title: Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
abstract: OBJECTIVE
  We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.
  
  
  METHODS
  For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.
  
  
  RESULTS
  RCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ(2) (1) = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.
  
  
  CONCLUSIONS
  ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.
authors.affiliation: Agency for Quality and Accreditation in Health Care, Zagreb, Croatia.
authors.forename: Mirjana
authors.initials: M
authors.lastname: Huić
authors.forename: Matko
authors.initials: M
authors.lastname: Marušić
authors.forename: Ana
authors.initials: A
authors.lastname: Marušić
mesh_terms: D015982:Bias; D016208:Databases, Factual; D035081:Editorial Policies; D006801:Humans; D020407:Internet; D010506:Periodicals as Topic / Q000592:standards*; D057766:Policy; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data*; D012042:Registries / Q000592:standards / Q000706:statistics & numerical data*; D058028:Research Report / Q000592:standards*