China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): Rationale and Design of a Prospective, Multicenter, Observational Study

Abstract

Background: Given the complexity of stroke treatment and the current widespread use of traditional Chinese medicine (TCM) in the absence of robust, large, long-term effectiveness and safety studies, and the lack of nationwide epidemiology and clinical characteristics of patients with stroke receiving TCM treatment, the acquisition of data from longitudinal cohorts is essential. We intend to generate the major clinical characteristics of patients with stroke who receive TCM treatment and to investigate the effectiveness and safety of TCM in the Chinese population.Methods: The China Stroke Registry for Patients with Traditional Chinese Medicine (CASES-TCM) study is a prospective, multicenter, observational disease registry aiming to register 20,000 hospitalized patients. Eligible adult patients with clearly diagnosed acute ischemic stroke or intracerebral hemorrhage within 7 days of symptom onset will be consecutively registered from 126 participating sites across China. Baseline data will be recorded, and all patients will be regularly followed up at 3, 6, 12, and 24 months after stroke onset. Collected data will be entered into a web-based system with high-level data security. The primary outcomes include the distribution of scores on the modified Rankin Scale at the 3-months follow-up, and recurrent stroke events within the 12-months follow-up.Conclusion: To our knowledge, the CASES-TCM study is the first and largest nationwide registry to document comprehensive data on TCM treatment in patients with acute stroke. The findings of this study will be valuable to improve our knowledge about TCM treatment for patients with stroke and its subsequent outcomes in the actual clinical setting, consequently facilitating and standardizing the optimization of individualized interventions with TCM for stroke prevention and treatment in China.Study registration: This study was registered with Clinicaltrials.gov (URL: https://clinicaltrials.gov/, Unique identifier: NCT04921397).

Registry for vascular cognitive impairment treatment with traditional Chinese medicine (REVIEW-TCM): Rationale and design of a prospective, observational study

“…It is worth noting that specific studies with hypotheses, such as comparative effectiveness research, pragmatic randomized clinical trials, or nested case-control studies, can be included in this registry study. This approach can lead to the generation of secondary hypotheses, which can be further tested in clinical trials [28].…”

Vital real-world experience regarding Naoshuantong capsules for unselected ischemic stroke (VENUS): Rationale, design, and baseline of a prospective, multicenter, observational study

“…Strict quality control in terms of research personnel training and timely audits will be conducted before study initiation to ensure the accuracy and completeness of the collected data. In addition, the VENUS registry will support the establishment of a database for further individual patient data pooling as per homogenous investigational variables with that of the China Stroke Registry for Patients with Traditional Chinese Medicine (CASES-TCM) study, embedding comparative effectiveness research, pragmatic randomized clinical trial, or nested case-control study to generate secondary hypotheses for extra validation in clinical trials (Feng et al, 2021). The VENUS registry is designed as a comprehensive, prospective, multicenter, post-marketing, observational study, aiming at evaluating the effectiveness and long-term safety of NC for patients with IS in a real-world setting.…”

“…Death will be confirmed by a death certificate. Recurrent stroke events leading to rehospitalization will be confirmed by discharge diagnosis while suspected recurrent stroke events will be determined by the endpoint judgment committee when without hospitalization ( Feng et al, 2021 ). Adherence to the NC treatment will be defined as the proportion of prescribed doses taken ( Osterberg and Blaschke, 2005 ).…”

Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study

“…Therefore, we designed this MMR study to explore the relationship between XNJI used within 24 h after stroke onset and the presence of END on the third day after symptom onset in patients with acute stroke. Evaluating the efficacy and safety of complex TCM interventions involves multiple associations ( Feng et al, 2021 ). Fortunately, the MMR design is suitable for an individualized evaluation of TCM in the actual clinical setting and enables us to explore and interpret research-related concerns from multiple dimensions in the real-world setting ( Qiu et al, 2020 ).…”