Background

Objective

Scope

Audience

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Pathology reports specific to cancer diagnosis and prognosis are increasingly done in structured, specifically synoptic, form.  These synoptic reports adhere to established guidelines and protocols set by national and international societies of pathology, national cancer registries and other similar bodies of authority.  These organizations include the College of American Pathologists, the Royal College of Pathology, the Royal College of Pathology Australasia, PALGA, the International Collaboration for Cancer Reporting and others.  The reporting protocols, also referred to as data sets, are highly concordant between each protocol publishing entity.  There is a need to represent the data elements contained within a cancer synoptic report in both a humanly readable format as well as in a computable, machine readable form.  Computable data elements can be stored within an electronic health record to support clinical care, electronically send to cancer registries for public health use, and are more readily used for clinical translational use.  Prior to 2020, the SNOMED CT content available for use in cancer synoptic reporting was either not available or ambiguous in nature.  In fact, the US Centers for Disease Control and Prevention (CDC) studied the use of SNOMED CT for use in cancer registry reporting in 2005 and again in 2009.  The findings of these CDC studies indicated that neither SNOMED CT nor LOINC had  concepts with sufficient definition to render cancer data unambiguously encoded and fit for use for cancer reporting or cancer data representation.  With the increased use and requirement for structured pathology reporting and the noted deficiency in SNOMED CT content, the Cancer Synoptic Reporting Working Group (CSRWG) was formed in 2020 with the explicit objective to create the SNOMED CT concepts necessary and sufficient for use in structured pathology reports and support the clinical, public health and research uses of these data.  More specifically, the objective of the CSRWG was to create the necessary SNOMED CT content for use in structured reporting for all solid tumor protocols, including pediatric protocols, published by the aforementioned bodies.

Objective

The objective of this implementation guide is to provide instruction and guidance regarding the SNOMED CT content produced by the CSRWG.  The guide provides instruction on implementing SNOMED CT for use in cancer synoptic reporting.  After review of this guide, the reader will have knowledge to implement SNOMED CT encoded cancer synoptic reports for use in the electronic health record, for electronic transmission and for use in analytics.

Scope

The scope of the Cancer Synoptic Reporting Working Group (CSRWG) was specific to the creation of SNOMED CT necessary to unambiguously represent the data elements required for cancer reporting for all solid tumors, adult and pediatric, as published by the College of American Pathologists (CAP) and the International Collaboration on Cancer Reporting (ICCR).    The ICCR is supported by the CAP, RCPath, and RCPA as well as other societies of pathology.   As a result, data sets produced by the Royal College of Pathology (RCPath) and the Royal College of Pathology Australasia (RCPA) were also used as references for this work.   Data sets produced by the ICCR are open source and are now the foundation for the data sets used throughout SNOMED International Member Nations in Europe and Australasia.  The protocols produced by the CAP are used in the United States and Canada and are required for laboratory certification.  It is estimated that there is a 95% overlap of content between the CAP and ICCR, thus making these two protocol providers reasonable foundations for this project.

As noted the content addressed in this guide is specific to structure pathology reporting of malignant neoplasms as specified by the CAP and ICCR.  The content created is intended to represent the specific observations made and reported by the pathologist during the examination of excised tissue.  It is NOT intended to define the clinical interpretation of the data.  Indeed, it is expected that the pathologist and clinicians using the pathology report understand the clinical meaning of the data as contained within any particular report.  For example, the criteria to differentiate between an adenocarcinoma and a mucinous carcinoma in the colon versus the breast is expected to be understood by the data creator (pathologist) and user (surgeon or clinician).  It is not reflected in the SNOMED CT concept.

The CSRWG highly leveraged the work of the Observables Project Group and used the observable entity hierarchy for much of the new SNOMED CT content developed in this project.  This decision was made for three specific reasons:

1. Synoptic reports are structured as a series of tumor features to be observed and the subsequent observation.  The use of observable entities to describe the "thing" being observed or measured is consistent with the definition of the observable entity hierarchy.
   
   
2. The context for the synoptic data elements is reflected in specific observations to be made by the pathologist.  The observations, or answers, to the feature of the neoplasm being observed are often repeated across protocols. (For example: Present, Absent, Adenocarcinoma, Carcinoma, etc).  To unambiguously represent all content for all forms of solid tumor protocols would require a substantial number of new concept definitions in many SNOMED CT hierarchies that would exceed the number of Observable entity concepts needed to represent the same data elements.
   
   
3. Legacy content as inherited as part of the creation of SNOMED International and the merger of SNOMED RT and the READ codes, was found in both the observable entity and clinical finding hierarchies.  SNOMED CT content in either hierarchy was exclusively primitive without concept definition.  Substantial changes to the clinical finding hierarchy concept model would have been required in order to create necessary and sufficient concept definitions for these findings.  Furthermore, new finding concepts for each tumor type would be necessary to meet the objective of this project as well as the observable entity hierarchy.  

Content included in this project consists of:

1. All required data elements for adult and pediatric solid tumors as specified by the CAP and ICCR
2. Biomarker data elements for immunohistochemistry 

Content to be further developed:

1. Biomarker data beyond immunohistochemistry, for example, fluorescent in situ hybridization
2. Reporting protocols used for Central Nervous System neoplasms and Hematolymphoid tumors
3. Cancer screening protocols

Content NOT included in this project:

1. Cancer disorder modeling
2. Data elements not explicitly enumerated in published structured pathology reporting protocols
3. Histology modeling quality improvement (separate but related project)
4. Genomics modeling 
5. Tumor staging modeling

Audience

SNOMED CT is a comprehensive, multilingual clinical terminology that can be used to standardize and improve the quality of data related to <scope of document>. This guide is targeted at the various stakeholders involved with the implementation of SNOMED CT:

• SNOMED International Members who are seeking uniform, clear best practices for documenting <scope of document> structured cancer pathology reports, and understanding how SNOMED CT can be applied in this domain

• Clinicians who are interested in understanding how SNOMED CT can support the clinical needs for data collection and acquisition within the field of <scope of document>of cancer pathology reports for patient care.

• Information managers who are looking to learn how SNOMED CT can be integrated into health information models within the domain of <scope of document> cancer pathology and cancer care to support the implementation of SNOMED CT and enhance data interoperability.

• Software developers who want to learn how to integrate SNOMED CT into software applications used in the domain of <scope of document>.

Attribution

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This section presents the main contributors to this guide, e.g. a Clinical Reference Group. Update the text below as required.

It also provides information about who to contact for questions about the work presented in the guide. The information may include:

Name: [Name of individual or group]

Title: [Title of individual or group, if applicable]

Affiliation: [Affiliation of individual or group, if applicable]

Description: [Brief description of the individual or group's role or contribution to the information being attributed]

Sources: [List of sources or references used to gather information about the individual or group, if applicable]

• structured cancer pathology reporting.

Attribution

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This SNOMED CT Implementation guide and the underlying work have been developed by the <name of CRG> Cancer Synoptic Reporting Working Group. The Clinical Reference Group (CRG) is composed of experts in the field of <scope of document> providing pathology providing input from the community of practice on the development, maintenance, and use of SNOMED CT in this specific domain. The CRG members have been instrumental in the development of this guide, providing their expertise, knowledge, and experience to ensure that it is accurate, up-to-date, and relevant to the needs of its intended audience. Their dedication and hard work have made this guide possible and SNOMED Internationalis is grateful for their contributions. This guide is a product of SNOMED International's ongoing commitment to improving healthcare through the use of high-quality, standardized clinical terminologies.

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Guide overview

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Guide overview

This SNOMED CT Implementation Guide is designed to provide guidance for the use of SNOMED CT within the domain of allergies, hypersensitivity, and intolerance. The guide is organized into five main chapters:

• Chapter 1: Introduction - This chapter provides a background on the guide, including the objectives, scope, and target audience.
• Chapter 2: Clinical Use Cases - This chapter describes the key use cases that have motivated the creation of this guide and explains scenarios where implementation of SNOMED CT within this domain is needed.
• Chapter 3: ?? Content in SNOMED CT - This chapter describes how SNOMED CT addresses the terminological needs within the domain of <scope of document>. It also elaborates on ....Cancer Synoptic Reporting.
• Chapter 4: Information Model and Terminology Binding - This chapter introduces ...the knowledge representation techniques used in this guide.
• Chapter 5: Technical Application - This chapter presents technical considerations related to the implementation of ...the cancer synoptic report forms as FHIR Questionnaires.

In addition, a number of appendixes present the results of the analysis performed and provide insights into the evolution of SNOMED CT and available information models.

Review

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This section provides information about the status of the work presented in this guide.

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