scholarly journals Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032256 ◽  
Author(s):  
Ruijin Qiu ◽  
Changming Zhong ◽  
Songjie Han ◽  
Tianmai He ◽  
Ya Huang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Semistructured Interviews

IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at:http://www.comet-initiative.org/studies/details/1243).

scholarly journals Outcome Reporting Variability in Trials of Chinese Medicine for Hyperlipidemia: A Systematic Review for Developing a Core Outcome Set

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Geng Li ◽  
Ruxue Han ◽  
Wencong Cao ◽  
Zehuai Wen ◽  
Xiankun Chen
Keyword(s):  
Systematic Review ◽  
Chinese Medicine ◽  
Total Effective Rate ◽  
Core Outcome Set ◽  
Density Lipoprotein ◽  
Effective Rate ◽  
Lipoprotein Cholesterol ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set

Introduction. Hyperlipidemia is an underlying process behind cardiovascular disease. Chinese medicine (CM) may be effective in treating hyperlipidemia, but there is a lack of studies with high methodological quality. A major reason for this is heterogeneity in outcome reporting. Therefore, this study explores the degree of outcome reporting variation in CM trials for hyperlipidemia. It then generates a list of potentially important outcomes for developing a core outcome set (COS). Methods. A systematic review of literature focusing on studies of CM for hyperlipidemia was conducted. Outcomes were listed verbatim and grouped into 8 domains. Outcome frequency and definition uniformity were analyzed. Results. 3,702 studies and 452 individual outcomes were identified. These outcomes were reported 27,328 times, of which 1.6% were reported as primary outcomes, and 13.3% were defined. The most frequent outcome was total triglyceride, represented in 86.7% of the studies, followed by total cholesterol (86.0%), total effective rate (75.1%), high-density lipoprotein cholesterol (73.2%), and low-density lipoprotein cholesterol (60.5%). However, 43.6% of outcomes were reported only once. The largest outcome domain was “pathological or pathophysiological outcomes,” which included 67.0% of outcomes. Of the “response rate related outcomes” domain, total effective rate was the most frequently reported outcome (n = 2,780), and 95.3% of the studies gave a clear definition. However, these definitions were often contradictory. Only 10 papers reported cardiovascular events, 3 of which referred to them as primary outcomes. Moreover, ten patient-reported outcomes were reported in the retrieved literature 19 times in total. The majority of the outcomes did not report measurement instruments (MIs) (269/453, 59.4%). MIs of the surrogate outcomes were reported more frequently. Conclusion. Outcome reporting in CM trials for hyperlipidemia is inconsistent and ill-defined, creating barriers to data synthesis and comparison. Thus, we propose and are developing a COS for CM trials for hyperlipidemia.

scholarly journals Outcomes reported in clinical studies of stable angina pectoris on traditional Chinese medicine: a systematic review towards a core outcome set

2021 ◽  
Author(s):  
Mingyan Zhang ◽  
Hui Zi Chua ◽  
Bohan Niu ◽  
Wenke Zheng ◽  
Fengwen Yang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Clinical Studies ◽  
Clinical Symptoms ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Symptoms And Signs

Abstract Background Traditional Chinese medicine (TCM) plays an important role in contributing to the public health in China. However, non-standardized outcomes in TCM related studies posed great difficulty in data synthesis for healthcare decisions. An agreed set of standardized outcomes, or termed as a core outcome set (COS), can solve this existing problem of outcome heterogeneity. This review aimed to analyze outcome heterogeneity, assess the quality of outcome reporting and providing a list of potential outcomes for COS development of SAP using TCM. Methods 8 literature databases were searched to identify clinical studies about TCM for SAP (SAP-TCM) of yearly samples of 2005, 2010, 2015, 2016, 2018 and 2019. 2 clinical registry databases were searched from inception to October 2020. Outcomes definition, measurement methods and time-point were extracted and categorized into 7 themes which include clinical symptoms and signs, physical and chemical examination, TCM-related outcomes, adverse events, quality of life, long-term prognosis and economic evaluation. Timing and quality assessment of the outcomes reported were analyzed and evaluated. Results A total of 1166 studies were included from 12962 potential studies, involving 111426 patients. 231 outcomes were identified and a total of 89 outcomes reported at least twice in the studies. The most commonly reported theme was clinical symptoms and signs. The most frequently reported outcomes were total rate of ECG efficiency and angina attack in clinical studies of published literature and clinical registries databases respectively. Outcomes reported in a single study ranged from 1 to 15, and 5 outcomes on average per study. 80% of the studies lack reporting of primary outcomes. A wide variation of measurement instruments or methods was used. A range of 1–17 measurement time-points were recorded. Quality assessment of outcome reporting was generally low, with 65.6% of the studies scoring 3 to 4 points. Conclusion Outcomes reported in studies on SAP-TCM are heterogeneous. A lack of standardization complicates comparisons of outcomes across studies. Developing a COS for SAP-TCM could contribute to the standardization of outcome reporting and offer a stronger evidence for health decision-making.

Sjogren's Syndrome in Clinical Trials of Traditional Chinese Medicine: Protocol for the Development of a Core Outcome Set

2020 ◽  
Author(s):  
Guangyan Chen ◽  
Yuan Yuan ◽  
Ming Liu ◽  
Bin Pu
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Initial List ◽  
Three Phases

Abstract Background: Sjogren's syndrome (SS) is a chronic autoimmune rheumatic disease, and the incidence of 0.03% to 0.3%. There are an increasing number of randomised controlled trials of Traditional Chinese Medicine (TCM) for SS. However, there are generally some problems in clinical trials: lack of reporting primary or long term outcomes, and the heterogeneous in different clinical trials’ outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders, and reach agreement on the core outcome set (COS) and syndromes to be measured and reported in all future TCM trials in patients with SS. Methods: A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (Ⅰ-a) Identifying of a long initial list of outcomes through: (1) systematic literature review; (2) semi-structured qualitative interviews. (Ⅰ-b) Identifying an initial list of TCM syndromes through: (1) systematic literature review; (2) referencing ancient Chinese medical books; (3) retrospective studies of medical records. (Ⅱ) Prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients. (Ⅲ) Through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes.Results: We summarized the actions of COS into three points: direct action, indirect action, final action. Our study is very necessary.Conclusion: After the final COSs is completed, we will publish this research in a journal to promote communication.Trial registration number: Core Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1429.

scholarly journals Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

2021 ◽  
Vol 8 ◽  
Author(s):  
Ruijin Qiu ◽  
Songjie Han ◽  
Xuxu Wei ◽  
Changming Zhong ◽  
Min Li ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Events ◽  
Health Professionals ◽  
Core Outcome Set ◽  
Essential Medicines ◽  
Core Outcome ◽  
Outcome Set

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine.Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting.Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences.Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

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