Rethinking informed consent: The case for shared medical decision-making

American Journal of Law and Medicine

Volumn 32, Issue 4, 2006, Pages 429-501

  King, Jaime Staples ^a,b,c,d   Moulton, Benjamin W ^b,e,f  

^a STANFORD LAW SCHOOL   (United States)

^b HARVARD UNIVERSITY   (United States)

^c EMORY UNIVERSITY SCHOOL OF LAW   (United States)

^d DARTMOUTH COLLEGE   (United States)

^e Amer Soc of Law Med and Ethics   (United States)

^f GEORGETOWN UNIVERSITY LAW CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEALTH CARE POLICY; HEALTH CARE QUALITY; HEALTH SERVICE; HUMAN; INFORMED CONSENT; LAW; MALPRACTICE; MEDICAL CARE; MEDICAL DECISION MAKING; MEDICAL ERROR; MEDICAL ETHICS; MEDICAL PRACTICE; MEDICAL SOCIETY; MEDICAL SPECIALIST; MEDICOLEGAL ASPECT; PATIENT RIGHT; PATIENT SATISFACTION; PHYSICIAN ATTITUDE; PROFESSIONAL PRACTICE; REVIEW;

EID: 33846323995     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880603200401     Document Type: Review

References (442)

1. See, e.g., JESSICA W. BERG ET AL., INFORMED CONSENT: LEGAL THEORY AND CLINICAL PRACTICE vii-viii (2d ed. 2001);
2. JAY KATZ, THE SILENT WORLD OF DOCTOR AND PATIENT (Johns Hopkins University Press 2002);
3. Ken Marcus Gatter, Protecting Patient-Doctor Discourse: Informed Consent and Deliberative Autonomy, 78 OR. L. REV. 941, 950 (1999);
4. John E. Wennberg & Philip G. Peters, Unwanted Variations in the Quality of Health Care: Can the Law Help Medicine Provide a Remedy/Remedies?, 37 WAKE FOREST L. REV. 925, 925-941 (2002).
5. While each state may have its own basic interpretation of each standard, they can easily be divided into the two groups based on their language and intent, with the exception of New Mexico and Minnesota, which have hybrid standards. For more information on the individual state standards please see Appendix A.
6. Tashman v. Gibbs, 556 S.E.2d 772, 777 (Va. 2002).
7. Canterbury v. Spence, 464 F.2d 772, 784 (D.C. Cir. 1972).
8. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, DARTMOUTH MEDICAL SCHOOL, DARTMOUTH ATLAS PROJECT TOPIC BRIEF: PREFERENCE-SENSITIVE CARE 6 (2005), http://www.dartmouthatlas.org/topics/preference_sensitive.pdf.
9. Sidney T. Bogardus et al., Perils, Pitfalls and Possibilities in Talking about Medical Risk, 281 JAMA 1037, 1039 (1999).
10. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, DARTMOUTH MEDICAL SCHOOL, THE DARTMOUTH ATLAS OF HEALTH CARE 1998 21 (1998), available at http://www.dartmouthatlas.org/atlases/ 98Atlas.pdf;
11. see also John E. Wennberg, Variation in Use of Medical Services Among Regions and Selected Academic Medical Centers: Is More Better?, COMMONWEALTH FUND REP., Dec. 2005, at 26, available at http://www.cmwf.org/usr_doc/ 874_wennberg_variation_medicaresvcs.pdf.
12. Deb Feldman-Stewart et al., Practical Issues in Assisting Shared Decision-Making, 3 HEALTH EXPECTATIONS 46, 49 (2000).
13. See, e.g., Wennberg & Peters, supra note 1, at 937; see also Katz, supra note 1.
14. Robert M. Kaplan, Shared Medical Decision Making: A New Tool for Preventative Medicine, 26 AM. J. PREV. MED. 81, 81 (2003).
15. Id.
16. See, e.g., Katz, supra note 1, at 121-128, 227-228.
17. See, e.g., Bogardus et al., supra note 6, at 1037-41; Geraldine M. Leydon et al., Cancer Patients' Information Needs and Information Seeking Behavior: In Depth Interview Study, 320 BRIT. MED. J. 909, 909-913 (2000);
18. Steven H. Woolf & Alex Krist, The Liability of Giving Patients a Choice: Shared Decision Making and Prostate Cancer, 71 AM. FAMILY PHYS 1871, 871-72 (2005).
19. See, e.g., Andrew S. Dunn et al., Physician-Patient Discussions of Controversial Cancer Screening Tests, 20 AM. J. PREVENTIVE MED. 130, 133 (2001) (finding that "a substantial number of physicians decide whether to screen patients for prostate and breast cancer without sufficiently involving patients in the decision"); Woolf & Krist, supra note 13, at 1871 (claiming that little shared medical decision making occurs in practice despite consensus among medical organizations on the benefits of this approach).
20. Steven H. Woolf, The Logic and Limits of Shared Decision Making, 166 J. UROLOGY 244, 244 (2001); Woolf & Krist, supra note 13, at 1871-72.
21. Daniel Merenstein, Winners and Losers, 291 JAMA 15, 15-16 (2004).
22. Id. at 15.
23. Id.
24. Id.; U.S. Preventive Services Task Force, Screening for Prostate Cancer: Recommendation and Rationale, 137 ANNALS. INTERNAL. MED. 915, 915 (2002).
25. U.S. Preventive Services Task Force, supra note 19, at 915.
26. Id.
27. Id.
28. Lars Holmberg et al., A Randomized Trial Comparing Radical Prostatectomy with Watchful Waiting in Early Prostate Cancer, 347 NEW ENG. J. MED. 781, 787 (2002).
29. U.S. Preventive Services Task Force, supra note 19, at 915.
30. Id.
31. Id. at 916.
32. Merenstein, supra note 16, at 15.
33. Id.
34. Id.
35. Id.
36. Id.
37. Id.
38. Id.
39. Id.
40. See generally RESTATEMENT (SECOND) OF TORTS § 281 (1965) (discussing elements for a cause of action for negligence);
41. FRANK J. VANDAL & ELLEN WERTHEIMER, TORTS: CASES AND PROBLEMS 179-89 (Michie 1997) (discussing the concept of the standard of care owed to others related to negligence claims).
42. Merenstein, supra note 16, at 15.
43. Id. at 15-16.
44. TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 12 (5th ed. 2001).
45. See id. at 12, 114-115, 176, 248.
46. Id. at 176; ONORA O'NEILL, AUTONOMY AND TRUST IN BIOETHICS 39 (Cambridge University Press 2002);
47. Alfred I. Tauber, Sick Autonomy, 46 PERSP. BIOLOGY & MED. 484, 488 (2003).
48. See also Mark Parascandola et al., Patient Autonomy and the Challenge of Clinical Uncertainty, 12 KENNEDY INST. ETHICS J. 245, 245-247 (2002) (discussing the challenges facing physicians in the face of clinical uncertainty about a patient's health).
49. Tauber, supra note 40, at 485.
50. Id.
51. Id.; see O'NEILL, supra note 40, at 29-31 (discussing naturalistic philosophy of individuality arising from "civil or social liberty").
52. Id. at 23.
53. Rebecca Kukla, Conscientious Autonomy: Displacing Decisions in Health Care, 35 HASTINGS CTR. REP. 34, 35 (2005).
54. Id.
55. Id.
56. BEAUCHAMP & CHILDRESS, supra note 38, at 166.
57. Id.
58. Id.
59. Id.
60. Id. at 176.
61. Parascandola et al., supra note 40, at 248.
62. Id.; BEAUCHAMP & CHILDRESS, supra note 38, at 12; Kukla, supra note 45, at 35; O'NEILL, supra note 40, at 34; Tauber, supra note 40, at 485.
63. See Tauber, supra note 40, at 485-86.
64. Id. at 486.
65. Alan Meisel & Mark Kuczewski, Legal and Ethical Myths About Informed Consent, 156 ARCHIVES INTERNAL MED. 2521, 2525.
66. Gatter, supra note 1, at 946-48.
67. See, e.g., Mohr v. Williams, 104 N.W. 12, 14-15 (Minn. 1905).
68. See, e.g., Canterbury, 464 F.2d at 787; Tashman, 556 S.E.2d at 777.
69. Lars Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 AM. J.L. & MED. 361, 367 (2002).
70. Id. at 368.
71. Mohr, 104 N.W. at 14.
72. RESTATEMENT (SECOND) OF TORTS § 18 (2006). Claims for battery may also be brought in criminal proceedings as well as civil proceedings as a tort. Battery in the medical malpractice context is generally considered a tort, rather than a criminal act.
73. Mohr, 104 N.W. at 14.
74. Id. at 13.
75. Id. at 14.
76. Id. at 15; see also Gatter, supra note 1, at 947.
77. Schloendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914).
78. Id. at 93.
79. Id.
80. KATZ, supra note 1, at 68.
81. Id. at 70.
82. See id. at 69.
83. See id. at 68.
84. Gatter, supra note 1, at 950.
85. Natanson v. Kline, 350 P.2d 1093, 1106 (Kan. 1960).
86. See KATZ, supra note 1, at 2.
87. Id. at 80-81.
88. See id. at 81.
89. See id. at 59.
90. Salgo v. Leland Stanford Jr., Univ. Bd. of Trs., 317 P.2d 170 (Cal. Dist. Ct. App. 1957).
91. Id. at 176.
92. Id. at 173-74.
93. Id. at 173.
94. KATZ, supra note 1, at 61.
95. Id. (quoting Salgo, 317 P.2d at 176).
96. Salgo, 317 P.2d at 181.
97. Natanson, 350 P.2d at 1093.
98. KATZ, supra note 1, at 70.
99. Natanson, 350 P.2d at 1106.
100. Id. at 1106.
101. Id. at 1103.
102. KATZ, supra note 1, at 65.
103. Tashman, 556 S.E.2d at 777 (citing Dickerson v. Fatehi, 484 S.E.2d 880, 881 (1997), Rogers v. Marrow, 413 S.E.2d 344, 346 (Va, 1992), & Raines v. Lutz, 341 S.E.2d 194, 196 (Va. 1986)).
104. Id. See Appendix A for language from the rest of the physician-based states.
105. See id. at 777-779.
106. Id. at 777.
107. Merenstein, supra note 1, at 15-16.
108. See infra Appendix A (listing the twenty-five physician-based states as Alabama, Arkansas, Arizona, Colorado, Delaware, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Missouri, Montana, Nebraska, Nevada, New Hampshire, New York, North Carolina, South Carolina, Tennessee, Vermont, Virginia and Wyoming). See Appendix A for a more detailed description of the laws on a state-by-state basis.
109. Canterbury, 464 F.2d at 772.
110. Id. at 787.
111. Mohr, 104 N.W. at 12.
112. See Canterbury, 464 F.2d at passim.
113. Id. at 776.
114. Id. at 778.
115. Id. at 780 (quoting Schloendorff, 105 N.E. at 93).
116. Id.
117. Id. at 784.
118. Id. at 784-85.
119. Id. at 785-87.
120. Id. at 786-87.
121. Id. at 787 (quoting Jon R. Waltz & Tomas W. Scheuneman, Informed Consent to Therapy, 64 NW. U.L. REV. 628, 639-40 (1970)).
122. See KATZ, supra note 1, at 74.
123. Scott v. Bradford, 606 P.2d 554 (Okla. 1979).
124. Id. at 559.
125. Id. at 558.
126. See id. at 559.
127. See id.
128. Bradford, 606 P.2d at 559 (emphasis in original).
129. See id. at 559.
130. Johnson v. Thompson, 971 F.2d 1487, 1499 (10th Cir. Okla. 1992); In re Baycol Prods. Litig., 2003 U.S. Dist. LEXIS 26846, at *22 (D. Minn. Feb. 25, 2003); Goss v. Okla. Blood Inst., 856 P.2d 998, 998 (Okla. Ct. App. 1990).
131. See, e.g., Masquat v. Maguire, 638 P.2d 1105 (Okla. 1981) (noting the lack of a causal link between unrevealed risk and injuries); Arena v. Gingrich, 733 P.2d 75, 79 (Or. Ct. App. 1987) ("[T]hat the test is subjective does not mean . . . that the only permissible determinants are the plaintiff's testimony and other evidence that pertains directly to the plaintiff's subjective choice").
132. See Masquat, 638 P.2d at 1107.
133. See id. at 1105.
134. See id. at 1106.
135. Id. at 1107.
136. See id. at 1106-07; Arena, 733 P.2d at 78.
137. See Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 122 (Tenn. 1999).
138. See id.; see also August Piper, Jr., Truce on the Battlefield: A Proposal for a Different Approach to Medical Informed Consent, J.L. MED. & ETHICS 301, 304-05 (1994).
139. See Ashe, 9 S.W.3d at 122.
140. See Scott, 606 P.2d at 559; Macy v. Blatchford, 8 P.3d 204, 210 (Or. 2000).
141. See infra Part XI.
142. Canterbury, 464 F.2d at 786.
143. Id. at 787.
144. See Scott, 606 P.2d at 559.
145. See infra Appendix A (listing patient-based states to include Alaska, California, Connecticut, District of Columbia, Georgia, Hawaii, Iowa, Louisiana, Maryland, Massachusetts, Mississippi, New Jersey, North Dakota, Oklahoma, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Washington, West Virginia and Wisconsin. The remaining two states, Minnesotta and New Mexico, have hybrid standards). See Appendix A for a more detailed description of the laws on a state-by-state basis.
146. Wennberg & Peters, supra note 1, at 925.
147. See id.
148. Id. at 934.
149. Dominick L. Frosch & Robert M. Kaplan, Shared Decision Making in Clinical Medicine: Past Research and Future Directions, 17 AM. J. PREVENTIVE MED. 285, 287 (1999).
150. See Deb Feldman-Stewart et al., The Information Required by Patients with Early-stage Prostate Cancer in Choosing Their Treatment, 87 BJU INT'L 218, 220-23 (2001).
151. See generally CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7 (concluding that health care varies with geography).
152. 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 (1999), available at http://www.dartmouthatlas.org/atlases/99Atlas.pdf;
153. John E. Wennberg & Alan Gittelsohn, Small Area Variations in Health Care Delivery: A Population-based Health Information System Can Guide Planning and Regulatory Decision-making, 182 SCIENCE 1102 (1973).
154. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 5, at 3.
155. Id. at 11-15; CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 107.
156. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 5.
157. CENTER FOR EVALUATIVE CLINICAL SCIENCES, supra note 5, at 3.
158. See CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 111-30 (for regions with below-average treatment rates for various procedures); see also Wennberg, supra note 7, at 2-3 (for data on the underuse of effective care).
159. Cf. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 38 (finding that the distribution of physician workforce in the United States did not change in any dramatic way from 1993-1996).
160. Wennberg, supra note 7, at 8.
161. Id. at 6-7.
162. Feldman-Stewart, supra note 8, at 47.
163. Id.
164. Id.
165. Id. at 46-47.
166. Id. at 47.
167. Id.
168. Wennberg, supra note 1, at 925.
169. See id. at 927-32.
170. Wennberg & Peters, supra note 9, at 927.
171. Id.
172. John E. Wennberg, Keynote Lecture at the Instit. for Health Care Improvement Nat'l Forum: Understanding Practice Patterns: A Focus on What the Quality Movement Can Do to Reduce Unwarranted Variations (Dec. 14, 2005) (transcript available at www.dartmouthatlas.org/atlases/lecture.shtm).
173. See Elizabeth A. McGlynn et al., The Quality of Health Care Delivered to Adults in the United States, 348 N. ENGL. J. MED., 2635, 2641-44 (2003) (indicating that on average, Americans receive about half of recommended medical care processes).
174. See Lane v. Candura, 376 N.E.2d 1232, 1233 (Mass. App. Ct. 1978).
175. See Wennberg & Peters, supra note 9, at 925-41; see also Annette M. O'Connor et al., Modifying Unwarranted Variations in Health Care: Shared Decision Making Using Patient Decision Aids, HEALTH AFF. (WEB EXCLUSIVE) 63, 63-72 (2004); Interview by Ben Moulton with Jack E. Wennberg, Co-Founder and Senior Policy Advisor of the Foundation for Informed Medical Decision Making (2006).
176. See Wennberg, supra note 164, at 9-14 (noting that doctors may treat patients with chronic hip, knee, and back conditions in more than one way).
177. Wennberg & Peters, supra note 9, at 928.
178. Id.
179. Id.
180. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 5, at 11-15.
181. Wennberg & Peters, supra note 9, at 928.
182. Viba Bhatnagar & Robert Kaplan, Treatment Options for Prostate Cancer: Evaluating the Evidence, 71 AM. FAM PHYSICIAN 1915, 1915 (2005).
183. Id. at 1916, 1918.
184. Id.
185. Id. at 1920.
186. Id.
187. Id.
188. See Bogardus et al., supra note 6, at 1037-41.
189. Wennberg, supra note 164, at 9.
190. Id.
191. Wennberg & Peters, supra note 9, at 930 (citing 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 (1999), available at http://www.dartmouthatlas.org/atlases/atlas_series.shtm).
192. Wennberg, supra note 164, at 10 (citing 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 (1999), available at http://www.dartmouthatlas.org/atlases/atlas_series.shtm).
193. See id.
194. Id. at 11.
195. Wennberg & Peters, supra note 1, at 932.
196. Frosch & Kaplan, supra note 141, at 287; see also Deb Feldman-Stewart et al., The Information Required by Patients With Early-Stage Prostate Cancer in Choosing Their Treatment, 87 BJU INT'L 218, 220-221 (2001).
197. Feldman-Stewart et al., supra note 8, at 49.
198. Id.
199. Id. An Index of Agreement was used to determine substantial agreement between patients and the threshold was set at 67% agreement. Id.
200. Canterbury, 464 F.2d at 787 (quoting Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 NW. U. L. REV. 628, 640 (1970)).
201. Frosch & Kaplan, supra note 141, at 286.
202. See supra Part V.
203. Id.
204. Wennberg, supra note 164, at 7.
205. See id.
206. O'Connor et al., supra note 167, at 63.
207. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 21.
208. Reed Abelson, Side Effects: A Stent Epidemic; Heart Procedure is Off the Charts in an Ohio City, N.Y. TIMES, Aug. 18, 2006, at A1.
209. Id.
210. Id.
211. Id.
212. Id.
213. Id.
214. Id.
215. Id.
216. Id.
217. Id.
218. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, passim.
219. Feldman-Stewart, supra note 8, at 49.
220. See infra notes 212-213 and accompanying text.
221. See Paul J. Feldstein, HEALTH POLICY ISSUES: AN ECONOMIC PERSPECTIVE ON HEALTH REFORM 38-46 (Health Administration Press & AUPHA Press 1999);
222. Tracy E. Miller & Carol R. Horowitz, Disclosing Doctors' Incentives: Will Consumers Understand and Value the Information?, 19 Health Affairs 149, 149-155 (2000);
223. Richard G. Frank, Behavioral Economics and Health Economics (Nat'l Bureau of Econ. Research, Working Paper No. 10881, 2004).
224. Kate T. Christensen, Ethically Important Distinctions Among Managed Care Organizations, 23 J.L. MED. & ETHICS 223, 224 (1995);
225. Eric S. Nadler et al., Does a Year Make a Difference? Changes in Physician Satisfaction and Perception in an Increasingly Capitated Environment, 107 AM. J. MED. 38, 38 (1999) (discussing capitation as financial incentive for physicians).
226. Feldstein, supra note 212, passim.
227. Center for the Evaluative Clinical Sciences, supra note 7, passim.
228. Id.
229. Wennberg & Peters, supra note 1, at 929.
230. See John E. Wennberg & Alan Gittelsohn, Small Area Variations in Health Care Delivery: A Population-Based Health Information System Can Guide Planning and Regulatory Decision-Making, 182 SCIENCE 1102 (1973) (finding regional variations in health care).
231. Karen R. Sepucha et al., Policy Support for Patient-Centered Care: The Need for Measurable Improvements in Decision Quality, HEALTH AFFAIRS, Oct. 7 2004, http://content.healthaffairs.org/cgi/reprint/ hlthaff.var.128v1.;
232. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, passim.
233. Beth Huntington & Nettie Kuhn, Communication Gaffes: A Root Cause of Malpractice Claims, 16 BAYLOR U. MED. CENTER PROC. 157,157-160 (2003) (attributing these problems to lack in physician communication);
234. Charles Vincent et al., Why Do People Sue Doctors? A Study of Patients and Relatives Taking Legal Action, 343 THE LANCET 1609, 1609 (1994) (discussing reasons patients take legal actions against doctors).
235. Piper, supra note 130, at 302.
236. Id.
237. Joseph P. Graskemper, The Standard of Care in Dentistry: Where Did It Come From? How Has It Evolved?, 135 J. AM. DENTAL ASS'N 1449, 1453-54 (2004).
238. Id.
239. See Merenstein, supra note 16, at 15-16.
240. Id.
241. Frosch & Kaplan, supra note 141, at 286.
242. Nadler et al., supra note 214, at 38.
243. Edward Guadagnoli & Patricia Ward, Patient Participation in Decision-Making, 47 SOC. SCI. & MED. 329, 332 (1998).
244. See supra pp. 446-448.
245. Id.
246. Id.
247. Id.
248. Canterbury, 464 F.2d at 788.
249. See supra pp. 446-448.
250. Bogardus et al., supra note 6, at 1039.
251. Id.; Woolf, supra note 15, at 244.
252. Frosch & Kaplan, supra note 141, at 287.
253. Id.
254. Joan Teno et al., Preferences for Cardiopulmonary Resuscitation: Physician-Patient Agreement and Hospital Resource Use, 10 J. GEN. INTERNAL MED. 179, 180 (1995); Woolf, supra note 15, at 244.
255. Teno et al., supra note 240, at 180.
256. Id. at 179.
257. Id. at 184; Frosch & Kaplan, supra note 141, at 287.
258. Teno et al., supra note 240, at 182-83.
259. Frosch & Kaplan, supra note 141, at 287; see supra pp. 2, 6.
260. Piper, supra note 130, at 303.
261. Id.
262. Id.
263. See id.
264. Bogardus et al., supra note 6 (discussing how doctors should approach informing patients of medical risks and the confusion surrounding their duty).
265. Katz, supra note 1, at 80 (citing McMullen v. Vaughn, 227 S.E.2d 40 (Ga. 1976); Woolley v. Henderson, 418 A.2d 1123 (Me. 1980); Bly v. Rhodes 222 S.E.2d 783 (Va. 1976)).
266. Id. at 80-82.
267. Jay Katz, Informed Consent - A Fairy-Tale?: Law's Vision, 39 U. PITT. L. REV. 137, 174 (1977).
268. See OFFICE OF PROGRAM AND POLICY INFORMATION, DIVISION OF CANCER PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND PREVENTION, State Laws Relating to Breast Cancer: Legislative Summary, January 1949 to May 2000 (2000) 3, available at http://www.cdc.gov/cancer/breast/pdf/BCLaws.pdf.
269. Id.
270. See id. The patient-based states are California, Louisiana, Maryland, Minnesota, Pennsylvania and Texas. The physician-based states are Florida, Kansas, Kentucky, Maine, Michigan, Montana, New York and Virginia.
271. See id.
272. See Angela Coulter, Editorial, Patient Information and Shared Decision-Making in Cancer Care, 89 BRIT. J. CANCER S15, S15 (Supp. 1 2003).
273. See id. at S15-S16; Angela Coulter & Paul D. Cleary, Patients' Experiences with Hospital Care in Five Countries, 20 HEALTH AFFAIRS 244, 247-48 (2001);
274. Richard Grol et al., Patients in Europe Evaluate General Practice Care: An International Comparison, 50 BRIT. J. GEN. PRAC. 882, 884-86 (2000).
275. See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.
276. See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.
277. See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.
278. Clarence H. Braddock et al., How Doctors and Patients Discuss Routine Clinical Decisions, 12 J. GEN. INTERNAL MED. 339, 340 (1997).
279. Id. at 339.
280. Id.
281. Id. at 342.
282. Id. at 344.
283. Id.
284. Id.
285. Id.
286. KATZ, supra note 1, at xiii-xxi. Wennberg & Peters, supra note 1, at 937; see also Angela Coulter, Editorial, Shared Decision-making: The Debate Continues, 8 HEALTH EXPECTATIONS 95-96 (2005).
287. See Steven H. Woolf et al., Promoting Informed Choice: Transforming Health Care to Dispense Knowledge for Decision Making, 143 ANNALS INTERNAL MED. 293, 293 (2005) (discussing the procedural and structural changes necessary to implement and difficulties in implementing shared decision-making in routine practice).
288. See Cathy Charles et al., Shared Decision-making in the Medical Encounter: What Does It Mean? (Or it Takes at Least Two to Tango), 44 SOC. SCI. & MED. 681, 687 (1997).
289. See generally Simon N. Whitney et al., A Typology of Shared Decision Making, Informed Consent, and Simple Consent, 140 ANNALS INTERNAL MED. 54 (2004) (distinguishing shared decision-making from the traditional legal doctrine of informed consent).
290. See Scott, 606 P.2d at 557.
291. See Charles, supra note 273, at 684 (suggesting that the requirements of share decision-making include interventions that not only provide patients with information, but also with a way of thinking about treatment decision-making that helps patients focus on key issues and evaluate relevant options).
292. Id. at 687.
293. See supra Part IV.B.2.a.
294. See supra Parts VA, V.A.3.
295. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 170-177; Feldman-Stewart, supra note 8, at 46-54.
296. One possible way of identifying minimally invasive, highly effective care is through the United States Preventative Services Task Force, which has created a system of evaluating medical treatments for invasiveness and effectiveness. See U.S. Preventative Services Task Force (USPSTF), http://www.ahrq.gov/clinic/uspstfix.htm (last visited May 1, 2006).
297. Cathy Charles et al., Treatment Decision Aids: Conceptual Issues and Future Directions, 8 HEALTH EXPECTATIONS 114, 114 (2005).
298. Foundation for Informed Medical Decision-Making, Decision Support and Shared Decision-Making, http://www.fimdm.org/decision_sdms.php (last visited August 30, 2006); see also Health Dialog, www.healthdialog.com (last visited August 30, 2006).
299. Id. For more information on how decision aids are created, see Foundation for Informed Medical Decision-Making, Decision Aids and Shared Decision-Making, Program Development and Updates, Foundation Procedures for Development of Decision Aids, www.fimdm.org/decision_sdms.php (last visited August 30, 2006).
300. Foundation for Informed Medical Decision-Making, supra note 283.
301. Id.
302. Id.
303. Annette O'Connor et al., Decision Aids for Patients Facing Health Treatment or Screening Decisions: Systemic Review, 319 BMJ 731, 732-733 (1999).
304. Woolf et al., supra note 272, at 296.
305. Id.
306. See Bogardus et al., supra note 6, at 1039-40.
307. See id. at 141.
308. Dartmouth Hitchcock Medical Center, Center for Shared Decision-Making, http://www.dhmc.org/webpage.cfm?site_id=2&org_id=108&gsec_id= 0&sec_id=0&item_id=2 486 (last visited Aug. 30, 2006).
309. Ottawa Health Research Institute, A-Z Inventory of Decision Aids, http://decisionaid.ohri.ca/AZinvent.php (last visited Aug. 30, 2006).
310. Id. We will discuss the importance of evaluating decision aids through methods like the CREDIBLE criteria in later in this section.
311. See Health Dialog, Collaborative Care, www.healthdialog.com/hd/ Core/CollaborativeCare/CCToolsResources.htm (last visited August 30, 2006).
312. See Health Dialog Awards, http://www.healthdialog.com/hd/ Ancillary/Aboutus/awards.htm (last visited Oct. 11, 2006) (listing awards Health Dialog's communications materials have received).
313. See Health Dialog History, http://www.healthdialog.com/hd/ Ancillary/Aboutus/history.htm (last visited Oct. 11, 2006).
314. Interview with Jack E. Wennberg, supra note 167.
315. See Foundation for Informed Medical Decision-Making, supra note 283.
316. See id.
317. See id.
318. See id.
319. Interview by Ben Moulton with Floyd J. Fowler Jr., President of the Foundation for Informed Medical Decision Making (2006).
320. The Cochrane Collaboration, Library Introduction, http://www.cochrane. org/reviews/clibintro.htm (last visited October 14, 2006).
321. Id.
322. See Frosch & Kaplan, supra note 141, at 291.
323. See O'Connor et al., supra note 167, at 64.
324. See id.
325. Frosch, supra note 141, at 287; Pamela J. McCabe & Penny Kalpin, Bold Voices in Progressive Care Using Shared Decision Making to Implement Evidence-Based Practice in Progressive Care, 25 CRITICAL CARE NURSE 76, 76 (2005); O'Connor et al., supra note 141, at 63-64.
326. See Natanson, 350 P.2d at 1104.
327. Cruzan v. Dir., Mo. Dept. of Health, 497 U.S. 261, 278 (1990).
328. Gonzales v. Oregon, 126 S. Ct. 904 (2006).
329. Id. at 904.
330. Teno et al., supra note 240, at 183-84.
331. See id. at 184-85.
332. Canterbury, 464 F.2d at 787 (citing Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 NW.U. L. REV. 628, 639-40 (1970)).
333. Guadagnoli & Ward, supra note 229, at 332 (1998).
334. Dennis J. Mazur & David H. Hickam, Patients' Preferences for Risk Disclosure and Role in Decision Making for Invasive Medical Procedures, 12 J. GEN. INTERNAL MED. 114, 116 (1997).
335. Wendy Levinson et al., Not All Patients Want to Participate in Decision Making: A National Study of Public Preferences, 20 J. GEN. INTERNAL MED. 531, 532 (2005).
336. James L. Bernat & Lynn M. Peterson, Patient-Centered Informed Consent in Surgical Practice, 141 ARCHIVES OF SURGERY 86, 87 (2006);
337. Dennis J. Mazur et al., The Role of Doctor's Opinion in Shared Decision Making: What Does Shared Decision Making Really Mean When Considering Invasive Medical Procedures?, 8 HEALTH EXPECTATIONS 97, 102 (2005).
338. David S. Brody et al., Patient Perception of Involvement in Medical Care: Relationship to Illness Attitudes and Outcomes, 4 J. GEN. INTERNAL MED. 506, 510 (1989);
339. Angela Coulter, Assembling the Evidence: Patient-Focused Outcomes Research, 11 HEALTH LIBR. REV. 263, 264 (1994); Levinson, supra note 320, at 531.
340. Guadagnoli & Ward, supra note 229, at 332; Sherrie H. Kaplan et al., Assessing the Effects of Physician-Patient Interactions on the Outcomes of Chronic Disease, 27 MED. CARE S110, S118-19 (Supp. 1989).
341. See David S. Brody et al., supra note 322, at 510; David S. Brody et al., The Relationship Between Patients' Satisfaction With Their Physicians and Perceptions About Interventions They Desired and Received, 27 MED. CARE 1027, 1032-33 (1989);
342. B.J. Evans et al., A Communications Skills Programme for Increasing Patient Satisfaction with General Practice Consultations, 60 BRIT. J. MED. PSYCHOL. 373, 373-378 (1987);
343. L.J. Fallowfield et al., Psychological Outcomes of Different Treatment Policies in Women with Early Breast Cancer Outside A Clinical Trial, 301 BRIT. MED. J. 575, 577-79 (1990); Guadagnoli, supra note 318, at 333-335
344. (citing J. Ashcroft et al., Mastectomy vs. Breast Conservation: Psychological Effects of Patient Choice of Treatment, in PSYCHOLOGICAL ISSUES IN MALIGNANT DISEASE 55-71 (M. Watson & S. Creer eds. 1986)).
345. Brody et al., supra note 322, at 510. The 'p' value associated with each result indicates the level of statistical significance. Typically, statistically significant results must have a 95% or higher probability that the results in the given data did not occur by chance. A 'p' value of .05 signifies that there is a 95% probability that the finding of these results did not occur by chance. Generally, in order to have statistical signicance, 'p' must be less than or equal to .05.
346. J. Morris & G. Royle, Choice of Surgery for Early Breast Cancer: Pre and Postoperative Levels of Clinical Anxiety and Depression in Patients and Their Husbands, 74 BRIT. J. SURGERY 1017, 1018 (1987).
347. Id.
348. Gail C. Webber, Patient Education: A Review of the Issues, 28 MED. CARE 1089, 1099 (1990).
349. Kaplan, supra note 323, at S119-120; P. Mendonca & S. Brehm, Effects of Choice on Behavioral Treatment of Overweight Children, 1 J. SOC. CLINICAL PSYCHOL. 343, 343-358 (1983);
350. Beryl A. Schulman, Active Patient Orientation and Outcomes in Hypertensive Treatment, 17 MED. CARE 267, 270 (1979).
351. Shulman, supra note 329, at 269-270.
352. Id. at 271-72.
353. Kaplan, supra note 323, at S120.
354. Id.
355. Id.
356. Guadagnoli & Ward, supra note 229, at 332.
357. Id.; Kaplan, supra note 323, at S118-19.
358. Coulter, supra note 322, at 265.
359. Id. at 268.
360. Nancy L. Keating et al., Treatment Decision Making in Early-Stage Breast Cancer: Should Surgeons Match Patients' Desired Level of Involvement?, 20 J. CLINICAL ONCOLOGY 1473, 1473 (2002).
361. Id. at 1476.
362. Id. at 1475.
363. Id. at 1476.
364. Id. at 1475-76.
365. Id. at 1476.
366. Id.
367. Id.
368. Huntington & Kuhn, supra note 220, at 160; Vincent et al., supra note 220, at 1613; Woolf et al., supra note 272, at 298.
369. Bernat & Peterson, supra note 321, at 87.
370. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 5, at 5.
371. Id.
372. Feldstein, supra note 212, at 115-19.
373. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 144, at 226.
374. Maria J. Silveira & Chris Feudtner, Letter to the Editor, Shared Medical Decision-Making, 293 JAMA 1058, 1058 (2005); Woolf et al., supra note 272, at 295; Woolf & Krist, supra note 13, at 1871.
375. Woolf et al., supra note 74, at 294-95.
376. See Woolf & Krist, supra note 13, at 1871-72.
377. Braddock et al., supra note 263, at 339-345; Woolf et al., supra note 272, at 295; Woolf & Krist, supra note 13, at 1871.
378. Foundation for Informed Medical Decision Making, Research Agenda, http://www.fimdm.org/research_agenda.php (last visited October 18, 2006).
379. Woolf & Krist, supra note 13, at 1871.
380. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 144, at 226-27.
381. See Woolf et al., supra note 347, at 295; see also David Blumenthal, Decisions, Decisions: Why the Quality of Medical Decisions Matters, HEALTH AFF. (WEB EXCLUSIVE) VAR 124, VAR 126-127 (2004).
382. Huntington & Kuhn, supra note 220, at 157.
383. Vincent et al., supra note 220, at 1612 (finding the breakdown of those for whom some form of communication would have prevented a lawsuit to be as follows: explanation and apology 37%; admission of negligence 14%; listened and not treated as neurotic 5%; and honesty 4%).
384. Huntington & Kuhn, supra note 220, at 157.
385. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 5, at 6.
386. The Cochrane Collaboration, http://www.cochrane.org (last visited Oct. 18, 2006);
387. Health Dialog, http://www.healthdialog.com/hd (last visited Oct. 18, 2006);
388. The Ottawa Health Research Institute, http://decisionaid.ohri.ca/index. html (last visited Oct. 18, 2006).
389. Michael J. Barry, Health Decision Aids to Facilitate Shared Decision Making in Office Practice, 136 ANNALS INTERNAL MED. 127, 133 (2002) (noting that the cost effectiveness of shared decision making has not been studied).
390. Coulter, supra note 322, at 263; Feldman-Stewart et al., supra note 8, at 52.
391. Woolf et al., supra note 272, at 295; see also Center for Information Therapy, http://www.informationtherapy.org (last visited March 29, 2006).
392. Woolf et al., supra note 272, at 295.
393. Frank, supra note 212, at 8; see also INST. OF MED., CROSSING THE QUALITY CHASM: A NEW HEALTH SYSTEM FOR THE TWENTY-FIRST CENTURY 32 (National Academies Press 2001).
394. Frank, supra note 212, at 8.
395. Feldman-Stewart et al., supra note 8, at 47-49.
396. Bogardus et al., supra note 6, at 1037; Woolf et al., supra note 272, at 295.
397. Bogardus et al., supra note 6, at 1037-1041.
398. See Baruch Fischoff, Risk Perception and Communication Unplugged: Twenty Years of Progress, 15 RISK ANALYSIS 137, 1937-45 (1995);
399. Baruch Fischoff et al., Risk Perception and Communication, 14 ANN. REV. PUB. HEALTH 183, 186-190 (1993).
400. Bogardus et al., supra note 6, at 1040; Amos Tversky & Daniel Kahneman, Availability: A Heuristic For Judging Frequency And Probability, 5 COGNITIVE PSYCHOL. 207, 207-32 (1973).
401. Bogardus et al., supra note 6, at 1040; Frank, supra note 212, at 14-20.
402. Feldman-Stewart et al., supra note 8, at 47.
403. O'Connor et al., supra note 288, at 733; Woolf et al., supra note 272, at 295-298.
404. Michael J. Green et al., Effect of a Computer-Based Decision Aid on Knowledge, Perceptions, and Intentions about Genetic Testing for Breast Cancer Susceptibility, 292 JAMA 442, 445-449 (2004);
405. A.G.W. Hunter et al., A Randomized Trial Comparing Alternative Approaches To Prenatal Diagnosis Counseling In Advanced Maternal Age Patients, 67 CLINICAL GENETICS 303, 303 (2005).
406. Woolf et al., supra note 272.
407. KATZ, supra note 1, at 168-75.
408. Coulter, supra note 322, at 264.
409. KATZ, supra note 1, at 204-05.
410. Levinson et al., supra note 320, at 533; Geraldine M. Leydon et al., Cancer Patients' Information Needs and Information Seeking Behaviour: In Depth Interview Study, 320 BMJ 909, 911, 913 (2000).
411. Levinson et al., supra note 385, at 532.
412. Id.
413. Id. at 531-35; Woolf & Krist, supra note 13, at 1872.
414. Teno et al., supra note 240, at 183-84.
415. See infra Part X.
416. Dara J. Kilmartin et al., Commentary: Sympathetic Ophthalmia Risk Following Vitrectomy: Should We Counsel Patients?, 84 BRIT. J. OPTHALMOLOGY, 448, 448-49 (2000).
417. See supra notes 36-37 and accompanying text.
418. Alan Meisel & Mark Kuczewski, Legal and Ethical Myths About Informed Consent, 156 ARCHIVES INTERNAL MED., 2521, 2525 (1996).
419. Bogardus et al., supra note 6, at 1039.
420. Feldman-Stewart et al., supra note 8, at 49.
421. Vibha Bhatnagar & Robert M. Kaplan, Treatment Options for Prostate Cancer: Evaluating the Evidence, 71 AM. FAM. PHYSICIAN, 1915, 1918 (2005).
422. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 7, at 18.
423. Feldman-Stewart et al., supra note 8, at 48-49.
424. Feldman-Stewart et al., supra note 142, at 221.
425. Id.
426. See id. at 222.
427. Bernat & Peterson, supra note 321, at 88; Meisel & Kuczewski, supra note 393.
428. Feldman-Stewart et al., supra note 142, at 218-223.
429. Foundation for Informed Medical Decision-Making, www.fimdm.org (last visited Aug. 30, 2006);
430. Health Dialog, www.healthdialog.com (last visited Aug. 30, 2006).
431. Wennberg, supra note 164, at 15.
432. See, e.g., Arnold J. Rosoff, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. HEALTH POL. POL'Y & L. 327 (2001).
433. See National Committee for Quality Assurance, NCQA Report Cards, http://hprc.ncqa.org/menu.asp (last visited August 30, 2006).
434. Wennberg, supra note 7, at 15.
435. Id.
436. Id.
437. See Annette M. O'Connor et al., Decision Aids for People Facing Health Treatment or Screening Decisions, 1 COCHRANE DATABASE SYSTEMATIC REVS. 1 (2003), available at http://decisionaid.ohri.ca/docs/Cochrane_Review.pdf (evaluating over two hundred decision aids using the CREDIBLE criteria).
438. Ottawa Health Research Institute, CREDIBLE Criteria, http://decisionaid. ohri.ca/cred.html (last visited Mar. 15, 2006).
439. CENTER FOR THE EVALUATIVE CLINICAL SCIENCES, supra note 5, at 6.
440. Coulter, supra note 322, at 268; Feldman-Stewart et al. supra note 8, at 53.
441. Coulter, supra note 322, at 263-64.
442. Feldman-Stewart et al. supra note 8, at 52.