys of adults with lived or living experiences of hazardous opioid use who are receiving substance use treatment at a large Canadian mental health hospital.

A qualitative descriptive study informed by the life course perspective will be conducted. Data will be collected using participant-led timeline mapping in combination with semistructured interviews. Participants will include 20–30 adults who are receiving or have received substance use treatment from the hospital where the study is being conducted. Timelines and interviews will be analysed using thematic analysis. A brief demographic questionnaire will also be administered to describe characteristics of the sample.

Ethical approval was granted on 1 October 2025 by the Centre for Addiction and Mental Health Research Ethics Board (Protocol no. 2025/026). Findings will be reported through peer-reviewed publications, lay language reports and/or academic conferences on mental health and substance use health research.

The functional resonance analysis method (FRAM) is increasingly used to analyse healthcare processes. FRAM uses four steps to analyse a process and its potential variability. We systematically reviewed studies using FRAM in healthcare on how the four steps in FRAM are reported, defined and supported by data.

Systematic review following the preferred reporting items for systematic reviews and meta-analyses 2020 guidelines.

Web of Science, PubMed, Embase, Scopus, PsycINFO, Dimensions and Lens were searched up to December 2025.

All peer-reviewed studies using FRAM in a healthcare context that presented a FRAM visualisation were included. The papers had to be written in English.

Two independent reviewers screened titles and abstracts, and subsequently the full text of selected papers. Data was extracted reporting on the steps of FRAM, how functions were supported by data, and the functions and couplings of the visualisations.

Sixty-eight papers were included, of which 20 (29%) reported at least one aspect of all four steps in FRAM. While most studies (85%) described how functions were supported by data, the methods used varied widely. Terminology was interpreted differently concerning variability, the output of variability and the effect of combined variability.

Most FRAM studies in healthcare do not report all steps of FRAM, and interpretations of key terms differ. FRAM studies should more clearly describe which steps of the method are conducted, and how data is collected and analysed. Refinement of FRAM guidelines, particularly on data use and terminology, would enhance consistency and comparability across studies.

CRD42024592858.

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

Qualitative evidence in ovarian cancer (OC) doctor-patient-caregiver communication is scarce. This study explored the information needs of patients and caregivers, comparing these to healthcare professionals’ (HCPs) perspectives, to uncover why gaps exist.

Qualitative, observational, multicentre and cross-sectional study with OC patients, their caregivers and HCPs. Qualitative data were collected through remote semistructured interviews. Themes were identified using thematic analysis. The EORTC QLQ-C30 and the disease-specific EORTC QLQ-OV28 were collected as quality of life measures and analysed descriptively.

Patients were recruited during their routine visits in five university hospitals in Spain.

Patients were ≥18 years of age in stages III or IV according to FIGO classification, were on first line treatment or recurrent and platinum sensitive with the most complex molecular profiles. 19 patients, 7 caregivers and 10 HCPs participated in the study.

Three main themes emerged: (a) patient information needs about the disease and pharmacological treatments, (b) patient information needs about non-pharmacological support and (c) caregiver information needs. The first theme was viewed through three differing attitudes (the Involved, Trusting and Indecisive), with HCPs’ agreeing with the attitudes but without adjusting transmitted information accordingly. For the second theme, patients expressly desired more information on psychosexual issues, psychological support and patient associations (PAs), and HCPs concurred with a need for more non-pharmacological support. Regarding the third theme, caregivers expressed not being engaged by HCPs, despite HCPs recognising their importance, with nurses being more empathetic than oncologists on this matter.

These results highlight the importance of understanding the information needs of OC patients and their caregivers. This understanding enables HCPs to provide better support, helping patients and caregivers make more informed health decisions.

Social prescribing is an approach to addressing non-medical issues affecting people’s health and well-being (eg, loneliness, housing or financial problems). It has gained international traction over recent years as complementary to medical care. A larger research project, comparing social prescribing across European countries, is considering how to tailor provision for the following groups: (a) LGBTIQ+persons, (b) refugees and first-generation immigrants and (c) older adults living alone. As part of this research, a qualitative study will address the question: What are the enabling and limiting factors associated with implementing social prescribing, across different European countries, from the perspective of key stakeholders?

Five European countries (Austria, England, Germany, Poland, Portugal) will be involved. Researchers from each country will conduct approximately 20 semi-structured interviews (total number will be 100). Interviewees will be people receiving, delivering, managing and funding/commissioning social prescribing. Interviews will be audio-recorded and transcribed. A cross-country analysis will be undertaken; framework analysis will support this process, with a chart developed in Excel in which data from across the five countries is summarised by the researchers involved. Summaries will be based on a thematic framework that researchers from the five countries develop together after initially analysing their own data.

Ethical approval was initially secured through the University of Oxford’s Medical Sciences Interdivisional Research Ethics Committee (IDREC 1806086) for data collection in England. This approved application was then used to secure ethics approval in Austria (through Ludwig Boltzmann Gesellschaft), Germany (through Bergische Universität Wuppertal), Poland (through Wroclaw Medical University) and Portugal (through NOVA University of Lisbon). Dissemination will include an academic journal article and presentation at relevant conferences. It will also include short videos, written summaries/policy briefs and an infographic.

This project has received funding from the European Union’s Horizon Europe Research and Innovation Programme under grant agreement No 101155873. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.

Musculoskeletal pain is a global issue affecting millions of individuals. Healthcare provider gender bias (HCP-GB) in pain management or treatment may have implications. This study aimed to systematically (1) identify and map the scientific and grey literature as it relates to HCP-GB in the assessment, diagnosis and management of musculoskeletal pain, and (2) identify current gaps that necessitate further research.

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

The following databases were searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (EBSCOhost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022 and updated in May 2025. Relevant grey literature was identified.

All screening was performed by two reviewers during title/abstract screening and full-text screening stages. Articles published in English, Spanish and German were included if they involved participants with musculoskeletal pain and examined HCP-GB as the dependent variable.

Two reviewers independently extracted data from the bibliometric, study characteristics and pain science variables. Results were descriptively mapped, and the frequency of concepts, population and characteristics was narratively reported.

21 full-text articles were included. All articles were published in North America and Europe. A total of 3694 healthcare providers from various specialty areas were examined. A majority of studies (57.1%; n=12) measured HCP-GB using written case vignettes, 33.3% (n=7) used case vignettes plus virtual human pictures/videos, and 9.5% (n=2) used real patients. The influence of patients’ sex in HCP pain assessment was reported in 28.5% (n=6) of the articles, while 42.9% (n=9) reported gender bias regarding HCP non-pharmacological treatment recommendations. Male patients were more likely to receive exercise recommendations for back pain and laboratory testing, whereas female patients received more psychological treatment recommendations and counselling from their HCP.

While there appears to be inconsistent use of the terms sex and gender, the literature informing this review suggests an existence of gender bias in the management of patients with musculoskeletal pain. Future research should be more purposeful in the use of sex/gender-related terms and consider exploring the impact of implicit bias training to rectify potential gender biases present in HCP.

Lesbian, gay, bisexual, trans, intersex, queer/questioning and other sexual and gender minorities (LGBTIQ+) face systemic barriers and discrimination in healthcare settings, leading to significant health disparities. These challenges persist in palliative and end-of-life care (PEOLC), where older LGBTIQ+ people often lack family support and experience social isolation. Despite the increasing ageing of the LGBTIQ+ population in Switzerland, there is limited evidence on their specific PEOLC needs. Additionally, healthcare providers’ knowledge and practices regarding LGBTIQ+ inclusivity in these settings remain understudied. This study aims to address these gaps by co-creating knowledge and developing best practice recommendations for inclusive PEOLC in Switzerland.

This study employs a mixed-methods participatory action research approach across three work packages (WPs). WP0 ensures participatory engagement through advisory boards, workshops and co-design processes across Switzerland’s four linguistic regions. WP1 investigates the palliative and PEOLC needs of LGBTIQ+ people and their (chosen) families through qualitative interviews (n30) and a quantitative survey embedded in the Swiss LGBTIQ+ Panel. WP2 explores healthcare providers’ perceptions and practices regarding LGBTIQ+ patients through qualitative interviews (n30) and a nationwide quantitative survey among palliative and PEOLC professionals. Data will be analysed using reflexive thematic analysis for qualitative data and multivariate regression models for quantitative data. Findings will be synthesised through a specific data integration framework, integrating community and healthcare perspectives.

This study has received ethical approval from the relevant Swiss Ethics Committees. The participatory approach promotes inclusivity, empowering LGBTIQ+ people and healthcare providers in shaping recommendations. Findings will be disseminated via peer-reviewed publications, policy briefs, stakeholder workshops and the co-created Rainbow Book, a best-practice guide for LGBTIQ+ inclusive palliative and PEOLC in Switzerland.

Adults with intellectual and/or developmental disabilities (IDD) experience higher rates of age-related health concerns, including dementia, than adults without disabilities. Despite this, current efforts to support brain health in ageing have often excluded this population. To address this gap, we will codesign, codeliver and evaluate a national virtual brain health education programme, Brain Health-IDD, for ageing individuals with IDD, family caregivers and health and social care providers.

This study will evaluate the Brain Health-IDD Program, an interactive virtual psychoeducation course codesigned and coled by an interdisciplinary team of clinicians and people with lived experience. Three participant groups will be recruited from across Canada: adults with IDD, aged 40 years and older; family caregivers who have a family member with IDD aged 40 years and older or who are themselves aged 60 years and older; and health or social service providers who support adults with IDD aged 40 years and older. Outcomes will be measured at baseline, postcourse and 3-month follow-up. Data will be collected through structured surveys, including both closed and open-ended questions, and focus group interviews.

Primary outcomes are participation, satisfaction and changes in knowledge and self-efficacy related to brain health among the three participant groups. Secondary outcomes for both adults with IDD and family caregivers include changes in health-related behaviours (social connections, sleep hygiene and physical activity), physical health, mental wellbeing, resilience and whether cognitive screening is initiated for adults with IDD and for caregivers. For health and social service providers, secondary outcomes include changes in brain health promotion practices and whether cognitive screening for older adults with IDD is initiated.

Analysis of open-text survey responses and qualitative data from focus group interviews will explore the experiences of participants with the Brain Health-IDD Program.

Institutional ethics approval was obtained from the Centre for Addiction and Mental Health Research Ethics Board. Programme findings and resources will be shared with advocacy groups, disability agencies, family caregiver organisations, clinicians and policymakers in the fields of disability, health and ageing at the provincial, national and international levels.

Glaucoma is the leading cause of irreversible blindness worldwide and the number of people with glaucoma is expected to increase to more than 112 million by the year 2040, making it a disease of public health interest. However, there is no consensus on public health indicators to monitor glaucoma care coverage. This scoping review aims to summarise published indicators for monitoring effective glaucoma care coverage globally, focusing on care needs, use of care services and outcomes achieved.

We will include studies that report the development and use of public health indicators for effective glaucoma care coverage in patients aged 18 years and older. Studies published from 1 January 2000, in all languages, will be included, provided they can be accurately and easily translated into English using Google Translate. Searches will be conducted by an information specialist on MEDLINE, Embase, Global Health and CENTRAL in the Cochrane Library. Two reviewers working independently will screen the search results, select studies for inclusion and extract data; any disagreements will be discussed with or resolved by a third reviewer. Data will be presented in tabular form, followed by a narrative synthesis based on the review objectives.

Ethical approval is not required as the review will use published data. Results will be published in a peer-reviewed journal, and summarised results will be available and contribute to the development of standardised glaucoma care indicators.

OSF registration on 19 May 2025: https://osf.io/zsyw9/

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

NCT07156552.

Drug poisoning, caused predominantly by fentanyl in the unregulated drug supply, is the leading cause of death among persons 10–59 years in British Columbia (BC), Canada. In March 2020, in response to the emergence of the COVID-19 pandemic, the province of BC released the Risk Mitigation Guidance (RMG) as a clinical tool for physicians and nurse practitioners, allowing prescribers to provide selective withdrawal management medications, such as hydromorphone, dextroamphetamine, diazepam and others, as a legal and regulated supply of pharmaceutical alternatives to individuals who were at-risk of COVID-19 and overdose. In July 2021, the government of BC released the prescribed safer supply (PSS) policy, extending the scope beyond the COVID-19 pandemic and initial medications offered under the RMG. Recent studies have shown clear benefits among people with a diagnosed opioid use disorder who were prescribed PSS, in reducing mortality, as well as improving retention on opioid agonist treatment for those who were coprescribed PSS medications. The objective of the analysis detailed in this protocol is to use a cross-model comparison approach, comparing two independently developed models which are currently used in public health institutions in BC, to estimate the impact of this policy on opioid overdose-related mortality, while also considering the potential negative impacts of PSS medication diversion to those who are opioid naïve. This project will add to the limited evidence-base on the population-level impact of pharmaceutical alternatives interventions to date.

We have identified two appropriate mathematical models to evaluate the impact of PSS on the number of opioid overdose-related deaths within BC from the inception of the programme (March 2020) until December 2022. We will use recently established guidelines on conducting a cross-model comparison to identify structural and parameter differences between the models and perform adaptation steps to generate the counterfactual scenarios. These will include creating additional health states for the population representing individuals receiving PSS, and parameterising the overdose risk, mortality and retention in the new compartments from a comprehensive population-level data set. Harmonisation will be conducted to ensure that both models evaluate the same scenarios with the same data. Further sensitivity analyses will be conducted to consider alternative counterfactual scenarios and changes to the population following the implementation of the intervention.

This study is exempt from research ethics board review, as outlined in the Tri-Council Policy Statement, because it relies on data that is available in the public domain and there is no possibility of identifying individual persons. Results of the model validation analysis will be distributed through peer-reviewed journals and knowledge translation materials posted on the websites of the BC Centre for Disease Control and Centre for Advancing Health Outcomes.

https://osf.io/kju2p/overview.

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.

Retrospective and prospective cohort study.

Secondary care RDC in London.

Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.

The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.

Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).

Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.

Police are frequently dispatched to a wide range of 911 calls, including mental and behavioural health crises, despite lacking the training, resources and time to respond effectively. In particular, people with serious mental illness are at elevated risk of experiencing excessive use of force, arrest and continued criminal legal involvement following police contact. Following the murder of George Floyd and other highly publicised police killings, Community Safety Response (CSR) programmes, staffed by unarmed peers, mental health professionals and other trained responders, have proliferated to provide non-police responses to mental and behavioural health and other quality-of-life concerns. CSR programmes have expanded rapidly, yet the evidence base remains fragmented and largely outside the peer-reviewed literature.

This scoping review will synthesise peer-reviewed and grey literature from 2020 to present on CSR programmes operating in North America. Guided by Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) standards, we will search multiple databases (Medline, PsycINFO, Embase, SocIndex, Web of Science, Policy Commons) and employ complementary grey literature search strategies, including targeted website searches, reference tracking and review of internal and external reports and evaluations. Inclusion criteria require that programmes provide non-police first response to calls traditionally served by law enforcement and include information on programme operations or outcomes. Two reviewers will independently screen and extract data on process metrics including operational characteristics, dispatch, funding, services provided and outcomes such as populations served, diversion from police, service linkage and use of force.

No ethical review for this study is required as it will not include human subjects or any identifiable information. Findings will provide the first national synthesis of CSR programme models, operations and outcomes. Results will inform policy-makers, practitioners, researchers and community members. Findings will be disseminated through peer-reviewed publications and public-facing products to support implementation, scale-up and sustainability of CSR programmes.

To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.

A cross-sectional study.

Five public hospitals in Eastern Ethiopia.

Healthcare professionals (N=582).

An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.

CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.

The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.