Aligning Ethics with Medical Decision-Making: The Quest for Informed Patient Choice

Glover J. A. , “The Incidence of Tonsillectomy in School Children,” Proceedings of the Royal Society of Med., (May 1938): 1219–1236, reprinted in: International Journal of Epidemiology 37 (2008): 9–19.

Id.

Id., at 18.

Id.

See, e.g., Center for the Evaluative Clinical Sciences, Dartmouth Medical School, “The Quality of Medical Care in the United States: A Report on the Medicare Program,” The Dartmouth Atlas of Health Care, 1999, available at <http://www.dartmouthatlas.org/atlases/99Atlas.pdf> (last visited February 3, 2010); Wennberg J. E. Gittelsohn A. , “Small Area Variations in Health Care Delivery: A Population-Based Health Information System Can Guide Planning and Regulatory Decision-Making,” Science 182, 4117 (1973): 1102.

Center for the Evaluative Clinical Sciences, Dartmouth Medical School, The Dartmouth Atlas of Health Care, 1998, at 5, available at <http://www.dartmouthatlas.org/atlases/98Atlas.pdf> (last visited February 4, 2010).

The origins of the Hippocratic Oath can be traced back to the 4th century B.C. Medical historian Ludwig Edelstein has suggested that it should be viewed as a code of a minority of Pythagorian physicians. The oath was largely ignored in Judeo Christian tradition until the Declaration of Geneva in 1948, when the World Medical Association recast the code in modern terms. The recast oath is explicit that the primary goal of the physician is to promote the health and welfare of the patient. Veatch R. M. , Cross Cultural Perspectives in Medical Ethics (Boston: Jones & Bartlett Publishers 2000): at 3, 21.

Sullivan M. , “The New Subjective Medicine: Taking the Patient's Point of View on Health Care and Health,” Social Science and Medicine 56, no. 7 (2003): 1595–604.

Blank T. Graves K. Sepucha K. , and Lewellyn-Thomas H. , “Understanding Treatment Decision-Making: Contexts, Commonalities, Complexities and Challenges,” Annals of Behavioral Medicine 32 no. 2 (2003): 211–217; Feldman-Stewart D. , “The Information Required by Patients with Early-Stage Prostate Cancer in Choosing Their Treatment,” British Journal of Urology International 86 no. 3 (2001): 218–223.

Quill T. E. Brody H. , “Physician Recommendations and Patient Autonomy: Finding a Balance between Physician Power and Patient Choice,” Annals of Internal Medicine 125 no. 9 (1996): 763–769; Meyers C. , “Cruel Choices: Autonomy and Critical Care Decision-Making,” Bioethics 18, no. 2 (2004): 104–119; Roenigk Lindsey Dr. , phone consultation March 24, 2009.

Faden R. R. Beauchamp T. L. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

Id.

Beauchamp T. L. Childress J. F. , Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001) at 166.

Kukla R. , “Conscientious Autonomy: Displacing Decisions in Health Care,” Hastings Center Report 35, no. 2 (2005): 34–44.

Snyder L. Leffler C. , “Ethics Manual, Fifth Edition,” Annals of Internal Medicine 142, no. 7 (2005): 560–82, at 560.

See Beauchamp Childress , supra note 13, at 176.

Emanuel E. J. Emanuel L. L. , “Four Models of the Physician-Patient Relationship,” JAMA 267, no. 16 (1992): 2221–2226; Szasz T. S. Hollender M. H. , “The Basic Models of the Doctor-Doctor Relationship,” Archives of Internal Medicine 97, no. 5 (1956): 585–592.

Savulescu J. , “Rational, Non-interventional Paternalism: Why Doctors Ought to Make Judgments of What Is Best for Their Patients,” Journal of Medical Ethics 21, no. 6 (1995): 327–331.

By definition, paternalism is “the intentional overriding of one person's known preferences or actions by another person, where the person who overrides justifies the action by the goal of benefiting or avoiding harm to the person whose preferences or actions are overridden.” See Beauchamp Childress , supra note 13, at 178.

See Savulescu , supra note 18.

Collins D. E. Moore C. P. Clay K. F. , “Can Women with Early-Stage Breast Cancer Make an Informed Decision for Mastectomy?” Journal of Clinical Oncology 27, no. 4 (2009): 519–525; see Blank , supra note 9; Feldman-Stewart D. , “Practical Issues in Shared Decision-Making,” Health Expectations 3, no. 1 (2000): 46–54; Teno J. M. , “Preferences for Cardiopulmonary Resuscitation: Physician-Patient Agreement and Hospital Resources Use,” Journal of General Internal Medicine 10, no. 4 (1995): 179–186.

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

American Medical Association, §E-8.08; American Medical Association, Informed Consent: Code of Medical Ethics, Chicago, 2006, at 227.

Schneider C. E. , The Practice of Autonomy: Patients, Doctors and Medical Decisions (New York: Oxford University Press, 1998); see Savulescu , supra note 18.

Lane v. Candura, 6 Mass. App. Ct. 377 (1978).

Brennan T. A. , “Medical Professionalism in the New Millennium: A Physician Charter,” Annals of Internal Medicine 136, no. 3 (2002): 243–246, at 244. Emphasis added.

Patient-Centered Primary Care Collaborative, “Joint Principles of the Patient Centered Medical Home,” February 2007, available at <http://www.pcpcc.net/content/joint-principles-patient-centered-medical-home> (last visited February 4, 2010).

National Priorities Partnership, Patient and Family Engagement, 2008, available at <http://www.nationalprioritiespartnership.org/PriorityDetails.aspx?id=596> (last visited February 4, 2010).

Woolf S. H. Chan E. C. Y. Harris R. Sheridan S. L. Braddock C. H. , and Kaplan R. M. , “Promoting Informed Choice: Transforming Health Care to Dispense Knowledge for Decision-Making,” Annals of Internal Medicine 143, no. 4 (2005): 293–300; Hibbard J. H. , “Moving Toward a More Patient-Centered Health Care Delivery System,” Health Affairs Suppl. Web Exclusive October 7, 2004: 133–135.

“Sicker patients” included patients who reported being in fair or poor health, having had a serious illness, being hospitalized, or having had a major surgery in the past two years.

Commonwealth Fund, First Report and Recommendations of the Commonwealth Fund's International Working Group on Quality Indicators: A Report to Health Ministers of Australia, Canada, New Zealand, the United Kingdom, and the United States, 2004.

Id.

For further discussion of these challenges, see infra Section II.

The nine domains included: clinical skill, provision of information, interpersonal skill, office support staff, patient involvement, non-financial access, coordination of care, finances, and office environment. Laine C. E. , “Important Elements of Outpatient Care: A Comparison of Patients; and Physicians' Opinions,” Annals of Internal Medicine 125, no. 8 (1996): 640–645.

Braddock C. H. Fihn S. D. Levinson W. Jonsen A. R. , and Pearlman R. A. , “How Doctors and Patients Discuss Routine Clinical Decisions: Informed Decision-Making in the Outpatient Setting,” Journal of General Internal Medicine 12, no. 6 (1997): 339–345.

Calkins D. R. , “Patient-Physician Communication at Hospital Discharge and Patients' Understanding of the Post-discharge Treatment Plan,” Archives of Internal Medicine 157, no. 9 (1997): 1026–1030.

Scheitel S. M. Boland B. J. Wollan P. C. , and Silverstein M. D. , “Patient-Physician Agreement about Medical Diagnoses and Cardiovascular Risk Factors in the Ambulatory General Medicine Examination,” Mayo Clinical Proceedings 71, no.12 (1996): 1131–1137.

O'Connor A. M. Bennett C. L. Stacey D. , and Barry M. , “Decision Aids for People Facing Health Treatment or Screening Decisions,” Cochrane Database of Systematic Reviews 2 (2003), updated Cochrane Database of Systematic Reviews 3 (2009), available at <http://decisionaid.ohri.ca/cochsystem.html> (last visited February 4, 2010); Wennberg J. E. O'Connor A. M. Collins E. D. , and Weinstein J. N. , “Extending the P4P Agenda Part 1: How Can Medicare Improve Patient Decision-Making and Reduce Unnecessary Costs?” Health Affairs 26, no. 6 (2007): 1564–1574.

See Box 1 for examples of Preference Sensitive medical conditions.

Hawker G. A. , “Determining the Need of Hip and Knee Arthroplasty: The Role of Clinical Severity and Patients' Preference,” Medical Care 39, no. 3 (2001): 206–216.

See Wennberg , supra note 38.

See Meyers , supra note 11; Schneider , supra note 25; Madder H. , “Existential Autonomy: Why Patients Should Make Their Own Choices,” Journal of Medical Ethics 23, no. 4 (1997): 221–225; Quill Brody , supra note 11; Savulescu , supra note 18.

See Quill Brody , supra note 10.

See Schneider , supra note 24.

Laine C. E. Davidoff F. , “Patient-Centered Medicine: A Professional Evolution,” JAMA 275, no. 2 (1996): 152–156.

See Savulescu , supra note 18.

Roenigk Lindsey Dr. , phone conversation with authors March 24, 2009; see supra note 43.

van Kleffens T. van Baarsen B. , and van Leeuwen E. , “The Medical Practice of Patient Autonomy and Cancer Treatment Refusals: A Patients' and Physicians' Perspective,” Social Science and Medicine 58, no. 11 (2004): 2325–2336.

See Collins , supra note 21.

Id.

Id.

Levinson W. , “Not All Patients Want to Participate in Decision-Making: A National Study of Public Preferences,” Journal of General Internal Medicine 20, no. 6 (2005): 531–535; Mazur D. J. Hickam D. H. , “Patients' Preferences for Risk Disclosure and Role in Decision-Making for Invasive Medical Procedures,” Journal of General Internal Medicine 12, no. 6 (1997): 114–117.

Mazur D. J. , “The Role of Doctor's Opinion in Shared Decision-Making: What Does Shared Decision-Making Really Mean When Considering Invasive Medical Procedures?” Health Expectations 8, no. 2 (2005): 97–102; Bernat J. L. Peterson L. M. , “Patient-Centered Informed Consent in Surgical Practice,” Archives of Surgery 141, no. 1 (2006): 86–92.

King J. S. Moulton B. , “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law and Medicine 32, no. 4 (2006): 429–501; Beauchamp Childress , supra note 13.

See Beauchamp Childress , supra note 12.

Moumjid G. , “Shared Decision-Making in the Medical Encounter: Are We Talking about the Same Thing,” Medical Decision-Making 27, no. 5 (2007): 539–546.

Id.

See King Moulton , supra note 54; Kaplan R. M. , “Shared Medical Decision-Making: A New Tool for Preventative Medicine,” American Journal of Preventative Medicine 26, no. 1 (2003): 81–83.

O'Connor A. M. , “Decision Aids for Patients Facing Health Treatment or Screening Decisions: Systemic Review,” British Medical Journal 319(1999): 731–734

See Collins , supra note 21, O'Connor A. M. , “Do Patient Decision Aids Meet Effectiveness Criteria of the International Patient Decision Aid Standards Collaboration? A Systematic Review and Metaanalysis,” Medical Decision-Making 27, no. 5 (2007): 554–574.

Guadagnoli E. Ward P. , “Patient Participation in DecisionMaking,” Social Science Medicine 47 no. 3 (1998): 329–339; Kaplan S. H. , “Assessing the Effects of Physician-Patient Interactions on the Outcomes of Chronic Disease,” Medical Care 27, no. 3 (1989): S110–S127; Mendonca P. Brehm S. , “Effects of Choice on Behavioral Treatment of Overweight Children,” Journal of Social Clinical Psychology 1, no. 4 (1983): 343–358; Schulman B. A. , “Active Patient Orientation and Outcomes in Hypertensive Treatment,” Medical Care 17, no. 3 (1979): 267–280.

See Kaplan , supra note 61; Schulman , supra note 61.

Id. (Kaplan); Mendonca Brehm , supra note 61.

A number of primary care practices have successfully adopted shared decision-making and the use of decision aids, including the University of North Carolina (UNC), Chapel Hill, NC; White River Junction VA, White River Junction, VT; Massachusetts General Hospital (MGH), Boston, MA; University of California Los Angeles (UCLA), Los Angeles, CA; University of California San Diego (UCSD), San Diego, CA; Maine Health – Portland, ME; Mercy Medical Center, Des Moines, IA; Stillwater Hospital, Stillwater, MN; Oregon Health Science, Portland, OR; Palo Alto Medical Center, Palo Alto, CA; and Dartmouth Hitchcock Medical Center (DHMC), Hanover, NH. In addition, specialty practices at the University of California, San Francisco (UCSF) and DHMC have also adopted shared decision-making and the use of decision aids.

See Braddock , supra note 35; Epstein R. M. Alper B. S. , and Quill T. E. , “Communicating Evidence for Participatory Decision-Making,” JAMA 291, no.19 (2004): 2359–2365.

Woolf S. H. , “The Logic and Limits of Shared Decision-Making,” Journal of Urology 166, no. 1 (2001): 244–245.

Wennberg J. E. , “Improving Quality and Curbing Health Care Spending: Opportunities for the Congress and the Obama Administration,” Dartmouth Atlas White Paper, December 2008.

Id.

See supra note 64.

Conversation and email communication with authors and Clay K. Berg S. regarding the Dartmouth Hitchcock Center for Shared Decision-Making, December 12, 2008.

See Collins , supra note 21; Clay and Berg, supra note 70.

Id. (Clay and Berg).

See Wennberg , supra note 38.

Id.

See Woolf , supra note 29.

“An Act Relating to Containing Health Care Costs,” Senate Bill 129, S.J. 50P, signed into law May 28, 2009, available at <www.leg.state.vt.us/database/status/summary.cfm?Bill=S.0129&Session=2010> (last visited February 4, 2010); “Resolve, To Study Implementation of Shared Decision Making To Improve Quality of Care and Reduce Unnecessary Use of Medical Services,” 124th Maine Legislature, SP 493, LD # 1398, signed into law June 9, 2009, available at <www.mainelegislature.org/legis/bills/display_ps.asp?LD=1358&snum=124> (last visited February 4, 2010).

Wyden Senator Wyden Gregg Blumenauer Put Patients in the Driver's Seat, Press Release, <http://wyden.senate.gov/newsroom/record.cfm?id=313384&> (last visited February 4, 2010).

<http://www.thomas.gov/cgi-bin/query/F?c111:1:./temp/∼c111VQGDjp:e1180:> (last visited February 4, 2010).

See Wennberg , supra note 67.

Not all covered services are medically necessary for each patient and not all medically necessary services are covered. Glassman P. A. Model K. E. Kahan J. P. Jacobsen P. D. , and Peabody J. W. , “The Role of Medical Necessity and Cost-Effectiveness in Making Medical-Decisions,” Annals of Internal Medicine 126, no. 2 (1997): 152–156.

42 USC § 1395y(a)(1)(A) (2009).

Rosenbaum S. Frankford D. M. , “Who Should Determine When Health Care Is Medically Necessary?” New England Journal of Medicine 340, no. 3 (1999): 229–232.

Id.; Berghold L. A. , “Medical Necessity: Do We Need It?” Health Affairs 14, no. 4 (1995): 180–190.

See Wennberg , supra note 38.

See Teno , supra note 21.

See Wennberg , supra note 38.

Teno J. M. Fisher E. S. Hamel M. B. Coppola K. , and Dawson N. V. , “Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival,” Journal of the American Geriatrics Society 50, (2002): 496–500.

Id.

Id.

Pauly M. V. , “What Is Unnecessary Surgery?” Milbank Memorial Fund Quarterly – Health & Society 57, no. 1 (1979): 95–117.

Leape L. L. , “Unnecessary Surgery,” Health Research Services 24, no. 3 (1989): 351–407.