1.Integration of clinical significance and statistical significance on clinical study results categorization: a Meta-epidemiology study
Yang WANG ; Xinyue LANG ; Yibing ZHU ; Xiaoyun LIU ; Yanyan ZHAO ; Sidong LI ; Wei LI
Chinese Journal of Epidemiology 2021;42(7):1280-1285
Objective:Statistical significance plays an important role in the interpretation of clinical trial results. However, on the basis of obtaining statistical significance, the assessment of clinical significance is often neglected. This study attempted to propose a simple and unambiguous new classification method for study results, focusing on studies with statistical positive findings to evaluate whether the results have clinical significance.Methods:Our study subjects were the clinical studies in 2019 ACC and ESC annual meetings. Meta-epidemiology methods were used to extract the characteristic variable from each study. The primary evaluation indicators included target effect-size and observed effect-size. Based on the difference between the two indicators, the studies that had statistical significance were subdivided to identify studies with possible insufficient clinical significance; Furthermore, the theoretical threshold based on power analysis was proposed, which was used as the basis for the interpretation of study results.Results:There were 12 clinical studies included in the final analysis. All of them were published on top journals. Those studies had relative high quality on both study design and reporting. The correlation coefficient between the observed and target effect-size was 0.892. Among the 7 studies with statistical significance, two of them were classified as insufficient clinical significance. The counts was 1 (1/3) and 1 (1/4) for the studies reported in ACC and ESC respectively.Conclusions:The achievement of clinical significance is critical even in the study with positive results. This paper proposes a new classification standard that combines clinical significance with statistical significance and further suggests a method to evaluate the reliability of clinical study results in order to assist researchers in identifying potential risks caused by insufficient clinical significance, and provide some reference and help for the reasonable interpretation of clinical study results.
2.Research on Evaluation Methods for the Scientific and Technological Influence of Cardiovascular Disease in China and in the World
Jun HAO ; Xinyue LANG ; Yang WANG ; Yeding CAO ; Wei LI
Chinese Circulation Journal 2024;39(3):279-284
Objectives:To evaluate the application of several comprehensive evaluation methods in the evaluation of scientific and technological impact of cardiovascular disease. Methods:According to the comprehensive evaluation system of global and China's scientific and technological influence and the weights,the standardized processing method,the extreme value processing method,the rank evaluation method,and the hierarchical multi-dimensional comprehensive evaluation method were used to evaluate the scientific and technological influence in cardiovascular diseases from 2016 to 2021. Results:The results of the four evaluation methods were consistent.The results of the standardized processing method and the extreme value processing method were similar.The rank evaluation method has a high similarity with the hierarchical multi-dimensional index comprehensive evaluation method.The hierarchical multi-dimensional index comprehensive evaluation can better highlight the importance of high-quality scientific and technological achievements. Conclusions:The hierarchical multi-dimensional index comprehensive evaluation is a comprehensive evaluation process that integrates the hierarchical index system,the echelon evaluation rules and the rank evaluation method.It can highlight the high-quality scientific and technological achievements and respond to the orientation of the classified and multi-dimensional evaluation of scientific and technological achievements.It is operable and generalizable,and provides a certain reference for the comprehensive evaluation practice of domestic medical institutions.