1. Schenker Y, Fernandez A, Sudore R, et al. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making 2011;31:151–73 [PMC free article] [PubMed] [Google Scholar] 2. Schloendorff v. Society of New York Hospital. Vol. 211 N.Y. 125, 105 N.E. 921914. 3. Berg JW, Appelbaum P, Lidz C, et al. The legal requirements for disclosure and consent: History and current status. In: Informed consent: legal theory and clinical practice. 2nd ed New York (NY): Oxford University Press; 2001. p. 41–74 [Google Scholar] 4. Canterbury v. Spence. Vol. 464 F.2d 772D.C. Cir. 1972. 5. Grisso T, Appelbaum P. Abilities related to competence. In: Assessing competence to consent to treatment: a guide for physicians and other health professionals. New York (NY): Oxford University Press; 1998. p. 31–60 [Google Scholar] 6. Berg JW, Appelbaum P, Lidz C, et al. Informed consent: legal theory and clinical practice. 2nd ed New York (NY): Oxford University Press; 2001. p. 41–70, 130–43 [Google Scholar] 7. The Joint Commission Standard R1.01.03.01. 2009 hospital accreditation standards. Oakbrook Terrace (IL): The Commission; 2009 [Google Scholar] 8. Lloyd A, Hayes P, Bell P. The role of risk and benefit perception in informed consent for surgery. Med Decis Making 2001;21: 141–9 [PubMed] [Google Scholar] 9. Leeb D, Bowers DG, Jr, Lynch JB. Observations on the myth of “informed consent.” Plast Reconstr Surg 1976;58:280–2 [PubMed] [Google Scholar] 10. Lavelle-Jones C, Byrne DJ, Rice P, et al. Factors affecting quality of informed consent. BMJ 1993;306:885–90 [PMC free article] [PubMed] [Google Scholar] 11. Hutson MM, Blaha JD. Patients’ recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg Am 1991;73:160–2 [PubMed] [Google Scholar] 12. Lashley M, Talley W, Lands LC, et al. Informed proxy consent: communication between pediatric surgeons and surrogates about surgery. Pediatrics 2000;105:591–7 [PubMed] [Google Scholar] 13. Tait AR, Voepel-Lewis T, Malviya S. Do they understand? (part II): assent of children participating in clinical anesthesia and surgery research. Anesthesiology 2003;98:609–14 [PubMed] [Google Scholar] 14. Morgan LW, Schwab IR. Informed consent in senile cataract extraction. Arch Ophthalmol 1986;104:42–5 [PubMed] [Google Scholar] 15. Hekkenberg RJ, Irish JC, Rotstein LE, et al. Informed consent in head and neck surgery: How much do patients actually remember? J Otolaryngol 1997;26:155–9 [PubMed] [Google Scholar] 16. Herz DA, Looman JE, Lewis SK. Informed consent: Is it a myth? Neurosurgery 1992;30:453–8 [PubMed] [Google Scholar] 17. Reading AE. Psychological preparation for surgery: patient recall of information. J Psychosom Res 1981;25:57–62 [PubMed] [Google Scholar] 18. Robinson G, Merav A. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 1976;22:209–12 [PubMed] [Google Scholar] 19. Newton-Howes PAG, Dobbs B, Frizelle F. Informed consent: What do patients want to know? N Z Med J 1998;111:340–2 [PubMed] [Google Scholar] 20. Dawes PJ, Davison P. Informed consent: What do patients want to know? J R Soc Med 1994;87:149–52 [PMC free article] [PubMed] [Google Scholar] 21. Courtney MJ. Information about surgery: What does the public want to know? ANZ J Surg 2001;71:24–6 [PubMed] [Google Scholar] 22. Bowden MT, Church CA, Chiu AG, et al. Informed consent in functional endoscopic sinus surgery: the patient’s perspective. Otolaryngol Head Neck Surg 2004;131:126–32 [PubMed] [Google Scholar] 23. Dawes PJ, O’Keefe L, Adcock S. Informed consent: using a structured interview changes patients’ attitudes towards informed consent. J Laryngol Otol 1993;107:775–9 [PubMed] [Google Scholar] 24. Sulmasy DP, Lehmann LS, Levine DM, et al. Patients’ perceptions of the quality of informed consent for common medical procedures. J Clin Ethics 1994;5:189–94 [PubMed] [Google Scholar] 25. Chan EC, Sulmasy DP. What should men know about prostate-specific antigen screening before giving informed consent? Am J Med 1998;105:266–74 [PubMed] [Google Scholar] 26. Wisselo TL, Stuart C, Muris P. Providing parents with information before anaesthesia: What do they really want to know? Paediatr Anaesth 2004;14:299–307 [PubMed] [Google Scholar] 27. Hibbard JH, Slovic P, Jewett JJ. Informing consumer decisions in health care: implications from decision-making research. Milbank Q 1997;75:395–414 [PMC free article] [PubMed] [Google Scholar] 28. Gilbert DT, Wilson TD. Miswanting: some problems in the forecasting of future affective states. In: Forgas JP, editor. Feeling and thinking: the role of affect in social cognition. New York (NY): Cambridge University Press; 2000. p. 178–200 [Google Scholar] 29. Schneider CE. The practice of autonomy: patients, doctors, and medical decisions. New York (NY): Oxford University Press; 1998. p. 35–75, 92–9 [Google Scholar] 30. Simmons RG, Marine SK, Simmons RL. Gift of life: the effect of organ transplantation on individual, family and societal dynamics: New Jersey (NY): Transaction Publishers; 1987. p. 244–50 [Google Scholar] 31. Fellner CH, Marshall JR. Kidney donors — the myth of informed consent. Am J Psychiatry 1970;126:1245–51 [PubMed] [Google Scholar] 32. Pierce PF. Deciding on breast cancer treatment: a description of decision behavior. Nurs Res 1993;42:22–8 [PubMed] [Google Scholar] 33. Nisbett R, Ross L. Human inference: strategies and shortcoming of social judgment. Englewood Cliffs (NJ): Prentice-Hall; 1980 [Google Scholar] 34. McKneally MF, Ignagni E, Martin DK, et al. The leap to trust: perspective of cholecystectomy patients on informed decision making and consent. J Am Coll Surg 2004;199:51–7 [PubMed] [Google Scholar] 35. McKneally MF, Martin DK. An entrustment model of consent for surgical treatment of life-threatening illness: perspective of patients requiring esophagectomy. J Thorac Cardiovasc Surg 2000;120:264–9 [PubMed] [Google Scholar] 36. Dixon-Woods M, Williams SJ, Jackson CJ, et al. Why do women consent to surgery, even when they do not want to? An interactionist and Bourdieusian analysis. Soc Sci Med 2006;62:2742–53 [PubMed] [Google Scholar] 37. Habiba M, Jackson C, Akkad A, et al. Women’s accounts of consenting to surgery: Is consent a quality problem? Qual Saf Health Care 2004;13:422–7 [PMC free article] [PubMed] [Google Scholar] 38. Akkad A, Jackson C, Kenyon S, et al. Informed consent for elective and emergency surgery: questionnaire study. BJOG 2004;111: 1133–8 [PubMed] [Google Scholar] 39. Akkad A, Jackson C, Kenyon S, et al. Patients’ perceptions of written consent: questionnaire study. BMJ 2006;333:528. [PMC free article] [PubMed] [Google Scholar] 40. Degner LF, Sloan JA. Decision-making during serious illness: What role do patients really want to play? J Clin Epidemiol 1992;45:941–50 [PubMed] [Google Scholar] 41. Hack TF, Degner LF, Dyck DG. Relationship between preferences for decisional control and illness information among women with breast cancer: a quantitative and qualitative analysis. Soc Sci Med 1994;39:279–89 [PubMed] [Google Scholar] 42. Miller VA. Parent–child collaborative decision making for the management of chronic illness: a qualitative analysis. Fam Syst Health 2009;27:249–66 [PMC free article] [PubMed] [Google Scholar] 43. Charles C, Gafni A, Whelan T. Decision-making in the physician–patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999;49:651–61 [PubMed] [Google Scholar] 44. Schneider CE. After autonomy. Wake Forest Law Rev 2006;41: 411–44 [Google Scholar] 45. Fink AS, Prochazka AV, Henderson WG, et al. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg 2010;252:27–36 [PubMed] [Google Scholar] 46. Braddock C, III, Hudak PL, Feldman JJ, et al. “Surgery is certainly one good option”: quality and time-efficiency of informed decision-making in surgery”. J Bone Joint Surg Am 2008;90:1830–8 [PMC free article] [PubMed] [Google Scholar] 47. Black SA, Nestel D, Tierney T, et al. Gaining consent for carotid surgery: a simulation-based study of vascular surgeons. Eur J Vasc Endovasc Surg 2009;37:134–9 [PubMed] [Google Scholar] 48. Katz J. The silent world of doctor and patient. New York (NY): Free Press; 1984 [Google Scholar] 49. Fowler FJ, Jr, McNaughton Collins M, Albertsen PC, et al. Comparison of recommendations by urologists and radiation oncologists for treatment of clinically localized prostate cancer. JAMA 2000;283:3217–22 [PubMed] [Google Scholar] 50. Braddock CH, III, Fihn SD, Levinson W, et al. How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting. J Gen Intern Med 1997;12:339–45 [PMC free article] [PubMed] [Google Scholar] 51. Braddock CH, III, Edwards KA, Hasenberg NM, et al. Informed decision making in outpatient practice: time to get back to basics. JAMA 1999;282:2313–20 [PubMed] [Google Scholar] 52. Hudak PL, Frankel RM, Braddock C, III, et al. Do patients’ communication behaviors provide insight into their preferences for participation in decision making? Med Decis Making 2008;28:385–93 [PubMed] [Google Scholar] 53. Gattellari M, Voight KJ, Butow PN, et al. When the treatment goal is not cure: Are cancer patients equipped to make informed decisions? J Clin Oncol 2002;20:503–13 [PubMed] [Google Scholar] 54. van Zuuren FJ, van Schie EC, van Baaren NK. Uncertainty in the information provided during genetic counseling. Patient Educ Couns 1997;32:129–39 [PubMed] [Google Scholar] 55. Leeper-Majors K, Veale JR, Westbrook TS, et al. The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study. Curr Surg 2003;60:615–22 [PubMed] [Google Scholar] 56. Marshall M, Bibby J. Supporting patients to make the best decisions. BMJ 2011;342:d2117. [PubMed] [Google Scholar] 57. Joffe S, Truog R. Consent to medical care: the importance of fiduciary context. In: Miller F, Wertheimer A, editors. The ethics of consent: theory and practice. New York (NY): Oxford University Press; 2010. p. 347–73 [Google Scholar] 58. Fink AS, Prochazka AV, Henderson WG, et al. Predictors of comprehension during surgical informed consent. J Am Coll Surg 2010;210:919–26 [PubMed] [Google Scholar] 59. O’Connor AM, Bennett CL, Stacey D, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2009;(3)CD001431. [PubMed] [Google Scholar] 60. Sepucha KR, Ozanne E, Silvia K, et al. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns 2007;65:261–9 [PubMed] [Google Scholar] 61. Sepucha KR, Fowler FJ, Jr, Mulley AG., Jr. Policy support for patient-centered care: the need for measurable improvements in decision quality. Health Aff (Millwood). 2004;Suppl Variation:VAR54–62 [PubMed] [Google Scholar] 62. Hickson GB, Federspiel CF, Pichert JW, et al. Patient complaints and malpractice risk. JAMA 2002;287:2951–7 [PubMed] [Google Scholar] 63. Levinson W, Roter DL, Mullooly JP, et al. Physician-patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA 1997;277:553–9 [PubMed] [Google Scholar] 64. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: facilitating quality patient–physician interaction. Arch Surg 2000;135:26–33 [PubMed] [Google Scholar] 65. Issa MM, Setzer E, Charaf C, et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 2006;176:694–9, discussion 9. [PubMed] [Google Scholar] 66. Hopper KD, TenHave TR, Tully DA, et al. The readability of currently used surgical/procedure consent forms in the United States. Surgery 1998;123:496–503 [PubMed] [Google Scholar] 67. Robb A, Etchells E, Cusimano MD, et al. A randomized trial of teaching bioethics to surgical residents. Am J Surg 2005;189:453–7 [PubMed] [Google Scholar] 68. Angelos P, DaRosa DA, Derossis AM, et al. Medical ethics curriculum for surgical residents: results of a pilot project. Surgery 1999;126:701–5, discussion 5–7. [PubMed] [Google Scholar] 69. Deyo RA, Cherkin DC, Weinstein J, et al. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care 2000;38:959–69 [PubMed] [Google Scholar] 70. Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 1997;30:239–45 [PubMed] [Google Scholar] 71. Dodd MJ, Mood DW. Chemotherapy: helping patients to know the drugs they are receiving and their possible side effects. Cancer Nurs 1981;4:311–8 [PubMed] [Google Scholar] 72. Lapid MI, Rummans TA, Pankratz VS, et al. Decisional capacity of depressed elderly to consent to electroconvulsive therapy. J Geriatr Psychiatry Neurol 2004;17:42–6 [PubMed] [Google Scholar] 73. Lapid MI, Rummans TA, Poole KL, et al. Decisional capacity of severely depressed patients requiring electroconvulsive therapy. JECT 2003;19:67–72 [PubMed] [Google Scholar] 74. Solomon J, Schwegman-Melton K. Structured teaching and patient understanding of informed consent. Crit Care Nurse 1987;7:74–9 [PubMed] [Google Scholar] 75. Greening J, Bentham P, Stemman J, et al. The effect of structured consent on recall of information pre- and post-electrocon-vulsive therapy: a pilot study. Psychiatr Bull 1999;23:471–4 [Google Scholar] 76. Decker C, Arnold SV, Olabiyi O, et al. Implementing an innovative consent form: the PREDICT experience. Implement Sci 2008;3:58. [PMC free article] [PubMed] [Google Scholar] 77. Arnold SV, Decker C, Ahmad H, et al. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. Circ Cardiovasc Qual Out-comes. 2008;1:21–8 [PubMed] [Google Scholar] 78. Barry MJ. Involving patients in medical decisions: How can physicians do better? JAMA 1999;282:2356–7 [PubMed] [Google Scholar] 79. Friedlander JA, Loeben GS, Finnegan PK, et al. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics 2011;37:194–200 [PubMed] [Google Scholar] Page 2Venn diagram showing the multiple overlapping purposes of informed consent. Image courtesy of Daniel Hall |