Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
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 assess the quality of budget impact analysis in China and Canada. Methods We searched databases including PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP from inception to 1st November, 2016, to collect studies about budget impact analysis. Two reviewers independently screened literatures, extracted data and assessed the quality of included studies. Results 27 literatures were included. The mean grades of Chinese and Canadian literatures were 3.8 and 5.5, respectively. Some Chinese studies did not explicitly clarify the research perspective. Few studies in China were conducted according to budget holders’ perspective and with a short time horizon, or examined the results using sensitivity analyses responsive to the uncertainty surrounding future market developments, or compared between current and comparator scenarios. These deficiencies were not conducive to scientific and rational decision-making. Conclusion The quality of budget impact analysis is relatively low in China. It is needed to establish uniform budget impact analysis guideline to improve quality to guide decision making.
Objective To investigate patients in gynecological endocrinology clinic with the following three pieces of information: how did they provide their symptom information, how did they understand diagnostic and therapeutic information, and what was their attitude towards the visit, and to get to know about the situation and problems in doctor-patient communication, so as to aim directly at improving the efficiency of diagnosis and treatment. Methods A total of 403 patients, who visited Prof. HAN Zi-yan’s clinic in the hospital from April to August 2010, were evaluated using self-edited Assessment on Doctor-patient Communication in Gynecological Endocrinology Outpatient Clinic. Results a) As to the situation of patients providing symptom information as well as understanding diagnostic and therapeutic information, when doctor asked, only 29% (118/403) of patients could narrate their treatment history clearly, and 38% (152/403) could tell their examination history exactly. After doctors’ explanation, only 21% (86/403) understood their examination results correctly, and 27% (108/403) understood management and therapeutic advice. The result of correlation analysis showed the accuracy of patients in providing disease information and accepting diagnostic and therapeutic information was higher in patients aged from 21 to 40 rather than those younger than 20, in patients well- educated rather than those with little education at the primary school, and in patients who were also engaged in medical work, All differences were significant (all Plt;0.05); and b) As to patients’ attitude towards visit, 55% (222/403) of patients hoped to get more attention from doctor, and 37.5% (151/403) overly expected the visit. Conclusion In the professor’s gynecological endocrinology outpatient clinic, many patients can’t clearly provide their treatment and examination history, neither understand exam situation and therapeutic advice at that visit, which are influenced by their age, education and occupation. In addition, psychological needs of patients should be concerned, too
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.
The current issue of air pollution has pushed the development of the corresponding observational air pollution studies. The World Health Organization has developed a new risk of bias (RoB) assessment instrument and a related guideline for assessing the risk of potential bias in observational air pollution studies. This study introduced the background, methods, uses, advantages and disadvantages, precautions, and usage scenarios of the RoB instrument. It is expected to provide researchers with corresponding quality evaluation tools when writing related systematic review and meta-analysis, which will also help provide reporting standards for observational air pollution studies, thereby improving the quality of studies.
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.
ObjectivesTo evaluate the quality of health information on diabetes in Chinese internet, so as to understand the current status of diabetes network health information, and provide reference for improving and enriching the three-level prevention of diabetes.MethodsThe three most common Chinese search engines: Baidu, Sogou and Haosou Search were searched with the keywords " diabetes” and " diabetes treatment”, using the health information evaluation tool DISCERN score to evaluate the quality of the information, and the integrity and accuracy of information content were evaluated with reference to the " Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)” issued by the Chinese Diabetes Society of Chinese Medical Association.ResultsA total of 300 links were accessed and included in 17 websites. The DISCERN review showed that only 1 item's average score exceeded 3 points. According to website content score, the excellent part accounted for 11.7%, the good part accounted for 35.2%, the fair part accounted for 47.1%, and the poor part accounted for 5.8%. 50% of websites contained error messages, and the subject of the most error-prone information was diagnosis and treatment. There was a positive correlation between the content score and the DSCERN score in the credibility score and the verbosity score (r=0.71, 0.73, P<0.001). The websites were evaluated by attributes, and the quality evaluation of diabetes-related information in some general-purpose websites was higher than that of diabetes specialist websites.ConclusionsThe quality of diabetes health information on Chinese websites is insufficient. It is necessary for China to establish a web-based information platform for diabetes. China has not yet formed a unified network health information evaluation standard in line with its national conditions. The key to solving the problem lies in the collaboration between professional health personnel and website developers.
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.
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.