EVIDENCE, INFLUENCES, AND PATIENT AUTONOMY:
UTILIZING THE ECOLOGICAL MODEL TO MAXIMIZE JUSTICE AND
AUTONOMOUS CHOICE
IN THE LEGAL DOCTRINE OF INFORMED CONSENT
by
Amanda Paige Burns
BA, College of Charleston, 2007
Submitted to the Graduate Faculty of
Graduate School of Public Health in partial fulfillment
of the requirements for the degree of
Master of Public Health
University of Pittsburgh
2013
UNIVERSITY OF PITTSBURGH
GRADUATE SCHOOL OF PUBLIC HEALTH
This essay is submitted
by
Amanda Paige Burns
on
May 1, 2013
Elizabeth Ferrell-Bjerke, JD
______________________________________
Visiting Assistant Professor
Department of Health Policy and Management
University of Pittsburgh Graduate School of Public Health
Adjunct Professor
University of Pittsburgh School of Law
Alan Meisel, JD
Professor of Law and Psychiatry
Dickie, McCamey & Chilcote
Professor of Bioethics
University of Pittsburgh
______________________________________
ii
Copyright © by Amanda Paige Burns
2013
iii
Elizabeth Ferrell-Bjerke, JD
EVIDENCE, INFLUENCES, AND PATIENT AUTONOMY:
UTILIZING THE ECOLOGICAL MODEL TO MAXIMIZE JUSTICE AND
AUTONOMOUS CHOICE
IN THE LEGAL DOCTRINE OF INFORMED CONSENT
Amanda Paige Burns, MPH
University of Pittsburgh, 2013
ABSTRACT
This essay evaluates the current legal doctrine of informed consent and its ability to promote the
rights of self-determination and autonomous choice. At the time that the doctrine was developed,
American courts determined that the doctrine need not incorporate a requirement that a patient
understand disclosed information, a determination largely based on the assumption that the vast
majority of patients would be able to understand a reasonable disclosure. By analyzing the current
body of research regarding patient health literacy, this paper seeks to establish that, contrary to the
doctrine’s presumption of understanding, only a small minority of patients are capable of
understanding and utilizing disclosed medical information in a way that allows them to make truly
autonomous decisions. Furthermore, this paper will show that, in addition to failing to promote selfdetermination, the doctrine’s failure to require reasonable patient understanding results in tangible
harm to the many patients who have limited health literacy, thus resulting in an unjust medical
system that disadvantages a large group of patients, many of whom are already vulnerable to poor
health outcomes due to other systemic and environmental influences. Recognizing these failures, this
paper proposes that patient self-determination should be viewed as an individual behavior that is
best promoted by a public health intervention that recognizes the complicated web of influences, of
which informed consent law is but one, that effect a patient’s ability to understand medical
iv
information and make truly autonomous medical decisions. This paper will use the ecological model
to identify these influences and suggest policy changes, including a revision of the legal doctrine of
informed consent, that are most likely to promote patient autonomous choice in light of the
complex web of influences that currently hinder patient autonomous choice.
v
TABLE OF CONTENTS
1.0
INTRODUCTION............................................................................................................. 1
2.0
A HISTORICAL OVERVIEW OF CONSENT TO MEDICAL TREATMENT....... 2
3.0
THE EVOLUTION OF THE LEGAL DOCTRINE OF INFORMED CONSENT ... 5
4.0
THE PRESUMPTION OF UNDERSTANDING......................................................... 10
4.1
THE NECESSITY OF UNDERSTANDING FOR AUTONOMOUS CHOICE .. 12
5.0
HEALTH LITERACY: MEASURING PATIENT UNDERSTANDING ................. 15
5.1
THE PREVELANCE OF LIMITED HEALTH LITERACY ............................... 17
5.1.1
VULNERABLE POPULATIONS ............................................ Error! Bookmark not defined.
5.1.2
AGE ........................................................................................... Error! Bookmark not defined.
5.1.3
MINORITY STATUS ............................................................... Error! Bookmark not defined.
5.1.4
LIMITED ENGLISH PROFICIENCY .............................................................................21
5.2
HARM ASSOCIATED WITH LIMITED HEATLH LITERACY ....................... 22
6.0
PATIENT AUTONOMY AS A PUBLIC HEALTH INITIATIVE ........................... 25
6.1
UTILIZING PUBLIC HEALTH TOOLS: THE ECOLOGICAL MODEL ........ 26
6.1.1
SUPERSTRUCTURAL INFLUENCES ........................................................................... 27
6.1.2
STRUCTURAL INFLUENCES ...................................................................................... 30
6.1.3
ENVIRONMENTAL INFLUENCES ............................................................................ 33
7.0
STRUCTURAL MODIFICATION TO ENHANCE PATIENT AUTONOMY ....... 35
7.1
JUDICIAL CHANGES .............................................................................................. 35
vi
7.1.1
8.0
LEGISLATIVE CHANGES................................................................................................41
CONCLUSION ............................................................................................................... 45
BIBLIOGRAPHY ....................................................................................................................... 46
vii
1.0
INTRODUCTION
The legal doctrine of informed consent is based upon a respect for self-determination and autonomy
that is fundamental to American jurisprudence. To that effect, the doctrine imposes upon physicians
a duty to disclose relevant information about the proposed treatment for which the physician is
seeking the patient’s consent, which is assumed to adequately protect the right of the patient to
make an autonomous choice. At the time that the duty to disclose was developed, American courts
determined that the duty to disclose need not incorporate a requirement that a patient understand
the disclosure, and this choice seems largely to be based on the assumption that the vast majority of
patient’s would be able to understand a reasonable disclosure if the physician only spoke in nontechnical terms. The merit, effect, and need for modification of this assumption will be the focus of
the paper.
1
2.0
A HISTORICAL OVERVIEW OF CONSENT TO MEDICAL TREATMENT
Medical practitioners have long practiced under professional codes of ethics, such as the well-known
Hippocratic Oath. Under the Hippocratic Oath, a new practitioner of the medical arts in ancient
Greece would have sworn to the Gods to uphold a number of medical professional standards. One
of these, the origin of what is commonly known today as a physician’s duty to “do not harm”
required a practitioner to “apply dietetic measures for the benefit of the sick according to my ability
and judgment, and keep them from harm and injustice.”1 In order to uphold this duty, physicians
were encouraged by many ancient medical texts to actively withhold information from their patients
in order to prevent the “harm” that would come to patients should they know the direness of their
prognosis, or the painful disease process that awaited them. 2
This view of information as more harmful than beneficial to patients endured even into the
modern era of medicine. Under this belief, practitioners of medicine abided by a professional
standard of “benevolent lying,” which allowed physicians to determine what to share with a patient,
if anything.3 At the beginning of the 20th century, this paternalistic nature of the doctor-patient
relationship started to change when courts began to recognize the right of the patient to refuse
medical treatment, and the duty of the physician to obtain a patient’s consent before operated upon
Greek Medicine: The Hippocratic Oath, UNITED STATES NATIONAL LIBRARY OF MEDICINE,
http://www.nlm.nih.gov/hmd/greek/greek_oath.html (last visited March 1, 2013)
2 Tom Beauchamp, Informed Consent: Its History, Meaning, and Present Challenges 20 CAMBRIDGE Q. HEALTHCARE ETHICS
515, 515-523 (2011)
3 Ruth Faden & Tom Beauchamp, A HISTORY AND THEORY OF INFORMED CONSENT 86 (1986)
1
2
him.4 One of these initial cases was Mohr v. Williams in 1905. In that case, a patient consented to
surgery on her right ear, but the physician ultimately determined that the left ear needed surgery and
proceeded to operate.5 The court found that the patient’s consent was required not just for the
surgery, but for the particular surgery that was actually performed.6 The court based this holding on
the fact that it was, yes, a different ear, but also that there were different dangers and risks involved
in the surgery that was actually performed.7 Under Mohr, a physician must disclose the dangers and
risks of the operation to the patient in order to avoid a charge of medical batter. 8 This construction
of a valid consent was later adopted in several cases that followed Mohr.
While these early cases focused on the tort of battery and “the free citizen’s right…to
himself” i.e., to be free from unauthorized intrusions of his or her bodily integrity, it was not until
Schloendorff v. New York Hospital in 1914 that a court expressly based a consent requirement in a
patient’s right to autonomy and self-determination, therefore incorporating the ethical and
philosophical doctrines into the basis of consent law.9 In the Schloendorff case, a patient consented to
an abdominal examination under anesthesia, though specifically told her physician that she did not
want any surgical procedure performed.10 Despite this instruction, the physician went ahead and
removed a tumor while the patient was sedated.11 Based on the court’s finding that “every human
being of adult years and sound mind has a right to determine what shall be done with his own
body,” the court held that “a surgeon who performs an operation without his patient’s consent
commits an assault, for which he is liable in damages…except in emergencies when consent cannot
See Schloendorff v. New York Hospital, 211 N.Y. 125 (1914)
Mohr v. Williams, 95 Minn. 261, 265 (1905)
6 Id. at 265
7 Id. at 269
8 Id. at 270
9 Schloendorff, 211 NY at 129
10 Id. at 127
11 Id. at 128
4
5
3
be obtained.”
12
In the medical battery cases that followed Schloendorff, courts adopted the self-
determination rationale of the consent requirement expressed in Schloendorff.
12
Id. at 130
4
3.0
THE EVOLUTION OF THE LEGAL DOCTRINE OF INFORMED CONSENT
Despite the importance of Schloendorff, it was not until the late 1950s that the idea of informed consent
became part of the legal lexicon. The first use of the phrase “informed consent” was in the legal
opinion of Salgo v. Leland Stanford Jr. University Board of Trustees in 1957. In that case, the plaintiff, who
became paraplegic following a procedure for a circulatory problem, alleged a tort of medical battery
claiming that his physician did not properly disclose essential information concerning risks prior to
his consent to the treatment.13 The court’s opinion “evoked a dramatic new development: the
evolution of the traditional duty to obtain consent into a new, explicit duty to disclose certain forms
of information and then to obtain consent.”14 Instead of focusing on whether consent for the
procedure had been obtained, as courts had done for the forty years following the Schloendorff
opinion, the Salgo court utilized the rationale of the Schloendorff court, the idea of patient selfdetermination, to justify an informed consent requirement that required a physician to disclose “any
facts which are necessary to form the basis of an intelligent consent by the patient to proposed
treatment.”15
In finding this new requirement, the Salgo court cites to Schloendorff and its progeny, despite
the fact that the consent requirements in that case include only the risks and benefits required by the
Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal. App. 2d 560, 578 (1957)
See Faden and Beauchamp, supra note 3, at 125
15 Salgo, 154 Cal. App. 2d at 560, 568
13
14
5
Mohr court back in 1905.16 Therefore, Salgo has been said to have “clearly introduced new elements
into the law.” 17 The conventional wisdom behind this sudden and somewhat unexpected expansion
in the requirements of medical consent law is that the rise of an expanded concept of selfdetermination within the medical world mirrored the larger rise of self-determination, individual
liberties, and social equality within the greater society. 18 The larger rights movement as advanced by
the civil rights, women rights, consumer rights, and public concern for research subjects and mental
health patients is thought to have propelled the expansion of the concept of consent to more fully
mirror the expanding view of what exactly self-determination required.19 No longer was the consent
requirement seen as a mechanism that served merely to avoid unwanted intrusion of one’s body by
accepting or denying proposed treatments for a physician. Instead, the idea of informed consent
served as a mechanism that forced physicians to respect a patient’s capacity to make their own
medical decisions, a capacity which the Salgo court’s decision assumed was a reality, and which they
assumed would promote the autonomy and individualism of patients.
Though the Salgo court used the phrase “intelligent consent,” the standard established in
Salgo does not require patient understanding of the mandated disclosure. “Intelligent consent,”
under the court’s standard merely means that the patient has been exposed to certain information by
the physician, the scope of which the Salgo court left mostly a considerable amount of room for
physician discretion in the scope of the patient.20 For instance, the court noted that in some cases,
full disclosure of the risks of a proposed treatment may be harmful to patients who are
“apprehensive” and “may as a result refuse to undertake surgery in which there is in fact minimal
risk,” or who, because of the disclosure, might be at increased risk of harm “by reason of the
Id. at 578
See Faden and Beauchamp, supra note 3, at 126
18 Faden and Beauchamp, supra note 3, at 87
19 Id.
20 Salgo, 154 Cal. App. 2d at 560, 568
16
17
6
physiological results of the apprehension itself.”21 In light of these concerns for the patient’s wellbeing, the court made clear that in deciding the scope of informed consent, the physician could
consider the patient’s mental and emotional condition in determining not only what to share, but
whether to share it. This exception to the general duty to disclose articulated in Salgo has come to be
known as the “therapeutic exception.” 22
After Salgo, the court’s holding spread through the judicial system and the doctrine in its
modern form was more or less constructed within just a few years following Salgo. The most
important modification of the doctrine within that time occurred in the case of Natanson v. Kline, a
negligence case, in which the Kansas Supreme Court adopted Salgo’s standard of disclosure, but
further expanded the scope of the duty to disclose by more fully explicating upon the topics that a
physician’s disclosure should encompass.23 The court specifically outlined four parts to the duty to
disclose, which obligated a physician to: “disclose and explain to the patient the nature of the
ailment, the nature of the proposed treatment, the probability of success or of alternatives, and the
risks of unfortunate results and unforeseen conditions within the body.”
24
The Natanson court also
did not address the issue of the patient’s understanding of the disclosure, though it noted that the
disclosure must be given “in language as simple as necessary.”
25
Due to the high degree of
discretion given to physicians by the standard articulated in Salgo and Natanson, the duty to disclose
as articulated in Salgo and Natanson has come to be known as the physician-based standard. This
standard is one of the two standards by which contemporary courts assess a physician’s duty to
disclose.
Id.
Id.
23 Natanson v. Kline, 350 P.2d 1093, 1106 (1960)
24 Natanson, 350 P.2d at 1106
25 Id.
21
22
7
The second standard used to assess the duty to disclose, which has come to be known as the
patient-based standard, was famously articulated in the 1970’s landmark case Canterbury v. Spence. In
the Canterbury case, a nineteen year-old boy underwent surgery for severe back pain and experienced
complications that resulted in paralysis.26 In his malpractice action against the surgeon, the patient
asserted that the physician failed to warn him of any risk of paralysis from the procedure, and
therefore failed to fully disclose the risks necessary to allow him to make an informed consent. 27 As
the Canterbury court did not have precedent of its own that spoke directly to the duty to disclose, the
court analyzed the origins and rationale behind the physician’s duty to disclose in order to construct
its own standard.28
Upon evaluating the physician-based standard for the duty to disclose, the Canterbury court
was unconvinced that the duty to disclose must be “germinated or limited by medical practice.”29 In
particular, the court was unwilling to base a standard for disclosure on the judgment of a profession
whose customary practice, historically, was not to disclose information to patients.
30
As the
physician-based standard would “arrogate the decision on revelation to the physician alone,” the
Canterbury court felt that that standard was inconsistent with the self-determination rationale behind
informed consent.31 Ultimately, the court held that the best way to facilitate the patient’s right of
self-determination was to adopt a standard “set by law for physicians rather than one which
physicians may or may not impose upon themselves.”32
To that effect, the court held that a patient’s right of self-determination should “shape the
boundaries of the duty to disclose” as self-determination cannot be exercised unless “the patient
Canterbury v. Spence, 464 F.2d 772, 785-86 (1972)
Id. at 785-86
28 Id. at 780
29 Id. at 787
30 Id. at 783
31 Id. at 784
32 Canterbury, 464 F.2d at 784
26
27
8
possesses enough information to enable an intelligent choice.”33 Therefore, the court held that the
duty to disclose requires a physician to inform a patient of the risks, benefits, and alternatives that
the average reasonable patient would consider to be material in making a treatment decision. 34 The
scope of this disclosure as adopted by the Canterbury court includes all information that is material to
the patient’s decision, where information is material when “a reasonable person, in what the
physician knows or should know to be the patient’s position…with the patient’s informational
needs…would be likely to attach significance to the risk or cluster of risks in deciding whether or
not to forego the proposed therapy.”
35
These “informational needs” referred to in the Canterbury
case refer to information regarding the proposed treatment, not the patient’s ability to understand
disclosed information. Specifically, the court outlined three types of necessary information that must
be disclosed including: information on the inherent and potential hazards of the proposed treatment
including information on the incidence of injury and the degree of the harm threatened, the
alternatives to the treatment, and the results likely if the patient remains untreated.36 While the court
maintained the therapeutic privilege established in Salgo, they severely curtailed its use by permitting
it only where the “patient’s reaction to risk information, as reasonably foreseen by the physician, is
menacing.”37 Additionally, the court specifically forbids use of the therapeutic privilege in order to
“prompt the patient to forego therapy the physician feels the patient really needs.”38
Id. at 785-86
Id. at 785-86
35 Id. at 787
36 Id. at 788
37 Id. at 789
38 Id.
33
34
9
4.0
THE PRESUMPTION OF UNDERSTANDING
Regardless of whether the patient- or physician-based standard applies, the current doctrine of
informed consent merely requires the disclosure of information to a patient, with no requirement to
assure the patient’s understanding of that information. While the Canterbury court seems to consider
patient understanding where they say that the patient’s informational needs must be considered, the
court explicitly state that the patient-based standard does not require a physician to assure
understanding and so just as “intelligent consent” in Salgo meant consent after exposure to
information, “informational needs” in Canterbury means what information the patient, with his or her
treatment options, needs.
39
Therefore, both standards rely on the premise that mere exposure to
information will permit a patient the “opportunity to evaluate knowledgably the options available
and the risks attendant upon each” which will lead to an exercise of self-determination, i.e.,
autonomous choice in deciding the patient’s treatment. 40
However, if one is given information, regardless of the reasonableness of that disclosure, and
one does not understand the information and how to use it, how can it be maintained that the
information given permits the patient to “evaluate knowledgably” his or her option, or promotes the
patient’s right to self-determination? After all, courts recognize that “the average patient has little or
no understanding of the medical arts.” 41 The answer to this question seems to be that a fundamental
Canterbury, 464 F.2d at 780
Id.
41 Id. at 788
39
40
10
assumption on which the current legal doctrine of informed consent is based is that, so long as a
disclosure is reasonable and free of “technical terms,” the vast majority of patients will understand
the disclosure in a way that sufficiently aids them in making autonomous medical decisions. 42
In
fact, the Canterbury court comes close to saying as much when, in a footnote, it responds to doubts
regarding the ability of patients to understand a reasonable disclosure by stating that “it must be the
exceptional patient who cannot comprehend such an explanation [as required by the duty to
disclose].” 43
As a result of the presumption of understanding, the doctrine fails to actually facilitate a
patient’s right to self-determination for two reasons. First, as this paper will show, autonomous
choice requires adequate understanding and the legal doctrine of informed consent fails to serve its
purpose of facilitating a patient’s self-determination if the doctrine’s presumption of understanding
is unmerited. Second, since the time that Canterbury was decided, researchers have consistently
shown that the health literacy of Americans, or their ability to understand health information in a
way that helps them make autonomous treatment choices, is quite low. As a result, the Canterbury
court’s assumption that it would be an “exceptional” patient who could not understand the
information shared with them by a physician fulfilling his or her duty to disclose has been proven to
be false for many Americans. Given that understanding is required for a patient to make an
autonomous choice, and that an assumption of understanding is unmerited, the duty to disclose
should be reevaluated in order to truly provide patients with a legal right to self-determination.
42
43
Id. at 782
Canterbury, 464 F.2d at 789
11
4.1 THE NECESSITY OF UNDERSTANDING FOR AUTONOMOUS CHOICE
Ever since Schloendorff, American courts have required physicians to respect a patient’s right to self
determination by requiring a physician to obtain some manner of consent from the patient before
treatment may begin. In general, court’s preoccupation with protecting a patient’s right to selfdetermination is based not only on fundamental American ideals, but also on the “general moral
requirement of respecting the autonomy of persons.”44 Under the legal doctrine, autonomy is
protected where physicians are required to respect a patient’s right to self-determination by
respecting the patient’s choice in medical treatment or non-treatment. Therefore, what the doctrine
seeks to ultimately produce is an environment where consent to or refusal of medical treatment
results from a patient’s “intelligent” or “knowledgeable” autonomous choice. What will be explored
in this section is what makes a choice autonomous, and how the court’s assumption of
understanding, if found to be unmerited, may or may not affect the doctrine’s ability to protect a
patient’s right to self-determination through autonomous choice.
In order to appreciate the role of understanding in autonomous choice, it is useful to look
to texts written on the ethical concept of autonomy on which the legal doctrine is partly based.
While there are many theories of autonomy that seek to outline the essential characteristics that
make a choice autonomous, these theories generally overlap in terms of requiring two conditions to
be present: liberty and agency. 45 The requirement or liberty makes certain that a choice is “free from
controlling influences,” and “voluntary.”46 The current legal doctrine of informed consent requires
health professionals to assure a patient’s liberty by generally allowing patients to make their own
medical decisions. While use of the therapeutic exception reduces a patient’s liberty, the ethical
Tom Beauchamp & James Childress, PRINCIPLES OF BIOMEDICAL ETHICS, 5-13 (5th ed. 2001)
Beauchamp & Childress, supra note 44, at 58-61
46 Id. at 59
44
45
12
requirement of liberty does not require “complete absence of influence,” but only a “substantial
degree of freedom from constraint.”
47
The patient-based standard is most protective of the liberty
requirement as courts applying this standard explicitly refuse to allow physicians to use the
therapeutic exception to coerce their patients into accepting treatment the physician believes to be
best by withholding information.
48
Jurisdictions that use the patient-based standard engage in
heightened scrutiny of a physician’s reliance on the therapeutic exception, which permits the patient
to enjoy a substantial, though not complete, degree of freedom from constraint.
It is not as clear that the physician-based standard assures the patient’s substantial liberty
interest. In theory, the physician-based standard protects a patient’s liberty as it restricts the exercise
of the therapeutic privilege to instances where information may harm the patient’s emotional and
mental health.49 In practice, the ability of the physician-based standard to assure patient’s liberty
likely comes down to the court’s willingness to accept the physician’s judgment that the disclosure
would do more harm than good. Therefore, the physician-based standard involves a high level of
subjectivity in its application, while also giving a physician broader discretion in the use of the
therapeutic privilege. For these reasons, it is important to note that the Canterbury court’s
apprehension that under this standard the exception may “devour the disclosure rule itself” is well
founded.50 While this fact serves to further underscore the argument that the current legal doctrine
of informed consent fails to assure autonomous choice, I will not continue to focus on the liberty
requirement of autonomous choice as it is not within the scope of this paper.
Id. at 59
Canterbury, 464 F.2d at 789
49 Salgo, 154 Cal. App. 2d at 578
50 Canterbury, 464 F.2d at 789
47
48
13
The agency requirement of autonomous choice requires a patient to have “capacity for
intentional action.” 51 To satisfy this requirement, a patient must be competent to understand and
decide, a disclosure of material information and a recommendation of a plan must be made, and the
patient must understand the disclosure and recommendation.
52
It is this agency element of
autonomous choice on which the current duty to disclosure focuses, but disclosure is not sufficient
for agency as it must be accompanied by the patient’s capacity to understand, as well as actual
understanding of the disclosure.
Like the liberty requirement, the understanding required for
autonomous decision-making does not have to be full and absolute, only substantial. 53 Given the
complexity of modern medicine, as well as the uncertainty inherent in applying medical generalities
to a particular patient’s case, a requirement of full understanding would likely only result in making
sure that no autonomous choices are ever made. Substantial understanding is achieved where the
patient understands the nature and consequences of the treatment for which the physician is seeking
authorization, i.e. the patient understands the physician’s legally required disclosure. Therefore, only
true understanding of information, as opposed to mere exposure to information, will suffice to make
a choice truly autonomous. As understanding is a necessary component of autonomous choice,
which cannot be accomplished by mere disclosure of information, by presuming, instead of
requiring, adequate patient understanding, the legal doctrine of informed consent fails to assure
autonomous choice if that presumption is unfounded. 54
Beauchamp & Childress, supra note 44, at 59
Id.
53 Id.
54 Id. at 63 (“To respect an autonomous agent is, at a minimum, to acknowledge that person’s right to hold views, to
make choices, and to take actions based on personal values and belief. Such respect involves respectful action, not
merely a respectful attitude. It also requires more than noninterference in others’ personal affairs.”)
51
52
14
5.0
HEALTH LITERACY: MEASURING PATIENT UNDERSTANDING
Health literacy is used among public health and health professionals as a measure of an individual’s
ability to understand and use health information to develop and reach his or her own health goals.
As such, health literacy is an excellent measure by which to assess whether a presumption of patient
understanding is merited. While research into health literacy has been conducted since the middle of
the twentieth century, the concept of health literacy remained relatively unknown and unexplored
outside academic circles until the early 1990s when the United State Department of Education
published its first report on the functional literacy of American adults, the National Adult Literacy
Survey.55 The results of this report uncovered widespread difficulties with reading and writing
among American adults.56 While this study focused solely on functional literacy—the “ability to use
printed and written information to function in society, to achieve one’s goals, and to develop one’s
knowledge and potential”—the results of the survey spurred health professionals to question their
own patients’ abilities to understand and utilize their professional advice and instruction. 57
Two years after the Department of Education’s survey was conducted, physicians at Emory
University published the results of a cross-sectional survey funded by the Robert Woods Johnson
Foundation.58 This study sought to assess the prevalence of health illiteracy among two patient
Office of Educational Research and Improvement, United States Department of Education, NCES 1993-275, ADULT
LITERACY IN AMERICA : A FIRST LOOK AT THE FINDINGS OF THE NATIONAL ADULT LITERACY SURVEY (2002)
56 Id. at 16-22
57 Id. at 2-3
58 M.V. Williams et al., Inadequate Functional Health Literacy Among Patients at Two Public Hospitals, 20 J AM MED ASSOC.
1677, 1680 (1995)
55
15
populations at Emory and University of California at Los Angeles hospitals by measuring patients’
ability to successfully complete basic reading and numeracy tasks required to function adequately in
a health care setting.59 In order to measure the health literacy skills of adult patients, the study
developed the Test of Functional Health Literacy in Adults (TOFHLA), which assesses the health
literacy of an individual by requiring completion of 50 reading comprehension and 17 numerical
questions developed using real hospital material with which patients would often come in contact.60
The results of the Emory survey found that of 2,659 participants, a high proportion of patients were
unable to read and understand basic written medical instructions such as comprehending directions
for taking medication, scheduling of appointments, and standard informed consent documents.61
Specifically, 59.5% of English-speaking patients had inadequate or marginal functional health
literacy. 62 The study also found that inadequate health literacy was most prevalent among the elderly
and those reporting poor overall health, as the number of patients with inadequate or marginal
health literacy rose to 81.3% among patients 70 and above. 63 These findings led the authors of the
study to suggest that further studies should be conducted to determine whether “inadequate health
literacy may be an important barrier to patients' understanding of their diagnoses and treatments,
and to receiving high-quality care.”64
In reply to the Emory study’s charge for more research, a quick surge in articles published
on the topic of health literacy was seen, and the concept saw a ten-fold increase in the number of
scholarly publications between 1997 and 2007.65 As the concept began to attract more research, the
breadth of health literacy as a concept began to expand outside the walls of the hospital to include
Id.
Id.
61 Id. at 1681
62 Id.
63 Id.
64 Id.
65 Deborah Chinn, Critical Health Literacy: A Review and Critical Analysis, 73 SOC SCI MED. 60 (2011)
59
60
16
information and decision-making skills occurring in the broader community. For instance, in 1998,
the World Health Organization adopted an expanded definition of health literacy that focused
beyond the ability to read pamphlets by looking at health literacy as a means to “improve people’s
access to health information, and their capacity to use it.”66 In this capacity, health literacy was seen
by the WHO as a critical element of empowerment (read: self-determination) and a vital measure of
“cognitive and social skills that determine the motivation and ability of individuals to gain access to
and to understand and use information in ways which promote and maintain good health.” 67 In the
United States, health literacy first became an important public health goal with the publication of the
Health and Human Service’s decennial report, Healthy People, which establishes the agency’s public
health goals for the following decade.68 In its report Healthy People 2010, the Department of Health
and Human Services included improved consumer health literacy as Objective 11-2, and identified
health literacy as an important component of health communication, medical product safety, and
oral health.69
5.1
THE PREVELANCE OF LIMITED HEALTH LITERACY
In general, the studies that followed the Emory-UCLA study focused on identifying the prevalence
of limited health literacy among other patient populations. This research consistently established
that contrary to the Canterbury court’s assumption that only “extraordinary” patients would fail to
understand health information, it is in fact adequate health literacy patients who are “extraordinary.”
World Health Organization, Division of Health Promotion, Health Promotion Glossary, 10 (1998)
Id.
68 United States Department of Health and Human Services, HEALTHY PEOPLE 2010: UNDERSTANDING AND
IMPROVING HEALTH, 56 (2000)
69 Id.
66
67
17
For example, in a follow-up assessment of the Department of Education’s 1992 literacy survey, the
Department published a second survey in 2003 that included a section dedicated solely to adult
health literacy.70 Using a method that required the completion of common health-related tasks, the
survey found that only 12% of American adults had “proficient” health literacy, meaning that they
possessed skills needed to manage their health and prevent illness.
71
Additionally, 53% of adults
were found to have intermediate health literacy, which allowed them to complete moderately
challenging literacy activities such as using a graph to determine a healthy weight range for a person
of a specified height. However, 36% of American adults were found to have basic or below basic
health literacy, meaning that they could perform only simple or everyday literacy activities such as
“locating straightforward pieces of information in short simple texts or documents” or using
information from a short pamphlet to answer simple questions.
72
As these figures are frequently
cited in recent articles setting the prevalence of limited health literacy (basic and below basic levels)
at 1 in 3, this survey seems to be the only and most recent national estimation of limited health
literacy in the United States.73
While sources of information on the national prevalence of limited health literacy are limited,
and perhaps outdated, numerous recent studies have been conducted to estimate the prevalence of
limited health literacy in a wide range of health care settings. For instance, studies have shown that
limited health literacy is estimated to affect 15-50% of adults seeking help in emergency
departments,74 16-21% of veterans seeking primary care visits at the VA, and 44% of hospitalized
United States Department of Education, supra note 55, at 5
Id.
72 Id. at 7
73 See e.g., Morris et al., Prevalence of Limited Health Literacy and Compensatory Strategies Used by Hospitalized Patients, 60 NURS
RES. 361, 365 (2011); See also, J. Demarco & M. Nystrom, The Importance of Health Literacy in Patient Education, 14 J
CONSUM HEALTH INTERNET. 294, 295 (2010)
74 A.A. Ginde et al., Multicenter Study of Limited Health Literacy in Emergency Department Patients, 15 ACAD EMERG MED. 577,
579 (2008); A.A. Ginde et al., Demographic Disparities in Numeracy Among Emergency Department Patients: Evidence from Two
70
71
18
patients with acute coronary syndromes.75 Additionally, health literacy has been studied among
research subjects in a variety of research settings. In a literature review of existing research in this
area published in the Journal of General Internal Medicine in 2012, reviewers found that current studies
show that comprehension of informed consent procedures among limited health literacy subjects
ranged from 17% among subjects giving consent for Schizophrenia treatment to 45% for subjects
giving consent for a cancer study. 76
5.1.1 VULNERABLE POPULATIONS
In addition to research into specific health care settings, research has shown that the
prevalence of limited health literacy varies among patient populations, and is more prominent
among vulnerable and at-risk patient populations that experience poorer health outcomes as
compared to the general populations. Given this association, much research has focused on
determining the relationship of limited health literacy to poor health outcomes in these populations,
which include the elderly, racial and ethnic minorities, those with lower education attainment, and
non-native English speakers. 77 These associations are limited as current studies published on such
associations are limited in scope, and therefore cannot be generalized to the general population.
However, what have been documented over time are higher levels of limited health literacy among
these groups as compared with other patient populations across many geographic locations.
Multicenter Studies, 72 PATIENT EDUC COUNS. 350, 354 (2008); T. Olives et al., Health Literacy of Adults Presenting to an
Urban ED. 8 AM J EMERG MED. 875, 878 (2010)
75 S. Kripalani et al., Medication Use Among Inner-city Patients after Hospital Discharge: Patient Reported Barriers and Solutions, 83
MAYO CLIN PROC. 529, 531 (2008)
76 L. Tamariz et al., Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review, 28 J GEN
INTERN MED. 121, 124 (2013)
77 Lynn Nielsen-Bohlman et al., HEALTH LITERACY: A PRESCRIPTION TO END CONFUSION, 80 (2004)
19
5.1.2 AGE
In general, levels of limited health literacy are stable among adults ages sixteen to sixty-four
with limited health literacy ranging from 34% in adults aged 16-18 and adults aged 50-64, to 28% in
adults ages 25-39. However, among elderly adults ages 65 and above, limited health literacy
dramatically increases to 59%.78 Researchers have found that levels of health literacy among elderly
adults continue to decline steadily from age 65, resulting in a steep drop-off at age 85.79 For
instance, researchers at Case Western University conducted home interviews with elderly persons
who completed the S-TOFHLA—a shortened version of the TOFHLA—in order to measure
participants’ health literacy levels.
80
The researchers found that there was a statistically significant
increase in the prevalence of limited health literacy between participants in five age groups
encompassing individuals who participated in Medicare programs in Cleveland, Houston, and South
Florida.81 S-TOFHLA scores, which range from 0 to 100, were documented for each of the five age
groups and were shown to decline as the age of participants increased.82 The health literacy of the
age groups steadily declined by about 7 points between the 65-69, 70-74, 75-79, and 80-84 age
groups, but the last age group, those over 85, saw a dramatic decline of over 12 points. 83 Even after
the researchers adjusted for gender, race, ethnicity, years of school completed, and other physical
indicators that can negatively affect cognitive ability, this relationship continued to be statistically
significant. 84
78United
States Department of Education, supra note 70, at 12
D. W. Baker et al., The Association between Age and Health Literacy among Elderly Persons, 55B J GERONTOL B PSYCHOL SCI
SOC SCI. 368, 371 (2000)
80 Id.
81 Id.
82 Id.
83 Id.
84 Id.
79
20
5.1.3 MINORITY STATUS
Racial and ethnic minority status other than Asian and Pacific Islander has also been found
to be a risk factor for limited health literacy. As a general matter, racial and ethnic minorities have
generally been found to have significantly higher rates of limited health literacy as compared to
Caucasian patients.85 Based on statistics gathered by the National Health Literacy Survey in 2003, no
race has an average health literacy score meeting the intermediate health literacy level.
86
However,
the proportion of black, Hispanic, and American Indian/Alaska native adults with limited health
literacy is significantly higher at 58% (black), 67% (Hispanic), and 48% (American Indian) as
compared to 28% (white). However, it is important to note that racial associations are often
complex associations that are the result of a vast web of realities for different racial groups. For
instance, studies have found that while black adults are significantly more likely to be health illiterate
than white adults, black adults also fare worse in all measures indicating poor access to care
including insurance status, socioeconomic status, education attainment, absence of a medical home,
and cost as a deterrent to seeking health care.87
5.1.4 LIMITED ENGLISH PROFICIENCY
Limited English Proficiency refers to individuals who do not speak English as their primary
language and who have limited ability to read, speak, write or understand English. According to the
See e.g., A.E. Volandes et al., Health Literacy Not Race Predicts End of Life Care Preferences, 11 J PALLIAT MED. 754 (2000);
United States Department of Education supra note 70, at 11
86 United States Department of Education supra note 70, at 11
87 S.I. Chaudhry et al., Racial Disparities in Health Literacy and Access to Care Among Patients with Heart Failure, 17 J CARD
FAIL. 122, 124 (2011)
85
21
most recent data, in 2010 there were 25.2 million individuals with limited English proficiency living
in the United States.88 This group accounts for only nine percent of the population, but the group
also experienced rapid and dramatic growth in the past twenty years; between 1990 and 2010, the
LEP population increased by 80%.89 According to the National Health Literacy Assessment in 2003,
those who spoke only Spanish or another non-English language before beginning school had Below
Basic health literacy as compared to intermediate health literacy for those who spoke only English or
English and another language before starting school.90 Assuring understanding among this group of
individuals is complicated. It is not just a matter or providing materials in a patient’s native language
as LEP patients have varying levels of health literacy in their own language as well. 91
5.2
HARM ASSOCIATED WITH LIMITED HEATLH LITERACY
In addition to a well-documented body of evidence showing that the legal doctrine of informed
consent’s presumption of patient understanding is unmerited, therefore seriously questioning the
ability of the doctrine to facilitate patient autonomous choice, there is also an increasingly developed
body of evidence that shows that presuming patient understanding can result in harm to those with
limited health literacy. In failing to require substantial understanding of required disclosures, the
current legal doctrine of informed consent requires patients who are not prepared to determine what
treatment is best for them to choose anyway. It is not surprising then that researchers have found
Migration Policy Institute, National Center of Immigrant Integration Policy, LEP Data Brief Limited English Proficient
Individuals in the United States: Number, Share, Growth, and Linguistic Diversity (2010) available at
http://www.migrationinformation.org/integration/LEPdatabrief.pdf
89 Id.
90 United States Department of Education supra note 70, at 12
91 Nielsen-Bohlman et al., supra note 77, at 114
88
22
that the health literacy of a patient can have a significant impact on the choices that patients make,
which can then lead to an ever-increasing range of undesirable health outcomes associated with
limited health literacy.
For instance, in a 2004 report commissioned by the Agency for Healthcare Research and
Quality, a group of researchers analyzed the then current body of scholarly work that evaluated the
relationship between health literacy levels and health outcomes.92 That report showed that among
the 44 studies reviewed, limited health literacy was “strongly associated with poorer knowledge or
comprehension of health care services and health outcomes.”93 Additionally, the report found that
patients with limited health literacy were more likely than patients with adequate health literacy to
have a higher probability of hospitalization, higher prevalence and severity of some chronic disease,
poorer global measures of health, and lower utilization of screening and preventive services. 94
However, one limit of these studies identified in the report was that the relationship between literacy
and health outcomes sometimes weakened or become statistically insignificant when the analysis was
adjusted for other factors such as age, education, socioeconomic status, health care access, or
experience in the health care setting. 95
In a similar review of research into health outcomes associated with limited health literacy,
the Institute of Medicine’s 2004 report on health literacy found that a patient’s literacy level was
associated with a broad range of important health outcomes and indicators.96 For instance, the
studies cited in the IOM report found evidence of statistically significant associations between
limited health literacy and an increased likelihood of self-reporting poor health; an increased
D.A. Dewalt et al,. Literacy and Health Outcomes: A Systematic Review of the Literature, 19 J GEN INTERN MED. 1228-39
(2004)
93 Id. at 1231
94 Id.
95 Id.
96 Nielsen-Bohlman et al., supra note 77, at 84-99
92
23
likelihood to have been hospitalized in the past year; an increased likelihood to receive an initial
cancer diagnoses in a later stage; an increased likelihood, among women, of having incorrect
knowledge about pregnancy risk factors; a three times higher rate of hospitals visitation within the
previous 12 months; an increased likelihood of having multiple co-morbidities;
a decreased
likelihood of reporting an undetectable HIV viral load; an increased likelihood of poor glycemic
control among diabetic patients; and a decreased likelihood of utilizing preventive health services
such a influenza vaccinations, mammograms, or pap smears. 97
In a follow-up to the Agency for Healthcare Research and Quality’s 2004 review, a similar
report was published in 2011, which again analyzed the current body of work in this area.98 Among
the 81 studies found to be of good or fair-quality, the relationship between health literacy and health
outcomes was found to be “variable.” 99 The relationship identified by the report to be the strongest
was the risk of mortality among seniors with lower health literacy.100 Additionally, the report found
“moderate” evidence to support a relationship between limited health literacy and increased difficult
in taking medication appropriately, understanding labels and health messaging, and poorer overall
health status among seniors.101
Id.
N.D. Berkman et al., HEALTH LITERACY INTERVENTIONS AND OUTCOMES: AN UPDATED SYSTEMATIC REVIEW,
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (2011)
99 Id. at 39
100 Id.
101 Id.
97
98
24
6.0
PATIENT AUTONOMY AS A PUBLIC HEALTH INITIATIVE
The legal doctrine of informed consent represents an attempt to improve patient’s autonomy.
However, as shown, current research shows that informed consent as it exists today serves to
protect the autonomy of a small portion of society while seriously disadvantaging a larger,
historically disadvantaged group. To remedy this situation, this paper proposes that patient selfdetermination should be viewed as an individual behavior that is best promoted by a public health
intervention that recognizes the complicated web of influences that affect a patient’s ability to
understand medical information and make truly autonomous medical decision. As such, the
application of the legal doctrine of informed consent is best considered, not in isolation within a
legal framework, but by considering the best role for informed consent within this larger framework.
In order to promote and facilitate a desired behavior, public health professionals have found
that it is important to first identify what influences that behavior, i.e. what hinders a patient’s ability
to exercise autonomous decision-making. This method of approaching patient autonomous choice
recognizes that there are many influences and actors that must be identified and engaged in order to
promote patient autonomous decision-making, not just the legal justice system. The advantage of
shaping the legal doctrine of informed consent in this way is that by standing back and looking at
the big picture of what influences and hinders patient autonomous choice, policy changes can be
made to reduce these negative influences and facilitate the desired behavior using current evidence
and research., the legal doctrine of informed consent Taking account of these influences, the
informed consent may be revised in a matter to best promote patient autonomous decision-making.
25
Such a goal is the basis for the legal doctrine of informed consent and courts must be willing to
modify the doctrine in light of growing evidence that the doctrine fails to serve its ultimate purpose
despite evidence that courts can utilize to tailor a new doctrine that truly promotes autonomous
decision-making.
6.1 UTILIZING PUBLIC HEALTH TOOLS: THE ECOLOGICAL MODEL
The first task in successfully developing a plan to improve patient self-determination and
autonomous choice is to identify methods that will help to achieve such a broad and daunting goal.
One way to approach such a goal that is widely used by public health professionals and researcher is
to utilize a theory such as an ecological framework, which has been used to frame public health
interventions and to develop public policy. The ecological model has two key concepts. First, that
behavior affects and is affected by multiple levels of influence. Second, that individual behavior
shapes, and is shaped by, the social environment. The ecological model is a useful theory here
because it helps to assess what entities, or stakeholders, are required to be engaged in order to
achieve the ultimate goal of patient autonomous choice making; these are the “levels of influence” in
the theory. Second, the framework is useful for this particular task because it also helps to identify
how downstream factors, here, a patient’s ability to make autonomous choices, are shaped by
upstream factors such as environmental factors, structural factors (laws and policies), and
superstructural factors (social justice issues such as race and class). The ecological model is used to
improve an intervention’s chance of facilitating a desired individual behavior by identifying practices
and policies at these three levels that hinder the targeted individual behavior, here the exercise of
26
autonomous choice, so as to develop an effective intervention that takes these influences into
consideration.
6.1.1 SUPERSTRUCTURAL INFLUENCES
The first level of influence of the ecological model is the superstructural level, which is
formally defined as “macrosocial and political arrangements, resources and power differences that
result in unequal advantages.” 102 These are systems that, on a broad level, affect individuals in an
indirect manner. These influences include social justice issues as well as how class, race, ethnicity,
gender, age and equity affect the individual desired behavior. Social justice issues that influence a
patient’s ability to make autonomous choices include racism and bias that influence patient-provider
interactions, and socioeconomic disparities While social justice issues are incredibly complex and it
is difficult to pinpoint policies and practices that directly influence particular outcomes such as
health literacy and autonomous choice, many studies have been able to find correlations that offer
plausible causal pathways through which disparities may prevent autonomous choice making due to
limited health literacy.
The most documented and studied causal pathway, or perhaps causal web, leading to a lack
of autonomous decision-making due to low health literacy is likely the relationship between
socioeconomic disparity, poor health outcomes, and education. While the association between low
socioeconomic status and poor health is not novel, current research has shown that this correlation
is more nuanced than simply showing that the rich are healthier than the poor.103 Further research
into this correlation has shown that health outcomes follow a “socioeconomic gradient,” which
See Sandro Galea, MACROSOCIAL DETERMINANTS OF POPULATION HEALTH, 9 (2007)(Macrosocial refers to “factors,
such as culture, political system, economics, and processes of migration or urbanization that are beyond the individual
and are explicitly a function of population systems.”)
103 Norman Daniels et al., IS INEQUALITY BAD FOR OUR HEALTH? 86 (2000)
102
27
means that not only are the rich healthier than the poor, but the richest are healthier than the rich,
who are healthier than the middle-class, and so on.104 This relationship continues to persist even
where the data is controlled for other influences such as access to care.105 In addition to research that
shows a correlation between wealth and health, research shows that education also plays a role in the
health disparities caused by the presence of lack of wealth.106 For instance, studies have shown that
health disparities between the poor and wealthy are greater in areas with lower education
opportunities as compared to health disparities between the poor and wealthy in areas with higher
education opportunities.107 Additional studies also show a correlation between low socioeconomic
status and adult illiteracy, which often tracks with health illiteracy.108 When these findings are
considered together, this research has resulted in speculation that lower socioeconomic status is
correlated with low educational opportunities, which leads to low adult literacy and low health
literacy, which then negatively affects a patient’s ability to make autonomous choices about his or
her health.
Another superstructural influence on patient autonomous choice includes conscience and
unconscious bias that can affect patient-provider communication and the relationship between the
two parties. Many studies have suggested that a provider’s perception of racial and ethnic minorities
may have an impact on the quality of the healthcare that the patient receives. 109 These disparities are
thought to result from the influence of the physician’s beliefs about how the “age, socioeconomic
status, race, or ethnicity of a patient affects the likelihood of their medical condition.”
110
In
combination with the physician’s own cultural experience, social conditioning, and acceptance of
Id. at 46
Daniel Goldberg, Justice, Health Literacy, and Social Epidemiology, 7 AM J BIOETH. 18, 19 (2007).
106 Id.
107 Id.
108 Id.
109 Brian D. Smedley et al., Unequal Treatment: Confront Racial and Ethnic Disparities in Health Care, National Academy of
Sciences 1, 172 (2003)
110 Id. at 167
104
105
28
stereotypes, these beliefs can influence the healthcare received by a minority patient.111 The existence
of bias and racism within the health system is difficult to quantify, but efforts to do so have relied on
several methods to garner a picture of its prevalence. One of these methods is the use of surveys
conducted among minority populations that ask questions regarding personal experience of
discrimination within the health care system. The picture of experienced racism or bias that is drawn
from this surveys varies widely, but, typically, experiences of discrimination in the healthcare systems
as reported in these surveys hovers around 10% to 30%.112
Another method for evaluating the prevalence of racism within the healthcare system is to
observe the interaction of patients and providers who are both race-concordant and racially
disconcordant. The rationale for studying and comparing these interactions is the assumption that
concordance may result in less biased interpretations and uncertainty of a patient’s viewpoint and
symptoms, with may facilitate communication and improve decision-making thereby increasing
health outcomes.113 Despite continuous interest in this area, however, there is still limited data on
which any correlation can be based, and the data is therefore, in most cases, merely observational.114
In a 2003 study conducted by the Commonwealth Fund, researchers found that when comparing
patient-physician communication in race-concordant relationships with that in race-discordant
relationships, race-discordant visits were shorter, patients cited lower satisfaction with the encounter,
and rated physicians as less participatory.115 Additionally, the research showed that physicians harbor
stereotypes based on patient characteristics such as race, which in turn may influence their
interpretation of the patient’s behaviors and symptoms, and ultimately, the doctor’s recommended
Id.
Vickie Shavers & Brenda Shavers, Racism and Health Inequity among Americans, 98 J NATL MED ASSOC. 386, 396 (2006)
113 Nielsen-Bohlman et al., supra note 77, at 132-35
114
Nielsen-Bohlman et al., supra note 77, at 34-35
115 Lisa Cooper & Neil Powe, Disparities in Patient Experiences, Health Care Processes, and Outcomes: The Role of Patient-Provider
Racial, Ethnic, and Language Concordance, Commonwealth Fund, 4 (2004)
111
112
29
treatment.116 The effect of these stereotypes can be particularly exaggerated by the healthcare
environment which requires cognitively demanding tasks to be completed in the short amount of
time that physicians have to spend with their patients.117 Studies have shown that this environment
can put physicians at a higher risk of “using stereotypes as cognitive short-cuts” in assessing needed
information and making medical decisions for minority patients. 118
6.1.2 STRUCTURAL INFLUENCES
The structural level of the ecological model focuses on laws, policies, and standard operating
procedures of federal, state, and local governments, as well as government agencies. The first
influence on autonomous choice at this level is the current doctrine of informed consent. As
previously discussed, the current presumption of understanding on which the legal doctrine of
informed consent fails to facilitate autonomous choice given that this assumption has been shown to
be unmerited by health literacy research. However, in addition to the general failure of the legal
doctrine of informed consent to facilitate its desired outcome—autonomous decision-making—
other scholars have chosen to highlight how the presumption of understanding affects equity and
justice by drawing attention to how the current standard of informed consent favors a small portion
of the society—those few Americans with adequate health literacy—over the substantial number of
Americans with low health literacy.
As already shown, limited health literacy is higher among at-risk and vulnerable populations
such as minorities and the elderly, populations that are already generally saddled with poor health
outcomes, lower levels of education, and low socioeconomic status.
In contrast, those with
D. Burgess et al., Reducing Racial Bias among Health Care Providers: Lessons from Social-Cognitive Psychology. 22 J GEN INTERN
MED. 882, 885 (2007)
117 D.L. Hamilton, COGNITIVE PROCESSES IN STEREOTYPING AND INTERGROUP BEHAVIOR 118 (1981)
118 Id.
116
30
adequate levels of health literacy tend to be Americans with higher levels of educational
opportunities, higher socioeconomic status, and better health outcomes. A presumption that most
patients will understand the information provided by their physicians therefore only perpetuates
existing health disparities as it creates a health care system that continues to work best for those with
high health literacy and the best health outcomes, while disadvantaging those with low health literacy
and poor health outcomes. Furthermore, as initial evidence indicates, limited health literacy is
associated with many negative health behaviors that result in poor health outcomes for those with
limited health literacy. Where a legal standard is harmful to a vast majority of the population, the
question of whether to revise the legal doctrine of informed consent moves past an argument for
promoting the right to self-determination, and questions the very morality of a legal presumption
that has such disparate and harmful results. Further exacerbating the inequity of the presumption
itself is the complexity of the healthcare environment as will be discussed below at the
environmental level.
Other laws and policies that influence autonomous medical decisions at the structural level
include laws that require treating physicians, rather than other qualified health care professionals, to
fulfill the duty to disclose. There is a growing body of research that shows that physicians are often
ill-equipped to communicate with patients, even those with higher health literacy. Much of this
inability may be caused by the low percentage of physicians who have received formal training in
indentifying and communicating with patients with limited health literacy. However, even among
health professionals who have been trained in methods to communicate effectively and efficiently
with limited health literacy patients, the success rates of these interventions vary widely indicating
that further study is needed in developing training interventions.
For instance, in a longitudinal study comparing medical students trained in communicating
with limited literacy patients, researchers discovered that use of these technique rose from 21%
31
before training to 31% after training.119 While this rise represents a 47% increase, it is still a
disappointing figure. Other interventions have shown some successful. For example, in a
randomized, controlled trial testing a complex clinician education intervention to improve colorectal
cancer screening, researchers found the number of limited health literacy patients completing
colorectal cancer screenings in the intervention group as compared to the control group was
significantly higher (30% to 56%).120 In the face of such research, the obvious question is whether
others who are specifically trained in health communication and identifying patients with varying
levels of health literacy may be better suited to disclosing information necessary to obtain the
patient’s informed consent in a manner that best facilities patient understanding and autonomous
choice.
Yet another example of a governmental policy or practice that influences a patient’s ability to
make autonomous medical decisions is the current reimbursement structure of Medicare and
Medicaid health insurance programs as determined by legislators and the Department of Health and
Human Services. Currently, Medicare and Medicaid do not reimburse physicians, or other health
professionals, for time spent with patients assessing his or her health literacy, or communicating
with the patient in a way that facilitates their understanding, autonomous decision-making.
Additionally, these insurance programs also neither require or incentivize health literacy
identification and communication training, nor reward the use of tools created to improve patient
understanding and communication.
W. Harper et al., Teaching Medical Students about Health Literacy: 2 Chicago Initiatives, 31 AMER J HEALTH BEHAV. S111,
S113 (2007)
120 M.R. Ferreira et al., Health Care Provider-Directed Intervention to Increase Colorectal Cancer Screening Among Veterans: Results of
a Randomized Controlled Trial. 23 J CLIN ONCOL. 1548, 1551 (2005)
119
32
6.1.3 ENVIRONMENTAL INFLUENCES
The environmental level of the ecological model focuses on the physical environment as well
as the social environment of organizations such as hospitals, insurance plans, and medical schools.
Influences on patient autonomous choice at this level include a health care system that increasingly
places greater pressure on patients to self-manage their health by requiring patients to “assume new
roles in seeking information, understanding rights and responsibilities, and making health decisions
for themselves and others.”
121
As the health care system moved away from paternalistic medicine
towards a model that required it to respect a patient’s right to self-determination, the new model
implicitly required patients to take on more responsibility for their own health care.122 This burden
has become heavier and heavier as medicine becomes increasingly complex, fragmented, and
expensive, and primary care providers, the one hope that most patients have in navigating the
system, become increasingly difficult to find. The current health care system requires patients to
find the right doctors from which they must seek out the right information by asking the right
questions, to compile all the information which they have received from multiple health
professionals, and to figure out how to afford the care that they need. As one can see, within this
environment, a patient’s ability to make autonomous choice is hindered by the sheer complexity of
environment in which the choices must be made. Further increasing this burden, as previously
discussed, is the legal doctrine of informed consent’s presumption of understanding, which assumes
instead of facilitates capacity to successfully navigate and utilize the healthcare system. The policies
and practices of medical schools can also result in an environmental influence on patients’
autonomous choice. For instance, a lack of curriculum that focuses on health literacy and improving
121
122
Nielsen-Bohlman et al., supra note 77, at 3
Nielsen-Bohlman et al., supra note 77, at 4
33
the communication skills of physicians, as well as a general lack of continuing education
requirements focused on health literacy and health communication, results in health professionals
that do not possess the skills necessary to adequately communicate with patients, even those with
adequate health literacy. Currently, there are no published guidelines for the recommended content
or structure of health literacy curricula for health professionals.
123
In an e-mail survey of medical
school deans, 47% of contacted schools responded and of that 47%, 72% reported that health
literacy was a part of their required curriculum.124 However, the median hours of instruction that
students received over their four year as medical students was three hours, which mostly occurred at
the beginning of their training in years one and two.
125
By far, the most common aspect of this
training was reported to be emphasis on using plain language in communications with patients
(95%) followed by teaching about health outcomes associated with health literacy (84%), prevalence
of health literacy (70%), and instruction on evidence-based communication techniques (70.5%).
126
Given the inadequate amount of training that students receive, it is no surprise that researchers
found that only 35% of physicians reported that they could “usually tell which of my patients have
low literacy skills” and only 18% of physicians reported that they “would be concerned about an
adult with low literacy making health care decisions for him or herself.”127
See Dr. Cliff Coleman, Presentation at the 4th Biennial Wisconsin Health Literacy Summit: Teaching Health
Professionals about Health Literacy: Approach, Techniques and Tools (April 12-13, 2011), available at:
http://www.fammed.wisc.edu/wisconsin-health-literacy-summit-2011-media
124 Id.
125 Id.
126 Id.
127 Id.
123
34
7.0
STRUCTURAL MODIFICATION TO ENHANCE PATIENT AUTONOMY
The interventions that will be suggested in this paper will focus on the structural level for several
reasons. First, this is the level in which legal influences, in particular the influence of the doctrine of
informed consent, are located. Second, because levels of influence create a web of influence on
individual behavior, many structural changes would likely result in changes to environmental
influences. Furthermore, because superstructural influences are often the result of structural and
environmental influences, changing the influences of these superstructural factors in large part
requires interventions on the structural and environmental levels. By focusing on the structural level,
important changes may result to both the environmental and structural influences, thereby also
having some effect of superstructural influences.
7.1
JUDICIAL CHANGES
The first structural-level influence that should be modified in order to facilitate patient autonomous
choice is the current legal doctrine of informed consent. Considering the weight of evidence
regarding health literacy, health outcomes, and health communication, the doctrine’s presumption of
understanding is unmerited and results in injustice, harm, and the prevention of patient autonomous
choice. All things considered, then, it is vital that the doctrine be revised in two ways. First, the
judicial system must recognize the unjust and harmful influence that the presumption of
35
understanding has by adopting a presumption of limited health literacy. In doing so, the doctrine
would be in line with current research into health literacy as it would assume the norm as opposed
to the exception, and would make certain that the health care system serves the interest of all
patients, not just those with high health literacy. This modification would also alleviate some of the
inequity of the disparate burden caused by the presumption of understanding by focusing on
facilitating the capacity of the least well-off. Many ethical and political philosophers have promoted
such an approach to societal systems with the goal of maximizing distributive justice, which is
concerned with the equitable allocation of goods within a society.128 Where the presumption of
understanding is modified to be a presumption of limited health literacy, limited health literacy
patients would garner systematic support to build their capacity to understand information necessary
to their medical decision-making and obtain services necessary to facilitate those decisions.
Therefore, under a modified presumption, health care resources are much more likely to be utilized
by all patients who truly need them, rather than by those with high health literacy who have the
knowledge and wherewithal to access them.
However, this presumption of limited health literacy should be rebuttable by evidence-based
health literacy testing as forcing physicians to treat all patients as if they are limited health literacy
patients would be overly taxing on the resources of the health care system, and would be
unbeneficial to those patients who have higher levels of health literacy. This rebuttable presumption
should not be understood as establishing that only patients with limited health literacy will benefit
from improved communication; all patients have been found to benefit from improved patientprovider communication.129 By permitting the presumption of limited health literacy to be rebutted
128
See e.g. John Rawls, A THEORY OF JUSTICE (1971); See also Martha Nussbaum, Capabilities and Human Rights, 66
FORDHAM L. REV. (1997)
129
M. Pignone et al., Interventions to Improve Health Outcomes for Patients with Low Literacy. A Systematic Review. 20 J GEN
INTERN MED. 185, 190-91 (2005); Barry D. Weiss et al., Literacy Education as Treatment for Depression in Patients with Limited
36
by evidence-based testing, health care professionals and entities would be highly motivated to initiate
literacy testing among their patients so as to avoid legal liability and spending unnecessary resources
or time with patients who have sufficient health literacy.
This testing should be simple, fast, effective, and embraced by patients—where health
literacy screenings have been conducted, studies show that 94% of those screened felt like the
exercise was useful.130 Two of the most widely used measures of health literacy are the rapid
estimate of adult literacy in medicine (REALM)131 and the test of functional health literacy in adults
(TOFHLA).132 These tests are mainly used in research, but they are suitable and practically capable
of being used in the clinical setting. Both of these tests can easily be given to a patient along with
regular office paperwork, and are a quick and easy way to reliably determine a patient’s health
literacy level.
However, each test has its own strengths and weakness and physicians must
understand and keeps these in mind when determining the suitability of the tests for an individual
patient.
Literacy and Depression: A Randomized Controlled Trial, 21 J GEN INTERN MED. 823, 826 (2006); R.I. Sudore et al., Use of a
Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study. 21 J GEN INTERN MED. 867, 871 (2006)
130
H.K. Seligman et al., Physician Notification of Their Diabetes Patients’ Limited Health Literacy. A Randomized, Controlled Trial,
20 J GEN INTERN MED. 1001, 1005 (2005)
131 The REALM is a word-recognition test that estimates health literacy based on a patient’s ability to pronounce a list of
medical terms. The test consists of 125 word recognition questions developed to identify patients with low literacy levels
and to provide a reading grade range for those with limited literacy skills. The patients are asked to read all words aloud
and are scored with a plus for correct pronunciation and a check for incorrect pronunciation. The raw scores are
converted to grade ranges corresponding with lower elementary, upper elementary, junior high, and senior high school
levels. The administration and scoring takes 3-5 minutes. In addition to the REALM test, a shortened version of the
REALM is available. The shortened REALM takes 1-2 minutes to administer and highly correlates with REALM results.
The REALM is only available in English..
132
The TOFHLA measures the functional literacy level of patients, real health care materials including patient education
information, prescription bottle labels, registration forms, and instructions for diagnostic tests. The TOFHLA assesses
numeracy and reading comprehension and has a total of 67 questions. The numeracy scale, used to measure the ability to
read and understand numbers, includes 17 items; the reading comprehension scale, used to measure the patient’s ability
to read and understand health care-related passages, contains 50 items. Raw scores are converted to scaled scores, which
range from 0-100. To interpret the total score, participants receiving a score of 59 or below are considered to have
inadequate functional health literacy; those scoring 60-74 have marginal functional health literacy and subjects scoring 75
and above have adequate functional health literacy. There are two additional versions of the TOFHLA: TOFHLA-S, a
validated Spanish translation, and the S-TOFHLA, a short form that requires up to 12 minutes to administer.
37
The second modification of the current legal doctrine of informed consent should be to
expand the duty to disclose to include both reasonable disclosure and reasonable efforts to assure a
patient’s substantial understanding. While patient understanding seems to be dismissed by the
Canterbury court as something outside the control of the physician, this is untrue as there are several
evidence-based methods to assure patient understanding. One highly successful method is called the
Teach-Back or the Show Me method, which is endorsed by the American Medical Association. 133
The Teach Back method is used to ensure that patients understand the information shared with
them by health professionals, and to encourage physicians not to rely on asking patients if they
understand the information shared with them as an indicator of comprehension, as patients,
especially those with limited health literacy, rarely truthfully answer.134 The Teach Back method
teaches physicians to ask their patients open ended questions, and to “explain or demonstrate how
he or she will undertake a recommended treatment or intervention” after disclosing necessary
information.
135
Where patients are unable to properly explain or demonstrate instructions,
physicians must provide the patient with further support in understanding information.136
Utilization of the Teach Back method has been shown to improve patients’ understanding and their
health outcomes. 137
Other methods that are widely endorsed by medical associations and those interested in
improving patient health literacy include encouraging physicians to slow down so that they speak
slowly and spend a small amount of additional time with their patients, to use plain language in their
communications that is free from medical-jargon, to utilize visuals to improve a patient’s
Barry D. Weiss, Removing Barriers to Better, Safer Care: Health Literacy and Patient Safety Manual for Clinicians, American
Medical Association Foundation, 33 (2007)
134 Id.
135 Id.
136 Id.
137 Id.
133
38
understanding, and to create a shame-free environment in which patients are encouraged to ask
questions and are assured that it is common for patients to need additional aid in understanding
medical information.138 By spending as little as three additional minutes with patients, averaging 18
minutes as opposed to 15 minutes, data shows that communication is improved and physicians are
more likely to avoid malpractice liability.
139
Using plain-language is also an important way to
improve patient understanding,140 especially when used in conjunction with visuals, which have been
shown to enhance patients’ understanding of what they need to know and do.141 However, many
physicians may not be able to simplify language enough, and in these cases, consent forms that have
been written specifically for those with limited health literacy may be useful when relied on by
physicians as a guide for how to communicate, and not as a substitute for a conversation.
Another evidence-based clinical intervention is the Ask-Me-Three program.142 This program
focuses on encouraging patients to pose three questions to their physicians: what is my main
problem, what do I need to do, why is it important for me to do this?143 This program has been
Id. at 19
Id. at 30
140 D. Baker et al., Literacy and Retention of Information after a Multimedia Diabetes Education Program and Teach-Back, 16 J
HEALTH COMMUN. 89, 97 (2011)(“After developing testing a plain language multimedia diabetes education program,
which included a brief video modules that was designed to clearly communicate essential self-management concepts to
diabetes patients across literacy levels, evaluation found that even though patients had very little baseline knowledge
about diabetes, the plain language video module significantly increased diabetes knowledge in English- and Spanishspeaking patients across literacy levels”); Schillinger et al., Closing the Loop: Physician Communication with Diabetic Patients Who
Have Low Health Literacy, 163 ARCH INTERN MED. 83, 86 (2003)(“After multivariate logistic regression, the 2 variables
independently associated with good glycemic control were higher health literacy levels (odds ratio, 3.97; 95% confidence
interval, 1.09-14.47) (P = .04) and physicians' application of the interactive communication strategy (odds ratio, 15.15;
95% confidence interval, 2.07-110.78) (P<.01).”)
141 Houts, P. et al., The Role Of Pictures in Improving Health Communication: A Review of Research on Attention, Comprehension,
Recall, and Adherence, 61 PATIENT EDUC COUNS. 173, 187-88 (2006)( “Pictures closely linked to written or spoken text
can, when compared to text alone, markedly increase attention to and recall of health education information. Pictures
can also improve comprehension when they show relationships among ideas or when they show spatial relationships.
Pictures can change adherence to health instructions, but emotional response to pictures affects whether they increase or
decrease target behaviors. All patients can benefit, but patients with low literacy skills are especially likely to benefit.
Patients with very low literacy skills can be helped by spoken directions plus pictures to take home as reminders or by
pictures plus very simply worded captions.”)
142 Weiss, supra note 134, at 34
143 Id.
138
139
39
found to engage patients in a conversation about their treatment.
144
The basis for encouraging
patients to engage with their physicians in conversation is to try to improve patients’ comfort levels
when interacting with physicians, and to reduce the shame that many patients feel in admitting to
their physician that they do not understand what the physician has said.145 Additionally, the Ask Me
Three program attempts to create an environment in which patients are assured that difficulty
understanding medical information is the norm, and that they should not feel embarrassment if any
information is not clear to them.146
In addition to promoting patient autonomous choice by assuring substantial understanding,
requiring reasonable assurance of patient understanding may encourage medical schools to include
health literacy and health communication training in their curriculum. Given that medical students
who are uneducated in identifying and communicating with limited health literacy patient would be
at risk of malpractice liability, such training may become more common and represent a larger
percentage of the medical school curriculum. Additionally, a change in the requirement of informed
consent to require assurance of substantial understanding would likely result in a rise in continuing
education classes dedicated to the issue given the chance for medical malpractice, which is obviously
a motivator for physicians to learn and utilize new skills. Such classes would assure that current
doctors would receive training that they did not get while in medical school, or which might be
outdated. At the very least, such a change in the legal doctrine of informed consent may cause
medical entities to require that their health professionals be trained in indentifying and
communicating with patients of all literacy levels.
Id.
Id.
146 Weiss, supra note 134, at 34
144
145
40
7.1.1
LEGISLATIVE CHANGES
Outside the judicial system, many legislative changes, both federal and state, would facilitate
patient autonomous choice. First, on the federal level, changes to the Medicare and Medicaid
reimbursement policies to permit payment for counseling would help to facilitate the time necessary
to encourage substantial patient understanding. Currently, medical professionals are typically
reimbursed for certain enumerated services that the professionals provide for the patient.
Unfortunately, health professionals cannot bill for the time that they spend counseling patients. As a
result of this reality, physicians, who are already pressed for time, have little incentive to obtain their
patient’s informed consent other than legal compliance. In order to combat this reality and to
provide patients with the amount of counseling that they need in order to make truly autonomous
medical decision, counseling should be a billable service for health professions.
Such a change in the payment structure of Medicare and Medicaid may be enticing to the
Department of Health and Human Services, which, under the Patient Protection and Affordable
Care Act, has been tasked with finding new and better ways to provide and pay for health care for
beneficiaries in an effort to reduce health care costs.147 As such, the Department may be open to
restructuring the payment system given that initial research into the cost of health literacy shows
both that patients with limited health literacy typically consume more health care resources despite
having generally worse health care outcomes and that utilization of effective health communication
tools has been shown to reduce limited health literacy. For instance, in a 2008 literature review
focused on the costs of limited health literacy, researchers located six studies that provided
estimations of costs to health care expenditures due to limited health literacy.148 For the most part,
147
148
See e.g.. 42 USC § 1395cc–4
K. Eichler et al., The Costs of Limited Health Literacy: A Systemic Review, 54 INT J PUBLIC HEALTH. 313, 318 (2009)
41
the studies used datasets from Medicaid and Medicare populations as individual patient datasets that
include both health literacy and cost data on an individual basis are uncommon.149 The studies found
a range of 3-10% of health care costs were due to limited health literacy of the population, with the
median cost calculated by the studies falling``` between 3-5% costs.150 Studies that estimated per
patient costs for limited health literacy gave amounts ranging from $143 to $7,798 per person per
year.151
Other studies have found several characteristics associated with limited health literacy
patients that could explain a link between limited health literacy and increased health care
expenditures. First, researchers have found that Medicare patients with inadequate and marginal
health literacy utilize more inpatient and emergency room services than those with adequate health
literacy.152 Compounding the use of expensive inpatient services, the same study also found that
limited health literacy patients also tend to have longer hospital stays.
153
Additionally, patients with
inadequate health literacy were no more likely than respondents with adequate health literacy to use
outpatient care or fill prescription drugs, though they had significantly more chronic conditions.154
These characteristics may translate into significantly higher inpatient care costs for patients with
inadequate health literacy.
155
Other studies have drawn similar conclusions by positing that some
measure of the increased costs from patients with limited health literacy is due to their consumption
of fewer preventive services while using more treatment services, which are more costly.
156
Given
Id.
Id.
151 Id.
152 D.H. Howard et al., The Impact of Low Health Literacy on the Medical Costs of Medicare Managed Care Enrollees. 118 AM J
MED 371, 373 (2005)
153 Id.
154 Id.
155 Id. at 374.
156 David W. Baker et al., Health Literacy and the Risk of Hospital Admission, 13 J GEN INTERN MED. 78, 795-971 (1998);
Tracy L. Scott et al., Health Literacy and Preventive Health Care Use among Medicare Enrollees in a Managed Care Organization, 40
MED CARE 395, 398-402 (2002)
149
150
42
the possibility of cost savings, allowing reimbursement for counseling services could be a costsavings initiative, as well as a means to facilitate autonomous choice. Furthermore, additionally
improving patient autonomous choice, if Medicare and Medicaid make these changes to their
reimbursement system, non-government insurers may follow their lead if the policy results in health
care savings.
On the state level, one influence that can be changed to support autonomous choice
includes passing legislation to override the generally accepted view that informed consent is the duty
of physicians, as opposed to hospitals or other health professionals. Evidence increasingly shows
that placing the burden of informed consent on physicians is ineffective given their lack of training
in health communications, results in reliance on stock informed consent given the time pressures
under which physicians practice, and further encourages poor health outcomes for limited literacy
patients. Considering this evidence, placing the responsibility of informed consent solely on
physicians may hamper the very goal of informed consent. One solution to this issue may be for
state legislatures to pass legislation that explicitly allows for the informed consent process to be
conducted by physicians or other qualified health professionals, such as nurses or physician
assistants who are specifically trained in health communication methods. These other qualified
health professionals are typically called patient navigators or patient educators.
Patient navigators are often used for patients with chronic conditions that require
particularly burdensome treatment and care like cancer and diabetes. The role of patient navigators
is to help patients to identify and overcome barriers to care, such as limited health literacy, and to
“connect individuals to screening, following patients post-screening, and assisting patients through
the course of treatment” by educating, coordinating care, and providing social or emotional support
43
to patients.157 While there is still limited research on patient navigation because it is a new concept,
initial research seems to indicate that navigation programs are successful on many levels. First,
patient navigation programs have been shown to aid racial and ethnic minorities in accessing
preventative and diagnostic treatment and education and outreach services.
158
Such successes may
be able to reduce the disparate burden on limited health literacy patients resulting from the
complexity of the healthcare system. Additionally, studies have shown that navigators increase
satisfaction among minority and ethnic populations, especially where navigators are representative
community members, which increases the likelihood of trust between patients and navigators, as
well as the health care system that the navigator represents.159 The creation of trust that results from
patient navigator programs may serve to reduce feelings of discrimination and unease among these
populations. Additionally, given disparities within the physician population that result in
underrepresentation of minority physicians, as well as the research previously mention regarding race
concordant patient-provider relationships, concordant patient navigator may be a way to gain the
positive outcomes associated with such relationships. Lastly, while the novelty of navigator
programs provides few studies regarding health outcomes associated with participant, and this area
needs additional research, at least one study did find that patients participating in navigator programs
were more likely to report feeling that they had someone to answer their questions during
treatment.160
D. Dohan, Using Navigators to Improve Care of Underserved Patients: Current Practices and Approaches, 104 CANCER. 848, 850
(2005)
158 A. Natale-Pereira et al., The Role of Patient Navigators in Eliminating Health Disparities, 117 CANCER. 3543, 3549 (2011)
159 Id.
160 M.L. Steinberg et al., Patient-Centered Satisfaction and Well Being Assessment in a Lay Patient Navigator Program for an
Underserved Radiation Oncology Patient Population, 69 J RADIAT ONCOL. S563, S564 (2007)(Analysis of demographics
revealed no significant differences (p . .05) between the two groups. The non-navigated outperformed the navigated in
all but one metric: During my cancer treatment, I had someone to answer my questions.)
157
44
8.0
CONCLUSION
The current presumption of understanding underlying the legal doctrine of informed consent is
unmerited based on current evidence regarding patient health literacy. Without revising the legal
doctrine of informed consent in light of this research and requiring substantial understanding, the
doctrine is incapable of promoting self-determination and patient autonomous choice—the very
fundamental rights which it was developed to protect. Additionally, any reassessment of the legal
doctrine of informed consent should approach its amendment first by considering health literacy
and health communication research, and then by considering the influences on autonomous decision
making that result from the complex web of superstructural, structural and environmental factors
that hinder patient autonomous choice. Appreciation of this web of causation can held to develop a
new standard of informed consent that minimizes negative influences on each of these levels while
truly facilitating patient autonomous choice.
45
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