Interpretation of the guidelines for reporting outcomes in trials and its significance and insight for research in the area of traditional Chinese medicine
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials,international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items:Recommendations for Interventional Trials(SPIRIT)2013 and the Consolidated Standards of Reporting Trials(CONSORT)statement 2010.The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports,regardless of trial design or population.This paper introduces and interprets the two guidelines for reporting outcomes,and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine.For example,using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results,which may improve the quality of research design and reporting.For core outcome set,the five core elements of outcomes may help researchers extracting and analyzing outcomes,which will standardize research;the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
OutcomesReporting guidelinesClinical trialsTraditional Chinese medicine
万方数据
维普
