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.
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.
ObjectiveTo construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, to determine the weight of indicators, and to provide references for the comprehensive evaluation of the efficacy, safety, and economy of Chinese patent medicines.MethodsTwo rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, and the weight of each indicator was determined by the analytic hierarchy process method.ResultsQuestionnaire recovery rates of 2 rounds were 92.59% and 96.00%, the expert authority coefficient was greater than 0.7, and the coordination coefficients of experts in the total index were 0.224 and 0.370 (P<0.001). A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy, safety, and economy. And there were 15 second-level indicators, and 33 third-level indicators. Through the analytic hierarchy process method, the weights of each first-level indicator were 0.626 4, 0.301 2, and 0.072 4, respectively.ConclusionThe comprehensive evaluation indicator system contains efficacy, safety and economy, and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke. The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke, the conduction of systematic reviews, and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.