This paper introduces the process of design and implementation on the clinical evidence database of acupuncture (ACU-CED), including establishing expert groups on the basis of demands to formulate top-design, project implementation plans and standard, comprehensively searching publications of clinical randomized controlled trials (RCTs) of acupuncture and moxibustion, conducting strictly data extraction and evaluation, and eventually achieve automatic utilization of clinical evidence. ACU-CED will become the first structural data platform with the function of searching-screening-result, analysis-data, and statistics-evidence extraction, which fills in gapes in database of clinical evidence sources, increases efficiency of evidence transformation, and reduces waste of resources. It will also achieve auto-completion of systematic review/meta-analysis as well as visualization of clinical evidence, so as to provide evidence for clinical decision, guidelines and disease spectrum of acupuncture therapy.
背景
通過確保對衛生服務使用者和其他特定領域衛生保健決策者關注的指標進行常規測量，核心指標集（core outcome set，COS）可以提高研究的相關性。到目前為止，已經形成了 200 多個 COS，但這些報告的透明度還不理想。如果 COS 的報告不夠完整和透明，COS 研究將無法實現其目標。
方法與結果
鑒于這些問題，由經驗豐富的 COS 制定者、方法學家、期刊編輯、COS 潛在用戶（臨床試驗者、系統評價員和臨床指南制定者）以及患者代表組成的一個國際性工作組，制定了核心指標集報告標準（Core Outcome Set-STAndards for Reporting，COS-STAR）聲明，作為 COS 研究報告的指南。其形成過程先后包括初始報告條目產生階段、代表關鍵利益相關方群體的 200 名人員的兩輪德爾菲問卷調查，最后是一個共識會議。COS-STAR 聲明由一個包含 18 個條目的清單組成，這些條目是確保所有 COS 研究報告透明度和完整性的必要條目。條目清單重點規范了形成特定 COS 的研究報告需涉及的前言、方法、結果和討論部分。COS-STAR 聲明的一個局限性在于其形成過程中缺乏低、中收入國家的代表性意見。而 COS 對在這些國家和地區開展的研究具有同等的相關性，故今后該指南可能需要不斷完善，以應對這些國家和地區 COS 形成的任何其他挑戰。
結論
隨著 COS 研究的不斷開展，COS-STAR 聲明將成為提高 COS 研究報告質量的有力工具，并使所有 COS 使用者受益。
The Core Outcome Set-STAndards for Reporting (COS-STAR) is a latest guide tool made by Core Outcome Measures in Effectiveness Trials (COMET) group. It can enhance the transparency and completeness of Core Outcome Set (COS) report. This paper introduces the generation process, report items and application of COS-STAR to provide reference for domestic similar researches.
Objective
To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes.
Methods
We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004.
Results
A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow.
Conclusion
The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.
The issue of waste in medical research has been widely concerned in recent years. Research waste is also significant in the field of traditional Chinese medicine (TCM). This study summarized the causes of research waste in TCM and provided suggestions to researchers and administrators for reducing research waste and promoting rational use of medical research resources.
With the advancement of modern research in traditional Chinese medicine (TCM), evidence regarding the clinical efficacy and mechanisms of action of TCM has rapidly accumulated. However, due to a lack of methodological safeguards, the disconnection between clinical and basic research in TCM has become increasingly prominent, making it difficult to form an evidence chain that supports the scientific value of TCM in a manner that is "clear and understandable". Therefore, it is necessary to develop methods for the translation and integration of clinical and basic research evidence oriented towards clinical value, to form a reliable evidence chain that can further discover patterns, confirm efficacy, and highlight advantages. This article discusses the construction and evaluation methods of the evidence chain for the efficacy of TCM, aiming to provide theoretical and methodological references for related work.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
The consolidated standards of reporting trials (CONSORT) is an internationally recognized guideline for reporting randomized controlled trials (RCTs), aiming to enhance the transparency, completeness, and reliability of trial findings. In response to the ongoing evolution of clinical trial methodology, the CONSORT group has issued updates to the CONSORT statement in 2001, 2010, and most recently in 2025. This article provides an applied interpretation of the background and key components of the CONSORT 2025 statement through the lens of a representative randomized controlled trial, with the aim of offering practical guidance and reference for domestic researchers utilizing this reporting tool.
To describe the construction and application of clinical evidence database of traditional Chinese medicine (TCM-CED) so as to provide evidence for TCM research. The construction process primarily includes: expert team building, TCM-CED function module design, evidence collection and quality control. The applications of TCM-CED primarily include the following aspects: automatic generation of systematic review/meta-analysis in TCM, automatic generation of evidence reports on dominant diseases of TCM, automatic generation of evidence index of Chinese patent medicine, optimizing the selection of outcomes in TCM research, tracking methodological and reporting quality of TCM research, and promoting international dissemination of TCM evidence. With the rapid development of information technology and artificial intelligence, TCM-CED will be combined with artificial intelligence to achieve the construction of all-dimensional TCM evidence chain and the automation of the whole process.
Clinical practice guidelines need to be based on evidence, but traditional Chinese medicine, especially integration of traditional Chinese and Western medicine guidelines, inevitably need to combine clinical research evidence, ancient literature, and expert experience and consensus. In the process of formulating, there are deviations in understanding and application of the expert consensus method and expert experience, resulting in opaque of the recommendations, unclear of the details of the diagnosis and treatment strategy, less prominent of the advantages and value of traditional Chinese medicine, which affects the scientificity, transparency, applicability, promotion and application of the guidelines of traditional Chinese medicine or integration of traditional Chinese and Western medicine. This study discusses the guiding principle of "evidence as a core, consensus as a supplement, and experience as a reference" that was generally followed and puts forward detailed methodological suggestions to the formulation of guidelines for traditional Chinese medicine and integration of traditional Chinese and Western medicine.
