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The Role of Oncology Clinical Practice Guidelines in the Managed Care Era

The Role of Oncology Clinical Practice Guidelines in the Managed Care Era

ABSTRACT: The development of clinical practice guidelines in oncology presents unique problems and challenges due to the heterogeneity of disease presentations and the complexity of therapeutic decisions. Guidelines should incorporate not only standard outcomes measures such as survival but, if feasible, quality of life measures, patient preferences, and cost-effectiveness analyses. Although clinical guidelines are being promulgated as a means of assisting physicians in making therapeutic decisions, another purpose of guidelines implementation reflects the goals of managed care, ie, to promote practice conformity and reduce the cost of care. Methods to monitor physicians' adherence to guidelines are expected to increase as a means of ensuring compliance. This article reviews the process of developing two common types of guidelines used in oncology: path guidelines (using stage II breast cancer as a paradigm) and boundary guidelines (such as the ASCO growth factor guidelines). [ONCOLOGY 9(Suppl):177-183, 1995]

The development of clinical practice guidelines
in oncology presents unique problems and challenges due to the
heterogeneity of disease presentations and the complexity of therapeutic
decisions. Guidelines should incorporate not only standard outcomes
measures such as survival but, if feasible, quality of life measures,
patient preferences, and cost-effectiveness analyses. Although
clinical guidelines are being promulgated as a means of assisting
physicians in making therapeutic decisions, another purpose of
guidelines implementation reflects the goals of managed care,
ie, to promote practice conformity and reduce the cost of care.
Methods to monitor physicians' adherence to guidelines are expected
to increase as a means of ensuring compliance. This article reviews
the process of developing two common types of guidelines used
in oncology: path guidelines (using stage II breast cancer as
a paradigm) and boundary guidelines (such as the ASCO growth factor
guidelines). [ONCOLOGY 9(Suppl):177-183, 1995]


Introduction

A s the US health-care system increasingly relies on managed care
mechanisms to direct patient management, new methods are needed
to assist providers, payers, and policymakers in implementing
this transformation. A method that currently figures prominently
in the planning of many health organizations is the derivation
of clinical practice guidelines [1].

Given the heterogeneity of disease presentations and the complexity
of therapeutic decisions, the development of guidelines in oncology
presents unique problems and challenges. As in all aspects of
health-care planning, concepts and objectives must be precisely
defined at the outset, so that the planning process has clear
direction and a solid underpinning.

The classic definition of clinical practice guidelines is "systematically
developed statements to assist practitioners and patients in decisions
about appropriate health care for a specific clinical circumstance"[2].
This definition is useful in that it focuses guidelines developers
on the concept of guidelines as an assistance to clinical decision
making. As guidelines are developed, reference to this aim will
assist oncologists in deciding whether the recommendations are
useful. If a clinician can use a guideline in arriving at a medical
decision, then it has been framed correctly. If, because of vagueness
or lack of specific direction, it does not provide any substantive
guidance, the guideline is not providing meaningful assistance
in patient management.

Do Guidelines Promote Conformity?

In reality, the recent emphasis on guidelines stems from a more
concrete goal than assistance in clinical decision making. The
reason for the tremendous energies being directed toward guidelines
development is the belief that they are a vehicle for assuring
conformity of practice [3,4]. A more pragmatic definition of guidelines
might be that they are a set of directives reflecting the most
appropriate management of a clinical situation, whose goal is
to promote conformity in the delivery of medical care. While not
absolute, this definition makes guidelines more prescriptive and
more realistically reflects the underlying reasons for the resurgent
interest in this area.

The assumption that guidelines can actually promote and result
in conformity must still be viewed as unproved [5]. Although,
theoretically, there is good reason to believe that they will
achieve this goal, the appropriate evaluation and assessment studies
have not been performed, and at this stage the entire process
must be considered experimental. The reasons for striving for
conformity in practice through the use of guidelines stem from
the major aims of managed care and may be listed as follows:

1. The use of clinical practice guidelines will eliminate inappropriate
interventions [6]. This concept is based primarily on health services
research studies that have demonstrated the high prevalence of
inappropriate procedures using evaluations by experts.

2. The cost of care can be more accurately gauged. One of the
prime reasons that many groups are currently developing guidelines
is to develop standard packages of care for which costs can be
analyzed by financial and administrative experts, so that they
can be used in managed care contracts. The methodology for these
costing analyses is still not well defined, and for a guideline
to obtain the specificity and comprehensiveness that will permit
the accurate estimate of standard costs will require extensive
economic modeling.

3. The cost of care may be driven down [7]. One of the presumptions
of conformity to guidelines prescriptions is that it will prevent
overutilization of medical services. While this may certainly
be true, it is also true that guidelines may uncover areas of
underutilization of medical care and lead to increased medical
costs [8]. If the more widespread use of guidelines leads to universal
compliance with currently accepted guidelines for adjuvant therapy
of early-stage breast cancer, the cost of medical care, at least
in the short term, may increase. Although economic modeling would
suggest that this is a "good buy"[ 9], the overall direction
of health-care spending may be up, not down, as a result of conformity
to a guideline.

4. Quality of care can be defined in terms of adherence to guidelines.
In response to the mandates of managed care, the issuing of "report
cards" and the credentialing of physicians and health-care
providers are becoming increasingly important. The derivation
of medical review criteria and performance measures will lead
to comparisons of physicians' practices with standards for adherence
to guidelines and assignment of levels of quality of care to specific
providers [10]. The determination of appropriate indicators of
guidelines adherence and the implementation of efficient computerized
systems to monitor these indicators will become areas of intense
investigation in the next few years. On balance, it is probable
that conformity, insofar as it eliminates inappropriate practices,
will benefit patients, but the assumption must be made that it
will not be a straight-jacket that precludes necessary modifications
to accommodate individual patient needs.

Approaches to Guidelines Development

The guideline process involves not only development but also validation,
dissemination, and assessment of impact. The current approaches
to guidelines development have been well described by Woolf [11].
Informal consensus methods consist of a group of experts deriving
a set of guidelines based on their expertise, with no explicit
definition of the data used or the process for reaching consensus.
The formal consensus process involves bringing together recognized
experts for a formal presentation of available data. The experts
are then left to their own devices on how to digest the data and
use it in arriving at their recommendations. The NIH consensus
process is a prominent example of the use of this methodology.

The third approach, evidence-based guidelines, is the method currently
considered to be the soundest for deriving objective guidelines.
The process utilizes a formal review of the literature, with evaluation
of the strength of the evidence based on explicit criteria. This
categorization and presentation of the data allow clinicians using
the guidelines to assess the strength of the evidence underlying
the recommendations and, by extension, the strength of the specific
guideline.

The fourth method, as promulgated by David Eddy and coworkers,
has been termed the explicit method. [12]. This method attempts
to assess the magnitude and probability of outcomes, and use the
results of this analysis in choosing between alternative practices.
Unfortunately, for the bulk of oncology clinical situations, the
quantitative data that would permit guidelines developers to use
this process are not available.

There is a plethora of terminology related to systematically derived
tools to assist in managed care. It is useful to distinguish between
two major classes: clinical practice guidelines, which detail
the appropriate tests and treatments, and critical pathways, which
lay out the plan of how to perform these tests and treatments.
Critical pathways are basically centered on the timing of medical
procedures [13] and are probably best derived at the local level.
Clinical practice guidelines may be divided into two types: path
guidelines and boundary guidelines, which are discussed below.

During the guidelines development process, it is imperative to
define the outcome measures that will be used in deriving the
recommendations prior to embarking on the specific guidelines
effort [14]. The most relevant outcomes in oncology are survival
and improved quality of life. Although the methodology for assessing
quality of life is still in a developmental stage, in many instances,
data exist that allow quality of life outcome measures to be factored
into guidelines development. The two other outcomes of importance
in oncology--cost effectiveness and patient preference--are not
currently used to any significant degree in guidelines development.
The methodology for incorporating patient preference into guidelines
in a systematic way must still be developed [15]. Economic analyses,
for the most part, are cost-minimization studies. Since data from
cost-effectiveness or cost-utility studies are not available for
most oncologic practices or procedures, it may prove difficult
to incorporate economic considerations into oncology guidelines
[16].

An example of the importance of determining the relevant outcomes
prior to deriving guidelines was apparent in the deliberations
of the American Society of Clinical Oncology (ASCO) growth factor
guidelines panel [17]. The panel's recommendations depended on
whether the outcomes to be considered were secondary outcomes
(such as decreased hospital days, decreased days on antibiotics,
or a decrease in infections) or the primary outcome of increased
survival. In many boundary guidelines processes, the first several
hours of discussion must focus on the appropriate outcomes to
use in framing the guidelines. If consensus about outcomes is
not achieved, the panel is at risk of deriving a set of recommendations
that are internally inconsistent, if not frankly contradictory.

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