Based on the existing clinical research of pediatric Tuina, this paper introduced the current types of pediatric Tuina and their applications in the aspect of growth of newborn babies, emotion problems, pain, respiratory system diseases, digestive system diseases, jaundice, brain and nerve system diseases. As for the clinical researches of pediatric Tuina, the authors found the challenges including different understandings of pediatric Tuina, poor quality of clinical researches, and lack of basic data regarding pediatric Tuina. Meanwhile, the authors suggested three corresponding strategies to improve the clinical researches, i.e. to extract valuable intervention methods based on clinical practice; to conduct high quality clinical studies; to gradually collect and accumulate basic data according to a certain plan.
Interpretation of results of clinical research should not only focus on statistical significance (P value less than 0.05) but also clinical significance. The minimal clinically significance difference (MCID) assists to answer the question with the results being clinically significant. In addition, MCID plays an important role in evidence assessment during clinical guideline development, sample size estimation for clinical trials, and clinical decision-making. This paper primarily introduces the terminology and definition of MCID and four common methods used to estimate MCID.
Propensity score methods belong to an analytical approach by incorporating the measured covariates and mimicking randomization to enhance the comparability between groups, hence reducing the impact of potential confounding in observational studies. Propensity score methods have been increasingly used in observational studies. This paper illustrates the principle and the methods based on the propensity score, in combination with its application in observational studies. It also compares results from propensity score methods with those from multivariable regression and randomized controlled trials. It was found that currently there has been a lack of recommendations for the selection of propensity score methods. Differences may exist when comparing results from propensity score methods with findings from typical regression analyses and randomized controlled trials.
In medical research, pilot and feasibility studies are conducted to reduce the uncertainty of future main trial and enhance its overall quality and probability of successful completion. The objective of a pilot and feasibility study is to answer whether the main trial can be performed, should be performed, and if so, how. Due to the tremendous resources, time, and funding required for a phase Ⅲ clinical trial, conducting a pilot and feasibility study is generally a pivotal step. While pilot and feasibility studies are gaining increasing attention in clinical research, efforts are largely required to promote the dissemination in China. Therefore, in this article, we briefly introduce the concepts of a pilot and feasibility study, its importance to the main trial, and current practice. Examples are also provided to help illustrate the introduction.
Objective To analyze and evaluate the present status of application of clinical pathway evaluation indexes in China, in order to provide references to establish an evaluation system on clinical pathway. Methods Such databases as CBM (2004-2009), VIP (2004-2009), CNKI (2004-2009) and WanFang Data (2004-2009), and some relevant websites were searched systematically for collecting Chinese literature about domestic clinical pathway evaluation indexes. Results Among the 1 175 articles included, 135 (11%) were published in the core periodicals, 19 (2%) were masterate theses, and 1 021 were other kinds of articles. As to 135 core periodical literature and 19 masterate theses, most of which were graded into the second level of evidence, accounting for 96%. The analysis on the appearance of indexes showed that 87% of inconsistency could be identified between the contents and terms of indexes. Common indexes were summarized as the following four aspects: cost index, clinical index, serving index and quality evaluation index. There were 78% of all the 1 175 articles focusing on the application of nursing and medical education, in which only one masterate thesis used social research methods such as Delphi, focus group, experts scoring (percentile), etc. Conclusion Currently, there are some issues existing in the evaluation indexes of clinical pathway in China, such as low methodological quality of literature, irregularly and randomly using statistical terms, and lack of studies on system construction of clinical pathway evaluation indexes.
Objective To define an objective evaluation model for metadata integrity of randomized controlled trials (RCTs) in traditional Chinese medicine (TCM), and to evaluate the data integrity of RCT reports published in TCM journals. Methods Retrieving Chinese medicine RCT literature and extracting data, using the metadata specification list and customized evaluation model defined in the project "Intelligent Construction and Application Demonstration of the Evidence System of Chinese Medicine Dominant Diseases" to analyze RCTs from the perspective of data integrity. Results A metadata interface specification and an objective evaluation model for RCT metadata integrity were proposed. A total of 37 361 articles of 10 diseases from 1986 to 2020 were evaluated. Among them, 6 743 reports failed to meet the basic requirements of metadata specifications. The proportion of reports with no missing required items was between 73% and 97%. "tcm_disease" and "num_drop_total" had a greater impact on completeness for the required items. The reporting rates of the items in the "age_sd" and "history_sd" in the "group" section, and "dosage", "dosage_form" and "dosage_freq" in the "interventions" section were low. The average score of RCT report was 71.39 points. Conclusions There is room for improvement in the integrity of RCT data in TCM, and data reporting is urgently required to be standardized. The metadata specification and completeness objective evaluation model proposed in this study can provide references for improving the data integrity of clinical trial reports of TCM.
ObjectiveTo compare the clinical effectiveness of Chinese medicine and integrated Chinese medicine and antimicrobial drugs in the treatment of pneumonia. MethodsThe electronic medical record (EMR) of patients with pneumonia who admitted to the Classical Department of Chinese Medicine of Guangdong Hospital of Traditional Chinese Medicine from November 29, 2012 to June 17, 2022 were retrospectively collected. The patients were divided into two groups according to whether they were treated with antimicrobial drugs on the basis of Chinese medicine treatment. The non-exposed group was the traditional Chinese medicine group, and the exposed group was the integrated Chinese medicine and antimicrobial drugs group. Propensity score matching method was used to balance possible confounding factors. COX regression analysis was performed on the matched cohort to compare death rates among the groups, and Kaplan-Meier curve was drawn to evaluate the survival probability during hospitalization. The proportion of maximum oxygen concentration and duration of fever remission were compared between the two groups. ResultsThis study included a total of 898 cases, with the majority (over 95%) falling within the range of mild to moderate severity. After propensity score matching,180 patients were remained in each group, among which the baseline characteristics were comparable. The primary outcome indicators showed that the risk of death during hospitalization was same in the integrated Chinese medicine and antimicrobial drugs group and in the Chinese medicine group (HR=1.52, 95%CI 0.36 to 6.39, P=0.566), the subgroup analysis is consistent with the overall trend of the results, and the differences were not statistically significant. The results indicate that during the hospitalization, the overall and subgroup mortality rates were similar between the two groups. The treatment effectiveness on the disappearance of major symptoms such as fever, cough, sputum production, fatigue, shortness of breath, and chest pain were comparable in both groups. The secondary outcome indicators showed that there was no statistical significance in the comparison of the proportion of maximum oxygen therapy concentration and the stable duration of fever remission between the two groups. ConclusionIn the treatment of patients with mainly mild to moderate pneumonia, the effectiveness of the Chinese medicine group and the integrated Chinese medicine and antimicrobial drugs group in the hospitalization mortality, the disappearance of major symptoms, the proportion of maximum oxygen therapy concentration and the stable duration of fever remission are similar. Chinese medicine has a positive significance in reducing the use of antimicrobials in patients with pneumonia.
Objective To enhance medical quality evaluation by conducting a systematic review and evidence-based synthesis of relevant research. Methods Such databases as CBM (1978 to 2009), VIP (1989 to 2009), CNKI (1990 to 2009), WanFang Dissertation database (1997 to 2009), and relevant websites were searched to identify relevant Chinese studies for the synthetical evaluation on methods evaluating medical quality. Results A total of 216 articles including 184 observational studies, 29 traditional reviews, and 3 experts’ opinions were identified. Twenty-one synthetical evaluation methods were used among 216 articles, and the top three methods which had been quoted more than 30 times were: RSR (19.72%), TOPSIS method (19.03%), and comprehensive index (12.80%). Among the 184 observational research papers, the documents using one kind of comprehensive evaluation took up 89.13% (164/184), the ones using two kinds of evaluation methods accounted for 9.78% (18/184), and those using three kinds of methods accounted for 1.09% (2/184). Conclusion a) The joint use of two or more than two methods is not common. The majority of studies using single comprehensive evaluation method focus on RSR, TOPSIS and comprehensive index method; b) The comprehensive evaluation method is considered non-uniform, some not even standardized; c) Most of the medical literatures do not correct the value of quality assessment; and d) Considerably most studies perform retrospective evaluation with historical data.
It is a complex and time-consuming process to rate the certainty (quality) of evidence from network meta-analysis. This paper aims to introduce a web application for rating the certainty of network meta-analysis-the CINeMA. CINeMA is based on GRADE framework and contribution matrix of network meta-analysis, which considers 6 domains including within-study bias, across-studies bias, indirectness, imprecision, heterogeneity, and incoherence.
In 2014, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group published guidance in BMJ to evaluate the certainty of the evidence (confidence in evidence, quality of evidence) from network meta-analysis. GRADE working group suggested rating the certainty of direct evidence, indirect evidence, and network evidence, respectively. Recently, GRADE working group has published a series of papers to improve and supplement this approach. This paper introduces the frontiers and advancement of GRADE approach to rate the certainty of evidence from network meta-analysis.