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AnteayerBMJ Open

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.

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review

Por: Berger-Höger · B. · Lewis · K. B. · Cherry · K. · Finderup · J. · Gunderson · J. · Kaden · J. · Kienlin · S. · Rahn · A. C. · Sikora · L. · Stacey · D. · Steckelberg · A. · Zhao · J.
Introduction

Decision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients’ involvement in informed values-based decision-making and use of evidence-based health information. A recent systematic review revealed low certainty evidence for its effectiveness with and without evidence-based information. However, there may be opportunities to improve the study and use of decision coaching in clinical practice by systematically investigating its determinants of practice. We aim to conduct a systematic review to identify and synthesise the determinants of practice for providing decision coaching to facilitate patient involvement in decision-making from multiple perspectives that influence its use.

Methods and analysis

We will conduct a mixed-methods systematic review guided by the Cochrane’ Handbook of Systematic Reviews. We will include studies reporting determinants of practice influencing decision coaching with or without evidence-based patient information with adults making a health decision for themselves or a family member. Systematic literature searches will be conducted in Medline, EMBASE, Cochrane CENTRAL and PsycINFO via Ovid and CINAHL via EBSCO including quantitative, qualitative and mixed-methods study designs. Additionally, experts in the field will be contacted.

Two reviewers will independently screen and extract data. We will synthesise determinants using deductive and inductive qualitative content analysis and a coding frame developed specifically for this review based on a taxonomy of barriers and enablers of shared decision-making mapped onto the major domains of the Consolidated Framework for Implementation Research. We will assess the quality of included studies using the Mixed Methods Appraisal Tool.

Ethics and dissemination

Ethical approval is not required as this systematic review involves only previously published literature. The results will be published in a peer-reviewed journal, presented at scientific conferences and disseminated to relevant consumer groups.

PROSPERO registration number

CRD42022338299.

Clinical characteristics and outcomes of patients with post-stroke epilepsy: protocol for an individual patient data meta-analysis from the International Post-stroke Epilepsy Research Repository (IPSERR)

Por: Mishra · N. K. · Kwan · P. · Tanaka · T. · Sunnerhagen · K. S. · Dawson · J. · Zhao · Y. · Misra · S. · Wang · S. · Sharma · V. K. · Mazumder · R. · Funaro · M. C. · Ihara · M. · Nicolo · J.-P. · Liebeskind · D. S. · Yasuda · C. L. · Cendes · F. · Quinn · T. J. · Ge · Z. · Scalzo · F. · Zela
Introduction

Despite significant advances in managing acute stroke and reducing stroke mortality, preventing complications like post-stroke epilepsy (PSE) has seen limited progress. PSE research has been scattered worldwide with varying methodologies and data reporting. To address this, we established the International Post-stroke Epilepsy Research Consortium (IPSERC) to integrate global PSE research efforts. This protocol outlines an individual patient data meta-analysis (IPD-MA) to determine outcomes in patients with post-stroke seizures (PSS) and develop/validate PSE prediction models, comparing them with existing models. This protocol informs about creating the International Post-stroke Epilepsy Research Repository (IPSERR) to support future collaborative research.

Methods and analysis

We utilised a comprehensive search strategy and searched MEDLINE, Embase, PsycInfo, Cochrane, and Web of Science databases until 30 January 2023. We extracted observational studies of stroke patients aged ≥18 years, presenting early or late PSS with data on patient outcome measures, and conducted the risk of bias assessment. We did not apply any restriction based on the date or language of publication. We will invite these study authors and the IPSERC collaborators to contribute IPD to IPSERR. We will review the IPD lodged within IPSERR to identify patients who developed epileptic seizures and those who did not. We will merge the IPD files of individual data and standardise the variables where possible for consistency. We will conduct an IPD-MA to estimate the prognostic value of clinical characteristics in predicting PSE.

Ethics and dissemination

Ethics approval is not required for this study. The results will be published in peer-reviewed journals. This study will contribute to IPSERR, which will be available to researchers for future PSE research projects. It will also serve as a platform to anchor future clinical trials.

Trial registration number

NCT06108102

Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial

Por: Hu · Z. · Li · W. · Zhao · G. · Liang · C. · Li · K.
Introduction

Stellate ganglion block (SGB) is usually used in the department of algiatry. But preoperative SGB may reduce adverse cardiovascular events in high-risk patients, although evidence remains sparse. Therefore, we aim to determine whether a single-shot postoperative SGB can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) and improve recovery in patients undergoing laparoscopic radical resection for colorectal cancer.

Methods and analysis

This is an investigator-initiated, single-centre, randomised, two-arm clinical trial enrolling patients aged over 45 years and scheduled for elective laparoscopic radical colorectal surgery with at least one risk factor for MINS. A total of 950 eligible patients will be randomised into a routine or block groups. The primary outcome is the incidence of MINS. The secondary outcomes include the Visual Analogue Scale of pain during rest and movement, the incidence of delirium, quality of recovery (QOR) assessed by QOR-15, and sleep quality assessed by Richards Campbell Sleep Questionnaire. Tertiary outcomes include time to first flatus, gastrointestinal complications such as anastomotic leak or ileus, length of hospital stay, collapse incidence of severe cardiovascular and cerebrovascular complications of myocardial infarction, cardiac arrest, ischaemic or haemorrhagic stroke, and all-cause mortality within 30 days after the operation.

Ethics and dissemination

The protocol was approved by Medical Ethics Committee of the China-Japan Union Hospital, Jilin University (Approval number: 2021081018) prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. The findings of this study will be published and presented through various scientific forums.

Trial registration number

ChiCTR2200055319.

Trends in the prevalence and economic burden of hypertension and its socioeconomic disparities in rural southwestern China: two repeated cross-sectional studies

Por: Fan · L. · Liu · L. · Zhao · Y. · Mo · Y. · Li · J. · Cai · L.
Objectives

This study aimed to analyse trends in the prevalence and economic burden of hypertension and its socioeconomic disparities in rural southwestern China.

Design

Two repeated cross-sectional studies were conducted to collect interview and health examination data among individuals aged ≥35 years in rural Yunnan Province, China.

Setting

Three rural areas of Yunnan, China.

Participants

We invited 8187 consenting participants in 2010–2011 and 7572 consenting participants in 2020–2021 to undergo interviews and health examinations.

Results

The standardised prevalence of hypertension significantly increased from 26.1% in 2011 to 40.4% in 2021 (p

Conclusions

The prevalence and economic burden of hypertension have visibly accelerated in rural Yunnan Province over the 10 years studied, and socioeconomic disparities have been found in the prevalence and economic burden of hypertension. These findings highlight that socioeconomic differentials should be tailored to address the timing of effective interventions for hypertension prevention and control and reduce the economic burden of hypertension in rural southwestern China.

Early monitoring of intravenous thrombolysis in acute ischaemic stroke using wearable intelligent vital sign devices: protocol for a prospective, multicentre, observational registry cohort study

Por: Liu · M. · Zhao · J. · Li · S. · Han · J. · Ma · G. · Wang · Y. · Chang · H.
Introduction

Continuous monitoring of vital signs during and after ischaemic stroke was recommended by the ‘Guidelines for the Early Management of Patients with Acute Ischaemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischaemic Stroke’. Vital sign data can be associated with disease conditions and prognosis, while there is limited evidence regarding continuous monitoring of vital signs during and after acute ischaemic stroke. The wearable intelligent vital sign monitoring device is small and lightweight and constantly monitors the health status during daily activities. However, wearable intelligent vital sign monitoring devices have not been widely used in clinical practice so far. Therefore, we will investigate the effectiveness and safety of wearable intelligent vital sign monitoring devices in early in-hospital management and monitoring programmes for patients with acute ischaemic stroke. This paper presents the study protocol.

Methods and design

This study is a prospective, multicentre, observational registry study starting from 20 March 2023 to 20 March 2025. A total of 5740 patients with acute ischaemic stroke from 10 Chinese hospitals are planned to be enrolled. Continuous vital sign data, demographics, medical history, medication history, treatments, laboratory tests, imaging scans and follow-up data will be collected. Follow-up time points were 30 days after discharge, 30 days after intravenous thrombolysis, 3 months after intravenous thrombolysis and 12 months after intravenous thrombolysis (until March 2026). The primary outcome included the evaluation of the modified Rankin Scale at 3 months, as well as the assessment of the rate of symptomatic and asymptomatic intracranial haemorrhage throughout the hospitalisation period.

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2022] 203). We plan to disseminate the research findings through publication in peer-reviewed scientific journals and presentations at international conferences.

Trial registration number

ChiCTR2300069512.

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.

Relationship Between Birth Weight and Asthma Diagnosis: A Cross-Sectional Survey Study Based on the National Survey of Childrens Health in the U.S.

Por: Ni · M. · Li · B. · Zhang · Q. · Zhao · J. · Li · W. · Qi · S. · Shen · Q. · Yao · D. · Chen · Z. · Wang · T. · Ding · X. · Lin · Z. · Cheng · C. · Liu · Z. · Chen · H.
Objective

To assess the association between birth weight and childhood asthma risk using data from the 2019–2020 National Survey of Children’s Health database.

Design

Cross-sectional study.

Setting

The USA.

Patients

A representative cohort of American children.

Exposure

The exposure of this study was birth weight regardless of gestational age. Birth weight was divided into three groups: 2500 g.

Main outcome measures

Primary outcomes were parent-reported diagnosis of asthma.

Method

The Rao-Scott 2 test was used to compare the groups. The main analyses examined the association between birth weight and parent-report asthma in children using univariable and multivariable logistic models adjusting for preterm birth, age, sex, race, family poverty, health insurance, smoking, maternal age. Subgroup analysis was performed based on interaction test.

Results

A total of 60 172 children aged 3–17 years were enrolled in this study; of these, 5202 (~8.6%) had asthma. Children with asthma were more likely to be born preterm, with low birth weight (LBW) or very LBW (VLBW). The incidence of asthma was the highest in VLBW children at 20.9% and showed a downward trend with an increase in birth weight class, with rates of 10.7% and 8.1% in the LBW and normal birthweight groups, respectively. Children with VLBW (OR 1.97; 95% CI 1.29 to 3.01) had higher odds of developing asthma in the adjusted analysis model. However, VLBW was only shown to be a risk factor for asthma among Hispanics, black/African-Americans and children between the ages of 6 and 12 years, demonstrating racial and age disparities.

Conclusions

VLBW increases the risk of childhood asthma; however, racial and age disparities are evident.

Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial

Por: Lu · Y.-Q. · Yang · G. · Li · M.-Y. · Hong · J. · Yang · Y.-T. · Wang · X.-J. · Kong · X.-H. · Zhao · Y. · Ma · Z. · Huang · X.-Y. · Zou · Y.-L. · Zhou · X.-T. · Ma · X.-P.
Introduction

Dry eye (DE) is a multifactorial ocular surface disease causing considerable medical, social and financial implications. Currently, there is no recognised long-term, effective treatment to alleviate DE. Clinical evidence shows that electroacupuncture (EA) can improve DE symptoms, tear secretion and tear film stability, but it remains controversial whether it is just a placebo effect. We aim to provide solid clinical evidence for the EA treatment of DE.

Methods and analysis

This is a multicentre, randomised, sham-controlled trial. A total of 168 patients with DE will be enrolled and randomly assigned to EA or sham EA groups to receive 4-week consecutive treatments and follow-up for 24 weeks. The primary outcome is the change in the non-invasive tear break-up time (NIBUT) from baseline to week 4. The secondary outcomes include tear meniscus height, the Schirmer I test, corneal and conjunctival sensation, the ocular surface disease index, corneal fluorescein staining, the numerical rating scale and the Chinese DE-related quality of life scale.

Ethics and dissemination

The trial protocol and informed consent were approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (identifier: 2021–119), Shanghai Eye Disease Prevention and Treatment Center (identifier: 2022SQ003) and Eye and ENT Hospital of Fudan University (identifier: 2022014).

Trial registration number

NCT05552820.

Willingness to vaccinate against herpes zoster in Chinese urban population: a mixed-methods study

Por: Wang · M. · Hu · M. · Wang · Y. · Long · C. · Xia · Y. · Zhu · D. · Zhao · W. · Yuan · B. · He · P.
Objective

Although the herpes zoster vaccine has been available in mainland China since June 2020, residents’ knowledge of herpes zoster and the herpes zoster vaccine is poor, and vaccination rates are low, especially among the elderly, who are at high risk for herpes zoster. This study assessed willingness to be vaccinated against herpes zoster and factors associated with vaccination among urban residents in China.

Methods

A mixed-methods study was conducted in community health centres from August 2022 to September 2022. We used convenience sampling to select 2864 residents from 9 Chinese cities for the quantitative study and 67 adults for the qualitative study. A structured questionnaire was used for the quantitative study, and data were collected through face-to-face interviews. Multinomial logistic regression was used to analyse factors associated with willingness to vaccinate. Qualitative data were analysed using thematic analysis of barriers to herpes zoster vaccination.

Results

A total of 2864 eligible respondents were included in the study. Of these, 42.67% intended to receive the herpes zoster vaccine, 21.44% refused and 35.89% were hesitant. The results of the quantitative and qualitative analyses showed that the factors associated with respondents’ willingness to be vaccinated against herpes zoster included: personal characteristics such as gender, age and income; knowledge and attitudes about herpes zoster and the vaccine; vaccine characteristics such as efficacy, safety and price; and other factors such as pain tolerance and accessibility to vaccination.

Conclusion

The low willingness to vaccinate, especially among the elderly, is mainly related to their poor knowledge and negative attitude towards the infection and vaccination. Therefore, health education about herpes zoster, immunisation promotion, and improvement of accessibility and affordability would be valuable in China.

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.

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.

Prevalence of and factors associated with symptoms consistent with a diagnosis of irritable bowel syndrome among resident physicians in standardised training in China: a cross-sectional study

Por: Zhao · J. · Li · X. · Yang · J. · Hao · X. · Tian · J. · Wang · X. · Wang · X. · Li · N. · Li · Z.
Objectives

This study aims to investigate the incidence of and factors associated with irritable bowel syndrome (IBS) among resident physicians in standardised training at eight traditional Chinese medicine (TCM) hospitals in China.

Design

A cross-sectional survey was administered to resident physicians in their first to third years of standardised training at eight TCM hospitals.

Participants and setting

A total of 514 resident physicians in standardised training were included.

Measures

The questionnaire consisted of two sections, namely: section A collected basic information, and section B included the four-item Perceived Stress Scale (PSS-4), the Patient Health Questionnaire-4 (PHQ-4), the Pittsburgh Sleep Quality Index (PSQI) and the Rome IV criteria for IBS. Univariate and multivariate logistic regression models were constructed to assess the associations of age, sex, body mass index, stress, depression, anxiety, sleep quality and IBS.

Results

Of the included resident doctors, 77.2% were female, 20.4% were obese or underweight and 8.6% had symptoms consistent with a diagnosis of IBS. There were no statistically significant differences in lifestyle factors (night shift work, overtime work or working efficiency during the COVID-19 pandemic) between patients with IBS and participants without IBS (hereafter, non-IBS participants) (p=0.429, p=0.572 or p=0.464, respectively). Notably, compared with non-IBS participants, patients with IBS had significantly higher mean scores on the PSS-4 and PHQ-4 (p=0.028 and p=0.012, respectively); however, there was not a significant difference in PSQI scores between these two groups (p=0.079). Depression symptoms were significantly associated with IBS (unadjusted OR 0.498, 95% CI 0.265 to 0.935, p=0.030).

Conclusion

These findings suggest that IBS is common among resident physicians in standardised training. Future studies should investigate emotional distress, especially stress and depression, in the development of prevention or treatment of IBS.

Optimal treatment of asymptomatic patients with severe aortic stenosis: protocol of a prospective, multicentre, registry study

Por: Xia · C. · Li · Y.-M. · Xiong · W. · Ma · L. · Xiong · T.-Y. · Zhao · Z.-G. · Peng · Y. · Wei · J. · Feng · Y. · Chen · M.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration

This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853.

Cost-effectiveness of camrelizumab combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma in China

Por: Zhao · Z. · Chen · T. · Zhou · Z. · Guo · R. · Liu · Q.
Objective

This study aimed to investigate the cost-effectiveness of adding Chinese-developed anti-PD-1 antibody camrelizumab to first-line platinum-doublet chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (L/M NPC) from the perspective of Chinese healthcare system.

Design

A Markov model consisting of four health states, progression-free survival, first progression survival, second progression survival and death, was built to simulate 3-week patient transitions over a 20-year horizon. A direct comparison between first-line camrelizumab in combination with gemcitabine plus cisplatin and gemcitabine plus cisplatin was performed by calculating transition probabilities from the CAPTAIN-1st trial. Costs and utilities were collected from the local public database and literature. One-way and probabilistic sensitivity analyses were employed to evaluate the robustness of the model.

Setting

The Chinese healthcare system perspective.

Participants

A hypothetical cohort of Chinese patients with pathologically diagnosed L/M NPC who had an Eastern Cooperative Oncology Group performance status of 0 or 1.

Interventions

First-line camrelizumab in combination with camrelizumab and gemcitabine plus cisplatin (CGP) versus gemcitabine plus cisplatin (GP).

Primary outcome measure

Cost, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER).

Results

The baseline analysis demonstrated that, compared with first-line GP, first-line CGP yields an effectiveness increase of 0.26 QALY, accompanied by an increment of US$6137.59 in healthcare cost. This results in an ICER of US$23 482.32/QALY. With the willingness-to-pay (WTP) threshold for a QALY set at US$37 654.50, first-line CGP proves to be cost-effective in 97.20% of the iterations. Deterministic sensitivity analyses indicated that the uncertainty in model parameters had no substantial effect on our results. Probability sensitivity analysis indicated that CGP was cost-effective at the assumed WTP threshold.

Conclusion

For Chinese patients with L/M NPC, adding Chinese-developed anti-PD-1 antibody camrelizumab to the first-line GP chemotherapy may be cost-effective.

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.

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.

Development and validation of a model to predict mortality risk among extremely preterm infants during the early postnatal period: a multicentre prospective cohort study

Por: Zhang · W.-w. · Wang · S. · Li · Y. · Dong · X. · Zhao · L. · Li · Z. · Liu · Q. · Liu · M. · Zhang · F. · Yao · G. · Zhang · J. · Liu · X. · Liu · G. · Zhang · X. · Reddy · S. · Yu · Y.-h.
Background

Recently, with the rapid development of the perinatal medical system and related life-saving techniques, both the short-term and long-term prognoses of extremely preterm infants (EPIs) have improved significantly. In rapidly industrialising countries like China, the survival rates of EPIs have notably increased due to the swift socioeconomic development. However, there is still a reasonably lower positive response towards the treatment of EPIs than we expected, and the current situation of withdrawing care is an urgent task for perinatal medical practitioners.

Objective

To develop and validate a model that is practicable for EPIs as soon as possible after birth by regression analysis, to assess the risk of mortality and chance of survival.

Methods

This multicentre prospective cohort study used datasets from the Sino-Northern Neonatal Network, including 46 neonatal intensive care units (NICUs). Risk factors including maternal and neonatal variables were collected within 1 hour post-childbirth. The training set consisted of data from 41 NICUs located within the Shandong Province of China, while the validation set included data from 5 NICUs outside Shandong Province. A total of 1363 neonates were included in the study.

Results

Gestational age, birth weight, pH and lactic acid in blood gas analysis within the first hour of birth, moderate-to-severe hypothermia on admission and adequate antenatal corticosteroids were influencing factors for EPIs’ mortality with important predictive ability. The area under the curve values for internal validation of our prediction model and Clinical Risk Index for Babies-II scores were 0.81 and 0.76, and for external validation, 0.80 and 0.51, respectively. Moreover, the Hosmer-Lemeshow test showed that our model has a constant degree of calibration.

Conclusions

There was good predictive accuracy for mortality of EPIs based on influencing factors prenatally and within 1 hour after delivery. Predicting the risk of mortality of EPIs as soon as possible after birth can effectively guide parents to be proactive in treating more EPIs with life-saving value.

Trial registration number

ChiCTR1900025234.

Axial length to corneal radius of curvature ratio and refractive error in Chinese preschoolers aged 4-6 years: a retrospective cross-sectional study

Por: Tang · T. · Zhao · H. · Liu · D. · Li · X. · Wang · K. · Li · Y. · Zhao · M.
Objective

This study aims to investigate the associations of axial length to corneal radius of curvature (AL/CRC) ratio with refractive error and to determine the effect of AL/CRC ratio on hyperopia reserve and myopia assessment among Chinese preschoolers.

Methods

This was a retrospective cross-sectional study that evaluated subjects aged 4–6 years. AL and CRC were obtained using a non-contact ocular biometer. Correlation analysis was performed to explore the associations of AL/CRC ratio with spherical equivalent refractive error (SER). The accuracy of AL/CRC ratio for hyperopia reserve and myopia assessment was analysed using cycloplegic refraction by drawing receiver operating characteristic (ROC) curves.

Results

The analysis included 1024 participants (537 boys, 52.4%). The mean AL/CRC ratios in hyperopes, emmetropes and myopes were 2.90±0.06, 2.95±0.05 and 3.08±0.07, respectively. The SER was found to be more strongly correlated with AL/CRC ratio (=–0.66, p

Conclusions

The SER showed a better correlation with AL/CRC ratio than either AL or CRC alone, especially in myopes, among children aged 4–6 years. These findings indicate that when cycloplegic refraction is unavailable, AL/CRC ratio could be used as an alternative indicator for identifying low hyperopia reserve and myopia among preschoolers, helping clinicians and parents screen children with low hyperopia reserve before primary school in a timely manner.

Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study

Por: Qian · C. · Chen · Q. · Lin · W. · Li · Z. · Zhu · J. · Zhang · J. · Luan · L. · Zheng · B. · Zhao · G. · Tian · J. · Zhang · T.
Objectives

To depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.

Design

Retrospective cohort study.

Participants

The observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.

Outcome

The CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.

Results

The overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p

Conclusions

The burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.

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