背景 通过确保对卫生服务使用者和其他特定领域卫生保健决策者关注的指标进行常规测量，核心指标集（core outcome set，COS）可以提高研究的相关性。到目前为止，已经形成了 200 多个 COS，但这些报告的透明度还不理想。如果 COS 的报告不够完整和透明，COS 研究将无法实现其目标。 方法与结果 鉴于这些问题，由经验丰富的 COS 制定者、方法学家、期刊编辑、COS 潜在用户（临床试验者、系统评价员和临床指南制定者）以及患者代表组成的一个国际性工作组，制定了核心指标集报告标准（Core Outcome Set-STAndards for Reporting，COS-STAR）声明，作为 COS 研究报告的指南。其形成过程先后包括初始报告条目产生阶段、代表关键利益相关方群体的 200 名人员的两轮德尔菲问卷调查，最后是一个共识会议。COS-STAR 声明由一个包含 18 个条目的清单组成，这些条目是确保所有 COS 研究报告透明度和完整性的必要条目。条目清单重点规范了形成特定 COS 的研究报告需涉及的前言、方法、结果和讨论部分。COS-STAR 声明的一个局限性在于其形成过程中缺乏低、中收入国家的代表性意见。而 COS 对在这些国家和地区开展的研究具有同等的相关性，故今后该指南可能需要不断完善，以应对这些国家和地区 COS 形成的任何其他挑战。 结论 随着 COS 研究的不断开展，COS-STAR 声明将成为提高 COS 研究报告质量的有力工具，并使所有 COS 使用者受益。
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.
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.
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.
Since its initial publication in 2013, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines have received widespread international attention. The guidelines aim to enhance the standardization and transparency of clinical trial protocol reporting. With continuous advancements in clinical trial methodologies, the SPIRIT group released an updated version, SPIRIT 2025, in 2025. The SPIRIT 2025 reporting guideline comprises 34 items; compared to the 2013 version, 2 items were added, 5 were revised, 2 were merged, and 3 were deleted. Its core updates are reflected in: The addition of an "open science" section, which emphasizes trial registration, accessibility of the trial protocol and statistical analysis plan, a data sharing statement, and a dissemination policy for research findings; The addition of a "patient and public involvement" item, which requires the protocol to describe the participation of patients or the public in the trial's design, conduct, and reporting phases; Structural optimization, which reorganizes the original items into five major sections for clearer logic and strongly recommends the use of a schedule diagram to present the trial timeline. This article provides an illustrative interpretation of the items contained in the SPIRIT 2025 statement using a randomized controlled trial protocol, aiming to offer guidance and convenience for domestic researchers utilizing this tool.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
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.
Objectives To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor. Methods CNKI, WanFang Data, PubMed, EMbase, SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using ReMan 5.3 software. Resluts A total of 15 RCTs were included. The results of meta-analysis showed that: compared with the chemotherapy alone, Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate (RR=1.26, 95%CI 1.07 to 1.49, P<0.000 01), the clinical efficacy of TCM syndrome (RR=1.71, 95%CI 1.50 to 1.96,P<0.000 01), and the quality of life scores of patients (RR=1.44, 95%CI 1.13 to 1.82,P=0.003). The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions. Conclusions Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract, clinical efficacy of TCM syndrome, the quality of life, and improving immune function. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.