The Wisdom Behind Cancer Protocols
Paul Bachner, MD
The College’s publication of the cancer protocols in September 1998 (Reporting
on Cancer Specimens, updated last February) is the result of years of effort by
the CAP Cancer Committee’s chairs-Robert V. P. Hutter, MD, Donald E. Henson, MD,
M. Elizabeth Hammond, MD, and now Carolyn C. Compton, MD, PhD-and its many dedicated
members. Several concerned and informed College members have sent inquiries to
me about the protocols and, in an attempt to respond, I have posed questions to
Drs. Compton and Hammond. I will share with you here what they told me.
Why were the protocols developed? The committee recognized that pathology
reports on cancer specimens were extremely heterogeneous, even within a group
of pathologists in the same institution. Specimen analysis and reporting (grading,
staging, and terminology) varied considerably, particularly when different institutions
were compared. Greater uniformity was needed for therapy and management decisions,
determinations of prognosis, predictions of response to therapies, data analyses
for clinical studies, tumor registries, quality assurance within pathology services,
and the advancement of the entire field of oncology. Data from the National
Cancer Data Base, for example, showed that the information necessary to assign
a pathologic stage was missing from many reports.
Was a consensus process used to develop the protocols? Multidisciplinary
groups of pathologists, surgeons, medical and radiation oncologists, and others
worked together to develop them. The protocols were reviewed extensively by
pathologists and other clinicians as well as by CAP resource committees, the
Commission on Anatomic Pathology, the Council on Scientific Affairs, and the
House of Delegates before the Board of Governors granted its final approval.
The process also included reading other protocols and pathology papers to ensure
that the information provided was consistent with that suggested by others.
Will the protocols help pathologists in practice and provide support to
clinicians that will lead to better patient care? Pathologists need to effectively
communicate cancer specimen information in reports so that clinicians can make
decisions. If the information is complete and conveyed in a clear and predictable
form, the report is less likely to confuse the clinician. This will result in
fewer interruptions and better, faster patient care. Standardized formats could
also lessen interobserver variation among the pathologists in a group, which
could lead to greater clinician satisfaction, reduce the number of errors related
to misinterpretation of pathology information, and result in better patient
care. Standardized (synoptic) reports are much easier for transcriptionists
to produce, and, when they’re used, results are available more quickly. Surveys
of clinicians indicate high levels of satisfaction with standardized reports.
Some CAP members are concerned that protocols are time-consuming and impose
the opinions of ivory-tower academics on practicing pathologists. The information
in the protocols is the information clinicians need to treat the patient. Most
practicing pathologists are already providing the data elements the protocols
are composed of, and, as noted, all protocols are subjected to consensual review
and reality testing by pathologists from a variety of practice environments.
Using the protocols is not time-consuming but time-saving, because the information
is simply listed in the same format each time. When all information is provided
and it is not confusing, pathologists are less likely to be interrupted to clarify
a report or review a slide.
Has the American College of Surgeons mandated the use of the protocols?
The American College of Surgeons has endorsed voluntary use of the cancer protocols
but has indicated a desire to make the protocols mandatory as soon as possible
for purposes of ACS accreditation. The surgeons’ desire for speedy implementation
is a reflection of how important they believe the protocols to be and the positive
impact they will have on cancer care. The protocols include so-called short
forms or checklists, which are summaries of data elements (synoptic formats)
created by the Cancer Committee to promote effective communication using a TNM
format. All of the key elements of the parent full protocols are contained in
the checklists, which may be used in place of or as a supplement to traditional
narrative reports. ACS has specified that the information in the short form
be included in pathology reports, but it has not specified the format the reports
should take, thus allowing for variation to accommodate local circumstances.
The long forms provide notes and references and are the only resource where
all information (for staging, grading, prognostic factor analysis) is available.
The protocols will be reviewed and updated regularly so that pathologists using
them can be confident their practice reflects current information.
In summary, I believe Drs. Compton and Hammond’s comments explain well the
value of the cancer protocols and their relevance to the practice of pathology.
The protocols are consistent with the College’s many other programs that support
pathologists in practice as we strive to improve performance. They also represent
an important initiative on the part of the CAP to meet the challenge of the
Institute of Medicine’s report on medical error. Although variation in diagnosis
or reporting practice is by no means equivalent to error, the pursuit of scientifically
validated reproducibility in diagnosis and reporting represents an important
component of the historical commitment of pathologists to achieving better patient
outcomes. Moreover, the recent announcement by the American Board of Pathology
of time-limited certification in pathology beginning in 2006, and the call by
the American Board of Medical Specialties for programs of maintenance of certification
that will include evidence of performance evaluation (CAPTODAY, October 2000),
denote a context of increasing professional and public expectation of accountability.
The cancer protocols represent an important, practical, and painless way for
pathologists to begin to meet these new expectations.