a b s t r a c tSince its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcriptionpolymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital
IntroductionChronic heart failure (CHF) is a serious and advanced stage of various cardiovascular diseases and portends poor prognosis. An increase in clinical studies has reported the effectiveness of traditional Chinese medicine (TCM). For example, intravenous Chinese medicine can significantly improve cardiac function and biomarkers in patients with CHF. However, there exists inconsistency, lack of practicality and unclear reporting of outcomes in these clinical trials causing difficulty in the comparison of results across similar studies during data synthesis. A core outcome set (COS) can help in the standardisation of outcomes reported across studies from the same healthcare area. The aim of this study is to develop a COS on TCM for CHF (COS-TCM-CHF) to reduce heterogeneity in reporting and improve quality assessment in clinical trials to support data synthesis in addressing the effectiveness of TCM treatment.Methods and analysisThis study will include constructing an outcome pool which will identify potential outcomes through systematic reviews of TCM randomised clinical trials, two clinical registry databases, semi-structured interviews of patients and the clinicians’ questionnaire. According to the characteristics of TCM and a taxonomy recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, all outcomes in the outcome pool will be classified into different domains. A preliminary list of outcomes which will then be used in the Delphi survey is generated using a certain criteria based on the length of the pool. The Delphi survey will include two rounds with seven key stakeholder groups to select candidate items for a consensus meeting. A final COS-TCM-CHF will be developed at a face-to-face consensus meeting involving representatives from the different stakeholders.Ethics and disseminationEthical approval of this study has been granted by Evidence-based Medicine Centre of Tianjin University of Traditional Chinese Medicine Research Ethics Committee (TJUTCMEC201200002). We will disseminate our research findings of the final COS on the website of Chinese Clinical Trials for Core Outcome Set, with open access publications and present at international conferences to reach a wide range of knowledge users.Trial registration numberhttp://www.comet-initiative.org/studies/details/1486.
Objective: This study aimed to develop a core outcome set (COS) for use in future studies of stable angina pectoris (SAP) in traditional Chinese medicine (TCM). Methods: Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes. Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings. Following the final consensus meeting, a final COS was generated. Results: An initial set of 324 outcomes was identified. A preliminary list of 65 outcomes was employed in the Delphi study. In total, 223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round: 87 completed round 1 and 47 completed round 2. Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains: frequency of angina attack, duration of angina attack, Seattle angina questionnaire, total exercise duration in the exercise treadmill test, cardiovascular events, and QT interval on electrocardiography. Conclusions: The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP. The employment of this COS may reduce heterogeneity across trials and facilitate evidence-based decision-making for stakeholders.
Background Squama Manitis (pangolin scale) has been used in traditional Chinese medicine for thousands of years. However, its efficacy has not been systematically reviewed. This review aims to fill the gap. Methods We searched six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database (CNKI), WanFang Database and SinoMed from inception to May 1, 2020. Search terms included “pangolin”, “Squama Manitis”, “Manis crassicaudata”, “Manis javanica”, “Malayan pangolins”, “Manis pentadactyla”, “Ling Li”, “Chuan Shan Jia”, “Shan Jia”, “Pao Jia Zhu”, “Jia Pian” and “Pao Shan Jia”. The Cochrane Risk of Bias (RoB) assessment tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the risk of bias of the included randomized controlled trials (RCTs) and case control studies (CCSs). Results After screening, 15 articles that met the inclusion criteria were finally included. There were 4 randomized controlled trials, 1 case control study, 3 case series and 7 case reports. A total of 15 different diseases were reported in these studies, thus the data could not be merged to generate powerful results. Two RCTs suggested that Squama Manitis combined with herbal decoction or antibiotics could bring additional benifit for treating postpartum hypogalactia and mesenteric lymphadenitis. However, this result was not reliable due to low methodological quality and irrational outcomes. The other two RCTs generated negative results. All the non-RCTs did not add any valuable evidence to the efficacy of Squama Manitis beacause of small samples, incomplete records, non-standardized outcome detection. In general, currently available evidence cannot support the clinical use of Squama Manitis. Conclusion There is no reliable evidence that Squama Manitis has special medicinal value. The removal of Squama Manitis from Pharmacopoeia is rational.
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