minimal Common Oncology Data Elements (mCODE) Implementation Guide
3.0.0 - STU3 Release United States of America flag

This page is part of the HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1 (v3.0.0: STU 3) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Outcomes

Recording patient outcomes in mCODE involves disease status, tumor size, and date of death. Other common outcome measures, such as progression-free survival, time to recurrence, and overall survival, can be derived from time-indexed observations of disease status. The date of diagnosis is also required for some derived measures (see Disease Characterization). At this time, mCODE does not include patient reported outcomes.

Disease Status

Formal recording of disease status is often limited to clinical trials, involving precise criteria such as RECIST. The lack of outcome data outside of trials greatly limits the application of real-world data. Disease status information is rarely found in structured form in EHRs. If recorded at all, the information is found in clinical notes, which is of limited usefulness.

mCODE asks for disease status to be recorded in structured form as part of patient encounters. In mCODE, disease status is defined as “A clinician’s qualitative judgment on the current trend of the cancer, e.g., whether it is stable, worsening (progressing), or improving (responding). The judgment may be based a single type or multiple kinds of evidence, such as imaging data, assessment of symptoms, tumor markers, laboratory data, etc.” In other words, the disease status is an assessment by the oncologist that synthesizes all currently available information about the patient. The ICAREdata™ Project is conducting a study in association with a randomized controlled trial (RCT), which aims to demonstrate the ability to calculate equivalent clinical trial endpoints using computable clinical treatment data.

In addition, the history of tumor size is indicative of treatment efficacy.

Remission and Relapse

PrimaryCancerCondition has a status field, Condition.clinicalStatus, that records high-level status of the disease. When the CancerDiseaseStatus is determined to be in remission, an update to PrimaryCancerCondition is required. Specifically, the Condition.clinicalStatus element of PrimaryCancerCondition should be updated to remission. If subsequently there is a relapse, the clinicalStatus field should be upated to relapse, then only in subsequent encounters is the CancerDiseaseStatus used to track the patient’s status on an encounter-by-encounter basis.

Date of Death

Date of death data is recorded using the Patient resource. The death date can be obtained from several sources outside of the clinical setting. If available in the EHR, it can be reported through via mCODE, but more likely, it will be filled in from vital records, after the last clinical interaction.

Tumor Identification

To track and compare tumor characteristics over time, it is necessary to have a method for persistent identification of specific tumors. Two profiles are provided for this purpose:

  1. Tumor SHALL be used when identifying tumors prior to removal from the body
  2. HumanSpecimen SHALL be used when identifying tumors after removal

A single Tumor-conforming resource SHOULD be created for a tumor when it is first identified, and this resource SHOULD be referenced in Observations of this tumor or other resources that refer to a specific tumor until the tumor is removed from the body. After removal, a single HumanSpecimen-conforming resource SHOULD be created and used in the same manner.

If both Tumor and HumanSpecimen are used to represent the same tumor, identifier SHALL be used to associate them: a persistent identifier from Tumor that is unique within the context of the Patient SHALL appear in HumanSpecimen.

Tumor Size

The TumorSize profile provides a mechanism for recording the dimensions of an identified tumor. It SHALL reference a Tumor if the measurement is made while the tumor is still in the body, or HumanSpecimen if the tumor has been removed. Multiple TumorSize instances MAY be used to record changes in tumor size over time.

Profiles

Extension

Value Sets