1.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
2.Progress in stroke after coronary artery bypass grafting and its association with carotid-cerebral artery disease
Yi LIU ; Yunpeng ZHU ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(10):1538-1546
Coronary artery bypass grafting (CABG) is the "gold standard" for revascularization of left main diseased and/or complex multi-vessel diseased coronary artery disease. Post-CABG stroke is a relatively rare but catastrophic complication with a serious health and economic burden. In recent years, the further understanding of the concept of "panvascular disease", the implementation of the philosophy of "cardio-cerebral integrated treatment", and the improvement of related diagnostic and therapeutic techniques have provided new options for the recognition, prevention and cure of post-CABG stroke. Focusing on the key factor of carotid-cerebral artery disease, this review systematically scrutinizes the incidence, epidemiology, risk factors, mechanisms and prevention and treatment of post-CABG stroke. This review analyzes the association between post-CABG stroke and carotid-cerebral artery disease, summarizes the status of evidence-based prophylactic carotid-cerebral artery revascularization strategy, and prospects for future research directions.
3.Incidence density of sleep disorders among adults in Yinzhou District
CHEN Yunpeng ; YIN Yueqi ; SUN Yexiang ; SHEN Peng ; ZHU Yu ; JIANG Zhiqin
Journal of Preventive Medicine 2024;36(12):1028-1031
Objective:
To investigate the incidence density of adult sleep disorders (SD) in Yinzhou District, Ningbo City, Zhejiang Province from 2017 to 2023, so as to provide insights into formulating the control measures of SD.
Methods:
The electronic health records of permanent residents aged 18 years and over in Yinzhou District from 2017 to 2023 were collected through the Yinzhou Regional Health Information Platform. New cases of SD were diagnosed for the first time a year after establishing health records. The incidence density was estimated using Poisson distribution. The temporal, population and regional distribution characteristics of new cases of SD were analyzed using a descriptively epidemiological method.
Results:
From 2017 to 2023, there were 1 255 129 permanent residents aged 18 years and over in Yinzhou District, with a total observed person-time of 6 292 884 person-years and a median of 5.67 (interquartile range, 3.74) person-years. There were 165 490 new cases of SD, including 67 095 males (40.54%) and 98 385 females (59.46%). The incidence density of SD in Yinzhou District from 2017 to 2023 was 26.30/1 000 person-years, with no significant trend observed (P>0.05). The incidence density of SD was higher in females than in males (29.63/1 000 person-years vs. 22.57/1 000 person-years, P<0.05). The highest incidence density of SD was observed in individuals aged 70 to <80 years (63.30/1 000 person-years), and the lowest was in individuals aged 18 to <30 years (7.24/1 000 person-years). The incidence density of SD in individuals aged 30 years and over was higher than that in individuals aged 18 to <30 years (all P<0.05). The incidence density of SD was 32.03/1 000 person-years in individuals with junior high school education or below, which was higher than individuals with senior high school/technical secondary school education (25.93/1 000 person-years) and college degree and above (18.87/1 000 person-years, all P<0.05). Dongliu Street, Dongjiao Street, and Baihe Street had relatively higher incidence densities of SD, at 45.11/1 000 person-years, 42.87/1 000 person-years and 40.16/1 000 person-years, respectively.
Conclusions
From 2017 to 2023, there was no significant trend in the incidence density of SD in Yinzhou District. Higher incidence density were observed in females, the elderly, and individuals living in central urban areas.
4.Progress in clinical studies in cardiovascular surgery 2022
Heng ZHANG ; Yi YANG ; Shuo YUAN ; Yunpeng ZHU ; Zhe ZHENG ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(08):1089-1096
In 2022, many excellent clinical studies emerged in the field of cardiovascular surgery. Selecting papers published in The New England Journal of Medicine and other top medicine and cardiology journals, this review focused on the research progress on 7 topics in the field of cardiovascular surgery: coronary artery surgery, vascular surgery, valvular surgery, structural heart disease, congenital heart disease, heart transplantation, perioperative management, and special population.
5.Epidemiological investigation of a cluster of COVID-19 in badminton venues
XIANG Zelin ; FU Xiaofei ; QI Yunpeng ; ZHU Guoying ; GU Weiling ; HU Jie ; LI Fudong ; ZHOU Wanling ; HOU Zhigang ; LIU Yang ; LIU Yanqing ; GUO Feifei ; LU Xianquan ; GUO Linjie ; CHEN Zhongwen
Journal of Preventive Medicine 2023;35(4):316-319
Objective:
To perform an epidemiological survey of the first case with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Pinghu City of Jiaxing City, Zhejiang Province on March 13, 2022, so as to provide insights into the management of coronavirus disease (COVID-19) epidemics.
Methods:
According to the requirements of the Protocol on Prevention and Control of COVID-19 (8th Edition), epidemiological investigations were performed among 39 cases with SARS-CoV-2 infections in Pinghu City from March 13 to 20, 2022. Cases' demographics, clinical symptoms, history of immunization and exposure were collected, and close contacts were identified. Pharyngeal swabs were sampled from infected cases for detection of SARS-CoV-2 nucleic acid and whole-genome sequencing, and the source of infection and transmission route were investigated.
Results:
The index case for this COVID-19 epidemic was an imported case from Shanghai Municipality, who infected 6 persons via aerosol transmission when playing in the badminton venue of Pinghu National Fitness Center on March 9; subsequently, one of these infected cases infected another 18 persons when playing in the badminton venue of Jiadian Village Resident's Fitness Center in Zhapu Township on March 12. Sixteen confirmed cases were reported, and all cases were mild; another 23 asymptomatic cases were diagnosed, with no death reported. This epidemic occurred from March 11 to 20, with 3 generations of spread and a median incubation period of 3 days. The SARS-CoV-2 infected cases had a median age of 33.5 (interquartile range, 12.0) years and included 36 cases with a history of COVID-19 vaccination. There were 16 cases with fever, cough, runny nose and sore throat, and 13 cases with imaging features of pneumonia. The effective reproductive number (Rt) of the COVID-19 epidemic was 7.73 at early stage, and was less than 1 since March 21. Whole-genome sequencing identified Omicron BA.2 variant among 33 cases, which had high homology with the index cases.
Conclusion
This epidemic was a cluster of COVID-19 caused by imported Omicron BA.2 variant infection from Shanghai Municipality, and the COVID-19 transmission was mainly caused by indoor aerosols.
6.Interpretation of methodological standards for the design, implementation, and analysis of randomized trials in cardiac surgery: A scientific statement from the American Heart Association in 2022
Yunpeng ZHU ; Heng ZHANG ; Zhe ZHENG ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(01):10-16
Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key
concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise,
feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be
predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a
high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical
experience.
7.Insights into the clinical studies related to cardiovascular surgery from the American Heart Association’s Scientific Sessions 2021: Part one
Yi YANG ; Jiaxi ZHU ; Yunpeng ZHU ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(04):407-410
In the American Heart Association’s Scientific Sessions 2021, the results of six clinical trials related to cardiovascular surgery were revealed. The PALACS trial demonstrated that posterior left pericardiotomy during open heart surgery was associated with a significant reduction in postoperative atrial fibrillation; the EPICCURE study found that injection of mRNA encoding vascular endothelial growth factor (VEGF-A mRNA) directly into the myocardium of patients undergoing elective coronary artery bypass grafting (CABG) improved patients’ heart function; the VEST trial once again proved the safety and potential value of external stent for vein graft. This article will interpret the above-mentioned three studies.
8.oncurrent surgical left atrial appendage occlusion should become routine procedure in cardiac surgery for atrial fibrillation patients — Commentary on LAAOS Ⅲ
Yiwei XU ; Yunpeng ZHU ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(09):1016-1020
Left atrial appendage occlusion is a common procedure for patients with atrial fibrillation history when they underwent cardiac surgery. Before the LAAOS Ⅲ research results, this operation has been lacking strong evidence-based support. LAAOS Ⅲ is a prospective, double-blind, international multicenter, randomized blinded trial. According to the results of LAAOS Ⅲ, the left atrial appendage occlusion can reduce the risk of stroke and systemic embolism. This article will perform detailed interpretation of LAAOS Ⅲ research.
9.Epidemiological characteristics and transmission routes of COVID-19 asymptomatic infected patients in Shaanxi Province
Ni ZHU ; Lei CAO ; Guojing YANG ; Sa CHEN ; Shaoqi NING ; Xinxin LI ; Yunpeng NIAN ; Gang WANG ; Yi ZHANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(2):186-189
【Objective】 To assess the epidemiological characteristics and transmission risk of asymptomatic COVID-19 infection in Shaanxi Province. 【Methods】 A dense population database of COVID-19 cases in Shaanxi Province was constructed as of March 26, 2020, and 28 asymptomatic infected patients were selected through case epidemiological investigation report for descriptive analysis. 【Results】 In Shaanxi Province, the majority of asymptomatic COVID-19 infections were in the 20-59 years old group, and women took up a higher proportion than men. 82.14% of asymptomatic infections were found in the centralized isolation state. Nearly 80% of asymptomatic infections and confirmed cases were mainly exposed by living together in the family. The median number of days from last contact with the source of infection for all asymptomatic infected persons was 13, with 3 (10.71%) showing clinical symptoms. Epidemiological investigations showed that asymptomatic infections could spread as a result of shared family life. 【Conclusion】 At present, imported cases in Shaanxi Province continue to exist. Considering the concealed transmission of asymptomatic infections, prevention and control work is still facing challenges.
10.The results of proficiency test of HIV-1 viral load testing laboratories in China from 2005 to 2019
Yunpeng XUE ; Xin ZHANG ; Qiyu ZHU ; Jing LIU ; Xiaoxia TAO ; Huazhou JIANG ; Ling ZHANG ; Yan JIANG ; Cong JIN ; Pinliang PAN
Chinese Journal of Experimental and Clinical Virology 2021;35(2):135-139
Objective:To evaluate the testing capacity of HIV-1 viral load testing laboratories, and to provide data references for further improving the accuracy of laboratory test result in China.Methods:The test result of 155 positive samples distributed by the National AIDS Reference Laboratory to each laboratory from 2005 to 2019 were summarized and grouped according to the test assay and sample number. The independent sample t-test was used to evaluate the economic status and the proficiency testing (PT) assessment period on the stability of the test results. And, one-way analysis of variance was used to evaluate the influence of the types of laboratories and reagents on the stability of test results.Results:The number of HIV-1 viral load testing laboratories increased from 13 in 2005 to 267 in 2019. The participating institutions were mainly centers for disease control and prevention(CDC)and hospitals. Since 2015, the excellent rate of laboratories has remained above 85%, and the unqualified rate has remained below 3%. The associated factor analysis showed that the laboratory testing stability of HIV-1 viral load associated with the PT assessment period and the types of testing reagents, and the laboratories participating in the PT assessment for more than 5 years showed better stability.Conclusions:Participating in the annual proficiency testing program helped improve the laboratory capability of HIV-1 viral load testing in China.


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