Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process

For a general overview of informed consent theory and practices, see Berg J. W. Appelbaum P. S. Lidz C. W. Parker L. S. , Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2001); Faden R. R. Beauchamp T. L. King N. M. P. , eds., A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

Canterbury v. Spence, 464 F.2d 772, 781 (D.C. Cir. 1972). But see Boozang K. M. , “The Therapeutic Placebo: The Case for Patient Deception,” Florida Law Review 54, (2002): 687–746.

Levinson W. Roter D. L. Mullooly J. P. Dull V. T. Frankel R. M. , “Physician-Patient Communication – The Relationship with Malpractice Claims among Primary Care Physicians and Surgeons,” JAMA 277, no. 7 (1997): 553–559.

Kutner M. Greenberg E. Jin Y. Paulsen C. , “The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy,” Washington, D.C., National Center for Education Statistics, U.S. Department of Education, 2006; Williams M.V. Parker R. M. Baker D. W. Parikh N. S. Pitkin K. Coates W. C. Nurss J. R. , “Inadequate Functional Health Literacy among Patients at Two Public Hospitals,” JAMA 274, no. 21 (1995): 1677–1682; Peters E. Vastfjall D. Slovic P. Mertz C. K. Mazzocco K. Dickert S. , “Numeracy and Decision Making,” Psychological Sciences 17, no. 3 (2006): 407–413.

Powers B. J. Trinh J. V. Bosworth H. B. , “Can This Patient Read and Understand Written Health Information?” JAMA 304, no. 1 (2010): 76–84; Hall M. A. Schneider C. E. , “How Should Physicians Involve Patients in Medical Decisions?” JAMA 283, no. 18 (2000): 2390–2391; Meisel A. Roth L. H. , “Toward an Informed Discussion of Informed Consent: A Review and Critique of the Empirical Studies,” Arizona Law Review 25 (1983): 265–346.

McNeil B. Pauker S. Sox H. Jr. Tversky A. , “On the Elicitation of Preferences for Alternative Therapies,” New England Journal of Medicine 306, no. 21 (1982): 1259–1262.

Epstein R. M. Peters E. , “Beyond Information: Exploring Patients' Preferences,” JAMA 302, no. 2 (2009): 195–197; Siegal G. Siegal N. Bonnie R. J. , “An Account of Collective Action Problems in Public Health,” American Journal of Public Health 99, no. 12 (2009): 1583–1587.

Rothberg M. B. Sivalingam S. K. Ashraf J. Visintainer P. Joelson J. Kleppel R. , “Patients' and Cardiologists' Perceptions of the benefits of Percutaneous Coronary Intervention for Stable Coronary Disease,” Annals of Internal Medicine 153, no. 1 (2010): 307–313.

Barr J. K. Steinberg M. K. , “A Physician Role Typology: Colleague and Client Dependence in an HMO,” Social Science & Medicine 20, no. 3 (1985): 253–261.

For a tabulation of states' informed consent laws, see King J. S. Moulton B. W. , “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law & Medicine 32, no. 4 (2006): 429–501, at 493–501.

Bogardus S. T. Holmboe E. Jekel J. F. , “Perils, Pitfalls and Possibilities in Talking about Medical Risk,” JAMA 281, no. 11 (1999): 1037–1041.

Schuck P. H. , “Rethinking Informed Consent,” Yale Law Journal 103, no. 3 (1994): 899–959; Manson N. C. O'Neill O. , Rethinking Informed Consent in Bioethics (Cambridge, U.K.: Cambridge University Press, 2007): At 27.

Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 122 (Tenn. 1999).

For example, Wilson-Toby v. Bushkin, 72 A.D. 3d 810, 898 N.Y.S.2d 633 (2010). (Although consent forms advised the plaintif generally that cosmetic breast surgery would result in permanent scarring, the court ruled that “consent forms signed by the plaintif ‘do not establish, as a matter of law, that the scarring that the plaintif actually experienced as a result of the procedure was, in its nature and in its extent, consistent with the type of scarring that, prior to the procedure, the plaintif had been told to consider as being among the reasonably foreseeable risks of the proposed procedure, or that a reasonable, fully informed person in the plaintif's position would have undergone the procedure despite the existence of such risk.’” [citation omitted]).

Appelbaum P. S. , “Assessment of Patients' Competence to Consent to Treatment,” New England Journal of Medicine 357, no. 18 (2007): 1834–1840.

Tversky A. Kahneman D. , “The Framing of Decisions and the Psychology of Choice,” Science 211, no. 4481 (1981): 453–458.

Smith S. K. Trevena L. Simpson J. M. Barratt A. Nutbeam D. McCaffery K. J. , “A Decision Aid to Support Informed Choices about Bowel Cancer Screening among Adults with Low Education: Randomized Controlled Trial,” BMJ (October 26, 2010): 341 (“Providing balanced, evidence based information about the benefits and harms of screening for bowel cancer may reduce participation in screening among adults with low education”).

Halpern S. D. Shaked A. Hasz R. D. Caplan A. L. , “Informing Candidates for Solid-Organ Transplantation about Donor Risk Factors,” New England Journal of Medicine 358, no. 26 (2008): 2832–2837. (“This policy should outline specific aspects of transplantation that should be disclosed during the consent process…to allow patients to make a dichotomous choice to accept or decline all nonstandard organs as a group, and eliminate the practice of organ-specific consent. In particular, we believe UNOS should abandon its current recommendation that patients be notified when organs are offered from donors with behavioral risk factors.” These phrases support the need to refrain from providing ‘all’ information.

Sage W. M. , “Unfinished Business: How Litigation Relates to Health Care Regulation,” Journal of Health Politics, Policy and Law 28, nos. 2–3 (2003): 387–419; LaBine S. J. LaBine G. , “Determinations of Negligence and the Hindsight Bias,” Law and Human Behavior 20, no. 5 (1996): 501–516.

Losanoff J. E. Litwinczuk K. M. Ranella M. J. Basson M. D. , “Elective Inguinal Hernia Repair: A Unified Informed Consent, or Who Wants to Know What?” American Surgeon 75, no. 4 (2009): 296–300.

Hall A. , “What the Navajo Culture Teaches about Informed Consent,” HEC Forum 14, no. 3 (2002): 241–246; Carrese J. A. Rhodes L. A. , “Western Bioethics on the Navajo Reservation. benefit or Harm?” JAMA 274, no. 10 (1995): 826–929.

Ormond K. E. Banuvar S. Daly A. Iris M. Minogue J. Elias S. , “Information Preferences of High Literacy Pregnant Women Regarding Informed Consent Models for Genetic Carrier Screening,” Patient Education and Counseling 75, no. 2 (2009): 244–250.

A federal judge recently struck down a key provision of Texas' new law requiring doctors to show pregnant women images from the sonogram and to play the sounds of the fetal heartbeat before an abortion, ruling that the measure violates the free speech rights of both doctors and patients. See Associated Press, “Texas: Judge Halts and Abortion Requirement,” New York Times, available at <http://www.nytimes.com/2011/08/31/us/31brfs-JUDGEHALTSAN_BRF.html?_r=1&ref=health> (last visited March 8, 2012).

O'Connor A. M. Wennberg J. E. Legare F. Llewellyn-Thomas H. A. Moulton B. W. Sepucha K. R. Sodano A. G. King J. S. , “Toward The ‘Tipping Point’: Decision Aids and Informed Patient Choice,” Health Affairs 26, no. 3 (2007): 716–725.

Hall D .E. Hanusa B. H. Switzer G. E. Fine M. J. Arnold R. M. , “The Impact of iMedConsent on Patient Decision-Making Regarding Cholecystectomy and Inguinal Herniorrhaphy,” Journal of Surgical Research (2011), available at <http://www.sciencedirect.com/science/article/pii/S0022480411004331> (last visited April 2, 2012); Franklin D. , “Uninformed Consent: Tech Solutions for Faulty Permissions in Health Care,” Scientific American, March 15, 2011, available at <http://www.scientificamerican.com/article.cfm?id=uninformed-consent-mar-11> (last visited March 8, 2012).

Fagerlin A. Ubel P. A. Smith D. M. Zikmund-Fisher B. J. , “Making Numbers Matter: Present and Future Research in Risk Communication,” American Journal of Health Behavior 31, no. 4, Supp. 1 (2007): S47–S56.

Tang H. Ng J. H. K. , “Googling for a Diagnosis – Use of Google as a Diagnostic Aid: Internet Based Study,” BMJ 333, no. 7579 (2006): 1143–1145; Hartzband P. Groopman J. , “Untangling the Web – Patients, Doctors, and the Internet,” New England Journal of Medicine 362, no. 12 (2010): 1063–1066; Siegal G. , “Electronic Medical Tourism and the Medical WWW,” in Cohen I. G. , ed., Globalization of Health Care (New York: Oxford University Press, in press).

See Hall , supra note 25: “… at the same time that the IC process appears to empower patient participation, it may over-whelm some patients with more information than they want. Fully 85% of patients arrived in the clinic wanting to know as many details as possible about their health status, but after the clinic visit, only 25% continued to report this preference. At the same time, the proportion of patients preferring as few details as possible increased from 0% to 36%. These preliminary findings may warrant reconsidering the amount of detail disclosed in the iMed documents and the IC process.”

Siegal G. Bonnie R. J. , “Closing the Organ Gap,” Journal of Law, Medicine & Ethics 34, no. 4 (2006): 415–423. Seventy percent of people forced to state their position vis-à-vis organ donation in mandated choice pilot programs in Texas and Virginia chose not to be a donor.