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Why 'Quality' Care Is Dangerous

Susan Notes:

Add this to your arsenal of
rebuttals when people ask why teachers can't be
more like doctors. Even doctors want some
latitude, pointing to the danger of following
scripts. The growing number of rigid protocols
meant to guide doctors have perverse

By Jerome Groopman and Pamela Hartzband

The Obama administration is working with
Congress to mandate that all Medicare payments
be tied to "quality metrics." But an analysis
of this drive for better health care reveals a
fundamental flaw in how quality is defined and
metrics applied. In too many cases, the quality
measures have been hastily adopted, only to be
proven wrong and even potentially dangerous to

Health-policy planners define quality as
clinical practice that conforms to consensus
guidelines written by experts. The guidelines
present specific metrics for physicians to
meet, thus "quality metrics." Since 2003, the
federal government has piloted Medicare
projects at more than 260 hospitals to reward
physicians and institutions that meet quality
metrics. The program is called "pay-for-
performance." Many private insurers are
following suit with similar incentive programs.

In Massachusetts, there are not only carrots
but also sticks; physicians who fail to comply
with quality guidelines from certain state-
based insurers are publicly discredited and
their patients required to pay up to three
times as much out of pocket to see them.
Unfortunately, many states are considering the
Massachusetts model for their local insurance.

How did we get here? Initially, the quality
improvement initiatives focused on patient
safety and public-health measures. The hospital
was seen as a large factory where systems
needed to be standardized to prevent avoidable
errors. A shocking degree of sloppiness existed
with respect to hand washing, for example, and
this largely has been remedied with
implementation of standardized protocols.
Similarly, the risk of infection when inserting
an intravenous catheter has fallen sharply
since doctors and nurses now abide by
guidelines. Buoyed by these successes,
governmental and private insurance regulators
now have overreached. They've turned clinical
guidelines for complex diseases into iron-clad
rules, to deleterious effect.

One key quality measure in the ICU became the
level of blood sugar in critically ill
patients. Expert panels reviewed data on
whether ICU patients should have insulin
therapy adjusted to tightly control their blood
sugar, keeping it within the normal range, or
whether a more flexible approach, allowing some
elevation of sugar, was permissible. Expert
consensus endorsed tight control, and this
approach was embedded in guidelines from the
American Diabetes Association. The Joint
Commission on Accreditation of Healthcare
Organizations, which generates report cards on
hospitals, and governmental and private
insurers that pay for care, adopted as a
suggested quality metric this tight control of
blood sugar.

A colleague who works in an ICU in a medical
center in our state told us how his care of the
critically ill is closely monitored. If his
patients have blood sugars that rise above the
metric, he must attend what he calls "re-
education sessions" where he is pointedly
lectured on the need to adhere to the rule. If
he does not strictly comply, his hospital will
be downgraded on its quality rating and risks
financial loss. His status on the faculty is
also at risk should he be seen as delivering
low-quality care.

But this coercive approach was turned on its
head last month when the New England Journal of
Medicine published a randomized study, by the
Australian and New Zealand Intensive Care
Society Clinical Trials Group and the Canadian
Critical Care Trials Group, of more than 6,000
critically ill patients in the ICU. Half of the
patients received insulin to tightly maintain
their sugar in the normal range, and the other
half were on a more flexible protocol, allowing
higher sugar levels. More patients died in the
tightly regulated group than those cared for
with the flexible protocol.

Similarly, maintaining normal blood sugar in
ambulatory diabetics with vascular problems has
been a key quality metric in assessing
physician performance. Yet largely due to two
extensive studies published in the June 2008
issue of the New England Journal of Medicine,
this is now in serious doubt. Indeed, in one
study of more than 10,000 ambulatory diabetics
with cardiovascular diseases conducted by a
group of Canadian and American researchers (the
"ACCORD" study) so many diabetics died in the
group where sugar was tightly regulated that
the researchers discontinued the trial 17
months before its scheduled end.

And just last month, another clinical trial
contradicted the expert consensus guidelines
that patients with kidney failure on dialysis
should be given statin drugs to prevent heart
attack and stroke.

These and other recent examples show why rigid
and punitive rules to broadly standardize care
for all patients often break down. Human beings
are not uniform in their biology. A disease
with many effects on multiple organs, like
diabetes, acts differently in different people.
Medicine is an imperfect science, and its study
is also imperfect. Information evolves and
changes. Rather than rigidity, flexibility is
appropriate in applying evidence from clinical
trials. To that end, a good doctor exercises
sound clinical judgment by consulting expert
guidelines and assessing ongoing research, but
then decides what is quality care for the
individual patient. And what is best sometimes
deviates from the norms.

Yet too often quality metrics coerce doctors
into rigid and ill-advised procedures. Orwell
could have written about how the word "quality"
became zealously defined by regulators, and
then redefined with each change in consensus
guidelines. And Kafka could detail the recent
experience of a pediatrician featured in Vital
Signs, the member publication of the
Massachusetts Medical Society. Out of the blue,
according to the article, Dr. Ann T. Nutt
received a letter in February from the
Massachusetts Group Insurance Commission on
Clinical Performance Improvement informing her
that she was no longer ranked as Tier 1 but had
fallen to Tier 3. (Massachusetts and some
private insurers use a three-tier ranking
system to incentivize high-quality care.) She
contacted the regulators and insisted that she
be given details to explain her fall in rating.

After much effort, she discovered that in 127
opportunities to comply with quality metrics,
she had met the standards 115 times. But the
regulators refused to provide the names of
patients who allegedly had received low quality
care, so she had no way to assess their
judgment for herself. The pediatrician fought
back and ultimately learned which guidelines
she had failed to follow. Despite her cogent
rebuttal, the regulator denied the appeal and
the doctor is still ranked as Tier 3. She
continues to battle the state.

Doubts about the relevance of quality metrics
to clinical reality are even emerging from the
federal pilot programs launched in 2003. An
analysis of Medicare pay-for-performance for
hip and knee replacement by orthopedic surgeons
at 260 hospitals in 38 states published in the
most recent March/April issue of Health Affairs
showed that conforming to or deviating from
expert quality metrics had no relationship to
the actual complications or clinical outcomes
of the patients. Similarly, a study led by UCLA
researchers of over 5,000 patients at 91
hospitals published in 2007 in the Journal of
the American Medical Association found that the
application of most federal quality process
measures did not change mortality from heart

State pay-for-performance programs also provide
disturbing data on the unintended consequences
of coercive regulation. Another report in the
most recent Health Affairs evaluating some
35,000 physicians caring for 6.2 million
patients in California revealed that doctors
dropped noncompliant patients, or refused to
treat people with complicated illnesses
involving many organs, since their outcomes
would make their statistics look bad. And
research by the Brigham and Women's Hospital
published last month in the Journal of the
American College of Cardiology indicates that
report cards may be pushing Massachusetts
cardiologists to deny lifesaving procedures on
very sick heart patients out of fear of
receiving a low grade if the outcome is poor.

Dr. David Sackett, a pioneer of "evidence-based
medicine," where results from clinical trials
rather than anecdotes are used to guide
physician practice, famously said, "Half of
what you'll learn in medical school will be
shown to be either dead wrong or out of date
within five years of your graduation; the
trouble is that nobody can tell you which half
-- so the most important thing to learn is how
to learn on your own." Science depends upon
such a sentiment, and honors the doubter and
iconoclast who overturns false paradigms.

Before a surgeon begins an operation, he must
stop and call a "time-out" to verify that he
has all the correct information and instruments
to safely proceed. We need a national time-out
in the rush to mandate what policy makers term
quality care to prevent doing more harm than

Dr. Groopman, a staff writer for the New
Yorker, and Dr. Hartzband are on the staff of
Beth Israel Deaconess Medical Center in Boston
and on the faculty of Harvard Medical


In "Why 'Quality' Care Is Dangerous" (op-ed,
April 8), Drs. Jerome Groopman and Pamela
Hartzband combine wisdom with unfortunate
overstatement. Of course poor guidelines are
unhelpful, and mindless enforcement of
standards is dangerous. However, widespread
investment in clinical guidelines in health
care comes less from bureaucratic control
freaks than from professionals and researchers
deeply concerned that variation in health-care
practice is widespread, injurious and costly.

The gap between what we know and what we offer
to patients is enormous. The Rand Corp. found
in one large study that patients receive only
about 56% of recommended care. There's also a
long list of unnecessary procedures in
widespread use. In other words, the care we get
too often reflects local habits and uninformed
beliefs, not science. This is not generally due
to inattention or incompetence among doctors
and nurses; it's because knowledge in medicine
is exploding, and the unguided human mind is
frail in the face of that volume.

Donald M. Berwick, M.D.
Cambridge, Mass.

Measures allow us to see where we are now and
make the changes that avoid medical errors,
save lives, and create a race to the top that
ensures world-class care no matter where you
live. We know from more than 30 years of data
in the Dartmouth Atlas that there is widespread
variation in the quality of care in many common
chronic conditions. We know that for certain
chronic conditions there are things you
absolutely should do. We have a very strong
evidence base of what should be done in many
areas like diabetes and cardiac conditions.
However, a Rand study shows that only about
half of patients receive the care that the
evidence base supports.

Bernard M. Rosof, M.D.
Huntington, N.Y.

The World Health Organization has ranked the
U.S. health-care system 37th in the world in
terms of quality. To change that sad status
quo, we must use the best tools that we have --
clinical guidelines and quality measures to
move forward, and all the while leverage new
discoveries to improve them.

Margaret E. O'Kane
National Committee for Quality Assurance

There is abundant evidence (see the Dartmouth
Atlas of Health Care) that our health-care
system's quality, costs and individual patient
outcomes suffer far more from unnecessary
variability than from over-standardization.
Quality improvement is an essential tool for
reducing undesirable variability in care,
enhancing patient safety, understanding
comparative effectiveness and more.

The problems start when policy makers leap
ahead of the scientific process, and make
regulation out of continuing investigation,
measurement and analysis. Every reader of this
newspaper understands and accepts the questions
good science regularly raises to teach us when
previous assumptions are incorrect.

Lawrence A. McAndrews
Alexandria, Va.

Using quality guidelines seems like good
thinking superficially, but these rigid rules
cannot fit the complexity of the human
condition. Worst of all, we have businessmen
and politicians, most of whom are lawyers,
making these unbending and bureaucratic
guidelines. Think of this: What if we had
"Legacare" (imagine lawyers paid by the
government to represent us) and we put the
American Medical Association in charge of
making the rules?

Peter Gentling
Asheville, N.C.

First, the federal incentive program entitled
"pay-for-performance" is really "pay-for-
process." Rather than measuring and rewarding
improved outcomes, the program which is also
being adopted by state and private insurers
rewards adherence to practice guidelines.
Second, there is little or no evidence the
quality measures that comprise the guidelines
correlate with improved outcomes. If government
and private insurers want to penalize and
reward physicians for their practices they
should measure those physicians' outcomes.

Joel M. Zinberg, M.D., J.D.
New York

Drs. Groopman and Hartzband state very well the
dangers of general mandates in the practice of
medicine. At our institution we are very
concerned about the emergence of multi-drug
resistant microbes, and we designed a treatment
regimen for community acquired pneumonia to
avoid certain antibiotics notorious for causing
antibiotic resistance and Clostridium difficile
infection. We were informed, however, that if
we varied from the prescribed medication
directive we would be out of compliance and
suffer the consequences. Naturally, we caved to
the pressure. Long-term consequences are not
involved in the "metric."

Daniel Keays
San Diego

— Jerome Groopman and Pamela Hartzband
Wall Street Journal


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