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Ayer — Octubre 2nd 2025Tus fuentes RSS

Glycaemic control and influencing factors among patients with post-chronic pancreatitis diabetes mellitus in China: a retrospective cross-sectional study

Por: Ye · J. · Xie · J. · Wang · Y. · Ru · N. · Mao · X. · Li · T. · Qian · Y. · Zou · W. · Cao · Y. · Liao · Z.
Objectives

Post-chronic pancreatitis (CP) diabetes mellitus (PPDM-C) is a distinct form of diabetes, in which complex pathogenesis hampers adequate glycaemic control. This study aimed to identify risk factors for poor glycaemic status in PPDM-C to guide clinical management.

Design

Cross-sectional study.

Setting

Shanghai, China.

Participants

Between January 2018 and March 2023, 1677 patients with CP were enrolled in the CP database of the National Clinical Research Center. After application of strict exclusion criteria, 302 patients diagnosed with PPDM-C were included in the study.

Primary and secondary outcome measures

The primary outcome was glycaemic control. The secondary outcomes were factors that affect glycaemic control among patients with PPDM-C.

Methods

This retrospective study was conducted in patients with PPDM-C. Poor glycaemic status was defined as a glycated haemoglobin A1c level of >7% at admission. Patients were stratified into those with and without diabetes treatment. Multivariate logistic regression was performed to identify risk factors. The area under the curve (AUC) analysis was used to evaluate the predictive efficacy of these risk factors.

Results

A total of 302 patients with PPDM-C were analysed. Poor glycaemic status was observed in 72.6% (61/84) of patients without diabetes treatment and 52.8% (115/218) of those with diabetes treatment. For those without diabetes treatment, a history of acute pancreatitis (AP) attacks (OR: 4.838, p=0.014) and smoking (1–20 pack-years, OR: 4.418; >20 pack-years, OR: 9.989; p0.001). In patients with diabetes treatment, AP attack history (OR: 5.640, p20 pack-years, OR: 11.395; p

Conclusions

Patients with PPDM-C in China exhibited a high prevalence of poor glycaemic status. Smoking and a history of AP attacks were significantly associated with an increased risk of poor glycaemic control. The early identification of patients with PPDM-C at elevated risk of poor glycaemic control may facilitate timely and optimised management of glycaemia.

Patient-reported outcome measured by EQ-5D and influencing factors among patients of systemic lupus erythematosus in China: a multicentre cross-sectional study from CSTAR Registry

Por: Li · L. · Bai · W. · Yu · B. · Zou · K. · Wang · Y. · Zuo · K. · Wang · L. · Wu · C.-Y. · Zhao · J. · Zeng · X. · Wang · Y. · Li · M.
Objectives

Until now, there has still been a lack of sufficient evidence on patient-reported outcomes (PROs) measured by the EuroQol-5 Dimension (EQ-5D) in patients with systemic lupus erythematosus (SLE) in China. This study aims to comprehensively assess EQ-5D outcomes and influencing factors in Chinese patients with SLE.

Design

A multicentre, cross-sectional study based on the Chinese Systemic Lupus Erythematosus Treatment and Research Group registry.

Setting

101 hospitals across 27 provinces of China.

Participants

1336 patients with SLE.

Outcome measures

The information on EQ-5D was collected via an online questionnaire. Medical records were obtained from the Chinese Rheumatology Data Centre (CRDC). Clinical influencing factors related to the reported health problems were identified using multivariate logistic regression. Then, each health state was converted into a health utility score based on the Chinese 2014 tariff. Given the ceiling effects, Tobit regression models were used to analyse the factors influencing health utility scores.

Results

A total of 1336 patients with SLE were included. Of them, 626 patients (46.9%) reported health problems using EQ-5D. The proportions of patients reporting problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 12.80%, 5.24%, 14.90%, 27.47% and 30.46%, respectively. The mean utility score was 0.89 (SD: 0.15), and the mean Visual Analogue Scale (VAS) score was 76.80 (SD: 16.54). There was a statistically significant correlation (r=0.503, p

Conclusions

EQ-5D may be a useful, preference-based PRO measure for SLE and could potentially be integrated into routine clinical monitoring of patients with SLE and applied in economic evaluations in the future.

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p16 expression and its correlation with the clinical pathological characteristics of patients with cervical cancer: a systematic review and meta-analysis

Por: Chong · L. · Zou · Z. · Xia · L. · Wang · X. · Dong · Z. · Zhao · Y. · Hou · Y.
Objectives

Overexpression of p16 has been documented in a variety of human tumours. Nonetheless, the association between p16 overexpression and the clinicopathological characteristics of patients with cervical cancer remains a subject of debate. This meta-analysis sought to systematically assess the relationship between p16 expression and the clinicopathological features of patients with cervical cancer.

Design

Systematic review and meta-analysis.

Data sources

The PubMed, Embase, Cochrane Library (Central), Web of Science (SCI Expanded), and Chinese databases (CNKI, VIP, Wanfang and CBM) were searched through 1 March 2024.

Eligibility criteria for selecting studies

Case-control studies examining the association between p16 expression and cervical cancer were analysed to evaluate whether p16 expression was correlated with the clinicopathological characteristics of patients with cervical cancer.

Data extraction and synthesis

Two independent reviewers employed standardised methods to search, screen and code the included studies. The risk of bias was evaluated using the Cochrane Collaboration tools and the Newcastle-Ottawa Scale. Statistical analyses and data processing were conducted using Review Manager V.5.4, which included heterogeneity tests and sensitivity analyses. Additionally, STATA V.16.0 was used for further sensitivity analyses of the included studies, and publication bias was assessed using Begg’s test.

Conclusions

The p16 protein is strongly associated with the onset and progression of cervical cancer and serves as a valuable biomarker for its early detection and diagnosis.

PROSPERO registration number

CRD42024546241.

Effect of intraoperative oesophageal pressure-guided PEEP on postoperative pulmonary complications in elderly patients undergoing major laparoscopic surgery: study protocol for a multicentre randomised controlled clinical trial in China

Por: Zhong · J. · Xu · P. · Zhou · X. · Zou · K. · Yu · J. · Liu · Y. · Zhu · M. · Wei · M. · Yang · H. · Miao · C.
Introduction

Postoperative pulmonary complications (PPCs) induced by mechanical ventilation in general anaesthesia are related to poor clinical outcomes. Positive end-expiratory pressure (PEEP) is a key component of the lung protective ventilation strategy. Individualised PEEP guided by end-expiratory oesophageal pressure (Pes) to maintain a positive end-expiratory transpulmonary pressure can avoid alveolar collapse and improve the respiratory mechanics. However, there is no research studying the relationship between the Pes-guided PEEP titration and PPCs. The aim of our study is to investigate the potential role of Pes-guided PEEP titration on the incidence of PPCs and respiratory mechanics.

Methods and analysis

A total of 232 elderly patients undergoing major laparoscopic surgery under general anaesthesia will be recruited in four tertiary teaching hospitals in China. Patients will be randomly allocated to the control group (PEEP set at 3 cm H2O) without lung recruitment manoeuvres (RMs) or Pes-guided PEEP group with RMs in a 1:1 ratio. Preoperative preparation, anaesthesia management and postoperative care will be performed similarly in both groups. The primary outcome will be the development of PPCs within 7 days after surgery. The intraoperative respiratory parameters, the oxygenation index, vital signs and non-respiratory complications within 7 days after surgery, the 15-item Quality of Recovery-15 questionnaire, unplanned reintubation and unplanned transfer to the intensive care unit, hospital stay, perioperative plasma levels of lung injury biomarkers, complications within 30 days after surgery and 90-day mortality after surgery will be recorded and evaluated as the secondary outcomes.

Ethics and dissemination

The study has received ethics approval from the ethics committee of the Zhongshan Hospital, Fudan University (China) with the approval number B2023-334R. The results of the study will be submitted for publication in peer-reviewed journals.

Protocol version

Version 1, on 9 October 2023.

Trial registration number

NCT06150079.

Acceptability and preferences of people with long-term conditions for delivery of digital healthcare interventions: scoping review protocol

Por: Gerlis · C. · Berry · A. · Thomas · R. · Pacey-halls · S. · Loizou · M. · Swales · C. · Cramp · F.
Background

Digital health interventions (DHIs) are prevalent and have been shown to help some people with long-term conditions (LTCs) to manage their condition. There are myriad options for digital delivery yet limited understanding of what modes of delivery are acceptable to people with LTCs. It is important to understand the acceptability of delivery methods of DHIs to inform future DHI development and promote engagement. This scoping review aims to explore the acceptability of the delivery of DHIs for people with LTCs.

Methods and analysis

This review will follow the Joanna Briggs Institute guidance for scoping reviews and will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping reviews extension checklist. Databases including MEDLINE, PubMed, CINAHL, AHMED and PsycINFO will be searched for primary studies that provide data on preferences for delivery methods of DHIs by people with LTCs. Narrative analysis is anticipated, and a summary of the findings will be presented in a tabulated format.

Ethics and dissemination

Ethical approval will not be required for this scoping review. The findings will be disseminated via appropriate peer-reviewed journals and conferences and PhD theses.

Pressure Injury Assessment Tools for Oncology Patients: A Systematic Review

ABSTRACT

Aim

The objective of this systematic review was to evaluate the measurement properties of pressure injury risk assessment tools for cancer patients using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology, and to serve as a reference for clinical nurses in their hospital duties when choosing high-quality assessment tools.

Design

A systematic review based on COSMIN methodology.

Data Sources

The English literature in PubMed, Embase, Web of Science, Cochrane Library, CINAHL and the search period ranged from the inception of the database to September 30, 2024.

Methods

Two reviewers independently screened the studies, extracted the data, and evaluated the methodological quality and measurement properties of the included studies.

Results

Seven studies met the inclusion criteria. Two tools—the PUSO (Pressure Ulcer Scale in Oncology) and the Cuire scale—demonstrated sufficient evidence of content validity and structural validity, meeting the COSMIN quality standards. None of the studies reported the cross-cultural validity, stability, and measurement error of the assessment tool.

Conclusion

Following the COSMIN assessment, the PUSO and the Cuire were developed using rigorous procedures, ensuring sufficient overall quality for content validity, structural validity, and other measurement properties. We recommend their use across various environments, based on the quantity and content of specific items. The PUSO was recommended for clinical screening, whereas the Cuire scale was deemed more suitable for use in outpatient, community, and scientific research settings. However, these measurement properties are not without flaws, and their clinical application requires further validation.

Machine Learning‐Based Classifier for Identifying Inpatients With Schizophrenia at High Risk of Suicide

ABSTRACT

Aims

The suicide rate of individuals with schizophrenia is higher than the general population. In clinical practice, it is essential to identify patients with schizophrenia who are at an elevated risk of suicide. However, previous studies may not fully account for potential factors that could influence the suicide risk among schizophrenia patients. Our study leverages machine learning to identify predictive variables from a broad range of indicators.

Design

Cross-sectional.

Methods

A total of 131 patients with schizophrenia were recruited at the Mental Health Center of West China Hospital from August 2021 to July 2022. We collected complete blood analysis, thyroid function, inflammatory factors, childhood trauma experiences, psychological impact related to the Coronavirus Disease 2019 epidemic, sleep quality, psychological distress, income level and other demographic data. We utilised machine learning algorithms to predict the suicide risk of patients with the above features. The Shapley values were used to illustrate important predictive variables of suicide risk.

Results

We gathered important variables for predicting suicide risk of patients with schizophrenia, such as the Nurses' Observation Scale for Inpatient Evaluation factor, neutrophil count, psychological impact during Coronavirus Disease 2019 epidemic, prolactin level and plasma thromboplastin component level.

Conclusion

The features identified in this study are anticipated to aid in the clinical identification of suicide risk in individuals with schizophrenia in the future. This study also promoted improvements in the suicide prediction model among patients with schizophrenia.

Impact

This study identified key predictive variables for suicide risk in schizophrenia patients using machine learning. Our findings will enhance clinical tools for assessing suicide risk in schizophrenia, potentially leading to more effective prevention strategies. This advancement holds promise for improving suicide prevention efforts and tailoring interventions to individuals' specific risk profiles.

Reporting Method

STROBE Statement (for cross-sectional studies).

Patient or Public Contribution

None.

Curating a knowledge base for patients with neurosyphilis: a study protocol of a DEep learning Framework for pErsonalized prediction of Adverse prognosTic events in NeuroSyphilis (DEFEAT-NS)

Por: Lu · Z. · Yang · L. · Li · J. · Wang · J. · Wu · W. · Fu · L. · Wang · B. · Tian · T. · Zhang · H. · Peng · Z. · Liu · S. · Zou · J. · Zou · H.
Introduction

Adverse prognostic events (APE) of neurosyphilis include ongoing syphilitic meningitis, meningovascular syphilis, parenchymatous neurosyphilis and death. Its complexity and rarity have the potential to result in the underestimated true burden of neurosyphilis worldwide, due to lack of recognition and under-reporting. The unmet need for a modern method of refined and targeted treatment of neurosyphilis is strengthened by the currently various distinct diagnostic criteria. The DEep learning Framework for pErsonalized prediction of Adverse prognosTic events in NeuroSyphilis study will develop and validate prediction models for personalised prediction of APE after initial diagnosis in neurosyphilis to aid shared decision-making and stratify care of patients with neurosyphilis at high risk of severe prognostic course.

Methods and analysis

We conducted formative research to conceptualise and design a robust and clinically acceptable deep learning framework. We will conduct a deep learning framework development and validation study using a retrospective, multicentre, longitudinal cohort design and applying unsupervised, semi-supervised machine learning and deep learning. It will be conducted following expert guidance for model development and validation and our previous research experience. This study design consists of six parts: development, calibration, validation, subgroup bias evaluation, clinical utility evaluation and explanation.

Ethics and dissemination

This study will be conducted according to the Declaration of Helsinki and the Harmonised Tripartite Guideline for Good Clinical Practice of the International Conference on Harmonisation. No patient will be directly involved in developing the study’s research question, design and implementation. This study will be a retrospective analysis of already anonymised data; therefore, ethical approval and informed consent were waived by the institutional review board of School of Public Health (Shenzhen), Sun Yat-sen University. The results will be disseminated through a peer-reviewed publication.

Varying oropharyngeal colostrum administration dosages on outcomes associated with very low birth weight infants: a randomised controlled trial protocol

Por: Jin · Y. · Fu · Z. · Jin · J. · Hu · Y. · Huang · C. · Zou · X. · Han · R. · Chen · J. · Quan · M.
Introduction

Oropharyngeal colostrum administration (OCA) confers immunological benefits to very low birth weight infants (VLBWIs) through nutrient absorption via oropharyngeal lymphatic tissue, potentially reducing complication rates and improving clinical outcomes. Current evidence demonstrates significant variability in OCA protocols regarding the initiation timing, application frequency, treatment duration and dosage of this therapy across studies, and limited research exists on its impact on haematological indices in infants. Notably, the dose-dependent effects of OCA on both clinical outcomes and haematological immunological parameters in VLBWIs remain insufficiently investigated. We hypothesise that varying OCA doses will demonstrate differential impacts on clinical outcomes and systemic levels of key immunological markers in VLBWIs.

Methods and analysis

This single-centre, three-arm, parallel-controlled randomised controlled trial will enrol 129 VLBWIs to evaluate the efficacy of OCA. Using a blinded design, both outcome assessors and data analysts will be masked to group allocation throughout the study. Participants will be randomly assigned in a 1:1:1 ratio into three groups: two receiving OCA (0.2 mL colostrum every 3 hours or 6 hours for 10 days) and a control group with standard care only. The primary endpoints of this trial are to compare the incidence of necrotising enterocolitis, bronchopulmonary dysplasia and retinopathy of prematurity across the three groups. Additionally, we will assess haematological and immunological indicators, including IL-2, IL-4, IL-6, IL-10, TNF-α, IFN- and serotype immunoglobulin A levels, to evaluate the potential effects of different OCA dosages on these parameters.

Ethics and dissemination

This study protocol received full ethical approval (No. KLL-2023–505) from the ethics committee of the Affiliated Hospital of Zunyi Medical University on 5 September 2023, after a thorough review. The study findings will be disseminated through publication in peer-reviewed journals.

Trial registration number

ChiCTR2300077114. Registration on 31 October 2023.

Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA): protocol for a multicentre prospective, longitudinal cohort study

Por: Lin · J.-Z. · Zhu · Y. · Li · Q.-H. · Ouyang · Z.-M. · Liu · H.-J. · Zou · Y.-W. · Yang · Y. · Yang · K.-M. · Yang · L.-J. · Yang · Z.-H. · Zhang · L. · Mo · Y.-Q. · Ma · J.-D. · Dai · L.
Introduction

The burden of rheumatoid arthritis (RA) is profound, although treated with the treat-to-target strategy for RA patients according to the two most influential organisations for rheumatology worldwide. The need to timely achieve the control of disease activity for RA patients, especially for those difficult-to-treat individuals, is still unmet. Besides, the data on the diagnosis and prognosis of RA-related complications or comorbidities such as sarcopenia, cardiovascular diseases (CVD), malignancies and infections in large real-world cohorts are still limited. Therefore, the aim of this large-scale cohort study is to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications/comorbidities and to evaluate their impact on the prognosis of RA.

Methods and analysis

In this real-world multicentre prospective cohort, consecutive RA patients are planned to be recruited during 2024 and 2033 and with at least 5-year follow-up. Sociodemographic characteristics collection, clinical assessment, muscle assessment, histopathological assessment, imaging examination and biological samples collection will be performed at baseline, 1st, 3rd, 6th and 12th month during the first year and subsequently every 6 months until 5 years to repeat the assessments and collect the information of interested outcomes. The outcomes of interest include RA disease outcomes (including disease activity, functional and radiographic indicators) and RA-related complications/comorbidities (eg, sarcopenia, CVD, malignancies and specific infection).

Ethics and dissemination

Ethical approval has been approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University (ID: SYSKY-2023-1235-01); the Affiliated Panyu Central Hospital of Guangzhou Medical University (ID: PYRC-2024-214-01); and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (ID: 2024-SSKY-118-01). All study participants sign an informed consent form. Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.

Trial registration number

NCT06233929.

Triangular perspectives of healthcare providers, patients and their families on ICU palliative care: a protocol for a systematic review of qualitative studies

Por: Shen · Y. · Xu · H. · Zou · Y. · He · L.
Introduction

In the intensive care unit (ICU), palliative care encounters obstacles such as decision conflicts, psychological stress and cultural differences among patients, families and healthcare providers. The well-being and the care quality of patients are influenced by these factors. The highly technical and curative-focused environment of the ICU presents a challenge for palliative care without appropriate integration. Certainly, it is imperative to comprehend these issues and devise strategies to reconcile curative and palliative needs. This paper employs qualitative metaintegration to appraise the experiences and perspectives of palliative care in the ICU, emphasising its outcomes, barriers and the necessity of balanced care and treatment.

Methods and analysis

This study conducted a comprehensive search of both the published and unpublished literature (such as grey literature) from a variety of databases, concerning PubMed, Google Scholar, Cochrane Library, CINAHL, Web of Science, Embase, Scopus, PsycINFO, CNKI, Wanfang, CBM and VIP, up to 10 July 2024. The articles will be retrieved and incorporated into EndNote X9 to facilitate organisation. Two independent researchers will evaluate the studies using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research, and a third researcher will resolve all discrepancies. Data extraction and results synthesis will be performed independently based on the JBI qualitative data extraction tool. Finally, the ConQual method will be employed to estimate the calibre of the compiled results.

Ethics and dissemination

The systematic review was conducted without the necessity of obtaining ethical clearance from a research committee, as it analysed previously published studies that did not contain any personal identifying information of participants. The review’s findings were presented to key stakeholders and submitted for consideration in peer-reviewed journals.

PROSPERO registration number

CRD42024571594.

Remission of type 2 diabetes is achievable in primary care with intensive lifestyle intervention

Por: Zoungas · S. · Sumithran · P.

Commentary on: Hocking SL et al. Intensive Lifestyle Intervention for Remission of Early Type 2 Diabetes in Primary Care in Australia: DiRECT-Aus. Diabetes Care 2024;47:66–70.

Implications for practice and research

  • Intensive lifestyle intervention in primary care can safely achieve type 2 diabetes (T2D) remission at 12 months in around half of selected participants with short-duration, well-controlled T2D.

  • Research on the effectiveness and acceptability of strategies to improve durability of remission is needed.

  • Context

    Although previously thought to be inevitably progressive, evidence is growing that type 2 diabetes (T2D) can be brought into remission with weight loss.

    This study by Hocking et al1 was a single-arm replication of the Diabetes Remission Clinical Trial (DiRECT) randomised controlled trial2 in an Australian setting. It confirms that with an intensive lifestyle intervention including total diet replacement (TDR), around half of adults with recently...

    Epidemiological association of the COVID-19 pandemic on Mycoplasma pneumoniae infections in children in Tianjin, China: a single-centre retrospective study (2017-2024)

    Por: Wang · W. · Wang · L. · Guo · R. · Bo · Y. · Zou · Y. · Cui · H.
    Objective

    To investigate the epidemiological characteristics and temporal-spatial distribution of Mycoplasma pneumoniae (MP) infections among paediatric inpatients with respiratory tract infections in Tianjin, China, across three distinct phases: pre-pandemic (2017–2019), pandemic (2020–2022) and post-pandemic (2023–2024). The primary hypothesis is that the COVID-19 pandemic altered the epidemiology of MP infections in children.

    Design

    Retrospective, single-centre study.

    Setting

    Secondary care paediatric hospital in a metropolitan area.

    Participants

    A total of 60 213 paediatric patients hospitalised with respiratory infections between January 2017 and December 2024 were included. The study population consisted of children aged 0–18 years, with a male-to-female ratio of 1.22:1.00. Selection criteria included children admitted with a diagnosis of respiratory infection, while those with incomplete clinical data or non-respiratory infections were excluded.

    Primary and secondary outcome measures

    The primary outcome was the overall positive detection rate of MP-RNA. Secondary outcomes included annual and seasonal variations in MP-RNA detection rates, differences by sex and age group, and the impact of the COVID-19 pandemic on MP epidemiology. All statistical methods, including those used to control for confounding, involved the use of ² tests for comparing positive rates between groups.

    Results

    The overall positive detection rate of MP-RNA among children hospitalised for respiratory infections during the study period was 36.58% (22 023/60 213). The annual MP-RNA-positive detection rates from 2017 to 2024 were as follows: 50.74% (411/810) in 2017, 36.28% (1150/3170) in 2018, 27.41% (1459/5323) in 2019, 10.18% (222/2181) in 2020, 11.42% (928/8129) in 2021, 13.27% (579/4364) in 2022, 28.97% (3064/10575) in 2023 and 55.38% (14 210/25 661) in 2024. The highest annual positivity rate was observed in 2024 (55.38%, 14 210/25 661), while the lowest rate occurred in 2020 (10.18%, 222/2181). Statistical analysis revealed significant differences in MP-RNA detection rates across different years (²=8331.511, p

    Conclusions

    The COVID-19 pandemic substantially altered MP epidemiology in Tianjin’s paediatric population, with infection rates demonstrating a U-shaped trajectory across pandemic phases. School-aged children and females exhibited heightened susceptibility. These temporal and demographic patterns emphasise the necessity of incorporating epidemiological surveillance into diagnostic algorithms for childhood respiratory infections, particularly in post-pandemic settings. Future research should focus on multicentre studies to validate these findings and explore the underlying mechanisms.

    Perceived Stress, Resilience, Perceived Social Support and Self‐Management Behaviour in Young‐ and Middle‐Aged Patients With Multiple Chronic Conditions: A Structural Equation Modelling

    ABSTRACT

    Aim

    To explore the structural relationships among perceived stress (PS), perceived social support (PSS), resilience and self-management behaviours in young- and middle-aged patients with multiple chronic conditions (MCC).

    Background

    Self-management behaviours are essential for young- and middle-aged patients with MCC. However, research specifically focusing on these behaviours in this demographic remains limited. Moreover, the structural relationships among PS, PSS, resilience and self-management behaviours have not yet been analysed within a single hypothesised model.

    Methods

    A total of 302 young- and middle-aged patients with MCC were recruited from March to June 2023 at a general hospital in Dalian, Liaoning Province. Data on self-management behaviours, resilience, PS and PSS were collected using the Self-Health Management Assessment Scale for Chronic Disease Patients, Connor–Davidson Resilience Scale, Chinese Perceived Stress Scale and Multidimensional Scale of Perceived Social Support. Structural equation modelling was employed to test the study's hypotheses. This cross-sectional study was reported in accordance with STROBE guidelines.

    Results

    The findings revealed that PS was negatively associated with resilience, PSS and self-management behaviours. PS demonstrated an indirect relationship with self-management behaviours through resilience and PSS. Resilience was found to positively influence both self-management behaviours and PSS. PSS was positively correlated with self-management behaviours.

    Conclusions

    This study confirmed the structural relationships among the four variables under investigation. Resilience and PSS were identified as mediators between PS and self-management behaviours.

    Relevance to Clinical Practice

    The findings offer practical guidance for improving self-management behaviours in young- and middle-aged patients with MCC. Interventions should aim to reduce PS and strengthen both resilience and PSS. Nursing approaches should incorporate individualised psychological care, organised disease management and family engagement in treatment. These strategies may support psychological stability, reinforce resilience and support systems and sustain commitment to self-management behaviours.

    Patient or Public Contribution

    Patients contributed by participating in the study and completing the questionnaire.

    Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM): study protocol of a randomised non-inferiority clinical trial

    Por: Aebi · P. S. · Adam · L. · Haller · M. · Bardoczi · J. B. · Gencer · B. · Bonnet · F. · Beer · J.-H. · Carballo · S. · Christ-Crain · M. · Feller · M. · Gabutti · L. · Haynes · A. G. · Moutzouri · E. · Chocano-Bedoya · P. O. · Bassetti · S. · Escher · R. · Egger · M. · Poortvliet · R. K.
    Introduction

    Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

    Methods and analysis

    This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.

    Ethics and dissemination

    The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.

    Trial registration number

    Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158– IDRCB 2022-A02481-42.

    Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for primary advanced or recurrent endometrial cancer: a prospective single-arm open-label phase II clinical trial

    Por: Lin · J. · Liu · T. · Chen · J. · Lin · Y. · Chen · X. · Zhuo · Y. · Li · Y. · Jiang · Y. · Yang · L. · Tu · C. · Liu · B. · Zou · J. · Chen · L. · Sun · Y.
    Introduction

    Recently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.

    Methods and analysis

    In this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.

    Ethics and dissemination

    The study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.

    Trial registration number

    NCT06066216.

    Blood pressure variability and mortality in patients admitted with acute stroke in a tertiary care stroke centre (2016-2019): a retrospective cohort study

    Por: Tawengi · M. · Hourani · R. F. · Alyaarabi · T. · Elsabagh · A. A. · Al-Dali · Y. · Ghassan Hommos · R. · Baraka · J. · Tawengi · A. M. · Abdallah · B. M. · Hatem · A. · Sardar · S. · Imam · Y. Z. · Akhtar · N. · Zahid · M. · Doi · S. · Danjuma · M. I.-M. · Elzouki · A.
    Objectives

    The influence of short-term variations in blood pressure (BP) in acute stroke on clinical outcomes remains uncertain. Our study explores the relationship between BP variability (BPV) from stroke admission up to 72 hours and in-hospital and 1-year mortality.

    Design

    Retrospective observational cohort study.

    Setting

    Hamad General Hospital (HGH) a tertiary care stroke centre in Qatar.

    Participants

    2820 participants were initially included. After the exclusion of ineligible subjects, 2554 patients (82.5% male, median age 53±9 years) were included. 893 (34.96%) were from the Middle East and North Africa, 1302 (50.98%) were from South Asia, 258 (10.10%) from Southeast Asia, 9 (0.35%) were from East Asia and 92 (3.60%) were from other regions. Eligible participants were adult patients above 18 years of age who presented with acute ischaemic or haemorrhagic stroke. Excluded individuals were those younger than 18 years, had incomplete data, had transient ischaemic attack (TIA), had severe hypoglycaemia on admission (

    Interventions

    We measured the BP every 4 hours over 3 days with a total of 18 readings from stroke admission. We then categorised BPV into five (L1–L5) and four (L1–L4) levels for systolic and diastolic BPs, respectively, and evaluated their association with mortality.

    Results

    There were increased odds of in-hospital mortality with increased systolic and diastolic variability (L2, OR 2.64, 95% CI 1.44 to 4.84; L3, OR 4.20 95% CI 2.14 to 8.24; L4, OR 10.14, 95% CI 4.93 to 20.85; L5, OR 23.18, 95%CI 10.88 to 49.37), (p=0.002 to

    Conclusion

    In a retrospective cohort of ethnically diverse acute stroke patient population, BPV was significantly associated with both in-hospital and 1-year mortality. Further prospective research is needed to define BPV and establish interventions and management accordingly.

    STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection

    Por: Delfino · C. · Carcel · C. · Lin · X. · Munoz-Venturelli · P. · Naismith · S. L. · Woodward · M. · Peters · R. · Wijesuriya · N. · Law · M. · Harding · I. H. · Wang · X. · Elliott · J. · Leder · K. · Hutchings · O. · Stecher · X. · Zoungas · S. · Anderson · C. S.
    Introduction

    Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.

    Methods and analysis

    The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.

    Ethics and dissemination

    This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.

    Trial registration number

    The study protocol is registered at Clinicaltrials.gov (NCT04904536).

    Efficacy of Yijinjing for Soft Tissue Improvement in Patients with Non-specific Chronic Neck Pain: Study Protocol for a Multicenter Randomized Controlled Trial

    Por: Zou · H. · Xie · F. · Yue · H. · Chen · X. · Wen · Z. · Fang · M. · Yao · F.
    Introduction

    As a mind–body exercise, Yijinjing has shown benefits in enhancing the effects of manual therapy for the treatment of pain, disability and soft tissue status associated with non-specific chronic neck pain (NCNP). The efficacy of Yijinjing as an independent exercise regimen for the treatment of NCNP has not been established. This study is designed to assess the efficacy of Yijinjing in patients with NCNP, compared with cervical function training (CFT).

    Methods and analysis

    A total of 132 consenting NCNP participants will be randomly assigned in a 1:1 ratio to either the Yijinjing group or the CFT group (three times a week for 8 weeks). Both groups will undergo an 8-week intervention phase. Outcome variables will be assessed at baseline and at 4-week, 8-week and 12-week follow-up. The primary outcome measure is the change in visual analogue scale scores at week 8. Secondary outcomes include neck disability index, cervical range of motion and soft tissue status parameters.

    Ethics and dissemination

    This study has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki, local laws and regulations. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

    Trial registration number

    ITMCTR2024000323.

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