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Current Status of Practice Guidelines in Oncology

Current Status of Practice Guidelines in Oncology

ABSTRACT: A large number of organizations are currently developing practice guidelines in oncology. These include federal agencies; medical societies and groups, including both oncologic and nononcologic specialty societies; and informal and formal groups of oncologists at the national, regional, and local level. Despite this marked increase in guideline activity, the science of guideline development must still be considered embryonic. Several general principles appear to be important for the generation of sound practice guidelines: (1) selection of suitable topics; (2) appropriate composition of the panel; (3) objectivity of the process used to arrive at recommendations; and (4) specific provisions for review and revision. Like the science of guideline development, the science of guideline implementation is still in its infancy. The factors facilitating physician acceptance of guideline recom-mendations have yet to be identified. Also, systematic evaluation of the effectiveness of different implementation strategies is needed. [ONCOLOGY 9(7):601-615, 1995]

Introduction

The Institute of Medicine has defined clinical practice guidelines
as "systematically developed statements to assist practitioner
and patient decisions about appropriate health care for a specific
clinical circumstance" [1]. The marked expansion of interest
in this area has arisen as a result of two converging themes in
modern health care. The first proposes that one step toward controlling
rising medical costs is the elimination of diagnostic tests and
therapeutic interventions that do not contribute to a beneficial
outcome for the patient [2].

The second maintains that today's physicians do not routinely
base their medical practices on solid evidence, since it is virtually
impossible for a single individual to process and objectively
evaluate the mass of data impacting on medical decision-making
[3]. This is especially true when, paradoxically, there may be
critical gaps in the data. The confluence of these perceptions
has led policy makers and health service researchers to consider
clinical practice guidelines as a vehicle for encouraging practices
that are sound, consistent, and cost-effective.

Faced with these demands, the oncologic disciplines are being
called upon by sundry sources to develop practice guidelines.
As all who venture into this field rapidly learn, the complexities
of managing the cancer patient place demands on oncology guideline
developers that far exceed those confronting experts in other
areas. Besides the sheer volume of diagnoses subsumed under the
term "oncology," the task is complicated by the heterogeneity
of clinical and pathophysiologic variables for each patient, which
makes the delineation of comprehensive pathways extremely difficult.
For these reasons, guideline activity in oncology has lagged behind
that in other disciplines. A recent survey of 831 articles related
to guidelines and outcome measures cites only 61 papers related
to cancer, of which half address screening issues [4].

Despite these difficulties, the goal of providing instruments
to assist in clinical decision-making remains a valid one, since
the ultimate objective, the improvement of care for cancer patients,
may be furthered by soundly derived guidelines.

Current Guideline Activity

As yet, no single authoritative body has emerged as the ultimate
developer of practice guidelines in oncology. However, a wide
spectrum of groups, ranging from federal agencies and medical
societies to formal and informal groups of oncologists, are currently
involved in developing these instruments (Table 1).

Federal Agencies

The federal initiative is being carried forth by the Agency for
Health Care Policy and Research (AHCPR) [5]. To date, panels of
this organization have developed seven guidelines, only one of
which, "The Management of Cancer Pain"[6], is directed
at cancer care.

The National Institutes of Health consensus process fosters the
development of statements that evaluate broad areas of clinical
care and delineate the current state of appropriate practice [7].
Consensus statements are the products of an invited panel of experts
who review relevant data and, in a nonstructured process, develop
a consensus opinion. Recent consensus statements in the area of
oncology have addressed the adjuvant therapy of colorectal carcinoma
(1990), early breast cancer (1991), diagnosis and treatment of
melanoma (1992), and management of ovarian cancer (1994).

The National Cancer Institute, in response to recent debates over
mammographic screening in women age 40 to 49 years, has redefined
its role in this area, reasoning that its goal should be to support
relevant research, and thereby serve as the scientific resource
agency in the guideline process [8].

Medical Groups and Societies

A second major developer of guidelines has been medical groups
and societies [9]. The American Cancer Society has been instrumental
in formulating the parameters and indications for a broad range
of screening and support activities [10,11]. The ACS has fulfilled
a major requirement of sound guideline practice, namely, the commitment
to periodic review and revision [12].

Another major group involved in guideline development has been
the American College of Physicians, through its Clinical Efficacy
Assessment Program (CEAP) [13]. Initiated in 1981, this project
has produced over 200 position papers, including several related
to cancer topics, such as parenteral nutrition in cancer patients
[14].

One of the first major guideline efforts in oncology was undertaken
by the Oncology Nursing Society, which published a comprehensive
set of pathways for performing nursing assessments of the cancer
patient [15]. The Association of Community Cancer Centers recently
announced plans to convene working groups to derive management
plans for the common cancer sites.

During the past 2 years, three of the major oncology specialty
societies, the American Society of Clinical Oncology, the American
Society of Hematology, and the Society of Surgical Oncologists,
have formed committees to develop guidelines related to oncology
practice. The American Society of Clinical Oncology is utilizing
expert panels to derive evidence-based guidelines. The first of
these documents, on hematopoietic growth factors, was published
recently [16]. Future guidelines will focus on the use of tumor
markers in breast and colon cancer, and issues related to the
role of peripheral stem-cell support of high-dose chemotherapy.

The American Society of Hematology is approaching guideline development
from a disease-oriented perspective, and will address specific
neoplastic entities in the future. The surgical group is developing
a set of guidelines related to the site-specific surgical management
of a broad range of tumors.

Another avenue to practice guideline development was recently
opened by the Eastern Cooperative Oncology Group, which has promulgated
a set of guidelines delineating practice para-meters related to
bone marrow transplantation [17].

In addition to the oncology specialty organizations, the subspecialty
oncology groups are also generating guidelines specific to their
areas. The American Society of Bone Marrow Transplant is developing
guidelines for the appropriate resources for performing transplant
procedures and for the credentialing of bone marrow facilities.
The International Society of Hematotransplant and Graft Enhancement
has been working with the Office of Health Technology Assessments
to formulate a set of guidelines covering the technical aspects
of procuring bone-marrow, peripheral stem-cell, and cord specimens.

Nononcologic specialty societies have also become involved in
cancer topics as part of their general guideline activities. Recent
examples include the American College of Obstetrics and Gynecology,
which developed several technical papers directly dealing with
oncologic problems [18]; the American Society of Colorectal Surgeons,
which promulgated guidelines for the management of colorectal
cancers [19]; and the American Academy of Dermatology, which published
guidelines for the management of malignant melanoma [20].

Other Groups

The third, and probably most active, locus of guideline development
has been a multiplicity of formal and informal groups operating
at the local, regional, and national levels. The aim of these
groups has been to delineate the clinical practice pathways for
the majority of common tumors. These pathways seek to standardize
diagnostic and staging workups, detail appropriate primary and
adjuvant therapies, specify types and schedules of follow-up examinations,
and outline options for salvage therapy.

The impetus for this grass-roots guideline effort is the desire
to decrease variations in oncology care, with the assumption that
this will curtail the overutilization of services and thereby
decrease costs. Since guidelines must be implemented on the local
level, "buy-in" by practicing oncologists may be heightened
if they are part of the developmental process.

Given the plethora of ad hoc guideline activities, there is probably
a considerable amount of overlap in the areas being covered. Since
the composition and authority of the panels differ, the methodology
used for deriving guidelines varies widely, ranging from the informal
consensus of experts to formal, evidence-based processes [21].

Major health maintenance organizations, such as Kaiser-Permanente,
are investing significant resources in developing a guideline
program. Insurance companies, too, may have a major impact on
guideline generation. Blue Cross and Blue Shield organizations
in several states have been either independently deriving or contracting
for
the development of clinical practice pathways.

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