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AnteayerBMJ Open

Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol

Por: Wong · H. · Chi · Y. · Zhang · R. · Yin · C. · Jia · J. · Wang · B. · Liu · Y. · Shang · Y. · Wang · R. · Long · Y. · Zhao · Z. · He · H.
Introduction

Previous studies suggested that electrical impedance tomography (EIT) has the potential to guide positive end-expiratory pressure (PEEP) titration via quantifying the alveolar collapse and overdistension. The aim of this trial is to compare the effect of EIT-guided PEEP and acute respiratory distress syndrome (ARDS) network low PEEP/fraction of inspired oxygen (FiO2) table strategy on mortality and other clinical outcomes in patients with ARDS.

Methods

This is a parallel, two-arm, multicentre, randomised, controlled trial, conducted in China. All patients with ARDS under mechanical ventilation admitted to the intensive care unit will be screened for eligibility. The enrolled patients are stratified by the aetiology (pulmonary/extrapulmonary) and partial pressure of arterial oxygen/FiO2 (≥150 mm Hg or 2 table proposed by the ARDS Network. The primary outcome is 28-day survival.

Analysis

Qualitative data will be analysed using the 2 test or Fisher’s exact test, quantitative data will be analysed using independent samples t-test or Mann-Whitney U test. Kaplan-Meier analysis with log-rank test will be used to evaluate the 28-day survival rate between two groups. All outcomes will be analysed based on the intention-to-treat principle.

Ethics and dissemination

The trial is approved by the Institutional Research and Ethics Committee of the Peking Union Medical College Hospital. Data will be published in peer-reviewed journals.

Trial registration number

NCT05307913.

Risk factors and glycaemic control in small-for-gestational-age infants born to mothers with gestational diabetes mellitus: a case-control study using propensity score matching based on a large population

Por: Li · J. · Pan · Y. · Zheng · Q. · Chen · X. · Jiang · X. · Liu · R. · Zhu · Y. · Huang · L.
Background

Small for gestational age (SGA) poses a significant concern for newborns, being linked to neonatal complications and potential metabolic disorders in adulthood, especially when born to mothers with gestational diabetes mellitus (GDM), elevating their risk of complications and mortality. However, the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM remain unclear.

Aim

To identify the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM.

Method

This case–control study was conducted among 1910 women with GDM in China. Data were collected by the integrated electronic medical record system. Using 1:4 propensity score matching analysis, we adjusted for gestational age as confounder. Univariate and multivariate analyses were performed to identify risk factors.

Results

Risk factors for SGA born to mothers with GDM included a history of low birth weight, gestational hypertension, oligohydramnios, short maternal height, underweight pre-pregnancy body mass index and inadequate weight growth. While SGA was protected by weakly positive ketonuria levels in the first trimester, multiparous, anaemia and previous uterine scar were protective factors for SGA. Moreover, 2-hour postprandial glucose and haemoglobin A1c in the second trimester, as well as the 0-hour and 2-hour 75 g oral glucose tolerance test (OGTT) were linked to risk of SGA.

Conclusions

SGA infants are the result of multifactorial interactions among GDM pregnant women. Notably, glycaemic control levels were associated with SGA. There is a need for enhanced perinatal monitoring and antenatal care to reduce SGA.

Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol

Por: Chen · X. · Jiang · X. · Zhang · X. · Ren · D. · Wei · C. · Xu · A. · Yang · H. · Bai · R. · Li · C. · Yue · F. · Bao · S. · Shi · J. · Fan · J.
Introduction

Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD.

Methods and analysis

This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage.

Ethics and dissemination

This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference.

Trial registration number

ChiCTR2300074554.

Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study

Por: Li · Y.-S. · Li · J.-B. · Wang · J.-J. · Wang · X.-H. · Jiang · W.-R. · Qiu · H.-N. · Xia · L.-F. · Wu · F. · Lin · C.-Y. · Liu · Y.-L. · Lin · J.-N.
Objective

The aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).

Methods

Subjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for cc

Results

The prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p

Conclusion

Age, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.

Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk--protocol of a prospective study

Por: Hou · J. · Li · M. · Han · J. · Yu · S. · Jia · X. · Sun · F. · Zhang · Y.
Introduction

Cardiovascular diseases are the leading cause of death and disease burden in China. However, there is a lack of prospective cohort studies suitable for evaluating early organ damage and its role in preventing and reducing cardiovascular risk among Chinese residents. This study intends to establish the first database based on the phenotypes of all early structural and functional damage of cardiovascular organs in Chinese population. Moreover, a digital follow-up mechanism will be formed, a prospective population cohort will be established, a biological sample bank for early cardiovascular organ damage will be established, and an intervention and management system for early damage of cardiovascular organs will be explored.

Methods and analysis

This study is a prospective cohort study built on the foundation of the Northern Shanghai Study I. People aged 18–75 years are enrolled. After the recruitment, first, corresponding physical measurements and clinical examinations are conducted to collect cardiovascular risk factors and establish the demographic baseline of the study population. Next, the latest equipment is used to evaluate early structural and functional cardiovascular organ damage including heart, macrovessels, microcirculation, renal function and fundus. Meanwhile, the blood, urine, faeces and other biological samples of participants are collected to establish the cardiometabolic and gut microbiota analysis databases. The population is followed up every 2 years. Comprehensive assessment of early organ damage will be used to predict cardiovascular risk, guide people to change lifestyles to achieve early prevention and provide corresponding treatment recommendations.

Ethics and dissemination

This study was approved by the Shanghai Tenth People’s Hospital Institutional Review Board. All participants signed a written consent form. The results of this study will be disseminated in peer-reviewed journals. Ethics approval: SHYS-IEC-5.0/22k148/P01.

Trial registration number

NCT05435898.

Changing epidemiology, microbiology and mortality of bloodstream infections in patients with haematological malignancies before and during SARS-CoV-2 pandemic: a retrospective cohort study

Por: Cai · L. · Chen · H. · Wei · Y. · Guo · X. · Zheng · H. · Jiang · X. · Zhang · Y. · Yu · G. · Dai · M. · Ye · J. · Zhou · H. · Xu · D. · Huang · F. · Fan · Z. · Xu · N. · Shi · P. · Xuan · L. · Feng · R. · Liu · X. · Sun · J. · Liu · Q. · Wei · X.
Objective

This study was to explore the changes in bacterial bloodstream infection (BSI) in patients with haematological malignancies (HMs) before and during SARS-CoV-2 pandemic.

Design

Retrospective cohort study between 2018 and 2021.

Setting

The largest haematological centre in southern China.

Results

A total of 599 episodes of BSI occurring in 22 717 inpatients from January 2018 to December 2021 were analysed. The frequencies of the total, Gram-negative and Gram-positive BSI before and during the pandemic were 2.90% versus 2.35% (p=0.011), 2.49% versus 1.77% (p

Conclusion

Our data showed that the incidence of total and Gram-negative organisms BSI decreased, but Gram-positive BSI incidence increased in patients with HMs during the pandemic along with the changes of main isolates and susceptibility profiles. Although the 30-day mortality due to BSI was lower during the pandemic, the new infection prevention strategy should be considered for any future pandemics.

Efficacy of cell-based immunotherapies on patients with glioma: an umbrella review of systematic reviews and meta-analysis protocol

Por: Nikoobakht · M. · Shamshiripour · P. · Mostafavi Zadeh · S. M. · Rahnama · M. · Hajiahmadi · F. · Ramezani · A. · Farzam Rad · V. · Nazari · E. · Moradi · A.-R. · Akbarpour · M. · Ahmadvand · D.
Introduction

Glial brain tumours are highly mortal and are noted as major neurosurgical challenges due to frequent recurrence or progression. Despite standard-of-care treatment for gliomas, the prognosis of patients with higher-grade glial tumours is still poor, and hence empowering antitumour immunity against glioma is a potential future oncological prospect. This review is designed to improve our understanding of the efficacy of cell-based immunotherapies for glioma.

Methods and analysis

This systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of main electronic databases: PubMed/MEDLINE, Scopus, ISI Web of Science EMBASE and ProQuest will be done on original articles, followed by a manual review of review articles. Only records in English and only clinical trials will be encountered for full-text review. All the appropriate studies that encountered the inclusion criteria will be screened, selected and then will undergo data extraction step by two independent authors. For meta-analyses, data heterogeneity for each parameter will be first evaluated by Cochran’s Q and I2 statistics. In case of possible heterogeneity, a random-effects meta-analysis will be performed and for homogenous data, fixed-effects models will be selected for reporting the results of the proportional meta-analysis. Bias risk will be assessed through Begg’s and Egger’s tests and will also be visualised by Funnel plots.

Ethics and dissemination

As this study will be a systematic review without human participants’ involvement, no ethical registration is required and meta-analysis will be presented at a peer-reviewed journal.

PROSPERO registration number

CRD42022373297

Association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer: a systematic review and meta-analysis

Por: Liu · Q. · Huang · M. · Yang · J. · Jiang · M. · Zhao · Z. · Zhao · H. · He · T. · Bai · Y. · Zhang · R. · Zhang · M.
Objective

Clinical practice guidelines recommend retrieving at least 12 lymph nodes for correct staging in colorectal cancer. However, it is difficult to retrieve adequate lymph nodes because of various factors. We aimed to evaluate the association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer.

Design

Systematic review and meta-analysis of primary studies.

Data sources

PubMed, Embase, Cochrane and Web of Science were searched from January 2016 to June 2023.

Eligibility criteria for selecting studies

Studies that evaluated the association between retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer were included.

Data extraction and synthesis

OR with 95% conference intervals was extracted and pooled.

Results

A total of 54 studies containing 2 05 821 patients were included in this meta-analysis. The results showed that fewer nodes were retrieved from elderly patients (OR=0.70, 95% CI (0.54 to 0.90), p=0.005), and from tumours located in the left colon than in the right colon (OR=0.43, 95% CI (0.33 to 0.56), p

Conclusions

The study results suggest that clinicians have an increased opportunity to retrieve sufficient lymph nodes for accurate pathological staging to guide treatment decisions in patients with colorectal cancer who are young, female, with tumours located in the right colon, advanced T stage and N2 stage.

Nationwide survey of physicians familiarity and awareness of diabetes guidelines in China: a cross-sectional study

Por: Jia · L.-y. · Huang · C.-x. · Zhao · N.-j. · Lai · B.-y. · Zhang · Z.-h. · Li · L. · Zhan · N. · Lin · Y.-b. · Cai · M.-n. · Wang · S.-q. · Yan · B. · Liu · J.-p. · Yang · S.-y.
Objective

This study aims to investigate physicians’ familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines.

Design

A cross-sectional study.

Setting

An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians.

Participants

1150 physicians from 192 cities across 30 provinces in China provided complete data.

Results

Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics.

Conclusions

Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians’ awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Risk factors of incontinence-associated dermatitis in older adults: a protocol for systematic review and meta-analysis

Por: Fan · S. · Jiang · H. · Shen · J. · Lin · H. · Yang · L. · Yu · D. · Chen · L.
Introduction

Due to their ageing skin, older adults are more likely to develop incontinence-associated dermatitis (IAD). Although previous attempts to look at the risk factors for IAD in older adults were done, methodological barriers hindered an in-depth understanding. By investigating risk factors for IAD in the ageing population, the development of precise clinical interventions and guidance could be facilitated, which in turn would enhance patient care standards for incontinence management in this target group. To address this knowledge gap, this systematic review with meta-analysis aims to explore the major risk elements linked to IAD among older adults.

Methods and analysis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols are adhered to in this systematic review and meta-analysis. To achieve its objectives, a comprehensive search strategy PubMed, Embase, Web of Science, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Medline, Chinese Scientific Journal Database (VIP database), WanFang Data Knowledge Service Platform, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, along with other relevant sources published until 18 July 2023 in both English and Chinese languages will be performed. The screening of articles, data abstraction and risk of bias evaluation will be done by two impartial reviewers. RevMan V.5.3 software will be used for data synthesis. The quality of the included study will be assessed using the Newcastle-Ottawa Quality Assessment tool and the Agency for Healthcare Research and Quality. The I2 test will identify the heterogeneity.

Ethics and dissemination

There is no need for ethical approval. Individual patient information or the rights of participants will not be compromised by this protocol. The findings will either be published in a peer-reviewed journal.

PROSPERO registration number

CRD42023442585.

Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)

Por: Zhang · J. · Hu · X. · Jiang · J. · Lu · D. · Guo · L. · Peng · X. · Pan · Y. · He · W. · Li · J. · Zhou · H. · Huang · J. · Jiang · F. · Pu · J. · Cheng · Z. · Yang · B. · Ma · J. · Chen · P. · Liu · Q. · Song · D. · Lu · L. · Li · S. · Fan · Y. · Meng · Z. · Tang · L. · Shin · E.-S. · Tu · S. · Koo · B.-
Introduction

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.

Method and analysis

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 mm22 and plaque burden>70%. The primary endpoint is a composite of all-cause death, myocardial infarction and revascularisation at 12 months after randomisation. We will test the non-inferiority of the angiography-derived FFR-guided strategy compared with the IVUS-guided decision for PCI and the stent optimisation strategy.

The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.

Ethics and dissemination

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.

Trial registration number

NCT04397211.

Relationship between mental health, sleep status and screen time among university students during the COVID-19 pandemic: a cross-sectional study

Por: Wang · W. · Jiang · J. · Qi · L. · Zhao · F. · Wu · J. · Zhu · X. · Wang · B. · Hong · X.
Objective

On 20 July 2021, after the outbreak of COVID-19 at Nanjing Lukou International Airport, several universities started closed management and online teaching. This had a large impact on students’ daily life and study, which may lead to mental health problems. The purpose of this study is to study the effect of screen time on mental health status of university students and the possible mediating effect of sleep status.

Methods

This was a cross-sectional study. A web-based questionnaire survey was employed that included demographic characteristics, sleep status and mental health status (depression, anxiety and loneliness). The Pittsburgh Sleep Quality Index scale was used to assess sleep status, while the Centre for Epidemiologic Studies Depression (CES-D) scale, Generalised Anxiety Disorder-7 (GAD-7) scale and Emotional versus Social Loneliness Scale (ESLS) were used to assess depression, anxiety and loneliness, respectively. Linear and logistic regression models were developed and adjusted for confounding factors, and finally the mediating effects were tested using the Karlson-Holm-Breen method.

Results

Finally, 1070 valid questionnaires were included. Among these, 604 (56.45%) indicated depressive symptoms (CES-D score ≥16) and 902 (84.30%) indicated anxiety symptoms (GAD-7 score ≥10). The mean ESLS score (for loneliness) was 26.51±6.64. The relationship between screen time and depressive symptoms (OR 1.118, 95% CI 1.072 to 1.166) and anxiety symptoms (OR 1.079, 95% CI 1.023 to 1.138) remained significant after adjusting for confounding factors. Meanwhile, sleep status plays an intermediary role in screen time and mental health status (depression and anxiety) and accounts for 13.73% and 19.68% of the total effects, respectively. We did not find a significant association between screen time and loneliness.

Conclusion

During the outbreak of COVID-19, screen time is inevitably prolonged among university students. There is a relationship between mental health and screen time, and sleep status plays a mediating role.

Virtual reality as an adjunct to pulmonary rehabilitation of patients with chronic obstructive pulmonary disease: a protocol for systematic review and meta-analysis

Por: Li · Y. · Jiang · H. · Lyu · Z.
Introduction

Chronic obstructive pulmonary disease (COPD) is a prevalent chronic lung disease characterised by persistent and progressive airflow obstruction resulting from tracheal and/or alveolar lesions. Patients afflicted with COPD endure a poor quality of life primarily due to the symptoms of the disease. Pulmonary rehabilitation (PR) constitutes a core component of the comprehensive management of individuals dealing with COPD. Nevertheless, suboptimal adherence and completion rates are the chief impediments associated with PR. Virtual reality (VR) is emerging as a promising approach to support patients with COPD in their PR journey. Currently, no comprehensive systematic review has evaluated the impact of VR as a PR adjunct in patients with COPD. We aimed to investigate and summarise the evidence from recent studies related to the effect of VR as an adjunct to PR in COPD cases.

Methods and analysis

We will conduct a comprehensive search of databases, including Web of Science, CINAHL, PubMed, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov, from their inception up to May 2023 to identify randomised controlled trials examining VR as an adjunct to PR in patients with COPD, with no restrictions on publication status or language. Our primary outcome measure will be the 6-min walk test. Two independent researchers will screen the literature for suitable articles for inclusion in this meta-analysis. Data collection and assessment of bias risk will be performed. This meta-analysis is intended to furnish data on each outcome as sufficient data become available. Heterogeneity will be assessed using the 2 test and I2 statistics. The current review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Ethics and dissemination

Ethical approval is waived due to the retrospective nature of this study. Furthermore, the findings will be disseminated through peer-reviewed journals.

PROSPERO registration number

CRD42022374736.

Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary

Por: Tian · L. · Wang · H. · Jia · Y. · Jin · L. · Zhou · C. · Zhou · H. · Yuan · S.
Introduction

Postoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO2) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous cerebral oximetry monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG.

Methods

This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSO2 less than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay.

Ethics and dissemination

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022–1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.

Trial registration number

ChiCTR2300068537.

Effects of non-invasive brain stimulation over supplementary motor area in people with Parkinsons disease: a protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Wei · Y. · Ye · S. · Jiang · H. · Chen · Y. · Qiu · Y. · Zhang · L. · Ma · R. · Gao · Q.
Introduction

Individuals with Parkinson’s disease (PD) often experience initial hesitation, slowness of movements, decreased balance and impaired standing ability, which can significantly impact their independence. Transcranial magnetic stimulation and transcranial direct current stimulation are two widely used and promising non-invasive brain stimulation (NIBS) modalities for treating PD. The supplementary motor area (SMA), associated with motor behaviour and processing, has received increasing attention as a potential stimulation target to alleviate PD-related symptoms. However, the data on NIBS over SMA in PD individuals are inconsistent and has not been synthesised. In this article, we will review the evidence for NIBS over SMA in PD individuals and evaluate its efficacy in improving PD function.

Method and analysis

Randomised controlled clinical trials comparing the effects of NIBS and sham stimulation on motor function, activities of daily living and participation for people with PD will be included. A detailed computer-aided search of the literature will be performed from inception to February 2023 in the following databases: PubMed, EMBASE, Physiotherapy Evidence Database (PEDro), Web of Science (WOS) and The Chinese National Knowledge Infrastructure (CNKI). Two independent reviewers will screen articles for relevance and methodological validity. The PEDro scale will be used to evaluate the risk of bias of selected studies. Data from included studies will be extracted by two independent reviewers through a customised, preset data extraction sheet.

Ethics and dissemination

Ethical approval is not required for this systematic review. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals.

PROSPERO registration number

CRD42023399945.

Effectiveness of a government-led, multiarm intervention on early childhood development and caregiver mental health: a study protocol for a factorial cluster-randomised trial in rural China

Por: Jiang · Q. · Wang · B. · Qian · Y. · Emmers · D. · Li · S. · Pappas · L. · Tsai · E. · Sun · L. · Singh · M. · Fernald · L. · Rozelle · S.
Introduction

The high incidences of both the developmental delay among young children and the mental health problems of their caregivers are major threats to public health in low-income and middle-income countries. Parental training interventions during early childhood have been shown to benefit early development, yet evidence on strategies to promote caregiver mental health remains limited. In addition, evidence on the optimal design of scalable interventions that integrate early child development and maternal mental health components is scarce.

Methods and analysis

We design a single-blind, factorial, cluster-randomised controlled, superiority trial that will be delivered and supervised by local agents of the All China Women’s Federation (ACWF), the nationwide, government-sponsored social protection organisation that aims to safeguard the rights and interests of women and children. We randomise 125 villages in rural China into four arms: (1) a parenting stimulation arm; (2) a caregiver mental health arm; (3) a combined parenting stimulation and caregiver mental health arm and (4) a pure control arm. Caregivers and their children (aged 6–24 months at the time of baseline data collection) are selected and invited to participate in the 12-month-long study. The parenting stimulation intervention consists of weekly, one-on-one training sessions that follow a loose adaptation of the Reach Up and Learn curriculum. The caregiver mental health intervention is comprised of fortnightly group activities based on an adaptation of the Thinking Healthy curriculum from the WHO. Primary outcomes include measures of child development and caregiver mental health. Secondary outcomes include a comprehensive set of physical, psychological and behavioural outcomes. This protocol describes the design and evaluation plan for this programme.

Ethics and dissemination

This study received approval from the Institutional Review Board of Stanford University (IRB Protocol #63680) and the Institutional Review Board of the Southwestern University of Finance and Economics in Chengdu, Sichuan, China. Informed oral consent will be obtained from all caregivers for their own and their child’s participation in the study. The full protocol will be publicly available in an open-access format. The study findings will be published in economics, medical and public health journals, as well as Chinese or English policy briefs.

Trial registration number

AEA RCT Registry (AEARCTR-0010078) and ISRCTN registry (ISRCTN84864201).

Comparison of drug-coated balloon angioplasty versus standard medical therapy on recurrent stroke and mortality rates among patients with symptomatic intracranial atherosclerotic stenosis: protocol for a systematic review and meta-analysis

Por: Sun · Y. · Luo · J. · Gong · H. · Xu · R. · Zhang · X. · Yang · B. · Ma · Y. · Wang · T. · Jiao · L.
Introduction

Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.

Methods and analysis

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.

Ethics and dissemination

This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.

PROSPERO registration number

CRD42022341607.

Efficacy and safety of intraperitoneal dexamethasone on postoperative nausea and vomiting following laparoscopy: study protocol for a systematic review and meta-analysis

Por: Xu · N. · Jiang · K. · Liu · L. · Chen · L.
Introduction

Intraperitoneal dexamethasone has been reported to be effective to reduce the incidence of postoperative nausea and vomiting (PONV). Therefore, this meta-analysis will analyse the efficacy and safety of intraperitoneal dexamethasone on PONV following laparoscopy.

Methods and analysis

Electronic databases (eg, Cochrane Library, PubMed, Excerpta Medica Database, Web of Science, National Institute of Informatics, Oriental Medicine Advanced Searching Integrated System and China National Knowledge Infrastructure) and clinical trial registries will be systematically searched from their inception to 1 October 2022. After the study and data collection processes, we will identify randomised controlled trials that reported details of intraperitoneal dexamethasone on PONV following laparoscopy to conduct a meta-analysis. We will perform the study process and data collection separately. The collected data will be statistically analysed using Review Manager 5.4 software. The risk of bias will be assessed using the Cochrane risk-of-bias tool 2. The Grading of Recommendations Assessment, Development and Evaluation certainty assessment, and a trial sequential analysis will be conducted to ensure the accuracy of this meta-analysis.

Ethics and dissemination

Ethical approval and patient consent are not required since this study is a systematic review and meta-analysis. The findings of this meta-analysis will be submitted to a peer-reviewed journal for publication.

PROSPERO registration number

CRD42022362924.

Health system barriers to timely routine measles vaccinations in rural southwest China: a qualitative study on the perspectives of township vaccination professionals and village doctors

Por: Cheng · M. · Lan · T. · Geater · A. · Deng · Q.-Y. · Lin · Y.-D. · Jiang · L.-Y. · Chen · N. · Zhu · M.-T. · Li · Q. · Tang · X.-Y.
Objectives

A well-functioning health system ensures timely routine measles vaccinations for age-appropriate children, minimising measles risk. However, there is limited knowledge about the impact of the performance of immunisation programmes in health systems on the timeliness of measles vaccination. This study aimed to identify health system barriers to timely routine measles vaccination in rural southwest China, integrating the perspectives of township vaccination professionals and village doctors.

Design, setting and participants

Qualitative study among township vaccination professionals and village doctors in rural Guangxi, southwest China.

Methods

20 focus group discussions (FGDs) at township level and 120 in-depth interviews (IDIs) at village level, based on a four-theme framework. We used convenience sampling to recruit 60 township vaccination professionals and 120 village doctors in 2015. Instruments used were a semistructured questionnaire and interview outlines. We collected township and village-level data focusing on themes of health resources allocation, pattern of vaccination services, management and supervision of vaccination services, and perceptions of vaccination policy. The FGDs and IDIs were audio-recorded and transcribed. Braun and Clarke’s thematic analysis approach was adopted to synthesise findings into meaningful subthemes, narrative text and illustrative quotations.

Results

The health system barriers to timely routine vaccinations were explored across four themes. Barriers in the health resources allocation theme comprised (1) inadequacy of vaccination-related human resources (eg, lack of township vaccination professionals and lack of young village doctors), and (2) incompatible and non-identical information system of vaccination services across regions. Barriers in the pattern of vaccination services theme included inflexible vaccination services models, for example, routine vaccination services being offered monthly on fixed vaccination days, limited numbers of vaccination days per month, vaccination days being set on non-local market days, vaccination days being clustered into a specific period and absence of formal vaccination appointments. Ineffective economic incentive mechanism was identified as a barrier in the management and supervision of vaccination services theme. Low-degree participation of village doctors in routine vaccination services was identified as a barrier in the perceptions of vaccination policy theme.

Conclusions

We encourage policymakers and stakeholders to apply these findings to improve the timeliness of routine vaccination. Barriers to timely routine vaccination include inadequate allocation of vaccination-related resources and inflexible vaccination service delivery models. Financial and non-financial incentives should be used to retain and recruit vaccination professionals and village doctors. Strengthening information systems with unified data standards enables cross-regional data exchange. Optimising immunisation services and rationalising vaccination days could eliminate health system barriers and improve vaccination timeliness in rural China.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial

Por: Hu · X. · Xu · H. · Wang · C. · Wang · Y. · Wang · Y. · Zhou · D. · Zhu · Q. · Xu · K. · Yang · J. · Zhang · H. · Jiang · N. · Zhang · J. · Fang · Z. · Fu · G. · Guo · Y. · Li · Y. · Wang · M. · Feng · D. · Niu · G. · Zhang · E. · Chen · Y. · Ye · Y. · Wu · Y.
Introduction

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

Methods and analysis

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

Ethics and dissemination

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

Trial registration number

NCT05375474.

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