bluuebunny/crossref_metadata_2025 huggingface dataset:
Prognostic factors for transplant-free survival in patients with secondary sclerosing cholangitis associated with critical illness
Authors: Konstantis Georgios , Moghadam Dorsa Ghaffar Loy , Frey Alexandra , Nuruzade Nargiz , Schramm Christoph , Gerges Christian , Lange Christian M , Schmidt Hartmut , Willuweit Katharina , Kahraman Alisan , Passenberg Moritz , Rashidi-Alavijeh Jassin
Published: January 2025

Objective

Secondary sclerosing cholangitis (SSC) represents a disease with a poor prognosis increasingly diagnosed in clinical settings. Notably, SSC in critically ill patients (SSC-CIP) is the most frequent cause. Variables associated with worse prognosis remain unclear. The primary aim of this study was to identify factors associated with transplant-free survival in SSC-CIP patients using readily available data.

Methods

A cohort of 47 patients diagnosed with SSC-CIP was retrospectively analysed for clinical, biochemical and endoscopic variables. Kaplan-Meier survival curves, log-rank tests and univariate Cox proportional hazards models were used to assess associations with transplant-free survival. A multivariable Cox regression model was constructed using Lasso regularisation and validated with Bootstrap resampling. Model performance was assessed using the C-statistic for discrimination.

Results

Kaplan-Meier analysis identified bile duct obstruction requiring stent placement, and cholangitis episodes, as significant prognostic factors. In univariable analysis, age over 47 years (HR 2.61 (95% CI 1.02, 7.06), p=0.04), at least one cholangitis episode (HR 2.46 (95% CI 1.005, 6.06), p=0.04), stent placement (HR 2.89 (95% CI 1.13, 7.38), p=0.03), lower albumin levels (HR 0.52 (95% CI 0.28, 0.97), p=0.04) and higher international normalised ratio (INR) (HR 3.22 (95% CI 1.09, 9.53), p=0.03) were significant. Multivariable analysis showed that age at diagnosis, albumin and INR were significant independent predictors. The C-index was 0.78 (95% CI 0.65, 0.91), surpassing the model of end-stage liver disease score’s prognostic accuracy (Concordance Index at 3 years: 66.2% vs 74.9%).

Conclusion

These findings provide valuable insights for establishing standard exception criteria for this rare liver disease, which could lead to improved organ allocation. Further prospective multicentre studies are necessary to validate our findings.
Clinical manifestations and outcomes of patients with intravascular large B-cell lymphoma with neurological involvement: highlighting longitudinally extensive myelopathy as a distinct feature
Authors: Uawithya Ekdanai , Lertsakworakul Palakorn , Owatthanapanich Weerapat , Jitprapaikulsan Jiraporn
Published: January 2025

Objective

This study aimed to elucidate the clinical manifestations, laboratory findings and outcomes of patients with intravascular large B cell lymphoma (IVLBCL) with neurological involvement and to differentiate IVLBCL with and without neurological involvement.

Methods

A cohort study was conducted at Siriraj Hospital, Mahidol University, Thailand, between January 2005 and September 2024. Clinical data, laboratory values and central nervous system imaging results were analysed. Categorical variables were compared using the χ² or Fisher’s exact test, while continuous variables were analysed with the Mann-Whitney U test, as appropriate.

Results

Of the 30 patients with IVLBCL, 10 had neurological involvement and 20 without neurological symptoms, including myelopathy (5 patients, 50%); cognitive impairment (3 patients, 30%); seizures (2 patients, 20%); optic neuropathy, hemiparesis, homonymous hemianopia, vertigo and global aphasia (each affecting 1 patient, 10%). 60% of IVLBCL with neurological involvement had systemic symptoms, including prolonged fever, anaemia, anorexia and weight loss. MRI showed hyperintense lesions in the supratentorial, infratentorial and spinal cord with the prominent findings being longitudinally extensive cord lesions (four patients, 40.0%). The median survival time of the IVLBCL with neurological involvement was 4.1 months (95% CI: 0.0 to 17.1 months), with a 1-year survival rate of 37.5% and a 2-year survival rate of 25.0%.

Interpretation

This study highlights the distinct clinical, laboratory features and imaging of IVLBCL with neurological involvement and compares it to IVLBCL without neurological involvement. Early recognition of these findings is crucial for accurate diagnosis and improved patient outcomes despite the aggressive nature of IVLBCL.
Dietary pattern and risk of thyroid cancer: a systematic review and meta-analysis protocol
Authors: Nagashima Yasmin Guerreiro , Soares Aline Alves , Alves Camila Xavier , Medeiros Kleyton Santos , Lopes Marcia Marilia Gomes Dantas , Brandao-Neto Jose
Published: January 2025

Introduction

Until now, the thyroid cancer case number has increased, and it is not entirely possible to attribute this continuous growth to more meticulous thyroid nodule selection and more accurate diagnostic techniques. While there is currently no conclusive evidence linking dietary factors to thyroid cancer, certain dietary patterns seem to have an impact on the development of the disease. There are interesting connections among diet, environment, metabolism and thyroid carcinogenesis; a deeper comprehension of the underlying mechanisms should help the identification of modifiable risk factors for thyroid cancer. This protocol aims to guide a systematic review and meta-analysis of the literature to search for an association between dietary pattern and risk of thyroid cancer.

Methods and analysis

The databases to search for observational studies will be PubMed, Embase, Scopus, Web of Science and LILACS, from inception to 10 December 2024. No language limitation or publication period will be imposed. The outcome will be the patients with thyroid cancer. Three impartial reviewers will choose the studies and extract data from the original publications. The Newcastle-Ottawa Quality Scale will assess the risk of bias, and the certainty of the evidence will be achieved by using the Grading of Recommendations Assessment, Development and Evaluation. The R (V.4.3.1) will be performed for data synthesis, and to measure heterogeneity, we will compute the I2statistics. Additionally, a quantitative synthesis will be performed if the included studies are sufficiently homogenous.

Ethics and dissemination

It is not necessary to acquire ethical approval, as this study will be a review of the published data. A peer-reviewed publication will publish the systematic review’s findings.

PROSPERO registration number

International Prospective Register of Systematic Reviews (PROSPERO) CRD 42023463802.
Effectiveness of home-based walking exercise for patients with peripheral artery disease and intermittent claudication: a systematic review and meta-analysis
Authors: Xu Zheng , Chuo Jing , Zhao Xiaoqin
Published: January 2025

Objective

This study aimed to assess the effect of home-based exercise interventions on walking performance in patients with peripheral artery disease (PAD) and intermittent claudication (IC).

Design

Systematic review and meta-analysis.

Data sources

We searched the Medline, Web of Science, Embase, Scopus and Cochrane Library databases to identify randomised controlled trials of patients with PAD and IC published in English up to August 2024.

Eligibility criteria

Randomised controlled trials of patients who participated in home-based exercise interventions and were assessed for walking performance were eligible for inclusion. Studies without available data were excluded.

Data extraction and synthesis

We analysed the pooled effect size on walking performance based on the standardised mean differences between groups. A leave-one-out sensitivity analysis was performed to ensure the robustness of the findings.

Results

A total of eight studies were included in the meta-analysis. The duration of interventions in the included studies ranged from 6 to 52 weeks. In the pooled analysis, compared with control groups, the home-based exercise intervention groups showed improved pain-free walking distance (standardised mean difference 0.67, 95% CI 0.20 to 1.15), and maximal walking distance (0.47, 0.05 to 0.89). The overall heterogeneity score of pain-free walking distance was I2=83% (p<0.001), and for maximal walking distance, I2=78% (p<0.001).

Conclusions

Home-based exercise interventions for patients with PAD and IC were beneficial in improving pain-free walking distance and maximal walking distance. Future studies should consider multiple factors that may affect the effectiveness of home training and intervention compliance.

Trial registration number

PROSPERO, CRD42024499020.
Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial
Authors: Hu Zhengfang , Zhang Kangda , Wu Youxuan , Wang Xinyan , Zhang Zihui , Hou Xuan , Jian Minyu , Wang Yunzhen , Liu Haiyang , Wang Anxin , Han Ruquan , Liang Fa
Published: January 2025

Introduction

Preclinical studies have shown that oxygen therapy can improve ischaemic brain tissue oxygen tension, reduce reperfusion injury after revascularisation, promote neuroregeneration and inhibit inflammatory responses potentially exerting a beneficial effect after endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS). However, the optimal fraction of inspired oxygen (FiO2) during EVT under general anaesthesia is currently unknown. Therefore, we are conducting a randomised controlled trial (RCT) to evaluate the impact of high-concentration oxygen vs low-concentration normobaric oxygen on early neurological function after EVT.

Methods and analysis

The Oxy-TARGET trial is an ongoing prospective, open-label, parallel-design RCT being conducted at Beijing Tiantan Hospital, Capital Medical University. It aims to enrol 200 anterior circulation AIS patients undergoing EVT under general anaesthesia between February 2024 and December 2026. Eligible participants are randomly assigned at a 1:1 ratio to receive FiO2=80% or FiO2=30% through endotracheal intubation, with the gas flow rate set at 4 L/min. The inspiratory oxygen concentration at the tracheal intubation site (delivered FiO2) was recorded concurrently. The primary outcome is the incidence of early neurological improvement (a National Institutes of Health Stroke Scale (NIHSS) score<10 points at 24±2 hours after EVT). Additional safety and efficacy parameters included the 24-hour ΔNIHSS (baseline NIHSS - NIHSS at 24-hour) score, final infarct volume at 72 hours postrandomisation, 90-day Modified Rankin Scale (mRS) score, early neurological deterioration, postoperative pulmonary complications, blood gas parameters, symptomatic intracranial haemorrhage and 90-day mortality.

Ethics and dissemination

Following a rigorous review process, Oxy-TARGET has received official approval from the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-257-02). The standardised research protocol adopted in this trial is designed to enhance anaesthesiologists’ understanding of respiratory management for AIS patients during EVT. The findings of this study are intended to be disseminated through publications in international peer-reviewed journals, presentations at national and international academic conferences and broad distribution via online platforms.

Trial registration number

NCT06224426.
Impact of tiered restrictions in December 2020 on COVID-19 hospitalisations in England: a synthetic control study
Authors: Zhang Xingna , Hungerford Daniel , Green Mark , García-Fiñana Marta , Buchan Iain , Barr Benjamin
Published: January 2025

Objectives

To evaluate the effectiveness of localised Tier 3 restrictions, implemented in England in December 2020, on reducing COVID-19 hospitalisations compared with less stringent Tier 2 measures and the variations by neighbourhood deprivation and the prevalence of Alpha (B.1.1.7) variant, the primary variant of concern then, to measure hospital services’ burden and inequalities across different communities.

Design

Observational study using a synthetic control method, comparing weekly hospitalisation rates in Tier 3 areas to a synthetic control from Tier 2 areas.

Setting

England between 4 October 2020 and 21 February 2021.

Participants

23 million people under Tier 3 restrictions, compared with a synthetic control group derived from 29 million people under Tier 2 restrictions.

Interventions

Tier 3 restrictions in designated areas were implemented from 7 December 2020, imposing stricter limits on gatherings and hospitality than Tier 2, followed by a national lockdown on 6 January 2021.

Primary and secondary outcome measures

Weekly COVID-19-related hospitalisations for neighbourhoods in England over 11 weeks following the interventions.

Results

Implementing Tier 3 restrictions were associated with a 17% average reduction in hospitalisations compared with Tier 2 areas (95% CI 13% to 21%; 8158 (6286 to 9981) in total). The effects were similar across different levels of neighbourhood deprivation and prevalence of the Alpha variant.

Conclusions

Regionally targeted Tier 3 restrictions in England had a moderate but significant effect on reducing hospitalisations. The impact did not exacerbate socioeconomic inequalities during the pandemic. Our findings suggest that regionally targeted restrictions can be effective in managing infectious diseases.
Tear matrix metalloproteinases-9 and ocular surface parameters in diabetics: a cross-sectional study in Shenyang, China
Authors: Qu Zhengpeng , Pazo Emmanuel Eric , Yang Ling , Chen Jiayan , Qin Guanghao , He Wei
Published: January 2025

Background

Overexpression of tear matrix metalloproteinases-9 (MMP-9) on the ocular surface tissues has been reported to result in ocular surface damage. MMP-9 levels in tears have been listed as one of many tools for confirming dry eye disease (DED).

Objective

This investigation aimed to compare MMP-9 levels and ocular surface parameters in diabetic patients with and without DED.

Design

A cross-sectional study.

Setting

He Eye Specialist Hospital, Shenyang, China.

Participants

This study recruited 144 right eyes of 144 diabetic patients between November and December of 2023, and 110 patients with similar propensity scores were included in the analyses.

Main outcome measures

Non-invasive breakup time (NITBUT), tear film lipid layer (TFLL), conjunctival hyperaemia (redness score (RS)), corneoconjunctival staining (CS), corneal sensitivity and Ocular Surface Disease Index (OSDI) questionnaire were evaluated. MMP-9 was measured using an immunochromatography assay.

Results

In total, 55 patients (55 eyes) were grouped as diabetic dry eye (DDE) and 55 patients (55 eyes) as diabetic non-dry eye (DNDE). The mean MMP-9 concentrations were higher in patients with DDE than DNDE (70.63±52.06 ng/mL vs 33.98±33.93 ng/mL; p<0.001). The optimal cut-off value of MMP-9 to predict DED in diabetic patients was>52.5 ng/mL, with 58.2% sensitivity and 78.2% specificity.

Conclusions

MMP-9 concentration was higher in patients with DDE than DNDE. The MMP-9 test is a potential diagnostic tool for DDE. It may help follow-up diabetic patients with DED and guide clinicians in deciding on anti-inflammatory treatments for these patients.
Exploring policy processes against microbial threats in Iran: a qualitative policy analysis
Authors: Raoofi Azam , Takian Amirhossein , Akbari Sari Ali , Yunesian Masud
Published: January 2025

Objectives

Microbial threats pose a growing concern worldwide. This paper reports the analysis of Iran’s policy process against microbial threats.

Design

This is a qualitative study.

Participants

We interviewed 16 purposefully identified key informants selected through snowball sampling.

Setting

Through the lens of stages heuristic framework, we analysed the interviews by using thematic content analysis. We used MAXQDA V.2020 software for data analysis, identified key themes and subthemes and discussed our findings to validate the results.

Results

We extracted four main categories in accordance with the stages heuristic domains. Through content analysis of the agenda-setting process, we identified three main themes: magnitude of the problem, actors’ power and priorities. Participants highlighted the significant impact of microbial threats, the influence of powerful stakeholders and the underprioritisation of infectious diseases based on perceived urgency and resources. In the process of policy formulation, we explored three main themes, related to governance, coherence and integration of policies and barriers to effective policy formulation. Governance issues included transparency, engagement with stakeholders, conflict of interest and use of evidence, while coherence and integration of policies focused on insufficient coherence and integration of plans as well as temporary and defensive policymaking. Barriers to effective policy formulation encompassed delay in policymaking, policy gap in response to public needs, weakness in policy feasibility, risk assessment and management. For policy implementation, we extracted governance and coordination, and health system capacity. Effective implementation of policies was hindered by fragmented governance, inadequate communication and accountability and systemic barriers, while health system capacity was limited in terms of infrastructure and human resources. Finally, content analysis of monitoring and evaluation (M&E) resulted in identification of two main themes: discrepancies in M&E and barriers to effective M&E. The discrepancies in M&E varied, with some programmes having regular evaluations and others lacking compliance with international standards. Barriers to effective M&E included inadequate data access, limited information-sharing and inefficiencies in the M&E system.

Conclusions

Iran needs to prioritise infectious diseases, invest in preventive measures, improve governance and coordination, strengthen health system capacity, enhance M&E and so on, to combat microbial threats effectively. Learning from successful experiences of other countries can help Iran develop more effective strategies to address microbial threats and strengthen global public health in the country.
Association between serum uric acid and dyslipidaemia in type 2 diabetes: a cross-sectional study
Authors: Zhao Mingyang , Ma Xiaoqing , Xia Zhang , Zhang Jinmei , Zhong Jiale , Ye Peiyu , Xu Guozheng , Qiao Sen , Shi Shulong , He Yan , Jiang Jiajia
Published: January 2025

Background

The association between serum uric acid (SUA) and dyslipidaemia is still unclear in patients with type 2 diabetes mellitus (T2DM). This study aimed to examine the association between SUA and dyslipidaemia and to explore whether there is an optimal SUA level corresponding to the lower risk of suffering from dyslipidaemia.

Research design and methods

This cross-sectional study included 1036 inpatients with T2DM and the clinical data were extracted from the hospital medical records. Multivariate logistic regression analysis was performed to assess the association between hyperuricaemia and dyslipidaemia. Restricted cubic splines (RCS) analysis was performed to determine the optimal SUA level for the lower risk of dyslipidaemia.

Results

After adjustment for the potential confounders, hyperuricaemia was significantly associated with dyslipidaemia (OR=3.72, 95% CI: 2.28, 6.07) and hypertriglyceridaemia (OR=2.63, 95% CI: 1.68, 4.12). Notably, mediation analysis revealed a significant mediating effect of SUA in this relationship (indirect effect=0.08, p<0.001), elucidating 20.1% of the total relationship.

Conclusions

Hyperuricaemia was positively associated with dyslipidaemia and hypertriglyceridaemia. SUA mediated the effect of insulin resistance on triglyceride metabolism in patients with T2DM. A potential benefit of stricter control of SUA levels among patients with T2DM is possibly reducing the risk of dyslipidaemia.
Factors influencing communication issues during hospital discharge for older adults in 11 high-income countries: a secondary analysis of the 2021 International Health Policy Survey
Authors: Ambade Preshit Nemdas , Hoffman Zach , Vest Tyler , Mehra Kaamya , Gunja Munira , MacKinnon Breagh H , MacKinnon Neil J
Published: January 2025

Objectives

To determine the prevalence of hospital discharge communication problems with older adults, compare them across countries and determine factors associated with those problems.

Design

Secondary analysis of cross-sectional survey data.

Setting

2021 Commonwealth Fund International Health Policy (IHP) Survey of Older Adults conducted across 11 high-income countries, including Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the UK and the USA.

Participants

4501 respondents aged 60 and older in the USA and 65 and older in all other included countries who were hospitalised at least once in the past 2 years before the survey and answered discharge communication-related questions.

Primary outcome measure

Our primary outcome measure is poor discharge communication (PDC), a composite variable of three IHP questions related to written information, doctor follow-up and medicines discussed.

Results

Overall PDC rate was 19.2% (864/4501), although rates varied by nation. PDC was highest in Norway (31.5%) and lowest in the USA (7.5%). Gender, education, income and the presence of at least one chronic disease were not statistically associated with PDC.

Conclusions

Given the high rate of PDC observed, hospital discharge teams and leadership should carefully examine communication during the hospital discharge process to ensure minimisation of care gaps, particularly regarding medication, since this was the most reported problem.
Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials
Authors: Siddiqua Towfida Jahan , Schulze Kerry J , Hasan SM Tafsir , Ahsan Khalid Bin , Bandyopadhyay Sulagna , Zavala Eleonor , Ali Hasmot , Haque Rezwanul , Sujan Hasan Mahmud , Rahman Md. Hafizur , Baker Sarah , Stephenson Katherine K , Ge Ximing , Gough Ethan K , Langevin Brooke , Wu Lee Shu Fune , Dyer Brian , Roy Anjan Kumar , Jubair Mohammad , Nishan Amena Al , Rosenblum Michael , Gopalakrishnan Mathangi , Kraemer Klaus , Erchick Daniel J , Ahmed Tahmeed , Christian Parul
Published: January 2025

Introduction

Optimising the micronutrient status of women before and during reproduction confers benefits to them and their offspring. Antenatal multiple micronutrient supplements (MMS), given as a daily tablet with nutrients at ~1 recommended dietary allowance (RDA) or adequate intake (AI) reduces adverse birth outcomes. However, at this dosage, MMS may not fully address micronutrient deficiencies in settings with chronically inadequate diets and infection. A bioefficacy study to determine amounts required to attain nutrient adequacy among women of reproductive age (WRA) and pregnant women (PW) aims to address this gap.

Methods and analysis

Two, four-arm, dose-response trials (n=240 participants/trial) with a double-blind, individually randomised, controlled design are underway in 18–35 year-old WRA and PW in rural northern Bangladesh. The trials will test dose response to four levels of 19 micronutrients from 1 RDA/AI up to ~75% of the tolerable upper intake level (UL), where applicable. These levels of micronutrients are delivered in the form of a reconstituted (in water) powdered drink, daily, including a placebo drink in the control arm, plus a fortified, balanced energy and protein (BEP) food product containing each micronutrient at ~1 RDA per serving. The supplement duration is 3 months in WRA and~6 months (until birth) in PW, who are enrolled at 12–16 weeks of pregnancy; women are randomised to one of the four arms at enrolment. Supplement consumption is directly observed by study staff and weekly side effects and adverse events are monitored. Blood and urine are collected at baseline, a midpoint, and at/near the end of supplementation, with a birth visit and postpartum biospecimen collection (post supplementation) for PW. Outcomes are biomarkers of nutrient status. Pharmacokinetic modelling will estimate micronutrient intakes at which sufficiency for each nutrient without excess is achieved. Enrolment was initiated on 22 October 2023.

Ethics and dissemination

The study was approved by the Institutional Review Board of Johns Hopkins Bloomberg School of Public Health and the research and ethical review committees of icddr,b, Bangladesh. A data safety and monitoring board is in place for the study. Findings will be disseminated in peer-reviewed papers and in-country meetings.

Trial registration number

NCT06081114Cite Now
Effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap on the soft-tissue closure after the immediate posterior implantation: study protocol for a randomised controlled trial
Authors: Fang Shuobo , Dong Zhengjie , Zhang Wei , Chen Tong , Lv Wanqi , Zhang Chenyang , Chen Si , Hao Keyi
Published: January 2025

Introduction

Soft-tissue defect is commonly seen in immediate maxillary posterior implantation because of tooth extraction wound and tension from bone graft. Bone graft materials exposure has a significant detrimental influence on bone augmentation. However, previous studies lack sufficient evidence to guide wound closure after immediate posterior implantation. This study aims to use 3D integration technology to evaluate the effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap (RPPCTF) on the soft-tissue closure after the immediate maxillary posterior implantation.

Methods and analysis

This is a single-centre, evaluator-blinded, randomised, two-arm parallel-group controlled trial. A total of 54 patients requiring immediate implant placement in the first upper molar extraction sockets will be recruited. The patients will be randomly assigned to two groups: one group will receive the porcine collagen matrix and the other group will receive RPPCTF on the soft-tissue closure after the immediate posterior implantation. The primary outcome is the soft-tissue volume change. Secondary outcomes include width of keratinised gingiva, healing status of soft tissue, marginal bone level and operation time.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of Shanghai Stomatological Hospital (SHSHIRB-2022016). The project has been registered on the ClinicalTrials.gov website and National Medical Research Registration and Filing Information System. Written informed consent was obtained from all the participants. The results of this study will be reported in a peer-reviewed journal.

Trial registration number

ChiCTR2300067770.
Changing the trajectories of mental health difficulties in Norfolk and Suffolk: a research-priority-setting project with patients, the public, clinicians, policymakers and other stakeholders—study protocol
Authors: Oduola Sherifat , Morgan Craig , Das-Munshi Jayati , Broomfield Niall , Parretti Helen , Sanderson Kristy , Notley Caitlin , Zile Amy , Morrissey Sol , Khadjesari Zarnie , Holmes Joni
Published: January 2025

Introduction

Mental health problems are the most significant cause of disability and have high annual economic costs; hence, they are a priority for the government, service providers and policymakers. Consisting of largely coastal and rural communities, the populations of Norfolk and Suffolk, UK, have elevated burdens of mental health problems, areas with high levels of deprivation and an increasing migrant population. However, these communities are underserved by research and areas with the greatest mental health needs are not represented or engaged in research. This National Institute of Health and Care Research-funded project aims to bring together key stakeholders to conduct extensive scoping work to identify mental health needs and priorities as a basis for conducting larger research to address the identified priorities over the next 5 years.

Methods and analysis

This 12-month mixed-methods research-priority-setting project consists of five phases. It is being conducted in Norfolk and Suffolk counties in the East of England, UK. Underpinned by Delphi methodology, it will adopt the James Lind Alliance approach to identify priorities for mental health research for the populations of Norfolk and Suffolk. The project will use multiple methods, including mapping and identification of stakeholders, online questionnaires, face-to-face focus groups and interviews, and consensus meetings with experts and mental health stakeholders. Key evidence-informed priorities will be collaboratively ranked and documented, and a final top 10 research priorities will be identified to inform future research, policy and service provision.

Ethics and dissemination

This study was approved by the University of East Anglia’s Faculty of Medicine and Health Research Ethics Committee (reference: ETH2324-2542), Norwich, UK. Research findings will be disseminated through workshops with stakeholders and collaborators and via peer-reviewed scientific publications, presentations at academic societies, blogs and social media.
Investigating a caregiver-assisted social skills group programme for primary and early high school-aged children with acquired brain injury or cerebral palsy: protocol for a pilot mixed-methods, two-group randomised trial of PEERS Plus
Authors: Thompson Bianca , Gilmore Rose , Hilton Nicola , Barfoot Jacqui , Moody Christine T , Whittingham Koa , Keramat Afroz , Boyd Roslyn N , Sakzewski Leanne
Published: January 2025

Introduction

Reaching social milestones is an important goal of childhood. Children with acquired brain injury (ABI) and cerebral palsy (CP) frequently experience challenges with social functioning and participation. The Programme for the Education and Enrichment of Relational Skills (PEERS) is a group-based social skills programme for adolescents. This study will compare an adapted PEERS programme with usual care in a pilot randomised waitlist-controlled trial for primary and early high school-aged children with brain injuries.

Methods and analysis

This single-centre study will be conducted at the Queensland Cerebral Palsy and Rehabilitation Research Centre at the Centre for Children’s Health Research in Brisbane, Australia. Thirty-two school-aged children (grades 3+; 8–13 years) with an ABI or CP and their caregiver(s) will be recruited and randomly assigned to either 12 week PEERS Plus or waitlist usual care. The waitlist group will then participate in PEERS Plus after the 3 month retention time point. The primary outcome will measure individualised social participation goals on the Canadian Occupational Performance Measure immediately postintervention at the primary endpoint (12 weeks). Secondary outcomes include the Social Skills Improvement System Social-Emotional Learning Edition Rating Forms and Quality of Play Questionnaire immediately postintervention, 12 weeks postintervention (26 weeks postbaseline), 36 weeks postintervention (52 weeks postbaseline) for retention. Following completion of the PEERS Plus programme, semistructured focus group interviews will be conducted separately with caregivers and children to explore the lived experience of PEERS. Interpretive description will be used to identify patterns and themes related to participants’ experiences. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. This study will estimate the unit costs of providing PEERS Plus at different levels of public health facilities in Australia.

Ethics and dissemination

This study has been approved by the Medical Research Ethics Committee of The University of Queensland (2022/HE002031) and the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/22/QCHQ/87450). Recruitment and participant informed consent process will be completed in accordance with institutional ethic procedures. Dissemination plans include peer-review publication of study results, presentations, and instructional workshops at national and international conferences.

Trial registration number

ACTRN12623000515695.
Quality indicators and development targets in the national clinical quality registries in cancer care and screening
Authors: Simoni Amalie Helme , Ahlstrøm Lina Marie Vinge , Ording Anne Gulbech , Iversen Lene Hjerrild , Johnsen Søren Paaske , Jensen Jens Winther , Møller Henrik
Published: January 2025

Background

The Danish clinical quality registries monitor and improve the quality of care, using quality indicators and defined development targets referred to as ‘standards’. This study aims to investigate the fulfilment of standards in the Danish clinical quality registries in cancer care and screening.

Methods

Data was included from annual reports in the 27 Danish clinical quality registries in cancer care and screening. The most recent report from each registry was downloaded the 13 December 2023. Indicators were included if: evaluating care or screening over 12 months, presenting a well-defined standard with a desired direction and presenting the proportion and number of individuals for which the standard was fulfilled. Data were extracted on national and regional levels for the last 3 years, and fulfilment of standards was presented as the proportion of indicators that fulfilled the standard within each unit of comparison.

Results

In total, 216 quality indicators were included. At the national and regional level, standards were fulfilled for 75% and 71%, respectively. Fulfilment within the registries varied from 5% to 100% on national and 12% to 99% on regional level. Standards were more often fulfilled for result (than process indicators) and for established (than supplemental indicators). Altogether, 43% of the standards were fulfilled across all regions delivering data for the specific indicator.

Conclusions

The approach to defining standards for clinical quality indicators as conservative minimum or ambitious development targets varied in the Danish clinical quality registries in cancer care and screening. This deviating behaviour seriously restrains possibilities for comparing clinical quality across cancers despite the robust infrastructure of the quality registries, limiting the possibilities for overview and prioritising resources and attention to the most urgent cancers.
Effectiveness of nurse-led care in patients with rheumatoid arthritis: a systematic review and meta-analysis
Authors: Yang Lin , Xiang Peng , Pi Guifang , Wen Ting , Liu Li , Liu Dan
Published: January 2025

Objectives

This study sought to assess the effectiveness of nurse-led care (NLC) in patients with rheumatoid arthritis (RA).

Methods

We conducted a comprehensive search of the Cochrane Library, Web of Science, PubMed, Embase, CINAHL, ClinicalTrials.gov databases and the references from relevant literature published prior to May 2023. Two independent reviewers assessed the studies using population/intervention/comparison/outcome/study criteria, and quantitative tools were used to gauge the methodological quality of the included studies. Independent quality assessments were carried out using the Cochrane Collaboration’s risk-of-bias tool. Effect sizes were determined using mean difference (MD) or standardised mean difference (SMD) with corresponding 95% CIs.

Results

Ultimately, 14 articles were included, encompassing a total of 3369 RA patients. NLC exhibited significant advantages in the primary outcome, disease activity (MD =−0.09, 95% CI (−0.17 to –0.01)), and the secondary outcome, self-efficacy (MD=0.40, 95% CI (0.03, 0.77)). In subgroup analysis, NLC was more effective in reducing disease activity compared with usual care (MD=−0.15, 95% CI (−0.26 to –0.04)), and there was no significant difference in disease activity reduction between NLC and rheumatologist-led care (MD=−0.02, 95% CI (−0.14, 0.10)). In terms of self-efficacy, no significant difference was observed between NLC and usual care (SMD=0.56, 95% CI (−0.09, 1.21)) or between NLC and rheumatologist-led care (SMD=0.20, 95% CI (−0.19, 0.59). When comparing other secondary outcomes (pain, satisfaction, quality of life, fatigue, stiffness, physical function and psychological status), the effectiveness of NLC for RA patients was similar to that of the control group, with no statistically significant differences.

Conclusions

NLC proves highly effective in managing RA patients, surpassing usual care and equating to rheumatologist-led care in primary and some secondary outcomes. It may be feasible to allow nurses to participate in the disease management of some RA patients instead of doctors.

PROSPERO registration number

CRD42022362071.
SIGLEC11 promotes M2 macrophage polarization through AKT–mTOR signaling and facilitates the progression of gastric cancer
Authors: Yin Jingxin , Lu Yang , Liu Yihao , Shi Qimeng , Shi Minmin , Zhu Zhenggang , Fu Da , Wang Zhenqiang , Li Chen
Published: January 2025

Background

Sialic acid-binding immunoglobulin-like lectins (SIGLECs) are widely expressed on immune cell surfaces, play an important role in maintaining immune homeostasis and regulating inflammatory responses, and are increasingly emerging as potential targets for tumor immunotherapy. However, the expression profile and crucial role of SIGLEC11 in gastric cancer (GC) remain unclear. This study aimed to elucidate the prognostic relevance of SIGLEC11 expression and its role in the immune microenvironment in patients with GC.

Methods

SIGLEC11 expression profile was analyzed using bioinformatics, immunohistochemistry, and immunofluorescence staining. Flow cytometry, mouse tumor models, patient-derived tumor organoid models, and RNA sequencing were used to explore the potential functions with the underlying mechanisms of SIGLEC11 in a coculture system of macrophages and GC cells.

Results

We demonstrated that SIGLEC11 was predominantly expressed in normal tissues. However, tumor-infiltrating SIGLEC11+cells in the high SIGLEC11 expression subgroups showed poor overall survival, which was associated with the expression of an immunosuppressive regulator. Our results showed that SIGLEC11 was predominantly expressed in monocytes and macrophages and selectively upregulated in tumor-associated macrophages. Furthermore, SIGLEC11 promoted macrophage M2 polarization via AKT–mTOR signaling. In addition, SIGLEC11+macrophages accelerate GC progression.

Conclusions

The abundance of SIGLEC11+M2-like macrophage-infiltrating tumors may serve as a biomarker for identifying immunosuppressive subtypes of GC. Thus, the potential role of SIGLEC11+M2 macrophages as therapeutic targets warrants further investigation.
Racial differences in clinical trial perceptions among a large, predominantly Black cohort of people with systemic lupus erythematosus in the Southeastern USA
Authors: Williams Jessica Nicole , Mozee Hilton , Bao Gaobin , Dunlop-Thomas Charmayne , Schofield Kim , Drenkard Cristina , Lim Sung Sam
Published: January 2025

Objective

Black people in the USA have a higher incidence and severity of SLE and worse outcomes, yet they are significantly under-represented in SLE clinical trials. We assessed racial differences in clinical trial perceptions among a large cohort of predominantly Black people with SLE.

Methods

Georgians Organised Against Lupus (GOAL) is a population-based, prospective cohort of people with a validated diagnosis of SLE living in Atlanta. The 2021–2022 GOAL survey included questions assessing knowledge, perceptions and experiences of lupus clinical trials involving drug therapy. Self-reported race was categorised as Black or non-Black. Survey responses by race were compared using χ2analyses. Among Black respondents, factors associated with willingness to participate in clinical trials were examined using univariable logistic regression.

Results

A total of 767 individuals responded to the 2021–2022 GOAL survey, of whom 80% were Black. There were 720 female respondents and 47 male respondents. There was no significant difference in willingness to participate in clinical trials between Black and non-Black respondents (28% vs 31%, p=0.071). Black respondents were less likely to correctly identify the definition of a clinical trial (34% vs 70%, p<0.001). Male gender, unemployed or disabled status, governmental health insurance and higher disease activity were associated with willingness to participate in clinical trials among Black respondents.

Conclusions

We found that only 28% of respondents were willing to participate in lupus clinical trials, with no difference by race. Efforts must continue to engage those resistant to trial participation, regardless of race. Our findings also indicate that further research is warranted to assess whether strategies such as clinical trial education and diversification of study staff may be helpful to increase Black patient recruitment. Sociodemographic factors (gender, work status, insurance status) and disease-related factors (lupus activity) may also play important roles in clinical trial participation among Black people.
Sex differences in ST-segment elevation myocardial infarction patients treated by primary percutaneous intervention
Authors: Cook Selma T , Allemann Laure , Cook Malica , Arroyo Diego A , Pittet Thais , Meier Pascal , Togni Mario , Brahim-Mathiron Amel , Puricel Serban , Cook Stéphane
Published: January 2025

Introduction

The impact of sex on coronary artery disease prognosis is debated. It has been postulated that women receive less prompt treatment compared with men, potentially adversely affecting their prognosis by significantly increasing the risk of morbidity and mortality. We aim to investigate the influence of sex on the timing and clinical outcomes of ST-segment elevation myocardial infarction (STEMI) patients using a controlled Swiss registry.

Methods and results

Based on the Fribourg STEMI Fast Track Registry, 1177 patients (288 women, 889 men) with >12 months clinical follow-up were selected. Women had longer first medical contact to reperfusion times (1.31 (1.14–2.00) vs 1.27 (1.09–1.54) hours, p=0.035) but similar total ischaemic times (3.04 (2.15–4.50) vs 2.56 (2.07–4.38) hours, p=0.064). Men had higher rates of diabetes, smoking and dyslipidaemia, while women had higher hypertension and renal insufficiency rates. No significant sex differences in clinical outcomes were observed at 1-year and 5-year follow-ups.

Discussion

The study found sex differences in patient profiles and minor treatment delays for women, which did not significantly affect outcomes. Efforts to improve sex equity in STEMI care are effective, as no significant outcome differences were observed. Disparities are more related to patient characteristics than sex.

Conclusion

Despite slight delays and different risk profiles for women with STEMI, clinical outcomes are similar between sexes. Ongoing efforts are needed to ensure sex equity in acute coronary syndrome management.

Trial registration number

NCT04185285.
Right ventricular strain impairment due to hypoxia in patients with COPD: a post hoc analysis of two randomised controlled trials
Authors: Preiss Helga , Mayer Laura , Furian Michael , Schneider Simon Rafael , Müller Julian , Saxer Stephanie , Mademilov Maamed , Titz Anna , Shehab Anwer , Reimann Lena , Sooronbaev Talant , Tanner Felix C , Bloch Konrad E , Ulrich Silvia , Lichtblau Mona
Published: January 2025

Background

Hypoxic pulmonary vasoconstriction leads to an increase in pulmonary artery pressure (PAP) and potentially right heart failure in healthy individuals and patients with respiratory diseases. Previous studies in patients with chronic obstructive pulmonary disease (COPD) exposed to hypobaric hypoxia have shown an increase in PAP, while traditional echocardiographic parameters revealed only minimal changes at high altitude. Speckle-tracking-derived analysis is potentially more sensitive to assess right ventricular (RV) function and we used this method to investigate the impact on RV function of patients with COPD ascending to high altitude and compared the results with the traditional echocardiographic parameters.

Methods

This post hoc analysis evaluates echocardiographic RV free wall strain (RVFWS) in patients with COPD GOLD grade 1–3 travelling from 760 m to 3100 m for a 2-day stay. An RVFWS over −20% was considered as an indicator of RV dysfunction.

Results

A total of 54 patients (57% men, mean±SD age 58±9 years, forced expiratory volume in 1 s (FEV1% predicted 77.3±22.5)) with echocardiographs of sufficient quality were included. The mean RVFWS worsened significantly from −26.0±4.9% at 760 m to −23.9±5.4% at 3100 m (p=0.02). The number of patients with relevant RV dysfunction based on RVFWS increased from 7.4% at 760 m to 25.9% at 3100 m (p=0.02), whereas the prevalence of RV dysfunction assessed by traditional indices remained unchanged.

Conclusion

Exposure to hypoxia led to RVFWS impairment in more than one quarter of patients with COPD. Strain analysis is a promising, non-invasive method for evaluating RV dysfunction, even in subclinical cases and might be prognostically relevant in patients with lung diseases.

Trial registration numbers

NCT02450968andNCT03173508.
Association between prophylactic intermittent non-invasive positive pressure ventilation and incidence of pneumonia in patients with cervical spinal cord injury: a retrospective single-center cohort study
Authors: Fukuyama Yuita , Okada Kazuhiro , Tagami Takashi , Hara Yoshiaki , Yokobori Shoji
Published: January 2025

Background

Patients with cervical spinal cord injuries (CSCIs) have a high incidence of respiratory complications. The effectiveness of non-invasive positive pressure ventilation (NPPV) in preventing respiratory complications such as pneumonia in acute CSCIs remains unclear. We evaluated whether intermittent NPPV (iNPPV) could prevent pneumonia in patients with acute CSCIs.

Methods

This single-center, retrospective study evaluated patients diagnosed with CSCIs with American Spinal Injury Association Impairment Scale scores of A–C between January 2012 and December 2022. Patients were categorized based on receipt of iNPPV into the iNPPV and usual care groups. Prophylactic iNPPV was defined as the initiation of iNPPV within 72 hours of admission. The primary outcome was the development of pneumonia. The secondary outcomes were other respiratory complications (tracheal intubation and tracheostomy) and adverse events (delirium and vomiting). The groups were compared with regard to outcomes after adjustment for patient backgrounds using inverse probability of treatment weighting (IPTW) with propensity scores.

Results

Of the 213 patients during the study period, 94 were included. Of these, 61 (64.9%) received prophylactic iNPPV. The incidence of pneumonia was 27.9% in the iNPPV group and 48.5% in the usual care group in the unadjusted cohort. In the propensity score analysis using IPTW, the iNPPV group showed a lower incidence of pneumonia than the usual care group (29.0% vs 56.5%, p<0.001). Tracheal intubation and tracheostomy were less common in the iNPPV group than those in the usual care group (10.6% vs 29%; p=0.001 and 10.6% vs 27.1%; p=0.003, respectively). The incidences of delirium and vomiting did not increase in the iNPPV group.

Conclusions

Prophylactic iNPPV was associated with a lower incidence of pneumonia in patients with acute CSCIs.

Level of evidence

Ⅳ.