title: Methodological reporting of randomized trials in five leading Chinese nursing journals.
abstract: BACKGROUND
  Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field.
  
  
  METHODS
  In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0.
  
  
  RESULTS
  In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score.
  
  
  CONCLUSIONS
  The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.
authors.affiliation: Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China; Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China; School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
authors.forename: Chunhu
authors.initials: C
authors.lastname: Shi
authors.affiliation: Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China; Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China; School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
authors.forename: Jinhui
authors.initials: J
authors.lastname: Tian
authors.affiliation: The First Clinical Medicine School, Lanzhou University, Lanzhou, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Ren
authors.affiliation: The Second Clinical Medical School, Lanzhou University, Lanzhou, China.
authors.forename: Hongli
authors.initials: H
authors.lastname: Wei
authors.affiliation: The Second Clinical Medical School, Lanzhou University, Lanzhou, China.
authors.forename: Lihuan
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China; Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China; The First Clinical Medicine School, Lanzhou University, Lanzhou, China.
authors.forename: Quan
authors.initials: Q
authors.lastname: Wang
authors.affiliation: Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China; Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China; School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
authors.forename: Kehu
authors.initials: K
authors.lastname: Yang
mesh_terms: D019983:Guideline Adherence / Q000592:standards; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D009729:Nursing; D010506:Periodicals as Topic / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*; D058028:Research Report / Q000592:standards*