Informed consent documents do not encourage good-quality decision making

Journal of Clinical Epidemiology

Volumn 65, Issue 7, 2012, Pages 708-724

  Brehaut, Jamie C ^a   Carroll, Kelly ^a   Elwyn, Glyn ^b   Saginur, Raphael ^a   Kimmelman, Jonathan ^c   Shojania, Kaveh ^d   Syrowatka, Ania ^e   Nguyen, Trang ^e   Hoe, Erica ^a   Fergusson, Dean ^a  

^a UNIVERSITY OF OTTAWA   (Canada)

^b CARDIFF UNIVERSITY   (United Kingdom)

^c MCGILL UNIVERSITY   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e UNIVERSITY OF OTTAWA   (Canada)

Author keywords

Clinical trials; Decision aids; Decision making; Informed consent; Research participants; Trial participation

Indexed keywords

ARTICLE; CLINICAL STUDY; DECISION MAKING; DOCUMENTATION; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; PRIORITY JOURNAL; PROBABILITY; RESEARCH SUBJECT; SAMPLING; STANDARD; VALIDATION PROCESS;

ALGORITHMS; CANADA; CLINICAL TRIALS AS TOPIC; CONSENT FORMS; DECISION MAKING; HUMANS; INFORMED CONSENT; PATIENT SELECTION;

EID: 84861618707     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2012.01.004     Document Type: Article

References (54)

1. J. Bergler, A. Pennington, M. Metcalfe, and E. Freis Informed consent: how much does the patient understand? Clin Pharmacol Ther 27 1980 435 440
2. C. Daugherty, D. Banik, L. Janish, and M. Ratain Quantitative analysis of ethical issues in phase 1 trials: a survey interview of 144 advanced cancer patients IRB 22 2000 6 14
3. C. Miller, and H.R. Searight Comprehension and recall of the informational content of the informed consent document: an evaluation of 168 patients in a controlled clinical trial J Clin Res Drug Dev 8 1994 237 248
4. M.P. Preziosi, A. Yam, M. Ndiaye, A. Simaga, F. Simondon, and S.G. Wassilak Practical experiences in obtaining informed consent for a vaccine trial in rural Africa N Engl J Med 336 1997 370 373
5. M. van Stuijvenberg, M.H. Suur, S. de Vos, G.C. Tjiang, E.W. Steyerberg, and G. Derksen-Lubsen Informed consent, parental awareness, and reasons for participating in a randomised controlled study Arch Dis Child 79 1998 120 125
6. C. Daugherty, T. Kiolbasa, M. Sieger, and Ratain M.J. Informed Consent (IC) in clinical research: a study of cancer patient (pt) understanding of consent forms and alternatives of care in phase I clinical trials [Meeting abstract; No 188] Am Soc Clin Oncol 1997
7. T.C. Davis, R.F. Holcombe, H.J. Berkel, S. Pramanik, and S.G. Divers Informed consent for clinical trials: a comparative study of standard versus simplified forms J Natl Cancer Inst 90 1998 668 678
8. H.W. Riecken, and R. Ravich Informed consent to biomedical research in Veterans Administration hospitals JAMA 248 1982 344 348
9. M.V. Williams, R.M. Parker, D.W. Baker, N.S. Parikh, K. Pitkin, and W.C. Coates Inadequate functional health literacy among patients at two public hospitals JAMA 274 1995 1677 1682
10. S.A. Grossman, S. Piantadosi, and C. Covahey Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 12 1994 2211 2215
11. K.D. Hopper, T.R. TenHave, and J. Hartzel Informed consent forms for clinical and research imaging procedures: how much do patients understand? AJR Am J Roentgenol 164 1995 493 496
12. T.J. Mader, and S.J. Playe Emergency medicine research consent form readability assessment Ann Emerg Med 29 1997 539
13. G.R. Morrow How readable are subject consent forms? JAMA 244 1980 56 58
14. R.D. Powers Emergency department patient literacy and the readability of patient-directed materials Ann Emerg Med 17 1988 124 126
15. The Personal Information Protection and Electronic Documents Act. Available at http://laws-lois.justice.gc.ca/eng/acts/P-8.6/index.html. Accessed May 9, 2011.
16. Health Insurance Portability and Accountability Act (HIPAA). Available at http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html. Accessed Feb 21st, 2012.
17. P. Breese, W. Burman, C. Rietmeijer, and D. Lezotte The Health Insurance Portability and Accountability Act and the Informed Consent Process Ann Intern Med 141 2004 897 898
18. D. Shalowitz, and D. Wendler Informed Consent for Research and Authorization under the Health Insurance Portability and Accountability Act Privacy Rule: an Integrated Approach Ann Intern Med 144 2006 685 688
19. J. Flory, and E. Emmanuel Interventions to improve research participants' understanding in informed consent for research: a systematic review JAMA 292 2004 1593 1601
20. J.C. Brehaut, D.A. Fergusson, J. Kimmelman, K.G. Shojania, R. Saginur, and G. Elwyn Using decision aids may improve informed consent for research Contemp Clin Trials 31 2010 218 220
21. M. Eccles, J. Grimshaw, A. Walker, M. Johnston, and N. Pitts Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings J Clin Epidemiol 58 2005 107 112
22. A.M. O'Connor, D. Stacey, V. Entwistle, H. Llewellyn-Thomas, D. Rovner, and M. Holmes-Rovner Decision aids for people facing health treatment or screening decisions The Cochrane Library 1 2003 CD001431
23. HealthLink BC BC HealthGuide Handbook. Available at http://www. healthlinkbc.ca/healthguide.stm. Accessed June 17, 2011.
24. Blue Ribbon Commission on Health Care Costs and Access: Implementing Recommendations. Senate Bill 5930; 2007.
25. A.M. O'Connor, A.G. Mulley, and J.E. Wennberg Standard consultations are not enough to ensure decision quality regarding preference-sensitive options J Natl Cancer Inst 95 2003 570 571
26. G. Elwyn, A. O'Connor, D. Stacey, R. Volk, and A.C.A. Edwards Developing a quality criteria framework for patient decision aids: online international Delphi consensus process BMJ 333 2006 417
27. G. Elwyn, A.M. O'Connor, C. Bennett, R.G. Newcombe, M. Politi, and M.A. Durand Assessing the quality of decision support technologies using the International Patient Decision Aid Standards instrument (IPDASi) PLoS ONE 4 2009 e4705
28. International Patient Decision Aids Standards (IPDAS) Collaboration. International Patient Decision Aid Standards (IPDAS) Collaboration Background Document. In: O'Connor AM, Llewellyn-Thomas H, Stacey D, editors; 2005. Available at http://ipdas.ohri.ca/IPDAS-Background.pdf. Accessed June 17, 2011.
29. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2010.
30. A. Edwards, G. Elwyn, and A. Mulley Explaining risks: turning numerical data into meaningful pictures BMJ 324 2002 827 830
31. H.T. Stelfox, G. Chua, K. O'Rourke, and A.S. Detsky Conflict of interest in the debate over calcium-channel antagonists N Engl J Med 338 1998 101 106
32. D.E. Barnes, and L.A. Bero Why review articles on the health effects of passive smoking reach different conclusions JAMA 279 1998 1566 1570
33. I. Albala, M. Doyle, and P.S. Appelbaum The evolution of consent forms for research: a quarter century of changes IRB 32 2010 7 11
34. General Medical Council. Consent: patients and doctors making decisions together. Available at http://www.gmc-uk.org/guidance/ethical-guidance/consent- guidance-index.asp. Accessed June 17, 2011.
35. Food and Drug Administration. A guide to Informed Consent-Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators. Available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm. Accessed June 17, 2011.
36. J. Brehaut, R. Saginur, and G. Elwyn Informed consent documentation necessary but not sufficient Contemp Clin Trials 30 2009 388 389
37. E.A. Akl, A.D. Oxman, J. Herrin, G.E. Vist, I. Terrenato, and F. Sperati Using alternative statistical formats for presenting risks and risk reductions Cochrane Database Syst Rev 3 2011 CD006776
38. K.J. Jorgensen, and P.C. Gotzsche Presentation on websites of possible benefits and harms from screening for breast cancer: cross sectional study BMJ 328 2004 148
39. Bohmer RM, Sepucha K. Shared decision-making. N9-604-0012003.
40. D. Feldman-Stewart, M.D. Brundage, L. Van Manen, and O. Svenson Patient-focused decision-making in early-stage prostate cancer: insights from a cognitively based decision aid Health Expect 7 2004 126 141
41. Code of Federal Regulations for the Protection of Human Subjects in Research: General Requirements for Informed Consent. 45 CFR 46.116. Code of Federal Regulations, 2009.
42. Health Canada. Good Clinical Practice: Consolidated Guidelines, International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1996. Available at http://www.hc-sc.gc.ca/dhp-mps/alt-formats/hpfb-dgpsa/pdf/prodpharma/e6-eng.pdf. Accessed April 7, 2011.
43. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement. Ethical Conduct for Research Involving Humans. 1998.
44. National Cancer Institute. Simplification of Informed Consent Documents. Available at http://www.cancer.gov/clinicaltrials/education/simplification-of- informed-consent-docs/page2. Accessed May 9, 2011.
45. G.F. Loewenstein, E.U. Weber, C.K. Hsee, and N. Welch Risk as feelings Psychol Bull 127 2001 267 286
46. L.M. Schwartz, S. Woloshin, and H.G. Welch Risk communication in clinical practice: putting cancer in context J Natl Cancer Inst Monographs 25 1999 124 133
47. S. Woloshin, L.M. Schwartz, S. Byram, B. Fischhoff, and H.G. Welch A new scale for assessing perceptions of chance: a validation study Med Decis Making 20 2000 307
48. S. Woloshin, L.M. Schwartz, and H.G. Welch Risk charts: putting cancer in context J Natl Cancer Inst 94 2002 799 804
49. A. Tversky, and D. Kahneman The framing of decisions and the psychology of choice Science 211 1981 453 458
50. J.A. Skolbekken Communicating the risk reduction achieved by cholesterol reducing drugs BMJ 316 1998 1956 1958
51. P. Abhyankar, H.L. Bekker, B.A. Summers, and G. Velikova Why values elicitation techniques enable people to make informed decisions about cancer trial participation Health Expect 14 2011 20 32
52. N.K. Aaronson, E. Visser-Pol, G.H. Leenhouts, M.J. Muller, A.C. van der Schot, and F.S. van Dam Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials J Clin Oncol 14 1996 984 996
53. S.J. Edwards, R.J. Lilford, J. Thornton, and J. Hewison Informed consent for clinical trials: in search of the "Best" Method Soc Sci Med 47 1998 1825 1840
54. D.B. Resnik Do informed consent document matter? Contemp Clin Trials 30 2009 114 115