The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
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.
ObjectivesWith the increasing number of core outcome sets (COS) in traditional Chinese medicine (TCM), some problems gradually emerged, which may affect the popularization and application of COS. This paper analyzes the COS research status in the field of TCM based on registry and literature databases, so that researchers may pay attention to it. Methods Registry platforms and literature databases of Chinese and English were both searched from inception to June, 2022. Qualitative analysis was used to analyze the research status of COS. ResultsSeventy-two COS studies were identified from registry platforms, and the results showed some problems, such as uneven disease distribution, insufficient attention to TCM characteristics, unclear COS scope, and insufficient patient and public participation. Ninety-nine studies were identified from different databases, only 7.07% (7/99) of the studies were COS results, and few of them were cited by clinical trials and/or systematic reviews. ConclusionThe authors proposed that standardizing the registration of COS in the field of TCM, improving the methodology of COS studies, expanding the application settings of COS, and strengthening the cooperation of different stakeholder groups are important to ameliorate sustainable development of COS.
ObjectiveTo overview of systematic reviews of the efficacy and safety of antimicrobials in the prevention of postpartum infection after vaginal delivery, and to provide evidence for the rational use of antimicrobials. MethodsThe CNKI, WanFang Data, VIP, PubMed, Embase, and Cochrane Library databases were searched to collect systematic reviews/meta-analyses on antibiotic prophylaxis for transvaginal delivery from inception to June 25, 2023. The data of the included systematic reviews were extracted by 2 investigators independently, and the methodological quality, risk of bias, and report quality were evaluated by AMSTAR 2.0 scale, ROBIS tool, and PRISMA, respectively. And a pool of outcomes for assessing the effectiveness of antimicrobials in prevention of postpartum infection after transvaginal delivery was developed. ResultsA total of 7 systematic reviews were included. And the AMSTAR 2.0 indicated that most studies (5/7) were from very low quality to low quality. The ROBIS tool showed 3 studies with low risk of bias, 3 with high risk of bias, and 1 with unclear risk of bias. The results of the PRISMA statement showed that the included system evaluation reports were relatively complete. The present evidence showed that prophylactic use of antimicrobials may be beneficial and recommended in women with Ⅲ-Ⅳ perineal fissures, with no significant benefit in women with manual placenta removal, but prophylactic use of antimicrobials was recommended considering their invasive nature, but it was controversial whether antimicrobials should be used in the categories of vaginal assisted delivery, perineal lateralization, and spontaneous delivery (without complications). ConclusionAntimicrobial prophylaxis may not be recommended for all the pregnant women undergoing vaginal delivery to prevent the postpartum infection, but considering the low methodological quality of the included systematic review and the inconsistent outcomes in this field, the conclusion should be further verified by future research with high-quality.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
It is crucial to select outcomes in clinical trials. Appropriate outcomes can improve value and significance of trials and reduce the cost of investment. This paper describes how to develop core outcome sets and core outcome measurement instrument sets with the theory of mixed methods research, so as to standardize the choice of outcomes and outcome measurement instruments in clinical trials.
Objective To summarize the current studies of the core outcome set of traditional Chinese medicine (COS-TCM) and analyze their possible problems. Methods The CNKI, WanFang Data, VIP, PubMed, Web of Science, Embase, and Cochrane Library databases were electronically searched to collect studies from inception to April 18, 2023. The relevant characteristics of the included studies were extracted, and the development steps, stakeholders, and outcomes of COS-TCM were analyzed. Results A total of 28 COS-TCM studies were included. Two studies, only published systematic reviews without providing more information, were excluded from the analysis. Among the 26 studies for analysis, 25 studies (96.15%) used a mixture of methods to develop COS-TCM. Clinicians (n=25) were the most common participants, followed by methodologists and patients. Fifteen studies (57.69%) reported measures to help patients better participate. Twelve consensus definitions were found in the included studies, of which 14 studies' consensus definitions were divided into three levels:"consensus in", "consensus out", and "no consensus". Among the 14 studies that reported the final COS-TCM results, only 4 studies recommended Chinese medicine characteristic outcomes. For the measurement of outcomes, 14 studies (53.85%) made plans for the selection of tools. Conclusion The current COS-TCM research has made some progress, and the common developing methods are roughly the same as those nationally used. However, there are still some problems, such as inadequate and low-transparency reports, lack of TCM characteristic outcomes, and so on. We suggest that future COS-TCM studies should refer to COS-STAP, COS-STAR, COS-STAD, and other international standards as well as emphasize the advantages of TCM during development and reporting so that it can improve the transparency of developing methods, research quality, and the proportion of TCM characteristics of the final COS.
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.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.