Lightening the cancer protocols’data demands
The College’s protocols for cancer reporting were never intended
to be marching orders. Developed and refined over the last 15 years,
the 38 sets of guidelines have been disseminated as educational tools.
But soon, as the College approves revised versions of the protocols,
they will no longer be strictly voluntary. The essential data elements
they specify will become required parts of pathology reports on cancer
specimens at the nation’s more than 1,400 approved cancer programs,
as the protocols become a new component of the American College of
Surgeons’ Commission on Cancer accreditation process.
The Commission on Cancer’s decision in 2000 to make the protocols
mandatory has rattled and even angered some members of the pathology
community, who maintain that the protocols weren’t designed for
this use, that many of the data elements they include are secondary
or trivial, and that converting pathology reporting systems in some
cases could be costly.
But CAP officials see no cause for alarm. They emphasize they
are narrowing down the number of required elements and seeking a
longer time frame to make the transition as smooth and unrushed
as possible. The Commission on Cancer, or CoC, had planned to make
the protocols mandatory as of Jan. 1, 2003, but at press time, the
CAP’s leaders had decided to request a one-year delay to give pathologists
more time to make the adjustment.
"When we wrote the protocols, we had no idea they were going to
be employed in the way they have by the ACS Commission on Cancer,"
says Carolyn Compton, MD, PhD, chair of the CAP Cancer Committee
and the CAP’s representative to the CoC. "But pathologic data is
so key to good cancer care that the commission wanted to make these
guidelines mandatory immediately."
"We argued successfully that pathologists needed to have time
to become conversant with the protocols and implement them in their
own practices before they became mandatory."
She adds that the CoC understands the protocols were written originally
as "optimal" reporting guidelines, not minimal reporting standards,
and that CAP’s Cancer Committee has been working feverishly in the
past six months to tailor the protocols to their new role.
"What we’ve done is update and reevaluate every single protocol
we’ve published to make certain they reflect the newest classification
of tumors and staging systems," Dr. Compton says. "At the same time
we’ve subclassified the reporting elements into those that are completely
validated and used routinely for patient care—and they would
be the ones to be considered mandatory by the commission—and
those that are exempt reporting ’suggestions’ in the protocols."
The latter are all data-driven and predictively important, but
not yet proven in large studies that definitively show their validity.
"We’ve designated them with asterisks, and those elements will be
considered optional, not mandatory. So this should quell any arguments
that the CoC will be demanding nonessential elements," she says.
The CAP Cancer Committee also feels the mandate is positive in
that it will give pathology more say in how cancer reporting is
conducted. In fact, says Dr. Compton, who chairs the pathology department
at McGill University in Montreal, Quebec, previous pathology reporting
standards used by the Commission on Cancer were more or less derived
by surgeons, not by pathologists.
"What we’re doing is taking the all-inclusive lists, and pulling from those
lists the essentials, the ’must-haves,’ and saying every pathology report has
to have those details,’ says Dina Mody, MD, who is an advisor to the Cancer
Committee and chair of CAP’s Cytopathology Committee. "If you decide to put
in other details, that’s your choice, but the reports are going to be inspected
on the ’essential elements.’"
No make-or-break standard
The word "accreditation" may strike fear into the hearts of many.
But unlike CAP accreditation of laboratories (which certifies whether
laboratories meet federal CLIA ’88 requirements), CoC’s designation
of approved cancer programs is itself voluntary and not linked to
government regulations that might make a hospital ineligible for
reimbursement. M. Asa Carter, manager of the accreditation and standards
section of ACS, also stresses that no hospital or medical center
would ever fail an accreditation survey on the basis of a single
standard such as the protocol mandate.
"We understood that the cancer protocols were intended to be voluntary,"
Carter says. But she notes that many similar guidelines prepared
by other organizations were not developed to be required, and "The
Committee on Approvals of the Commission on Cancer felt [cancer
reporting] was an important enough issue that it was time to take
Pathology reports from 2003 will not be examined until 2004, Carter
says. And if some of the essential data elements are found to be
missing, an amended report can be filed.
Initially, the CoC Committee on Approvals considered requiring
the two major protocols—those for colon and breast cancer—but
it voted after much discussion to require use of all CAP protocols.
After approval by the CAP’s Council on Scientific Affairs and the
Board of Governors, the revised cancer protocols will be posted
on the CAP Web site, many of them by December. Any protocol not
revised by then may be taken out of circulation, and the CoC has
said it will not try to mandate anything the College has not approved.
The protocols have been driven primarily by what is needed by
the American Joint Committee on Cancer and the International Union
Against Cancer, says CAP Cancer Committee member Philip Branton,
MD, a staff pathologist at Inova Fairfax Hospital in Fairfax, Va.
These groups promulgate the TNM (tumor, node, metastasis) staging
system, and their cancer staging manual is used not only by pathologists
but also by clinicians.
"When a patient is staged for cancer, the surgical pathology findings
are simply one set of the data points used," Dr. Branton says, "You
also need to look at radiographic studies, CT scans, nuclear medicine
studies, in some cases serum markers for different types of tumors.
So all of those data elements need to be considered."
It hasn’t really been demand from the surgical community that
has brought the protocol mandate, confirms University of Kentucky
Chand-ler Medical Center surgeon Daniel E. Kenady, MD, a member
of the CoC and chair of the ad hoc committee to revise standards.
"The reporting elements from CAP, we think, are very important just
because we are mandating that cancer cases be staged, and we feel
really that the most accurate stagings are the ones that utilize
the templates," he adds, noting that at his own institution templates
have significantly improved accuracy of staging.
"Obviously the pathologist doesn’t have access to the whole patient," says
Dr. Kenady, "but the copies of the path reports to the physicians who are responsible
for completing the staging forms are used extensively and are much more helpful
than operative notes and other parts of the medical record."
Qualms about standardization
The protocols should make life easier for pathologists, Dr. Compton
says. "It can be difficult to keep abreast of developments in fields
that are rapidly moving like breast and prostate cancer. The protocols
are a way that any surgical pathologist can keep up with the most
important and essential issues in pathologic analysis without having
to read all of the literature themselves."
But it’s what "standardization" connotes that has unsettled some
members of the pathology community. Thomas P. Anderson, MD, president
of Consulting Pathologists of Connecticut, P.C., is one of them.
At his 200-bed community hospital, the four pathologists now use
one (non-CAP) template for carcinoma of the breast, but adopting
all the protocols will be a huge task.
"I’m not terribly in favor of protocols in the first place because
they may come back to bite you in a legal situation. I’ve been practicing
pathology for 20 years and am familiar with the types of information
the oncologists and other clinicians need. I work very closely with
them, and if by any chance a piece of information is not included
in the report, they can call me up and say, ’Tom, what about this?’
and I can either tell them or review the case."
Dr. Anderson says the protocols should remain voluntary. "From
my point of view, as your day-to-day practicing CAP member, slugging
it out at a community hospital without residents, the protocols
are an unnecessary burden. Academic pathologists, who primarily
devised the protocols, are a different breed with a totally different
Roger A. Reichert, MD, PhD, chief of the Department of Pathology
at St. Luke’s Hospital in St. Louis, Mo., was also an early critic
of the CoC initiative to make the protocols mandatory. "CoC was
concerned that important staging information was not always present
in pathology reports, but commandeering the highly detailed CAP
cancer reporting protocols that were intended to be used only as
educational tools was the wrong approach to addressing this problem,"
In a letter Dr. Reichert wrote to CAP TODAY earlier this year, he used the
colon cancer protocol to highlight how some of the items in the original versions
of the protocols represent information that is not essential for patient treatment.
He also noted that the 90 percent compliance standard set by the CoC is too
rigorous to be used in conjunction with these protocols. However, he says the
CAP has been responsive to his concerns and he is awaiting the final version
of the revised protocols, which his group plans to use as a framework for narrative
reports. An opponent of man-datory checklists, Dr. Reichert cited a study that
found that synoptic reporting actually reduced physicians’ comprehension of
the critical information pathologists were trying to convey (Arch Pathol
Lab Med. 2000; 124: 1040-1046).
The need for more uniformity in reporting has become increasingly
apparent, says Linda Trapkin, DO, a member of the CAP’s Council
on Public Affairs and a staff pathologist at St. Joseph’s Hospital
in Syracuse, NY. "Twenty years ago, your clinicians got used to
what you’d call ’moderately differentiated,’ and everybody was happy.
Now a person treated in rural Maine expects the same analysis for
treatment options as in New York City, and that can only be done
by uniformity of reporting. Those who disagree and say I’m not going
with the mainstream, I think they’re wrong."
But there is room for individual approaches, she says. "I probably
follow prostate protocols 100 percent, but the one on colon cancer
I don’t. There is something on tumor border and lymphocytic invasion.
I was not taught to report these aspects and have not seen either
as a consensus recommendation in the literature. I have never put
either of these descriptions in my reports, and I’ve never been
called by the surgeon or the oncologist to do so."
She questions other areas as well. "If you look at the protocols
for breast and colon cancer, the instructions when doing lymph node
dissection say the entire lymph node is to be put through if it
looks benign. I think that’s controversial because most pathologists
aren’t doing it yet. I’ve tried it and it’s a lot more work. So
pathologists do have the right to look to the CAP to upgrade the
CPT payment code for lymph node dissection." Most important, she
says, "I think this aspect of the protocols needs to be settled
because it is one of the few things that can’t be retrospectively
reevaluated, like looking back at a slide to count mitoses."
The breast cancer protocol has run into the most controversy—wrongly,
she believes. "I spoke at the House of Delegates meeting, and people
from my own delegation said they don’t use the recommended grading
system. But if you pick up any recent authoritative textbook, that’s
the system being used."
To a certain degree, differences in philosophy and practical needs
between those in academia and those in the field are to blame, Dr.
Trapkin contends. "The proof that lymphocytic invasion of colon
cancer is important is obviously coming from academic centers where
research studies are looking at numerous variables, maybe publishing
their findings, and the authors may think they are on to something
very important, but we in the community hospitals are not hearing
feedback from our oncologists that such data is important for diagnostic,
prognostic, or treatment decisions. And this does not worry me;
if something like lymphocytic infiltration becomes important, it’s
still on the slide for retrospective evaluation."
But the trend throughout medicine has been to move toward evidence-based
practices. "Whether it’s the drugs clinicians used for heart disease,
or antibiotics for infections, 25 years ago it was very idiosyncratic
across the country, and sometimes what people were doing was relatively
ineffective. Then there was a push to standardize protocols, and
our clinical colleagues were presented with algorithms, practice
protocols, and clinical guidelines, and they’ve been dealing with
them for years longer than we have," Dr. Trapkin points out.
"In the beginning they may also have balked and said this is cookbook
medicine, but they’ve calmed on this and now they expect and look
for the newest protocol. In pathology we’re still a little cranky
Once there is agreement on the essentials, Dr. Trapkin expects
most pathologists will go along with the protocols, though some
will resist changing their style of reporting. The CoC has agreed,
however, it doesn’t have to be in tabular form. "So then it becomes
whether we are arguing format over content. And I strongly believe
that pathologists in this day and age need to be selling themselves
lest some commercial outfit comes in and takes over their services.
If I can convince pathologists to look at this as a marketing tool,
hopefully their attitude will change and they will see that complete
and easily understood reports are a marketing plus."
"I’ve lost the vast majority of my prostate business to commercial
companies that realize they can make a lot of money off of global
billing," she continues. "And when my urologists get a report from
a commercial anatomic pathology lab, I’m sure all the recommended
information is there, plus the photograph." With office business
up for grabs, the urologist is now in the driver’s seat and can
say, "This is what I want in my report."
Says the ACS’ Carter: "We don’t say they’re required to use a
checklist. We’re asking them to include the data items in their
pathology report, and if they choose to do it in a narrative, that’s
their choice. However, it’s certainly easier to monitor if they
use a checklist."
The ACS Commission on Cancer, she adds, has been told by CAP members that
adopting a checklist has saved pathologists a lot of time spent going back to
pull slides because they had left something off. "Certainly if I were a physician
I would rather have this information up front rather than get it later. If I
were a physician I would think I’m placing an additional burden on the pathologist
to go back to review slides."
The resistance by some pathologists is understandable, Dr. Compton
acknowledges. "People don’t like to be told what to do, even by
their peers." In pathology reporting, standardization has not been
the tradition; rather, the tradition has been one of "poetic license,"
with people being able to say what they wanted on their own reports.
"But we can no longer afford poetic license," she contends. Given
the global nature of cancer care, with patients traveling from one
center to another for care, for followup, or for clinical trials
of new therapies, "it’s absolutely mandatory we all be speaking
the same language, and using the same data elements and the same
parameters to evaluate those elements."
Making anything mandatory is inevitably going to be controversial,
says David Frishberg, MD, chief of pathology at Sinai Hospital of
Baltimore in Maryland and a member of the CAP’s Surgical Pathology
Committee. But he favors more standardization. "I don’t think patient
reports are really designed to be creative exercises. They’re designed
to convey information, so I’ve always been strongly for protocols
and strongly for a synoptic format on cancer reports." He trained,
in fact, in a program where all of the cancer reports were done
with protocols and synoptic-style reports, and it led to fewer phone
calls from physicians.
When he reviewed a draft of a CAP cancer protocol, however, he
admits to getting into a "fairly vibrant disagreement over one of
the elements for melanoma, specifically radial versus vertical growth
phase. I felt that should be optional; it’s vaguely and variably
defined in the literature, so it’s hard to expect general pathologists
to apply it, and not everyone accepts it as important."
"But the biggest problem with mandating specific elements—even
ones for which there is a relatively broad consensus—is that
it’s a moving target. The literature changes, and things considered
important now could become less so in the future and vice versa,"
Many cite another possible hazard: legal liability. Potentially,
the protocols do increase pathologists’ exposure, Dr. Frishberg
acknowledges. "I think if we have mandatory inclusion of elements
that even experts might differ on, a pathologist who declined to
put it in could be [unfairly] accused of violating standards of
practice. But I would say for a lot of the elements, it probably
would be a violation of standards of practice" to leave them out.
Furthermore, he says, the greater the number of specific items listed,
"the more there are that can be challenged as ’wrong’ in a medicolegal
Even well-meaning educational efforts carry this risk, Dr. Mody
cautions. "Unfortunately, the legal profession has mucked it up
wherever they’ve put their finger. If you use the word ’guideline’
or ’protocol,’ the next thing you know if the patient has a bad
outcome and somebody did not include an obscure detail from the
guideline, there is a possibility some lawyer may imply you were
In cytology, she notes, Pap test lookback was an educational and
quality improvement activity. "Guess what? It became part of the
regulations. Now, every time there is a patient with cancer, that
educational and quality assurance activity has become a bonanza
for trial lawyers."
But following protocols can be a safeguard in litigation, says
M. Elizabeth Hammond, MD, chair of the Department of Pathology at
LDS Hospital/Intermountain Healthcare in Salt Lake City. "In Intermountain
Healthcare, we try to develop protocols for many aspects of care
including pathology reporting. Our legal counsel has noted that
they provide a potent weapon in litigation." If a protocol has been
adopted and followed, she says, it becomes the responsibility of
the lawyer for the injured party to show how the protocol, rather
than the individual physician using the protocol, might have produced
harm to the patient. "Cases where this defense has been employed
have been ruled on favorably by judges and prelitigation panels,"
Accentuating the essentials
Whether a litigation help or hindrance, the protocols are needed,
contends Dr. Mody, of Baylor College of Medicine in Houston. "Unfortunately,
I still see reports where the tumor size is not reported when it’s
required. Sometimes I get reports from rural pathologists that are
excellent and have all the data points, and I could get a report
from within a short radius of the Texas medical center, the largest
medical center in the world, and not have those."
"You can’t say the little guy out in the community is not doing
a good job," Dr. Mody continues. "It’s just human nature. If you’re
doing a rambling report, maybe you just forget. But it’s nice to
have nine or 10 things on a checklist. If you forgot it in the narrative,
well, you can check it off at the bottom."
Says Dr. Branton: "There are a lot of reports floating around
that leave out a lot of critical data elements. Some people don’t
necessarily keep up with the times. Maybe they’re in smaller practices,
either rural or in-city, or maybe they’re simply in a practice setting
that rarely sees a breast biopsy—for example, a VA hospital.
If you haven’t looked at a breast cancer for four or five years,
you might not be quite up to snuff. With the protocols, a working
pathologist in a smaller group setting has a convenient, concise,
one-stop shopping format for what needs to be put into a report."
He says the synoptic format averts the problem of critical data
being "buried in the verbiage" of a traditional report. "In residency
we were all taught the Dickensian narrative, to give very lengthy
microscopic descriptions of everything. Part of the reasoning for
that was very sound, and on the [CAP] committee the resistance we’ve
encountered in the pathology community has been a concern that if
you have a template kind of pathology report, it’s all cookie-cutter;
we’re all the same and there’s no role for individual skill. But
the bottom line is we still need a highly trained and skilled person
looking at the slide. The difference is the reports are going to
be stripped down and streamlined so that oncologists and surgeons
can look at them and quickly gather the information they need."
For any cancer section, "the kind of detail needed by the treating
clinician has just exploded in the last five years," he adds. "When
I was a resident 15 years ago, they wanted to know how big the breast
tumor was, was the margin involved, were the lymph nodes involved,
and was there any pre-invasive cancer or duct car-ci-no-ma in situ.
Now a report has 15 to 18 parameters." For example, multi-cen-ter
studies have found that the pres-ence of vascular invasion is pre-dic-tive
of a worse course. "Those patients would probably be offered che-mo-therapy
even if the lymph nodes don’t have tumors in them. Fifteen years
ago we didn’t know that."
In the 1950s through the 1970s, he says, "surgical pathology was
fairly static. It was basically light microscopy, looking at slides
and saying this is or isn’t cancer and how big it is. People of
that era are sometimes a little bewildered by what’s going on, and
that’s one reason why CAP has been working on these cancer protocols."
"Any good pathologist would not want this to happen," says Dr. Compton, "but
with the high volume of work and the labor intensity of cancer cases, some reports
get signed out inadvertently with missing information needed for patient management."
The national cancer database bears out this fact, she adds. "It’s clear, for
instance, that as many as one quarter of all colon cancer cases get signed out
without a lymph node assessment, and as many as 50 percent of all sarcoma cases
get signed out without a grade."
Advice and consent
Dr. Hammond became involved in the cancer protocols in the early
1990s, later chairing the Cancer Committee. But the committee started
convening task forces on multiple specific tumor types as far back
as the mid-80s, beginning with Hodgkin’s disease, breast cancer,
and colon cancer. "In every case," she says, "the same practice
was followed. A panel of experts including clinicians and pathologists
would meet and talk together about what information was important
and how it should be reported so that it was clear. Then they came
up with a protocol and published it in the Archives."
None of the task forces’ work was easy, she adds. "I think all
of them have been difficult. With prostate cancer there was difficulty
getting unanimity of opinion among the experts, and the same with
bladder cancer." The key to their success, however, was that clinicians
drove the conversation. "We tried to pick people who were reasonable
human beings. There were surgeons as well as radiation and medical
oncologists, and we said, ’What do you need and how should we present
it so you can use it?’"
While the ACS was not directly involved, "it was the organization
that really sponsored the early efforts to stage cancers in the
U.S., and they wanted staging information to be improved, so they
watched with interest as the efforts by the Cancer Committee were
"What’s being mandated are really just the elements," Dr. Hammond
emphasizes. "Not how the pathologist gives the information but merely
that he or she does. For example, in breast cancer you give the
lymph node status; in prostate cancer you give the Gleason score.
But how you write that in the report is not part of the requirements."
At LDS Hospital/Intermountain Healthcare, the checklist format
has been used exclusively for cancer reporting since 1992—largely
because of a review she performed of 1991 pathology reports (Arch
Pathol Lab Med. 1997;121:1171-1175). "I found that only 299
of 356 narrative breast cancer reports were complete and clear.
Thirty-two reports contained missing information, such as size of
the tumor or margin status, and another 25 were confusing because
of the way the information was reported in the narrative. A log
of phone calls showed the majority of calls by oncologists were
to report missing information. The large number of phone calls on
cancer reports saying ’What do you mean?’ caused us to change to
a synoptic format."
When the oncologists were surveyed later to see if they liked
the synoptic format, they answered that they would never go back
to the previous system, because now they knew every single time
what grading scheme was being used, and there was no confusion from
one doctor to another. "Another valuable aspect of synoptic or checklist
reporting is that it allows these discrete data elements to be captured
in a data warehouse to help in cancer care modifications," Dr. Hammond
says. To make it possible to search the data, some degree of standardization
of terminology or format or both is necessary—even more so
now that so many institutions are moving to computerized medical
"I think the place for narrative is dwindling," Dr. Hammond continues.
"The reason is that clinicians are forced to work with less and
less time. If you can read something as a bulleted list, you’re
much more likely to get to that kernel of information more quickly
than if you have to read an entire report. That’s why doctors like
to read abstracts instead of whole manuscripts, so I think the day
of writing long narrative reports is going to disappear." Very few
of the reports produced by successful clinical laboratories are
done in narrative format anymore, she adds, except when a comment
is needed to clarify difficulties with the checklist format.
For Joel Sennesh, MD, vice chairman of the Department of Pathology
at Inova Fairfax Hospital in Fairfax, Va., there will not be much
of an adjustment to make since his tertiary-level care center has
been using the protocols for several years. "I’ve heard anecdotally
that the CoC wants to give its accreditation to hospitals that use
this systematized reporting. But we try to do as many of the common
cancer diagnoses as possible in protocol format, since our surgeons
and oncologists have indicated they’d like to see reports as giving
a TNM." In addition, most of the reports he sees are from academic
centers like Duke or Johns Hopkins universities, "which all seem
to be adhering to those protocols, so we really don’t see that much
that diverges from the protocols."
In his view, cancer reporting should be a straightforward matter.
"I see my job as being somebody who helps compile objective data.
For the benefit of future science and future patients, it’s probably
worthwhile to be as standardized as we can."
Are the mandatory protocols a sign that surgeons are decreeing
medical practices to pathologists? Dr. Compton says the reverse
is true. "Actually, pathologists were dictated to by surgeons more
before they got these guidelines. Now at least the guidelines are
pathology-generated, and they’ve gone through a huge gauntlet of
pathologists at all levels, and we’ve taken feedback from all CAP
members and incorporated it into these guidelines."
Says Dr. Branton: "I think CAP is doing a superb job by showing
leadership in this area. Certainly from the reports I’ve gotten,
the surgeons are absolutely delighted with what CAP is doing, and
they’ve seized on the protocols as exactly what they’re looking
It’s important to remember that College members developed these
protocols, Dr. Frishberg notes. "We’re very lucky we didn’t have
non-pathologists specifying protocols to pathologists. Other entities
[like the Association of Directors of Anatomic and Surgical Pathology]
have published their protocols, and it’s good that the College really
stepped up to the bat to take responsibility here. CoC is obviously
the authority for accrediting cancer programs, so if they had to
pick someone to do it, I’m glad it’s us."
Anne Paxton is a writer in Seattle. Each of CAP’s approved cancer protocols
consists of a long form, containing all information for staging, grading, and
prognostic factor analysis, and a short form, or checklist. The 2002 versions
are available free on the Web at www.cap.org.