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Lipid-focused dietary education intervention in pregnant women: study protocol for an open-label, parallel, randomised, intervention study addressing adverse pregnancy outcomes in China

Por: Zhang · Y. · Gao · X. · Zhu · H. · Sun · S. · Contento · I. R. · Koch · P. A. · Yu · H.
Introduction

The incidence of infants who are large-for-gestational-age (LGA) is on the rise in China, and its detrimental effects on health have received increasing attention. Diet-based interventions have the potential to reduce adverse birth outcomes, particularly in decreasing the occurrence of LGA infants. We aim to evaluate the effect of lipid-focused diet education based on the theories of behaviour change in pregnant women on maternal and offspring outcomes through a randomised controlled trial.

Methods and analysis

We have designed an open-label, parallel, multicentre randomised controlled trial in collaboration with three hospitals in Beijing, China.

Pregnant women will be recruited before reaching 12 weeks of gestation and will be randomised in a 1:1:1 ratio into three arms: (1) online education arm, (2) pregnancy nutrition checklist and ‘one-page flyer’ arm and (3) routine antenatal education. The primary outcome LGA will be recorded at birth. Demographic information, physical activity, sleep and medical history will be collected through questionnaires and case cards prior to enrolment. Questionnaires will also be used to collect dietary behaviours and psychosocial factors of pregnant women at enrolment, at 24–28 weeks and 34–36 weeks of gestation. Additionally, information on breastfeeding and complementary food supplementation for infants and young children will be obtained through questionnaires. Physical development indicators of children and taste tests will be assessed 3 years after delivery.

Ethics and dissemination

The study has received ethical approval from the Capital Medical University Ethics Committee and other collaborating study centres. Informed consent will be introduced to pregnant women, and their consent will be obtained. The findings will be reported in relevant national and international academic conferences and peer-reviewed publications.

Trial registration number

ChiCTR2300071126.

Hypertension, socioeconomic status and depressive and anxiety disorders: a cross-sectional study of middle-aged and older Chinese women

Por: Wang · X. · Gao · D. · Wang · X. · Zhang · X. · Song · B.
Objectives

To investigate the association of hypertension with depressive and anxiety disorders in middle-aged and older Chinese women, and to further assess whether the association was influenced by socioeconomic status (SES).

Design

Nationwide cross-sectional study.

Setting

Six provinces of the eastern, central and western regions of China.

Participants

Women aged 40–70 years were included by a multistage stratified random cluster sampling in 2018 (N=9900).

Primary outcome measures

Depressive and anxiety disorders were measured by the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7, respectively. Logistic regression models were used to evaluate the OR and 95% CI for hypertension and the odds of depressive and anxiety disorders.

Results

18.5% of participants reported having hypertension; 20.9% and 15.3% of women experienced depressive and anxiety disorders, respectively. After adjusting for potential confounders, women diagnosed with hypertension were more likely to have depressive (OR=1.27, 95% CI 1.11 to 1.45) and anxiety disorders (OR=1.48, 95% CI 1.28 to 1.71) than those without hypertension. Stratified analyses demonstrated that hypertension was significantly associated with higher odds of depressive disorders in women living in rural areas (OR=1.34, 95% CI 1.13 to 1.59), with lower levels of education (OR=1.28, 95% CI 1.12 to 1.46) and with average monthly household income

Conclusions

Hypertension was associated with increased odds of depressive and anxiety disorders among middle-aged and older women, especially in those with low SES. Effective strategies and actions for identification and management of hypertension and depressive and anxiety disorders are needed.

Association of epicardial and visceral adipose tissue in relation to subclinical cardiac dysfunction in Chinese: Danyang study

Por: Yao · F. · Zeng · L. · Hua · M. · Zhang · S. · Liang · J. · Gao · Y. · Chen · C. · Zhao · X. · He · A. · Liu · M.
Objective

Our study aims to examine the associations of visceral adipose tissue (VAT) and epicardial adipose tissue (EAT) with subclinical cardiac dysfunction in a Chinese population.

Design

Cross-sectional.

Background

EAT and VAT are the most important ectopic fat pools which were previously shown to be associated with subclinical cardiac dysfunction. However, few studies simultaneously measured both EAT thickness and VAT area, and explored their associations with cardiac dysfunction. Our study aims to examine the associations of VAT and EAT with subclinical cardiac dysfunction in a Chinese population.

Methods

The study subjects were recruited from Danyang County from 2018 to 2019. Using Philips CX50, we recorded EAT thickness at the end-systole in a long-axis view. The subclinical systolic and diastolic function were assessed by two-dimensional speckle tracking, and transmitral and tissue Doppler imaging, respectively. Using Omron HDS-2000, we measured VAT area by dual bioelectrical impedance analysis.

Results

The 1558 participants (age, 52.3±12.8 years) included 930 (59.7%) women. Compared with women, men had higher VAT area (99.4 vs 70.1 cm2; p

Conclusions

Increased EAT thickness was associated with worse subclinical systolic dysfunction, while greater VAT area was associated with early diastolic dysfunction.

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.

Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey

Por: Yuan · Y. · Jin · A. · Zhao · M.-H. · Wang · H. · Feng · X. · Qiao · Q. · Zhang · R. · Gao · R. · Wu · Y.
Objectives

Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions.

Design

A cross-sectional study conducted from September 2017 to March 2018.

Setting

48 residential elderly care facilities in northern China.

Participants

Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia.

Exposure

Potassium intake is measured by 24-hour urinary potassium.

Outcomes

Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect.

Results

Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted β=0.0040/L; p=0.017) and high (adjusted β=0.0078/L; p=0.003) but not low (adjusted β=0.0018/L; p=0.311) risk of hyperkalaemia.

Conclusions

A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns.

Trial registration number

NCT03290716; Post-results.

Early offering transcatheter aortic valve replacement to patients with moderate aortic stenosis: quantifying costs and benefits - a Markov model-based simulation study

Por: Nguyen · D. · Marwick · T. · Moodie · M. · Gao · L.
Objective

Aortic stenosis (AS) is one of the most common acquired cardiac valvular diseases. The success of transcatheter aortic valve implantation (TAVI) for severe AS has led to increasing interest in its use to earlier disease—moderate AS (MAS).

Design

Model-based study using a Markov microsimulation technique to evaluate the long-term costs and benefits associated with ‘early’ TAVI. Key data inputs were sourced from the international literature and costs were obtained from Australian sources.

Setting

Australian health care system perspective.

Participants

10 000 hypothetical MAS patients with or without left ventricular diastolic dysfunction or impaired left ventricular ejection fraction.

Intervention

Comparing early TAVI to medical management over a life time horizon for MAS patients aged >65 years. We evaluated the cost-effectiveness of offering early TAVI in five scenarios (10%, 25%, 50%, 75% and 90% take-up rates).

Primary and secondary outcome measures

The primary outcome measure is quality-adjusted life years (QALY) gained and the incremental cost–utility ratio (ICUR). Secondary outcomes are life-years gained and the number of heart failure case avoided.

Results

Offering early TAVI for MAS patients resulted in both higher healthcare costs and greater benefits (an increase of 3.02 QALYs or 3.99 life-years) per person treated. The ICUR was around $A10 867 and $A11 926 per QALY gained for all five scenarios, with the total cost of early TAVI to the healthcare system being anticipated to be up to $A3.66 billion. Sensitivity analyses indicated a 100% probability of being cost-effective with a willingness to pay threshold of $A50 000/QALY. The benefits remained, even with assumptions of high levels of repeat valve replacement after TAVI.

Conclusion

While ongoing randomised controlled trials will define the benefit of TAVI to MAS patients, these results suggest that this intervention is likely to be cost-effective.

Association between dyslipidaemia and dry eye disease: a systematic review and meta-analysis

Por: Li · Y. · Xie · L. · Song · W. · Chen · S. · Cheng · Y. · Gao · Y. · Huang · M. · Yan · X. · Yang · S.
Purpose

To report a systematic review and meta-analysis of the association between dry eye disease (DED) and dyslipidaemia.

Methods

PubMed, Embase, Web of Science and Cochrane Library were systematically searched from January 2000 to December 2021. We included observational studies to assess the correlation of DED with meibomian gland dysfunction and dyslipidaemia without any language restrictions. The pooled OR with 95% CI was calculated in Stata V.15.

Results

Of 6727 identified studies, 18 studies (21 databases) with a total of 2 663 126 patients were analysed in our meta-analysis. The results showed that DED risk was associated with dyslipidaemia (OR=1.53, 95% CI: 1.41 to 1.66, p=0.001), especially elevated total cholesterol levels (OR=1.57, 95% CI: 1.25 to 1.99, p

Conclusions

The findings suggested that dyslipidaemia and lipid-lowering drug use might be associated with an increased risk of DED. More evidence is needed to confirm the findings by prospective studies.

PROSPERO registration number

CRD42022296664.

Chronotypes and their association with sleep quality among Chinese college students of Anhui Province: a cross-sectional study

Por: Tong · X. · Gao · M.-m. · Zhang · L. · Song · J.-g. · Feng · Y. · Tao · Y. · Zhu · L.-j. · Wen · L.-y. · Jin · Y.-l. · Chang · W.-w.
Objectives

To describe the prevalence of chronotype and sleep quality among Chinese college students and explore the relationship between chronotype and sleep quality.

Design

A cross-sectional study.

Setting

Four colleges and universities in Anhui, China, between November and December 2020.

Participants

A total of 4768 college students were recruited using a stratified, multistage, cluster sampling survey.

Outcome measures

Morningness-Eveningness Questionnaire 19 was used to determine the chronotype of the students and the Pittsburgh Sleep Quality Index (PSQI) was used to measure their sleep quality. The multiple logistic regression model was used to explore the potential association between chronotype and sleep quality.

Results

The self-reported proportions of evening-type (E-type), neutral-type and morning-type among college students were 51.17%, 45.14% and 3.69%, respectively. The mean PSQI score was 4.97±2.82 and the prevalence of poor sleep quality was 18.2%. After adjusting the covariates by multiple logistic regression analysis, E-type was positively associated with subjective sleep quality (OR=1.671, 95% CI 1.414 to 1.975), sleep latency (OR=1.436, 95% CI 1.252 to 1.647), sleep duration (OR=2.149, 95% CI 1.506 to 3.067), habitual sleep efficiency (OR=1.702, 95% CI 1.329 to 2.180), daytime dysfunction (OR=1.602, 95% CI 1.412 to 1.818) and overall poor sleep quality (OR=1.866, 95% CI 1.586 to 2.196).

Conclusions

College students mainly exhibited E-type, and an elevated prevalence of poor sleep quality existed among these students. The E-type was positively associated with poor sleep quality.

Impact of dexmedetomidine on mortality in critically ill patients with acute kidney injury: a retrospective propensity score matching analysis

Por: Wang · W. · Jin · Y. · Zhang · P. · Gao · P. · Wang · H. · Liu · J.
Objectives

This study sought to estimate the effect of dexmedetomidine (DEX) administration on mortality in critically ill patients with acute kidney injury (AKI).

Design

A retrospective cohort study.

Setting

The study sourced its data from the Multiparameter Intelligent Monitoring in Intensive Care Database IV (MIMIC-IV), a comprehensive database of intensive care unit patients.

Participants

A total of 15 754 critically ill patients with AKI were enrolled from the MIMIC-IV database.

Primary and secondary outcome

Primary outcome was in-hospital mortality and secondary outcome was 180-day mortality.

Results

15 754 critically ill AKI patients were included in our analysis. We found that DEX use decreased in-hospital mortality risk by 38% (HR 0.62, 95% CI 0.55 to 0.70) and 180-day mortality risk by 23% (HR 0.77, 95% CI 0.69 to 0.85). After adjusting for confounding factors, DEX can reduce all three stages of AKI in in-hospital mortality.

Conclusions

Our retrospective cohort study suggests that DEX significantly correlates with decreased risk-adjusted in-hospital and 180-day mortality in critically ill AKI patients. Nonetheless, future randomised controlled trials are warranted to validate our findings.

The risk factors for and the frequency and outcomes of subsyndromal delirium among patients who have undergone cardiac surgery: a protocol for systematic review and meta-analysis

Por: Gao · Y. · Bai · X. · Zhang · H. · Yang · L. · Wu · T. · Gan · X.
Introduction

Several key symptoms must be present for the accurate diagnosis of patients with postoperative cardiac delirium. Some patients present with symptoms of delirium but do not meet the diagnostic criteria for delirium; such individuals are considered to have having subsyndromal delirium (SSD). SSD is associated with misdiagnosis and poor outcomes. However, to date, no systematic review (SR) has examined the frequency of, risk factors for, and outcomes of SSD among adults who have undergone cardiac surgery.

Methods and analysis

The aim of this SR is to identify those studies that have explored SSD after cardiac surgery. MeSH and free entry terms associated with "subsyndromal delirium" and "subclinical delirium" will be used to search for relevant studies. The PubMed, Web of Science, OVID, Cochrane Library, CINAHL, EMBASE, PsycINFO, China National Knowledge Infrastructure, Wanfang data, VIP database and SinoMed will be searched from inception to the date of retrieval without any restrictions. The primary outcomes will be the frequency of SSD, the risk factors for SSD, and the outcomes of SSD. Analyses will be performed using STATA V.16.0, and descriptive analyses will be performed if the data are not suitable for meta-analysis (ie, data with significant heterogeneity or from different comparisons).

Ethics and dissemination

The SR will examine the frequency of, risk factors for and outcomes of SSD in adults who have undergone cardiac surgery. The results will provide guidance for the identification of knowledge gaps in this field, and areas for further research will be highlighted. The review protocol will be submitted for publication in peer-reviewed journals for dissemination of the findings. Individual patient data will not be included in this protocol, so ethical approval will not be needed.

PROSPERO registration number

CRD42022379211.

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burde

Por: Zhang · Z. · Sheng · Z. · Che · W. · An · S. · Sun · D. · Zhai · Z. · Zhao · X. · Yang · Y. · Meng · Z. · Ye · Z. · Xie · E. · Li · P. · Yu · C. · Gao · Y. · Xiao · Z. · Wu · Y. · Dong · F. · Ren · J. · Zheng · J.
Introduction

ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.

Methods and analysis

The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.

Ethics and dissemination

The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.

Trial registration number

NCT05554588.

Qualitative study of the perceived experiences and needs coping of primary caregivers of patients with breast cancer during operation in central China

Por: Li · M. · Guo · J. · Gao · J. · Wang · L. · Ding · Y.
Purpose

The purpose of this study is to gain an in-depth understanding of the intraoperative waiting period experience and needs response of primary caregivers of patients with breast cancer.

Method

Using a purposive sampling method, 16 primary caregivers of patients with breast cancer admitted to the Department of Breast Surgery of Shanxi Bethune Hospital from January to May 2022 were selected as study subjects. Semistructured in-depth interviews were conducted using a qualitative research method.

Results

Five themes were extracted from the levels of safety and security, information transfer, emotion management, psychological adjustment and role adaptation: safety first and intraoperative care, lack of information and misdirection, negative emotions and tired of coping, ineffective worry and overthinking, and role multiplicity and bearing alone, respectively.

Conclusion

The intraoperative waiting period for primary caregivers of patients with breast cancer felt multidimensional and had less than optimal needs satisfaction. Healthcare professionals should use the existing needs as an entry point to give appropriate interventions to enhance the coping ability of caregivers of patients with breast cancer.

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