Does Patient-Centered Care Mean that Informed Consent is Necessary for Clinical Performance Measures?
- SourceAvailable from: Anne-Marie Audet[Show abstract] [Hide abstract]
ABSTRACT: Patient-centered care has received new prominence with its inclusion by the Institute of Medicine as 1 of the 6 aims of quality. Seven attributes of patient-centered primary care are proposed here to improve this dimension of care: access to care, patient engagement in care, information systems, care coordination, integrated and comprehensive team care, patient-centered care surveys, and publicly available information. The Commonwealth Fund 2003 National Survey of Physicians and Quality of Care finds that one fourth of primary care physicians currently incorporate these various patient-centered attributes in their practices. To bring about marked improvement will require a new system of primary care payment that blends monthly patient panel fees with traditional fee-for-service payment, and new incentives for patient-centered care performance. A major effort to test this concept, develop a business case, provide technical assistance and training, and diffuse best practices is needed to transform American health care.Journal of General Internal Medicine 11/2005; 20(10):953-7. · 3.42 Impact Factor
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ABSTRACT: To describe the extent to which patient decision aids (PtDAs) meet effectiveness standards of the International Patient Decision Aids Collaboration (IPDAS). Five electronic databases (to July 2006) and personal contacts (to December 2006). Among 55 randomized controlled trials, 38 (69%) used at least 1 measure that mapped onto an IPDAS effectiveness criterion. Measures of decision quality were knowledge scores (27 trials), accurate risk perceptions (12 trials), and value congruence with the chosen option (3 trials). PtDAs improved knowledge scores relative to usual care (weighted mean difference [WMD] = 15.2%, 95% confidence interval [CI] = 11.7 to 18.7); detailed PtDAs were somewhat more effective than simpler PtDAs (WMD = 4.6%, 95% CI = 3.0 to 6.2). PtDAs with probabilities improved accurate risk perceptions relative to those without probabilities (relative risk = 1.6, 95% CI = 1.4 to 1.9). Relative to simpler PtDAs, detailed PtDAs improved value congruence with the chosen option. Only 2 of 6 IPDAS decision process criteria were measured: feeling informed (15 trials) and feeling clear about values (13 trials). PtDAs improved these process measures relative to usual care (feeling uninformed WMD = -8.4, 95% CI = -11.9 to -4.8; unclear values WMD = -6.3, 95% CI = -10.0 to -2.7). There was no difference in process measures when detailed and simple PtDAs were compared. PtDAs improve decision quality and the decision process's measures of feeling informed and clear about values; however, the size of the effect varies across studies. Several IPDAS decision process measures have not been used. Future trials need to use a minimum data set of IPDAS evaluation measures. The degree of detail PtDAs require for positive effects on IPDAS criteria should be explored.Medical Decision Making 09/2007; 27(5):554-74. · 2.27 Impact Factor
- JAMA The Journal of the American Medical Association 10/2009; 302(16):1805-6. · 29.98 Impact Factor
Does Patient-Centered Care Mean that Informed Consent
is Necessary for Clinical Performance Measures?
R. Scott Braithwaite, MD, MS, FACP1and Arthur Caplan, PhD2
1The Division of Comparative Effectiveness and Decision Science, Department of Population Health, New York University School of Medicine,
New York, NY, USA;2Division of Bioethics, Department of Population Health, New York University School of Medicine, New York, NY, USA.
KEY WORDS: patient centered care; performance measurement;
informed consent; decision making.
J Gen Intern Med 29(4):558–9
© The Author(s) 2013. This article is published with open access at
making, such as patient-centered medical homes.1The
purpose of patient-centered decision making is to allow
each patient to make an informed decision, taking into
account their preferences while knowing potential harms
and benefits; it is an important facet of patient-centered
care.2However, at the same time as patient-centered care is
being pursued, clinical performance measures are prolifer-
ating (for example, requiring diabetics to have hemoglobin
A1Cs≤7).3Whereas patient-centered care seeks to tailor
decisions based on the harms and benefits for individual
patients, and how individual patients value those harms and
benefits, performance measures seek to standardize care,
therefore pushing in the opposite direction. Clinical perfor-
of evidence-based interventions that provide clinical benefit.
Given the vast reservoir of preventable morbidity and
mortality in the United States, clinical performance measures
are also crucial for healthcare systems, even though they may
occasionally conflict with patient-centered care.
How can patient-centered care coexist with clinical perfor-
mance measures? One approach would be to identify patients
with preferences that conflict with a particular clinical
performance measure. Such patients would have the option
of declining to meet the performance measure, which would
remove them from the “denominator” when achieving that
performance measure is calculated. It may be noted that if
clinical performance measures were constructed to exclude
patients who refuse to participate or who are otherwise
‘nonstandard’ (e.g., unusual preferences), this could make
them unsuitable candidates for any formal consent process.
However, clinical performance measures are generally not
constructed or implemented with explicit consideration of
Consider a typical patient for whom the non-health benefit
from declining a performance measure may exceed the health
here is great enthusiasm for new models for health
systems that may promote patient-centered decision
benefit from assenting to that performance measure: a diabetic
with a short life expectancy due to multiple chronic diseases,
who is well-informed about potential diabetes complications
and the importance of complying with the diabetes perfor-
mance measures (e.g. obtaining a hemoglobin A1C below 7),
yet values these health benefits less than the non-health
benefits of avoiding the logistical hassles of additional
medications and needle sticks. This patient should have the
option of refusing to consent to the diabetes performance
measure, and to have this refusal documented through an
informed consent procedure. Then that patient would be
removed from the denominator when that measure is
calculated. Patient-centered decisions to ignore performance
standards would then not “count against” the physician or the
health system by lowering their grades on the particular
performance measure. Additionally, requiring a formal “opt-
out” process would guard against practitioners “gaming” the
Of course, competent patients always have the option of
declining care. But given that some clinical environments
pursue clinical performance measure targets with sufficient
zeal so as to nearly constitute a coercive environment,
practitioners facing such pressures are less likely to engage
in a shared decision involving communication of harms and
INDIVIDUAL RIGHTS VERSUS SOCIETAL GOOD
Some ethicists may wonder if the question of opting out of
a tension between individual rights versus social good. For
example, a diabetic patient refusing to meet treatment
guidelines because of personal choice may impose an
inappropriate burden on society by encroaching on the rights
of a population not to pay for poor choices made by others.
However, it is important to keep in mind that this argument
seldom applies in clinical care. The overwhelming majority of
clinical care, performance measures included (for example,
hemoglobin A1C standards for diabetics), is cost-generating
rather than cost-saving. In the minority of situations in which
opting out of performance measures may impose a financial
burden on others, it is more consistent with patient autonomy
Published online October 22, 2013
to impose a tax (or, equivalently, increased cost-sharing) to
LIMITATIONS OF INFORMED CONSENT
Informed consent is sometimes viewed negatively by clini-
cians, because its legal origins have led to language that is
often incomprehensible, particularly to patients with low
numeracy and literacy, and sometimes even to clinicians
themselves. Informed consent documents often read like a
laundry list, and fail to explicate the likelihood and severity of
different adverse events. Additionally, informed consent can
be susceptible to coercion and manipulation. However,
informed consent can be more effectively implemented when
it also encompasses decision aids4and other approaches that
provide comprehensible information about harms and bene-
fits, using risk communication methods that have been shown
to increase comprehension and decision satisfaction.
Not all clinical performance measures require informed
those measures that are “preference sensitive,”5meaning it is
plausible that a reasonable person might value the non-health
benefits of avoiding an intervention more than the health
benefits of receiving that intervention. For example, the
performance guideline requiring a short time until administra-
tion of antibiotics for a patient admitted for pneumonia does
would be an unsuitable use of an informed consent procedure.
Additionally, using informed consent to facilitate patient-
centered care requires an evolution in how informed
consent is contextualized, from applying exclusively to acts
of commission to applying to acts of omission. Organiza-
tions and practitioners are often reluctant to change long-
established practices even when better, more effective and
cheaper alternatives exist. Patients have a right to know
when this is so, and practice guidelines ought to be attentive
to such circumstances.
OTHER SITUATIONS IN WHICH INFORMED CONSENT
WOULD NOT APPLY
If harm is likely to exceed benefit (as may occur, for
example, if patients with high comorbidity burdens are
offered prophylactic surgery to repair aortic aneurysms,
which carries greater risks than benefits, yet is a common
phenomenon), it can be argued that it is unethical to offer
the service to the patient at all. Thus, informed consent is a
moot issue. It is also important to note that if harm to the
patient from a performance measure is extremely small
compared to benefit to society (e.g. influenza vaccinations),
it may be argued that it is unethical for a patient to decline,
and therefore informed consent would be unnecessary.
In summary, patient-centered care proposes to allow a patient
to make an informed decision, taking into account his/her
activity. It can be argued that informed consent should be
employed when pursuit of clinical performance is potentially
in conflict with patient-centered care. The type of informed
consent that would be most suitable for patient-centered care
would be the clinically oriented (e.g. decision aids)rather than
the legally oriented dimension of the concept.
Conflicts of Interest: The authors declare that they do not have a
conflict of interest.
Corresponding Author: R. Scott Braithwaite, MD, MS, FACP;
Division of Comparative Effectiveness and Decision Science,
Department of Population Health, New York University School of
Medicine, 550 First Avenue, VZ30 6th floor, 615, New York, NY
10016, USA (e-mail: Scott.email@example.com).
Open Access This article is distributed under the terms of the
Creative Commons Attribution License which permits any use,
distribution, and reproduction in any medium, provided the original
author(s) and the source are credited.
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Braithwaite and Caplan: Patient-Centered Care and Clinical Performance Measures