Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.

Data Element
Karnofsky
Description

The Karnofsky Performance Status (KPS) is a tool used to measure a patient's functional status. It can be used to compare the effectiveness of different therapies and to help assess the prognosis of certain patients, such as those with certain cancers. The KPS score ranges from 0 to 100 in intervals of 10. Higher scores are associated with better functional status, with 100 representing no symptoms or evidence of disease, and 0 representing death.
Submitted By: Andre Quina / MITRE
Data Element Information
Use Case Description(s)
Use Case Description Information on functional status is becoming increasingly essential for fostering healthy people and a healthy population. Achieving optimal health and well-being for Americans requires an understanding across the life span of the effects of people’s health conditions on their ability to do basic activities and participate in life situations, in other words, their functional status. Functional status information can serve the management needs of health care providers and payers in such areas as financial management, utilization review and quality assurance.

CMMI is also requiring the collection of certain specific “clinical data elements” (CDEs) from participants in the mandatory Radiation Oncology (RO) model scheduled to begin in January 2021 and has issued an informal RFI soliciting public comment on the draft CDEs. Functional status (ECOG) is one of the proposed CDEs required for reporting in the RO model. See: https://innovation.cms.gov/media/document/ro-clin-data-elements-rfi-v2

Event for its collection and use: Functional status information is used, or could be used, to evaluate outcomes, compare treatment modalities, and predict costs. Changes in functional status is often one of the first signs of illness or exacerbation of a chronic condition.

Frequency of use: Functional status assessment is fundamental to geriatric care and cancer care and are regularly assessed throughout care.

Broader collection and use: Functional status information is routinely used to assess and care for patients, but the information is often not structured in medical records. This prevents a host of possible beneficial uses of the information for management, research, public health, and policy purposes.

Reference: https://www.ncvhs.hhs.gov/wp-content/uploads/2017/08/010617rp.pdf
Estimate the breadth of applicability of the use case(s) for this data element Functional status assessment is fundamental to geriatric care and cancer care. As such, it is relevant to 50M seniors and 8M cancer patients.
Use Case Description The Care Plan itself describes how one or more practitioners intend to deliver care for a particular patient, group or community for a period of time, possibly limited to care for a specific condition or set of conditions. The Care Plan tracks the progress of activities associated with the plan. Practitioners regularly review the care plan and make changes for a variety of reasons. Recording the date of review, whether the plan was changed, a coded reason for change, and a narrative describing the change is important for the understanding of the progression of care and associated outcomes of treatments in the care plan.

Through the ICAREdata study treatment plan change with rationale for change is being collected in the EHR for patients that are currently enrolled in a clinical trial that incorporates the ICAREdata protocol (currently 3 trials). The goal of the ICAREdata study is to evaluate the suitability of treatment change (among other patient outcomes) to drive a real-world data based research endpoints.

Event for its collection and use: Treatment change is recorded when a care plan is modified.
Estimate the breadth of applicability of the use case(s) for this data element Treatment change is being evaluated as part of the ICAREdata study across 5 health systems and 3 clinical trials to assess the applicability of treatment change as a real world evidence based endpoint. The broader suitability of treatment change is still being evaluated.
Link to use case project page https://confluence.hl7.org/display/COD/EHR+Endpoints+for+Cancer+Clinical+Trials
Healthcare Aims
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC, SNOMED-CT, and FHIR

see:
https://search.loinc.org/searchLOINC/search.zul?query=functional+status
http://hl7.org/fhir/us/mcode/
https://browser.ihtsdotools.org/?perspective=full&conceptId1=273472005&edition=MAIN/2020-07-31&release=&languages=en

Additional Specifications HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1

http://hl7.org/fhir/us/mcode/
Current Use In limited use in production environments
Supporting Artifacts Functional status information for cancer is collected in most EHR systems. For cancer the representation of functional status is standardized through ECOG and Karnofsky. Beyond cancer there are a number of other functional status assessments across different specialties.

There are several initiatives developing FHIR use cases for the exchange of functional status between healthcare settings. See: https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability

Collection and use of treatment change is being evaluated as part of the ICAREdata study across a number of health systems (currently 5 health systems being onboarded).
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 Functional status is frequently assessed and recorded for cancer and geriatric patients. There are a number of initiatives working on the exchange of functional status information. See: https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability

Through the ICAREdata study treatment change is being collected at an increasing number of health systems (currently 5 health systems being onboarded). Treatment change is being exchanged between those health systems and the Alliance for Clinical Trials in Oncology using FHIR APIs for analysis against clinical trial data.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) none
Restrictions on Use (e.g. licensing, user fees) none
Privacy and Security Concerns Usual HIPAA restrictions apply
Estimate of Overall Burden The IMPACT Act requires the reporting of standardized patient assessment data with regard to quality measures and standardized patient assessment data elements (SPADEs). The Act also requires the submission of data pertaining to measure domains pertaining to resource use, and other domains. In addition, the IMPACT Act requires assessment data to be standardized and interoperable to allow for exchange of the data among post-acute providers and other providers. The Act intends for standardized post-acute care data to improve Medicare beneficiary outcomes through shared-decision making, care coordination, and enhanced discharge planning. The requirement of assessment data as part of the impact act supports the inclusion of assessments in USCDI.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures

Comment

Submitted by suchen on

This data element has…

This data element has support from the HL7® FHIR® CodeX™ Accelerator community. CodeX supported FHIR data standards for cancer, genomics and cardiovascular health have a rapidly growing footprint of traction and adoption. The CodeX community is rapidly growing its membership, with invested Member leaders driving implementation-focused use case pilots forward.

The ECOG & Karnofsky Performance Status data element exchange in CodeX leverages the minimal Common Oncology Data Elements (mCODE) Implementation Guide. Pertinent links for mCODE, and mCODE’s real world adoption and traction include:

The CodeX Integrated Trial Matching for Cancer Patients and Providers Use Case aims to automate the existing trial matching process and complete the eligibility screening in one step to increase enrollment and diversity of patients in clinical trials. There are 11 key partners, including industry, advocacy organizations, and research, involved in the use case. Additionally, this use case is in process of rolling out into prospective phase at one health site, and looking to expand to another health site by the end of 2023.

ECOG and Karnofsky Performance Status assessments are one of eight key Optimized Patient Data Elements (OPDE) used in the trial matching tool developed through this CodeX initiative. Phase 1, via retrospective data, validated the use of OPDE for effectively filtering cancer clinical trials for patients.

Pertinent links include:

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