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- 1. foundation.cap.org Introduction to theCAP Cancer Protocols June 7, 2023 7:00 am (CDT)
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- 3. Our MISSION isto improve people’s health by: • Developing tomorrow’s pathology leaders through awards for advanced training, research and education. • Mobilizing pathologists to expand health equity in medically underserved communities within the US and globally. Our VISION is to • Support all pathologists to be leaders in their communities and at the forefront of patient- centered care. Mission & Vision of the CAP Foundation
- 4. CAP Cancer Protocols JosephKhoury, MD, FCAP University of Nebraska Medical Center Stokes-Shackleford Professor and Chair, Department of Pathology and Microbiology Chair, CAP Cancer Committee
- 5. • Synoptic dataentry tools aimed at improving the quality of cancer reporting • Clinically relevant evidence-based data elements drawn from standard-setting sources (WHO and AJCC) • Applicable to academic and non-academic pathology practices • Partnerships on data harmonization CAP Cancer Protocols
- 6. Structured Data Reporting PathologyReport Biomarker Data Structured Synoptic Data CAP Cancer Committee Tumor Registries SEER NCI Decision Support Cancer Care Team AJCC WHO ASCO
- 7. Rigorous Content Optimization CAPCancer Committee Expert Panel Resource Cmtes House of Delegates Public Input Structured Synoptic Data
- 8. Breast Hematolymphoid GI PediatricsGU Head & Neck Endocrine Bone & Soft Tissue Skin PERT WHO AJCC NACCR NCI/SEER ASCO - Community pathology - Outbound liaisons - ACS/CoC - ICCR - WHO - PERT
- 9. • 98 CAPCancer Protocols • 89 electronic Cancer Checklist (eCC) Case Summaries • 11 Biomarker Templates • Utilized in pathology reporting by providing standard question and answer sets • Explanatory Notes and References • Compilation of standards • AJCC • WHO Blue Books • FIGO • Collaborative Staging • CAP/ASCO Center Guidelines • Inclusion of core data elements in pathology cancer reporting mandated for accreditation by ACoS- CoC & CAP LAP (for resection specimens only) • Quarterly scheduled releases 9 CAP Cancer Protocols
- 10. Development of CancerProtocols Uma Krishnamurti, MD, PhD, FCAP Yale University Associate Professor, Department of Pathology Director of Breast Pathology Member, CAP Foundation Global Pathology Workgroup Member, CAP Cancer Committee
- 11. • The CancerCommittee has pathologists with subspecialty expertise • Primary authors are responsible for the scientific content of the protocols in a specific pathology subspecialty • The authors work closely with the cancer committee staff members for the final protocol output (Committee Advisor, Clinical Product Manager & Clinical Quality Manager of Cancer Protocols and Data Standards) CAP Cancer Committee
- 12. • Pathologists regularlyreview and update the protocol checklists • Where required new protocols are created such as the “Protocol for the Examination of Resection Specimens From Patients with Phyllodes Tumor of the Breast” was first posted in March 2022 (designated as Version: 1.0.0.0) CAP Cancer Committee
- 13. • On thewebsite, the protocols are arranged by Organ systems. • https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates CAP Cancer Protocol Templates
- 14. CAP Cancer ProtocolTemplates
- 15. First page of the Cancerprotocol Major change, significant revision, moderate revision, minor revision
- 16. • Second pageAccreditation requirements are given which entails “Synoptic reporting” “Synoptic reporting” is described in detail • Third page gives the Summary of changes in the latest version of the protocol • Reporting template follows standards set by AJCC and WHO • Explanatory notes for each reporting section
- 17. • Core dataelements • These are required in reports to adequately describe appropriate malignancies. • For accreditation purposes, core data elements must be reported in all instances, even if the response is “not applicable” or “cannot be determined.” • Conditional data elements • These are only required to be reported if applicable as delineated in the protocol. For instance, the total number of lymph nodes examined must be reported only if nodes are present in the specimen. • Optional data elements are identified with “+” and although not required for CAP accreditation purposes, they may be considered for reporting as determined by local practice standards. CAP Cancer Protocol Elements
- 18. • For uniformityand ease of use, for most anatomic sites the data elements (DE) are in specific order with section headings that are capitalized. • The main Cancer protocol template headings are: • SPECIMEN (Type of surgical procedure performed on which the cancer is being reported) • TUMOR • MARGINS • REGIONAL LYMPH NODES • DISTANT METASTASIS • pTNM CLASSIFICATION (latest AJCC Edition) • ADDITIONAL FINDINGS • SPECIAL STUDIES Order of Data Elements in the Cancer synoptic
- 19. • TUMOR + Tumorsite Histologic type Histologic grade Tumor size + Tumor focality Ductal carcinoma in situ Tumor extent Lymphatic and / or Vascular Invasion +Dermal Lymphatic and / or Vascular Invasion +Microcalcifications Treatment effect Data Elements within a section heading for e.g., Invasive breast
- 20. Subheadings with aCore Heading maybe Core or optional TUMOR Lymphatic and / or Vascular Invasion (Note I) ___ Not identified ___ Present +___ Focal (LVI in one block only) +___ Extensive (LVI in two or more blocks) ___ Cannot be determined: _________________ Subheadings within a Core Data element
- 21. Wherever needed clarifyingtext is given to guide pathologist in filling the data element. In addition, pathologist can refer to the appropriate explanatory notes Notes within the reporting section
- 22. Custom Web basedtool to help streamline process for review and rollout of Cancer and electronic Cancer Protocols (eCP) Allows for authors to edit, collaborate, save, and produce the CAP Cancer Protocols within a web-based tool Both CAP Cancer Protocols and eCP will be created from a single database, thus removing the issue of discrepancies between the paper protocols and eCP Single Source Product (SSP) Author Draft to Data Entry by End-User
- 23. 31 May 2023 CAPCancer Protocol Release Process
- 24. • To testthe electronic version, several mock cases are entered and tested in an electronic platform (mTuitive) to ensure that all data elements (core, conditional, and optional) function as expected and that the TNM category output is accurate. • Cancer Protocols & Data Standards team publishes protocol to the CAP website and licensed eCP users • Pathologist users can reach out anytime to the CAP and/or protocol authors with comments and questions related to the protocol. Steps before releasing a cancer protocol
- 25. Authoring, modeling, andQA takes up a lot of time. • Primary author spends at least ~20 hours making major revisions on an existing protocol and working with CAP staff to go over modeling and editing metadata for electronic versions of the protocol • The CAP staff spends about 160-180 man-hours per protocol for major revisions and 270-300 man-hours for a new protocol. Steps before releasing a cancer protocol
- 26. Value of theCancer Protocols Lara R. Harik, MD, FCAP Associate Professor, Emory University School of Medicine Medical Director, Clinical Laboratories Hospital Service Line Vice Chair, CAP Cancer Committee Member, CAP Foundation Global Pathology Workgroup
- 27. Value Free resource Follow standardsby WHO/ AJCC Standardization of Reporting Explanatory notes
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- 30. • World HealthOrganization (WHO) • American Joint Committee on Cancer Staging * Cancer Protocols are updated following updates of WHO or AJCC 2. Our Guiding Standards
- 31. Cancer Protocols ensure standardpatient care reporting • Resection Specimens • Elements extracted from gross and microscopic H&E • Core elements are mandatory and clinically important • They are NOT research elements 3. Standardization of Information
- 32. • Type ofresection • Histologic subtype • Tumor Grade • Tumor extent • Margins • Lymph nodes • pTNM staging Diagnostic Prognostic Therapeutic 3. Standardization of information: Core elements (mandatory)
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- 38. Value Free resource Follow standardsby WHO/ AJCC Standardization of reporting Explanatory notes
- 39. Follow the latestWHO and AJCC updates Ensure consistent reporting Prevent omission of clinically relevant data Cancer Protocols
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