Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law

Thaddeus Mason Pope

doi:10.1177/1073110517703097

Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law

Published online by Cambridge University Press: 01 January 2021

Thaddeus Mason Pope

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Abstract

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

Type: Symposium Articles
Information: Journal of Law, Medicine & Ethics , Volume 45 , Issue 1: Under Attack: Reconceptualizing Informed Consent , Spring 2017 , pp. 12 - 40

DOI: https://doi.org/10.1177/1073110517703097 [Opens in a new window]
Copyright: Copyright © American Society of Law, Medicine and Ethics 2017

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References

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To be fair, physicians may have “technically” disclosed more information than the outcomes measures reflect. But health literacy is so low that patient's may not have comprehended or absorbed the information. National Center for Education Statistics, available at <https://nces.ed.gov/naal/health.asp> (last visited January 31, 2017). (last visited January 31, 2017).' href=https://scholar.google.com/scholar?q=To+be+fair,+physicians+may+have+“technically”+disclosed+more+information+than+the+outcomes+measures+reflect.+But+health+literacy+is+so+low+that+patient's+may+not+have+comprehended+or+absorbed+the+information.+National+Center+for+Education+Statistics,+available+at++(last+visited+January+31,+2017).>Google Scholar

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See, e.g., Mohr v. Williams, 104 N.W. 12, 13 (Minn. 1905); Rolater v. Strain, 137 P. 96 (Okla. 1913); Schloendorff v. Soc'y N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).Google Scholar

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See Pope, T. M., “Voluntarily Stopping Eating and Drinking: A Legal Treatment Option at the End of Life,” Widener Law Review 17, no. 2 (2011): 363, 402-407 (analyzing battery claims for unwanted treatment); DiGeronimo v. Fuchs, 927 N.Y.S.2d 904, 908 (N.Y. Sup. Ct. 2011), affirmed, in part, 2011-08304, 2012 LEXIS 8613 (N.Y. App. Div. Dec. 19, 2012) (noting that “[a]dministering a blood transfusion without informed consent is best characterized as a battery”) (citing Salandy v. Bryk, 864 N.Y.S.2d 46 (N.Y. App. Div. 2008)).Google Scholar

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See, e.g., Scholendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914) (addressing patient consented to biopsy, not surgery); Pizzalotto v. Wilson, 437 So. 2d 859 (La. 1983) (addressing patient consented to exploratory surgery, not removal of reproductive organs); Perna v. Pirozzi, 457 A.2d 431 (N.J. 1983) (consenting to operation with only one specific doctor); Paulsen v. Gunderson, 260 N.W. 448 (Wis. 1935) (analyzing patient consent to a “simple” ear operation, and instead underwent a “radical” ear operation); Franklyn v. Peabody, 228 N.W. 681 (Mich. 1930) (operating on thumb without consent); Gill v. Selling, 267 P. 812 (Ore. 1928) (performing spinal puncture on wrong patient), overruled by Fredeen v. Stride, 525 P.2d 166 (Ore. 1974); Hively v. Higgs, 253 P. 363 (Ore. 1927) (noting removal of tonsils during septum operation); Hershey v. Peake, 223 P. 1113 (Kan. 1924) (concerning wrong tooth); Throne v. Wandell, 186 N.W. 146 (Wis. 1922) (addressing patient consent to examination, not extraction of six teeth); Moos v. U.S., 225 F.2d 705 (8th Cir. 1955) (operating on wrong leg); Kaplan v. Mamelak, 75 Cal. Rptr. 3d 861 (Cal. Ct. App. 2008) (operating on wrong spinal disk); Perry v. Shaw, 106 Cal. Rptr. 2d 70, 72 (Cal. Ct. App. 2001) (concerning patient consent to removal of excess skin, not breast augmentation); Ashcraft v. King, 278 Cal. Rptr. 900 (Cal. Ct. App. 1991) (analyzing patient imposed condition on consent); Bommareddy v. Superior Ct., 272 Cal. Rptr. 246 (Cal. Ct. App. 1990) (concerning patient agreed to tear duct surgery, not cataract extraction); Lane v. U.S., 225 F. Supp 850 (E.D. Va. 1964) (addressing surgery on wrong knee); McCoid, A. H., “A Reappraisal of Liability for Unauthorized Medical Treatment,” Minnesota Law Review 41, no. 4 (1957): 381-434.Google Scholar

In re Dinnerstein, 380 N.E.2d 134, 135-36 (Mass. App. 1978); see also Meisel, Cerminara & Pope § 6.02 (collecting cases); see Markart v. Zeimer, 227 P. 683 (Cal. App. 1924) (concerning removal of testicle).Google Scholar

D. B. Dobbs, The Law of Torts § 33, at 81 (St. Paul: West Academic, 2000) (“It is enough that the defendant intends bodily contact that is ‘offensive,’ which is to say a bodily contact that does not appear acceptable to the plaintiff.”); Moore, N. J., “Intent and Consent in the Tort of Battery: Confusion and Controversy,” American University Law Review 61, no. 6 (2012): 1585-1656, at 1595; Horace, “Ars Poetica,” line 467 (Transl. A.S. Kline 2005) (“[W]ho saves one, against his will, murders him”).Google Scholar

See, e.g., Mohr, 104 N.W. at 15 (requiring consent in non-emergency situations), overruled in part by Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957); Restatement (Second) of Torts §§ 892, illus. 1, at 435 (1965); see also Montgomery v. Bazaz-Seghal, 742 A.2d 1125, 1130 (Pa. Super. Ct. 1999), aff ’d, 798 A.2d 742 (Pa. 2002) (discussing urologist implanted penile prosthesis without patient's knowledge or consent); Taylor v. Johnston, 985 P.2d 460 (Alaska 1999) (obtaining patient consent by fraud); Millard v. Nagle, 587 A.2d 10 (Pa. 1991) (seeking damages for unauthorized surgery despite physician intention); Perna v. Pirozzi, 457 A.2d 431, 439 (N.J. 1983) (“A nonconsensual operation remains a battery even if performed skillfully and to the benefit of the patient.”); Pugsley v. Privette, 263 S.E.2d 69 (Va. 1980) (holding that unconsented medical treatment constitutes a battery, even though such medical treatment may be beneficial to the plaintiff); Rogers v. Lumbersmens Mut. Casualty Co., 119 So. 2d 649 (La. 1960); Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957) (performing surgery without consent is battery); Kennedy v. Parrott, 90 S.E.2d 754 (N.C. 1956) (analyzing causation between doctor's action and patient's harms in battery action); Franklyn v. Peabody, 228 N.W. 681 (Mich. 1930) (operating on patient's right thigh without consent to obtain tissue for a procedure on patient's thumb constitutes battery); Perry v. Hodgsen, 148 S.E. 659 (Ga. 1929) (noting patient consent required unless emergency); Barrette v. Lopez, 725 N.E.2d 314 (Ohio Ct. App. 1999) (distinguishing medical negligence from battery); Rodriguez v. Pino, 634 So. 2d 681 (Fla. Dist. Ct. App. 1994) (holding physician not liable for patient's refusal to consent); Lounsbury v. Capel, 836 P.2d 188, 199 (Utah Ct. App. 1992) (remanding for damages even though surgery somewhat beneficial); Estate of Leach v. Shapiro, 469 N.E.2d 1047, 1051 (Ohio Ct. App. 1984) (“A physician who treats a patient without consent commits a battery, even though the procedure is harmless or beneficial.”); Mims v. Boland, 138 S.E.2d 902 (Ga. Ct. App. 1964) (recognizing physician treatment without consent is guilty of technical battery); McCandless v. State, 162 N.Y.S.2d 570 (N.Y. App. Div. 1957) (affirming $2,000 in damages even though procedure less harmful and improved patient's mental health); Church v. Adler, 113 N.E.2d 327 (Ill. App. Ct. 1953) (reviewing cause of medical negligence); Mulloy v. Hop Sang, 1 W.W.R. 714 (Can. A.R. 1935) (holding that even a successful operation, contrary to patient instructions, was still a battery).Google Scholar

Dobbs, supra note 31, at 80 (“Even beneficial touchings such as medical procedures may warrant damages if they are batteries.”). The Second Restatement of Torts provides an applicable example: A has a wart on his neck. His physician, B, advises him to submit to an operation for its removal. A refuses to do so. Later A consents to another operation…B removes the wart. The removal in no way affects A's health, and is in fact beneficial. A has suffered bodily harm. Restatement (Second) of Torts § 15, illus. 1 (1965).Google Scholar

See Meisel, Cerminara & Pope § 2-24 n.104; Chambers v. Nottebaum, 96 So. 2d 716 (Fla. Dist. Ct. App. 1957) (concerning lack of consent for spinal anesthesia); Corn v. French, 289 P.2d 173 (Nev. 1955) (alleging mastectomy without consent); Woodson v. Huey, 261 P.2d 199 (Okla. 1953) (affirming need for consent to give anesthesia); Tabor v. Scobee, 254 S.W.2d 474 (Ky. Ct. App. 1952) (addressing removal of fallopian tubes during operation for appendicitis); Williams, 104 N.W. at 15-16 (discussing operation on left ear but consent obtained only for right ear), overruled in part by Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957); Rolater v. Strain, 137 P. 96 (Okla. 1913) (addressing removal of sesamoid bone without consent); Hively v. Higgs, 253 P. 363 (Or. 1927) (addressing removal of tonsils with only consent for septum surgery); Wells v. Van Nort, 125 N.E. 910 (Ohio 1919) (analyzing physician decision to remove fallopian tubes); Schloendorff v. Soc'y N.Y. Hosp., 105 N.E. 92 (N.Y. 1914) (addressing unauthorized surgery), abrogated by Bing v. Thunig, 143 N.E.2d 3 (1957); Sekerez v. Rush Univ. Med. Ctr., 954 N.E.2d 383 (Ill. App. Ct. 2011) (reversing directed verdict for defendants who administered Lovenox to terminally ill cancer patient against his stated and documented wishes); Gragg v. Calandra, 696 N.E.2d 1282, 1290 (Ill. App. Ct. 1998) (“Although a defendant may reasonably believe that his objective is legitimate, it does not provide him with carte blanche to pursue that objective by outrageous means.”); Kaplan v. Blank, 419 S.E.2d 127 (Ga. Ct. App. 1992) (claiming lack of written consent for tubal ligation); Markart v. Zeimer, 227 P. 683 (Cal. Ct. App. 1924) (reviewing negligence in hernia surgery).Google Scholar

Medical associations and policymakers are focused on identifying commonly performed tests and procedures that offer little or no clinical benefit. This is a great start on reducing overuse and improving healthcare quality. But it is not enough. Benefit is a function not only of medical science but also of patient preferences. Schwartz, A. L. et al., “Measuring Lower-Value Care in Medicare,” JAMA Internal Medicine 174, no. 7 (2014): 1067-1076.Google Scholar

Moore at 1611, 1621; Curtis v. Jaskey, 326 Ill. App. 3d 90, 94 (2001) (noting that it is unnecessary for plaintiff to prove defendant physician had hostile intent); McNeil v. Brewer, 304 Ill. App. 3d 1050, 1154-55 (1999).Google Scholar

Dobbs, supra note 31, at 342 (“Even beneficial…medical procedures warrant damages if they are batteries.”). “A person is entitled to refuse well-intentioned medical treatment.” Id., at § 29, at 54; see Urlaub v. Select Specialty Hosp. Memphis, No. W2010-00732-COA-R3-CV, 2011 WL 255281 1, 6 (Tenn App. Jan. 20, 2011) (administering dialysis contrary to instructions could constitute a battery by not following the standard of care necessitated by informed consent); Mink v. Univ. Chicago, 460 F. Supp. 713, 717 (N.D. Ill. 1978); Beane v. Perley, 109 A.2d 848, 850 (N.H. 1954) (recognizing the difficulty in providing medical expert testimony as required in malpractice suits). But see Pleasure v. Louisiana Organ Procurement Ass'n, 83 So. 3d 174 (La. App. 2011) (affirming judgment that continuing life-support and removing organs without consent sounded in medical malpractice), rev. denied, 85 So. 3d 1248 (La. 2012). While the conferral of “benefit” by the unwanted treatment does not affect the cause of action, it is considered in determining the amount of the award. Harper, F. V. et al., Harper, James and Gray on Torts, 3d ed. (New York: Aspen, 2006): at 348. Nevertheless, it is problematic to characterize as a “benefit” a state of life the person living that life finds intolerable.Google Scholar

As litigation costs decrease, clinician compliance rates should rise. Hylton, K. N., “Litigation Cost Allocation Rules and Compliance with the Negligence Standard,” Journal of Legal Studies 22, no. 2 (1993): 457-476, at 459.Google Scholar

See Dobbs, supra note 31, at § 42, at 79 (“When the trespassory tort causes no physical harm, the traditional tort rule is that the plaintiff can nevertheless recover substantial as distinct from nominal damages…The invasion of the plaintiff's rights is regarded as harm in itself…”); id., § 100, at 234 n.17 (“The difference is that a battery is actionable without proof of bodily harm or economic loss; the offensive touching is harm in itself.”); id., § 28, at 54 (“Battery today vindicates the plaintiff's rights of autonomy and self-determination, her right to decide for herself how her body will be treated by others”); B v. NHS Hosp. Trust [2002] EWHC 429 (awarding £100 nominal damages).Google Scholar

See, e.g., Whitley-Woodford v. Jones, 600 A.2d 946, 947-48 (N.J. Super. Ct. App. Div. 1992) (noting that an operation undertaken without consent, even if perfectly performed with good medical results, may entitle the plaintiff to at least nominal damages and even punitive damages).Google Scholar

This has been confirmed in battery cases involving life-sustaining treatment. See generally Shandell, R. E. and Smith, P., The Preparation and Trial of Medical Malpractice Cases § 1.06[6] (New York: Law Journal Press, 2006); Gragg v. Calandra, 696 N.E.2d 1282, 1286 (Ill. App. 1998); Russell v. Murphy, 86 S.W.3d 745, 748-50 (Tex. App. 2002) (holding medical standards irrelevant where anesthesiologist administered sedative despite patient's specific request for local anesthetic); Jones v. Ruston La. Hosp. Co., 71 So. 3d 1154 (La. App. 2011) (holding Medical Malpractice Act and review by “medical review panel” inapplicable where clinician resuscitated Agnes Liles despite “knowledge of the DNR order”); Abeyta v. HCA Health Servs. of Tenn., No. M2011–02254–COA–R3–CV, 2012 WL 5266321 (Tenn. App. Oct. 24, 2012) (having not filed a certificate of good faith did not amount to malpractice, but ordinary negligence, not requiring expert testimony). But cf. Shuler v. McGrew, No. 12–2003–STA–dkv, 2012 WL 3260685 1, 6 (W.D. Tenn. Aug. 8, 2012) (holding that administration of Heparin over patient's objections was not battery because it was a “component part of the treatment process” and providers had patient's consent to be treated at the hospital).Google Scholar

See Harper et al., supra note 37, at § 3.10, at 351.Google Scholar

See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972); Cobbs v. Grant, 8 Cal.3d 229 (1972); Holt v. Nelson, 523 P. 2d 211 (Wash. 1974); Riedinger v. Colburn, 361 F. Supp. 1073 (D. Idaho 1973); Scaria v. St. Paul Fire & Marine Ins. Co., 227 N.W.2d 647 (Wis. 1975); Sard v. Hardy, 379 A.2d 1014, 1021 (Md. 1977). A handful of cases had earlier articulated a theory of informed consent. See, e.g., Salgo v. Leland Stanford, Jr., University Board of Trustees, 154 Cal. App. 2d 560, 317 P. 2d 170 (Dist. Ct. of App. 1957); Natanson v. Kline, 186 Kan. 393, 402, 350 P.2d 1093, 1100 (1960). But the doctrine was not more fully articulated and more widely adopted until the 1970s. Cf. Krause, J. H., “Reconceptualizing Informed Consent in an Era of Cost Containment,” Iowa Law Review 85, no. 1 (1999): 261-386, at 270-271.Google Scholar

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In some states, there is no common law duty of informed consent. It exists solely as a matter of statute and is often more narrowly circumscribed. Alicea (Ga. 2016); Pruette v. Ungarino, No. A131833 (Ga. App. 27 Mar. 2014); Pagani v. Weiss, No. J-A05017-14 (Penn. Super. Ct. 27 Mar. 2014). See also Sawicki, N. N., “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” University of Illinois Law Review 2016, no. 3 (2016): 821-872 (collecting citations from Iowa, Louisiana, and Pennsylvania).Google Scholar

The most salient enforcement of informed consent obligations occurs through medical malpractice litigation. But there are other mechanisms to enforce clinicians' obligation to obtain informed consent. The state medical boards are particularly frequent enforcers of informed consent duties. Miller, T., “Informed Consent: A Medical Board Analysis,” Journal of Medical Regulation 96, no. 3 (2010): 16-22. For example, the Maine Board of Licensure in Medicine recently reported that approximately one-third of the cases it investigates each year includes allegations of failure to obtain adequate and meaningful informed consent. D. Nyberg, “Obtaining Meaningful Informed Consent: Guidelines from the Maine Board of Licensure in Medicine,” Journal of Medical Regulation 99, no. 3 (2013): 18-21. Similarly, a recent report by the Wisconsin Medical Examining Board reviewed eleven years of final decisions and orders by the board. This report shows that informed consent violations were one of the most common reasons for discipline. Furthermore, Maine and Wisconsin are not alone. Other state medical boards have also been regularly enforcing informed consent duties. In re George Der Mesropian, No. 13-418, 2013 WL 6869796 (N.Y. Board of Professional Medical Conduct 16 Dec. 2013); In re Richard Godt, No. 13-181, 2013 WL 3288372 (N.Y. Board of Professional Medical Conduct 14 June 2013); J.V. v. D.G.C., 2013 CanLII 40382 (ON HPARB); Fitness to Practice Medicine: Robert Theodore Henri Kees Trossel, General Medical Council (29 Sept. 2010). While rare, breaches of informed consent have sometimes resulted in criminal liability. T.M. Pope and M. Hexum, “Legal Briefing: Informed Consent in the Clinical Context,” Journal of Clinical Ethics 25, no. 2 (2014): 152-174.Google Scholar

See King and Moulton, supra note 44. This article includes an appendix of state informed consent laws. Similar appendices can be found in other recent articles. Studdert, D. M. et al., “Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks,” Journal of Empirical Legal Studies 4, no. 1 (2007): 103-124; W.G. Cobb, “Defending the Informed Consent Case,” Defense Counsel Journal 72, no. 4 (2005): 330-346. Some states, like Minnesota, are identified as using a “modified” or “hybrid” approach.Google Scholar

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See, e.g., Wheeldon v. Madison, 374 N.W.2d 367, 374 (S.D. 1985); Largey v. Rothman, 540 A.2d 504, 508 (N.J. 1988); Cross v. Trapp, 294 S.E.2d 446, 455 (W. Va. 1982). Cf. Montgomery v. Lanarkshire Health Board, [2015] UKSC 11 ¶ 46 (“The doctor cannot form an objective, “medical” view of these matters, and is therefore not in a position to take the “right” decision as a matter of clinical judgment.”); id. ¶ 115 (“[A] responsible body of medical opinion, becomes quite inapposite. A patient is entitled to take into account her own values, her own assessment of the comparative merits.”). Recognizing the subjectivity of benefit, many encourage clinicians to do as much as possible “for” the patient and as little as possible “to” the patient.Google Scholar

See, e.g., Jandre v. Physicians Ins. Co., 340 Wis.2d 31, 813 N.W.2d 627 (2012). See generally Derse, A. R., “Flying Too Close to the Sun: Lessons Learned from the Judicial Expansion of the Objective Patient Standard for Informed Consent in Wisconsin,” Journal of Law, Medicine & Ethics 45, no. 1 (2017): 51-59.CrossRef Google Scholar

Wis. A.B. 139 (2013), enacted as 2013 Wis. Acts 111, amending Wis. Stat. § 448.30.Google Scholar

Id.Google Scholar

Wisconsin Department of Safety and Professional Services, Analysis of Proposed Order of the Medical Examining Board (May 21, 2014), available at <http://dsps.wi.gov/Documents/Board%20Services/Agenda%20Materials/Medical/2014/20140521%20MED%20Open%20Session.pdf> (last visited January 31, 2017). See also A. Szczygiel, “Beyond Informed Consent,” 21 Ohio Northern University Law Review 21, no. 1 (1994): 171-262; J. L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” Cambridge Quarterly Healthcare Ethics 19, no. 1 (2010): 97-109, at 101 (noting how other state legislatures replaced court adopted reasonable patient standard with the professional standard, and noting how that standard is preferred by physicians).+(last+visited+January+31,+2017).+See+also+A.+Szczygiel,+“Beyond+Informed+Consent,”+21+Ohio+Northern+University+Law+Review+21,+no.+1+(1994):+171-262;+J.+L.+Dolgin,+“The+Legal+Development+of+the+Informed+Consent+Doctrine:+Past+and+Present,”+Cambridge+Quarterly+Healthcare+Ethics+19,+no.+1+(2010):+97-109,+at+101+(noting+how+other+state+legislatures+replaced+court+adopted+reasonable+patient+standard+with+the+professional+standard,+and+noting+how+that+standard+is+preferred+by+physicians).>Google Scholar

The plaintiffs may also have to contend with the physicians' argument that one or more “exceptions” applies.Google Scholar

For both an overview and in-depth analysis of informed consent law, see Rozovsky, F. A., Consent to Treatment: A Practical Guide, 4th ed. (New York: Wolters-Kluwer, 2009); S. E. Pegalis, American Law of Medical Malpractice, 3rd ed. (St. Paul: Thomson/West, 2009): at chap. 4.Google Scholar

On some measures, the impact was dramatic. In 1961, 90% of physicians refrained from telling patients about a cancer diagnosis. By 1979, that dropped to just 2%. See Dolgin, supra note 53, at 100 (citing Oken, D., “What to Tell Cancer Patients: A Study of Medical Attitudes,” JAMA 175, no. 13 (1961): 1120-1128; D. H. Novack et al., “Changes in Physicians' Attitudes toward Telling the Cancer Patient,” JAMA 241, no. 9 (1979): 897-900.Google Scholar

See supra notes 4 to 12. Indeed, some of the limitations were recognized early on. See President's Commission for the Study of Ethical Problems in Medicine, Making Health Care Decisions A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship Volume One: Report (October 1982).Google Scholar

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See, e.g., D. Merenstein, “A Piece of My Mind: Winners and Losers,” JAMA 291, no. 1 (2004): 15-16; D. Merenstein, “PSA Screening - I Finally Won!” JAMA Intern Medicine 175, no. 1 (2015): 16-17; see M. Hall, “The Defensive Effect of Medical Practice Policies in Malpractice Litigation,” Law and Contemporary Problems 54, no. 2 (1991): 119-145, at 129-30 (noting that medical practice is guided by instinct and localized habit).Google Scholar

See, e.g., Faden and Beauchamp, supra note 18, at 305-306 (arguing that a subjective standard is more in line with the principles underlying informed consent); Tenenbaum, E. M., “Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation, Oklahoma Law Review 64, no. 4 (2011): 697-758, at 717-719 (arguing that an objective standard is “unfaithful” to the underlying autonomy-based ideals of informed consent).Google Scholar

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See Tenenbaum, supra note 61. On the other hand, courts have recognized that a subjective standard may be difficult one for physicians to comply. See, e.g., Canterbury, 464 F.2d at 790-91.Google Scholar

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Other commentators have analogized the practice of informed consent to “banking” in which the physician “deposits” information into the patient's “bank.” Volandes, A. E. et al., “The New Tools: What 21st Century Education Can Teach Us,” Healthcare 1, no. 3-4 (2014): 79-81, at 79. The practice might also be analogized to giving someone the keys to a new experimental vehicle without explaining how to drive it.Google Scholar

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Pope and Hexum, supra note 46. Admittedly, opponents will assert similar objections against PDAs, since they too intrude upon physicians' professional autonomy and discretion.Google Scholar

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“[T]he road to fully integrating SDM into clinical practice likely will be long and winding.” Alston et al., supra note 12, at 25. While overall use remains low, PDAs are used in some facilities and systems, like the Massachusetts General Hospital and Seattle-based Group Health. See, e.g., Sepucha, K. R., “Ten Years, Forty Decision Aids, and Thousands of Patient Uses: Shared Decision Making at Massachusetts General Hospital,” Health Affairs 35, no. 4 (2016): 630-636; M. Hostetter and S. Klein, Quality Matters: Helping Patients Make Better Treatment Choices with Decision Aids, The Commonwealth Fund (2012).CrossRef Google Scholar

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See infra Section VI.D. The intended entity appears to have been the National Quality Forum.Google Scholar

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The bill directed the certification entity to prioritize PDAs for: (1) arthritis of the hip and knee, (2) chronic back pain, (3) chest pain (stable angina), (4) enlarged prostate (benign prostatic hypertrophy, or BPH), (5) Early-stage prostate cancer, (6) early-stage breast cancer, (7) end-of-life care, (8) peripheral vascular disease, (9) gall stones, and (10) threat of stroke from carotid artery disease.Google Scholar

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Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law

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