title: Reporting of consent rates in critical care studies: room for improvement.
abstract: Reporting of consent rates in published articles is important to determine potential sources of bias and validity and generalizability of results. Our objective was to determine the percentage of critical care studies for which the consent rate was reported.
  
  
  
  We reviewed all articles published in eight medical journals in 2013. Studies meeting the following inclusion criteria were selected: (1) randomized controlled trial (RCT) or observational clinical study, (2) study population involving critically ill patients, and (3) part of the study occurring in an intensive care unit.
  
  
  
  A total of 1,871 articles were screened of which 156 were included. The consent rate was discernable in 30.8% of articles (48/156, 95% confidence interval: 24.1, 38.4) with a median consent rate of 86.9% (interquartile range, 71.6, 94.1). A statement on Research Ethics Board approval was included in 96.8% of studies. There was a significant difference in reporting of consent rates between RCTs and non-RCTs (58.70% vs. 19.09%, P < 0.0001).
  
  
  
  Consent rates are reported in less than one-third of critical care studies. We encourage journals to require reporting of consent rates to improve interpretation, validity, and generalizability of critical care study results.
authors.affiliation: University of Ottawa, 75 Laurier Ave E, Ottawa, Ontario K1N 6N5, Canada.
authors.forename: Avanti
authors.initials: A
authors.lastname: Garde
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Research Building 2, 2nd Floor, Room 2119, Ottawa, Ontario K1H 8L1, Canada.
authors.forename: Katie
authors.initials: K
authors.lastname: O'Hearn
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Research Building 2, 2nd Floor, Room 2119, Ottawa, Ontario K1H 8L1, Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Nicholls
authors.affiliation: Department of Pediatrics, University of Ottawa, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada. Electronic address: menon@cheo.on.ca.
authors.forename: Kusum
authors.initials: K
authors.lastname: Menon
mesh_terms: D035843:Biomedical Research / Q000706:statistics & numerical data*; D003422:Critical Care / Q000379:methods*; D015340:Epidemiologic Research Design; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D058028:Research Report
keywords: Bias; Consent; Consent rate; Critical care; Intensive care unit; Medical ethics