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- RESEARCH DESIGN AND STATS
Introduction to Clinical Practice Guidelines
Introduction
Life care planners must base recommendations upon reasonable,
ethical, and appropriate analyses of patient-specific needs.
How are these analyses generated? Where can life care planners
obtain such information? What is meant by “clinical
practice guidelines”?
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Definition
Definitions of clinical practice guidelines vary slightly
from one another, but are very similar in intent. For example:
“Practice guidelines are statements that are systematically
developed to assist practitioner and patient decisions about
appropriate healthcare for certain clinical diagnoses. They
are intended to be flexible: deviations are expected, acceptable
and justified depending upon individual characteristics and
circumstances.” (Callender, 1999)
“…systematically developed statements to assist
practitioner and patient decisions about appropriate health
care for specific circumstances.” (Institute of Medicine,
1990)
The Joint Commission of Accreditation of Healthcare Organizations
(2000) defines clinical practice guidelines as, "…descriptive
tools or standardized specifications for care of the typical
individual in the typical situation, developed through a
formal process that incorporates the best scientific evidence
of effectiveness with expert opinion. Synonyms include clinical
criteria, parameter, protocol, algorithm, review criteria,
preferred practice pattern and guideline.”
The American Medical Association (Hirshfeld, 1990) has not
yet formulated a universally accepted definition of clinical
practice guidelines, but has defined what it refers to as “practice
parameters.” These parameters have been established
as, “recommendations for patient management that may
identify a particular management strategy or a range of management
strategies.”
Wyer (2002) asserts that clinical practice guidelines are
not:
*Decision rules
*Computerized support systems
*Decision analyses
*Cost-effectiveness analyses
Oetgen and Wiley (1996) note that the development of formal
practice guidelines was initiated in the 1980s as a result
of three primary forces. First, health care costs assumed
by the federal government were expanding at an ever-increasing
rate. With Medicare expenditures soaring, Congress became
interested in developing a methodology for analyzing physician
services for medical necessity and effectiveness.
Secondly, a wider database which incorporated medical outcomes
research findings was being utilized more efficiently by
health care professionals and health policy administrators.
Third, as more data was amassed, it became apparent that
inappropriate care practices were going unchecked and causing
harm to patients. In addition, inequalities in access to
care and necessary treatment were recognized.
While most definitions of clinical practice guidelines are
similar, not all organizations and fields of expertise are
in agreement regarding the appropriate use of guidelines
in practice.
The Purpose of Clinical Practice Guidelines
The Joint Commission of Accreditation of Healthcare Organizations
(JCAHO, 2000) and MacLean (2002) assert that the purpose
of clinical practice guidelines is to:
*To improve outcomes and quality of care provided to patients
*To reduce undesirable variations in care and treatment
by providing continuity of care
*To reduce inflation of healthcare costs and identify the
most effective practices considering costs and resources
expended (money, effort, and risk)
*To manage quality by setting measurable standards
Amon (2000) points out that the notion of established clinical
practice guidelines is not a new concept but, “What
is new is the emphasis placed on systematic, evidence-based
guidelines and the structure, process, and incentives that
support their effective use and as a mechanism of internal
assessment of such guidelines.”
Ultimately, clinical practice guidelines serve as recommendations
for patient care and injury/disability management. The purpose
of these recommendations is to guide the decision-making
process of professionals contemplating the most beneficial
medical and therapeutic interventions.
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Policymakers and Clinical Practice Guidelines
Policymakers sometimes have a slightly different perspective
with regard the purpose and utility of clinical practice
guidelines. In general, policymakers are interested in:
*Reducing the incidence of inappropriate care
*Minimizing wide variations in level of care and/or therapy
*Maximizing the value of each health care dollar spent toward
recovery and rehabilitation
If these purposes appear to be similar to those espoused
by JCAHO and MacLean, they are. However, the way each group
determines that it will accomplish its goal may differ enormously.
The same set of clinical practice guidelines used to treat
and rehabilitate patients may also be used to determine “medical
necessity,” “cost-effective” treatment,
and to establish standardization of care. In order for life
care planners to better appreciate the capacity of clinical
practice guidelines, the scientific data upon which they
are based and the process by which they are developed must
be understood.
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Development of Clinical Practice Guidelines
Clinical practice guidelines have been developed through
the collaborative efforts of many committees, organizations,
and federal agencies.
Agency for Healthcare Research and Quality
In 1999 President Clinton reauthorized the Agency for Healthcare
Research and Quality (AHRQ), which is a branch of the U.S.
Department of Health and Human Services agency. The following
statement was extracted directly from the Agency’s
website (http://www.ahcpr.gov/about/ahrqfact.htm ):
“The legislation also positions the Agency as a ‘science
partner,’ working collaboratively with the public and
private sectors to improve the quality and safety of patient
care.
Under the legislation AHRQ will:
*Meet the information needs of its customers—patients
and clinicians, health system leaders, and policymakers—so
that they can make more informed healthcare decisions.
*Build the evidence base for what works and doesn't work
in healthcare and develop the information, tools, and strategies
that decision-makers can use to make good decisions and provide
high-quality healthcare based on evidence.
*Develop scientific knowledge in these areas but will not
mandate guidelines or standards for measuring quality.”
Health Insurance Companies
For many years health insurance companies have been utilizing
practice guidelines as a way of making claims decisions and
selecting care providers. Over time, the guidelines referenced
by health insurance companies have become more well defined
and, in some cases, more reflective of clinical input from
physician organizations.
Other Sources of Development
Amon (2000) notes that more than 35 medical groups, physician
organizations, and specialty associations have developed
clinical practice guidelines, including the American Medical
Association and the Council of Medical Specialty Societies.
In addition, independent and academic research centers, such
as the RAND Corporation and the Institute of Medicine, are
working to establish protocols for the development of guidelines.
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The Validity of Clinical Practice Guidelines
As you read about the following classifications of practice
guidelines, consider each category with respect to the discussion
of validity. The validity of a specific set of clinical practice
guidelines depends upon the methodology utilized by the developers
in identifying appropriate components of the final document.
Further, the purpose for which the developers created the
practice guidelines should be considered. If the foundations
(i.e., methodology and purpose) are faulty, little credibility
may be invested in the product.
Classification of Development Methodologies
Amon (2000) describes a classification system consisting
of four categories; informal consensus development, formal
consensus development, evidence-based guideline development,
and explicit guideline development.
Informal Consensus Development
Informal consensus development is the simplest, most commonly
employed method of developing practice guidelines. In most
cases, a panel of field experts meets to discuss the relevant
issues and form a consensus through discussion and debate.
There are positive aspects to this method in that the process
is uncomplicated and decisions may be made in a brief period
of time.
However, there are several disadvantages to this method.
Many times, consensus opinion is reached without providing
an explanation to others as to how recommendations were reached,
without explicitly linking knowledge within the field (scientific,
clinical, or otherwise), and without documenting the methodology
utilized to arrive at the summative consensus.
Amon (2000) provides an example of such non-disclosure by
explaining that insurance companies often utilize sophisticated
methods of analyses, but because of proprietary concerns,
they will not disclose the analytical methodology relied
upon to develop guidelines. Unfortunately, when life care
planners do not have access to such information significant
limitations may be imposed upon the practical usefulness
of these guidelines.
Formal Consensus Development
The primary difference between informal and formal consensus
development is that the latter typically involves structured
workshop sessions held over several days and efforts are
made to document the methodology applied throughout the process.
In general, formal procedures include detailed literature
reviews, debate, and votes by a panel of experts recognized
in the field.
While it is a more structured attempt to define practice
guidelines, this method of development is, nonetheless, based
upon expert opinion and the “tools” with which
they choose to evaluate the relevant issues. For example,
if a group of experts in the health insurance industry were
to perform in-depth literature reviews, analyze claims data,
debate, vote, and publish practice guidelines, should life
care planners deem the product valid? Consider the fact that
research literature may be flawed or irrelevant and that
insurance claims data is often erroneous. As with an informal
process, expert opinion ultimately determines the form of
the guidelines.
Evidence-based Approach
The evidence-based approach emphasizes the need to distinguish
between guidelines derived from a scientific foundation,
and those based upon expert opinion. This method includes
a formal evaluation and analysis of scientific evidence,
an exchange of information among panel members, and open
forums that seek to reach a wide audience.
While this process increases the scientific rigor of practice
guideline development methodology, it may be limited by the
lack of acceptable “evidence” reported in the
research literature. Anon (2000) reports that a very small
percentage (only about 10 percent) of current medical interventions
have been validated through well-designed clinical studies.
Because of this, neutral recommendations may be made but
are not likely be useful for large numbers of practitioners.
Explicit Guideline Development
Professionals employing this method of development outline
the benefits, harms, and costs of potential interventions
then calculate explicit numerical probabilities of each outcome.
Estimates may be generated using scientific evidence, mathematical
models, or expert opinion, but the sources of each recommendation
are distinctly cited.
Amon (2000) describes a “balance sheet” which
is created to display the alternatives to interested parties
(i.e., patients, families, physicians, payers, etc.). This “objective” data
is then compared with the preferences and desires of the
patient in order to arrive upon decisions.
This approach is becoming more popular, but because it is
still a relatively new method of guideline development, published
reviews and critiques are limited.
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Are Clinical Practice Guidelines Helpful or Harmful?
The manner in which clinical practice guidelines should
best be utilized is somewhat controversial and depends in
large part upon the goals of the particular group stating
a position on the issue.
The Medical Community
Physicians groups have expressed concerns that practice
guidelines may be encouraging reliance upon “cookbook
medicine,” rather than sound clinical judgements based
upon patient-specific factors (Amon, 2000). Some view the
advocacy of practice guidelines as an effort to standardize
care which is an obstacle in providing individualized care
to patients within a specific demographic or practice setting.
Professionals in the health industry are concerned that
practice guidelines may:
*interfere with their ability to exercise clinical judgement
*cite unreasonable recommendations, particularly when prepared
by non-practitioners, payers, or those unfamiliar with clinical
practice
*be used to deny coverage of physician recommended procedures
*be inappropriately used to rate physician competence
*serve as evidence in malpractice cases
*threaten specialty areas of practice through intervening
guidelines of other groups
*become compulsory standards
*obstruct physicians’ attempts to obtain malpractice
insurance unless they are compliant with all guidelines
The Health Insurance Coverage Community
There is little doubt that rising costs of health insurance
coverage, emergency/trauma treatment, acute medical care,
and rehabilitation certainly provides a powerful motivation
for considering alternatives to the system currently utilized.
As mentioned earlier, some health insurance companies will
not disclose the methodology employed to analyze and develop
practice guidelines because of proprietary concerns.
The Patient Community
Even when pleased with their medical professionals of choice,
patients often seek reassurances that the care and treatments
they are receiving from their personal providers are, indeed,
appropriate and comparable to the treatments prescribed by
other professionals. Practice guidelines may provide some
level of comfort to patients and families and allow for improved
communication, education, and compliance with recommended
interventions.
However, patients also recognize that practice guidelines
may be inappropriately applied to their specific case and
used as a basis for denial of claims, provider groups, or
coverage. Practice guidelines developed to maximize outcomes
for a target population may not adequately meet the needs
of individual patients within that group.
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Enforcement and Litigation
Some groups believe that the underlying impetus for rising
health care costs rests with physicians. Following this logic,
these groups seek to develop enforcement policies which penalize
physicians (through denial of reimbursement for services,
pre-certifications, or reasonable malpractice coverage) who
do not comply with the established guidelines. Further, physicians
failing to comply with guidelines may be subjected to medical
review and/or confront challenges when acquiring licensure,
specialty practice re-certification, and hospital privileges
(Amon, 2000).
Many physicians groups object to the publication of practice
guidelines because of the probability that they will be submitted
as “evidence” in litigated cases against professionals
who exercise clinical judgments beyond the stated guidelines.
They are concerned that deviations from the practice guidelines
will be argued to constitute substandard care or negligence.
Oetgen and Wiley (1996) report that no jurisdictions have
allowed guidelines to be submitted as the sole piece of evidence
regarding standards of care. In fact, Oetgen and Wiley (1996)
state that the presentation of practice guidelines in most
jurisdictions necessitates the appearance of an expert witness
who must explain the guidelines to the jury/judge, discuss
their validity and relevance, and participate in cross-examination,
if requested by the opposing counsel.
While physicians should not be expected to comply with erroneous
guidelines, professionals who administer inappropriate care
must be identified and prevented from harming patients. Consider
the notion that although guidelines may not be entirely valid
in every patient’s circumstance, they may provide a
limited measure of professional competence in cases where
obvious infractions are committed.
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Limitations of Clinical Practice Guidelines
There are three primary areas in which clinical practice
guidelines are limited (Amon, 2000). First, medical science
is not able to unequivocally define “optimal” care,
even with advancing technologies and an ever-growing databank
of knowledge. For example, a review of research literature
in nearly any aspect of disability will result in few studies
involving minority groups, patients who do not fit the “stereotypical” profile,
or those from rural communities.
As discussed previously, it is very difficult to design
true experimental research studies (i.e., multiple randomized
clinical trials with large numbers of participants) involving
human subjects. Most studies are inherently limited in their
ability to offer undisputed results, validity, practical
significance, and generalizability. Certainly, the existing
body of research may be used to determine the most probable
benefits of interventions, it is not possible to state that
practice guidelines based upon these studies are indisputably
accurate and appropriate for all patients.
Second, the methodology of practice guideline development
is questionable. While efforts are made to perform thorough
review s of the existing literature and to integrate objective
expert opinion, the resulting recommendations cannot be deemed
to be “right” or to accurately reflect optimum
care; these guidelines continue to represent what experts
identify as being the best course of action.
Third, patients are unique individuals with factors distinguishing
them from the average subject as defined within a set of
practice guidelines. The recommended course of action for
the average patient with a given diagnosis may be inappropriate
and/or harmful to a specific patient with a unique medical
and rehabilitation history, comorbidities, and lifestyle.
Patients respond differently to treatments and interventions
which requires physicians to make necessary adjustments in
recommendations. In addition, patients have unique preferences,
motivations, and tolerances for certain types of treatment
and may/may not have adequate support to maintain recommended
interventions over time.
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Utility of Clinical Practice Guidelines
While clinical practice guidelines cannot account for all
of the individual variations patients represent, they can
serve as a foundation for initial care and treatment. Amon
(2000) asserts:
“Limitations of practice guidelines are not a
problem, as long as they are communicated honestly in the
working of the recommendations and rational. Honest uncertainty
is communicated in the rationale by stating clearly which
parts of the recommendations are based on science and the
quality of the evidence, and which recommendations are
based on opinion and how that opinion was gathered.”
When reviewing clinical practice guidelines, life care planners
must actively question:
*the goals of the group who developed them
*the methodology of development
*the language within the document (flexible or absolutist?)
*the degree to which inherent limitations are acknowledged
*the degree to which the guidelines apply to an individual
patient
Clinical practice guidelines serve as one of the resources
to be considered when developing a life care plan. Like any
other source, professionals must view all practice guidelines
with a critical eye, question the validity of the recommendations,
and recognize the limitations of the development methodology.
Most importantly, life care planners must determine whether
specific practice guidelines are applicable and appropriate
for the individual with whom we are working.
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