May 2010
Feature Story

Anne Paxton

When the revised CAP cancer protocols were released last fall, pathologists generally responded positively, but some raised concerns about the protocols’ complexity and felt they might be too prescriptive.

Forged over a multi-year span by the CAP Cancer Committee, the protocols represent a consensus on and commitment to cancer reporting of the highest quality, and they have won approval from the American College of Surgeons and Canadian Association of Pathologists. Now the College is undertaking a slightly different project: presenting the protocols anew to pathologists in a form that is as user-friendly as possible.

“The protocols were developed through a committee process, and while every review panel did have community-based pathologist members, I think we recognized their voices were not as strongly heard as they might be,” says Mary K. Washington, MD, PhD, chair of the CAP Cancer Committee and director of gastro­intestinal and hepatic pathology, Vanderbilt University Medical Center, Nashville. “We’re working to simplify the complex protocols and make them more user-friendly.”

The committee has agreed to add a streamlined “work aid” for a series of protocols that shows only the required elements and not the optional ones. A work aid, as it pertains to the cancer protocols, is a single-page worksheet for someone who has read the full protocol but needs a memory jog during daily practice. The work aid idea evolved as an alternative to the list format employed in the synopsis, says Kalisha Ashara Hill, MD, a member of the CAP Cancer Committee and medical director, Department of Pathology, St. James Hospital and Health Center, Olympia Fields, Ill. The committee will place a temporary embargo on posting protocols online until the work aids are complete. At press time, the plan was to post the work aids online in May. The committee also announced plans to improve the user-feedback process.

Dr. Washington believes that some concerns about the protocols arose because the American Joint Committee on Cancer’s Cancer Staging Manual, 7th edition, on which the staging elements of the protocols were based, was delayed beyond its initial targeted release date. “Unfortunately,” she says, “this meant we did not really have time to field-test the protocols with broader input from the pathology community.” In her view, there may be another factor: The protocols have two roles to fill. “In one sense, the protocols represent a gold standard for the best pathology report you can create. But the essential elements from each protocol should also represent a minimum data set that can be practically implemented and applied to routine practice.”

Jerry W. Hussong, MD, DDS, vice chair of the CAP Cancer Committee and director of hematopathology and medical director of clinical operations, Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, says, “There’s been variable comment, and some has been negative and some has been positive. Some pathologists feel they’re being told how to produce a report as opposed to doing it the way they’d like it.”

The intent of the protocols is not to tell pathologists how to practice, he is quick to add. “They basically just ask for you to include all of the required elements” in the pathology report. Other elements marked with an asterisk are recommended but not required.

A broad base of pathologists worked on the latest version of the protocols. “We convened review panels for each of the areas, which included one member of the Cancer Committee as well as other nationally or internationally known experts across the country who were not on the committee,” Dr. Hussong says. The review panels that wrote and reviewed the protocols included private practice and community pathologists, as well as academic pathologists, “because we wanted to be sure we were writing cancer protocols able to be utilized and implemented by pathologists from across the spectrum.”

“A lot of work went into establishing the review panels,” he says. But “we could have done a little better at educating pathologists on how much effort had gone into trying to incorporate the viewpoints of the whole spectrum of practice.”

The majority of the review panels also had representation from the clinical side of medicine, including surgeons or medical or radiation oncologists, says Dr. Hussong, “so we were able to address and answer the questions they needed to have answered in a pathology report to treat their patients.”

The work aids, a ready reference and reminder system that uses formatting and check-boxes to truncate information, are a response to criticism from the field that some of the protocols are too cumbersome to use daily in practice. “We were trying to come up with an aid that people could more readily refer to as they are signing out cases—a sort of summarized ‘cheat sheet,’ if you will, as opposed to having to wade through more information,” Dr. Hussong explains. It’s always a balancing act, he adds, to include enough information in a pathology report but not so much that it becomes bogged down and difficult to use.

Dr. Hill, who became a member of the Cancer Committee during the final phases of the protocol revision, recalls the major feedback she received: “Some of the protocols were too long, not all the asterisked items need to be included, and some items need to be formatted differently.” However, the protocols clearly say the format can be changed as long as the elements are there, she notes.

“I would say,” Dr. Hill continues, “that because there’s so much variability in the way pathologists report different conditions, having the protocols contain basically every single element is good—including asterisked elements so pathologists can choose what they want their clinicians to read.”

Dr. Hill explains how she showed the draft of the invasive breast cancer synopsis to various oncologists and pathologists and received a variety of responses on what elements belonged in the templates. “Some surgeons want all the asterisked items related to margin status, not just notations like ‘all margins negative’ or ‘all margins positive.’ They specifically want the distance from each margin because they find that that information is clinically useful. Previously I would get called to give that information from the final microscopic description, and sometimes that information is given in the gross description—but not always, and not by all pathologists. Some would just say which margin was the closest.”

“By having it [the distance from each margin] part of the protocol, pathologists now more clearly understand that every margin needs to be mentioned and each distance given. All the surgeons and many of the oncologists really appreciate that, even though some physicians may not require all that information. Basically we’re trying to issue a report that would make both the oncologist and the surgeon happy.”

Some pathologists may leave off the asterisked items entirely and some might include all of them, Dr. Hill notes. “Neither of those is wrong—absolutely not. But by having them, you do allow the more demanding surgeon or oncologist to have a mechanism for the pathologists to report all of the pieces of information they prefer to be included in the report.”

Paul N. Valenstein, MD, chair of the CAP Council on Scientific Affairs and manager of a group of 13 pathologists in Ann Arbor, Mich., recognizes that some practitioners believe the protocols are too detailed for everyday use.

“Like many pathology groups of our size, we turn each of the CAP cancer protocols into a short dictation checklist or work aid that reminds us what we want to report for certain cancers. Our dictation checklists include only the CAP-required elements with a few additions important to the community we serve. Each of our dictation checklists is assigned to a particular pathologist in our group. When the new cancer protocols came out from the CAP, I sent an e-mail telling everybody to update their dictation checklists.”

“I have reason to believe this sort of activity is going on in most larger practices, although many small practices don’t have the staff to create their own dictation checklists and use the full CAP protocols,” he says. Some have called the CAP protocols “checklists,” but to his thinking, “their length drifts from the original checklist concept.”

“If you go into an airplane flight deck, the pilot has a pre-flight checklist the size of a five-by-seven card. The CAP protocols contain notations and explanatory text that help ensure pathologists are interpreting terms similarly, and that’s important. But it’s a slightly different function than a dictation checklist designed as a memory aid for someone who has already been trained.”

The Cancer Committee is developing the one-page work aids with only the required elements—more like a pilot’s checklist—and the work aids will provide the kind of mental ticklers checklists typically offer. “What we’re moving to,” Dr. Valenstein explains, “is a program that provides both a reference protocol—a full listing of required and optional elements and commentary about ambiguities—and a short work aid that will be useful to a community practitioner on a daily basis.”

Going forward, he says, the Council on Scientific Affairs will also consider adding a “usability review” to the other reviews the protocols pass through. “Right now there isn’t a separate usability review of each new cancer protocol by community pathologists who diagnose these cancers in their everyday practice.” A pre-publication review by community practitioners will be an important step, he says, to add to the production of the next release of the cancer protocols, which should take place in a few years. (The protocols will be housed now under the new CAP Pathology and Laboratory Quality Center, which plans a usability review before introducing Center guidelines.)

Some in the pathology community questioned the term “scientifically validated,” used for years in reference to the required elements. Several CAP committees debated what exactly the term meant, Dr. Valenstein says. “In the end, we opted to use the terms ‘CAP required’ or ‘required elements’” instead. “Science doesn’t ‘validate’ a fact,” he explains. “At best the scientific method can disprove a hypothesis; it cannot establish that something is true. Reasonable individuals may have different views about whether a particular conclusion has been subjected to sufficient study to be ‘validated’ in an affirmative sense.

“We decided it was best to move away from the term ‘scientifically validated’ and instead recognize that the CAP decision about what to require in pathology reports is made by human beings—a panel of experts, duly appointed by the College. These experts review the evidence and judgmentally determine which elements have been adequately shown to be useful in managing cancer patients and belong in every report.”

The committees are also reviewing the definition of “synoptic reporting,” which is a reporting format that the American College of Surgeons Commission on Cancer advocates, and plan to clarify its meaning later this year.

Dr. Hill is cautiously optimistic that much of the concern about the protocols will subside after a period of adjustment. “Most of the reactions are to the sudden change in the length and the number of protocols that came out,” she says. In response to previous versions of the protocols, pathologists expressed concerns that were allayed as they got used to the new format. “I’m sure the same thing will happen this time. There are just a great deal more protocols to manage.”

Pathologists need not feel daunted by protocols that appear lengthy, she adds. “Whenever there are asterisked items, pathologists should view them not as more requirements, but as ways to further enhance their reports and offer clinicians, more or less, the information they need.”

Dr. Hill envisions a continuing international consensus on how cancer should be reported. “I see a firm trend. The CAP protocols are being viewed as a more standard way of reporting, and with time, more and more countries will go with the CAP protocols.”

As part of the next round of reviews leading to a new release of protocols, Dr. Val­enstein says the committees will actively consider the opinions of anyone who has submitted suggestions. “We’re going to try to encourage feedback. The College is special in that it’s a network of users more than a top-down, formally structured delegation of authority. So we get a tremendous amount from our practitioners, and we want to enhance that capability. Cultivating our network of users will go a long way toward improving the cancer protocols as they evolve in future versions.”

Guidelines for reporting molecular testing have yet to be determined, Dr. Hussong notes. “If there are specific molecular tests that are either important for diagnosis or maybe prognosis or treatment, we want to be sure they are mentioned or required in the protocol so they get reported to clinicians. There’s still some controversy as to whether or not they should be part of the protocol as a required element or just be referred to in the protocol as something to be reported separately.”

The protocols have always allowed individual pathologists to put any of the data elements in any part of the pathology report, including the diagnostic field, microscopic field, or gross description field, he says. “It had never been a requirement that you had to report them in a specific way or specific style in the past. We just provide some guidelines, through a checklist, of a suggested way to put them all together.”

Evidence indicates that reporting these elements in a synoptic style will more often generate a more complete pathology report, or, at the very least, that items won’t be inadvertently left out, he says. “That is still controversial. Not everybody’s buying into that all across the country, but at least that’s what one study has shown.”

“Part of the struggle we have,” Dr. Hussong continues, “is that everybody practices in a different environment, and there are so many different information systems that it’s not always easy to incorporate changes to the protocols on the individual pathologist’s practice basis. And it’s certainly not easy to do it quickly.”

On the upside, the response from oncologists and surgeons has been uniformly positive, Dr. Hussong says. “Everything I’ve heard from clinicians is that they love the protocols. I have heard absolutely nothing negative from them either personally or thirdhand being reported back to CAP. If anything, they applaud these protocols because they [the protocols] allow them to really get the pathology report complete in their mind.”

The protocols will always be a “work in progress,” Dr. Hussong adds. “There will always be a need to make adjustments as we learn more and as we get feedback from the CAP constituency and the pathology community as a whole.”

But it’s a process that cannot be done randomly. “It takes 140 or 150 pathologists across the country who, over a period of two or three years, work to produce these protocols, and it’s not something you can just quickly do again,” he says. People start using the protocols and implementing them, and then if you make changes, suddenly they never know what to do or what version should be used. If there are glaring errors, we need to identify and publish them, then put them on the Web site. But, in my opinion, we should not publish the protocols and then tweak them every couple of months.”

Bibliography

1. Amin MB. The 2009 version of the cancer protocols of the College of American Pathologists. Arch Pathol Lab Med. 2010; 134:326–330.

2. Srigley J, McGowen T, Maclean A, et al. Standardized synoptic cancer pathology reporting: a population-based approach. J Surg Oncol. 2009;99:517–524.