Operational Ontology for Oncology (O3): A Professional Society-Based, Multistakeholder, Consensus-Driven Informatics Standard Supporting Clinical and Research Use of Real-World Data From Patients Treated for Cancer

Abstract

Purpose: The ongoing lack of data standardization severely undermines the potential for automated learning from the vast amount of information routinely archived in electronic health records (EHRs), radiation oncology information systems, treatment planning systems, and other cancer care and outcomes databases. We sought to create a standardized ontology for clinical data, social determinants of health, and other radiation oncology concepts and interrelationships.

Methods and materials: The American Association of Physicists in Medicine's Big Data Science Committee was initiated in July 2019 to explore common ground from the stakeholders' collective experience of issues that typically compromise the formation of large inter- and intra-institutional databases from EHRs. The Big Data Science Committee adopted an iterative, cyclical approach to engaging stakeholders beyond its membership to optimize the integration of diverse perspectives from the community.

Results: We developed the Operational Ontology for Oncology (O3), which identified 42 key elements, 359 attributes, 144 value sets, and 155 relationships ranked in relative importance of clinical significance, likelihood of availability in EHRs, and the ability to modify routine clinical processes to permit aggregation. Recommendations are provided for best use and development of the O3 to 4 constituencies: device manufacturers, centers of clinical care, researchers, and professional societies.

Conclusions: O3 is designed to extend and interoperate with existing global infrastructure and data science standards. The implementation of these recommendations will lower the barriers for aggregation of information that could be used to create large, representative, findable, accessible, interoperable, and reusable data sets to support the scientific objectives of grant programs. The construction of comprehensive "real-world" data sets and application of advanced analytical techniques, including artificial intelligence, holds the potential to revolutionize patient management and improve outcomes by leveraging increased access to information derived from larger, more representative data sets.

Figure 1

A professional society based, consensus driven approach was taken in developing the Operational Ontology for Oncology to address standardization gaps that undermine ability to aggregate and learn from “real-world” data, supporting clinical practice improvement and research.

Figure 2

A) An iterative, progressive engagement method including multiple health care electronic systems vendors, government agencies, specialty groups within professional societies, institutions and the public were engaged with a publicly accessible website for collecting comments and direct engagement with representatives to ensure incorporation of multi-stakeholder perspectives. B) building in prior work in 2018, the work was carried over multiple years with progressive engagement of stakeholders

Figure 2

A) An iterative, progressive engagement method including multiple health care electronic systems vendors, government agencies, specialty groups within professional societies, institutions and the public were engaged with a publicly accessible website for collecting comments and direct engagement with representatives to ensure incorporation of multi-stakeholder perspectives. B) building in prior work in 2018, the work was carried over multiple years with progressive engagement of stakeholders

Figure 3

An O3 website screenshot illustrating the details of one of five attributes under the Key Element of “Patient Treatment Outcome”. The O3 is formatted in a user-friendly drop-down menu with each key element listed to the left of the page (e.g., Patient Treatment Outcome), providing users the ability to access additional information through menu expansion including value name (e.g. Disease Status), value type (Attribute), definition, list of standard values with reference for such standard along with O3 codes for the value in comparison to current SCTID, NCITC and NCIMT codes. Relationships that should also be tracked are tabulated.

Figure 4

Illustration of radiotherapy treatment concepts of radiation therapy course, phase, plan, session, and fraction using three clinical examples ordered by increasing complexity. A) Prostate cancer, including three treatment plans delivered to increasingly focused targets of the pelvis, prostate/seminal vesicles (SV) and prostate in 3 sequential phases for a total of 35 fractions/sessions. B) Bilateral breast cancer, including three treatment plans delivered to left (L) breast/axilla, boost site of L breast and right (R) breast. In this case there is a fourth plan due to adaptation required of the L breast/axilla plan which had only 3 fractions delivered of the 16 planned. While the L breast/axilla and L breast boost phases were treated sequentially, the phase of R breast plan was treated concurrently (in the same sessions) with those of the contralateral treatments. C) Oligometastatic disease, including a total of 4 treatment plans delivered over a total of 12 sessions. The two plans within the liver phase were treated asynchronously. Following evaluation of treatment response, the second liver plan of 2 fractions was delivered one month after the first liver plan of 3 fractions, which had been treated concurrently with the whole brain (10 fraction) and spine (5 fraction) plans

Figure 4

Illustration of radiotherapy treatment concepts of radiation therapy course, phase, plan, session, and fraction using three clinical examples ordered by increasing complexity. A) Prostate cancer, including three treatment plans delivered to increasingly focused targets of the pelvis, prostate/seminal vesicles (SV) and prostate in 3 sequential phases for a total of 35 fractions/sessions. B) Bilateral breast cancer, including three treatment plans delivered to left (L) breast/axilla, boost site of L breast and right (R) breast. In this case there is a fourth plan due to adaptation required of the L breast/axilla plan which had only 3 fractions delivered of the 16 planned. While the L breast/axilla and L breast boost phases were treated sequentially, the phase of R breast plan was treated concurrently (in the same sessions) with those of the contralateral treatments. C) Oligometastatic disease, including a total of 4 treatment plans delivered over a total of 12 sessions. The two plans within the liver phase were treated asynchronously. Following evaluation of treatment response, the second liver plan of 2 fractions was delivered one month after the first liver plan of 3 fractions, which had been treated concurrently with the whole brain (10 fraction) and spine (5 fraction) plans

Figure 4

Illustration of radiotherapy treatment concepts of radiation therapy course, phase, plan, session, and fraction using three clinical examples ordered by increasing complexity. A) Prostate cancer, including three treatment plans delivered to increasingly focused targets of the pelvis, prostate/seminal vesicles (SV) and prostate in 3 sequential phases for a total of 35 fractions/sessions. B) Bilateral breast cancer, including three treatment plans delivered to left (L) breast/axilla, boost site of L breast and right (R) breast. In this case there is a fourth plan due to adaptation required of the L breast/axilla plan which had only 3 fractions delivered of the 16 planned. While the L breast/axilla and L breast boost phases were treated sequentially, the phase of R breast plan was treated concurrently (in the same sessions) with those of the contralateral treatments. C) Oligometastatic disease, including a total of 4 treatment plans delivered over a total of 12 sessions. The two plans within the liver phase were treated asynchronously. Following evaluation of treatment response, the second liver plan of 2 fractions was delivered one month after the first liver plan of 3 fractions, which had been treated concurrently with the whole brain (10 fraction) and spine (5 fraction) plans