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find Author "张明妍" 10 results
  • Core Outcome Set-STAndards for Reporting: The COS-STAR Statement

    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。

    Release date:2017-04-24 03:30 Export PDF Favorites Scan
  • Introduction of Core Outcome Set-STAndards for Reporting (COS-STAR)

    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.

    Release date:2017-07-19 10:10 Export PDF Favorites Scan
  • Quality evaluation of randomized controlled clinical trials in Chinese Journal of Integrated Traditional and Western Medicine

    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.

    Release date:2017-04-01 08:56 Export PDF Favorites Scan
  • Causes and countermeasures of waste in clinical research of Chinese medicine

    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.

    Release date:2018-11-16 04:17 Export PDF Favorites Scan
  • Analysis on the influencing factors of constructing an outcome pool in core outcome set study for traditional Chinese medicine

    Inconsistency, impracticability and non-standardization of the selection, measurement and reporting of outcomes are three primary existing issues in clinical trials. These problems pose a threat to huge research waste when the results of similar studies are not able to be combined or compared. The key for resolution will be to standardize outcomes in traditional Chinese medicine (TCM) clinical trials and to establish a core outcome set (COS), which is a set of outcomes to be reported as a minimum in all TCM clinical trials of similar healthcare system and syndromes. The first step in the development of COS is to collect all existing outcomes, that is, to build a pool of outcomes for clinical trials of TCM. A pool of outcome is the basis of developing COS, which is important to follow strict and scientific methodology. This paper aims to construct an outcome pool from published literature, clinical trial registration protocols, and clinicians, and patients questionnaires were used to form a list of outcomes. In addition, the influencing factors of constructing an outcome pool and considerations for each problem are summarized in order to provide guidance and reference for the development of COS in clinical trials for TCM.

    Release date:2021-05-25 02:52 Export PDF Favorites Scan
  • Efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor: a meta-analysis

    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.

    Release date:2018-01-20 10:09 Export PDF Favorites Scan
  • Introduction of COS-STAD recommendations and its application of TCM

    Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.

    Release date:2018-06-04 08:48 Export PDF Favorites Scan
  • The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals

    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.

    Release date:2018-07-18 02:49 Export PDF Favorites Scan
  • 译文:核心指标集研制标准:COS-STAD 推荐

    背景 核心指标集(Core Outcome Set,COS)的应用是为确保研究人员测量并报告那些与其研究最可能相关的结局指标。目前,已开展数百个 COS 研究,但还没有对这些研究进行正式的质量评价。核心指标集研制标准(Core Outcome Set-STAndards for Development,COS-STAD)项目目的是制定国际工作组公认的 COS 研究最低设计标准,而对于 COS 研究的最终报告还有其他具体指南:COS-STAR(Core Outcome Set-STAndards for Reporting,COS-STAR)。 方法与结果 一个由经验丰富的 COS 研制者、方法学家、期刊编辑、COS 潜在使用者(临床试验员、系统评价员和临床指南制定者)及患者代表组成的国际组织制定了 COS-STAD 推荐,用以帮助改善 COS 的研制质量,并为判断已经形成的 COS 所采用的方法是否恰当提供评估支撑。通过公开的专家问卷调查产生了一份初始条目清单,并经两轮德尔菲(Delphi)问卷调查优化,共有近 250 名来自关键利益相关方的代表参加。参与者使用一个 1~9 分的量表为每个条目的重要性打分。某个条目可以进入到最低标准集合的共识原则是,每个相关方的投票参与者中至少有 70%对该条目打分为 7~9 分。德尔菲调查之后,还要与代表多个相关方的研究管理组进行共识讨论。COS-STAD 包含 11 条最低标准,是所有 COS 研究项目的最低设计建议规范。本推荐重点包括 3 个关键领域:范围、相关方和共识过程。 结论 COS-STAD 项目确立了 11 条最低标准,供 COS 研制者设计研究项目和 COS 使用者判断已形成的 COS 研究方法学是否应用合理。

    Release date:2018-07-18 02:49 Export PDF Favorites Scan
  • Construction of the systematic review/meta-analysis database of traditional Chinese medicine

    The systematic review/meta-analysis database of traditional Chinese medicine (SMD-TCM) was focused on incubation and application of the secondary research achievement. At present, the establishment of front and back websites, evidence input and evaluation have been completed. In the near future, the automation of overview and the visual presentation of evidence information will be realized, which provides the technical support for integration, analysis and application of evidence in the secondary research of TCM. This paper introduces the construction of SMD-TCM database which includes: requirements of construction, design principles, working process, evidence processing, ensuring quality of data input, data analysis and application, etc.

    Release date:2020-02-04 09:06 Export PDF Favorites Scan
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