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" . 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 .
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 . 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 .
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.
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).
The federal initiative is being carried forth by the Agency for Health Care Policy and Research (AHCPR) . To date, panels of this organization have developed seven guidelines, only one of which, "The Management of Cancer Pain", 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 . 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 .
Medical Groups and Societies
A second major developer of guidelines has been medical groups and societies . 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 .
Another major group involved in guideline development has been the American College of Physicians, through its Clinical Efficacy Assessment Program (CEAP) . Initiated in 1981, this project has produced over 200 position papers, including several related to cancer topics, such as parenteral nutrition in cancer patients .
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 . 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 . 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 .
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 ; the American Society of Colorectal Surgeons, which promulgated guidelines for the management of colorectal cancers ; and the American Academy of Dermatology, which published guidelines for the management of malignant melanoma .
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 .
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
the development of clinical practice pathways.