“When COVID-19 came, it was clear that creating a searchable data platform — housing clinical and imaging data — to inform and empower radiologists during the pandemic was crucial. Providing that kind of integrated data isn’t easy, but we believed it was possible,” says Sharyn I. Katz, MD, director of research for thoracic radiology at the University of Pennsylvania and chair of the ACR’s COVID-19 Imaging Research Registry (CIRR) Steering Committee.
The CIRR emerged earlier this year — a joint effort of the ACR Center for Research and Innovation™ (CRI), the ACR Data Science Institute® (DSI), and in collaboration with the Society of Thoracic Radiology. The registry’s aim is to aggregate diagnostic imaging and clinical information to provide a real-time integrated data stream that can serve as a public health surveillance tool. The first phase will focus on COVID-19, with a longer-term expansion to include other diseases.
“We believe the registry will enhance the quality, safety, and effectiveness of patient care during this public health crisis,” says Etta D. Pisano, MD, FACR, chief research officer of the ACR. “Using both clinical and imaging data is more important than ever, as COVID-19 is still a serious threat — particularly in rural areas where data may not be easily accessible,” she says. “The idea is to monitor and predict the course of the pandemic as we move into 2021.”
The goal of the registry is to translate new, evidence-based research into clinical practice. In addition to radiology, the registry will engage clinical experts and diagnostic modalities, including clinical medicine, biomarker discovery, and laboratory sciences. Participating sites will contribute demographic information, clinical data on signs and symptoms, images, laboratory test data, and outcomes for U.S. patients tested for COVID-19.
The CIRR will include the U.S. adult and pediatric population — those patients tested for COVID-19 on or after January 2020, and those with at least one imaging exam for the same period. The registry’s aggregated data can guide radiologists in the treatment of the viral disease.
“Aggregating case data across this country is necessary to inform care for patients, develop treatments, and predict vulnerable groups,” Katz says. CRI’s registry will allow for the linking of other existing COVID-19 registries and datasets, and CIRR data collection and uploading is now underway.
“We are hoping to have a robust dataset that empowers the big data needs in radiology,” Katz says. “The data can complement AI research, broaden COVID-19 education, accelerate regulatory processes, and so on.” In the bigger research picture, she says, ACR is working with other medical specialty and science-based groups who are committed to guiding healthcare providers through the persisting pandemic.
The ACR, the RSNA, and the American Association of Physicists in Medicine formed a research consortium earlier this year to develop the Medical Imaging and Data
Resource Center (MIDRC). The MIDRC is funded by the National Institutes of Health and hosted by the University of Chicago. The open-source database will house medical images from thousands of COVID-19 patients. CIRR will contribute clinical and imaging data to MIDRC. The resource represents the country’s largest medical
imaging associations, and its data platform will provide a critical tool for doctors and scientists to better understand COVID-19 and its effects, Pisano says. “The MIDRC will help them diagnose, monitor, and treat the disease through the collection, analysis, and dissemination of imaging and related data. This will ultimately help providers save lives,” she says.
CRI has also partnered with the Society of Critical Care Medicine to evaluate the safety and efficacy of COVID-19 practices through the Virtual Infection and Respiratory Illness Universal Study (VIRUS). CRI will collect diagnostic images for the VIRUS COVID-19 registry and establish links between those images and SCCM clinical data. Archived images will then be available to participating sites through combined dashboard reporting.
“These types of collaborations are very important as we continue to monitor and work to predict the course of the pandemic in the months ahead,” Pisano says. “Merging clinical and imaging data is critical, and VIRUS is laying the groundwork for future collaborative efforts that really harness the power of bringing data together in an accessible model.”
In yet another collaboration, CRI is working with Oregon Health & Science University to provide image coordination for the COVID-19 Observational Study (CORAL) as part of the Prevention & Early Treatment of Acute Lung Injury (PETAL) Network. PETAL is a consortium of academic and affiliated hospitals funded by the National Heart, Lung, and Blood Institute, and is part of the NIH.
“We are proud to be part of this effort by our colleagues who are caring for patients hospitalized with COVID-19,” Pisano says. “This imaging and clinical data from the PETAL project may well lead to improved treatment and diagnosis of COVID-19 complications — including advanced lung disease, stroke, and cardiac dysfunction.”
“With data ready to upload to the CIRR by the end of this year, we have a number of institutions now engaged and ready to contribute,” Katz says. “One of many good things that comes from that engagement is that any participating institution also has access to its own data, curated by our registry,” Katz says. “This kind of centralized and searchable access is something any institution conducting research would want — and could hopefully translate into practice.” This is in addition to the access to multi-institutional data curated by ACR, including physical data, statistical analyses of that data, and other tools included in the CIRR.
Institutions that have built their own COVID-19 databases since the outbreak can upload all data to the CIRR. “You shouldn’t need someone to manually enter the information of all the patients who have come in for diagnosis and treatment,” Katz says. “The idea is to aggregate as much data that already exists as quickly and easily as possible, then add to that data over time. CIRR and ACR, via existing platforms like TRIAD®, already have the ability to upload information from the data collection systems of institutions/practices.
Because patient privacy is top of mind during any clinical or imaging data exchange, Katz emphasizes that no personal information will be shared with the COVID-19 data. “We know it could be a barrier to participation if institutions are concerned they are putting patients’ identities out in the open,” Katz says. “A patient’s identity, medical record number, date of birth, and other personal identifiers will be removed before any data sharing takes place.”
The process involves anonymized unique case identifiers and study accession numbers that are deposited into the registry in lieu of real medical record numbers. Follow-up imaging can then be linked back to a patient without exposing their identity. The same identifier will also support future links with other datasets without
disclosing private patient data.
Physicians from ACR’s membership have led this effort scientifically, designing the registry by informing the data elements it collects. We are tremendously grateful for their countless volunteer hours, sharing of expertise, and collaboration.
“I’m proud to see ACR, the CRI, and our membership leading this COVID-19 data resource charge,” says Christine Davis, MBA, senior director of CRI. “Our whole mission is around supporting and managing research studies that translate new evidence into better clinical practice.”
“ACR is already well-positioned to simplify and streamline imaging exchange. Imaging submission tools like TRIAD® (an application that allows for image submission
electronically for ACR Accreditation, National Radiology Data Registry, and clinical research) and ACR Connect (a communication platform for data exchange) make data contribution to CIRR easy,” Davis notes. “With TRIAD already installed at over 38,000 sites, we have a pre-established site network able to collect and aggregate data. It makes sense for radiologists and the CRI to take a leading role in navigating COVID-19.”
A multi-institution, searchable COVID-19 registry brings together siloed hospital and state findings on the disease, Davis says. CIRR will demonstrate how COVID-19 is affecting patients and practitioners, and can show which therapies are working and which are not. “It has been designed as a public health tool, and we think this approach is the only way to truly, statistically identify the most vulnerable patient populations,” she says.
A small percentage of ACR members participate in research or are leading a research project, Davis says. With a disease like COVID-19 that affects so many of us and
we’re learning while fighting it, there’s an urgency to break down walls, aggregate data, and share insights, she adds, especially with the pandemic unchecked moving into winter. Radiologists are counting on ACR to provide guidance and best practices.
“With a novel pandemic viral disease like COVID-19, the ability to better understand disease spread, prevent infection, and treat affected patients — possible through the aggregated information of CIRR and other research registry efforts has huge potential,” Davis says. “Evidence-based findings may also lead to new health policy and cost-effectiveness strategies.” In addition to research and data collection, CRI is seeking approval by CMS to incentivize participation in the registry. “We are in the
process of working with CMS to get improvement activity credit under the Merit-Based Incentive Payment System for participating sites who submit data.”
It is worth pointing out that CRI’s operational budget is self-sustaining — funded entirely by grants and commercial contracts. “We are not funded by ACR membership dues and that allows us to operate independently, as an honest broker in our research collaborations not swayed by perceived or actual bias,” says Davis. That matters when it comes to data collection and the prolific white papers that are expected to emerge from CIRR.
“Physicians from ACR’s membership have led this effort scientifically, designing the registry by informing the data elements it collects. We are tremendously grateful for their countless volunteer hours, sharing of expertise, and collaboration. They are glad ACR is taking the lead in this space and we are happy to spotlight them,” Davis says.
“The research that the ACR CRI is involved with today will translate into the imaging innovations of tomorrow,” says Pamela K. Woodard, MD, FACR, chair of the ACR Commission on Research and a member of the ACR BOC. “It is important that radiologists do evidence-based research so that we will know which new technology
developments and imaging paradigms answer the questions needed to drive the best patient care.”
“When we approach CMS, we should be approaching them with data from rigorous research that has informed us in terms of imaging procedures and policy as well as what is best for patients — when we should image and when we should not,” Woodard says. That is not to say that other groups and institutions are not doing imaging research, she adds. The NIH’s National Institute of Biomedical Imaging and Bioengineering, for instance, had been working to improve health through the development and application of biomedical imaging technologies well before COVID-19 and the creation of the MIDRC.
More research is needed, Woodard says, and radiologists should be finding the data — always independently of financial incentives. “Imaging has the potential to add to the understanding and management of COVID-19, and the ACR is committed to an investment in scientific and data-driven approaches to patient care,” she says.
“ACR’s unique contributions allow us to combine research with the practical, everyday understanding of imaging application and how imaging will be implemented through the radiologist to their patients,” Woodard says. “It is a combination that can have a powerful impact on healthcare.”
“The COVID-19 registry is going to serve not only individual participants, but the radiology community as a whole,” Katz says. “We are expecting many contributors, and we are open and ready to go.”