ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
Meta-research is the "research of research", which aims to explore the existing quality of research in the scientific field, so as to help researchers comprehensively and systematically understand the current status of research development in a certain field, and to find relevant solutions to improve the quality of research in the field, which is a kind of scientific research concept. The concept of meta-research is widely used in the field of medicine, but its definition and use are still unclear in China. Therefore, this paper explores the origin of the definition of meta-research, the scope of research areas involved, and the path of its translation and implementation from the medical perspective, to help domestic researchers understand and familiarize themselves with the theoretical basis of meta-research, and provide them with a framework of ideas for the correct conduct and implementation of meta-research, so as to promote the scientific application and development of meta-research in the domestic medical field.
Objective To systematically evaluate the quality of published pharmacoeconomics studies on Chinese patent medicines for neoplasms. Methods Datasets including CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase were searched to collect pharmacoeconomics studies of Chinese patent medicines in neoplasms from the establishment of the database to September 30, 2022. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and quality of health economics studies (QHES) were used to evaluate the reporting quality and methodological quality. Results A total of 25 studies were included, with an average CHEERS 2022 coincidence rate of 40.09% and an average QHES score of 53.2. Conclusion The quantity and quality of pharmacoeconomics studies on Chinese patent medicines in neoplasms are insufficient and flawed. It is suggested to strenthen the collaboration between scientific research institutions and hospitals and standardize the pharmacoeconomics studies on Chinese patent medicines in neoplasms to provide hygienic decision-making evidence for Chinese patent medicines in neoplasms.
In order to promote the effective development of hospital day surgery mode, a construction method of information management platform that meets the characteristics of day surgery mode is presented. By analyzing the business process of the day surgery mode, the system architecture of the information platform is given; according to the difficulty of the surgical scheduling, the two-stage surgical scheduling algorithm based on the ranking theory is given; by analyzing the day surgery data statistically, a multi-angle surgical index analysis module is provided. The information management of the day surgery mode has been realized, and the work efficiency has been improved. A reasonable day surgery information platform construction can help to optimize the daytime surgical procedure and promote the smooth development of day surgery.
Objective To evaluate the quality of Chinese literatures on the methodology of D-dimer diagnostic test. Method We searched CNKI (1994 to 2006) and CBM (1978 to 2006) for articles involving the diagnostic tests of D-dimer for coagulation disorders. Result A total of 63 relevant articles were retrieved and 7 were included in our review. Only one of these provided useful data on two two table for the evaluation of diagnostic accuracy. Conclusions Few studies on the diagnostic tests of D-dimer have been performed and publ ished in China, all of poor quality. Further studies should focus on clinical diagnostic sensitivity and specificity, so as to provide more valuable information for readers.
Objective To evaluate the quality of controlled trials on 131I therapy for thyroglobulin positive and radioactive iodine negative metastases（131I WBS-/Tg+）. Methods We electronically searched MEDLINE (1966 to Mar. 2004), EMBASE (1984 to 2003), The Cochrane Central Register of Controlled Trial, CENTRAL (Issue 2, 2004), CBMdisc (1978 to 2004) and CNKI (1994 to 2004), and handsearched 5 radiotherapy and endocrinology journals (Jan. 1980 to Apr. 2003). The methodological quality of included studies was assessed by using quality assessment criteria of the Cochrane systematic review guideline. Results Three non-randomized controlled trials were included. One was historical controlled trial, and two prospective trials. The sample sizes of three trials were 26, 60 and 70 respectively without mentioning the calculation base. The comparability of baseline was mentioned but not comparable across the trials. No double blind studies were used in the assessment of 131I efficacy. The time of follow-up varied from 2 to 15 years. None studies mentioned the side effects of 131I therapy for 131I WBS-/Tg+ metastases. Only two studies applied statistical methods properly. Conclusions Problems about allocation of groups, double blind, sample size, and follow-up period continue to exist in published controlled trials. RCT or prospective controlled trials of high quality are urgently needed in order to define the efficacy and safety of 131I therapy for 131I WBS-/Tg+ metastases.
National Center for Medical Service Administration of National Health and Family Planning Commission of China was established at the beginning of 2015. It is mainly in charge of developing and managing standards of medical technology and organizing their implementation, and giving technical guidance and consulting for evaluation of medical institutions. The foundation of the center fills in the blank of lacking central administrative department of the guideline development and evaluation. This paper introduces the definition and the function of clinical practice guideline, and analyzes the current situation, problems and challenges of domestic guidelines, and proposes some potential suggestions on improving the quality of Chinese guidelines from national level for promoting the standardization, scientification and transparency of clinical practice guidelines in China.
Focusing on research quality is a crucial aspect of modern evidence-based medical practice, providing substantial evidence to underpin clinical decision-making. The increase in real-world studies in recent years has presented challenges, with varying quality stemming from issues such as data integrity and researchers’ expertise levels. Although systematic reviews and meta-analyses are essential references for clinical decisions, their reliability is contingent upon the quality of the primary studies. Making clinical decisions based on inadequate research poses inherent risks. With the lack of a specialized tool for evaluating the quality of real-world studies within systematic reviews and meta-analyses, the Gebrye team has introduced a new assessment tool - QATSM-RWS. Comprising 5 modules and 14 items, this tool aims to improve real-world research evaluation. This article aims to elaborate on the tool’s development process and content, using this tool to evaluate a published real-world study as an example and providing valuable guidance for domestic researchers utilizing this innovative tool.
Objective To evaluate the current situation of the design of the randomized controlled trials (RCTs) in Clinical Anesthesiology, Chinese Journal of Anesthesiology and Chinese Journal of Pain Medicine from 1999 to September in 2003. Method The clinical therapeutic studies in the three journals from 1999 to September of 2003 were hand searched over page by page to identify strictly the randomized controlled trials according to Chinese Cochrane Center hand search guideline. Results 412, 378 and 142 papers of the three journals were published, among which, there were 237, 221 and 68 papers of RCT. Conclusions Although the quality of RCT in the three journals has been increased significantly year by year, but there still exist some problems. The quality of RCT papers needs more improvement to guarantee RCT to be more precise as it demands.
ObjectiveWe constructed a real-world evidence evaluation system to provide reference for obtaining high-quality evidence in evidence-based medicine.MethodsThrough the investigation and analysis of the key factors influencing the real-world research evidence, combined with domestic and foreign literature and evaluation tools, we preliminarily constructed the indicators of the real-world evidence evaluation system, then consulted experts in related fields by the Delphi method, modified and determined the final evaluation indicators. ResultsThe indicators of the final real-world evidence evaluation system included 40 items. The recovery efficiencies of the two rounds of expert consultation were 88.2% and 100%; The expert coordination coefficients were 0.174 (P<0.001) and 0.189 (P<0.001). After the second round of consultation, the mean of Likert scale in the range of 3.73~4.93, and the coefficient of variation varied in the range of 0.05~0.21. ConclusionThe real-world evidence evaluation system constructed in this study has certain reliability and scientificity, which can provide a basis and help for the transformation of real-world research into high-quality evidence.