The evaluation of clinical studies published in Chinese Pediatric Emergency Medicine during 2011 to 2015 according to CONSORT statement

Abstract

Objective To search and evaluate the quality of reports of clinical trial studies published in Chinese Pediatric Emergency Medicine according to CONSORT statement. Methods We collected all articles published in Chinese Pediatric Emergency Medicine from January 1, 2011 to November 31, 2015 through searching the WanFang Database, then evaluated and analyzed clinical trial studies. Results Among all 1 317 articles we retrieved, 62(4.7%)of them belong to clinical trial study.According to CONSORT statement, all the articles satisfied items from 1b to 6b(including abstract, introduction, trial design, participants, interventions and outcomes), only 30(48.4%)and 4(6.5%)articles mentioned item 8a(method used to generate the random allocation sequence)and 8b(type of randomization; details of any restriction), respectively.None of the editors reported item 9(mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned)and 10(who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions). Among 62 included studies, 33(53.2%)studies concentrated on respiratory system diseases.However, studies about nervous system, circulatory system and digestive system were 5(8.1%), 4(6.5%)and 4(6.5%)respectively.Although all the results had statistical significance, only 38(61.3%), 7(11.3%)and 5(8.1%)mentioned randomization, follow-up and blinding respectively.Flow diagram was only included in one(1.6%)article. Conclusion The articles of clinical trial studies published in Chinese Pediatric Emergency Medicine did not take CONSORT statement as reference completely. Key words: CONSORT statement; Pediatric Emergency Medicine; Clinical trial study