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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 Pittsburgh2013
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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 ProfessorDepartment of Health Policy and ManagementUniversity of Pittsburgh Graduate School of Public HealthAdjunct ProfessorUniversity of Pittsburgh School of Law
Alan Meisel, JD ______________________________________
Professor of Law and PsychiatryDickie, McCamey & ChilcoteProfessor of BioethicsUniversity of Pittsburgh
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Copyright © by Amanda Paige Burns
2013
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, 2013ABSTRACTThis 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 self-
determination, 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
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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 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.
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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........................................................19
5.1.2 AGE.................................................................................................20
5.1.3 MINORITY STATUS.........................................................................21
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
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7.1 JUDICIAL CHANGES...............................................................................................35
7.1.1 LEGISLATIVE CHANGES.................................................................41
8.0 CONCLUSION................................................................................................................45
BIBLIOGRAPHY...................................................................................................................46
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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 non-technical 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
1 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)
2
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 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
3 Ruth Faden & Tom Beauchamp, A HISTORY AND THEORY OF INFORMED CONSENT 86 (1986)4 See Schloendorff v . New York Hospital , 211 N.Y. 125 (1914)5 Mohr v. Williams, 95 Minn. 261, 265 (1905)6 Id. at 2657 Id. at 2698 Id. at 270
3
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 be obtained.” 12 In the medical battery
cases that followed Schloendorff, courts adopted the self-determination
rationale of the consent requirement expressed in Schloendorff.
9 Schloendorff, 211 NY at 129 10 Id. at 12711 Id. at 12812 Id. at 130
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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 self-determination, to justify an informed consent
requirement that required a physician to disclose “any facts which are
13 Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal. App. 2d 560, 578 (1957)14 See Faden and Beauchamp, supra note 3, at 125
5
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 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 self-determination 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
15 Salgo, 154 Cal. App. 2d at 560, 568 16 Id. at 57817 See Faden and Beauchamp, supra note 3, at 12618 Faden and Beauchamp, supra note 3, at 8719 Id.
6
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 physiological results of the apprehension itself.”21
In light of these concerns for the patient’s well-being, 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 20 Salgo, 154 Cal. App. 2d at 560, 56821 Id. 22 Id.
7
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.
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
23 Natanson v. Kline, 350 P.2d 1093, 1106 (1960)24 Natanson, 350 P.2d at 1106 25 Id. 26 Canterbury v. Spence, 464 F.2d 772, 785-86 (1972)
8
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
27 Id. at 785-8628 Id. at 78029 Id. at 787 30 Id. at 783 31 Id. at 784 32 Canterbury, 464 F.2d at 784
9
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 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
33 Id. at 785-86 34 Id. at 785-86 35 Id. at 78736 Id. at 788
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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
37 Id. at 78938 Id.
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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
39 Canterbury, 464 F.2d at 78040 Id.
12
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 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 41 Id. at 788 42 Id. at 78243 Canterbury, 464 F.2d at 789
13
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.
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
self-determination 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
44 Tom Beauchamp & James Childress, PRINCIPLES OF BIOMEDICAL ETHICS, 5-13 (5th ed. 2001)
14
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
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 45 Beauchamp & Childress, supra note 44, at 58-6146 Id. at 5947 Id. at 59
15
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.
48 Canterbury, 464 F.2d at 78949 Salgo, 154 Cal. App. 2d at 578 50 Canterbury, 464 F.2d at 789
16
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, 51 Beauchamp & Childress, supra note 44, at 5952 Id.53 Id.
17
adequate patient understanding, the legal doctrine of informed consent fails
to assure autonomous choice if that presumption is unfounded. 54
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.”)
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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
55 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
19
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
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
57 Id. at 2-358 M.V. Williams et al., Inadequate Functional Health Literacy Among Patients at Two Public Hospitals, 20 J AM MED ASSOC. 1677, 1680 (1995)59 Id.60 Id. 61 Id. at 168162 Id.
20
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 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
63 Id.64 Id.65 Deborah Chinn, Critical Health Literacy: A Review and Critical Analysis, 73 SOC SCI MED. 60 (2011) 66 World Health Organization, Division of Health Promotion, Health Promotion Glossary, 10 (1998)
21
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.” 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
67 Id.68 United States Department of Health and Human Services, HEALTHY PEOPLE 2010: UNDERSTANDING AND IMPROVING HEALTH, 56 (2000)69 Id.
22
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
70 United States Department of Education, supra note 55, at 571 Id.72 Id. at 773 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)
23
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 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
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 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)
24
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.
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 77 Lynn Nielsen-Bohlman et al., HEALTH LITERACY: A PRESCRIPTION TO END CONFUSION, 80 (2004)78United States Department of Education, supra note 70, at 1279 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.
25
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
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
81 Id.82 Id.83 Id.84 Id.85 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
26
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 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 86 United States Department of Education supra note 70, at 1187 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)88 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
27
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 89 Id.90 United States Department of Education supra note 70, at 1291 Nielsen-Bohlman et al., supra note 77, at 114
28
determine what treatment is best for them to choose anyway. It is not
surprising then that researchers have found 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
92 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 123194 Id.95 Id.
29
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 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
96 Nielsen-Bohlman et al., supra note 77, at 84-9997 Id.98 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
30
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
100 Id.101 Id.
31
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 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 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
32
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. 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
33
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 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 102 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.”)
34
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
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
103 Norman Daniels et al., IS INEQUALITY BAD FOR OUR HEALTH? 86 (2000)104 Id. at 46105 Daniel Goldberg, Justice, Health Literacy, and Social Epidemiology, 7 AM J BIOETH. 18, 19 (2007).
35
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
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)
36
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 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,
110 Id. at 167111 Id. 112 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
37
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 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
114 Nielsen-Bohlman et al., supra note 77, at 34-35115 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)116 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.
38
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 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
39
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
40
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% 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
119 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)
41
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.
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
121 Nielsen-Bohlman et al., supra note 77, at 3
42
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 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
122 Nielsen-Bohlman et al., supra note 77, at 4
43
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
123 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-media124 Id.125 Id.126 Id.127 Id.
44
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.
45
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 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,
128See e.g. John Rawls, A THEORY OF JUSTICE (1971); See also Martha Nussbaum, Capabilities and Human Rights, 66 FORDHAM L. REV. (1997)
46
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
patient-provider communication.129 By permitting the presumption of limited
health literacy to be rebutted 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
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 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)
47
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
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.
48
strengths and weakness and physicians must understand and keeps these in
mind when determining the suitability of the tests for an individual patient.
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
133 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.
49
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 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 137 Id.138 Id. at 19139 Id. at 30140 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 Spanish-speaking 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).”)
50
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 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
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 34143 Id.144 Id.145 Id.
51
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.
146 Weiss, supra note 134, at 34
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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
147 See e.g.. 42 USC § 1395cc–4
53
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, 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
148 K. Eichler et al., The Costs of Limited Health Literacy: A Systemic Review, 54 INT J PUBLIC HEALTH. 313, 318 (2009) 149 Id.150 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)
54
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 the possibility of
cost savings, allowing reimbursement for counseling services could be a
cost-savings 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
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)
55
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 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
157 D. Dohan, Using Navigators to Improve Care of Underserved Patients: Current Practices and Approaches, 104 CANCER. 848, 850 (2005)
56
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
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
57
navigated in all but one metric: During my cancer treatment, I had someone to answer my questions.)
58
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.
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