Randomized Controlled Trials For Prevention And Treatment Of Gastric Cancer,2008-2017:Quality Assessment And Bibliometric Analysis

OBJECTIVES: Randomized controlled trials(RCTs)on gastric cancer prevention and treatment published between 2008 and 2017 were retrieved.The methodological quality was evaluated to understand the shortcomings of RCTs in the implementation process,and to analyze the differences of RCTs implemented between China and abroad.Compare and analyze the characteristics of RCTs reported in China and abroad,and analyze the strengths and weaknesses of the reports.Meanwhile,bibliometric analysis was conducted to exploring the research hotspots,and provide help for the design and implementation of RCTs.METHODS: The CNKI,WanFang Data,VIP,PubMed and Web of Science databases were retrieved by computer to obtain literature about RCTs of gastric cancer published in China and abroad from January 1,2008 to December 31,2017.Screening according to the inclusion and exclusion criteria,using the Cochrane risk-of-bias tool to assess the methodological quality of the included RCT original study,and using the CONSORT 2010 to assess the quality of the literature report.Bibliometric analysis was performed to describe the characteristics of these literatures retrieved from the Web of Science Core Collection.RESULTS: Between 2008 and 2017,the related research on randomized controlled trials of gastric cancer in China and abroad showed an overall upward trend.Among them,China,Japan,South Korea,Germany,Italy published the most relevant literature.The sample size of the included studies was positive skewed distribution,with the largest sample included 2361 cases,and the least sampled study included 10 cases,the median sample size is 97.5 and the interquartile range is 60 to 202.The mainly research directions are gastric cancer chemotherapy,perioperative care,surgical procedures,early gastric cancer treatment,and targeted therapy.The evaluation results of methodological quality showed that 46.44% of the studies did not indicate the method of random sequence generation,and only 0.19% of the randomization methods used in the study were unreasonable.Seventy-six percent of the study did not specify specific concealment measures,and 1.5% of the studies described the allocation concealment measures may have a high risk of bias.Nearly 20% of the studies directly reported that there was no blindness.Over 96% of the studies had a lower proportion of missing data;and 77.72% of the studies reported all of the pre-set outcomes.The quality evaluation results of the literature reports showed that the literatures on RCTs published interior and abroad were statistically different in 22 items(P<0.05),such as the title,specific objectives or hypotheses,and eligibility criteria for participants.Bibliometric analysis showed that 6 of the top 10 hospitals were from China,Japan and Korea.The Osaka National Hospital in Japan published the most literature.Nine of the top 10 research institutions in from China,Japan and Korea.Sichuan University and Sun Yat Sen University in China ranked fifth and sixth.The top 10 journals which published the mostly articles are top journals in the field of cancer and surgery.The top 10 literatures which cited mostly are co-authors of researchers from many countries in the world and published in top medical journals.The researchers are mainly in Europe,America,Japan and Korea,and the researchers come from China are less involved.Nine of the top 10 authors who published the most articles were from Japan and South Korea,and Dr.Mitsuru Sasako,ranking number one,from the Hyogo Medical University in Japan participated 35 articles.The results of keywords co-occurrence analysis indicated that gastric cancer researches involving chemotherapy,surgery,lymph node dissection,neoadjuvant chemotherapy,Helicobacter pylori infection,quality of life,etc.;the researcher co-authored network map shows that domestic researchers have less communication with foreign countries.CONCLUSIONS: From 2008 to 2017,the methodologies quality of RCTs for gastric cancer prevention and treatment interior and abroad was high,but the mask and allocation were still lacking.The quality of RCT literature reports in China still has a large gap compared with foreign countries.The RCTs related to the prevention and treatment of gastric cancer interior and abroad are increasing year by year,but there are still a lack of large sample,multi-center RCTs in China.