Nationwide EHR-linked database of real-world patients aids rheumatologists

Photo: United Rheumatology

Not too long ago, Hauppauge, New York-based United Rheumatology had limited opportunities to directly capture the experience of patients across the country to answer important clinical questions.


Although a given practice might capture data in its own electronic health record, even the largest of practices did not have enough patients to understand the real-world response to medicine or to capture the data from practices across the country as part of a value-based care initiative.

Other databases either did not capture information directly from the EHR, leading to risk of bias in which patients were captured, or had restrictive policies for data access.


“United Rheumatology Normalized Integrated Community Evidence allows for access to real-world evidence EHR data that can be analyzed to address specific research questions in the real-world community rheumatology setting,” explained Dr. Max Hamburger, founder, executive chairman and chief medical officer of United Rheumatology.

“Currently, the best clinical paradigm for treating patients with rheumatic disease is the use of a treat-to-target strategy wherein the activity of a patient’s disease is measured at each visit and trends can be identified to guide shared decision making about changing treatment,” he continued.

“Although the EHR could capture that information for an individual patient, encouraging clinicians to routinely capture the data required for such an approach has been challenging.”

UR-NICE addresses this challenge through the ability to gather data across clinicians, practices and locations across the country to evaluate clinicians’ performance, gain insights as to the best clinical approaches, and yield insights on how to evolve care toward better value, he added.

“Thus, the data housed in UR-NICE provides direct insight into the outcomes of patients across that country that serves as the data source, or the life-blood, of value-based care initiatives designed to improve individual-level patient outcomes and reduce the cost of care,” he said.

“United Rheumatology has created an enterprise software platform, Capricorn, as a companion to UR-NICE to support direct patient engagement via text or email to facilitate capture of patient-reported outcome measures and/or patient-reported experience metrics.”

Dr. Max Hamburger, United Rheumatology

UR-NICE allows direct capture of a wide variety of clinical data from patients across the country and houses it in a single repository. Clinical questions can be asked and answered by querying and analyzing the data of 1.8 million active rheumatic disease patients.

Critically, this data is from the real world, not from clinical trials. This is important, since the phenotypes, or presenting clinical features, of patients in clinical trials that are designed to get medications approved, versus those of patients in the real world, are quite different.

“For example, in a recent study more than 90% of patients with rheumatoid arthritis (RA) in real-world registries would not have been eligible to enter the clinical trials that led to the approval of each of the major medications used to treat the disease,” Hamburger noted. “Patients in clinical trials tend to have much more florid disease.

“Therefore, even after a medication is approved, we lack information as to how real-world patients will respond to new medicines in terms of treatment effects, side effects and the patient experience of medication use,” he continued. “Data from UR-NICE is critically important to help fill in these gaps in understanding how real-word patients, rather than their clinical trial counterparts, respond to treatment.”

One recent project allowed assessment of the three-month, real-world effectiveness of a medication for RA. Prior to this analysis, understanding of the medication response at that critical time-point for treatment-to-target decision-making had been unclear.

“These capabilities are important to each of the stakeholders in the rheumatology care ecosystem,” he explained. “Pharmaceutical manufacturers partner with United Rheumatology to ask nuanced, ‘retrospective’ clinical questions that benefit patients such as, ‘Among rheumatoid arthritis patients with specific phenotypes, such as certain positive serologies (antibody blood tests), what is the response to drug X versus drug Y.'”

Health plans can match disease activity data with medical and pharmacy claims information to answer questions such as, “Is it more expensive for patients to be in moderate or high disease activity versus remission or low disease activity?” or “What clinical factors or data elements predict high healthcare resource utilization among patients with disease X?”


With the ability to ask retrospective questions from UR-NICE about the past responses to treatment approaches or specific medications, new questions and hypotheses are developed about how patients’ results might be improved by approaching care differently on a prospective basis.

“Accordingly, United Rheumatology has created an enterprise software platform, Capricorn, as a companion to UR-NICE to support direct patient engagement via text or email to facilitate capture of patient-reported outcome measures and/or patient reported experience metrics,” Hamburger said. “This information can be brought to the attention of treating clinicians to inform shared decision-making, for instance, about the need for treatment changes.

“In doing so, the system can granularly capture the patient experience of the 90 days between office visits,” he continued. “The Capricorn platform is completely configured, supporting bespoke data capture requirements that can be leveraged to address prospective questions, including establishing the impact of value-based care programs on clinical outcomes.”

These programs have brought together health plans, pharmaceutical companies and United Rheumatology members to demonstrate new approaches to improve patients’ conditions and lower healthcare costs.

“One example is programs that encourage dose optimization of targeted immune modulators among patients with RA or psoriatic arthritis who have sustained excellent control of disease to provide only the precise amount of medication required to maintain disease control and eliminate unnecessary medication,” Hamburger noted.

“The UR-NICE database supports numerous EHR vendors to extract data and translate it to a canonical data model,” he continued. “The technology has been adapted to interface with multiple EHRs allowing practices to continue to use their desired EHR vendor, rather than requiring the use of a specific EHR solution to participate in UR programs.”

Capricorn has likewise been designed to “meet practices where they are,” offering a range of integration options, including HL7 FHIR, custom file and online portal access. These options allow practices to participate with data collection via high-tech or low-tech solutions, based on their capability.


United Rheumatology has established a medical policy committee of members from across the country who have written clinical pathways to reflect the approach to the care provided in the organization’s clinics. These pathways include a standardized set of disease-specific outcome measures and a “standard data model” to homogenize collection at the practice level.

Additionally, a dashboard has been generated to reflect the performance of clinicians from member practices in capturing disease-specific outcome measures. The dashboard results create accountability in adherence to the clinical pathways to ensure robust data capture and have improved the completeness of UR-NICE data collection of measures such as the Clinical Disease Activity Index (CDAI) for RA.

It also helps move practices along a continuum of readiness that United Rheumatology has identified to help practices prepare for the implementation and adoption of value-based care programs.

“In a disease like systemic lupus erythematosus – lupus or SLE – the complexity of disease manifestations make standardized data collection challenging,” Hamburger explained. “A first step in meeting the recognized need for the application of treat-to-target principles in SLE is operationalizing and routinizing the capture of a disease activity measure.

“By working with national experts, UR has developed such a measure and incorporated its capture into the Capricorn platform to simplify its capture,” he added.


“It is absolutely critical for the advancement of care quality that individual-level data capture be standardized and its collection routinized as an everyday function of real-world clinical medicine,” Hamburger stated. “If outcomes are not measured, they cannot be compared or improved. Yet practices vary in their readiness to adopt the innovative strategies required to collect such data.

“A detailed implementation plan is necessary that takes into account the sociotechnical interface including the needs of patients and clinic personnel as well as the culture of the workplace to smooth the transition to a data- and technology-focused practice model,” he continued. “Developing a road map for the transition from the standard work of the present state versus the standard work required can aid this transition.”

A real-world database requires significant curation to optimize the interpretability of results, he added. Simple challenges, such as practices using different units of measure for body weight (pounds versus kilograms), must be recognized and addressed to yield actionable data, he said.

“Additionally, including providers in programmatic planning stages and visiting the clinic environment, as the pandemic allows, can help identify the impact of adaptations of programmatic methodology that define the positive or negative impact of the difference between ‘work as planned’ and ‘work as done,'” he concluded.

Twitter: @SiwickiHealthIT
Email the writer: [email protected]
Healthcare IT News is a HIMSS Media publication.

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