From this and ongoing work through OMERACT, the investigators arrived at a consensus of five common core domains for the measurement of flares: pain, physical function, fatigue, participation in activities and stiffness (in press).5-8 Using these measurements, the group is now collecting data on patients who experience flares to understand the range of each domain (e.g., how much pain, how great the fatigue).
Results of the final version of the flare measure will be presented at the May 2016 OMERACT meeting and open to ratification by OMERACT attendees.
Patient-Centered Care Approach to Management
Building on the work done through the OMERACT collaboration, Drs. Bingham and Bartlett are collaborating on several projects funded through the national Patient-Centered Outcomes Research Institute (PCORI), a major funding agency in the U.S.
In their first project, initiated in 2011, the investigators evaluated how patient-reported outcome information could be integrated within the clinical setting.9
A major focus was to understand whether the generic Patient-Reported Outcome Measurement Information System (PROMIS) measures could reflect the symptoms and impact that patients with RA described. Developed by the National Institutes of Health, PROMIS offers precise, reliable ways to evaluate patient-reported symptoms across disease (see PROMIS Instruments, above left).
The overall project goals, Dr. Bingham says, were to see if more patient-centered information could be gathered in the context of a clinical visit, to see what the information could tell physicians about people with RA, and to determine how that information would be interpreted by patients and their physicians and whether it could be used in making treatment decisions.
Results of the project, published in September 2015, provide preliminary evidence of the validity of PROMIS measures to assess RA symptoms and their impact on patients.9
“The measurement system of PROMIS is highly precise in the ways it can measure symptoms and impacts across the spectrum of RA disease activity,” says Dr. Bingham.
“Results are provided in the context of where someone falls in relation to the general population.”
PROMIS can measure symptoms and functional status in people with RA, such as fatigue, sleep, emotional distress and participation in everyday activities. Results are reported using T-scores in which all scales have a mean of 50 and standard deviation of 10. Using a common metric across all scales makes it easier to interpret and compare results across visits, between RA patients and those with other medical conditions.
The ability to use such measures as PROMIS to quantify patient reports that traditionally have been seen as subjective, and therefore harder to quantify, comes from the use of an advanced statistical methodology, called item response theory. Dr. Bartlett likens the methodology to the way standardized tests are constructed. “The answer you give on one question will determine the next question you get, and the computer will give you questions that help pinpoint what is being evaluated,” she says.