Audience

SNOMED CT is a comprehensive, multilingual clinical terminology that can be used to standardize and improve the quality of data related to cancer synoptic reporting. This Cancer Synoptic Reporting Clinical Implementation Guide is targeted at the various stakeholders involved with the implementation of SNOMED CT in this domain:

• SNOMED International Members who are seeking uniform, clear best practices for documenting 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 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 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 structured cancer pathology reporting.

Objective

The objective of this Cancer Synoptic Reporting Clinical Implementation Guide is to provide instruction and guidance regarding the SNOMED CT content produced by the Cancer Synoptic Reporting Project Group.  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 Project Group 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 Cancer Synoptic Reporting Project Group 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

Background and Attribution

Pathology reports for cancer diagnosis and prognosis are increasingly structured in synoptic form, following guidelines from esteemed organizations such as the College of American Pathologists, the Royal College of Pathology, and others. These reports, guided by national and international protocols, ensure consistency and accuracy across various entities involved in cancer care.

These structured reports, often referred to as data sets, maintain high consistency among different publishing entities. It's imperative to represent the data elements within these reports in both human-readable and machine-readable formats. Computable data elements enable integration into electronic health records for clinical support and seamless transmission to cancer registries for public health purposes, enhancing clinical translational research.

However, prior to 2020, the availability and clarity of SNOMED CT content for cancer synoptic reporting were lacking. Studies by the US Centers for Disease Control and Prevention in 2005 and 2009 highlighted the inadequacy of SNOMED CT and LOINC in encoding cancer data unambiguously for reporting purposes.

Recognizing this deficiency, the Cancer Synoptic Reporting Project Group was established in 2020 with a specific aim: to develop comprehensive SNOMED CT concepts suitable for structured pathology reports. Their objective encompasses supporting clinical, public health, and research applications. Specifically, they aim to create SNOMED CT content necessary for structured reporting across all solid tumor protocols, including those tailored for pediatric cases, as published by leading pathology organizations.

This SNOMED CT Clinical Implementation guide and the underlying work have been developed by the Cancer Synoptic Reporting Project Group. This Clinical Project Group (CPG) is composed of experts in the field of pathology providing input from the community of practice on the development, maintenance, and use of SNOMED CT in this specific domain. The CPG 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 International is 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.

Guide overview

This SNOMED CT Clinical 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 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.

Review

This SNOMED CT Clinical Implementation Guide represents the culmination of work started by Scott Campbell and James Campbell in 2014 and continued by the the Cancer Synoptic Reporting Project Group in 2020. 

We welcome feedback from readers on the Guide and encourage them to share their insights and experiences with us. Your comments and suggestions will help us improve the content of the Guide and ensure that it is relevant and useful to those who use it. We will review any feedback received and make updates to the Guide as needed. 

We appreciate your interest in this Guide and thank you for your contributions to the improvement of healthcare through the use of high-quality, standardized clinical terminologies like SNOMED CT. Please raise any comments to this document by emailing info@snomed.org, and please mark your response "Cancer Synoptic Clinical Implementation Guide"