title: Elements of informed consent and decision quality were poorly correlated in informed consent documents.
abstract: OBJECTIVE
  Although informed consent (IC) documents must contain specific elements, inclusion of these elements may be insufficient to encourage high-quality decision making. We assessed the extent to which documents conform to IC standards and how well conformity to decision quality (DQ) standards can be predicted by IC standards, IC document characteristics, and study characteristics.
  
  
  METHODS
  We obtained 139 IC documents for trials registered with ClinicalTrials.gov from study investigators. Using a four-point scale, two raters independently assessed each IC document on 36 IC standard items and 9 DQ items.
  
  
  RESULTS
  Overall agreement between raters across all 45 items was 93%. Across the 36 IC standards items, conformity was generally quite high but variable, with 20 items showing conformity of 80% or more and seven items showing conformity of 50% or lower. IC standards concordance, overall length of the IC document, and country of study were all significant predictors of DQ standards but together accounted for less than 20% of the variance in DQ standards.
  
  
  CONCLUSIONS
  Conformity to recommendations for improving IC documents was relatively high but variable. The extent to which an IC document conformed to these recommendations was only moderately related to whether it conformed to recommendations for improving DQ. Existing IC regulations may not describe the optimal approach to helping people make good study participation decisions.
authors: Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada K1H 8M5. Electronic address: jbrehaut@ohri.ca.
authors: Jamie C
authors: JC
authors: Brehaut
authors: Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6.
authors: Kelly
authors: K
authors: Carroll
authors: The Dartmouth Center for Health Care Delivery Science and The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, 37 Dewey Field Road, Hanover, NH 03755, USA.
authors: Glyn
authors: G
authors: Elwyn
authors: Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, Ontario, Canada K1Y 4E9.
authors: Raphael
authors: R
authors: Saginur
authors: Biomedical Ethics Unit, McGill University, 3647 Peel Street, Montreal, Quebec, Canada H3A 1X1.
authors: Jonathan
authors: J
authors: Kimmelman
authors: Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto Centre for Patient Safety, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5.
authors: Kaveh
authors: K
authors: Shojania
authors: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec, Canada H3A 1A2.
authors: Ania
authors: A
authors: Syrowatka
authors: Population Health Modeling, Social Determinants and Science Integration Directorate, Public Health Agency of Canada, 785 Carling Ave, Ottawa, Ontario, Canada K1A 0K9.
authors: Trang
authors: T
authors: Nguyen
authors: Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6.
authors: Dean
authors: D
authors: Fergusson
mesh_terms: D002986:Clinical Trials as Topic; D003657:Decision Making; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000592:standards*; D012042:Registries; D014481:United States
keywords: Clinical trials; Decision quality; Decision support; Informed consent; Research participants; Trial participation