To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.
The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs.
ObjectiveTo systematically review the difference in 30-day readmission rates among acute heart failure patients between real-world studies vs. randomized controlled trials (RCTs). MethodsPubMed, EMbase, The Cochrane Library, CNKI, CBM, VIP and WanFang Data databases were electronically searched to collect clinical studies on 30-day readmission rates in patients with acute heart failure from inception to April 12th, 2021. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using Stata 16.0 software. ResultsA total of 33 real-world studies and 11 RCTs involving 106 722 subjects were included. The results of meta-analysis showed that the 30-day heart failure-related readmission rates in the real-world studies and RCTs were 10.8% (95%CI 9.3% to 12.3%) and 6.9% (95%CI 5.3% to 8.4%), respectively. The 30-day all-cause readmission rates in real-world studies and randomized controlled studies were 18.6% (95%CI 15.7% to 21.4%) and 14.2% (95%CI 12.0% to 16.3%), respectively. There were statistically significant differences between two kinds of studies (P<0.05). ConclusionsCurrent evidence suggests that the 30-day heart failure-related and all-cause readmission rates in patients of acute heart failure in real-world studies are significantly higher than those in patients of RCTs. Due to the limited quality and quantity of included studies, more high-quality studies are required to verify the above conclusions.
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.
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
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 firstly introduces and interprets “core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Secondly, this study surveyed the use of core outcomes in 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.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.