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.
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.
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.
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.
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.
ObjectiveTo analysis the regularity of prescriptions of Chinese Medicine for syndrome of intense fire and heat (syndrome of Shi-Re-Huo-Du), and to provide evidences for the clinical treatment.MethodsCNKI, Sinomed, WanFang Data, VIP and Chinese medical databases were electronically searched to collect literatures about traditional Chinese Medicine for syndrome of Shi-Re-Huo-Du from inception to October, 2018. Two reviewers independently screened literature and extracted data. Then BICOMS 2 software was used to generate the co-occurrence matrix, NetDraw software was used to draw network maps.ResultsA total of 381 literatures involving 335 patients were included. There were 716 prescriptions of Shi-Re-Huo-Du (390 Chinese medicinal herbs), in which the frequently used herb included radix glycyrrhizae (346), Scutellariae Radix (255), Fructus Gardeniae (241), Rehmanniae Radix (239), Moutan Cortex (218), etc. The classification was performed according to traditional efficacy, Qing-re herbs (73), Bu-xu herbs (47), and Hua-tan-zhi-ke-ping-chuan herbs (39), accounted for 40.77% of the total herbs. The results of the analysis showed that the top herbs in Degree and Betweenness were consistent with high-frequency herbs. Among them, Rehmanniae Radix, Fructus Gardeniae, Scutellariae Radix, Moutan Cortex are the most important traditional Chinese herbs. High-frequency herbs are mainly based on Qing-re herbs, and the highest frequency of the herbs combination is Scutellariae Radix-Fructus Gardeniae.ConclusionAlthough there are kinds of herbs for syndrome of Shi-Re-Huo-Du, the commonly used herbs are relatively concentrated, and there is obvious interaction between high-frequency herbs, which is in line with the principle of compatibility of Chinese medicine. The high-frequency Chinese herbs and herb pairs were main components of the Chinese patent medicines and classic prescription. It reflected the rule of medicine used and essence in the treatment of syndrome of Shi-Re-Huo-Du.