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Evidence-Based Practice Forum
Ethical Considerations Related to
Evidence-Based Practice
E
thical issues are part of every
health care encounter. Moral principles, such as truth, fairness,
doing the right thing, avoiding harm,
and respecting autonomy, lie at the heart
of these ethical concerns. Each patient
care encounter includes issues related to
the established practices of the discipline,
what the patient prefers, concern for
quality of life, and contextual features
(Jonsen, Siegler, & Winslade, 1998;
Kornblau & Starling, 2000). The contextual features include the backdrop or personal story that places the experience
within a real-life context for the patient.
Driven by increased accountability
and the widespread and convenient
availability of information spawned by
the Information Age, the health care
community is turning increased attention toward evaluating established practices. This movement, which focuses on
searching and appraising available evidence on the advantages and disadvantages of various intervention options, is
described by occupational therapy and
other health care professions as evidencebased practice.
Evidence-Based Practice:
Origins and Processes
Evidence-based practice is rooted in
medicine but has quickly been embraced
by the entire health care community. As
defined by leading authorities (Sackett,
Rosenberg, Gray, Haynes, & Richardson, 1996), evidence-based practice is
“the conscientious, explicit, and judicious use of current best evidence in
making decisions about the care of individual patients” (p. 71). As Holm (2000)
noted, the process of evidence-based
practice involves being aware of the variThe American Journal of Occupational Therapy
Charles Christiansen,
Jennie Q. Lou
Charles Christiansen, EdD, OTR, FAOTA, is
George T. Bryan Distinguished Professor
and Dean, School of Allied Health
Sciences, University of Texas Medical
Branch, Galveston, Texas.
Jennie Q. Lou, MD, MSc, OTR/L, is Associate
Professor of Occupational & Public
Health, College of Allied Health, Health
Professions Division, Nova Southeastern
University, 3200 S. University Drive, Ft.
Lauderdale, Florida 33328;
[email protected]
This article was accepted for publication
February 8, 2001.
Associate Editor
Linda Tickle-Degnen
ous levels of existing evidence underlying
a given intervention approach and carefully appraising that evidence as it
applies to a specific patient encounter.
Typically, the method involves carefully
formulating a clinical question, finding
evidence that bears on the question, and
evaluating the evidence without bias and
applying it as appropriate to a given
patient (Tickle-Degnen, 1999).
Implementing the process of evidence-based practice has implications for
resource use, for professional credibility,
and for improving outcomes. These
worthwhile benefits are often emphasized
without sufficient attention to the underlying ethical principles involved. One can
argue that the primary reason for implementing evidence-based practice is a
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moral one. Professional caregivers are
responsible for practicing in a manner
that keeps the patient’s interest foremost
by achieving the greatest good and avoiding harm in the process. In their pledges
to practice ethically, professionals already
commit to making decisions that are
right for a given patient at a given time.
Rogers (1983) stated it thusly, “The ultimate question we, as clinicians, are challenged to answer is: What, among the
many things that could be done for this
patient, ought to be done? This is an ethical question” (p. 602).
Given the widespread and growing
interest in evidence-based practice, it
might appear to an outside observer as
though the health care community had
just realized that the careful and objective examination of evidence provides a
sounder basis for making decisions than
tradition, conjecture, or authority.
However, although a professional’s obligation to stay fully informed has existed
for centuries, only recently has a practical means for doing so (e.g., the personal
computer, the World Wide Web) created
the environment of expectation and
accountability necessary to drive the evidence-based practice movement to its
current level of influence. As with so
many endeavors pursued with enthusiasm, the fervor that accompanies evidence-based practice may cause us to
overlook its limitations. We may neglect
to apply to evidence-based practice the
fundamental principles of objective
analysis that are so central to the process
itself. In our zeal to be objective and
informed, we may forget that clinical
decision making, at its core, is an ethical
matter, and we may lose sight of the ethical dilemmas hidden beneath our efforts
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to produce the most effective medical,
rehabilitation, and health outcomes.
Evidence-Based Practice and
Ethical Issues in Occupational
Therapy and Rehabilitation
In the sections to follow, we identify and
discuss some ethical issues called forth by
the process of evidence-based practice.
The focus is on occupational therapy and
rehabilitation, but the issues may be
equally valid for other domains of practice. Our identification of these issues is
not intended to diminish the importance
of the evidence-based practice but, rather,
to point out that ethical issues are embedded throughout health care practices. To
the extent that we are aware of them, we
are better prepared to avoid the dilemmas
and complications that result when they
arise.
The Status of Evidence
As in medicine, much of traditional rehabilitation practice unfortunately lacks
sufficient research for the careful, welldocumented analyses expected in making
confident, evidence-based decisions.
More often than not, available evidence
in many health care arenas consists mostly of expert opinions. Despite important
advances in occupational therapy research
over the past quarter century, only a few
areas of intervention have amassed sufficient data to enable research-based confidence in treatment interventions (Holm,
2000; Law & Baum, 1998; TickleDegnen, 1999).
Moreover, some occupational therapy practitioners underappreciate the
value of evidence-based practice
(Dubouloz, Egan, Vallerand, & von
Zweck, 1999). The reasons for this lack
of appreciation remain unclear. It may
represent a discomfort with the uncertainty associated with interpreting probabilities for relationships and effects of
interventions. Many practitioners expect
research to provide explanations of the
underlying mechanisms of change. In the
new world of evidence-based practice,
however, practitioners must become
more comfortable with the ambiguity
associated with probability tables.
The Institute of Medicine acknowledged the dearth of evidence to inform
rehabilitation practice in a report entitled
Enabling America (Brandt & Pope,
1997). In practice, some of the outcomes
of interest to occupational therapists are
difficult to define or measure, thus making some studies that address important
issues more difficult. For example, pain,
which can often result in occupation limitations and diminish social participation,
is highly subjective and difficult to measure. Similarly, a single, well-validated,
quality of life measure has not yet
emerged with sufficient recognition to
serve as a gold standard. These definitional
and measurement issues in rehabilitation
must be addressed if the International
Classification of Functioning, Disability
and Health (World Health Organization,
2000) is to be of maximal use. This taxonomy emphasizes that disability is the
product of environmental circumstances
and functional impairment, which individually or in combination can result in
reduced quality of life through limitation
of activity and reduced social participation.
More research is needed to provide
evidence to guide interventions that
reduce disability for specific conditions,
populations, and settings. Meanwhile,
practitioners must base their interventions on clinical tradition, anecdotal
results, and expert opinion. In working
with patients to plan treatment goals and
interventions, therapists must acknowledge the basis upon which a given intervention approach is made.
Consumer Autonomy
Patient and family participation in planning intervention (autonomy) is an
important dimension of rehabilitation
practice (Tickle-Degnen, 2000), yet this
involvement often does not extend to
decision making about research agendas.
Although the National Institutes of
Health have made significant steps
toward involving consumers in processes
designed to protect human subjects, this
participation (e.g., on Institutional
Review Boards) comes after studies have
already been designed. Ideally, consumers
should participate more in strategic decisions related to the allocation of research
funds for conditions, populations, and
settings.
This participation should also
include decision making under difficult
political circumstances, as, for example,
when competing or contradictory claims
by different groups result in different
interpretations of available evidence. The
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process of evidence-based practice itself
does not provide a means for judging the
political wisdom of allocating resources,
yet decisions must be made. It can be
argued, therefore, that it is even more
important that consumers be included in
the process when competing political
interests are decided.
Evaluating Evidence
According to the process of appraising
available information, evidence should be
ranked on the basis of the manner in
which it was obtained (Holm, 2000).
Because some methods that have less rigorous controls (e.g., expert opinion, anecdotal experience) are discouraged in favor
of studies that meet or approach the gold
standard (prospective randomized controlled trials), practitioners should not
lose sight of the values brought by each
approach (Culpepper & Gilbert, 1999).
For example, within the traditional
model described by evidence-based practice, a study using Functional Independence Measure (FIM™1) scores would be
rated more highly than one based on the
judgment of a patient or family members
(Granger, 1998). In this instance, issues of
autonomy come into play. Should discharge decisions be made on the basis of
an FIM score or patient satisfaction with
outcomes achieved? In other words,
instances may exist where the value of
autonomy (the patient’s right to choose)
is more important than adherence to an
objective research measure.
Conflict of Interest
Although studies designed with high levels of control for competing hypotheses
are emphasized as necessary for achieving
valid conclusions, the ethical threats
involved in conducting such research are
sometimes understated. Again, scientists
rather than patients mostly determine
decisions about who participates in studies and whether intervention continues,
thus creating a conflict of interest
(Gordon, Sugarman, & Kass, 1998).
Conflicts of interest may be represented in other ways associated with evidence-based practice. When scientists are
induced to conduct clinical trials that
have associated financial benefits, ques1
FIM™ is a trademark of the Uniform Data
System for Medical Rehabilitation, a division
of UB Foundation Activities, Inc.
May/June 2001, Volume 55, Number 3
tions arise about the validity of conclusions. Although such enticements are
most often associated with studies of
pharmaceutical agents, they can also
occur when clinical investigators in rehabilitation have fiduciary relationships
with manufacturers of medical and rehabilitation devices. Researchers should
take care to avoid situations where financial inducements or other gains may create the potential for perceived or actual
conflict of interest. To be ethically sound,
an investigator should have no actual or
potential sources of bias associated with
personal or facility gain. The Food and
Drug Administration has issued strict
rules and regulations governing disclosure
of financial conflict of interest by scientists involved in clinical trials involving
medical devices or drugs (Department of
Health and Human Services, 1998).
Researchers should also ensure that
disciplinary loyalty does not introduce
potential bias into trials involving interventions associated with a given profession. What is of concern to the patient is
not the standing of a particular professional group but, rather, the efficacy of a
particular intervention.
Informed Consent
Ethical oversights also extend to the matter of informed consent for those invited
to participate in clinical research. The
idea of informed consent is again
grounded in the principle of autonomy.
This principle respects the right of a person to weigh the pros and cons of a decision and to make a choice on the basis of
his or her consideration of alternatives.
To make a fully informed choice, potential research participants must be advised
of the expected benefits and risks of the
research trials in which they are asked to
participate.
The Human Research Ethics Group,
administered by the Center for Bioethics
at the University of Pennsylvania Health
System, extensively reviewed the status of
existing human subjects protections and
federal reports with the aim of making
recommendations for improvement and
reform. As noted in a subsequent report
(Moreno, Caplan, & Wolpe, 1998), federal regulations had not been revised in
nearly 2 decades, and considerable evidence suggested the need for stronger
regulations, especially to protect special
populations placed at additional risk
because of cognitive disabilities. These
populations might face additional risk
because of their inability to fully evaluate
the risks of research participation. The
Human Research Ethics Group specifically recommended improvements in
review board requirements to provide a
clear and complete statement of the
expected benefits and risks associated
with enrollment in a study.
The point is that as the pressure to
produce evidence to justify existing practices mounts, researchers may be more
likely to infringe on ethical boundaries in
their zeal to collect it. If risks are understated and potential benefits are exaggerated, the cumulative effect may be to bias
significantly and imprudently the decision of a potential research participant in
the direction of participation. Here, the
ethical principle of greatest societal good
(which is the expected consequence of
conducting the research even in the face
of potential risk to participants) is in
conflict with the principle of autonomy.
Biases in Research Selection
Another nettlesome problem in evidence
generation concerns biases in the selection and support for research to be
undertaken. Earlier, we addressed the
need for consumer participation in strategic decision making. Here we discuss
how the traditions of disciplines and cultures may create biases in the selection
and support of research.
In particular, we maintain that
research in rehabilitation methods, social
reintegration, and palliative care may not
occur as frequently as other types of
research because of prevailing models of
care in western medicine. These models
tend to emphasize life extension and survival rather than life quality and acceptance of death. The net result is that the
potential benefits of approaches that
emphasize life quality rather than life
extension may be underappreciated and,
thus, used less frequently, even though
they may represent the “right thing to
do” under the circumstances. Here the
selection of research to provide evidence
for practice interventions can reflect a
bias that leads to practices that may not
be “right” for a particular patient when
that patient’s quality of life is considered.
In the play Whose Life Is It Anyway?
by British author Brian Clark, the protagonist with high-level quadriplegia files suit
The American Journal of Occupational Therapy
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for the right to terminate his treatment
against medical advice. Because his condition renders him unable to continue pursuing his passion for sculpture, he reasons
that life no longer provides sufficient
meaning to warrant its continuation. In
litigation against his caregivers, he sues for
the right to determine his level of care
and prevails. This drama vividly illustrates
the current dilemma between interventions aimed at prolonging life and those
aimed at providing a life with greater
quality. The same biases are evident in
decisions affecting research support. Far
more attention (and resources) are devoted to studying approaches aimed at saving
or continuing lives in proportion to studies that address issues related to adaptation following devastating injury and its
effect on quality of life.
Using Evidence
Once research evidence has been generated, the relevance of its application to specific situations must be determined. In
rehabilitation, the extent to which outcomes are satisfactory highly depends on
contextual factors of a social and psychological nature. Outcomes are thus harder
to measure and compare, making the
application of group data to individual
patients difficult because conditions are
never exactly the same for any two
patients.
Difficult-to-apply data, however, are
better than none at all. The paucity of
studies in rehabilitation increases the likelihood that judgments and decisions will
be based on conjecture or tradition. As
more the rule than the exception, insufficient attention may be given to practices
that have not been validated by research.
Additionally, the nature of some occupational therapy interventions is such that
the perceived risk to the patient is viewed
as minimal. Here, a bias toward action
seems justified by the assumption that
the intervention can do no harm, which
we now know from our expanding
knowledge base that this is not always
true. Although we know well that poorly
fabricated splints can cause pressure sores,
we are less confident in concluding that
failed therapeutic encounters affect selfimage, personal identity, and morale.
Unknown consequences to the neuroendocrine system may be possible, and to
us, dismissing these out of hand as
inconsequential seems to treat the very
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principle of avoiding harm far too casually. Furthermore, although a failed therapeutic intervention may not result in
physical harm, the psychological effect to
the patient’s confidence or self-efficacy
may be ignored or underestimated.
Moreover, the resource costs of providing
ineffective care also must be considered.
The opposite also can occur.
Because resources are increasingly allocated to proven treatments, the availability
of useful options that are yet unsubstantiated in clinical trials may be reduced
(Christiansen, 1983; Landry & Mathews,
1998). This bias may also create a milieu
that unintentionally diminishes interest
in behavioral factors related to health or
to studies of means to prevent disease or
injury or promote wellness. Prevention
studies are less often undertaken because
of the difficulties or expenses associated
with randomization and control in natural environments. Such studies have
engendered less urgency and interest
because their potential benefits may not
be realized (or known) until many years
later. The same bias can be seen in support and interest for studying palliative
care and hospice services, where the
reports are difficult to obtain and compare and the situations themselves symbolize a failure of the medical establishment to prevent death.
Because studies must define and
measure variables, the complexity of serious illness or injury, which represent
important life events by any standard,
must be simplified for the purposes of
research. Traditional science has a bias
toward studying the observable and the
measurable. As a result, matters difficult
to observe or measure, such as feelings,
how people understand and interpret
their worlds, and the personal meaning
they derive from events, are often not
considered. Yet, these issues are important to lives and personal identities
(Christiansen, 1999). More importantly,
these issues are fundamental to being well
(or well-being).
Scholars in occupational therapy
(e.g., Wood, 1998; Yerxa, 1988) have
identified oversimplification as one of the
difficult challenges impeding the development of the field. Perhaps the most
problematic aspect of oversimplification
and the scientific tendency to objectify
phenomena is that they create the illusion that the unobservable is unimportant. In the service of objectivity, we may
unintentionally compromise our values
of caring and compassion. When superimposed on the reality that many rehabilitation patients have sensory or cognitive
losses or deficits that impede communication and understanding, the resulting
disability affects both the practitioner
and the patient. If such services become
dependent on our ability to show objective change, rehabilitation itself may be at
a disadvantage for receiving the public
support necessary for any health care
enterprise to survive and flourish.
Summary
In this article, we have identified some of
the ethical considerations related to evidence-based practice and surrounding
issues as they bear on occupational therapy and rehabilitation. We acknowledge
that practitioners are professionally and
morally obligated to ensure that their
decisions are informed and reflect best
practices. Further, we recognize the value
of encouraging practitioners to assume
responsibility for searching and appraising available evidence so that informed
options can be shared with patients.
Table 1 summarizes the ethical considerations in evidence-based practice.
Ethical dilemmas are a natural part
of the health care enterprise. They existed
before evidence-based practice became an
everyday term, and they present themselves whether or not evidence-based
practice is introduced into a clinical decision. From a moral and professional
standpoint, the dangers of not attending
to evidence are just as significant as the
ethical issues attending to its application.
Evidence-based practice has clear
limitations in occupational therapy and
rehabilitation. Currently, these limitations loom as major obstacles to practice
behaviors that are better informed and
influenced by research. In the United
States, the implementation of a prospective payment system in rehabilitation will
provide increased impetus for research
and for attention to the results of that
research. As we consider and apply this
research to practice, we must do so judiciously, mindful that evidence-based
practice is a gift that comes to health care
in ethical wrappings. ▲
Acknowledgments
We thank the following experts for providing
insightful feedback during the preparation of
the manuscript: Barbara Kornblau, JD, OTR,
FAOTA, Professor of Occupational Therapy &
Public Health, Nova Southeastern University;
William J. Winslade, JD, PhD, James Wade
Rockwell Professor of Philosophy of
Medicine, The University of Texas Medical
Branch; and Gordon Guyatt, MD, MSc,
Professor of Clinical Epidemiology and
Biostatistics and Medicine, Faculty of Health
Sciences, McMaster University.
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Table 1
Ethical Considerations in Evidence-Based Practice
Selecting and Using Intervention for a Given Patient
• Base decision on best evidence for given patient, condition, and setting
• Involve patients in the choice of intervention
• Appreciate the importance of research evidence over tradition or expert
opinion
• Recognize the psychological and resource costs of ineffective intervention
• Avoid the use of unethical studies
•
•
•
•
•
Participating in or Advocating for Research
Monitor ethical practices in research in which one participates
Assure complete and appropriate informed consent
Advocate for research balancing survival with quality of life
Respect the right of participant autonomy
Involve consumers in strategic decisions about research directions
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May/June 2001, Volume 55, Number 3
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