Conflict of interest: None declared.
The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics
Article first published online: 17 FEB 2011
© 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization
International Journal of Stroke
Volume 6, Issue 4, pages 355–361, August 2011
How to Cite
Wang, Y., Cui, L., Ji, X., Dong, Q., Zeng, J., Wang, Y., Zhou, Y., Zhao, X., Wang, C., Liu, L., Nguyen-Huynh, M. N., Claiborne Johnston, S., Wong, L., Li, H. and on behalf of the investigators for the China National Stroke Registry (CNSR) investigators (2011), The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. International Journal of Stroke, 6: 355–361. doi: 10.1111/j.1747-4949.2011.00584.x
Funding: The CNSR is funded by the Ministry of Science and Technology and the Ministry of Health of the People's Republic of China. The Grant Numbers are 2006BA101A11 and 2009CB521905.
- Issue published online: 11 JUL 2011
- Article first published online: 17 FEB 2011
- acute stroke therapy;
- developing countries;
- risk factors;
- stroke subtypes
Background As a leading cause of severe disability and death, stroke places an enormous burden on the health care system in China. There are limited data on the pattern of current medical practice and quality of care delivery for stroke patients at the national level.
Aim The nation-wide prospective registry, China National Stroke Registry, will be considered with regard to its design, progress, geographic coverage, and hospital and patient characteristics.
Methods Between September 2007 and August 2008, the China National Stroke Registry recruited consecutive patients with diagnoses of acute cerebrovascular events from 132 hospitals that cover all 27 provinces and four municipalities (including Hong Kong region) in China. Clinical data were collected prospectively using paper-based registry forms. Patients were followed for clinical and functional outcomes through phone interviews at three, six, 12, 18, and 24 months after disease onset.
Results These patients (n=21 902) were 63·8 years of age on average, and 39% were females. Ischaemic stroke was predominant (66·4%), and the other subtypes were intracerebral haemorrhage (23·4%), subarachnoid haemorrhage (3·4%), and transient ischaemic attack (6·2%).
Conclusions The China National Stroke Registry is a large-scale nationwide registry in China. Rich data collected from this prospective registry may provide the opportunity to evaluate the quality of care for stroke patients in China.
Stroke is the second leading cause of death following cancer worldwide (1). The burden will increase considerably in the next 20 years due to the ageing population, especially in developed countries (2). In China, the most populous developing country, stroke accounts for almost 20% of all death (3, 4). Currently, more than seven million Chinese suffer from stroke, with another two million newly diagnosed patients occurring each year (4). To reduce stroke mortality and improve the quality of stroke care, a number of national guidelines, such as the Beijing Cerebrovascular Disease Guidelines (5) and the Chinese Stroke Guideline 2005 (6), were developed and modified recently based on guidelines from developed countries (7–13), in order to provide guidance to physicians on stroke prevention and management. It is unclear whether these guidelines are optimal for China, given the huge differences between China and developed countries in culture, patient characteristics, financial resources, healthcare infrastructure, and clinical practices.
Several efforts have been undertaken to evaluate the current stroke practice in China from different perspectives (14–17). However, these recent studies were small to moderate in size, mostly regional, and focused on certain stroke subtypes. As China is a huge country with over 1·3 billion residents, stroke treatment and prevention can be diverse and depend highly on the local economic status (4, 18). It is necessary to evaluate current stroke care delivery at the national level to identify the lesser examples of stroke care quality and help to select better therapeutic goals. In this report, we look at the China National Stroke Registry (CNSR), its rationale, study design, progress, as well as its uniqueness and potential limitations.
Overview of the CNSR
The CNSR is a nationwide prospective registry for patients presented to hospitals with acute cerebrovascular events initiated in 2007 and sponsored by the Ministry of Health. The CNSR was designed to help develop strategies, based on evidence observed through the registry, with the goal to improve stroke care in China.
The primary objectives of the CNSR were to evaluate the quality of care during the acute hospitalisation phase by determining the performance indicators for stroke care delivery and to identify the factors associated with these performance indicators. The secondary objectives included measuring longitudinal trends in clinical and functional outcomes at three, six, 12, 18, and 24 months after disease onset, their relationship with the quality of care during hospitalisation, and adherence to secondary stroke prevention medication.
In China, hospitals are classified into three grades; community hospitals are defined as grade I, hospitals that serve several communities are defined as grade II, and central hospitals for a certain district or city are defined as grade III and are usually teaching hospitals (19). In total, 242 potential sites including 114 grade III, 71 grade II, and 57 grade I hospitals, from both urban and rural areas, were initially identified by soliciting applications from neurology investigators or physicians. The CNSR steering committee evaluated the research capability and commitment to the registry of each hospital with preliminary surveys. A total of 132 study sites were selected, including 100 grade III and 32 grade II urban hospitals. The steering committee also attempted to ensure representation from each of the 27 provinces and four municipalities in Mainland China. One hundred and ten sites were excluded, including all rural and grade I hospitals because of low anticipated volumes and a lack of research personal, relevant research experience, or proved commitment to the study. All selected sites were voluntary and none of them were involved in quality improvement programmes. These sites generally had more resources and stroke expertise than the typical Chinese general hospitals, especially the rural hospitals.
The hospital characteristics for the selected sites are listed in Table 1. The geographical locations of the participating hospitals are illustrated in Fig. 1. The study was approved by the central institutional review board at Beijing Tiantan Hospital. For a complete list of CNSR members and sites, see Appendix A.
|Grade II||32 (24·2)|
|Grade III||100 (75·8)|
|Number of beds in total*||800 (150–2500)|
|Number of beds in ND*||45 (20–176)|
|Stroke out-patients clinic||112 (84·8)|
|Emergency department||81 (61·4)|
|Stroke Unit||39 (29·5)|
|Inpatients' rehabilitation||92 (69·7)|
|Neurological rehabilitators||97 (73·5)|
|Speech therapist||52 (39·4)|
|Brain CT scan 24/7||85 (64·4)|
|Digital subtraction angiography||112 (84·8)|
|Extracranial duplex sonography||121 (91·7)|
The registry recruited consecutive patients between September 2007 and August 2008 who met the following criteria:
- •older than 18
- •ischaemic stroke (IS), transient ischaemic attack (TIA), intracerebral haemorrhage (ICH), or subarachnoid haemorrhage (SAH) within 14 days of the index event
- •direct admission based on physician evaluation or arrival through the emergency department, and
- •ability of patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.
Eligible events were confirmed by brain CT or MRI within 14 days after the onset of symptoms.
Baseline data collection and data management
A standard data collection protocol was developed by the steering committee. Trained research coordinators and study investigators were trained before the trial kick-off meeting. Trained research coordinators at each institute reviewed the medical records daily to identify, consent, and enroll consecutive patients. Paper-based registry forms (PRF) developed by the expert advisory panel were used for data collection. Information including prehospital care, prestroke modified Rankin scale (mRS), and baseline severity (including the National Institutes of Health Stroke Scale (NIHSS) and Glasgow Coma Scale scores) was collected through a direct interview by trained research coordinators. The remaining data were extracted from the medical records that included patient demographics, medical history, medication use, diagnosis and disease status (i.e., NIHSS score, stroke subtypes, and neuroimaging studies), disease management in different hospital settings, and discharge status. The main vascular risk factors included history of stroke (defined as a medical chart-confirmed history of IS, TIA, ICH, or SAH), hypertension (including self-reported history of hypertension, oral antihypertension drugs, or blood pressures ≥140/90 mmHg at admission), dyslipidaemia (self-reported history of all types of dyslipdaemia, or oral antidyslipdaemia drugs), history of coronary heart disease, atrial fibrillation (history of atrial fibrillation, confirmed by at least one electrocardiogram, or the presence of the arrhythmia during hospitalisation), diabetes mellitus (including history of diabetes mellitus, or taking oral hypoglycaemic agents/insulin), current or previous smoking, moderate or heavy alcohol consumption (≥2 standard alcohol consumption per day), and body mass index (BMI) (calculated as measured weight divided by the square of measured height).
The information from patients' insurance schemes was collected based on the following categories (20–22):
- •Basic Health Insurance Scheme for urban and governmental employees and urban residents, which is jointly funded by the government, employers, and employees
- •New Cooperative Medical System provided by the Chinese government to rural residents
- •commercial insurance, and
- •self-payment (no insurance coverage).
Subjects provided contact information at enrolment for themselves and their care-givers (mostly close relatives, otherwise indicated), as well as two other alternative contacts. Written consent was obtained from each participating patient.
At each site, all data elements from each PRF were manually checked for completeness, correct coding, and proper application of diagnostic algorithm by a research specialist, from an independent contract research organisation, throughout the study period. A professional data processing company was responsible for the computer data entry. Beijing Translational Medicine Research Center, an independent research organisation, served as the data analysis centre and analysed the aggregate de-identified data for research purposes.
Follow-up data collection and data management
Patients were contacted over the telephone by trained research personnel at Beijing Tiantan Hospital, who used standard scripts to collect study data at three, six, 12, 18, and 24 months after disease onset. The enrollee was the targeted respondent for the questionnaire. When it was impossible to speak to the patient or when the information provided by the patient was deemed unreliable by the interviewer, the care-giver was contacted and interviewed. During the follow-up periods, stroke recurrences associated with rehospitalisation were sourced to the attended hospitals to ensure a reliable diagnosis. In the case of a suspected recurrent cerebrovascular event without hospitalisation, judgement was made by the research coordinators together with the principal investigator (Y. W.). Each case fatality was either confirmed on a death certificate from the local citizen registry or from the attended hospital. In case of lack of local citizen registry information or death without hospitalisation, case fatality was deemed to be reliable if death was reported on two consecutive follow-up periods from different proxies.
The follow-up questionnaire included self-reported information on medication use, functional status, and clinical outcomes. Medication use was collected through a series of questions targeting the current prescriptions for grade II hospital prevention protocols. Medication adherence was determined by the proportion of prescribed doses taken. The direct medication cost during the corresponding follow-up period was also recorded. The mRS was used to assess patients' functional dependence. The follow-up questionnaires were identical for all follow-up periods.
The interviewers entered the data collected into a password-protected Microsoft Access database at Beijing Tiantan Hospital.
Quality of care indicator
Fifty-six evidence-based performance indicators for stroke care delivery during acute hospitalisation were evaluated by the Steering Committee after reviewing the literature (5, 6, 11, 23, 24). Each indicator was scored using the Delphi method and sorted between two aspects: importance and feasibility. Eleven key performance indicators were selected as Grade A indicators, which were widely accepted and easy to measure. The 11 key performance indicators were applied to create a group of eligible patients for each specific indicator. The proportion of acute IS patients who received intravenous recombinant tissue plasminogen activator within three-hours of symptom onset, when presenting within two-hours of the patient being well, was determined.
We evaluated medical complication prevention including stroke patients who received venous thromboembolism prophylaxis on the day of or after hospital admission and stroke patients who were screened for dysphagia before they were given food or drink. We determined the proportion of patients with an acute IS in the anterior circulation who underwent carotid imaging during stroke hospitalisation. We also evaluated the quality of grade II prevention, including aspirin prescribed in the first 48 h of hospitalisation in patients admitted for an IS; antithrombotic therapy at discharge; warfarin for patients with IS and atrial fibrillation at discharge; statin medication on discharge in IS patients with low-density lipoprotein >100 mg/dl, or low-density lipoprotein not measured, or patients on a lipid-lowering medication before arrival to the hospital. Finally, we evaluated education and rehabilitation, including stroke patients or their caregivers who were given educational materials during the hospital stay, stroke patients assessed for or who received rehabilitation services, and smoking cessation counselling. Patients were excluded if insufficient information was available to assess eligibility or if a contraindication (e.g., treatment intolerance, excessive risk of adverse reaction, patient refusal, or terminal illness/comfort care only) was documented as the reason for not providing the intervention. Patients discharged against medical advice or whose discharge destination could not be determined were also excluded. These performance indicators will be used to evaluate and identify deficiencies in the quality of stroke care among different types of hospitals across regions of China.
Clinical outcomes, which were assessed by patient self-report or proxy at the three, six, 12, 18, and 24 months follow-up visits, included the following: stroke or TIA recurrences, rehospitalisation, death, and disability. Death was assessed by vascular death (including fatal stroke, fatal MI, and other cardiovascular death) or death for any causes. Disability was measured by the mRS from 0 to 5 (death was rated as 6). The presence of disability was defined as mRS 2–5 and moderate-to-severe disability was defined as mRS 3–5.
Drop-outs and missing values
At each follow-up period, a patient was considered as a drop-out if the patient clearly refused to further participate in the study or could not be reached after three phone contact attempts each day (morning, afternoon. and early evening) for a working week.
Patients who were not eligible at the baseline were excluded from the study (i.e., patients younger than 18 or with an onset to door time longer than 14 days). The patients with missing diagnosis were also excluded from further study. The missing rates for covariates were expected to be low. Any covariates with missing rates larger than 10% were excluded in later analyses or indicated otherwise. If necessary, medical histories might be computed as missing. Medians and most common categories were considered as replacement of missing values for continuous and categorical variables, respectively. Degrees of freedom needed to be adjusted if any imputation for missing values occurred.
In this article, the analyses focused on characterising the participating hospital and patient baseline characteristics. Proportions were used for categorical variables, means with standard deviation were used for continuous variables, and median together with the interquartile range (or 5th–95th percentile) were used for ordinal variables. Body mass index was categorised into three groups: normal (BMI <25 kg/m2), overweight (BMI 25–30 kg/m2), and obese (BMI >30 kg/m2). The severity of the presented symptoms was determined by the NIHSS scores with three levels, <5, 5–14, and >14, respectively. All analyses were conducted using sas 9·1.
The patient recruitment phase has been completed. We initially screened 39 741 patients and 17 290 patients were excluded based on our inclusion criteria. There were 22 451 stroke patients who consented and were enrolled from 132 participating sites between September 2007 and August 2008. Of these, 21 902 (>95%) were eligible and had complete information at baseline. The detailed patient recruitment flow chart is illustrated in Fig. 2.
Patient demographic characteristics are summarised in Table 2. Overall, 38·8% of these patients were female. The average age at disease onset was 63·8 years, and 21·6% of the patients had no insurance coverage at all. The proportions of overweight or obese patients were 32·6% and 3·5%. respectively. Overall, 38·9% of the patients were either current or past smokers.
|Age (year), mean ± SD||63·8 ± 12·9|
|Female, N (%)||8493 (38·8%)|
|BMI, N (%)||24·4 ± 4·0|
|Normal <25 kg/m2||11 821 (61·9%)|
|Overweight 25–30 kg/m2||6224 (32·6%)|
|Obese >30 kg/m2||1045 (5·5%)|
|Ethnicity (non-Han), N (%)||695 (3·2%)|
|Current smoker, N (%)||8480 (38·9%)|
|Heavy drinker*||2103 (9·6%)|
|Elementary or below||9891 (45·8%)|
|Middle school||5766 (26·7%)|
|High school or above||5948 (27·5%)|
|Types of health Insurance|
|BHIS||11 792 (55·6%)|
Stroke subtypes, patient medical history, and conditions are listed in Table 3. Ischaemic stroke was predominant (66·3%), followed by ICH (23·4%), SAH (3·4%), and TIA (6·2%). Among the patients, 30·9% had a past history of stroke and 63·2% were hypertensive.
|IS||14 526 (66·3%)|
|History of stroke||6773 (30·9%)|
|Diabetes mellitus||3866 (17·7%)|
|Hypertension||13 842 (63·2%)|
|Coronary heart disease||2590 (11·8%)|
|Atrial fibrillation||1200 (5·5%)|
|Baseline NIHSS group|
|<4||10 887 (49·7%)|
We compared our registry with a number of recently available stroke registries (14–17) for hospitalised patients, and the patient sizes, area coverage, target population, disease subtypes studied, and some basic patient characteristics are listed in Table 4.
|Author||Liu (16)||Heeley (14)||Kong (17)||Ding (15)||CNSR|
|No. of patients||752||5557||2774||1951||21902|
|Numbers of sites||1, Nanjing||62||1, Chengdu||32 (11 cities)||132|
|Age (mean ± SD)||67·2 ± 12·7||63 ± 12||Male: 63 ± 13·6; Female: 65·2 ± 13·5||62·7 ± 10·4||63·8 ± 12·9|
|Follow-up||1 year||1 year||1 year||1 year||2 years|
|Onset to admission||≤7 days||≤30 days||Unknown||≤6 months||≤14 days|
CNSR has enrolled 21 902 patients from September 2007 to August 2008. The hospital and patient characteristics were reported. Compared with the existing stroke registries (Table 4) for patients presented to hospitals, CNSR was unique, being a national databank of stroke patients from hospitals covering all regions of China (except for Taiwan and Macao regions), which provided the opportunity to evaluate current stroke care practice, and the medical resources allocated across different hospital settings and different geographical areas at the national level.
CNSR is also unique because it is a prospective registry collecting comprehensive information on in-hospital treatment, postdischarge medication, and clinical outcomes. The data being collected will be used to determine the influence of risk factor profiles, and quality of care on the short- and long-term health outcomes.
There were several limitations in this study. The selection of participating hospitals, although covering all areas of China, was by convenience in nature. In addition, these study sites may represent the institutes with more resources and expertise than county level or even more grassroots-level hospitals. It is not known what proportion of stroke patients in China currently have access to similar levels of hospital care as those who participated in our study.
As the data collected were not used if there was no documentation, some data (such as swallow assessment on admission) might not always be reported in the medical records even though they might have been collected at the bedside. Therefore, the adherence of some performance indicators in practice might be underestimated.
Limited by the budget, detailed rehospitalisation data could not be collected in this study. Except for the recurrent events associated with a rehospitalisation, which were sourced from the attending hospitals, most follow-up information, including case fatality and disability, was assessed by phone interviews. The accuracy of these self-reported events, however, needs to be evaluated. In addition, any negative events were considered to be reliable, which may lead to underestimation of mild clinical events.
China National Stroke Registry was designed to be the first phase of a comprehensive programme for the continuous improvement of stroke care. Data from the first two-years of CNSR will be analysed to formulate recommendations for best practice in stroke management and determine the use of evidence-based stroke care intervention in future stroke patients at participating hospitals in subsequent phases.
Appendix A: the CNSR investigators
Principal investigator: Yongjun Wang.
Steering committee: Yongjun Wang, Lawrence Wong, Qiang Dong, Liying Cui, Xunming Ji, Jinsheng Zeng, Mai N. Nguyen-Huynh, S. Claiborne Johnston, Suming Zhang, David Wang, Peiyi Gao, Xingquan Zhao, Chunxue Wang.
Study organization executive committee: Yilong Wang, Yong zhou, Liping Liu, Xiaoling Liao, Jingyu Luan.
Statistician: Hao li,
Data monitoring committee: Zhijiang Wang, Haibo Wu.
Clinical Centers (site principal investigator):
Yongjun Wang, Beijing Tiantan Hospital; Qi Bi, Beijing Anzhen Hospital; Weiwei Zhang, Beijing Military District Gengral hospital of Chinese People's Liberation Army; Liying Cui, Peking Union Medical College Hospital of Peking University; Yuheng Sun, Beijing Jishuitan Hospital; Maolin He, Beijing Shijitan Hospital; Dongsheng Fan, Peking University Third Hospital; Xunming Ji, Beijing Xuanwu Hospital; Jimei Li, Beijing Friendship Hospital Affiliated to Capital Medical University; Fang Zhang, Beijing Guangwai Hospital; Kai Feng, Beijing Shunyi District Hospital; Xiaojun Zhang, Beijing Tongren Hospital; Yansheng Li, Shanghai Renji Hospital; Shaoshi Wang, Shanghai First Municipal People's Branch hospital; Wei Fan, Zhongshan Hospital of Fudan University; Zhenguo Liu, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University; Xiaojiang Sun, The sixth People's Hospital Affiliated to Shanghai Jiao Tong University; Wei Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Jianrong Liu, Shanghai Ruijin Hospital; Xu Chen, Shanghai 8th People's Hospital; Qingke Bai, Pudong New Area People's Hospital; Dexiang Gu, Shanghai Yangpu Area Shidong Hospital; Xin Li, Shanghai Yangpu Area Center Hospital; Qiang Dong, Huashan Hospital of Fudan University; Yan Cheng, Tianjin Medical University Gengeal Hospital; Lan Yu, Tianjin Huanhu Hospital; Bin Li, Dagang Oilfield Gengeal Hospital; Tongyu Wang, Bohai Oilfield Hospital; Kun Zhao, Baodi District People's Hospital of Tianjin; Chaodong Zhang, The First Afflicated Hospital of China Medical University; Dingbo Tao, The First Afflicated Hospital of Dlian Medical University; Lin Yin, The Second Afflicated Hospital of Dlian Medical University; Fang Qu, Dlian Second People's hospital; Jingbo Zhang, Dlian Third People's hospital; Jianfeng Wang, Dalian Central hospital; Ying Lian, Dalian Economic and Technological Development District Hospital; Fang Qu, Shenying Military District Gengral hospital of Chinese People's Liberation Army; Jun Fan, Shenyang Military District 202 Hospital; Ying Gao, National Traditional Chinese Medicine (TCM)Thrombus Treatment Center of Liaoning Province; Mingdong Cheng, En'liang hopital of Tai'an County; Jiang Wu, The First Clinical College of Jilin University; Huashan Sun, Jilin Chemical Industrial Group General hopital; Jinying Li, Jilin Oilfield General Hospital; Guozhong Li, The First Clinical College of Harbin Medical University; Yulan Zhu, The Second Clinical College of Harbin Medical University; Zichao Yang, The Fourth Clinical College of Harbin Medical University; Fengmin Yang, Daqing Oilfield General Hospital; Jun Zhou, Mudan Jiang Second hospital of Hailongjiang Province; Minxia Guo, Shaanxi Provincial People's Hospital; Zhengyi Li, The First Afflicated Hospital of Medical College of Xian Jiaotong University; Qilin Ma, The First Hospital of Xiamen; Renbin Huang, Chenzhou First People's Hospital; Bo Xiao, Xiangya Hospital of Centre-south University; Kangning Chen, Southwest Hospital; Xinyue Qin, The First Affiliated Hospital of Chongqing Medical University; Changlin Hu, The Second Affiliated Hospital of Chongqing Medical University; Li Gao, Chengdu Third Municipal People's Hospital; Jinsheng Zeng, The First Affiliated Hospital of Sun Yat-Sen University; Anding Xu, The First Affiliated Hospital of Jinan University; Xiong Zhang, Guangdong People's Hospital; Ming Shao, The First Affiliated Hospital of Guangzhou Medical University; Feng Qi, LiWan Hospital of GuangZhou Medical College; Weimin Xiao, Dungun Municipal People's Hospital; Suping Zhang, Guangzhou Red Cross Hospital; Xiaoping Pan, Guangzhou First TMUNICIPAL People's Hospital; Suyue Pan, Nan Fang Hospital; Yefeng Cai, Guangdong Provincial Hospital of Traditional Chinese Medicine; Qi Wan, Jiang Su People's Hospital; Yun Xu, Drum Tower Hospital Affiliated to Nanjing Medical University Upper First-class Hospital; KaiFu Ke, he Affiliated Hospital of Nantong University Upper First-class Hospital; Yuenan Kong, Wuxi Second People's Hospital Upper First-class Hospital; Qing Di, Neurology Hospital Affiliated to Nanjing Medical University Upper First-class Hospital; Fengyang Shao, Jiangsu Province Lianyungang Hospital of TCM Upper First-class Hospital; Yajun Jiang, Jiangsu Province Hospital of TCM Upper First-class Hospital; Daming Wang, The First People's Hospital of Changzhou Upper First-class Hospital; Li Guo, The Second Hospital of Hebei Medical University; WencuiXue, Qinhuangdao C.
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Appendix S1: The CNSR investigators.
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|IJS_584_sm_appendixs1.doc||33K||Supporting info item|
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