title: Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics.
abstract: OBJECTIVE
  Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials.
  
  
  METHODS
  Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication.
  
  
  RESULTS
  82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals.
  
  
  CONCLUSIONS
  Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs.
authors.affiliation: Department of Emergency Medicine, University of Calgary, Calgary, Alberta, Canada. Andrew.McRae@albertahealthservices.ca
authors.forename: Andrew
authors.initials: A
authors.lastname: McRae
authors.forename: Monica
authors.initials: M
authors.lastname: Taljaard
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
authors.forename: Carol
authors.initials: C
authors.lastname: Bennett
authors.forename: Zoe
authors.initials: Z
authors.lastname: Skea
authors.forename: Robert
authors.initials: R
authors.lastname: Boruch
authors.forename: Jamie
authors.initials: J
authors.lastname: Brehaut
authors.forename: Martin
authors.initials: M
authors.lastname: Eccles
authors.forename: Jeremy
authors.initials: J
authors.lastname: Grimshaw
authors.forename: Allan
authors.initials: A
authors.lastname: Donner
mesh_terms: D032984:Ethics, Research; D006302:Health Services Research / Q000941:ethics* / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D055811:Journal Impact Factor; D016015:Logistic Models; D015999:Multivariate Analysis; D016017:Odds Ratio; D010506:Periodicals as Topic; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods; D012107:Research Design; D058028:Research Report