To evaluate the effectiveness of a system based psychological first aid (PFA) training programme for emergency medical first responders in China.
Parallel-group, assessor-blinded, cluster randomised controlled trial.
42 clusters of health workers from various health facilities in China.
1399 health workers who provide emergency service for survivors of disasters.
One-day system based PFA training programme (PFA) or training as usual (TAU).
The primary outcome was the PFA skills, knowledge and attitude (SKA-PFA) score at 2 months postintervention. Secondary outcomes included post-traumatic growth, self-efficacy and professional quality of life.
The intervention group (n=690) had significantly higher SKA-PFA scores than the control group (n=709) at 2 months postintervention (adjusted mean difference=4.44; 95% CI 1.17 to 7.52; p=0.007; Cohen’s d=0.35). The intervention group also had higher scores on post-traumatic growth (p=0.113, d=0.24), self-efficacy (p=0.032, d=0.20) and professional quality of life (p=0.281, d=0.04).
The system based PFA training programme was more effective than the TAU in enhancing the PFA knowledge and skills of the emergency medical first responders and in increasing their competence to provide emergency service for survivors in China.
ChiCTR2200060464.
To construct a scientific and systematic competency evaluation tool for master of nursing specialists (MNS) and to provide a reference for the training, assessment and competency evaluation of MNS.
A first draft of the indicators for assessing MNS core competencies was developed on the basis of published research and group discussions. Between June and December 2020, the indicators were revised using two rounds of the Delphi expert consultation method, with questionnaires completed by 16 experts from five provinces in China.
The valid retrieval rate of the two questionnaires was 100.00%, and the coefficient of expert authority was 0.931. The Kendall’s concordance coefficients of the two rounds of questionnaires were 0.136 (p
The MNS competency assessment tool constructed in this study is focused and highly credible. The findings can be used as a guide for the training, assessment and competence evaluation of MNS in the future.
This study aimed to investigate the association between socioeconomic status (SES) and the prevalence of hypertension in Fujian province, China, and to evaluate the mediating effect of body mass index (BMI) and cooking salt intake between SES and hypertension.
Community-based cross-sectional survey was conducted between June 2018 and December 2019.
Fujian province, China.
A total of 26 500 participants aged >18 years completed the survey.
The primary outcome was the prevalence of hypertension. Education, income and occupation were used as SES indicators. Meanwhile, certain health behaviours and metabolic risk factors were used as secondary indicators of SES.
The prevalence of hypertension was relatively high among participants who finished primary education (34.8%), had the lowest annual income (46.0%), were unemployed or retired (34.7%). Education and income levels were negatively associated with the prevalence of hypertension (p
SES was associated with the prevalence of hypertension among adults in Fujian province, China. BMI and cooking salt intake were partial mediators of the association between SES and hypertension.
The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.
The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.
The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.
The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.
To investigate the prevalence of depression and anxiety symptoms among older adults in an urban district in China, as well as their associated factors.
Cross-sectional study.
General communities in Shenzhen, Guangdong, China.
A total of 5372 community-dwelling older adults aged 65 years or older were initially recruited. Ultimately, 5331 participants met the inclusion criteria and were included in this study.
Participants completed a sociodemographic questionnaire, along with assessments including the Patient Health Questionnaire-9, Generalised Anxiety Scale-7, UCLA Loneliness Simplification Scale, Insomnia Severity Index Scale (ISI), Community Dementia Brief Screening Scale and the 8-item Dementia Screening Questionnaire. Statistical analyses included the Shapiro-Wilk test, independent t-test, Wilcoxon rank test, 2 test and univariate and multivariate linear regression analysis.
The prevalence of depression and anxiety symptoms among older adults in Shenzhen communities was 10.4% and 11.3%, respectively. In multivariate analysis, age (B=–0.01, p
We observed a high prevalence of depression and anxiety symptoms among older adults in this study. The existing welfare system and infrastructure should remain and targeted mental health programmes addressing the identified risk factors should be proposed.
To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.
Cross-sectional study.
The data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure.
Participants were residents aged 18–69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018.
All participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg.
Age-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p
The mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.
Emmetropia depends on the precise coordination of ocular biometry, including axial length (AL), corneal curvature, lens thickness and anterior chamber depth (ACD). Disruption of this coordination leads to refractive errors such as myopia. This article aimed to determine the factors affecting ocular biometry and myopia development in young children.
A cross-sectional study.
This study was conducted in a primary school in the Yanqing district of Beijing, China.
792 students in grades 1–3 without hyperopia (>+2.00 D), strabismus, or amblyopia were selected. Exclusions: students had conditions affecting best corrected visual acuity and whose guardians refused to provide informed consent. Ocular biometric measurements and non-cycloplegia autorefraction were performed. The questionnaire addressed factors such as perinatal factors and environmental factors.
None.
Ocular biometry and myopia.
According to the multivariate logistic regression analysis, electronic screen use >2 hours/day (OR=2.175, p=0.013), paternal myopia (OR=1.761, p=0.002), maternal myopia (OR=1.718, p=0.005), taller height (OR=1.071, p2 hours each day (OR=3.596, p2 hours each day (OR=0.431, p=0.001) influenced ACD incidence. Central corneal thickness (CCT) was associated with older age (OR=1.113, p=0.008), paternal education (OR=1.474, p=0.007), premature birth (OR=0.494, p=0.031), history of blue light therapy in infancy (OR=0.636, p=0.041) and history of incubator therapy in infancy (OR=0.263, p=0.009). Only sex influenced corneal curvature.
The factors associated with myopia were partly related to ACD and AL, and perinatal factors were associated with myopia and CCT.
ChiCTR2200065398.
Postoperative pancreatic fistula (POPF) remains one of the most severe complications of laparoscopic pancreaticoduodenectomy (LPD). Theoretically, transecting the pancreatic neck more distally has both advantages (more blood supply, and more central pancreatic duct) and disadvantages (maybe smaller the pancreatic duct) in preventing POPF. This theoretical contradiction pushed us to organise this trial to explore the impact of the level of pancreatic transection in clinical practice. We conduct this randomised trial with the hypothesis that extended pancreatic neck transection has superiority to conventional pancreatic neck transection.
The LPDEXCEPT (Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy) trial is a multicentre, randomised-controlled, open-label, superiority trial in 4 centres whose annual surgical volume for LPD is more than 25 cases with pancreatic surgeons who had completed their learning curve. A total of 154 patients who meet the inclusive and exclusive criteria are randomly allocated to the extended pancreatic neck transection group or conventional pancreatic neck transection group in a 1:1 ratio. The stratified randomised block design will be applied, with stratified factors are surgical centre and the diameter of the main pancreatic duct measured by preoperative CT scan (preMPD). The primary outcome is the incidence of the clinically relevant pancreatic fistula.
Ethics Committee on Biomedical Research of West China Hospital of Sichuan University has approved this trial in March 2023 (approval no. 2023-167). Results of this trial will be published in peer-reviewed journals and conference proceedings.
Decisions regarding the optimal timing of intervention for asymptomatic aortic stenosis (AS) are controversial. The study aims to identify potential risk factors for asymptomatic patients with severe AS that are associated with worse prognosis and to evaluate the benefits of early interventions for asymptomatic patients presenting with one or more additional risk factors.
This is a non-interventional, prospective, open-label, multicentre registry study across China. A total of 1000 patients will be enrolled and categorised as symptomatic or asymptomatic. The primary endpoint is the occurrence of all-cause mortality, stroke, acute myocardial infarction and heart failure-related hospitalisation at 1-year follow-up. In asymptomatic severe AS patients presenting with one or more risk factors, the occurrence rate of the primary endpoint between those who undergo transcatheter aortic valve replacement (TAVR) and those who do not will be compared. We will also compare the occurrence rate of the primary endpoint for asymptomatic severe AS patients with additional risk factors who undergo TAVR with those presenting with symptoms. This study is believed to provide additional evidence to help clinicians identify and refer severe AS patients who are asymptomatic but present with additional risk factors for early intervention of TAVR.
The study protocol has been approved by the local ethics committee of each participating site: West China Hospital, Sichuan University; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Second Hospital of Hebei Medical University; Tianjin Chest Hospital; and First Affiliated Hospital of Nanchang University. All participants will provide written informed consent. Study results will be published through academic conferences and peer-reviewed journals.
This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853.
Frailty has been currently considered as a multidimensional concept, including physical, cognitive and social frailty. Frailty has also been associated with a range of adverse events, which might increase the risks of disability, falls, fractures, delirium and death. Increasing evidence has shown that multicomponent exercise training can improve physical and cognitive function, delay or reverse frailty. However, there is still a lack of exercise intervention programmes for the frail older adults in China. This trial aims to investigate the effects of the muscle-building and antifrailty exercise combined with Baduanjin on the physical function of frail older adults, as well as the effectiveness and safety of the intervention.
This study is a prospective randomised controlled trial. A total of 192 patients, aged 70 years or older, who are diagnosed as prefrailty or frailty based on the Fried criteria will be included. Prior written and informed consent will be obtained from every subject. These subjects will be randomly assigned to the exercise intervention group (n=96) and the control group (n=96). The exercise intervention group will undergo different exercise programmes for different levels of physical function. They will perform the muscle-building and antifrailty exercise three times per week for 30–60 min for 24 weeks. The control group will implement health education on frailty and maintain the old lifestyle without any intervention.
The primary outcomes include the change in frailty and functional capacity, assessed according to the Fried Scale and the Short Physical Performance Battery. Secondary outcomes include the changes in body composition, Activities of daily living, Mini-Mental State Examination, The Geriatric Depression Scale-15 and the haematological indicators.
The study has been approved by the Medical Ethics Committee of the PLA General Hospital (approval no.: S2022-600-02).
ChiCTR2300070535.
To investigate the relationship between alcohol consumption and hyperuricaemia (HUA), we conducted a study based on a large population.
Cross-sectional study.
A total of 20 833 participants aged 30–79 years were enrolled in the China Multi-Ethnic Cohort, Chongqing region.
The serum level of uric acid, fasting blood glucose and blood lipids were tested. Basic demographic statistics such as age, gender, marital status, education level, family annual income and the detail information of alcohol consumption were collected using a standardised questionnaire.
After controlling for potential confounders, compared with participants who never consumed alcohol, participants who drank 3–5 days per week had the highest risk of HUA (OR: 1.51, 95% CI: 1.25 to 1.82) and those who drank alcohol harmfully had the highest risk of HUA (OR: 1.81, 95% CI: 1.41 to 2.32). In addition, we found that those who drank moderately had no significant association with risk of HUA. However, among men, compared with participants who never consumed alcohol, those who drank moderately was also a risk factor of HUA (OR: 1.23, 95% CI: 1.03 to 1.46) and those who drank alcohol harmfully had the highest risk of HUA (OR: 2.13, 95% CI: 1.64 to 2.78). Compared with participants who drank alcohol moderately, the OR (95% CI) for those who drank alcohol harmfully had the highest risk of HUA was 1.88 (1.42 to 2.48), and the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.22 (1.12 to 1.33). Among men, compared with participants who drank alcohol moderately, those who drank alcohol harmfully had the highest risk of HUA (OR: 1.93, 95% CI: 1.45 to 2.57), as well as the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.24 (1.13 to 1.35).
This study suggested that the frequency and degree of alcohol consumption may be the risk factors for HUA, especially in males.
Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.
The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm2
The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.
FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.
Although task-oriented training (TOT) may provide added therapeutic value to stroke survivors, current TOT guidance offers insufficient advice on standardisation, particularly choices of intensity, for clinical practice. Therefore, this study aims to explore the effects of different intensities of TOT on motor function and self-care ability of stroke survivors.
This randomised controlled clinical trial will recruit 72 participants from a tertiary hospital, diagnosed with decreased self-care ability and upper limb motor dysfunction post-stroke. All participants will be randomly assigned to one of three experimental groups or the control group to undergo intervention for 8 weeks. The participants in the control group (n=18) will receive traditional occupational therapy, while those in the experimental groups will receive different intensities of TOT (50%, 75% and 100% intensity for groups A, B and C, respectively). This protocol designed a more innovative and optimised TOT programme to explore the optimal intensity of TOT on stroke survivors. The primary outcome is Canadian Occupational Performance Measure, and the secondary outcomes include Modified Barthel Index, Wolf Motor Function Test and Motor Activity Log.
The Second Affiliated Hospital of Hainan Medical University Ethics Committee approved the medical and ethical protocol for this study (LW2022015). All participants will sign an informed consent form. The results will be presented in scientific conferences and published in peer-reviewed journals.
ChiCTR2200056390.
This work aimed to analyse the risk factors for poor outcomes and mortality among patients with anterior large vessel occlusion (LVO) ischaemic stroke, despite successful recanalisation.
This study conducted a secondary analysis among patients who underwent successful recanalisation in the CAPTURE trial. The trial took place between March 2018 and September 2020 at 21 sites in China. The CAPTURE trial enrolled patients who had an acute ischaemic stroke aged 18–80 years with LVO in anterior circulation.
Thrombectomy was immediately performed using Neurohawk or the Solitaire FR after randomisation in CAPTURE trial. Rescue treatment was available for patients with severe residual stenosis caused by atherosclerosis.
The primary goal was to predict poor 90-day survival or mortality within 90 days post-thrombectomy. Univariate analysis, using the 2 test or Fisher’s exact test, was conducted for each selected factor. Subsequently, a multivariable analysis was performed on significant factors (p≤0.10) identified through univariate analysis using the backward selection logistic regression approach.
Among the 207 recruited patients, 79 (38.2%) exhibited poor clinical outcomes, and 26 (12.6%) died within 90 days post-thrombectomy. Multivariate analysis revealed that the following factors were significantly associated with poor 90-day survival: age ≥67 years, internal carotid artery (ICA) occlusion (compared with middle cerebral artery (MCA) occlusion), initial National Institutes of Health Stroke Scale (NIHSS) score ≥17 and final modified Thrombolysis in Cerebral Infarction (mTICI) score 2b (compared with mTICI 3). Additionally, the following factors were significantly associated with mortality 90 days post-thrombectomy: initial NIHSS score ≥17, ICA occlusion (compared with MCA occlusion) and recanalisation with more than one pass.
Age, NIHSS score, occlusion site, mTICI score and the number of passes can be independently used to predict poor 90-day survival or mortality within 90 days post-thrombectomy.
Patients with breast cancer and endocrine therapy-related symptoms often experience pain, self-denial, anxiety, fear of recurrence and despair, which can be extremely physically and psychologically traumatising for the patients. Failure to receive effective support and management reduces adherence to medications, leading to a higher risk of relapse and mortality. Clearly, it is paramount to identify what support these patients may need and how to meet their symptom management needs. This paper outlines a protocol to synthesise qualitative evidence on endocrine therapy symptom experiences, management expectations and preferences of patients with breast cancer.
The following databases were searched in November 2023 with no date restriction applied: The Cochrane Library, PubMed, Embase, Web of Science, Scopus, CINAHL and OpenGrey. Published studies on qualitative or mixed-method on symptom experiences and management needs during endocrine therapy in patients with breast cancer will be retrieved. We will also search for reference lists and perform a forward citation search. Before inclusion in this review, two reviewers will independently apply the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research to ensure methodological validity. Any disagreements regarding the evaluation of the articles will be resolved through discussion with or by a third reviewer. Data will be extracted using the standardised data extraction tool EndNote20 for unified management, assessment, and review of information. The common sense model of self-regulation will guide data extraction and synthesis. The final synthesised findings will be graded according to the GRADE-CERQual approach to establish confidence.
This systematic review addressed previously published studies without personally identifiable participant information. Ethical approval from the research committee was not required. The findings of this systematic review will be disseminated to various key stakeholders and published in peer-reviewed journals.
CRD42023406987
The optimal puncture technique for neuraxial anaesthesia in different populations is unclear. We sought to obtain data from randomised controlled trials comparing the impact of ultrasound-guided technology and traditional positioning technology on the success rate of neuraxial anaesthesia.
Systematic review and network meta-analysis using study populations, interventions, intervention comparisons, outcome measures and study types.
PubMed, Embase, Cochrane Library and Web of science were searched until 31 September 2022.
We included randomised controlled trials comparing three types of neuraxial anaesthesia: ultrasound-assisted, ultrasound real-time guidance and conventional positioning to describe which neuraxial anaesthesia modality is best for patients and to recommend the appropriate one for different populations.
Five independent reviewers retrieved, screened and edited included studies using standardised methods. Assess risk of bias using the Cochrane Collaboration and Evidence Project tools. Network meta-analysis was performed using STATA V.15 statistical software.
Twenty-two studies containing three different interventions were included. The SUCRA values of first-pass success rates for the three neuraxial anaesthesia methods were real-time guidance (82.8%), ultrasound-assisted (67.1%) and traditional positioning (0.1%). Both ultrasound techniques improved first-pass success rates compared with traditional localization, but there was no significant difference between the two. Subgroup analysis showed that the use of real-time ultrasound guidance for neuraxial anaesthesia in pregnant and patients with obesity improved first-pass success rates. Ultrasound-assisted technology can improve first-attempt success rates in older patients with abnormal lumbar spine anatomy.
Compared with conventional positioning, ultrasound guidance technology can improve the first-pass success rate of neuraxial anaesthesia, but there is no significant difference between ultrasound-assisted and real-time guidance technology. The results of subgroup analysis tell us that the most suitable neuraxial anaesthesia method is different for different groups of people.
PROSPERO number: CRD42022376041.