Developing a core outcome set for gender-affirming healthcare in transgender and gender diverse adults in Sweden using the Delphi approach: a study protocol

Introduction
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.

Methods
Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.

Analysis
The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.

Ethics and dissemination
The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.

Trial registration number
COMET registration number 3223.

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A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study)

Introduction
Septic shock-associated acute kidney injury (AKI) is known to carry a poor prognosis. The present study aims to evaluate the effect of absorptive blood purification on haemodynamic status and clinical outcomes in patients with septic shock-associated AKI.

Methods and analysis
This multicentre, randomised controlled trial will evaluate an adsorbent filter (oXiris) in patients with abdominal septic shock requiring continuous renal replacement therapy (CRRT). The study plans to recruit 192 participants from intensive care units, who will be randomly assigned to either the intervention group (oXiris set) or the control group (ST 150 set). The primary endpoint is the reduction in norepinephrine equivalence following the initiation of CRRT. Key secondary endpoints include changes in cardiac index and systemic vascular resistance index, as measured by pulse indicator continuous cardiac output, following CRRT initiation, as well as overall survival and kidney recovery rates.

Ethics and dissemination
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The Ethics Committee of Shanghai Jiaotong University School of Medicine, Renji Hospital (no. LY-2024–082-B) approved this study on 27 May 2024. The results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number
NCT06504316 (https://clinicaltrials.gov/study/NCT06504316).

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Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial – a protocol for a multicentre randomised controlled trial

Introduction
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

Methods and analysis
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

Ethics and disseminationf
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

Trial registration number
NCT06678438.

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Tumore della prostata: presentata la campagna 'Allo Specchio della Salute' [Oncologia-Ematologia]

In Italia, il carcinoma della prostata rappresenta la neoplasia più diffusa tra gli uomini over 50, incidendo per circa il 30% su tutti i tumori maschili, con 40.192 nuovi casi stimati solo nel 2024. È stata presentata oggi, in Senato la campagna di sensibilizzazione ‘Allo Specchio della Salute – uno spazio di confronto sul carcinoma prostatico’, pensata per coinvolgere l’intera comunità nel dibattito intorno alla gestione e cura di questa patologia. Un’intera giornata dedicata al carcinoma della prostata suddivisa in due appuntamenti sinergici e xomplementari: la conferenza stampa seguita dalla campagna di awareness.

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Impact of vaccine mandates and removals on COVID-19 vaccine uptake in Australia and international comparators: a study protocol

Background
Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.

Methods and analysis
This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.

Ethics and dissemination
The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.

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Interventions that use highly visual social media platforms to tackle unhealthy body image in adolescents and young adults: a systematic review protocol

Introduction
Social media sites are increasingly used to assess and treat different mental health problems in adolescents and young adults. However, it is still unclear which social network sites are the most used for this purpose and what interventions for tackling unhealthy body image have been validated. This systematic review will assess evidence on the effectiveness of social media interventions in improving unhealthy body image among adolescents and young adults.

Methods and analysis
Five databases, including Embase, Scopus, MEDLINE, Web of Science (Core Collection) and PsycINFO, will be consulted, with a publication window starting in 2011 and ending on 31 October 2024. Rayyan software will detect and eliminate duplicates. We will include only studies based on social media-based interventions for adolescents and young adults with body image problems. Two independent reviewers will screen titles, abstracts and full-text articles, resolving conflicts through discussion with a third reviewer as needed. The two reviewers will complete the risk of bias assessments for each included study, using the Joanna Briggs Institute critical appraisal checklists for randomised controlled trials and quasi-experimental studies. We will report on the characteristics of studies, participants and interventions in descriptive narrative form, along with the results from the assessment of social media interventions.

Ethics and dissemination
Universidad Cesar Vallejo’s ethics committee approved this systematic review protocol as part of a wider project (code 100-CEI-EPM-UCV-2022). Results will be shared via social media to engage stakeholders and promote awareness of body image issues.

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Multisectoral coordination during the COVID-19 pandemic: practices, challenges and recommendations for future preparedness–a systematic literature review protocol

Introduction
The COVID-19 pandemic amplified the need for robust multisectoral coordination; yet the specific mechanisms, benefits and challenges of such collaboration particularly in low- and middle-income countries (LMICs) remain poorly synthesised. This review aims to delineate the key elements, benefits, challenges and improvement strategies of multisectoral coordination during COVID-19 and to compare patterns between LMICs and high-income countries (HICs).

Methods and analysis
Eligible studies will include empirical qualitative, quantitative or mixed-methods research published in English between 1 January 2020 and 15 August 2024 that examines formal coordination mechanisms (eg, task forces, public-private partnerships, inter-agency committees) within the context of COVID-19. Searches will be conducted across PubMed, EBSCOhost, Emerald Insight, Google Scholar and selected grey-literature repositories. Citation chaining will be employed to identify additional sources.
Two reviewers will independently screen all records using Covidence, applying pre-piloted eligibility criteria to 5% of citations and proceeding only if inter-rater reliability achieves ≥0.70. Data will be extracted into a Consolidated Framework for Implementation Research (CFIR)-informed template. Qualitative data will be analysed through framework synthesis, structured by the five CFIR domains. Quantitative data will be narratively summarised and, where outcomes are sufficiently similar across at least two studies, synthesised using a fixed-effect model.
Risk of bias will be assessed using Critical Appraisal Skills Programme for qualitative and Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. Studies with serious or critical risk will be excluded from pooling. Subgroup analyses (LMIC vs HIC), sensitivity analyses (model and risk) and confidence grading using Confidence in the Evidence from Reviews of Qualitative Research and Grading of Recommendations, Assessment, Development and Evaluations will be conducted.

Ethics and dissemination
No primary data will be collected; thus additional Research Ethics Committee approval is unnecessary. The results will be disseminated via open-access publication, conference presentations and policy briefs for Nairobi County health stakeholders.

PROSPERO registration number
CRD42023466849.

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Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study

Background
Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.

Objective
This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.

Design
A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p

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Use of an electronic medication management application to support Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC): a study protocol for a parallel cluster randomised controlled trial

Introduction
Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.

Methods and analysis
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.

Ethics and dissemination
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.

Trial registration number
ACTRN12624001409561.

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Quick pathway for patients with high pRobability of dislocatEd hemiarthroplasty or total hip arthroplasty to minimise the time from hospital aDmission to redUCtion of the prosthesis (Q-REDUCE): protocol for a prospective cohort study

Introduction
Patients with total hip arthroplasties and hemiarthroplasties are both subject to hip dislocations. Although the incidence of complications differs, both patient groups suffer immediate high pain and need acute treatment. The purpose of this study is to design a fast-track pathway for patients with a dislocated hip prosthesis primarily to reduce the time from arrival to reduction and the total hospitalisation time. The secondary aim is to investigate whether quicker prosthesis reduction influences subsequent hip function and quality of life, reduces pain experience immediately and in the long term, and increases patient satisfaction.

Methods and analysis
This is a prospective observational cohort study, initiated on 1 December 2024 and continuing for 2 years. During the first year, patients admitted to the University Hospital of Southern Denmark, Esbjerg, will follow the current standard treatment pathway. After 1 December 2025, a newly developed treatment pathway (fast-track) will be adhered to. Based on a sample size calculation, 120 patients will be included. The main clinical outcomes (time to reduction (primary outcome), total hospitalisation) are registered from patient files. The patients are followed up for 1 year to measure patient-reported outcomes.

Ethics and dissemination
The study is conducted as a treatment quality study and is locally approved by the Executive Board at the University Hospital of Southern Denmark. The results will be published in relevant national and/or international journals and presented at relevant congresses.

Trial registration number
NCT06639334.

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Correction: pancreatic STAT5 activation promotes KrasG12D-induced and inflammation-induced acinar-to-ductal metaplasia and pancreatic cancer

Lin Y, Pu S, Wang J et al. Pancreatic STAT5 activation promotes KrasG12D-induced and inflammation-induced acinar-to-ductal metaplasia and pancreatic cancer. Gut 2024;73:1831–3.
A magnified version of figure 3E was incorrectly used for figure 7L. The article has been amended to show the correct version of figure 7L.
A magnified version of figure 2D was incorrectly used for figure 4A. The article has been amended to show the correct version of figure 4A.
In the view of the editor, these errors and their corrections do not alter the findings of the article.

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Definition and key concepts of high-performing health systems: a scoping review

Objectives
To determine how high performing is defined in relation to a health system and chart the literature on the definitions and key concepts of high-performing healthcare systems.

Design
Scoping review.

Data sources
MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to July 2024. The grey literature was also searched.

Eligibility criteria
Included studies reported on health systems and high performance to identify explicit definitions, research outcomes and knowledge gaps.

Results
Two reviewers independently screened 5721 citations and 507 full-text articles, resulting in the inclusion of 35 primary articles and 47 companion documents in the review. Three independent definitions for a high-performance health system were identified. 24 research studies reported outcomes on the elements of a high-performing health system (58%), system evaluation (32%) and tool development or validation (10%). Knowledge gaps identified were the lack of a common definition, a lack of common indicators, strategies for moving evidence into policy and practice, and difficulties with comparisons across health systems.

Conclusions
We found limited definitions and a lack of empirical evidence on our topic. There is an opportunity for primary research in the area of health systems and high performance.

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Associations between optimism and mental health in postradiotherapy cancer survivors: a cross-sectional survey study

Objectives
Cancer patients often experience psychological distress, while optimism has been identified as a protective factor. However, the mental health of postradiotherapy cancer survivors and its association with optimism remain largely unexplored. This study assesses the mental health status and optimism levels of postradiotherapy cancer survivors and evaluates their associations.

Design
Cross-sectional survey study.

Participants
114 Hong Kong cancer survivors who (1) were aged 18 years or above and (2) had received radiotherapy for their cancer treatment and finished the radiotherapy within the previous 3 years (2021–2024).

Outcome measures
Mental health was assessed using the Chinese Depression, Anxiety and Stress Scale, and optimism was measured using the Revised Life Orientation Test. Correlation and regression analyses were used to examine the associations between these measures.

Results
Participants reported overall low optimism with mild to moderate depression, anxiety and stress. Strong negative correlations were identified between optimism and depression (r=–0.833, p

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