Risk ratio (RR) and hazard ratio (HR) are two common effect measures in prospective studies. When describing the magnitude of clinical effects in the original study and meta-analysis, they cannot be used interchangeably. Selecting an appropriate measures and interpreting them correctly is critical in clinical research. In this study, we summarized similarities and differences between risk and hazard, compared differences between RR and HR in estimation methods and clinical interpretation. The magnitude of RR and HR estimated from the same studies were compared, and two feasible formulas converting between RR and HR were presented for meta-analysis.
Objective To explore the methodological characteristics of Chinese clinical practice guidelines/expert consensus based on usage of GRADE. MethodsCNKI, PubMed, WanFang Data databases, and Medlive.cn were electronically searched to collect Chinese clinical practice guidelines/expert consensus over the past 11 years from January 1st 2010 to December 31st 2020. Four reviewers independently extracted data according to the content of appraisal of guidelines quality evaluation tool AGREE Ⅱ. The clinical practice guidelines/expert consensus were divided into two groups based on whether GRADE was used or not. The changes and development of methodological quality in the past 11 years were explored between the two groups. ResultsIn recent years, the number of clinical practice guidelines/expert consensus which used the GRADE in China had increased annually. The practice guidelines/expert consensus which did not use GRADE had lower methodology quality (P<0.01). ConclusionsThe use of GRADE in clinical practice guidelines/expert consensus requires improvement, and mastering GRADE methodology can effectively improve the methodological quality of the clinical practice guidelines/expert consensus.
Based on previous evidence-based researches and teaching experience, our team conducted literature and book review, and summarized 4 requirements, 1) effect measure calculation and conversion, 2) registration of evidence-based research, 3) evidence-based research database and 4) quality evaluation tools and reporting guidelines. We developed an online platform of evidence-based medicine research helper using the front-end and back-end technology, which can be accessed using www.ebm-helper.cn. Currently, the online tool has included 46 scenarios for effect measure calculation and conversion, introduction of 7 evidence-based research registration platforms, 26 commonly used databases for evidence-based research and 29 quality evaluation tools and reporting guidelines. This online tool can help researchers to solve specific problems encountered in different stages of evidence-based medicine research. Promoting the application of this platform in evidence-based medicine will help researchers to use the tool scientifically and improve research efficiency.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
ObjectiveTo systematically review the researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine (TCM). MethodsPubMed, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine from inception to June 2021. Two reviewers independently screened literature, extracted data; and then, descriptive analysis was performed using qualitative methods. ResultsA total of 18 studies were included. Specifically, 8 studies presented both the level of evidence and the strength of recommendations, 9 presented the level of evidence, and 1 presented the strength of recommendations. Thirteen studies considered both TCM evidence and modern medical evidence sources, 3 included only evidence from ancient literature, 1 focused only on post-marketing safety evaluation of Chinese medicine, and 1 focused only on real-world studies of TCM. ConclusionCurrently, there are numerous criteria for TCM related quality of evidence and strength of recommendations, and some are developed only for TCM characteristic evidence. Most researchers of TCM guidelines expect to fully value the significance of ancient literature and expert experience or opinion in guideline development.
ObjectiveTo analyze the epidemiological burden and change trend of five sexually transmitted infections (STIs) in China from 1990 to 2019. MethodsThe estimated numbers and standardized rates of STIs incidence, prevalence, and disability-adjusted life years (DALY) in China and other regions were obtained from the Global Burden of Disease Study 2019. The epidemic burden and change trend of STIs in China were compared and evaluated. ResultsIn 2019, STIs affected about 242 million people in China, resulting in 173 million new cases and 350 000 person years of DALY losses. Compared with 1990, the prevalence and incidence of STIs increased by 59.75% and 30.02%, respectively, and the number of DALY decreased by 35.19%. From 1990 to 2019, the incidence rate of chlamydia infection and gonococcal infection in the young and middle-aged group (aged 15-49 years) showed an upward trend; in addition, the DALY rate of genital herpes and trichomoniasis also increased. Among the 5 STIs, the disease burden caused by trichomoniasis infection in women was much higher than that in men. With the increase in the socio-demographic index (SDI), the burden of STIs in China gradually decreased. After the SDI exceeded 0.65, the decline rate of standardized DALY rate sharply increased. ConclusionThe disease burden of STIs in China shows a downward trend from 1990 to 2019, and the disease burden of the young and middle-aged group (aged 15-49 years) is the most significant, especially in trichomoniasis and chlamydia infection.
Systematic review (SR) and meta-analysis, as the highest level of evidence-based medicine, are an indispensable part of guiding medical staff to make medical decisions. At the same time, the status of patients as shared decision-making is rising. At present, the results of SR and meta-analysis are mainly presented in the form of effect (relative risk or mean difference) and forest plot. The expression is not intuitive or professional. The process of evidence-based evidence guiding clinical decision-making lags behind, which cannot meet the needs of rapid decision-making. With the continuous progress in artificial intelligence and big data analysis tools, researchers have attempted to introduce visual presentations to improve the timeliness of clinical decision-making. Through the interpretation of the outcomes of SR and meta-analysis, this paper presents different visualization results from the perspective of patients and clinical decision-makers, which not only helps the majority of people without medical background understand clinical evidence more intuitively and participate in the process of clinical decision-making, but also helps improve residents' health literacy, promotes the dissemination and sharing of knowledge, and provides references for further promoting the technology of automatic decision-making system.
Objective The ultimate goal of developing guidelines is for using them in clinical practice. In this study, an implementation evaluation tool was developed to promote the overall evaluation of guidelines and to improve their promotion and implementation. Methods The research group set up a team to formulate and establish a guideline implementation evaluation tool, through preliminary research, interviews, a systematic review of relevant literature, two expert consensus meetings and two Delphi expert consensus meetings to evaluate the guideline implementation tool. Experts were invited to give opinions and grades on the fields, items and overall implementation evaluation method of the tool. Results The evaluation tool for the implementation of guidelines included 5 fields, accessibility, communicability, performability, recognizability and applicability, with a total of 7 items. The scale-level CVIs in two rounds of Delphi expert consensus were 0.91 and 0.93. We collected opinions and suggestions and made some revisions and insertions without deleting any items based on the parameter that no items fulfilled the standard if mean <3.5, coefficient of variation >15% and I-CVI<0.78. Conclusion In this study, in order to provide a standard and method for the evaluation of guideline implementation, a guideline implementation evaluation tool has been developed and evaluated by clinically-related physicians and guideline formulation methodology experts. The guideline implementation evaluation tool presents satisfactory face and content validity. Empirical research is needed to verify the tool’s performance in evaluating guideline implementation.
ObjectiveTo develop the questionnaire and test its reliability for investigating route, prevention, and control of SARS-CoV-2 infection in medical staffs.MethodsThis questionnaire was development based on the COVID-19 relevant guidelines, official documents issued by the National Health Committee of the People's Republic of China, and published studies. The development group performed repeated discussions and drafted the first questionnaire, then performed expert consultation and revised the draft according to their suggestions. Eventually, some frontline medical staffs were invited to carry out pre-test investigation of the questionnaire and test its reliability.ResultsThe first draft included 48 items; 18 experts were invited in the first round questionnaire and 10 experts in the second round questionnaire. The positive coefficient of experts in these two rounds was both greater than 75%, and the authority coefficient of experts' opinions was greater than 0.70. The variation coefficient of these items was between 0.00 and 0.35, the coordination coefficient of experts was 0.193 (P<0.05). The experts of above two rounds put forward 14 suggestions for text modification or adjustment options of some items; after the development group held repeatedly discussions, a total of 8 items were performed secondary consultation and finally reached consensus. The final questionnaire included two domains of questionnaire before and after confirmed diagnosis. The domain "before confirmed diagnosis" covered 4 sections and 29 items involving infectious cause, plan and knowledge of prevention and control, and psychological symptoms. The domain "after confirmed diagnosis" covered 5 sections and 21 items, included symptoms, treatment, and psychological status after diagnosis; impact on the surrounding environment and people, and awareness of protection after infection. The pre-test results showed that the total items were considerably numerous, some items were difficult to understand, some laboratory results and treatment conditions were ambiguous, etc. After modification and re-testing, the test-re-test reliability of each domain was between 0.74 and 0.93, and the overall re-test reliability of the questionnaire content was 0.82.ConclusionsThis research has developed a questionnaire for investigating infection process, prevention and control of SARS-CoV-2 infection in medical staff, and the items considered two domains prior to and after confirmed diagnosis. The reliability and practicability of the questionnaire are acceptable.