Abstract:
Objective The aim of this report is to make judgment on the safety reporting in randomized controlled trial (RCT) related to breast cancer using Ioannidis checklist and the expanded version of CONSORT statement.
Methods Search the China Knowledge Resource Integrated Database(CNKI), Chinese Biomedical Literature Database(CBM), Chinese Scientific Journals Database (VIP) and the Wanfang data resources, and activities in accordance with the inclusion and exclusion criteria to obtain the RCTs of breast cancer. The quality of included reviews was assessed in accordance with the Ioannidis checklist and the expanded version of CONSORT statement. Based on the degree of conformity with each criterion, the reviews were scored as “1”,“0.5” or “0” orderly. The data were put into Excel, and the RevMan5.0 software was used for statistical analysis.
Results A total of 964 studies were included, and the number of publications was increasing annually. There were 812 (84.2%) studies mentioned adverse reactions or adverse events, the median of CONSORT score was 3 (2.94 ± 1.68); the median of Ioannidis score was 1 (0.94 ± 1.00), and all the entries were lower than 50%. The results of stratified analysis showed that: the difference of Ioannidis score between CSCD and non CSCD was statistical significance (P=0.03), other differences of other stratified factors didn’t have statistical significance(P>0.05).
Conclusion The safety reporting in randomized controlled trial related to breast cancer published of Chinese is not comprehensive enough. That requires authors and editors to supervise and learn with each other, and work together to improve the quality of safety reporting.