title: Secular changes in the quality of published randomized clinical trials in rheumatology.
abstract: OBJECTIVE
  To assess the quality of published randomized clinical trials (RCTs) in rheumatology and to determine whether there has been improvement in quality between 2 time periods, 1987-1988 and 1997-1998.
  
  
  METHODS
  Using MEDLINE and a hand search of selected rheumatology journals, we identified RCTs of adult rheumatic diseases published in English in 1987-1988 or 1997-1998. We examined trial quality with an expanded version of the Jadad scale, which assesses the adequacy of reported random sequence generation, allocation concealment, blinding, and analysis. All trials were read by 1 reviewer, with prior standardization using a random sample read by 2 reviewers. We also evaluated "high"- versus "low"-impact journals based on citation index.
  
  
  RESULTS
  Two hundred forty RCTs (1987-1988 119 RCTs, 1997-1998 121 RCTs) were assessed. Results showed improvement in the quality of the trials, but the rates of reported random sequence generation, allocation concealment, power, and intent-to-treat analyses were persistently low. Low rates of reports of random sequence generation, allocation concealment, and intent-to-treat analyses were present even in the high-impact journals.
  
  
  CONCLUSIONS
  There has been improvement in the quality of reporting of RCTs in rheumatology between 1987-1988 and 1997-1998. However, methodologic problems such as lack of allocation concealment, inadequate random sequence generation, lack of reporting of power, and lack of intent-to-treat analyses remain common. Many of these problems are established sources of bias in RCTs and are easily rectifiable.
authors.affiliation: Boston University Arthritis Center, Boston, Massachusetts, USA. Catherine.Hill@nwahs.sa.gov.au
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Hill
authors.forename: Michael P
authors.initials: MP
authors.lastname: LaValley
authors.forename: David T
authors.initials: DT
authors.lastname: Felson
mesh_terms: D006801:Humans; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012219:Rheumatology / Q000592:standards*