Table of Content

20 May 2025, Volume 20 Issue 5

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From Inception to Excellence: Two Decades of Stroke Clinical Research in China

XIONG Yunyun, WANG Yongjun

2025, 20(5):  519-528.  DOI: 10.3969/j.issn.1673-5765.2025.05.001

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Stroke is one of the major diseases causing disability and death in Chinese residents, placing a significant burden on the healthcare system. Evidence-based medical research provides reliable data to guide stroke diagnosis and treatment, significantly reducing stroke-related disability and mortality rates. Over the past two decades, Chinese clinicist and researchers have played an increasingly prominent role in clinical research on stroke. Focusing on various aspects of stroke diagnosis and treatment, they have contributed valuable evidence-based medical evidence in major and hot fields such as reperfusion therapy for acute ischemic stroke, secondary prevention of stroke, brain cytoprotection, application of new devices and techniques, perioperative management of endovascular treatment, and quality control and management of stroke diagnosis and treatment. This article briefly reviews the development history of evidence-based medicine for stroke in China, summarizes the contributions and achievements of Chinese researchers in evidence-based practice for stroke diagnosis and treatment, and looks forward to the next phase of stroke research.

The Power of Changing Guidelines: Two Decades of Key Clinical Trials on Ischemic Cerebrovascular Disease in China

TAN Zefeng, XU Anding

2025, 20(5):  529-548.  DOI: 10.3969/j.issn.1673-5765.2025.05.002

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Over the past two decades, China has made remarkable strides in clinical research on cerebrovascular disease, gradually shifting from relying on foreign research achievements to an international research model led by Chinese researchers. The CHANCE study marks the starting point of this progress, and with the introduction of other landmark studies, China has increasingly gained prominence in the global cerebrovascular disease research community. A series of key Chinese clinical studies have directly revised both national and international cerebrovascular disease guidelines. This article reviews the important clinical studies on ischemic cerebrovascular disease in China over the past two decades, explores the evidence-based basis for changing guidelines, and discusses future research directions, aiming to further advance the high-quality development of clinical research on ischemic cerebrovascular disease in China.

Thrombolytic Therapy in Chinese Stroke Clinical Research: Achievements over the Past Two Decades and Future Directions

DONG Yi, DONG Qiang

2025, 20(5):  549-554.  DOI: 10.3969/j.issn.1673-5765.2025.05.003

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In 2002, the results of multicenter RCT of Intravenous Thrombolysis with Urokinase for Acute Cerebral Infarctions were published, marking the beginning of research on thrombolytic drugs for ischemic stroke in China. Subsequently, Chinese researchers in the field of cerebrovascular disease have cautiously learned from international advanced experience, followed the guidance of international guidelines, and continuously standardized and improved thrombolytic therapy for ischemic stroke in China. Today, two decades later, China is capable of independently carrying out innovative research and development. The continuous introduction of new thrombolytic drugs, the continuous breakthroughs in treatment time windows, and the continuous innovation in combination therapy programs have propelled China’s stroke thrombolysis research to the forefront of the global stage. China’s stroke thrombolytic therapy has undergone two decades of rapid development. This article reviews the transformative journey of thrombolytic therapy in Chinese clinical research on ischemic stroke over the past two decades from the perspective of a participant.

Clinical Studies of Severe Cerebrovascular Disease in Recent 20 Years

ZHANG Zhe, ZHENG Li’na, YANG Zhonghua, LIU Liping

2025, 20(5):  555-565.  DOI: 10.3969/j.issn.1673-5765.2025.05.004

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Severe cerebrovascular disease is the most common type of disease in neurocritical care medicine. Clinical studies in this domain have laid the foundation for clinical practice. Over the past two decades, key and hot topics in the diagnosis and treatment of severe cerebrovascular disease have included: endovascular thrombectomy for anterior circulation stroke with large infarct cores and for posterior circulation ischemic stroke, blood pressure management after reperfusion therapy, decompressive craniectomy for large hemispheric infarction, anti-edema therapy for ischemic stroke, minimally invasive and medical hemostatic treatment for intracerebral hemorrhage, reversal of anticoagulation therapy, blood pressure management during the acute phase of intracerebral hemorrhage, management of ruptured aneurysms in aneurysmal subarachnoid hemorrhage, and monitoring and treatment of delayed cerebral ischemia and elevated intracranial pressure. Addressing these issues, this article outlines key clinical studies conducted by domestic and international scholars, discusses the inspirations drawn from these studies. Based on the summarized clinical research, researchers outline the future research trends in this area. 

An Integrated Analysis of Disease Burden and Economic Burden of Stroke in China

ZHAI Yi, YANG Fan, LI Tianqi, XIE Yuting, LIU Gaifen

2025, 20(5):  566-580.  DOI: 10.3969/j.issn.1673-5765.2025.05.005

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Objective  To conduct an integrated analysis of the disease burden and economic burden of various types of stroke in China. 
Methods  Based on published literature and public databases, including data from the 2013 national epidemiological survey of stroke in China, the annual report on cardiovascular health and diseases in China, the China health statistical yearbook, and the 2021 GBD study, a comprehensive analysis was conducted on the indicators reflecting the disease burden and economic burden of various types of stroke in China, such as the incidence, death, prevalence, DALYs, number of discharged patients, average hospitalization cost per visit, and the total hospitalization cost for patients with stroke. 
Results  (1) Current situation: from 2021 to 2022, the surveillance of cardiovascular and cerebrovascular events among Chinese residents revealed that the age-standardized incidence rate of stroke among individuals aged 18 and above in China was 338.6/100 000. According to the China health statistical yearbook, the crude death rate of stroke among urban residents in China in 2021 was 140.02/100 000, accounting for 21.71% of total urban deaths. Among rural residents, the crude death rate of stroke was 175.58/100 000, representing 23.62% of total rural deaths. The 2021 GBD study indicated that the age-standardized prevalence rate of stroke in China in 2021 was 1301.4/100 000, with ischemic stroke at 1018.8/100 000, intracerebral hemorrhage at 222.1/100 000, subarachnoid hemorrhage at 68.9/100 000, and the age-standardized DALYs rate for stroke was 2648.0/100 000. (2) Trends: the 2021 GBD study showed that compared to 1990, the age-standardized incidence rate of stroke decreased by 9.8%, the age-standardized death rate decreased by 43.0%, the age-standardized prevalence rate increased by 11.5%, and the age-standardized DALYs rate decreased by 45.2%. The age-standardized incidence and prevalence rates of ischemic stroke continued to exhibit an upward trend. In contrast, the downward trends in the age-standardized death rate and DALYs rate were not statistically significant. Further gender-specific analysis indicated that the age-standardized death rate and DALYs rate of ischemic stroke in females showed a statistically significant downward trend, while the corresponding trend in males was not statistically significant. (3) Economic burden: in 2020, the total hospitalization cost of ischemic stroke in China amounted to 74.77 billion yuan, and for intracerebral hemorrhage reached 30.91 billion yuan. The average hospitalization cost per visit was 9824.9 yuan for ischemic stroke and 20 397.6 yuan for intracerebral hemorrhage, respectively. After excluding the effects of price fluctuations, since 2004, the average annual growth rates of total hospitalization costs for ischemic stroke and intracerebral hemorrhage were 16.8% and 12.8%, respectively. Meanwhile, the average annual growth rates of the average hospitalization cost per visit were 1.1% and 4.4%, respectively.
Conclusions  From 1990 to 2021, the age-standardized incidence rate, age-standardized death rate, and DALYs rate of stroke in China exhibited a downward trend. However, the age-standardized incidence and prevalence rates of ischemic stroke continued to exhibit an upward trend. From 2004 to 2020, the average hospitalization cost per visit for ischemic stroke and intracerebral hemorrhage in China increased substantially. With the rapid process of population aging in China, the future disease burden and economic burden attributable to stroke will continue to rise.




Two Decades of Stroke Prevention in China

ZHANG Runhua, LI Tianqi, ZHAI Yi, JIANG Yong, LIU Gaifen

2025, 20(5):  581-594.  DOI: 10.3969/j.issn.1673-5765.2025.05.006

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Preventing the occurrence of stroke is the fundamental approach to reducing the burden of stroke disease. As a disease caused by multiple factors, the pathogenesis of stroke involves various risk factors such as lifestyle, genetics, and the environment. Controlling risk factors is the core strategy for reducing the incidence of stroke. Both primary prevention for the non-diseased population and secondary prevention for stroke patients hold significant value in stroke prevention and management. This article systematically reviews the development of stroke prevention in China over the past two decades, focusing on the following three research achievements: first, it summarizes the epidemiological trends and changing characteristics of major stroke risk factors in China based on epidemiological data; second, it examines the implementation of pharmacological interventions in secondary prevention of stroke, with a specific focus on the progress of antiplatelet therapy, and reviews the landmark clinical studies in the field of stroke prevention and their guiding value for clinical practice; finally, it provides a comprehensive review and summary of the evolution of China’s stroke screening system and prevention and control strategies. In addition, this article also looks forward to the future development of stroke prevention technology and research directions: emerging technologies such as wearable medical devices and artificial intelligence-assisted decision-making provide new technical means for stroke prevention. However, the application effects and promotional value of these new technologies still need to be further validated by large-scale clinical studies.



Two Decades of the Construction of Stroke Prevention and Control System in China

DAI Liye, YANG Xin, LI Tianqi, XIE Yuting, LIN Lin, ZHANG Jiuchuan, JIANG Yong

2025, 20(5):  595-603.  DOI: 10.3969/j.issn.1673-5765.2025.05.007

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The construction of China’s stroke prevention and control system has evolved from scratch, progressing through three critical phases, including theoretical foundation, framework formation, and deepening and improvement. Gradually, a four-tiered stroke prevention and control system (national-provincial-prefectural-county level) has been established. This article systematically reviews the development and progress of China’s stroke prevention and control system, highlighting its significance in promoting equity and accessibility in stroke prevention and control. The construction of this system requires the integration of macro-level organizational frameworks with grassroots networks. This paper provides an in-depth analysis of the intrinsic construction of this system, including the responsibilities and capabilities required of health administrative departments, leading units for cerebrovascular disease prevention and treatment technology, hospitals at all levels, and grassroots medical and health institutions, as well as the collaborative roles among different departments and institutions. Moreover, the current construction of China’s stroke prevention and control system remains in the early stages, facing challenges such as insufficient funding, talent shortages, and inadequate technical support. To address these issues, it is necessary to break down information barriers, strengthen multi-level collaboration, accelerate the clinical translation of new technologies, and continuously enhance China’s stroke prevention and control capabilities.



Two Decades of Stroke Rehabilitation in China

YAO Jingfan, XIE Yuting, GUO Shuanghui, ZANG Dawei, ZHANG Yumei, LIU Gaifen

2025, 20(5):  604-614.  DOI: 10.3969/j.issn.1673-5765.2025.05.008

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Rehabilitation therapy has been proven by evidence-based medicine as an effective method for reducing disability caused by stroke. Over the past two decades, the field of stroke rehabilitation in China has experienced rapid development, achieving significant progress in policy promotion, service system construction, and the application of new technologies. The concept of “comprehensive and full-cycle rehabilitation medical services” in our country has been further developed, and the three-tier rehabilitation network of stroke has taken shape. The development of new rehabilitation technologies, such as robot technology, virtual reality technology, and 
brain-computer interface technology, has provided new means for the recovery of functional impairments after stroke. However, stroke rehabilitation in China still faces challenges such as insufficient understanding of rehabilitation concepts, uneven resource distribution, inadequate community and home rehabilitation medical construction, shortage of professional talents, and heavy economic burden related to rehabilitation treatment. In the future, it is necessary to further strengthen the construction of the rehabilitation service system, optimize resource allocation, and promote the clinical transformation and popularization of new technologies, so as to improve the rehabilitation effects and quality of life for stroke patients in China.




CONSORT 2025 Statement: Updated Guideline for Reporting Randomised Trials

Translator: LI Hui, XIE Xuewei

2025, 20(5):  620-629.  DOI: 10.3969/j.issn.1673-5765.2025.05.009

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Background  Well-designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. 
Methods  We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, non-pharmacological treatment), other related reporting guidelines [template for intervention description and replication (TIDieR)], and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts.
Results  We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate the implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.
Conclusions  Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.



Interpretation of the CONSORT 2025 Statement: Explanation of Patient and Public Involvement

LI Hui, XIE Xuewei

2025, 20(5):  630-635.  DOI: 10.3969/j.issn.1673-5765.2025.05.010

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The CONSORT 2025 statement is the latest international guideline for reporting randomised trials. It was simultaneously released in April 2025 by leading medical journals worldwide, such as BMJ, JAMA, and Lancet. The statement is aiming to enhance the transparency, completeness, and scientific rigor of randomised trial reports, thereby making research findings more reproducible and practically significant. Compared to the 2010 version, CONSORT 2025 not only optimizes existing items and their wording, but also introduces seven new items. Among them, the newly added item 8, “patient and public involvement”, formally mandates the reporting of the role of patients and the public throughout the clinical trial process. This item stipulates that researchers must specify at which phases (design, implementation, and/or reporting) of the trial and in what manner patients and/or the public are involved. This revision originates from the increasing emphasis on patient-centered approaches in clinical research, which is regarded as key to enhancing trial relevance, real-world value, and ethical standards. Both domestically and internationally, an increasing number of policies and authoritative guidelines regard patient and public involvement as fundamental to ensuring the scientific rigor of clinical research, meeting public health needs, and strengthening public trust. This article comprehensively reviews the definition and historical development of patient and public involvement, examines its current status in China, and aims to provide an in-depth interpretation of the patient and public involvement requirements in the CONSORT 2025 statement.



SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomised Trials

Translator: LI Hui, XIE Xuewei

2025, 20(5):  636-646.  DOI: 10.3969/j.issn.1673-5765.2025.05.011

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Importance  The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users.
Objective  To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.
Design  We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT  extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines [template for intervention description and replication (TIDieR)]. The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting.
Findings  Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.
Conclusions and Relevance  Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.



Interpretation of the SPIRIT 2025 Statement: Open Science 

LI Hui, XIE Xuewei

2025, 20(5):  647-652.  DOI: 10.3969/j.issn.1673-5765.2025.05.012

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In April 2025, leading international medical journals such as BMJ, JAMA, and Lancet simultaneously released the updated SPIRIT 2025 statement. This statement is an internationally recognized guidance framework for the development and reporting of clinical trial protocols, aiming to enhance the scientific rigor, transparency, and ethical standards of clinical trial protocols, thereby promoting higher quality and more standardized medical research worldwide. Compared to the SPIRIT 2013, the SPIRIT 2025 statement added two new items, revised five items, deleted three items, and merged two items. Additionally, the overall structure of the checklist was also reorganized, integrating items on trial registration, protocols and statistical analysis plans, data sharing, funding and conflicts of interest, and publication policies into a single open science section. Open science is not merely a technical or policy provision, but a spiritual pursuit embedded in the ethics and values of the scientific community. Achieving open science requires seamless communication at multiple levels, including scientific dissemination, data openness, and method sharing. This article elucidates the definition, historical development, and challenges of open science, enabling readers to deeply understand, support, and participate in open science initiatives in the development of clinical trial protocols.