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PUTRA-CV study protocol: a multicentre observational study of ethnic-specific genetic variants and dietary patterns in relation to lipoprotein(a) levels and their association with coronary artery disease severity in Malaysian adults

Por: Pannirselvam · S. · C Thambiah · S. · Appannah · G. · Ling · K. H. · Samsudin · I. N. · Hooper · A. J. · Yusoff · M. R. · Zakaria · A. F. · Razali · R. · Kiong · G. L. S. · Zahari Sham · S. Y. · Lai · Y. Y. · Abdul Rahman · T. H. · Zainal Abidin · I.
Introduction

Although low-density lipoprotein cholesterol (LDL-C) is established as the primary cardiovascular disease (CVD) risk factor, some individuals with LDL-C within desirable limits still develop coronary artery disease (CAD). Lipoprotein(a) (Lp(a)) has emerged as a genetically determined independent risk factor for CVD. This study aims to investigate Lp(a) by determining its association with coronary artery stenosis severity, identifying its ethnic-specific genetic determinants and assessing its relationship with an energy-dense dietary pattern.

Methods and analysis

The PUTRA-CV study is a 3-year, multicentre, case-control observational study involving adult patients who have undergone coronary angiography. The primary outcome is the association between Lp(a) levels and the severity of angiographic CAD (assessed by Gensini or Syntax score). Secondary outcomes include the frequencies of Lp(a)-associated single nucleotide polymorphisms (SNPs) (rs10455872 and rs3798220) and the association between dietary patterns and Lp(a) levels. Lp(a) will be measured using a particle-enhanced immunoturbidimetric method, and SNPs will be genotyped using high-resolution melting. Dietary intake will be assessed using a validated semiquantitative food frequency questionnaire. Data will be analysed using SPSS. Descriptive statistics will be used to summarise population characteristics. Bivariate analyses will use chi-square (2), independent t-tests or Mann-Whitney U tests as appropriate. The independent association between Lp(a) and coronary artery stenosis severity will be determined using multivariable logistic regression, adjusting for confounders. Empirically driven dietary patterns will be derived using reduced rank regression, and their association with Lp(a) will be assessed. For genetic analysis, allele frequencies of the LPA SNPs rs10455872 and rs3798220 will be calculated and compared between cases and controls.

Ethics and dissemination

Ethical approval has been obtained from the ethics committees of the Ministry of Health Malaysia (NMRR ID-24-00877-2ID-IIR), Universiti Putra Malaysia (JKEUPM-2024–246), Universiti Teknologi MARA (REC/07/2024-OT/FB/2) and Universiti Malaya Medical Centre (MREC ID NO: 2 02 453–13692). The findings will be disseminated via peer-reviewed journals and conferences.

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d
Objective

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

Design

A synthesis of qualitative research using meta-ethnography.

Data source

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

Eligibility criteria for selecting studies

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

Results

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

Conclusions

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

PROSPERO registration number

CRD42022362903.

Analysis of global, regional and national trends in the burden of soft tissue and other extraosseous sarcomas from 1990 to 2021: A systematic analysis of the global burden of disease study 2021

by Xing Chen, Zhixiong Zhang, Jiwei Xiang, Ruliu Xiong, Xingmao Zhou

Background

Soft tissue and other extraosseous sarcomas (STSES) are rare malignant tumors originating from mesenchymal tissues with complex etiologies. A systematic analysis of global burden trends is urgently needed.

Methods

Utilizing the Global Burden of Disease (GBD) 2021 database, we assessed STSES incidence, mortality, disability-adjusted life years (DALYs), age-standardized incidence rate (ASIR), age-standardized mortality rate (ASMR), and age-standardized DALY rate (ASDR) across regions and countries from 1990 to 2021, stratified by sociodemographic index (SDI). Spatiotemporal models, Joinpoint regression (to calculate average annual percentage changes, AAPC), and decomposition analysis were employed to evaluate the impacts of population growth, aging, and epidemiological factors on disease burden.

Results

In 2021, there were 96,201 new STSES cases globally, resulting in 50,203 deaths and 1.678 million DALYs. While age-standardized rates (per 100,000 person-years) showed declining trends (AAPC for ASIR = −0.13, ASMR = −0.60, ASDR = − 0.94), absolute burden increased by 77.97% due to population growth. Males exhibited consistently higher burden than females, with incidence peaking at 55–74 years. Notably, young females (10–29 years) transiently surpassed males in DALYs. Significant regional disparities emerged: High-SDI regions (e.g., Western Europe) demonstrated lower ASMR attributable to advanced diagnostics and treatment, whereas low-SDI regions (e.g., Uganda, ASMR = 1.96/100,000) faced poorer prognoses due to healthcare deficiencies. SDI exhibited a nonlinear association with disease burden—middle-SDI regions (0.4–0.8) showed rising ASIR, potentially linked to industrial pollution and improved diagnostic capabilities. These findings underscore the critical need for context-specific prevention and resource allocation strategies to address the evolving global STSES burden.

Conclusions

The global STSES burden is predominantly driven by population growth, necessitating targeted prevention strategies addressing occupational exposures in males and subtype-specific risks among young females. While high-SDI regions demonstrate mortality reduction through precision oncology, low-SDI regions require urgent improvements in healthcare accessibility to mitigate survival disparities. Persistent regional heterogeneity underscores the imperative for international collaboration to standardize diagnostic protocols and ensure equitable resource allocation. These insights emphasize the need for stratified surveillance systems and translational research to optimize context-specific intervention frameworks.

Access to oxytocin, misoprostol, heat-stable carbetocin and tranexamic acid for management of postpartum haemorrhage in the Democratic Republic of the Congo, India and Kenya: a cross-sectional survey of drug availability and pricing

Por: Metzler · M. · Stationwala · M. · Mukumbayi · P. · Kibonge · S. · Doi · N. · Coffey · P.
Objectives

The aim was to assess point-in-time stock availability and pricing of drugs used for postpartum haemorrhage management (oxytocin, misoprostol, heat-stable carbetocin and tranexamic acid (TXA)).

Design

Cross-sectional point-in-time survey using an adapted version of the WHO/Health Action International methodology.

Setting

In public, for-profit and not-for-profit private health facilities and in pharmacies in the Democratic Republic of the Congo (DRC), India and Kenya.

Participants

211 health facilities in the DRC (n=63), India (n=76) and Kenya (n=72).

Primary and secondary outcome measures

Availability was calculated as a mean percentage of facility types where each medicine was observed on the day of data collection. Average procurement prices were calculated by obtaining the current purchase price per drug at each facility and then averaging prices across all facility types.

Results

Availability of the four medicines was limited, and only oxytocin in the DRC met the WHO’s benchmark of 80%. Across all countries, availability of oxytocin, misoprostol and TXA was lower in public health facilities than in other facility types, indicating an important gap. Where the four medicines were available, non-quality-assured products were predominant across the three countries. The average facility procurement prices in India and Kenya were reported to be lower than those in the DRC.

Conclusions

Availability of oxytocin, misoprostol, heat-stable carbetocin and TXA was suboptimal and varied by facility type and geography, and similar trends were found across the four drugs. This indicates that access strategies should be tailored to each drug, geographical area and facility type. Strategies to improve commodity access in public-sector facilities will be especially important, as well as improving the availability of quality-assured products, possibly through value-based procurement practices.

Are we closing the gender gap in academic oncology? An observational study of gender disparities in participant engagement at the ASCO 2024 annual meeting

Por: Puhr · H. C. · Cammarota · A. · Ettaieb · M. · Flierman · I. · Gisinger · T. · Glas · A. · Guven · D. C. · Siebenhüner · A. · Steindl · A. · Szydlik · V. · Valpione · S. · Yip · M. · van Laarhoven · H. W. M.
Objective

Despite global efforts, gender disparities in oncology may persist. Understanding these disparities within the context of major conferences can inform strategies to promote gender inclusiveness in the field. This study evaluates the participation of women and men at the American Society of Clinical Oncology (ASCO) 2024 congress, focusing on chairs, speakers and audience questioners.

Design

Observational study.

Setting

152 recorded sessions of the ASCO 2024 annual meeting, one of the largest conferences in the field of oncology, available on the ASCO website.

Participants

Individuals serving as chairs, speakers and audience members who asked questions.

Primary and secondary outcome measures

In this observational study, gender for chairs, speakers and audience questioners across 152 sessions of the ASCO 2024 congress was assessed by two independent reviewers using audio and video recordings. Speaking times for questions and responses were also evaluated. Statistical analyses, including 2 and unpaired t-tests, were conducted to analyse the data.

Results

Women were well represented as chairs (n=124) and speakers (n=402) in 66% and 95% of sessions, respectively. However, only 21% of questions from the audience were posed by women, while 37% of questions were asked by men and 42% online or by chairs/speakers. Women were more likely to pose questions when the sessions were chaired by women (71% vs 53%; p=0.047). There were no statistically significant gender disparities concerning speaking time (questions: p=0.30; responses: 0.53). The response dynamics indicated a pattern of gender homogeneity, with individuals more frequently responding to questions from their own gender.

Conclusions

While the balanced representation of women in leadership roles at the ASCO 2024 congress reflects positive development in gender equality, disparities in active participation persist. These findings underscore the need for strategies that not only promote women in visible roles but also foster an environment that supports their active engagement in scientific discussions.

Design of aSpiration based thrombectomy in acUte large vessel oCclusive sTroke with dIfferent etiOlogies: a real-world multiceNtre (SUCTION) study

Por: Yan · P. · Li · M. · Yang · L. · Song · C. · Liu · S. · Chen · X. · Chen · S. · Yuan · H. · Li · K. · Guo · Q. · Liu · H. · Lu · Y. · Wang · F. · Mu · L. · Li · Z. · Han · J. · Sun · Y. · Qin · H. · Jiao · L. · Sun · Q. · SUCTION study Investigators
Introduction

Intracranial atherosclerosis is the main cause of stroke globally, with acute large vessel occlusive (LVO) stroke being a predominant contributor to stroke-related mortality. In recent years, aspiration thrombectomy (AT) has emerged as a novel therapeutic method for treating acute LVO stroke. The purpose of this study aims to investigate the safety and efficacy of AT alone or combined with stent retriever thrombectomy (SRT) in the treatment of acute LVO stroke

Methods and analysis

This is a multicentre and observational real-world study involving patients diagnosed with acute LVO stroke. Participants will be treated with AT alone or combined with SRT. According to the actual annual number of embolectomy in the sub-centre and the research years, the sample size of this study is estimated to be 400 patients, of which 300 patients of anterior circulation lesions and 100 patients of posterior circulation lesions are planned to be recruited, being considered that the incidence of posterior circulation is about 20–25%. Clinical data, including baseline characteristics, intraoperative details, postoperative outcomes and follow-up results, will be systematically collected using an Electronic Data Capture system over a follow-up period of 3 months. The primary efficacy endpoint is the rate of excellent functional outcome (modified Rankin Scale score range 0–3) after 90 days, and the successful recanalisation confirmed by digital subtraction angiography. The primary safety outcome is symptomatic intracranial haemorrhage within 48 hours (National Institutes of Health Stroke Scale score increase ≥4). This study will provide us with powerful guidance for the treatment of acute LVO stroke with different aetiologies.

Ethics and dissemination

This study protocol was approved by the Ethics Committee on Human Experimentation at Shandong Provincial Hospital Affiliated to Shandong First Medical University (approval number: SWYX:2022–1025). All the participating sites have received the ethics approval. The outcomes will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ChiCTR2200065172.

Understanding the game experiences and mental health of youth: protocol for the Game-in-Action Quebec cohort study

Por: Paquin · V. · Raugh · I. · Davies · M. · Lepage · M. · Lavigne · K. M. · Dion · J. · Abdel-Baki · A. · Shah · J. L. · Iyer · S. N. · Ferrari · M.
Introduction

Video games have been linked to a range of positive and negative effects on the mental health of adolescents and young adults. However, to better understand how games affect the mental health of young people, their use and experiences must be situated in the sociocultural and personal life contexts of individuals. Drawing from a cultural-ecosocial approach, this study combines cross-sectional and digital phenotyping measures to examine the effects of video games on the mental health of youth.

Methods and analysis

Participants will be young people aged 16–25 years from the community and living in the province of Quebec, Canada. An initial sample of 1000 youth will complete a cross-sectional survey online, including measures of socio-demographic context, gaming practices and experiences, streaming practices and experiences, as well as personality and well-being. Qualitative questions will explore personal views on games and mental health. A subsample of 100 participants will be selected for digital phenotyping, including daily surveys of well-being, gaming, streaming and social experiences, combined with passive mobile sensing (eg, geolocation). Analyses will include regression and mixed models for quantitative data, reflexive thematic analysis for qualitative data, and an integration of quantitative and qualitative results using participatory methods.

Ethics and dissemination

The study received ethical approval from the Institutional Review Board of McGill University (24-02-015). The dissemination of results will be conducted in partnership with a multi-stakeholder advisory committee, including youth who play video games, and will involve peer-reviewed publications, presentations to policymakers in Quebec, and workshops for clinicians and researchers.

Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer surv

Por: De Groef · A. · Dams · L. · Moseley · G. L. · Heathcote · L. C. · Wiles · L. K. · Catley · M. · Vogelzang · A. · Hibbert · P. · Morlion · B. · Van Overbeke · M. · Tack · E. · Van Dijck · S. · Devoogdt · N. · Gursen · C. · De Paepe · A. L. · Mertens · M. · van Olmen · J. · Willem · L. · Tja
Introduction

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

Methods and analysis

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

Trial registration number

ClinicalTrials.gov Identifier: NCT06308029.

Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication--protocol for an international mixed-method consensus study (PrECiSIOn)

Por: Nasa · P. · Yurttas · T. · Battaglini · D. · Blot · S. · Fernandez-Bustamante · A. · Gama de Abreu · M. · van Meenen · D. M. · Myatra · S. N. · Serpa Neto · A. · Oppong · R. · Paulus · F. · Renukappa · S. · Schultz · M. J. · Slutsky · A. S. · Hemmes · S. N. T. · for the PrECiSIOn-gro
Introduction

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

Methods

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Analysis

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.

Ethics and dissemination

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

Trial registration number

NCT06916598 (clinicaltrials.gov).

Erector spinae plane block versus intercostal nerve block for postoperative analgesia: a protocol for systematic review and meta-analysis

Por: Wu · Y. · Xiong · Z. · Zhang · D.
Introduction

An increasing number of randomised controlled trials (RCTs) have compared the analgesic effects of erector spinae plane block with those of intercostal nerve block for postoperative analgesia in various surgeries, but the results have been inconsistent. This protocol of a systematic review and meta-analysis aims to evaluate whether the analgesic effects of erector spinae plane block are superior to those of intercostal nerve block.

Methods and analysis

A comprehensive search will be conducted by two authors via PubMed, EMBASE, the Cochrane Library and Web of Science from inception to 25 December 2025. No search language restrictions will be set. We will include RCTs that compared the analgesic effects of erector spinae plane block with those of intercostal nerve block after surgery. Total opioid consumption over 24 hours postoperatively will be the primary outcome. The duration of analgesia, pain intensity and incidence of adverse effects will be the secondary outcomes. RevMan V.5.4 software will be used to conduct the statistical analysis. The Cochrane Collaboration’s tool will be used to assess the risk of bias. The I2 test will be used to assess heterogeneity. Subgroup analysis and meta-regression will be performed to explore the source of heterogeneity. Sensitivity analysis will be used to examine the reliability of the pooled data. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to recommend evidence quality. Publication bias will be evaluated via Egger’s test.

Ethics and dissemination

Ethical approval is not applicable. The results will be publicly published on completion.

PROSPERO registration number

CRD420251073023.

Association between initial lipid and lipoprotein levels, oxidative stress indicators and clinical efficacy of intravenous methylprednisolone in moderate-to-severe thyroid-associated ophthalmopathy: protocol for a real-world prospective cohort study

Por: Liu · S. · Lu · S. · Xiong · W. · Zhang · F.
Background

Thyroid-associated ophthalmopathy (TAO), the most common orbital disease in adults, is an autoimmune disease of the orbital and periorbital tissues. Typical ocular symptoms of TAO include periorbital oedema, conjunctival congestion and oedema, eyelid retraction, exophthalmos, restrictive strabismus, etc. Hypercholesterolaemia is considered one of the modifiable risk factors of TAO. However, it is unclear whether lipid levels are related to TAO activity and severity and the intravenous glucocorticoids (GC) therapeutic effect. The study aims to evaluate the association between initial lipid and lipoprotein levels, the clinical features of TAO and the efficacy of intravenous methylprednisolone in patients with moderate-to-severe TAO, as well as to explore the oxidative stress-related mechanisms involved.

Methods and analysis

This real-world prospective cohort study will recruit 178 patients with moderate-to-severe TAO who receive two intravenous methylprednisolone regimens, respectively. The primary outcome is the improvement in the composite index at 3 months after baseline treatment, with secondary outcomes including other ocular features, changes in serological characteristics and major adverse events.

Ethics and dissemination

The study protocol was approved by the ethics committees of Xiangya Third Hospital of Central South University (Kuai241012) on 29 November 2024. The study will be conducted according to the guidelines of the Declaration of Helsinki. Participants will be informed of the purpose and content of the study and will complete a written informed consent form before being recruited. The findings will be published in peer-reviewed journals as well as in reports of relevant conferences.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2400094094). Registered on 17 December 2024.

Impact of increased resident preparation time on internal medicine rounds in a tertiary teaching hospital: a time-motion study with a before-and-after comparison

Por: Garnier · A. · Cominetti · F. · Monti · M. · Marques-Vidal · P. · Bastardot · F. · Vollenweider · P. · Waeber · G. · Castioni · J. · Gachoud · D. · Kraege · V.
Objectives

To determine whether postponing daily medical rounds to provide additional preparation time for residents reduces round duration and alters time allocation during rounds, with the hypothesis that increased preparation leads to more efficient rounds without reducing patient contact.

Design

Time and motion study with a before-and-after comparison.

Setting

Internal medicine division of Lausanne University Hospital, a Swiss tertiary teaching hospital.

Participants

75 residents; 60% women; mean age of 29.6 years and 3.0 years of training.

Intervention

In 2017, the daily work schedule was reorganised by postponing rounds from 09:00 to 10:00 and moving educational sessions to the afternoon, thereby freeing 90 min to prepare patient cases before rounds.

Primary and secondary outcome measures

The primary outcome was the duration of rounds and the proportion thereof spent with patients, using computer systems or in discussion with colleagues. Secondary outcomes included the detailed distribution of resident activities during the officially scheduled round period, particularly time dedicated to supervision, teaching and administrative tasks.

Results

Round duration decreased from 142 min per shift (95% CI 128 to 156) in 2015 to 112 min (95% CI 101 to 124) in 2018 (p=0.001). The proportion of round time spent directly with patients remained stable at 47%. Computer use during rounds decreased from 43% to 32% (p

Conclusions

Postponing rounds to allow more preparation time was associated with shorter, possibly more efficient rounds, reduced computer use in patient presence and increased supervision and teaching.

Trial registration number

ISRCTN69703381, https://doi.org/10.1186/ISRCTN69703381 (registration date: 24 April 2018).

Deconstructing resuscitation training for healthcare providers: a protocol for a component network meta-analysis

Introduction

The necessity of enhancing resuscitation training has been encouraged by The International Liaison Committee on Resuscitation and the American Heart Association to reduce mortality, disability and healthcare costs. Resuscitation training is a complicated approach that encompasses various components and their mixture. It is essential to identify the most effective of these components and their combinations, to measure the corresponding effect size and to understand which participant groups may enjoy the greatest advantage.

Methods and analysis

We will systematically search 12 databases and two clinical trial registries for randomised controlled trials (RCTs) that examine different resuscitation training methods from inception to April 2025. The analysis will be carried out using the standard network meta-analysis and component network meta-analysis models. Resuscitation skills of staff will be the primary outcome of this analysis. Paired reviewers will independently screen and extract data. A consensus will be sought with the principal investigators to resolve any disagreements that cannot be achieved through regular meetings. Each intervention in each RCT will be decomposed according to its constituent components, such as delivery method, interactivity, teamwork, digitalisation and type of simulator. The analysis will be conducted using the frequentist and bayesian approach in the R environment. RoB V.2.0 and Confidence in Network Meta-Analysis will, respectively, be used to assess the risk of bias and the certainty of the evidence.

Ethics and dissemination

As we will use only aggregated secondary data without individual identities, ethical approval is not required. Results of this review will be shared through a peer-reviewed publication and presentation of papers at any relevant conferences.

PROSPERO registration number

CRD42024532878

Effect of acupoint stimulation after caesarean section: a protocol for systematic review with meta-analysis and trial sequential analysis

Por: Xiong · F.-j. · Zhao · W. · Jia · S.-j. · Song · K. · Lei · X.-h. · Jia · W.-n. · Chen · L.-m. · Nie · H.-m.
Introduction

Although caesarean sections (CSs) are essential for the management of obstructed labour and other obstetric complications, postoperative pain, delayed recovery and complication risks continue to be significant challenges in perioperative management. Improvements in traditional medications and surgical techniques have helped, yet issues, including medication side effects and extended recovery times, persist. Therefore, it is particularly important to seek non-pharmacological interventions, such as acupoint stimulation, to optimise the perioperative management of CS. The aim of this systematic review protocol is to synthesise the available evidence and assess the effect of acupoint stimulation in the perioperative period of CS.

Methods and analysis

We plan to search PubMed, Web of Science, EMBASE, Scopus, the Cochrane Library and China National Knowledge Infrastructure, from their inception to August 2025. Primary outcome indicators will include pain, time to first defecation, time to first bowel movement and time to return of bowel sounds. Secondary outcome indicators will include postoperative complications, such as nausea and vomiting, bloating, anxiety and depression, as well as length of hospital stay and morphine consumption. Subgroup analyses, meta-regression and sensitivity analyses will be used to investigate the potential sources of heterogeneity and to test the stability of the results. Trial sequential analysis will be introduced to enhance the reliability of the evidence.

Ethics and dissemination

No ethical approval is required as this study synthesises the existing published data. Results will be disseminated through peer-reviewed publications and conference presentations. Any protocol amendments will be documented in PROSPERO and detailed in the final publication.

PROSPERO registration number

CRD42024558572.

Application of protein A immunoadsorption in thyroid-associated ophthalmopathy (TAO): study protocol for a non-randomised controlled clinical trial

Por: Lu · S. · Chen · H. · Liu · S. · Zhang · F. · Xiong · W.
Introduction

Thyroid-associated antibodies are crucial in the occurrence and development of thyroid-associated ophthalmopathy (TAO). Protein A immunoadsorption is a more specific and plasma-independent antibody removal technology, which has been used in a variety of autoimmune diseases, such as systemic lupus erythematosus and antineutrophil cytoplasmic antibodies associated vasculitis (ANCA-associated vasculitis). This study protocol aims to verify the efficacy and safety of the application of protein A immunoadsorption in TAO to provide a new method for the treatment of this pressing disease.

Methods and analysis

This clinical trial is a single-centre, prospective, non-randomised controlled trial in China. 174 screened patients with moderate to severe active TAO will be divided into three groups: protein A immunoadsorption treatment group, methylprednisolone hormone pulse group and tocilizumab injection group, with 58 patients in each group. They will undergo 1-year treatment and follow-up. The primary outcomes include: (1) improvement of eyelid retraction greater than 2 mm; (2) a reduction of the Clinical Activity Score (CAS) by ≥1 point; (3) the exophthalmos retreats to ≥2 mm. The secondary outcomes include: (1) Improvement of Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire score after 6 months of treatment; (2) reduction of thyroid-associated antibody titre. Treatment is considered effective if two or more primary outcomes are met or if one primary outcome and two secondary outcomes are met. Otherwise, the treatment is ineffective. The evaluation of the results is based on the most severely affected eye, and the efficacy is evaluated by the outcome of this eye at the end point.

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board (IRB) of Third Xiangya Hospital, Central South University. Findings will be reported to (1) participating patients; (2) funding bodies, institutes and the hospital; (3) presented at local, national and international conferences and (4) disseminated by peer-review publications.

Trial registration number

ChiCTR 2500095461. Registered on 7 January 2025; https://www.chictr.org.cn/.

Efficacy and safety of intensive triglyceride-lowering therapy on reducing recurrence of hypertriglyceridemia-associated pancreatitis (REDUCE): protocol for a multicentre, randomised controlled trial

Por: Xu · X. · Ding · L. · Chen · T. · Liu · G. · Deng · L. · Sheng · J. · Zhu · C. · Sheng · J. · Zhang · H. · Wu · D. · He · W. · Xia · L. · Luo · L. · Xiong · H. · Lu · N.-H. · Ke · L. · Zhu · Y. · the Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG) · Zhu · Ding · Xu · Huang · Lei · Wu
Introduction

Recurrence of hypertriglyceridaemia-associated acute pancreatitis (HTG-AP) is common. Uncontrolled HTG after hospital discharge is an important risk factor for recurrence. However, the optimal triglyceride (TG) goal of lipid-lowering therapy for outpatients remains unclear. The efficacy and safety of intensive TG-lowering therapy on reducing recurrence of HTG-AP trial aims to determine whether intensive TG-lowering therapy (with a TG goal of

Methods and analysis

This is an investigator-initiated, multicentre, open-label, parallel, superiority, randomised, controlled trial. Adult patients who have been successfully treated and discharged from their index episode of HTG-AP will be screened for eligibility after a 4-week to 3-month run-in period in the outpatient setting, and then patients with the fasting serum TG levels ≥150 mg/dL at baseline are eligible. During the study period, a total of 256 study participants will be randomised to receive either intensive TG-lowering therapy or usual care. In the intensive TG-lowering therapy group, the goal of TG levels is lower than 150 mg/dL, which will be monitored at 1 month, 3 months, 6 months, 12 months and 18 months after randomisation. In the usual care group, the goal of TG levels is lower than 500 mg/dL according to the current guidelines. Lifestyle suggestions and TG-lowering agents are the main strategies to manage the lipid level. The primary endpoint is the incidence of recurrent episodes of HTG-AP at 18 months after randomisation.

Ethics and dissemination

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2023101–3). Ethics approval of each participating centre is required before initiation of enrolment. The results of this study will be published in peer-reviewed journals and reported at international conferences.

Trial registration number

ChiCTR2300073483 (Chinese Clinical Trial Registry)

Protocol version

V.4.0 (2024).

Role and responsibilities of a forensic mental health nurse: a scoping review protocol

Por: Tulloch · L. · Harkess-Murphy · E. · Walker · H. · Cheyne · J. · McCaig · M. · Ion · R.
Introduction

Forensic mental health nursing (FMHN) is a subspeciality of psychiatric nursing. An area of mental health nursing care that is situated at the intersection of health, social and criminal justice systems. Over the past two decades, FMHN has evolved beyond custodial and containment practice. Contemporary FMHN has an emphasis on therapeutic interventions, identifying patients as partners in care and nursed through a trauma-informed, recovery-orientated lens. Numerous scholars have examined the role of the FMHN and its inherent complexities. However, much of the existing literature is outdated and is limited in scope, describing the role and responsibilities of an FMHN relevant to contemporary practice. This paper maps the literature over the last 20 years to establish what explicitly defines the modern FMHN, specifically examining factors that have shaped the role and influenced patient outcomes and care delivery; including areas of good practice.

Methods and analysis

In line with the Joanna Briggs Institute (JBI) guidance on scoping reviews, including Arksey and O’Malley’s (2005) five-step framework, we will conduct a search within MEDLINE (EBSCO), CINAHL (EBSCO), PsycINFO (Ovid) and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials in the Cochrane Library. The first author conducted a preliminary search in October 2024 to identify literature in this area and a review of keywords to develop the foundation search strategy. The search strategy was constructed in the MEDLINE (EBSCO) database May 2025 by the lead author and an information specialist/librarian. Eligibility criteria of publications written in English, with a date range of 2004–2024, including the first quarter of 2025, forensic mental health nurse population and secure inpatient settings. All extracted literature will be exported into EndNote V.21 in order to support the removal of duplicates and assist in the screening and selection process. A two-step data selection process will include stage one, where two authors independently conduct a preliminary title and abstract screen of all extracted data using a data extraction instrument developed per JBI scoping review guidance. Each paper will be categorised as ‘yes’, ‘no’ or ‘maybe’. Step two: All documents categorised as ‘yes’ or ‘maybe’ will undergo a full-text screening. Narrative summaries and tables will present the results in full.

Ethics and dissemination

This scoping review will analyse existing published data; therefore, ethical approval is not required. The findings of this review will be presented at local and international conferences and published in peer-reviewed journals. The formal search will commence in June 2025, with an aim to submit in full for peer-review publication by October 2025.

GRACE: protocol for a UK, secondary care, multicentre, assessor-blinded randomised controlled trial with a non-inferiority comparison to evaluate graduated compression stockings as an adjunct to extended duration pharmacological thromboprophylaxis for ven

Por: Lawton · R. · Heatley · F. · Beggs · A. D. · Everington · T. · Hamady · Z. · Hunt · B. J. · Jasionowska · S. · Kyrgiou · M. · Liddle · A. · Machin · M. · Norrie · J. · Pinkney · T. · Rees · J. L. · Saghdaoui · L. B. · Shalhoub · J. · Smith · S. · Toh · S. · Watkin · N. · Williams · L. · Davi
Introduction

Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.

HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.

Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.

Methods and analysis

GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.

The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.

Ethics and dissemination

On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.

Trial registration number

ISRCTN11667770.

Work ability during the COVID-19 pandemic: A cross-sectional study in a low-income urban setting in Brazil

by Ana Paula Cândido Oliveira, Daniela Alencar Vieira, Cristiane Wanderley Cardoso, Tereza Magalhães, Rosangela Oliveira Anjos, Eduardo José Farias Borges Reis, Kionna Oliveira Bernardes Santos, Guilherme Sousa Ribeiro

Work ability is a subjective concept that reflects the balance between an individual’s perception of the physical, mental, and social demands of work and their competence and resources to meet those demands. The COVID-19 crisis significantly impacted health, work, and socioeconomic conditions worldwide. However, few studies have examined work ability in disadvantaged urban communities during this period. To analyze factors associated with work ability within the context of social vulnerability during the COVID-19 pandemic, we conducted a cross-sectional study in a low-income neighborhood in Salvador, Brazil, between February and June 2022. Sociodemographic, health, and labor data were collected, and work ability was assessed using the Work Ability Index (WAI), a widely used tool for evaluating work ability. Multivariable analyses based on a hierarchical model were run to investigate factors associated with low WAI scores. The study included 292 workers aged ≥16 years (59.6% women; median age 41 years). Most workers (84.6%) were classified as having adequate work ability based on their WAI scores. Multivariable analyses found that inadequate work ability was more frequent among women (prevalence ratio [PR]: 1.89, 95% confidence interval [CI]: 1.02-3.48), individuals who self-rated their health as moderate/good (PR: 5.91; 95% CI: 1.45-24.05) or poor/very poor (PR: 21.62; 95% CI: 5.14-90.91) compared to those with excellent/very good health, and those reporting diabetes (PR: 2.1; 95% CI: 1.13-3.9). Working >40 hours per week (PR: 0.47; 95% CI: 0.28-0.96) was negatively associated with inadequate work ability, suggesting that individuals with adequate work ability may be selected for longer working hours. A history of COVID-19 was not associated with inadequate work ability. These findings suggest that targeted interventions to improve work ability in low-income communities should prioritize women and workers with chronic health conditions, such as diabetes.

Wearable device monitoring of HIV health in the face of climate change and weather exposures: protocol for a mixed-methods study

Por: Kassem · N. · Boutros · P. · Kwaro · D. · Muma · J. · Obor · D. · Munga · S. · Maggioni · M. A. · Bärnighausen · T. · Winkler · V. F. · Barteit · S.
Introduction

Climate change and HIV are interconnected epidemics that increase vulnerability in people living with HIV (PLWH), particularly in sub-Saharan Africa. Despite their public health significance, research on the synergistic effects of these epidemics on the health of PLWH is limited. The advancement of non-invasive wearable technology offers an opportunity to leverage objective health data for large-scale research, addressing this knowledge gap. This study will examine the impact of weather events on distinct health variables of PLWH within the Siaya Health and Demographic Surveillance System (HDSS) in rural Kenya.

Methods and analysis

Over a period of 6 months, we continuously monitored health parameters of a total of 200 participants including heart rate, activity and sleep, using consumer-grade wearable devices. We will correlate these health data with real-time weather parameters (ambient temperature, wet bulb globe temperature, precipitation level) from five weather stations within the HDSS area and compare between HIV-positive participants and an HIV-negative control group. Additionally, a convergent mixed-methods approach will explore participants’ perceptions of the impact of weather events on their health and personal experiences. The study aims to inform future research on the complex relationship between HIV and weather events, which are projected to increase in frequency in this region due to climate change and provide valuable insights for policymakers to develop effective measures to protect this vulnerable population amid the growing climate crisis.

Ethics and dissemination

This study has been approved by the Research Ethics Committees at Kenya Medical Research Institute, Nairobi (approved on 23 October 2023; SERU 4826) and Heidelberg University Hospital, Germany (approved on 14 February 2023; S-824/2022). Written informed consent was obtained from all participants prior to enrolment, with data anonymised and handled according to Kenyan and German data protection regulations. Research findings will be disseminated through peer-reviewed publications and presented at scientific conferences.

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