title: Quality of reporting on randomized controlled trials on recurrent spontaneous abortion in China.
abstract: BACKGROUND
  Despite increasing numbers of RCTs done in China, detailed information on the quality of Chinese RCTs is still missing. The aim of this study was to assess the reporting quality of RSA RCTs and to identify significant predictors of reporting quality.
  
  
  METHODS
  A literature review was conducted with the aim of identifying published RCTs on RSA conducted in China. In order to rate the report quality, we scored 1 for the item of CONSORT 2010 if it was reported and 0 if it was not stated or unclear. An overall quality score (OQS) with a range of 0-15 and a key methodological index score (MIS) with a range of 0-3 were calculated for each trial.
  
  
  RESULTS
  A total of 98 relevant RCTs were included in the final analysis. The median OQS was 7, with a minimum of 1 and maximum of 12. The general level of OQS was not high, especially among 'sample size,' 'baseline data,' 'outcomes and estimation,' and 'ancillary analyses,' all of which had a positive rate of less than 10%. The median MIS was 1 with a minimum of 0 and maximum of 1. 'Allocation concealment,' 'blinding,' and 'intention-to-treat analysis' were mentioned in 1 (1%), 1 (1%) and 69 (70%) of the studies, respectively. In univariate analysis, funding was the only factor associated with an increased OQS. Specifically, the mean OQS increased by approximately 1.52 for manuscripts supported by funding (95% CI: 0.12 - 2.92; p = 0.03). With regard to the MIS, no association was found for any variable.
  
  
  CONCLUSIONS
  RCTs of RSA conducted in China need improvement in order to meet the level of "reporting quality" required by the CONSORT statement.
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. gjfkts@qq.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Gao
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. denggaopi1@126.com.
authors.forename: Gaopi
authors.initials: G
authors.lastname: Deng
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. fuddyhu@163.com.
authors.forename: Yunyun
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. yxh880904@163.com.
authors.forename: Yanxi
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, Guangdong, China. lulimingleon@126.com.
authors.forename: Liming
authors.initials: L
authors.lastname: Lu
authors.affiliation: Department of Anorectal, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 290335997@qq.com.
authors.forename: Dandan
authors.initials: D
authors.lastname: Huang
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 1653110872@qq.com.
authors.forename: Yadi
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 2275898821@qq.com.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 279752706@qq.com.
authors.forename: Xiaojing
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Anorectal, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 314444858@qq.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Jin
authors.affiliation: Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. luosongping1@126.com.
authors.forename: Songping
authors.initials: S
authors.lastname: Luo
mesh_terms: D000026:Abortion, Habitual / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control; D015706:Bibliometrics; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards*; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic; D018401:Sample Size; D016037:Single-Blind Method; D014956:Writing / Q000592:standards*