Data Element
AJCC M Category
Description

For both Clinical (cM) and Pathological (pM) the M Category is defined as the absence or presence of distant metastases in sites and/or organs outside the local tumor area and regional nodes as defined for each cancer site. For some cancer sites, the location and volume or burden of distant metastases are included. Distant Metastasis (M) Categories: The distant metastasis category specifies whether distant metastasis is present. M0 No evidence of distant metastasis M1 Distant metastasis
Submitted By: Martin Madera / American College of Surgeons
Data Element Information
Use Case Description(s)
Use Case Description Level 2

The Stage, or extent, of cancer at the time of diagnosis is a key factor that defines prognosis and is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar Stage. In addition, Stage often is a key component of inclusion, exclusion, and stratification criteria for clinical trials. Accurate staging is necessary to evaluate the results of treatments and clinical trials, to facilitate the exchange and comparison of information across treatment centers and within and between cancer-specific registries, and to serve as a basis for clinical and translational cancer research. At the national and international levels, a cohesive approach to the classification of cancer provides a method of clearly conveying clinical experience to others without ambiguity.
Cancer treatment requires assessment of the extent and behavior of the tumor and patient-related factors. The most clinically useful staging system is the tumor, node, and metastasis (T,N,M) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC), herein referred to as the AJCC Cancer Staging System
In the United States, 1,701,315 new cancer cases were reported last year. Every time a patient is diagnosed with cancer, the clinician should provide the T, N, M and Stage to the patient and document it in the medical record for reporting purposes.
The AJCC data elements are currently used in over 1,500 Commission on Cancer (CoC) accredited hospitals where the information is used with accreditation standards, quality measures, and reported to the National Cancer Database (NCDB). Electronic Health Records (EHR) systems used in these hospitals play a critical role. The EHR systems in these hospitals allow physicians to record the T,N,M and Stage of their patients at the point of care. The Stage is used to communicate the prognosis and discuss treatment plans with the patient. This information goes directly to the cancer registries for state and federal reporting. The EHR vendor community is an important stakeholder with whom the AJCC has formed strong relationships to ensure accurate staging content is provided to the clinicians treating patients. Working together, the AJCC and the EHR vendors continue to improve the capture and exchange of the information across providers and systems.
Estimate the breadth of applicability of the use case(s) for this data element The data elements of the AJCC Cancer Staging System are currently used by a broad range of stakeholders that encompass physicians, patients, registries and researchers. The AJCC is comprised of twenty-two (22) member organizations across oncology. The AJCC data elements and cancer staging play a vital role for each of these organizations.
• American Association of Pathologists' Assistants
• American Cancer Society
• American College of Physicians
• American College of Radiology
• American College of Surgeons
• American Head and Neck Society
• American Society for Radiation Oncology
• American Society of Clinical Oncology
• American Society of Colon and Rectal Surgeons
• American Urological Association
• Canadian Partnership Against Cancer
• Centers for Disease Control and Prevention
• College of American Pathologists
• International Collaboration on Cancer Reporting
• National Cancer Database
• National Cancer Institute
• National Cancer Registrars Association
• National Comprehensive Cancer Network
• North American Association of Central Cancer Registries
• Society of Gynecologic Oncology
• Society of Surgical Oncology
• Society of Urologic Oncology

https://cancerstaging.org/About/membership/Pages/membership.aspx

Additionally, the AJCC works with all the EHR systems involved in oncology to license AJCC content and ensure the most accurate and up to date information is being presented to the physicians at the point of care. The AJCC works closely with over thirty (30) licensees, providing both content and technical support in an effort to ensure every physician is presented with the most accurate and up to date AJCC content.
Link to use case project page https://cancerstaging.org/About/membership/Pages/membership.aspx
Use Case Description Cancer comprises a large set of nationally reportable diseases. The Cancer Registries Amendment Act {Public Law 102-515} established national data collection in 1992. Hospitals, physicians, practitioners, and other healthcare facilities are required by state or jurisdictional laws to report newly diagnosed cancer cases to population-based cancer registries, which are active in every U.S. state, the District of Columbia, Puerto Rico, the Virgin Islands, and the U.S. Pacific Island jurisdictions.
Data collection and transmission on new cancer cases are required by law from all providers [e.g., hospitals (>6000), outpatient physicians, radiation therapy facilities (>2000), and laboratories into state cancer registries (CCRs)] and ultimately, into Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR) (supports 50 CCRs) and the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program (supports 20 CCRs). Additionally, more than 1,500 hospitals across the United States are accredited by the Commission on Cancer (CoC) and report T,N, M and Stage to the National Cancer Database (NCDB) where approximately 70% cancer cases in the U.S. are captured.
Estimate the breadth of applicability of the use case(s) for this data element An estimate of all the stakeholders who capture, access, and exchange the AJCC stage data elements is difficult to quantify because of the ubiquity of the T,N,M and Stage across clinical care and research in cancer.
These data elements are captured and exchanged everyday as new cancer patients are diagnosed and clinicians manage the care of existing patients. In parallel, clinical trials and epidemiological studies are utilizing these data elements in critical research efforts. For example, the U.S. Cancer Statistics data is used by researchers, policy makers, patient advocates and academics interested in cancer.
With several stakeholders using the AJCC data elements in different ways it is easy to underestimate the number of individuals using the information. However, knowing that there are 1.7 million new cancers every year, and recognizing most patients see multiple physicians over their course of care, and accepting that every cancer case is required to be reported through state cancer registries, it would be reasonable to assume the AJCC data elements are used by up to 2 million stakeholders each year.
Link to use case project page https://www.cdc.gov/cancer/uscs/index.htm https://www.cdc.gov/cancer/npcr/index.htm https://seer.cancer.gov/ http://datadictionary.naaccr.org/default.aspx?Version=21 https://www.facs.org/quality-programs/cancer/coc
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published.
However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

https://www.nlm.nih.gov/healthit/snomedct/us_edition.html https://vsac.nlm.nih.gov/
Additional Specifications There are multiple technical specifications and implementation guides using the AJCC data elements referenced below.
o IHE Quality Research and Public Health: Structured Data Capture Technical Framework [Internet], 2016. http://ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf
o Moldwin R (ed): IHE Structured Data Capture (SDC)Technical Reference Guide (TRG) [Internet], 2020. https://github.com/IHE-SDC-WG/SDC-Schema-Packages/blob/master/Documentation/CAP SDC Technical Reference Guide_v0.42 (Feb 2020).pdf
o HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment 2) http://hl7.org/fhir/us/breastcancer/2018Sep/
o HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1 (v1.0.0: STU 1) based on FHIR R4 http://hl7.org/fhir/us/mcode/ValueSet-mcode-tnm-primary-tumor-category-vs.xml.html
o College of American Pathologists (CAP) eCC (electronic Cancer Checklists) https://www.cap.org/laboratory-improvement/proficiency-testing/cap-ecc
o North American Association of Central Cancer Registries Version 21 Data Standards and Data Dictionary (http://datadictionary.naaccr.org/default.aspx?c=10&Version=21)
o Pathology Laboratory Electronic Reporting, Version 5.0 – May 2020 (revised July 2020). https://www.naaccr.org/wp-content/uploads/2020/07/NAACCR-Vol-V_Revised_20200720.pdf
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems.
The AJCC data elements of this submission have been used at scale across several different EHR environments for more than a decade. Every year, the AJCC data elements on over 1.7 million newly diagnosis cancers are sent between patient care facilities throughout cancer patients’ treatment. Staff at health care facilities abstract data from patients’ medical records, enter it into the facility’s own cancer registry and then sends the data to the state cancer registry. Other data sources include physicians’ offices, radiation facilities, freestanding surgical centers, and pathology laboratories.
All EHR/HIT systems that capture and exchange cancer information have an existing paid license agreement to use the AJCC data elements in their production environments. There are approximately thirty (30) EHR systems using AJCC Data Elements. A complete list can be provided if needed.

The only place where use of the AJCC data elements’ transmission has been standardized is through the cancer registries (CDC, NCI, CoC/NCDB) where the NAACCR Data Standards are used.

Cancer Registries using AJCC Data Elements in Standardized Format
National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program (NCI-SEER) https://seer.cancer.gov/about/overview.html
Centers for Disease Control and Prevention National Program of Cancer Registries (CDC-NPCR) https://www.cdc.gov/cancer/npcr/index.htm
Commission on Cancer (CoC) https://www.facs.org/quality-programs/cancer/coc
National Cancer Data Base (NCDB) https://www.facs.org/quality%20programs/cancer/ncdb
North American Association of Central Cancer Registries (NAACCR) Version 21 Data Standards and Data Dictionary (http://datadictionary.naaccr.org/default.aspx?c=10&Version=21)

Laboratory Information Systems
The College of American Pathologists (CAP) electronic Cancer Checklists (eCCs) are computer-readable templates for the capture of consistent and complete sets of cancer pathology data elements, including the AJCC data elements, in EHR and AP-LIS systems. The eCC XML templates are supported by all major vendors of anatomic pathology software systems. Each eCC template is based on a case summary (checklist) inside a CAP Cancer Protocol. Since their first eCC XML release in 2009, eCC use has increased to include 35-40% of North American anatomic pathologists and continues to grow.
https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates/cancer-protocol-and-ecc-faqs
https://seer.cancer.gov/about/overview.html https://www.cdc.gov/cancer/npcr/index.htm https://www.facs.org/quality-programs/cancer/coc https://www.facs.org/quality%20programs/cancer/ncdb http://datadictionary.naaccr.org/default.aspx?c=10&Version=21
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Level 2 – exchanged between four (4) or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to next draft version.
Data on over 1.7 million newly diagnosis cancers are sent from patient care facilities including medical centers, hospitals, physicians’ offices, radiation facilities, freestanding surgical centers, and pathology laboratories. Data from these facilities are frequently exchanged from their EHR/LIS systems to state cancer registries.
71 Certified EHR Technology (CEHRT) products certified to 2014 Edition and 288 products certified to 2015 Edition for cancer registry reporting, both of which include the AJCC data elements, thereby demonstrating their ability to exchange these elements with external organizations.
Future Exchange
The current state of adoption and exchange of the AJCC data elements is quite mature as demonstrated with the previous supporting artifacts. However, there remains potential for improvement, particularly in standardization of future exchange of the AJCC data elements.
There are existing interoperability standards like Structured Data Capture (SDC) and Fast Healthcare Interoperability Resources (FHIR) that are poised to make significant advances in cancer care and interoperability if these already collected and exchanged AJCC data elements were to be added to USCDI ONDEC. This would allow for the adoption of a standardized representation of the AJCC data elements and enable standardized exchange across EHR systems and into state cancer registries. This would reduce the burden on EHR systems who are currently managing and maintaining AJCC data elements independently. It would also reduce the burden on the hospital and state registries who manually abstract the AJCC data elements from the record. Adding the AJCC data elements to USCDI ONDEC and making them available from an authoritative repository like the National Library of Medicine’s VSAC, would make a significant impact on interoperable health information exchange and cancer care.

https://github.com/IHE-SDC-WG/SDC-Schema-Packages/blob/master/Documentation/CAP SDC Technical Reference Guide_v0.42 (Feb 2020).pdf https://vsac.nlm.nih.gov/
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) The AJCC Cancer Staging System has been ubiquitous in cancer care in the U.S. for over forty years and the T,N,M and Stage group have been a standard in cancer care since that time. The AJCC data elements are the Intellectual Property of the American College of Surgeons, but there is a willingness to make these codes available through the National Library of Medicine’s Value Set Authority Center (VSAC ) if it will contribute to improving interoperability.
There is clear consensus about how these data elements are represented, and they have been exchanged across providers and medical centers even prior to the wide adoption of EHR systems in care settings.
Restrictions on Use (e.g. licensing, user fees) Using the AJCC Cancer Staging System data elements as defined previously (T,N,M, Stage Group) would not be restricted. There would be no fee for the use of these data elements. However, the Criteria of each of these Categories (T,N, M) are distinct to each disease site, and that would continue to be maintained and licensed separately. Similarly, the logic used in each disease site to combine Categories to determine the correct Stage Group would continue to be maintained and licensed separately. This would keep consistent with the current arrangement with EHR systems who pay a license fee to access the licensed AJCC content.
However, if the AJCC data elements were included in the USCDI ONDEC and available through VSAC, the EHR systems would benefit from having the AJCC data elements available and accessible in a manner that better enables exchange of this information across systems.

Privacy and Security Concerns None.
Estimate of Overall Burden A low level of burden is estimated based on the fact that AJCC T,N, M and Stage Group are already widely implemented in nearly all electronic health record systems and all cancer registry systems. Providers who diagnose or treat patients with cancer already document the AJCC data elements in the EHR, but not always in a structured format.
With adoption and use of the AJCC data elements already pervasive across cancer care, the challenge that remains is achieving a consensus on how to exchange the data elements in a standardized format.
This is a challenge shared by all the EHR systems, but there is also a mutual benefit for them to achieve consensus on standardized exchange of AJCC data elements. It will reduce their development burden and enable a more frictionless exchange of these data elements across systems. It will greatly reduce the time developers spend maintaining these data elements, and the related metadata, within internal code. Instead, the EHR systems will be able to reference an external repository as a single source of truth where these data elements/value sets are maintained along with the appropriate documentation. This will enable AJCC data elements to be automatically retrieved by the system in a production environment.
Other Implementation Challenges No other challenges to implementation are know at this time.

Comment

Submitted by AJCCancer on

Important update to AJCC USCDI ONDEC submission

The American Joint Committee on Cancer (AJCC) would like to provide an important update on the Cancer Staging (AJCC TNM), AJCC T Category, AJCC N Category, AJCC M Category, and AJCC Stage Group data elements originally submitted to USCDI ONDEC on October 23, 2020.   The AJCC requests that the USCDI reviewers reconsider the Classification Level of the AJCC data elements based on the recent development of a license agreement that will make the AJCC data elements accessible from the SNOMED CT terminology.  The AJCC feels that the availability of the AJCC data elements in a standard terminology that is freely available and in wide use significantly strengthens the original submission and demonstrates previous challenges have been addressed. The American College of Surgeons and SNOMED International entered into a license agreement to allow AJCC data elements to be included in the SNOMED CT terminology.  Provided below are links to the announcements from both organizations.

The original and full comment from the AJCC is linked here: https://www.healthit.gov/isa/uscdi-data/cancer-staging-ajcc-tnm

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