The CodeX team believes the minimal Common Oncology Data Elements (mCODE™) standard could be leveraged to achieve more equitable health outcomes for cancer patients from diverse populations. As part of our exploration, we are releasing a white paper, “Advancing Health Equity in Cancer Research, Care, and Surveillance,” available here and will host a companion webinar, “Leveraging Interoperability to Drive Health Equity in Cancer Care, Research, and Surveillance.” Please join us on January 27th, 2022 at 1PM ET by registering here.
More About Health Disparities in Cancer Care
Despite a reduction in overall cancer burden, cancer health disparities persist in the United States. As documented in the AACR Cancer Health Disparities Progress Report, diverse populations characterized by race and ethnicity, location, and other attributes experience worse cancer-related outcomes.
The causes behind cancer health disparities are multifaceted and complex, with different dynamics for different populations. In the case of the greater prostate cancer burden among African American men compared to white men, factors that drive the disparate outcomes include a lower likelihood of being screened for prostate cancer, a longer time-to-initiation of treatment, a lower likelihood of receiving standard treatment, and greater exclusion from research that informs new, groundbreaking treatments. Spotlighting the social determinants of health, research has also shown that prostate cancer patients living in disadvantaged neighborhoods experience lower survival.
Expanding this frame to include the disparities present in other types of cancers across different populations shows that there are many steps that must be taken to achieve health equity.
The CodeX Health Equity Initiative Approach
CodeX is committed to advancing health equity in oncology and is actively engaging with partners on incorporating equity-related objectives to its mCODE use cases. Increased data standardization and data interoperability can contribute to equity-related goals such as:
- Increasing diversity in clinical trial participation
- Making it easier to analyze standardized real-world data across populations
- Improving treatment quality
- Monitoring the safety and efficacy of approved therapies
- Strengthening the public health surveillance of data crucial to identifying inequities
- Accelerating prior authorization in oncology to reduce financial obstacles to treatment.
For more information and specific examples of how mCODE could be a foundational tool for health equity efforts in oncology, be sure to read our white paper. Register for the January 27th webinar to learn more about how CodeX’s work in clinical trial matching and radiation therapy treatment could be leveraged to support health equity.
Welcome to the CodeX Blog - CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications that lead to step-change improvements in cancer patient care and research.
We recently talked with cancer patients, survivors, and advocates to hear their stories and learn more about their perspective through the cancer care coordination process. This "Patient Voices Series" shares the patient perspective with the CodeX community. The plan is to increase participation of cancer patients in the work of CodeX, and that we and our work are inspired and informed by their stories and collaboration.
Author: Omkar Ratnaparkhi
How is the Standard of Care Defined?
“Everyone just said this is the standard of care!” Today, Desiree D. has no evidence of disease, but in 2017 she was diagnosed with stage 2b breast cancer at the age of 40. When trying to make decisions about her course of treatment, Desiree was repeatedly told by doctors that she was getting the standard of care. In reality, the “standard of care” is relatively loose terminology. When making treatment decisions, Desiree felt that the standard of care where she was living in Virginia meant something different than the standard of care in Massachusetts or to the standard of care in Vermont.
Imagine if a chef could not make a soup because he only understood Portuguese and the soup’s instructions were in Hindi. The chef could look elsewhere and find a solution after further research; however, the lack of a common language has cost the chef time and the chef’s soup is not going to be the same as he wished. This scenario is harmless, but a similar and much more serious situation exists across healthcare systems. The healthcare industry remains significantly less standardized than other industries. This means that treatments for the same type of cancer might vary greatly by geographic location, cancer center, and even oncologist in part because healthcare data is not collected or shared in a standard manner.
Accessing Clinical Trials
Lack of standardization does not mean the healthcare system is completely ineffective at treating cancer. However, it does mean that many patients feel as though they haven’t been provided with the most effective or personalized options. I asked Desiree what treatment options she wished she knew about after her diagnosis, and she said, “I would’ve like to have known about clinical trials immediately.” Clinical trials offer important options, and important sources of hope, for all patients—and even patients who have not experienced success via more traditional interventions. Clinical trials can help treat current patients, and lead to the discovery of more effective treatments for future patients. Unfortunately, fewer than 6% of American cancer patients are enrolled in clinical trials. Patients are unaware of potentially lifesaving and life improving clinical trials. Those who search for clinical trials struggle to match with one, because insufficient standardization of Electronic Health Record (EHR) data makes efficient matching of patients to promising clinical trials extremely difficult.
When Desiree was making decisions about her course of treatment, her oncologist assumed that she would not qualify for any clinical trials. However, Desiree did her own research and found the website BreastCancerTrials.org. BreastCancerTrials.org has a search tool that takes in data from breast cancer patients and matches them with trials for which they may be eligible. Desiree used the search tool and matched with a clinical trial; despite being told by her oncologist that matching to a trial was impossible. Desiree believes that BreastCancerTrials.org’s work is so crucial, and even at times life-saving, that she is now a patient advocate and the Outreach & Operations Manager for the website.
Despite the hard work of patient advocates like Desiree, it can be challenging for patients to use existing search tools because of the lack of standardization in patient data and of the clinical trials’ enrollment criteria. To find the correct trial a patient needs to enter their health data, often drawn from multiple sources (and memory), into the search tool. According to Desiree, the most important data source when using the search tools at BreastCancerTrials.org is a pathology report. Pathology reports are confusing and difficult to interpret for many patients. Pathology reports and other health records are not written so patients can read them easily, instead, the records are written to provide information that researchers and providers find valuable. On top of the overwhelming confusion caused by complex health records, results come back from matching services in different formats and sometimes do not contain the specific data required for patients to understand how well they match to a trial. Sometimes, patients are able to use the search tool based upon input from their health record but are barraged with search results featuring hundreds of clinical trials.
Clinical Trial Awareness
Desiree wasn’t the only patient or patient advocate I spoke to who hadn’t heard about clinical trials from their primary oncologist. Lydia G., a lymphoma and thyroid cancer patient, explained how she didn’t hear about clinical trials, “It was not brought up by a medical provider, but it was something that I had looked into because I was trying to seek alternative types of [treatments].” Like almost all the patients I spoke with, Lydia’s doctors never suggested clinical trials to her, instead she had to communicate with non-profit patient advocacy groups to research clinical trial eligibility and availability.
To find out more on why patients aren’t recommended by providers for clinical trials, I spoke with Lee J., a patient advocate for the Southwest Oncology Group (SWOG). “Patient advocates suspect that if a trial is not being held or being sponsored at your institution where you’re going [for primary care], your doctor may not be interested in referring you for that trial [at another institution] because that may mean losing you to that institution. So, it’s not only knowing about the trial, but seeing if you can be on that trial locally or [have to] fly in to someplace [far away].”
Integrated Trial Matching
The CodeX use case project most focused on streamlining the clinical trial matching process is Integrated Trial Matching for Cancer Patients and Providers. This project leverages mCODE to help patients, providers, and trial matching services—like BreastCancerTrials.org—make the clinical trial matching process more efficient. Instead of tediously and manually entering information from a pathology report, a patient seamlessly matches to a trial by linking their EHR to the trial matching service. On the other hand, if a medical provider wishes to find the perfect clinical trial for their patient, then they quickly send the EHR mCODE data to the mCODE-enabled trial matching service to find the most promising trials.
Empower the System, not Just the Patient
To learn more about how data standardization can directly benefit the lives of patients, I was referred by Christine K.—the principal investigator for the ICAREdata Patient Engagement Portal— to Patty S. Patty is the Chair of The Alliance for Clinical Trials in Oncology’s Patient Advocate Committee. According to Patty, empowering the healthcare system is just as important as empowering individual patients. “As a former scientist diagnosed with cancer, I had the tools and means to look and find clinical trials.” Even if some patients are empowered and can use search tools to comb through hundreds of clinical trials, not all patients have the tools or means to look for clinical trials or second opinions about available treatments.
Cancer diagnoses cause great trauma, shock, and confusion. Patients struggle to understand what options are available to them. Patty explained, everyone who is newly diagnosed does not know anything about their cancer or how it’s treated—regardless of their background. After diagnosis, patients are bombarded with information from doctors, but still do not fully understand what options they have. Lack of health literacy leads many patients who would qualify for clinical trials to not discover trials they qualify for—because they have never heard of clinical trials. Patty outlined her goal for the future, “I would like a system in which every patient is asked every time for every study (clinical trial) that they might qualify for—without any preconceived notion of whether they will say yes or no.”
Omkar Ratnaparkhi is a rising senior at Fordham University and is sharing patient stories to highlight firsthand accounts of the cancer patient experience.
Welcome to the CodeX Blog—we recently talked with cancer patients, survivors, and advocates to hear their stories and learn more about their perspective through the cancer care coordination process. CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications that lead to step-change improvements in cancer patient care and research.
Author: Omkar Ratnaparkhi
Bias in Healthcare is Deadly
“It’s almost like negligent homicide. Because of the bias that’s there—whether it’s explicit or implicit—is resulting in these people—patients of color—not receiving the full scope of care that they should be.” Jamil Rivers is a person with breast cancer and the Founder of The Chrysalis Initiative. The Chrysalis Initiative is a patient advocacy organization looking to disrupt harmful disparities in accessibility, quality, and outcome of cancer care. Looking at the source of disparities is the first step to rectifying them, and The Chrysalis Initiative provides equity assessments that evaluate all types of healthcare services that offer cancer care. The assessments evaluate whether the experiences of patients of color differ from White patients. When Jamil first started the equity assessments, she expected around 50% of patients of color to experience racism and bias. However, Jamil quickly discovered that this number was much higher, “90% of our preliminary data indicated that they [patients of color] were receiving substandard care and experiencing racism and bias in their care.” According to Jamil, many medical providers and researchers are cognizant of racism and bias affecting patients, but few understand the true pervasiveness of explicit and implicit racism in patient care. Even biases that at first glance seem trivial can be deadly because each action based upon bias deteriorates the quality of care a patient receives.
Ensuring Trust and Continuity in Care for People of Color in the Healthcare System
“Do they have the sufficient resources to trust and verify? It’s the same thing with law enforcement and education and other aspects of society. If you are a person of color, you understand that you might have to potentially do those extra verifications.” Jamil, like most people of color, experiences racism in many aspects of modern-day society. Therefore the skepticism seen in communities of color towards healthcare providers is rational. Jamil shared “It totally makes sense to have that skepticism and it can be healthy. The only way it can be dangerous is if you’re not engaging with the medical system at all.”
Jamil explained, one specific reason people of color are skeptical of the healthcare system is because of disparities in continuity of care caused by racism and bias, “If you [the medical provider] don’t value a Black or Brown life the same way you value a White life, then it’s hard to make that connection that it should be that same level of urgency and continuity when ensuring that person is getting optimal care.” Jamil detailed how many patients of color notice disparities in the quality and continuity of care that they receive, “I run into situations where despite the standard operating procedures, White patients will receive a certain level of care and continuity, but Black patients don’t. And, when the Black patients or Brown patients ask about it and say, ‘Well why can’t I have access to that?’, there are sometimes intimidation tactics brought on and hostility, or they’re threatened to be discarded from the health system for questioning.”
Ivis S. is a breast cancer survivor and patient advocate who works to enhance the quality of care of Asian, Black, and LatinX patients. Racism and bias are not the only factors challenging the trust between patients and the healthcare system. Structural barriers prevent access to better care for many—including language. During her work as an advocate, Ivis encountered many situations where English was the only language used in consent forms. Ivis even had to ask health administrators – “If you weren’t French and an informed consent form was in French, would you sign it?” – because even when some healthcare providers know a patient can’t read English, they still give them consent forms in English. Consent forms are not the only area that language barriers deteriorate patient-provider trust. Ivis was once working with a panel of young doctors and did a mock cancer diagnosis of a doctor in Spanish, and then said, “Now you know what it feels like, to be diagnosed with a deadly disease, where you know nothing [about] what they’re telling you, but you do understand the word cancer and know that it can be deadly.” All of the young doctors’ worldviews shifted, because they had previously subconsciously assumed that it was the patient’s role to understand the diagnosis—even when it was in an unknown language. This language barrier is just one of many barriers that minority patient populations might experience, throughout their cancer care.
In addition to biases based on race and ethnicity, there are other types of bias that negatively impact cancer care. Ivis directly experienced the negative effects of bias as a young mother. Because of her age, Ivis’ OB-GYN doctor continued to assure her that the sensations she had been feeling in her breast for 18 months was normal. “The bias was that I was a young woman—and I was healthy—so I was not the norm.” Ivis’ diagnosis was delayed for 18 months because of her doctor’s ageism, and in October of 1993, she was diagnosed with breast cancer. A few days before the diagnosis, a sonogram showed something bigger than a dime in her breast. Ivis was told to come back after 6 months, but she demanded to see a surgeon immediately based upon what she had read from a magazine on breast cancer symptoms. Ivis went to call the surgeon and realized something shocking, “I realized he was in the same office building [as the OB-GYN doctor], and then they gave me the directions and everything and I realized he’s actually on the same floor as my OB-GYN.” It turned out that the surgeon who would diagnose Ivis with breast cancer was only a few feet away across the hall from her OB-GYN. “Something that really stood out to me was that this doctor [the OB-GYN] could have said, ‘You know she keeps questioning, she keeps saying something’s wrong, let me take her to [the surgeon]’, but that didn’t happen.” A few days later Ivis found out that she had cancer based upon the results of a biopsy. Ivis’ OB-GYN’s bias prevented him from being proactive, listening to Ivis, investigating her concerns, and he never once decided to consult his nearby coworker—the surgeon—who ultimately diagnosed Ivis. Despite being diagnosed later than she could have because of her OB-GYN’s bias, Ivis is now a two-time breast cancer survivor and patient advocate. Unfortunately, countless other patients who face biases are not as fortunate.
Better Data can Lead to a More Equitable Healthcare System
Bias and structural barriers in healthcare can be alleviated using standardized data. Jamil explained, “The more data the better, and the more tech the better.” By streamlining the process of interaction between the patient and provider and limiting manual entry and collection of data, bias can be curbed or eliminated. Also, data that is standardized can provide insight into disparities in quality of care. Many White service providers are not cognizant of their biases or don’t realize the effects of their biases, but after seeing data from equity assessments their eyes are opened. “Once you see, you can’t unsee. It just makes their engagement with patients of color that much better. And, they’re also holding other staff members accountable to make sure it’s equitable across the board.”
Omkar Ratnaparkhi is a rising senior at Fordham University and is sharing patient stories to highlight firsthand accounts of the cancer patient experience.
Welcome to the CodeX Blog—we recently talked with cancer patients, survivors, and advocates to hear their stories and learn more about their perspective through the cancer care coordination process. CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications that lead to step-change improvements in cancer patient care and research.
Author: Omkar Ratnaparkhi
Creating Patient-Centered Care
“We see patient-centered care as the patient is in the center, fully alert, fully informed, and fully able to contribute to the information as well as what [treatment] they want to happen in their lives.” Debi Willis is a kidney cancer survivor and the CEO and Founder of PatientLink and MyLinks. The phrase “patient-centered care” is frequently mentioned, but what do these words really mean? According to Debi, patient-centered care is sometimes mistakenly interpreted as having multiple medical professionals focusing on a single patient where the patient has little understanding nor input in decisions that are made. Instead, “patient-centered care” should involve the patient in all decision making and ensure that the patient understands all decisions that are made throughout the care process.
In the early 90s, Debi worked at the Federal Reserve Bank of Kansas City as a software engineer. She noticed that the financial sector was highly automated, but the healthcare industry was almost completely reliant on manual entry of data. Medical providers who switched to using EHR (Electronic Health Record) systems found them tedious and difficult to use. To explore the new field, Debi switched from the banking technology industry to medical technology and created software that would allow patients to easily send their information into their physician’s medical record as structured data. This allowed the physician to focus on their patient instead of typing into the EHR. Although it wasn’t in her initial plans, the demand for her technology from medical providers led her to launch PatientLink.
In 2011, Debi was diagnosed with kidney cancer. After years of not feeling well and being told by multiple doctors that she was fine, Debi felt as though her medical providers had given up on her. Finally, a nurse practitioner decided to do a sonogram and found out that Debi had kidney cancer. Immediately following her diagnosis, Debi had many thoughts running through her mind: solemn thoughts, “I want to know—am I going to die?” but also, more productive thoughts, “I wanted to understand what research experts are finding around kidney cancer and other cancers that have impacted my family.” Debi had hundreds of questions for doctors, patients, survivors, and researchers, but no way to get the answers she wanted. According to Debi, many who are diagnosed with cancer appreciate each day that they live more than they did before their diagnosis. Debi’s family had a history of cancer with her sister and two uncles passing away from brain cancer, and Debi began to think, “I was given these days; what is it that I need to accomplish?”.
Debi’s diagnosis and her family’s experience with cancer led her to change the way she viewed EHR data collection and sharing. For twelve years, PatientLink took data reported by the patient and put it into the EHR, to be viewed by providers. This helped providers better understand the patient’s condition. Debi wanted to create software to allow patients to gather their data from their physicians and have it available for their own use, allowing patients to better understand their conditions and make decisions based on all the information. MyLinks was created to make the sharing of data bi-directional; instead of only going from patient to provider, patients and providers could share data both ways. Also, MyLinks assists in making sure that the information from different providers is in one place, controlled by each patient, and conforms to FHIR standards. Debi also wanted to have an easy platform for patients to find and enroll in clinical trials. Clinical trial matching, enrollment, and data sharing is an important part of MyLinks. Now that patients have all their data, they are empowered to use their data to improve and prolong their lives.
Patient-Provider Communication for the Elderly and their Caretakers
Sharon Hensley Alford is the Co-founder and Chief Information Officer of Cancer Insights. After her sister was diagnosed with metastatic breast cancer at the age of 29, Sharon decided to do her PhD in breast cancer epidemiology. Sharon’s sister experienced poor communication and a lack of trust with her first doctor. This, in part, made her move to a larger more established healthcare organization. Through her work as a patient advocate and her sister’s experience, Sharon realized a common trend, “When patients are not in an integrated delivery system and dealing with docs who are in silos, it makes that care coordination [and] information sharing not only with the patient but between clinicians difficult.” Patients who need access to doctors outside of their primary care network experience gaps in communication that have the potential to deteriorate the quality of care they receive.
For Natalia Johnson, a caretaker for her late father who was diagnosed with stage 4 cancer of the head and neck in April 2018, communication between her father and his providers was challenging. Unfortunately, Natalia’s father passed away in August of 2019. During her father’s final months, Natalia used her time off during maternity leave to help her mother take care of her father. Natalia’s sister was also able to help because she worked part time. Natalia and her family made sure that when her father had an appointment, there would always be someone available to take him to the doctor’s office. After being diagnosed, some of the doctors— a special dentist, ENT, and gastroenterologist—were out of the healthcare network that he normally visited and communication became more challenging, “It makes it really hard for the patient—let alone the family—to communicate with the doctors outside of those who usually see him.” Aside from her father’s primary oncologist and a few other doctors, many doctors needed to be told verbally by her father and family of recent developments in her father’s health record before and during each appointment. “We wish there was a system in which you could look up the patient and see all of the health history instead of each time we have to go and reexplain things from top to bottom on what has happened so far.” Elderly patients have an especially difficult time, “For patients who don’t have a family to help them—keeping track of all the appointments and doctors—it’s almost impossible. There were three of us who were able to do it together. I don’t think if it were me by myself or my mom by herself, we would be able to handle it.”
Ensuring Patients are on the Same Page with their Providers
To better understand how communication can affect the patient experience I spoke with Julie Krause a patient advocate for Fight CRC and The Alliance for Clinical Trials in Oncology’s Patient Advocacy Committee. According to Julie, communication is crucial to ensuring patients are on the same page as their oncologists when making decisions about their treatment, “Some doctors say these are the pitfalls and the risks, I’m leaving the decision up to you. Other patients don’t want that type of doctor, they want a doctor to tell them what to do.” Either way, patients need to be able to make the final decision on their treatment, and patient-centered care is care that works together with the patient to come to the best solution.
Omkar Ratnaparkhi is a rising senior at Fordham University and is sharing patient stories to highlight firsthand accounts of the cancer patient experience.
Join the mCODE/CodeX Community of Practice next Friday to hear Jessica Skopac from MITRE who will provide an introduction to HL7 Fast Healthcare Interoperability Resources (FHIR). Register for the July 30, 12-1 ET call.
New Member Joins the CodeX Movement
The work of the CodeX Community is moved forward by the dedicated work of our Members.
Principia Health joined CodeX as a Developer/Implementer Member this month. The Principia Health team will inform development efforts of the CDC’s MedMorph architecture using their FHIR expertise and familiarity of the CIBMTR SMART on FHIR app.
Please email Steve Bratt or Kim Ball if your organization would like to learn more about becoming a CodeX Member and drive the future of “Smarter data for the fight against cancer.”
Recent CodeX Use Case Achievements
Use cases leveraging the mCODE standard are making substantial progress. CodeX teams are demonstrating how the mCODE standard can be employed to collect oncology data once and enable it to be shared for multiple purposes. Here are the most recent updates for CodeX use cases:
ICAREdata or EHR Endpoints for Clinical Trials continues to expand training across the nine health systems that are implementing tools to capture and/or extract mCODE data in their electronic health record systems, with collection underway at three institutions. Five clinical trials partnered with this use case to have ICAREdata methods embedded in their protocols and more trials are under joining through a companion protocol.
The Trial Matching use case team will present an early look at its Phase 1 results at the September Community of Practice meeting. (Register here) Final tasks include (a) converting patient data from the University of Texas Southwestern Medical Center into mCODE records, (b) running the records through clinical trial matching services to conduct analysis on the discriminatory value of the optimized patient data elements and (c) wrapping up the pilot with Cancer Insights. The team will discuss the findings from the patient data manager application (Phase 1A) and EHR (Phase 1B) pilots. The team would like to congratulate TrialJectory on completion of their now mCODE-enabled matching service! Please contact Caroline Potteiger (cpotteiger@mitre.org) for more information and to join this work.
The use case for cancer Registry Reporting is planning a pilot for a proof of concept with the University of California San Francisco and the California Cancer Registry (additional California based systems are welcome to join this pilot). The team is also coordinating with the Michigan Cancer Surveillance Program (MCSP) for support of a pilot activity involving Michigan based health systems. All pilots plan to leverage the CDC’s eCR/MedMorph Reference Architecture, with a cancer reporting module specifically developed for this use case. Reach out to Greg Shemancik (gshemancik@mitre.org) for more information and to join in the work.
The Radiation Therapy use case continues to plan for the Integrating the Healthcare Enterprise – Radiation Oncology (IHE-RO) Connectathon in early November. At the connectathon the radiation therapy end of treatment summary data defined by the CodeX Radiation Therapy team will be created and tested via vendor systems. The team is also defining and modeling radiation therapy prescription data elements, preparing for the transmission of an in-progress treatment summaries. Reach out to Anthony DiDonato (adidonato@mitre.org) if you’re interested in joining this project.
The Prior Authorization in Oncology team will begin hosting open meetings to continue the community discussion from June 3rd to explore current state of problems faced in provider-payer oncology data exchange. Starting on July 27th, the team will lead public working sessions to drive toward standards that leverage FHIR, including the Da Vinci and mCODE Implementation Guides. See the HL7 Calendar for details and to add the meeting to your calendar. All interested community members are welcome. Reach out to kim.ball@pocp.com with any questions or for more information about joining this effort.
mCODE/CodeX Community of Practice Recap
The June 25th mCODE/CodeX Community of Practice call (presentation slides and recording) featured presentations from Ryan Bernard, Technical Coordinator and Team Lead, Epic, discussing current and future support plans for mCODE, as well as Melanie Combs-Dyer, Director of Innovation, Mettle Solutions, and Sreekanth Puram, CTO, Mettle Solutions, delivering an update and proof-of-concept demonstration on behalf of the CodeX Prior Authorization in Oncology use case team.
Ryan covered the current documentation support for mCODE accessible within Epic to support the ICAREdata use case. Highlights included Epic’s build guide for mCODE, which includes step-by-step directions for building Smartforms that streamline documentation (using quick buttons) of critical mCODE data elements—like disease status and reason for disease status. (Note: As of November 2020, this Smartform is already pre-built into Epic and can be used in provider workflows as is.) The build guide also includes directions for adding “reminders” to ensure data collection. Ryan also discussed Epic’s approach to implementing the next waves of mCODE data elements in Epic systems. The first wave includes approximately 32 data elements critical to advancing CodeX use cases. Epic customers can also anticipate implementation guides to support analysis of mCODE data elements that are being captured. All vendors interested in supporting mCODE are welcome to engage in the CodeX community.
Next Melanie presented key themes and next steps from the Codex Prior Authorization in Oncology use case team’s June 3 public discovery session. Sreekanth followed the summary with a demonstration of the team’s initial proof of concept using a mock EHR and medication order workflow – showing how a provider would check payer prior authorization requirements for a medication order, interact with a questionnaire pre-populated with existing EHR data and submit the data back to the payers. The proof-of-concept highlights use of mCODE data elements as well as existing Da Vinci Burden Reduction Project standards applied to oncology.
mCODE Update
The mCODE standard is currently available for use as a first version of a standard for trial use, referred to as STU1. A second version of the standard (STU2) has been balloted by the standards community, and about 65 comments on the revised version have been submitted, based on CodeX experience and other stakeholder input. Follow progress on mCODE by reviewing the continuous integration (CI) build. Also, review differences between STU1 and STU2 via this change log.
Look for the 2.0 release in September.
Upcoming Events
- Join the July CodeX/mCODE Community of Practice call next Friday with Jessica Skopac from MITRE who will be providing an introduction to HL7 Fast Healthcare Interoperability Resources (FHIR). Register for the July 30, 12-1 ET call. Participation is open to all.
- Prior Authorization in Oncology Working Session – July 27, 10:30-11:30 a.m. ET. See the HL7 Calendar
- Connect with CodeX at HIMSS! Andre Quina, Principal Investigator, Oncology Standard Health Record at MITRE, will participate in the HIMSS Interoperability Showcase in a session titled “Igniting Interoperability with the FHIR Accelerators” on August 11, 3-4 ET
Stay in Touch!
If you would like to stay up to date with the latest mCODE and CodeX related news and updates, please go to our CodeX Confluence home page and click "Join a CodeX Listserv." Please contact Steve Bratt or Kim Ball with any questions, comments, or content ideas!
- New Approach Could Make Clinical Trials More Equitable and Accessible. The MITRE Corporation. June 2021.
- The Future of Oncology Data is Happening Now. ASTRO Blog. June 2021.
- American Cancer Society Cancer Action Network. (2021. May 18). ACS CAN and CodeX Lead Project to Expand Cancer Clinical Trial Enrollment Through Improved Technology [Press release]
- Informonster Podcast Steve Bratt, CodeX Program Manager, and Carmela Couderc, Clinical Informaticist at MITRE, to discus mCODE and CodeX and accelerating healthcare innovation. Part One. Part Two.
- "The Dish on Health IT" Podcast - Episode 11: HL7 CodeX: Transforming Cancer Care and Research
Welcome to the CodeX May newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below.
Reminder: Hear from Epic and the CodeX Prior Authorization in Oncology team during the June Community of Practice call this Friday. Register for the June 25, 12-1 ET call.
Recent CodeX Use Case Achievements
Use cases involving the mCODE standard continue to make strides in real-world initiatives, deployments of mCODE are happening more widely, moving beyond synthetic data to real patient data. CodeX teams are demonstrating how the mCODE standard could be employed to collect oncology data once and enabling it to be shared for multiple purposes, such as in gaining prior authorization, adjudicating claims, disseminating information to multiple registries and helping patients and providers find clinical trials.
Recent updates across the eight CodeX active use cases are below:
ICAREdata or EHR Endpoints for Clinical Trials has nine health systems implementing tools to capture and/or extract mCODE data in their electronic health record systems, with collection underway at three institutions. Five clinical trials partnered with this use case to have ICAREdata methods embedded in their protocols and more trials are under joining through a companion protocol.
- The University of Chicago (UChicago) and MITRE teams completed validation of queries to generate comma-separated values (CSV) files to support mCODE extraction. In collaboration with Epic, these queries will be made available to other Epic sites in the community to accelerate implementation.
- The form to capture mCODE Cancer Disease Status is available as Epic-released development to all Epic customers as of the November 2020 release.
- Data modeling work continues for a new ICAREdata pilot for mCODE-enabled adverse event reporting.
The Trial Matching use case is collecting real patient data from patients who have consented and been onboarded to understand whether initial data elements being shared via the standard are sufficient to narrow down the trials for which the patients may qualify. Trial match results are being returned in a FHIR bundle. The team is also collecting app end user feedback from patient and providers to inform Phase 2 work and scaling conversations.
The use case for cancer Registry Reporting continues to work with the Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR) and additional organizations to identify data elements required for reporting information to cancer registries including mCODE. Team members are planning a pilot for a proof of concept with the University of California San Francisco and the California Cancer Registry - additional California based systems are welcome to join this pilot. The team is also coordinating with the Michigan Cancer Surveillance Program (MCSP) for support of a pilot activity involving Michigan based health systems, again interested systems are welcome to join. All pilots plan to leverage the CDC’s eCR/MedMorph Reference Architecture, with a cancer reporting module specifically developed for this use case. Reach out to Greg Shemancik (gshemancik@mitre.org) for more information.
The Radiation Therapy use case team moved to the Execution stage after the CodeX Steering Committee meeting vote on June 2nd. With much of the planning completed, the use case team is expected to participate in the Integrating the Healthcare Enterprise – Radiation Oncology (IHE-RO) Connectathon in early November. During this Connectathon, radiation oncology systems will generate end of treatment summary reports that will be retrieved by other information systems. This radiation therapy end of treatment summary data has been defined by the CodeX Radiation Therapy terminology team and will be used and tested by the CodeX vendor systems participating at the IHE-RO Connectathon. Currently, substantial testing and technical documentation work is underway to prepare for these Connectathon goals and deliverables. Additionally, the terminology team is meeting to define and model radiation therapy prescription data elements, which will be leveraged to achieve transmission of an in-progress treatment summary – the project team’s anticipated next phase of work. Reach out to Anthony DiDonato (adidonato@mitre.org) if you’re interested in joining this project.
The Prior Authorization in Oncology team hosted a multi-stakeholder discovery session with 70 participants on June 3. Review the session summary and next steps from this lively 90-minute session. The team is planning a second public discovery session to identify a strong starting place to advance provider-payer data exchange within the oncology ecosystem. Look for registration information to join CodeX Members United Healthcare/Optum, MITRE, Mettle Solutions, and Pfizer for a follow-on session. All interested community members are welcome. Reach out to kim.ball@pocp.com with any questions or for more information about joining this effort.
mCODE/CodeX Community of Practice Recap - mCODE Role in Exchanging Genomic Data Has Potential
A large audience on the May 28th mCODE/CodeX Community of Practice call (presentation slides and recording) heard Dr. Jim Chen, Associate Professor, Medical Director, Clinical/Research Informatics James CCC from The Ohio State University present “Small Data – for Big Data: mCODE and Genomics.”
The use of mCODE in exchanging genomic data for a variety of purposes could support better patient care and research, contends Jim Chen, MD, medical director of clinical and research informatics at the James Comprehensive Cancer Center of The Ohio State University.
During the presentation, Chen called on attendees to work toward a use case that could enable an mCODE approach to improving the capture and sharing of genomic information.
There’s a growing understanding that no two patients, diseases or responses to treatment are alike, and the growing use of genomic research can help optimize treatment by taking patient variations into account, Chen said. This is particularly true in oncology care, where biomarkers are helping to identify cancer variations and the best approaches to treatment.
Clinical pathways are becoming increasingly complex as oncologists and researchers look to improve cancer treatment. “Therapies and biomarkers are multiplying, and there are also emerging biomarkers being discovered,” he added. Multiplied across all cancer types, that can result in increased opportunities to personalize care – but more challenges for clinicians, who need better ways to exchange information.
However, no standards exist for exchanging data on the increasing number of biomarkers, and the importance of that grows as genomic testing gains complexity. Where in the past genomic testing would look at a single gene marker, today it’s more likely to involve comprehensive genomic panels. Various companies are promoting these panels, and they generally used proprietary formats. “There are no standards for transmitting molecular data,” Chen asserted.
That’s where work by CodeX could make a difference, he said. Finding a standardized way to share biomarker information could result in huge benefits in care for cancer patients. “If we don’t get the biomarker right, your patient is not going to get treated (correctly),” he said. “If you don’t have the key fact right,” it can change medical care. For example, there are no ways to represent fusion genes.
“There are even more biomarkers on the horizon. People are talking about this idea of immune-phenotyping, for example what is the expected amount of white blood cells and is that prognostic,” he said. “That’s the challenge you have a limited amount of space to think about a continually growing list of biomarkers.”
The key is to capture all this growing amount of information for patient care, “so we really need to think long and hard about this,” Chen said. “There are many sorts of other types of genomic alterations that are actionable. All companies are coming up with their new genomic signatures. But how do you embed that in mCODE. These are the types of things we’re really challenged by.”
The question becomes how this information is effectively transmitted in mCODE, which cannot handle many actionable biomarkers in its current form. So what can we do to change things?” One idea is to create a biomarker template for mCODE, which can contain what the biomarker is, what the biomarker value is and what the biomarker interpretation is. A use case could help with the ability to use FHIR to share patient information across organizations to see if there are applicable treatments. “If I wanted to send a list through mCODE, how would I do that? How would I send a whole host (of patients) at one time?”
“I believe mCODE will shine in the future. Obviously, collaboration will be key. Everybody has a stake in making sure the data is transmitted accurately and consistently,” Chen concluded. “What do we need to know, what is the minimal amount needed to do the work, and that should determine the structure of the data. And how do we transmit this among institutions.”
mCODE Update
The mCODE standard is currently available for use as a first version of a standard for trial use, referred to as STU1. A second version of the standard (STU2) has been balloted by the standards community, and about 65 comments on the revised version have come in, based on CodeX experience and other stakeholder input, for mCODE STU2 closed May 17th. Follow progress on mCODE by reviewing the continuous integration (CI) build. Also, review differences between STU1 and STU2 via this change log.
Look for the 2.0 release in September.
Upcoming Events
Join the June CodeX/mCODE Community of Practice call this Friday with Ryan Bernard, who will provide an update on Epic's implementation of mCODE and plans to iteratively develop an Implementation Guide describing how to collect and access mCODE data elements. Additionally, Melanie Combs-Dyer and Sreekanth Puram from Mettle Solutions will be sharing a summary of the CodeX multi-stakeholder discovery session on oncology provider-payer data exchange. The Prior Authorization team will also be demonstrating a breast cancer chemotherapy regimen prior authorization workflow. Register for the June 25, 12-1 ET call. Participation is open to all.
Stay in Touch!
If you would like to stay up to date with the latest mCODE and CodeX related news and updates, please go to our CodeX Confluence home page and click "Join a CodeX Listserv." Please contact Steve Bratt or Kim Ball with any questions, comments, or content ideas!
mCODE/CodeX in the News
- New Approach Could Make Clinical Trials More Equitable and Accessible. The MITRE Corporation. June 2021.
- The Future of Oncology Data is Happening Now. ASTRO Blog. June 2021.
- American Cancer Society Cancer Action Network. (2021. May 18). ACS CAN and CodeX Lead Project to Expand Cancer Clinical Trial Enrollment Through Improved Technology [Press release]
- Informonster Podcast Steve Bratt, CodeX Program Manager, and Carmela Couderc, Clinical Informaticist at MITRE, to discus mCODE and CodeX and accelerating healthcare innovation. Part One. Part Two.
- Structured Data Capture for Oncology; Alexander K. Goel, Walter Scott Campbell, and Richard Moldwin; JCO Clinical Cancer Informatics 2021 :5, 194-201
- HL7 News February 2021 Edition - CodeX Community Accelerates Smarter Data for the Fight Against Cancer (p.16)
- HL7 News October 2020 Edition - CodeX Community Stress-Tests the Value of a Common Language for Cancer Data
- "The Dish on Health IT" Podcast - Episode 11: HL7 CodeX: Transforming Cancer Care and Research
Welcome to the CodeX May newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below.
Reminder: Dig into genomics data challenges in the May Community of Practice call this Friday. Register for the May 28, 12-1 ET call.
Recent CodeX Use Case Achievements
CodeX initiatives aim to collect patient data once and then use it for multiple reasons, employing mCODE standards, which are expected to have a growing impact in collecting and sharing cancer data. The standard can create efficiencies in routine data sharing, such as that required by prior authorization, enabling patients to access their information, or sharing data to multiple registries for research or enabling connections to clinical trials.
Recent updates on the progress across the eight CodeX active use case follow. Four are in the Execution Phase – mCODE++ Extraction, ICAREdata, Trial Matching, Registry Reporting. Radiation Therapy is in the Planning Phase, with Members preparing for Execution. Oncology Clinical Pathways, Prior Authorization, and Genomics Data Sharing are in Discovery.
ICAREdata or EHR Endpoints for Clinical Trials is making great progress. Nine health systems are implementing tools to capture and/or extract mCODE data in their electronic health record systems, with collection underway at three institutions.
Thanks to strong partnership with health systems and Epic, implementation of the ICAREdata collection and extraction tools continues to become simpler over time. The University of Chicago (UChicago) and MITRE teams are close to completing validation of queries to generate comma-separated values (CSV) files to support mCODE extraction. In collaboration with Epic, these queries will be made available to other Epic sites in the community to accelerate implementation. Furthermore, the form to capture mCODE Cancer Disease Status is available as Epic-released development to all Epic customers as of the November 2020 release. Data modeling work is underway for a new ICAREdata pilot for mCODE-enabled adverse event reporting.
With the Trial Matching use case, efforts have reached the point where real patient data is being used, and about half a dozen patients have been onboarded. Trial match results are being returned in a FHIR bundle. Further analysis will show whether initial data elements being collected and shared via the standard are sufficient to narrow down the trials that patients may qualify for.
Last week, members of the Trial Matching team—Cancer Insights, MITRE, and PatientLink—participated in the HL7 Connectathon, demonstrating the ability of patient data elements to be sent to mCODE-enabled matching services trials through a patient data management application. Please see the “Connectathon” section for links to the materials presented and learn how to engage in the use case.
Trial Matching use case champion American Cancer Society Cancer Action Network recently published a press release detailing the important work underway and partners involved to improve technology and use of data standards to integrate matching capability into existing medical record systems and patient data management applications to reach more patients and care providers.
The use case for cancer Registry Reporting also is achieving progress, with support from the Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR) and additional organizations working on identifying data elements required for reporting information to cancer registries. Team members are continuing pilot planning for a proof of concept with the University of California San Francisco and the California Cancer Registry leveraging the CDC’s MedMorph Reference Architecture. The registry reporting team has also been meeting with the College of American Pathologists (CAP), exploring ways that mCODE can be bundled with pathology data elements to provide a more robust patient summary to state registries.
The Radiation Therapy use case team expects to move into the Execution stage after the CodeX Steering Committee meeting on June 2nd, with champions American Society for Radiation Oncology (ASTRO) and the American Association of Physicists in Medicine (AAPM) playing a lead role in solidifying terminology and architecture. Along with ASTRO and AAPM, CodeX Members Canadian Organization of Medical Physicists (COMP), MITRE, Society for Imaging Informatics in Medicine (SIIM), Varian, and Wemedoo are collaborating with others to develop, test and deploy open data standards that enable interoperable, multi-purpose exchange of radiation therapy treatment summary data for care coordination and data reuse. This team contributed to the definition of new radiation therapy concepts in mCODE and were submitted as part of mCODE STU 2.
The Prior Authorization in Oncology team is hosting a multi-stakeholder discovery session on June 3, 1-2:30 ET to learn more about current state problems being faced in provider-payer data exchange and where FHIR standardization can add the most value within the oncology ecosystem. CodeX Members United Healthcare/Optum, MITRE, Mettle Solutions, and Pfizer will be joined by CodeX program management support organization Point-of-Care Partners and interested community members representing payers, health systems, electronic health record system vendors, clinical pathway vendors, government agencies and patient advocacy organizations. Click on the following link to register: http://bit.ly/CodeXListeningSession
HL7 FHIR CONNECTATHON Synopsis
From May 17th to 19th, CodeX Members and program management staff participated in the Virtual HL7 FHIR CONNECTATHON to demonstrate prototypes, test backend application development progress, and take in feedback from the larger HL7 community.
The Trial Matching team led a track at the Connectathon with two scenarios. The first scenario could be completed by any FHIR developer and showed how patients using an mCODE record could request and receive potential clinical trial matches. The second scenario detailed how a clinical trial matching service could mCODE-enable their matching service by creating a matching service wrapper. The team also put together two demos, showing how a patient can send data to clinical trial matching services and view the results, all through a patient data manager application. Full track details can be found here.
The Cancer Registry Reporting team attended the two-day MedMorph Track of the May Connectathon, testing and evaluating the MedMorph reference architecture that underpins the registry reporting use case. The MITRE team developed a Backend Services App which was successfully tested on Day 2 and operates as the core component of the MedMorph reference architecture, submitting data from a test EHR to a test state registry. Full MedMorph track details can be found here.
On behalf of the Prior Authorization in Oncology team, CodeX Members Mettle Solutions and MITRE demonstrated a colorectal cancer and breast cancer chemotherapy regimen prior authorization workflow that leverages existing standards in the oncology context as part of Da Vinci Project Burden Reduction Track. The workflow outlines a way for payers and providers to efficiently communicate and exchange information—bundling multiple services—to execute prior authorizations in oncology. More information can be found on the Connectathon Confluence site: breast cancer chemotherapy example and colorectal cancer example.
mCODE Community of Practice Recap
The April Community of Practice presentation (slides and recordings part 1, part 2, part 3) focused on the realities of clinical trials data—how crucial it is to ensure data quality—with multiple manual steps required to verify the accuracy of information and then gather it so it can be disseminated.
But mCODE offers the potential to facilitate data collection and exchange, said Vivek Upadhyay, a fellow in hematology and oncology at Dana-Farber Cancer Institute and a joint fellow in Clinical Informatics at Mass General Brigham. He described current efforts at his organization to implement mCODE data collection tools developed through and supported by the ICAREdata use case.
The value of automating the clinical trial data process became painfully obvious during the COVID-19 pandemic, because remote monitoring of patients added extra expense and work to the process of verifying clinical trial information. Data verification, typically called monitoring “is very expensive — it accounts for one third of all costs in clinical trials. For example, a 100-patient Phase 2 clinical trial may cost a total of $20 million to conduct, but $7 million to $8 million of that cost likely would be directed to monitoring,” he said.
The pandemic sparked interest in electronic initiatives, such as eSource and a FHIR-based approach, which is expected to achieve more efficiency. “FHIR allows more efficiency,” Upadhyay said. In particular, FHIR offers more potential in effectively gathering and sharing unstructured data, such as in the information contained in SOAP notes. “That’s where mCODE-based solutions offer a profound solution — it enables the information that is unstructured to be formatted in a way that is structured.”
At Mass General Brigham, two tests of mCODE are underway to measure the results of treatment. One of the tests involves patients with solid tumors and measuring the effects of high doses of vitamin D in conjunction with standard chemotherapy, while the other is studying the effect of genomics-guided treatments for patients with brain metastasis.
The effort to gather clinical data on these patients is challenging because it involves multiple patients being treated at several institutions; however, because it involved organizations all using the same instance of the Epic records system, patient data could be collected more easily by using a SmartForm within the Epic record.
Much work lies ahead, but automated, standardized data collection in these trials could greatly reduce the manpower needed now in data-gathering, particularly for initiatives that feed data into cancer registries, he said.
mCODE Update
HL7 ballot comments (based on CodeX experience and other stakeholder input) for mCODE STU2 closed May 17th. Follow progress on mCODE by reviewing the continuous integration (CI) build. Also, review differences between STU1 and STU2 via this change log.
Look for the 2.0 release in September.
Upcoming Events
- Join the May CodeX/mCODE Community of Practice call this Friday with Dr. James Chen of Ohio State University, who will be discussing challenges to standardizing and structuring genomics data, how mCODE is working to improve these challenges, and an early introduction to the CodeX genomics work group . Register for the May 28, 12-1 ET call. Participation is open to all.
- AHIP will have its Institute and Expo virtually, June 22 to 24. Hear from Steve Bratt, CodeX Program Manager, June 23, 12:30 p.m. - 1:15 p.m. EST, in a panel titled Creating Scalable Data Solutions with Multistakeholder Collaboratives along with a HL7 FHIR Accelerator colleagues, Lenel James (Blue Cross Blue Shield Association), Jocelyn Keegan (Point-of-Care Partners) and Patrick Murta (Humana).
- More information, including registration links, can be found at https://www.ahip.org/events/institute-expo-online/#d=all. Steve Bratt, CodeX Program Manager, will participate in a panel titled Creating Scalable Data Solutions with Multi-stakeholder Collaboratives.
mCODE/CodeX in the News
- American Cancer Society Cancer Action Network. (2021. May 18). ACS CAN and CodeX Lead Project to Expand Cancer Clinical Trial Enrollment Through Improved Technology [Press release]
- Informonster Podcast Steve Bratt, CodeX Program Manager, and Carmela Couderc, Clinical Informaticist at MITRE, to discus mCODE and CodeX and accelerating healthcare innovation. Part One. Part Two.
- Structured Data Capture for Oncology; Alexander K. Goel, Walter Scott Campbell, and Richard Moldwin; JCO Clinical Cancer Informatics 2021 :5, 194-201
- HL7 News February 2021 Edition - CodeX Community Accelerates Smarter Data for the Fight Against Cancer (p.16)
- HL7 News October 2020 Edition - CodeX Community Stress-Tests the Value of a Common Language for Cancer Data
- "The Dish on Health IT" Podcast - Episode 11: HL7 CodeX: Transforming Cancer Care and Research
Stay in Touch!
If you would like to stay up to date with the latest mCODE and CodeX related news and updates, please go to our CodeX Confluence home page and click "Join a CodeX Listserv." Please contact Steve Bratt or Kim Ball with any questions, comments, or content ideas!
Welcome to the CodeX April newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below. |
Join Us in Welcoming our Newest CodeX MembersThe work of the CodeX Community is moved forward by the dedicated work of our Members, and we are excited to announce the addition of new Members to join in the effort. These new Members represent key perspectives in the cancer ecosystem and will dedicate time and effort to advance CodeX use cases. New Members include the Michigan Cancer Surveillance Program as a government agency member; the Canadian Organization of Medical Physicists (COMP), the Learning Health Community and the Society for Imaging Informatics in Medicine(SIIM) as sponsored members; and Massive Bio, NeuralFrame and PatientLink as developers/implementers. Please email Steve Bratt or Kim Ball if your organization would like to become a CodeX Member and drive the future of “Smarter data for the fight against cancer.” Recent CodeX Use Case AchievementsAt the March 26 Community of Practice meeting (recording and presentation), Steve Bratt provided an update on progress so far this year on the seven active use case projects under the CodeX umbrella. Four are in the Execution Stage – mCODE++ Extraction, ICAREdata, Trial Matching, Registry Reporting. Radiation Therapy is in the Planning Stage, with Members preparing for Execution. Oncology Clinical Pathways, Prior Authorization, and Genomics Data Sharing are in Discovery. Here are some highlights from the presentation: ICAREdata (EHR Endpoints for Clinical Trials) is in Phase 2, with several health systems implementing the mCODE-based data collection and extraction tools or planning to do so. Recently, the University of Chicago successfully tested their implementation of the mCODE extraction framework and ICAREdata client with synthetic data. Five health systems have made the ICAREdata collection tools available in their production EHR environments (Massachusetts General Hospital (MGH), Brigham and Women’s Hospital, Dana Farber Cancer Institute (DFCI), Mayo Clinic, and University of Pennsylvania). Collection is underway at MGH, DFCI, and Mayo Clinic. With support from CodeX Member and use case champion the Alliance for Clinical Trials in Oncology Foundation, clinical trial partnerships are expanding. Five clinical trials have or will soon launch with ICAREdata methods embedded in their protocols; a recently approved companion study protocol will enable even broader partnership with Alliance clinical trials. Data modeling work is underway for a new ICAREdata pilot for mCODE-enabled adverse event reporting. Work is also advancing with Trial Matching; Cancer Insights, Massive Bio, and University of Texas Southwestern Medical Center (UTSW) are pilot testing the use case. Several patients have signed up to participate by joining the Cancer Insights application to test the value and usability of this approach. Additionally, a study has been activated at UTSW and Massive Bio to send patient data through multiple mCODE-enabled matching services to test the discriminatory value of the optimized patient data elements. The team championed by CodeX Member American Cancer Society Cancer Action Network expects to have patient data in place to test matching in April. In tandem with the upcoming HL7 Connectathon, there is a potential opportunity to test mCODE-enabled matching services to find clinical trials and engage with other community members. Register now for the HL7 FHIR Connectathon, May 17 to 19, and join this team to test the CodeX Integrated Trial Matching for Cancer Patients and Providers implementation guide in the Trial Matching Connectathon track. In Registry Reporting, the terminology and technical architecture sub-workgroups continue to meet, determining items such as data elements for Phase 1 implementation and Pilot Activity reporting capabilities respectively. The Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR) continue to champion this use case, along with the newly added Michigan Cancer Surveillance Program. Contributors are currently scoping a Pilot Activity leveraging the CDC’s MedMorph Reference Architecture, fulfilling a proof of concept with the University of California San Francisco and the California Cancer Registry. All in the effort of collecting data in an EHR once and sharing that data in a registry agnostic and low-burden way. Radiation Therapy Treatment Data is in the Planning Stage and is close to moving to execution. Champions for this use case include the American Society for Radiation Oncology (ASTRO) and the American Association of Physicists in Medicine (AAPM). CodeX Members ASTRO, AAPM, MITRE, Varian, COMP, SIIM, and Wemedoo are collaborating with others to develop, test and deploy open data standards that enable interoperable, multi-purpose exchange of radiation therapy treatment summary data for care coordination and data reuse. This team is making progress in defining the radiation therapy treatment data elements that will be generated as a summary report and exchanged between systems. Work in this group is influencing the next version of mCODE. Parties interested in Prior Authorization in Oncology , including CodeX Members United Healthcare and Mettle Solutions, worked on a proof of concept showing how a patient’s mCODE-based health data could help inform a payer’s prior authorization or requests for additional information for treatments. The team is actively seeking payer and health system collaborators and additional partners from the cancer ecosystem to learn more about current state problems being faced in provider-payer data exchange and where FHIR standardization can add the most value within the oncology ecosystem. Stay tuned for an email invite to the upcoming multi-stakeholder discovery sessions. Report Shows mCODE ProgressAt the March Community of Practice meeting, Dr. Mark Kramer, chief engineer for MITRE, provided a progress report for the mCODE standard. Proposed updates to mCODE based on CodeX experience and other stakeholder input - mCODE STU2 are being ballots in HL7 now, and through mid-May. Subsequent to the STU2 ballot, Dr. Mark Kramer expects release of the newest version of the standard in the fall. Because of the range of organizations working on CodeX initiatives supporting these advances, Dr. Mark Kramer believes “the transition from STU1 to STU2 will be relatively smooth.” Upcoming Events
mCODE/CodeX in the News
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Stay in Touch!If you would like to stay up to date with the latest mCODE and CodeX related news and updates, please go to our CodeX Confluence home page and click "Join a CodeX Listserv." Please contact Steve Bratt or Kim Ball with any questions, comments, or content ideas! Thank you, |
CodeX (Common Oncology Data Elements eXtensions) is an HL7 FHIR Accelerator building a community – through new applications and use cases – around the mCODE (minimal Common Oncology Data Elements) FHIR Implementation Guide. mCODE STU1 describes a set of 90 essential data elements that will enable the interoperable exchange of cancer patient data and step-change improvements in cancer care and research. Refer to the mCODE and CodeX overview slide deck for more information.
Founding Member Opportunity
The opportunity to join CodeX as a Founding Member ends December 31st, 2020. This special membership option is designed for organizations to get in on the ground level and lead in developing project plans, engaging partners, and overseeing project work. Please email Steve Bratt (sbratt@mitre.org) or Anthony DiDonato (adidonato@mitre.org) if you would like to learn more and discuss this opportunity.
New Members Contributing New Perspectives
CodeX welcomes new Members: American Association of Physicists in Medicine (AAPM) recently joined as a Founder. TrialJectory joined as a Member. Varian, Mettle Solutions and Quantum Leap Healthcare Collaborative have joined as Developer/Implementers. Several leading health systems, vendors, payers, and others are discussing joining CodeX.
Recent CodeX Use Case Achievements
CodeX has seven active use case projects: four in Execution Phase – mCODE++ Extraction, ICAREdata, Trial Matching, Registry Reporting – and three in Planning Phase – Oncology Clinical Pathways, Prior Authorization, and Radiation Therapy.
Here are some highlights:
- The Registry Reporting use case kicked off on October 27th, now holding regular Member leadership and workgroup meetings. Meeting notes are available on the Registry Reporting meetings page. Led by CodeX Members the Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR), the plan for Phase 0 is to send mCODE-compliant demographic data from two or three health systems to the California Cancer Registry and the CIBMTR registry. This proof of concept will highlight the ability to collect mCODE data once and share with multiple registries. Future phases become increasingly ambitious. To get involved on the ground level of this project, please feel free to reach out to Greg Shemancik (gshemancik@mitre.org).
- The Trial Matching use case project team has completed their Phase 0 work by demonstrating the ability of a trial matching service to receive an mCODE record, analyze the record to make matches, and then present the matches back to the patient or provider. To view more information about these achievements, take a look at the Phase 0 final report. The team is now in the process of completing Phase 1. Phase 1 aims to send patient records to multiple mCODE-enabled trial matching services to demonstrate mCODE enablement and evaluate the effectiveness of the optimized patient data elements. If you would like to join this project team and participate on these workgroup meetings, please contact Caroline Potteiger (cpotteiger@mitre.org) regarding project opportunities.
This use case is sponsored by the Biomedical Research and Regulation (BR&R) Work Group.
- The Radiation Therapy use case team is conducting their first workgroup meeting on December 11th. CodeX Members will be leading development of a project plan, with activities, deliverables and measures for multiple phases of work. This team is working to highlight a minimal set of mCODE data elements that will be used for future Phase 0 work, sending data from specialty radiation oncology systems to the main health system EHR. If you would like to join the Radiation Therapy team and participate in these workgroup meetings, please contact George Neyarapally (gneyarapally@mitre.org) or Sharon Sebastian (ssebastian@mitre.org).
mCODE Community of Practice
Each month, the Community gathers to discuss the mCODE standard and applications in the real world being developed through CodeX. During these conversations, participants:
- Update the community on the latest developments and innovations regarding mCODE and CodeX
- Share best practices for clinical workflows, data modeling, and data exchange
- Ask questions and learn from the experience of other community members
Visit the mCODE Community of Practice (CoP) Monthly Meeting Minutes page to learn more about upcoming Community of Practice monthly meetings and view resources from previous calls.
Please register here to join the next meeting, and feel free to tell your colleagues. Participation is open to all.
mCODE Educational Resources
The mCODE team recently published mCODE resources that provide overviews of mCODE profiles and categories, a playbook that offers guidance and best practices for the implementation of mCODE in health systems’ IT software, and how mCODE compares to other research-oriented standards. Interested community members are able to search for detailed information about the mCODE profiles, model best practices, and troubleshoot tips for common problems. Please reach out to May Terry (mayt@mitre.org) or Caroline Potteiger (cpotteiger@mitre.org) to learn more.
Stay in Touch!
If you would like to stay up to date with the latest mCODE and CodeX related news and updates, please go to our CodeX Confluence home page and click "Join a CodeX Listserv". Please don't hesitate to reach out to Steve Bratt sbratt@mitre.org or Anthony DiDonato adidonato@mitre.org with any questions or comments!
Thank you,
The CodeX Community Support Team
Welcome to the CodeX September newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below.
Join Us in Welcoming our Newest CodeX Members
We are excited to announce the Centers for Disease Control and Prevention (CDC) has joined CodeX as a Founder/Premier member.
The American Cancer Society Cancer Action Network (ACS CAN) has also joined CodeX as a Founder/Premier member.
And niAnalytics, a software development company with expertise in radiation therapy, has joined as a Developer/Implementer member.
Please email me, Steve Bratt (sbratt@mitre.org), if you’d to like to become a CodeX member and drive the future of smarter data for the fight against cancer. Founder membership opportunities extend through the end of 2020.
Integrated Trial Matching - Open Public Call
The Integrated Trial Matching use case team had an open call on September 16th where they discussed recent achievements in their effort to make clinical trial participation equitable and easy for all patients and providers.
The open call provided background information on this project, a demonstration of the work done in Phase 0 (implementation of a proof-of-concept), and discussed details for future phases. Please follow this link if you would like to view the presentation slides and a video of the Phase 0 demonstration.
Registry Reporting Use Case - Starting Soon
The Registry Reporting CodeX use case team is excited to announce that project work will begin in October 2020! Stay informed by visiting the Registry Reporting Confluence page for information related to the project kickoff and any other exciting news and updates. The project team is in communication with health systems interested in piloting the solution, and also exploring how synthetic data could enhance the use case.
Oncology Clinical Pathways: Prior Authorization
CodeX presented at the Da Vinci Burden Reduction weekly call on August 28th and discussed how to leverage oncology clinical pathways and mCODE data elements supporting prior authorization. The use case goal is to improve the current state of oncology prior authorization to reduce clinical burden when requesting oncology treatment regimens.
Also some exciting news in the health information exchange world: The Council for Affordable Quality Healthcare Committee on Operating Rules for Information Exchange (CAQH CORE) updated the Prior Authorization and Referrals (278) Infrastructure Rules. Notably, the rule requires that there be a 2-business-day response turnaround by payers for a provider's prior authorization request, once all documentation is provided.
mCODE Education Materials and Knowledge Base
Coming soon: the mCODE (minimum Common Oncology Data Elements) Confluence page will contain educational resources such as knowledge base articles and FAQs. Interested mCODE community members will be able to search for detailed information of the mCODE profiles, model best practices, and troubleshoot tips for common problems.
mCODE Community of Practice
The next Community of Practice meeting will be held on September 25th, 2020 from 12-1pm ET. To join this call, register here. This month we will have two presentations: Keri Reardon, Senior Director at Alliance for Clinical Trials in Oncology, will be giving updates to the ICAREdata project, and Rob Lieberthal, Principal Health Economist at MITRE, will be discussing the health economics of mCODE and CodeX.
Upcoming Briefings - HL7 Birds of a Feather
CodeX will be presenting at the HL7 34th Annual Plenary and Working Group Meeting on Tuesday, September 22nd at 6pm ET. This five day virtual event provides valuable news, updates, and educational resources to the health IT community, as well as the opportunity for HL7 work groups to come together and work on standards. To register and pay for this working group meeting, visit the HL7 events page. (presentation can be found here)
mCODE/CodeX in the News
- Healthcare Innovation: ICARE Study Gathers EHR Data for Oncology Research
- Healthcare IT News: MITRE working with Nuance and Mayo Clinic on AI and automation for clinical datasets
- NASEM Health and Medicine Division - Monica Bertagnolli, Dana-Farber Cancer Institute/Brigham and Women’s Cancer Center
Stay in Touch!
If you would like to stay up-to-date with the latest mCODE and CodeX related news and updates, please go to the CodeX home page, click on “Join a CodeX Listserv” and add their names to the CoP and/or other email lists.
Thank you,
The CodeX Community Support Team
The CodeX Oncology Clinical Pathways: Prior Authorization project team will be presenting at the Da Vinci Prior Authorization Support weekly conference call on Friday, August 28th at 3pm EDT. If you would like to join the call, please follow this link.
Led by Dr. Jim O’Connor and Carmela Couderc, the CodeX Prior Authorization team will discuss how to leverage oncology clinical pathways and mCODE data elements supporting prior authorization. The use case goal is to improve the current state of oncology prior authorization to reduce clinical burden when requesting oncology treatment regimens.
Dear CodeX Community
Since our last update on mCODE and CodeX, the world has changed dramatically. I hope you and yours are safe.
If you are on reading this, you also understand the impact that cancer has on those close to and far from you and yours. You understand the potential for a common language for cancer data to improve cancer care, research and policy, and to reduce burden and cost.
Here is an abbreviated summary of the substantial progress over the past 4 months:
mCODE Standard
- The mCODE 1.0 FHIR Implementation Guide (IG) officially became an HL7 Standard for Trial Use on March 18th. This is a big deal. It signals to vendors and other implementers that mCODE is stable and ready for developers to kick the tires. We are already seeing vendors implementing this version of mCODE.
Building the CodeX Community
- Many thanks to our Founding CodeX members, so far! A number of other organizations are in the process of joining. CodeX members drive development and execution of Use-Case-Based Projects and support sustainable program management for the vibrant community that CodeX aims to be. Due to challenges that many are facing, and in response to requests, we’ve extended the deadline for organizations to be Founders until the end of 2020. Our first member meeting/call is being planned for August or September. Please email me, Steve Bratt (sbratt@mitre.org), if you’d to like to become a CodeX member and drive the future of smarter data for the fight against cancer.
- The CodeX / mCODE Community of Practice (CoP) has been an amazing forum. The CoP open the public as a place for sharing updates on CodeX use case projects, as well as sharing independent initiatives that organizations are conducting with mCODE as their lingua franca. To receive notices about future CoP calls, go to the CodeX home page, click on "Join a CodeX Listserv" (upper right side of home page), and add your name and organization to the CoP and other email lists.
Use Case Projects
- The most advanced of our CodeX projects is “Integrated Trial Matching for Cancer Patients and Providers”. Phase 0 – a Proof of Concept using only mCODE data elements – is nearly complete. The American Cancer Society’s Cancer Action Network, Cancer Insights, TrialScope, BreastCancerTrials.org, MITRE and others are collaborating to enable mCODE-based, interoperable, scalable, and accessible clinical trial matching services that give patients and their providers maximum visibility into reasonable trial matches. The next public meeting and demonstration is scheduled for September 16, 2020 at 1PM ET. Register here.
- Use Cases in the Planning Phase include Registry Reporting, Radiation Therapy Treatment Data, and Clinical Pathways / Prior Authorization Support. We are working with current and prospective members and partners to develop plans that include identified stakeholders, short phases, clear objectives and deliverables, and measures of success. Expect announcements on some of these over the next 2 months.
- Many thanks to presenters Dr. Lawrence Shulman and Dr. Peter Gabriel of UPenn, Melanie Combs-Dyer from Mettle Solutions, and Tyler Haydell from Flatiron Health for their excellent presentations at the “Oncology Clinical Pathways: Prior Authorization Listening Session”. Please join (see above) the July 31, 2020 CodeX mCODE Community of Practice meeting on July 31, noon EDT, where we’ll discuss the CodeX Oncology Clinical Pathways: Prior Authorization use case. If you would like to attend this month’s CoP call, please register here.
Synthetic mCODE Data for Testing and Demos
- Finally, we all know the importance of data to developing and demonstrating functional software and workflows to support use cases. Real patient data is best, but has limitations due to PHI/PII. Perhaps the most advance synthetic patient health record generator is Synthea™ an open-source patient population simulation made available by The MITRE Corporation. We’ve used Synthea to generate 2200 synthetic mCODE records for patients with a focus on breast cancer. Please have a look, and let us know what you think. We are working to generate additional records for synthetic patients with Diffuse Large B Cell Lymphoma (DLBCL), so that we will have a test data appropriate for hematologic cancers and CAR-T therapies.
Looking forward to your questions and participation in our shared mission.
Best regards,
Steve
--
Steven R. Bratt, Ph.D.
Leader, CodeX HL7 FHIR Accelerator https://bit.ly/3b6DHlD
Thanks to presenters Dr. Lawrence Shulman, Dr. Peter Gabriel of UPenn, Melanie Combs-Dyer - Director of Innovation at Mettle Solutions and Tyler Haydell - Senior Product Manager at Flatiron Health. The slides and a recording of the meeting can be found here. Please join the July 31, 2020 CodeX mCODE Community of Practice meeting on July 31, 2020, noon, where we will discuss the CodeX Oncology Clinical Pathways: Prior Authorization use case. We hope to see you there!
MITRE and the HL7® FHIR® Accelerator CodeX Community invite you to a unique MITRE Listening Session on oncology clinical pathways and prior authorization of cancer therapies on June 26, 2020 from 10:00-11:30 EDT.
Oncology is a dynamic specialty with a rapid expansion of new therapies and tumor genomics. Over the past five years the use of oncology clinical pathways became a standard approach to assist oncologists in treatment recommendations. Oncology clinical pathways can facilitate prior authorization for cancer treatments through interaction with payers using evidence-based treatment recommendations.
The session will include three 15-minute presentations, each from a different stakeholder: health system, payer, and pathway vendor. The focus of the presentations will be on the experiences, challenges, and opportunities of each stakeholder. There will be opportunity for discussion at the end of the session.
Register in advance for this meeting:
https://mitre.zoomgov.com/meeting/register/vJItdOCtqDMjHf9HtHV-I6ZnIjEyp_KpsVs
After registering, you will receive a confirmation email containing information about joining the meeting.
AGENDA
Oncology Clinical Pathways and Prior Authorization Listening Session
June 26, 2020
Time 10 – 11 am ET
Note: additional discussion time reserved from 11:00 – 11:30 ET
- Introduction
- CodeX – Steve Bratt, PhD, FHIR CodeX Accelerator Lead, MITRE
- 5 minutes to set the stage for the listening session
- Health system perspective
- Larry Shulman, MD/Peter Gabriel, MD, MSE
- University of Pennsylvania Cancer Center
- 15-minute presentation
- Payer perspective
- Melanie Combs-Dyer
- Director of Innovation, Mettle Solutions LLC
- 15-minute presentation
- Pathways vendor perspective
- Tyler Haydell
- Senior Product Manager
- Flatiron Health
- 15-minute presentation
Discussion / Q&A
- 40 minutes
Since last October’s Cancer Data Summit, we’ve made substantial progress in our goal to enable interoperability across cancer patient data and systems. Using mCODE™ to collect, share, and extract data from EHRs means that every interaction between a clinician and cancer patient provides data that could be used to improve care for all future patients.
More and more people are learning how mCODE could help their organizations meet the needs of cancer patients. Stakeholders—including patients, vendors, providers, payers, research organizations, and government agencies—are starting to work together within the new CodeX™ HL7 FHIR Accelerator and elsewhere.
New CodeX Members and Use Cases
One way to bring oncology stakeholders together is through CodeX (Common Oncology Data Elements eXtensions), the new HL7 FHIR Accelerator focused on implementing and testing solutions.
CodeX is building a community to accelerate interoperable data modeling and application development, leveraging mCODE. By convening project work groups, CodeX is developing and testing solutions around new use cases, including radiology, clinical pathways, registry reporting, and patient - clinical trial matching.
CodeX members get the benefits of HL7’s Accelerator Program, pioneered through efforts such as the Argonaut and Da Vinci projects. CodeX members can work and learn together, and leverage advanced tooling and processes that speed implementation, adoption and, ultimately, value to cancer patients and all stakeholders.
Founding CodeX Members (so far) include: The Alliance for Clinical trials in Oncology Foundation, EMD Digital, HL7, MITRE, and Pfizer. Many other organizations are in the process of joining.
Please visit here for more information on membership and use cases.
New CodeX / mCODE Community of Practice
We created the CodeX / mCODE Community of Practice to expand the network of health systems, which have been and will be at the forefront of piloting mCODE in real-world settings. This group of cancer centers meets online monthly to share experiences and develop best practices for implementing mCODE into production EHRs and other systems.
Joining the Community of Practice is free and open to all interested parties. Participants in the first meeting in January included: Brigham and Women’s Hospital, Dana Farber Cancer Institute, Duke University Health System, Intermountain Medical Center, Kaiser Permanente, Memorial Sloan Kettering Cancer Center, MITRE, Partners HealthCare, Trinity Health/Saint Joseph Health System, University of California San Francisco Medical Center, and the University of Texas Southwestern Medical Center.
If you're interested in joining the Community of Practice, please contact Blake Bergstrom, bbergstrom@mitre.org.
New ICAREdata Study Pilots
The ICAREdata Study is piloting the application of mCODE to support the prospective collection of high-quality real-world data to enable clinical oncology research. The ICAREdata Study collaborates with clinical trials to collect key outcome data not yet well represented in EHRs and partners with clinical sites to share this critical outcome data, as well as the rest of mCODE. ICAREdata’s hypothesis is that dramatic improvements in clinical trial operational efficiency and reductions in clinical trial cost will be achieved by using the patient’s EHR as the source of study data.
In Phase 2 of our ICAREdata work, MITRE and the Alliance for Clinical Trials in Oncology are partnering with clinical trials to demonstrate the real-world data from the EHR based on mCODE can support equivalent clinical trial endpoints. The first trials include:
- A071701 – Genomically Guided Treatment Trial in Brain Metastases
- A021703 – SOLARIS: Randomized Double-blind Phase III Trial of Vitamin D Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer
We are looking for other partners/clinical trials. Those that have already begun planning for the implementation of prioritized mCODE data elements within their EHRs to support the ICAREdata Study include:
- Massachusetts General Hospital
- Brigham and Women’s Hospital
- Dana Farber Cancer Institute
- The Mayo Clinic
- The University of Pennsylvania Health System
mCODE Version 1.0 Approved
The mCODE underwent an HL7 ballot as a trial standard in September 2019. The ballot process involves collecting comments from the broad HL7 voter community and formally resolving each comment. All comments have now been addressed, and the mCODE team expects HL7 to officially publish mCODE Standard for Trial Use version 1.0 in March 2020.
mCODE 1.0 contains 90 data elements across six domains: patient, disease, labs/vitals, treatment, genomics, and outcomes. The 1.0 version—stable for adoption and approved for trial use—will be available in March from here and on GitHub for developers to test.
On behalf of the mCODE / CodeX Team ... Very best regards,
Steven R. Bratt, Ph.D.
Leader, CodeX HL7 FHIR Accelerator
Leader, MITRE Health Standards and Interoperability Group