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c
Methods for Setting Priorities for Guidelines
Development: Medical Malpractice
Troyen A. Brennan, M.D., J.D., Ph.D.
INTRODUCTION
The Institute of Medicine's Committee on Methods for Setting Priorities for
Guidelines Developments is preparing a report on priority setting for the Agency
for Health Care Policy and Research (AHCPR). AHCPR has requested that the
agenda include health care reform. As the policy debate moves into its final
days, malpractice reform is critical to congressional proposals. Hence, the role
of malpractice litigation as a source of priorities for developing guidelines is of
interest to the committee.
This paper outlines the proposals regarding malpractice reform now being
considered by Congress, reviews the conceptual relationship between the
outcome/guideline movement and malpractice underwriting, provides some
examples of the ways in which malpractice insurers have set priorities for
guidelines development, and then returns to the specific reforms dealing with
guidelines in malpractice litigation. For the sake of brevity, the exposition
forgoes the usual introductory remarks on the definition and evolution of
guidelines.
Paper prepared by Troyen A. Brennan, M.D., J.D., Ph.D., professor of law and
public health and associate professor of medicine, Harvard School of Public Health,
Boston, Massachusetts.
99
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SEWING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
MALPRACTICE LITIGATION AND MALPRACTICE REFORM
The social functions of malpractice litigation are two fold: the compensation
ofthe costs associated with iatrogenic injuries and the deterrence of practices that
lead to such injuries. The malpractice plaintiff must prove four points: (1) that
he or she was Injured, (2) that the physician or other health care provider failed
to meet the standard expected of the reasonable medical practitioner (was
negligent), (3) that the negligent action was the proximate cause of the injury,
and (4) that there was a dutiful relationship between the health care provider and
the injured patient. The injured plaintiff must produce expert testimony by a
health care provider on the standard of care or medical custom. The profession
sets the standard in most areas of malpractice litigation.
Unlike almost all the other areas of tort law, malpractice litigation has been
subject to a variety of empirical studies. While tort theorists presume that every
negligent injury leads to claims and that claims arise only in cases of a negligent
injury, this is simply not the case. There are far more negligent injuries leading
to some degree of disability than there are malpractice claims. Indeed the ratio
is on the order of seven medical injuries due to negligence for every malpractice
claim. This means that the deterrent effect of malpractice litigation must be quite
blunted. With estimates of the mortality due to medical malpractice reaching as
high as 100,000 deaths per year, one would presume that a great deal of
governmental effort would be expended sharpening malpractice litigation by
reforms that increase claims.
Such efforts would, however, inflame health care providers who can
justifiably point to the fact that many malpractice claims are brought in situations
in which there is no negligence or no injury. Indeed it would appear that less
than a quarter of all malpractice claims are based on negligent medical injuries.
Given the emotional impact suits have on physicians, the medical profession
particularly, and the health care industry generally, weighs in heavily against any
reform that would increase claims, and tends to support legislation that would
reduce claims.' Thus, the system that remains is like a traffic cop who lets
many speeding motorists pass by and gives tickets to those who are obeying the
limits.
Since the mid-1980s it has been abundantly clear that, with appropriate
legislative enactments, rates of malpractice claims can be reduced. The critical
element to so-called tort reform is to reduce the value of any given claim to the
critical economic player in a malpractice case, the plaintiff s attorney. Since the
plaintiff s attorney typically relies on a contingent fee system, he or she is only
All these issues are discussed in more detail in Chapters 1 and 2 of Paul C. Weller,
et al., A Measure of Malpractice: Medical Injury, Malpractice Litigation, and Patient
Compensation. Cambridge, Mass.: Harvard University Press, 1993.
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APPENDIX C
101
willing to take claims that have certain economic value and a high probability of
success. Therefore proponents of tort reform have put into place a series of
obstacles to litigation that either force the plaintiff's attorney to put in more time
to bring a successful claim or reduce the ultimate amount paid by the defendant
or the defendant's insurer. These reforms have included mandatory collateral
source offset (the malpractice award is offset by the patient's existing insurance,
for example, disability insurance and health insurance), caps on economic and
noneconomic damages (especially caps on pain and suffering awards), reductions
in the percentage contingency fee allowed, use of screening panels, and
mandatory but nonbinding arbitration before a claim can be brought before a
court.
Empirical research has demonstrated that these reforms "work." Multivariate
models have shown that states that have enacted such laws have lower
malpractice claims rates than states that have not. The result has been that
nationwide the claims per 100 physicians per year has dropped from over 17 in
1986 to somewhere around 11 in 1993.
The deflation in claims rates is good news for the malpractice insurance
industry. Physicians and hospitals are typically insured for medical malpractice
liability for the first dollar of any payment. Since the initial malpractice crisis
of the mid-1970s, the malpractice insurance industry has slowly evolved into a
market that has a few important commercial elements; a very substantial
physician-owned component, often closely allied with state medical societies; and
large hospital self-insurers. With the decrease in claims rates, many of these
malpractice insurers have become quite wealthy, since the premiums were set in
the late 1980s and the early l990s by actuaries who assumed there would be
further inflation, rather than deflation, in the malpractice litigation rates.
The liability insurers, allied with other professional groups such as the
American Medical Association, have formed a strong lobby for further reform.
In the national health care debate, they emphasized federal tort reform. While
malpractice has long been a state issue, both Republicans and Democrats, no
doubt influenced by polls that show the public to be opposed to high rates of
malpractice litigation, came together behind malpractice reform. The president's
proposal was to enact mandatory, nonbinding arbitration, put into place collateral
source offsets, and reduce contingency fees. Alternative plans went quite a bit
further and included more severe limits on contingency fees and caps on pain
and suffering awards.
Some set of constraints on malpractice litigation is likely to be part of a
modest congressional package in 1995, especially if the Republican party does
well in the November 1994 election. Any such reform will likely be intended
to reduce the number of claims, and not the number of medical injuries. In the
policy debate, the morbidity and mortality associated with iatrogenic injuries has
been largely overlooked. To extend the traffic cop analogy, even larger numbers
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SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
of speeders are avoiding penalties, while some unjustly accused good drivers
may no longer face inappropriate litigation.
This is not to say that malpractice insurers and providers are ignorant of or
do not care about reduction of medical injuries. In addition to pursuing a
legislative strategy, it is very much in their interest to manage risks by reducing
the incidence of behaviors that lead to medical injuries. A number of insurers
have pursued such risk management and loss control programs aggressively, and
some have included use of practice guidelines in these efforts. Clearly, however,
these activities arise not as a part of health care reform at the national level, but
as a result of sound insurance practice and risk management.
MALPRACTICE LITIGATION AND PRACTICE
GUIDELINES: THE CONCEPTUAL RELATIONSHIP
The conceptual relationship between practice guidelines and malpractice
litigation has been carefully explored. In 1988, the Physician Payment Review
Commission supported the work of several leading academics in an effort to
define the ways in which the guidelines movement and malpractice might
interact.2 As noted above, malpractice litigation requires a definition of the
standard of care. In any malpractice case, the plaintiff or defense attorney will
rely on expert testimony, as well as information from leading textbooks and
treatises to try to set forth a definition of the standard of care. Quite obviously,
practice guidelines can provide a succinct definition of the standard of care in
certain kinds of cases. Therefore it follows that malpractice litigants should be
quite interested in using guidelines.
However, many medical practice guidelines are not use fill in medical
malpractice cases. Practice guidelines first received impetus hom data shoving
wide geographic vanations in rates of procedures. As the committee realizes, the
work of Wennberg and others set the stage for more systematic reviews of the
appropriateness of certain types of procedures by Brook and investigators at He
RAND Corporation. Much of the focus in these studies was on inappropriate
care, or care that was simply not indicated by the present state of medical
knowledge. Guidelines have evolved to define appropriateness and so to reduce
2See Mark Hall, The Defensive Effect of Malpractice Policies in Malpractice
Litigation. Law and Contemporary Problems 54(21:1 19-145, 1991; Clark Havighurst,
Practice Guidelines as Legal Standards Governing Physician Liability. Law and
Contemporary Problems 54~2~:87-117, 1991; and Deborah Garnick, et al., Can Practice
Guidelines Reduce the Number of Costs and Costs of Malpractice Claims? Journal of
the American Medical Associatior' 266~20~:2856-2860, 1991.
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APPENDLY C
103
rates of various types of procedures.3 Subsequently, many specialty societies and
governmental agencies have promoted the development of guidelines. In
addition, insurers and integrated providers have carefully incorporated guidelines
into their utilization review efforts.
These appropriateness guidelines should be distinguished from what might
be called standard of care guidelines. The latter are intended to ensure that
physicians reach a certain standard of care that provides a reasonable level of
safety for the patient. Their major aim is to reduce medical injuries, rather than
reducing the numbers of inappropriate procedures.
An example sharpens this distinction. Guidelines for cardiac catheterization,
along the lines of those developed by the RAND Corporation, are intended to
reduce inappropriate cardiac catheterizations. While cardiac catheterization can
lead to medical injury, an inappropriate catheterization that does no hann to the
patient would not likely be actionable under current malpractice norms.4
Contrast this with the anesthesia guidelines developed first at Harvard University
and subsequently adopted by the American Society of Anesthesiologists. These
guidelines mandated use of pulse oximetry and end tidal CO2 monitoring in
patients under general anesthesia. They were not intended to reduce costs (in
fact, the addition of these instruments increases costs), but to reduce the number
of injuries resulting Mom the procedures. Their emphasis is on the standard of
care and safety, not the costs of medical care. Appropriateness guidelines are of
greatest utility to the utilization reviewer; standard of care guidelines are of
greatest use to the risk manager.
Consider another example. An appropriateness guideline may determine
situations u~ which an expensive contrast medium is unnecessary in cardiac
catheterization. A standard of care guideline, on the other hand, might specify
the more expensive, but safer, medicine for all catheterizations. Safety is the
goal of the latter, cost of the former.
Eventually, we can expect the distinctions between appropriateness and
standard of care guidelines to disappear as vertical integration of health care
brings cost concerns even more intrinsically into the clinical encounter. As this
occurs, the cost-effectiveness of care will be increasingly salient in malpractice
litigation.5 Risk managers will have to consider cost as well as safety In their
guidelines. Enterprise liability will speed this development.
3See Troyen A. Brennan, Practice Guidelines and Malpractice Litigation: Collision
or Cohesion? Journal of Health Politics, Policy and Law 16(~1~:67-85, 1991.
4The plaintiff could bring a claim that he or she had undergone an inappropriate
medical procedure, but without the plaintiff suffering some further injury, the claim would
likely not be substantial enough in monetary terms to warrant being brought by a
plaintiffs attorney.
ssee Havighurst, supra note 2.
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SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
In the meantime, however, standard of care guidelines will be used primarily
to reduce the incidence of medical injuries. Recognizing this, a number of
malpractice insurers have begun to show interest in the promulgation of
guidelines. Of course, to do so they must make some decisions about which
areas of clinical practice merit attention.
SETTING PRIORITIES FOR GUIDELINES DEVELOPMENT
THROUGH MEDICAL MALPRACTICE EXPERIENCE
Medical malpractice insurers are relatively wealthy today. As a result, they
are able to undertake fairly critical analyses of their claims' history and evaluate
new methods for loss control. This review and reflection has led to systematic
guidelines development efforts by certain companies.
Every malpractice insurer carefullyrecords claims according to the specialty
of the primary defendant in the case. Most malpractice insurers rely on similar
sets of definitions of specialty areas and claims. They also typically have some
"denominator data," that is, information on the number of clinical encounters
with the average clinician in a given specialty. Therefore insurers can somewhat
precisely measure rates of claims per number of patient encounters. This is
especially true in such areas as obstetrics (the number of deliveries is usually
letdown), emergency medicine (the number of emergency department visits is.
calculated), and surgery/anesthesia (the number of cases is typically available).
Moreover, they can do some crude benchmarking, especially insofar as there is
pooling and sharing of information on claims rates, for instance through the
Physicians Insurance Association of America database.
Using this information, malpractice insurers can understand whether there
are deficiencies within their own pool of insureds. They are also able to trend
data over time and observe newly emerging areas of litigation. For example,
many malpractice insurers have seen striking increases in the number of claims
brought for failure to diagnose in the ambulatory setting. They have also been
able to keep a careful eye on obstetrics claims, which are a significant source of
liability because of the very high average severity of any claim.
Malpractice insurers are also in an enviable position with regard to
enforcement of guidelines. While to a large extent controlled by providers
themselves, and thus somewhat hesitant about any insured perception of
trespassing on clinical judgment, malpractice insurers can insist on the use of
certain guidelines or protocols distilled from those guidelines. While few are
willing to do so, the at least implied threat of loss of malpractice coverage
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APPENDIX C
105
should one not follow a guideline represents a significant incentive for provider
compliance with guidelines.6
The best known example of a malpractice insurer mandating certain
guidelines is the Risk Management Foundation's efforts in anesthesia care. In
the early 1980s, the Risk Management Foundation, which acts as the claims
processor and risk manager for the Controlled Risk Insurance Company, which
in turn is the Harvard University captive, off-shore self-insurer for malpractice
liability, noted an increase in anoxic brain injuries in patients undergoing general
anesthesia. At much the same time, new technologies that allowed continuous
monitoring of a patient's respiratory status began to come on line. End tidal CO2
measurements and pulse oxi~netry were expensive, but obviously very helpful to
anesthesiologists monitoring patients in surgery. They were not, however, the
standard of care.
After careful study of the rates of anoxic brain injury and the cost of
technology, the Risk Management Foundation mandated use of the new
technology and also required that anesthesiologists stay in the operating room at
all times. The results of this intervention were extraordinarily gratifying. Rates
of malpractice claims and rates of injuries dropped dramatically and,
subsequently, so did anesthesiologists' premiums. The guidelines were adopted
by the American Society of Anesthesiologists and have become widely accepted.7
The anesthesiology guidelines are an excellent example of standard of care
guidelines. They require additional costs (for the purchase of new technology)
in an effort to reduce medical injuries. These costs are passed along to the
patient and, as a result, standard of care guidelines can increase medical care
costs, in contrast with appropriateness guidelines, which are meant to reduce
rates of inappropriate procedures arid so reduce overall health care costs. This
underlines a critical element of the standard of care guidelines that they will
often call for increased expenditures of one sort or another. Indeed, this issue
has bedeviled the Risk Management Foundation's efforts to produce guidelines
for obstetric care. Initial investigations suggested that continuous physician
attendance at labor might have increased safety, but this would have required a
commitment of resources that was too costly for teaching hospitals. Thus,
standard of care guidelines have to involve a careful calculation of the tra~le-off
between safety aloud cost, which perhaps explains why more insurance companies
have not gotten involved in guidelines development.
60f course, compliance with guidelines has been one of the great problems noted thus
far. See Robert Grilli et al., The Impact of Practice Management Guidelines on the Care
of Breast, Colorectal and Ovarian Cancer. Medical Care 29:50-67, 1991.
7See Frederick W. Cheney, Karen Posner, Robert A. Caplan and Richard J. Wort,
Standard of Care in Anesthesiology Liability. Journal of tile American Medical
Association 261: 1599-1605, 1989.
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SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
Although there are anecdotal reports of guidelines use by other malpractice
insurers, it appears that, among physician insurers, only two companies are
seriously engaged in authorship of guidelines: the COPIC Insurance Company
in Colorado and the Utah Medical Insurance Association.8 COPIC has publicized
its efforts and continues to promulgate new guidelines.9 Using a database of
10,000 closed medical liability claims, COPIC identified its high-risk areas.
These included informed consent, altered medical records, anesthesiology
monitoring, obstetrics, and diagnosis of breast cancer. Advisory committees
were formed in each of these areas, consisting of COPIC-insured practicing
physicians and defense attorneys. The committees proposed guidelines for safer
patient care management. Once the guidelines were accepted by the board of the
insurance company, theywere incorporated into a Participatory Risk Management
Program (PRMP). Under the PRMP, any physician wishing to purchase
insurance from COPIC is asked to sign a written agreement that he or she will
comply with guidelines to the extent feasible in a given clinical situation. To
date no physician has refused to sign the agreement.
COPIC attributes decreases in anesthesiology and obstetrics malpractice
premiums to the PRMP. In addition, compliance with the guidelines is now
incorporated into an experience rating system that helps define the amount
physicians will pay for premiums. This aggressive policy is being carefully
followed by the rest of the professional liability insurance industry.
The other major development in risk management and guidelines is the Risk
Management Foundation's newest initiative in loss control. Reviewing claims
files, the RMF loss control staff has identified certain areas of concern. Working
with the insured institutions and health services researchers at the Harvard School
of Public Health, the foundation has provided significant funds for the study of
the quality of care in these areas.
The first such project, the Harvard Emergency Department Quality Study,
has focused on emergency department care. In addition to development of
certain minimal clinical criteria (defined as parameters of care for common
diagnoses), the research has involved use of health status measurement, patient
satisfaction and problem score surveys, arid record review. An initial study of
5,000 patient encounters has demonstrated broad deficiencies in the care rendered
to emergency department patients and has allowed insured institutions to
benchmark their care against one another.~° Following the initial data collection
Personal communication from Lawrence Smarr, Executive Director, Physician
Insurance Association of America, July 7, 1994.
9See George O. Thomasson, Participatory Risk Management: Promoting Physician
Compliance in Practice Guidelines. Journal on Quality Improvement 20:317-329, 1994.
Resee Harvard Emergency Department Quality Study Investigators, The Quality of
Emergency Department Care. Phase One, January 15, 1994.
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APPENDIX C
107
and analysis, the Foundation is now supporting quality improvement efforts at
each of the institutions with an eye to reassessing emergency department care
once the quality improvement efforts are put into place. This combination of
health services research and continuous quality improvement methodologies is
exciting.
Central to the Harvard Emergency Department Quality Study has been the
creation of minimal clinical criteria. They were the product of consensus
sessions conducted by the emergency department chiefs at the Harvard hospitals,
followed by modified Delphi technique validation by nationwide experts. The
criteria were then converted into explicit data collection instruments. Record
review using these instruments has demonstrated compliance with these minimal
clinical criteria has ranged hom 30 to 75 percent. In light of this surprisingly
poor performance, the emergency department directors are now planning new
medical record forms that will force individual clinicians to consider and
document minimal clinical criteria in appropriate cases. It is thought that this
will reduce misdiagnoses in emergency departments and also provide better
documentation in cases in which claims are brought. This is yet another example
of an insurer enforcing compliance with guidelines.
GUIDELINES AND MALPRACTICE
LITIGATION: LEGISLATIVE EFFORTS
While COPIC and RMF guidelines are intended to decrease malpractice
litigation by decreasing the rates of injuries, it is important to note that guidelines
are a two-way street. Guidelines promulgated by malpractice insurers, or any
other entities, can be used by either a defendant or a plaintiff to define the
standard of care. In Colorado in 1992, a malpractice plaintiff brought a claim
against a COPIC-insured physician and alleged that the defendant had failed to
follow the PRMP guidelines for breast cancer diagnosis. The State Supreme
Court upheld a decision by the trial court that the guidelines could not be
admitted as evidence." The court recognized that the promotion of guidelines
by insurance companies would have an overall safety-inducing effect and wished
to avoid chilling that initiative by allowing the guideline to be used against the
malpractice insurer.
lessee Virginia Quigley and James Quigley vs. William Jobe, M.D., Supreme Court,
State of Colorado, Denver Case No. 93 S.E. 47, 1993.
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SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
The decision was atypical. In most situations, guidelines have been freely
admissible in courts of law. Indeed, both review of litigation records and
surveying of attorneys reveals that guidelines are more likely to be used for
inculpatory purposes (that is, demonstrating that a defendant failed to comply
with the standard of care) than they are for exculpatory purposes. This is not
surprising. If in a specific situation a guideline favors the defendant, and the
plaintiff s attorney is aware of the guideline, it is very unlikely that any case will
be brought. On the other hand, a guideline that shows a failure to meet a
standard is an extremely inexpensive demonstration of the standard of care and
hence very valuable to the plaintiff's attorney. Thus we would expect guidelines
to be used widely by plaintiffs. Medical malpractice liability insurers who are
interested in promulgation of guidelines will have to be prepared for the
occasional case based on their own guidelines, and for the frequent use of other
guidelines by plaintiffs.
States have been quite aware of the relationship between guidelines and
malpractice litigation. Led by the state of Maine, and now closely followed by
Minnesota and Vermont, legislatures have incorporated practice guidelines into
tort reform.~3 The Maine Medical Liability Demonstration Project is a five-year
experiment to understand the relationship between practice parameters and
medical liability. In Maine, four specialties (emergency medicine,
anesthesiology, obstetrics/gynecology, arid radiology) have been allowed to
endorse certain guidelines for malpractice purposes. Any physician who follows
these guidelines can use them as exculpatory evidence if sued. The precise
procedural impact of the so-called "affirmative defense" has not become clear,
largely because no cases have been brought against physicians complying with
the guidelines. It appears the compliance with the guidelines would be
considered by the prelitigation claims screening panel that occurs in Maine, but
this would not prohibit the plaintiff from going to trial. Much more draconian
from the point of view of litigant's rights is the Minnesota statute that suggests
that compliance with the guideline would be per se exculpatory evidence, thereby
ending litigation once a panel determines a physician has complied with the
guideline. These sorts of reforms are being actively studied by a number of
other states and have become part of the standard tort reform package of the
1990s.
Thor a general discussion see Andrew L. Hyams, et al., Malpractice Litigation and
Practice Guidelines, Report to the Physician Payment Review Commission, January
1994.
Resee generally, Hyams, supra note 11. On Maine in particular see Gordon H. Smith,
A Case Study in Progress: Practice Guidelines in the Affirmative Defense in Maine.
Journal on Quality Improvement 19:355-368, 1993 ..
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APPENDIX C
109
Congressional architects of malpractice reform have also become very
excited about guidelines. The Clinton Health Security Act, as well as proposals
from Senator Chafee, Representative Cooper, and the conservative Republican
proposals all contain provisions that would allow or encourage use of practice
guidelines in malpractice litigation. The Clinton Administration has proposed
experimentation with the use of guidelines, but others are quite willing to move
forward with direct exculpatory use.
Both state and federal reformers overlook the fact that practice guidelines
and malpractice litigation are a two-way street, as outlined above. Existing
legislative proposals endorse guidelines solely for exculpatory purposes. From
a quality perspective, the use of practice guidelines in malpractice litigation is
most efficient if both plaintiffs and defendants are accorded equal procedural
footing. If failure to comply with a guideline were to be per se evidence of
negligence, thus ensuring a successful suit by a plaintiff, insurance companies
will have great interest in bringing about compliance with those guidelines. If
there is an ultimate bar to litigation should the physician follow the guideline, the
compliance is doubly enforced. This should be quite clear to reformers, but in
their efforts to please providers and insurers both state and federal representatives
have ignored the importance of symmetry in the use of guidelines in malpractice
litigation.
They have also tended to overlook the problem of dueling guidelines. In
some critical situations, such as the diagnosis of breast cancer, plaintiffs and
defendants are able to take advantage of guidelines that conflict with one another.
The differences between the Public Health Service and the National Cancer
Institute ma~nmogra~n recommendations provide both plaintiffs and defendants
with ample ammunition in a failure to diagnose case. Existing legislation does
not provide much direction for courts in these situations.
Thus, existing legislative proposals regarding the use of guidelines in
malpractice litigation are relatively crude. More careful consideration ofthe role
of guidelines as exculpatory and inculpatory evidence, and of the limits of such
evidence, will have to be undertaken in the future.
SUMMARY
Malpractice litigation can provide a basis for determining priorities for
development of guidelines that set a standard of care. Some insurers are already
talking this step and have gone so far as to require physicians to comply with
guidelines. As databases on claims grow and are snore systematically analyzed
by insurers, the potential for guidelines promulgation will only increase. Hence,
malpractice litigation should be seen as a valuable source of information for
priority setting.
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SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
~ a somewhat separate issue, malpractice insurers will have to be prepared
to incorporate guidelines into their defense of some cases and counter the use of
guidelines by plaintiff's attorneys in other cases. Every indication is that the use
of practice guidelines in malpractice litigation will continue to grow. Hence,
even if they are not in the business of promulgating guidelines, malpractice
insurers will become much more aware of and familiar with the nature of
guideline-based evidence.
Representative terms from entire chapter:
practice guidelines
