ObjectiveTo analyze the research hotspots and development trends of core outcome set (COS) from 2015 to 2024, providing a reference for future research in this field. MethodsWe retrieved literature on COS research from the Web of Science Core Collection and CNKI spanning January 1, 2015 to December 31, 2024. We extracted and organized data on the number of publications, journals, citation frequency, and keywords using Excel 2021. We performed keyword clustering analysis using VOSviewer 1.6.13 and generated strategic coordinate maps using Bibliometrix 3.13 in R 4.3.1. ResultsWe included a total of 1 288 studies, comprising 1 085 English publications and 203 Chinese publications. From 2015 to 2024, the number of COS publications showed a steady increase. English journals covered a wide range of fields, while Chinese journals were mainly focused on traditional Chinese medicine. High-impact articles primarily focused on COS methodology. Chinese literature mainly concentrated on the application of COS in traditional Chinese medicine, while English literature focused on child health, Delphi surveys, quality of life, and pain. The results of the strategic coordinate map showed that research on acupuncture core outcome indicators, qualitative studies of surgical COS, and Delphi-based COS for quality of life in patients with rheumatoid diseases were relatively weak, with significant room for improvement. ConclusionOver the past decade, COS research has shown a steady growth trend and has gradually become an important tool for improving the standardization and scientific rigor of clinical research. As COS research continues to expand, there is increasing overlap in the scope and findings of different studies. Future research could incorporate umbrella and basket study designs to optimize resource utilization and promote the application of COS in clinical practice.
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.
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.
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.
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.
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.
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.
Core outcome set (COS) is an agreed and minimal set of outcomes that should be measured and reported in all clinical trials in specific areas of health or healthcare, which can reduce the heterogeneity of outcomes in similar clinical trials, so that much more trials can merge in systematic reviews. Meanwhile, using COS may be easy to identify potential selective reporting bias in clinical trials. The research of COS has been developed for more than 30 years in western countries. At present there are much more researchers focusing on this area in China. However the status and progress of COS remain unclear. This paper reviewed the quantity of COS, the disease distributions of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so as to clarify the general situation of COS.
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.
The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring, passive monitoring and literature review. However, there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types. So far, it is impossible to further produce more comprehensive and objective high-level evidence-based evidence, which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use. The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method, the formation of weighted quantitative scoring model applied to the comprehensive evaluation method. Mixed methods research (MMR) can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data. Secondly, for the most critical index weighting and weight adjustment research in the model construction research, the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method, and introduces the quantitative research part of the MMR design. It ensures the accurate weighting of indicators in the process of model construction. Therefore, based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test, this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data, and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data. It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine injections.