Pilot points way to speedier
  cancer surveillance

February 2005
Feature Story

Building a timely, more accurate national cancer surveillance system requires you to think big and then beat the devil in the details to make it happen.

A pilot project now winding up in Ohio and California and funded by the Centers for Disease Control and Prevention’s National Program of Cancer Registries aims to do both. The project’s ultimate vision is a real-time, standardized way for pathologists to report cancer cases to cancer registries using a computerized program that incorporates the CAP’s cancer checklists. The checklists are encoded with concepts from the CAP’s Systematized Nomenclature of Medicine Clinical Terms, or SNOMED CT, which provides a common language for capturing, sharing, and aggregating health data.

But the CDC-NPCR pilot, "Reporting of Pathology Protocols for Colon and Rectum Cancers," is also laying the intricate groundwork for turning that cyber idea into standard practice. Launched in 2001, the pilot was nearing completion at CAP TODAY press time and moving into its final phase. A second project will focus on reporting melanomas as well as breast and prostate cancers.

Both phases of the CDC-NPCR pilot project make use of the SNOMED-CT-encoded CAP cancer checklists. The CAP Cancer Committee first published the cancer protocols (the checklists are the short forms of the protocols) in the 1990s, and have updated them since, to aid surgical pathologists in reporting malignant tumor specimens completely, accurately, and uniformly. Using the CAP protocols standardizes the content of reports, and encoding with SNOMED CT standardizes the meaning.

"If everyone used the format [developed in the pilot] for reporting and transmitting data, we would be able to process cancer cases more quickly, and potentially see causes of cancers in real time," says Ken Gerlach, MPH, CTR, a CDC health scientist and the project officer for the pilot.

Epidemiologists could hone in more quickly on geographical cancer clusters to search for underlying causes of certain cancers. Some experts say such a standardized reporting system could have potentially hastened discovery of the link between human papillomavirus and cervical cancer—or identified geographical clusters of Kaposi’s sarcoma and lymphoma associated with HIV infection.

Using a more real-time surveillance system, researchers could more quickly contact patients with life-threatening cancers to participate in clinical trials. And the improved accuracy of the reporting system would make it possible for researchers to compare the exact type of cancers to incidence, survival statistics, and outcomes to identify best practices in prevention and treatment.

The CDC-NPCR pilot project’s approach circumvents the need for cancer registrars to pore over narrative pathology reports to extract and encode information about a patient’s cancer, as they now often do to enter cases into their databases. The paper review slows the cancer data stream and leaves room for errors in translation. "When you use narrative reports alone, some of the information can be ambiguous," says Bette Smith, BTM, RHIT, CTR, program manager for the Ohio cancer registry.

What’s more, hospitals and laboratories report cancer using a hodgepodge of software programs, including homegrown versions, which have varying data specifications and capabilities.

By contrast, the two anatomic pathology laboratories participating in the pilot—University Hospitals of Cleveland/Case Western Reserve University in Ohio and the University of California Irvine Medical Center—report cases of colon and rectal cancer on a trial basis to the state cancer registries using computerized synoptic checklists encoded with SNOMED CT.

"The pathologist toggles through a data entry screen and checks off the appropriate items to describe a case of colorectal cancer," the CDC’s Gerlach says. The report also includes a narrative clinical history and miscellaneous text report, which pathologists can enter themselves or dictate and have someone else enter, says Joseph Willis, MD, associate professor of pathology and oncology for the University Hospitals of Cleveland/Case Western Reserve University.

The software program automatically links each data element in the synoptic checklist to a SNOMED CT code, a process that’s invisible to the pathologist completing the cancer checklist. "Pathologists and clinicians don’t go around talking in SNOMED codes where they say this patient has an MA302 or whatever. They use medical terminology," Dr. Willis notes.

But the SNOMED CT coding ensures the pathologist’s examination of a colorectal cancer is reported to the state central cancer registry in a standardized nomenclature. The cases, after they’re consolidated and identifications are removed, will be transmitted to the CDC-NPCR and the National Cancer Institute’s Surveillance, Epidemiology, and End-Results, or SEER, program.

"SNOMED goes into depth, so that for every cell type on this checklist the pathologist reads there is a term universally used and equivalent to the World Health Organization’s code list," or ICD-O-3, says Barry Gordon, PhD, director of C/Net Solutions, the maker of cancer registry software used by the California cancer registries (and the University of California Irvine in this pilot) and part of the nonprofit Public Health Institute.

The computerized synoptic format improves the accuracy and completeness of the colorectal cancer report to the state cancer registry. For one, Dr. Willis says, the software is a definition-driven process, with the definitions for the fields embedded in the software. And the pathologist can’t sign off on the report without completing all of the fields. For example, "the pathologist cannot omit certain tumor features required in routine reporting, such as circumferential margins on rectal cancers, which tell if the surgeon excised the tumor completely," he says.

University Hospitals of Cleveland uses Cerner Corp.’s CoPathPlus system with Synoptic Reporting to enter and transmit the SNOMED-encoded colorectal cancer checklists to Rocky Mountain Cancer Data System, a nonprofit cancer registry software vendor in Salt Lake City serving 22 state cancer registries. Rocky Mountain translates them into NAACCR format (North American Association of Central Cancer Registries) before transmitting them to the Ohio registry.

Cancer registries are excited by the work being done in the pilot. "They see the potential for efficiencies and data accuracy in terms of bringing in the cases and prepopulating the cancer surveillance report," Dr. Gordon says. "The data forms some of the core data for reporting a case." (Cancer registrars would still have to review the medical record for information about the diagnostic workup and treatment to complete the report on a patient’s cancer.)

Others see different but equally promising potential. Fritz Lin, MD, director of surgical pathology and cytopathology at the University of California at Irvine Medical Center, says the synoptic reporting would make it possible for pathologists to retrieve and survey cases and conduct operational research targeting colorectal cancers. "If someone wants to do molecular genetic studies, for example, they could retrieve the blocks and have all the information available about the tumor on the synoptic report," he says.

Yet developing a more real-time, standardized electronic cancer reporting system is more than a mouse click away, as the pilot study participants realized at the project’s outset.

"The major challenge involves translating a paper document, developed initially as a guide for pathologists to report malignant tumors, into machine-readable codes that can be transferred" to state cancer registries, says Kathleen Davidson-Allen, a quality control specialist at the California Cancer Registry.

The CDC-NPCR project brings to the table the various players in pathology, public health, cancer surveillance, and information technology needed to figure out how to pull off that feat. Says C/Net’s Dr. Gordon: "Half of the pilot project has involved defining standards for messages so that other vendors that want to implement synoptic reporting will have a clear guide. As people get excited about this type of system, we don’t want vendors to develop incompatible products, which means we will go back to being the Tower of Babel."

The most difficult part of the project was combining the expertise of the CDC, the Ohio and California cancer registries and their software vendors, the CAP’s Cancer Committee and the CAP’s Division of SNOMED International (the latter maintains SNOMED CT), and the two anatomic pathology labs that are transmitting the data for the pilot.

"The group had to look at the way data are coded and how to standardize information in a way that could be used for computerized functions," says Georgette Haydu, administrative manager for the Ohio cancer registry. "Although that required a lot of work and cooperation, it was great to watch people from different fields unite and come up with a ’programmable’ pathology reporting checklist."

To standardize data submission and transmission, the pilot participants chose to use Logical Observation Identifiers Names and Codes, or LOINC, as the codes for the questions or metadata, and the CAP’s SNOMED CT codes for the answers (or data items) to the questions on the three CAP colon and rectal cancer checklists. The pathology synoptic reports are thus encoded with LOINC and SNOMED CT codes and transmitted using Health Level 7, version 2.3.14. HL7 is an information exchange protocol used in health care and by the CDC’s Public Health Information Network for reporting other diseases.

Though the pilot study had a couple of months to go at press time, the Ohio and California cancer registries already had preliminary results that will help fine-tune the process for phase two of the pilot.

For one, they found they could exchange computerized text messages using the standardized format, which was a key goal of the project.

The pilot involves a retrospective examination of existing narrative pathology reports generated by the laboratories involved in the project to see if pathologists in those labs routinely gather enough information to complete the CAP colorectal checklists. "The goal," Dr. Gordon says, "is to look at how much the labs would have to change their operations to use the synoptic reporting, since this is a study about making pathology reports more efficient to use by cancer registries." Based on a review of 50 narrative reports, they found they could code what’s needed for the synoptic reports— "96 percent of the required data items were completed," he says.

In performing the retrospective review, the California Cancer Registry also found a few items in the software program’s colorectal cancer protocol data set that could not have been captured by looking solely at the narrative, Dr. Gordon adds. "That means having to complete the synoptic report is good for encouraging complete compliance with the CAP checklist."

The Ohio cancer registry is having two different cancer registrars abstract data from the narrative reports at University Hospitals of Cleveland to compare to reports coming in the synoptic form in the pilot project. "While the analysis isn’t yet complete, it has thus far shown the synoptic reporting system to be very accurate," Smith says.

To help anatomic pathology laboratory information system vendors use the pilot project’s blueprint, the pilot participants are preparing a report that describes the project, including its method, evaluation, and conclusions. "The report will also include tables and appendices related to actual message and transport—or how we packaged the data—so other people can use it as they develop these kinds of projects," says CDC’s Gerlach. "Other people in the anatomic pathology and cancer registry community will be able to access the findings of our pilot project."

The CDC-NPCR has started preliminary work on phase two of the project, using CAP checklists for breast and prostate cancers and melanoma, which will employ the same LOINC, SNOMED CT, and HL7 combination for encoding and transmitting cancer cases to state cancer registries in California, Maine, and Pennsylvania.

"The second phase of the CDC-funded project will be good because it covers more reportable cancers at major common anatomical sites," Dr. Gordon says. "And melanoma is a problematic cancer site because specimens and diagnoses are handled by so many settings—big and small labs, physician offices, out-of-state labs, etc." It’s also staged differently than other cancers, he adds. The CAP’s SNOMED division will be involved in the project.

Adopting the findings of the pilot project will be voluntary for hospitals and laboratories reporting cancer. "There won’t be a federal mandate for people to report cancer using this approach," says Gerlach, "but to be accredited by the American College of Surgeons’ Commission on Cancer, a hospital or cancer center has to use the essential data elements of the CAP cancer protocols." Taking the reporting to the next step using the synoptic form of the cancer protocols, he says, "isn’t a major leap if organizations take advantage of the groundwork laid by the pilot projects."

Problems remain in terms of finding a way to report in situ cancers and benign brain tumors, which cancer registries are required to do. "The CAP checklists are for invasive carcinomas only," says the California Cancer Registry’s Davidson-Allen. "And while the CAP breast checklist does list some in situ histologies, those would have to be in conjunction with invasive tumors since the checklist applies only to invasive carcinomas." In that respect, another mechanism would be needed to identify in situ cancers. "But that’s part of the evolution of the CAP cancer checklists," she says.

Dr. Willis of University Hospitals of Cleveland agrees the CAP checklists are a work in progress. For example, he sees no reason why the checklists won’t evolve over time to include additional information about tumor characteristics, such as molecular processes and other prognostic markers. "The checklists can be expanded in terms of information collected without having to invent a new system for synoptic reporting and data transmission," he says.

As for predictions about how long it might take to get a real-time national public health surveillance system in place, the CDC’s Gerlach believes that could occur "within years" as opposed to decades.

"President Bush is talking about the importance of the electronic health record as a national priority," Gerlach says. "And as we move in that direction, we’ll see more electronic reporting in all areas, including pathology."

Karen Lusky is a writer in Brentwood, Tenn.