Literature Analysis of Outcome Indicators of Randomized Controlled Trials for the Treatment of Acute Coronary Syndrome from"Toxin"
Objective:To evaluate the selection of outcomes in randomized controlled trials(RCTs) for the treatment of acute coronary syndrome(ACS) from "toxin",to provide reference for future related studies and the establishment of core outcome indicator data sets. Methods:Keywords such as "toxicity","coronary heart disease" and "acute coronary syndrome" were used to search the Chinese and English databases,and references were screened according to the preset exclusion criteria.Cochrane risk bias assessment tool was used to evaluate the quality of the included literatures.Qualitative analysis and outcome index classification were used for statistical analysis.Results:A total of 4206 literatures were initially retrieved,with 58 were in Chinese.All 58 RCTs included reported effective outcome measures.The Corhrane bias risk assessment tool showed that the majority of generation of random sequences,allocation concealment,and blinding of researchers and subjects were assessed as unclear bias risk. The majority of terms of blinding of outcome assessors were assessed as high bias risk.The majority of terms of completeness of outcome data,selective reporting,and other biases were assessed as low bias risk.Fifty-eight RCTs involved 5172 patients,with an average sample size of about 89 cases. A total of 108 outcome indicators were obtained,with a total frequency of 337 times.The outcome indicators of a single RCT were at least 2 and up to 15,with an average of about 6,which were mainly summarized as clinical efficacy,symptoms and signs,physical and chemical detection,quality of life,safety,and long-term prognosis indicators.Conclusion:The overall bias risk of RCTs for the treatment of acute coronary syndrome with Chinese medicine for invigorating blood and resolving toxins was not clear,with a wide range of outcome indicators,obvious differences in the number of choices,lack of priority,different methods,uncertain time points and lack of traditional Chinese medicine "disease and evidence combination" features.
acute coronary syndromeinvigorating blood and resolving toxinsrandomized controlled trialsoutcome indexcore outcome set