The Lyme Times

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2014 Volume 26 Number 3 3
Evidence-Based Medicine
Knowing where evidence ends and values begin is important to patients
By Lorraine Johnson, JD, MBA
We are in the midst of a sea of change
driven largely by healthcare reform and
evidence-based medicine (EBM). Public
trust is critical to the success of healthcare
reform. But many patients believe that
EBM is vulnerable to corruption by stake-
holders, like insurers seeking to control
costs and panel members who have in-
dustry conflicts of interest. Distrust in
IDSA Lyme guidelines is high because
Lyme patients believe that the guidelines
panel was corrupted by industry con-
flicts (diagnostic tests, vaccines and
insurance) and researcher self-in-
terest.
Today, a shift from old
models of medicine
toward patient-centered
medicine is emerging.
It seeks to focus
medical attention
on the needs and
concerns of the
individual patient
rather than those
of physicians, in-
surers, pharma-
ceutical companies
and researchers.
At LymeDisease.org
we have been up to
our eyeballs in EBM and
patient-centered care since
2004, when we launched the two
standards of care campaign.
From the beginning we have em-
phasized that when science is uncertain,
different research and physician groups
can hold different viewpoints about what
to do. They can do this based on their in-
terpretation of the evidence and the values
they hold about different outcomes. This
is not simply a matter of opinion. A recent
study found that given identical evidence
two groups of expert panels reached con-
trasting therapeutic recommendations.
We know this happens with Lyme disease,
but this panel was looking at angina, not
Lyme!
Although EBM is defined as “the in-
tegration of best research evidence with
clinical expertise and patient values,”
patient values are frequently over-
looked. This is shifting, however. Gov-
ernment institutions, like the Institute of
Medicine (IOM) and Patient Centered
Outcomes Research Institute (PCORI),
now recognize that trustworthy policies,
guidelines and research require the partic-
ipation of patients.
If we are basing healthcare coverage
decisions on EBM, we need to know
where the evidence begins and ends. We
need to know whose clinical expertise
we are relying on. Is it the clinical ex-
pertise of treating physicians or that of
researchers who see few patients? And
we need to know how patient values are
taken into account. Are patients involved?
Whose values and viewpoints are repre-
sented? Patient involvement in EBM is es-
sential to enforce the boundary between
evidence and values and to ensure that
patient values are accurately represented
in the process.
We cannot do this without entering
into the public discussion of EBM. The
need for patient involvement is now
being recognized by the IOM, which re-
quires patient involvement in guidelines
deemed “trustworthy.” It is also being rec-
ognized by newly emerging organizations
established under healthcare reform, like
Patient Centered Research Outcomes In-
stitute (PCORI). PCORI, which had a
2013 research budget of $350 million, is
creating researcher/patient partnerships
that bring stakeholders into the process
as active partners. National organi-
zations of patient groups, like
Consumers United for Ev-
idence-Based Healthcare
(CUE), are helping to
define the patient’s role
in EBM. To this, I say
count me in!
The Lyme com-
munity needs to
be part of the con-
versation that
determines the
role of patients in
healthcare. Without
a seat at the table, our
concerns fall on deaf
ears.
Resources
Gerber AS et al. A national survey reveals
public skepticism about research-based treatment
guidelines. Health Affairs (Millwood). 2010
Oct;29(10):1882-4.
Institute of Medicine. Clinical Practice Guidelines We
Can Trust. Washington, DC: National Academies
Press; 2011.
Laine C, Davidoff F. Patient-centeredmedicine, a pro-
fessional evolution. JAMA. 1996 Jan 10;275(2):152-6.
Sackett D et al. Evidence-Based Medicine: How to
Practice and Teach EBM (2000).
Lorraine Johnson, JD, MBA, serves as the
co-chair of CUE and a patient grant reviewer
for PCORI. She is the executive director of
LymeDisease.org and posts regularly on her
blog Lyme Policy Wonk at Lymedisease.org.
Contact her at
Evidence
Patient
Values
Clinical
Expertise