People with Lupus Help Guide Development of the Lupus Foundation of America’s Disease Activity Measure – LFA-REAL
Lupus can affect many different organs, and because of this people living with lupus experience a wide range of symptoms, and these symptoms can change through the course of the disease. That’s why monitoring disease activity in lupus is complex. To better understand and measure patients’ symptoms, the Lupus Foundation of America supports the development of the REAL™ - Rapid Evaluation of Activity in Lupus - LFA-REAL.
Traditionally, lupus activity is evaluated using clinician-based measures. On the other hand, patient reported measures/outcomes, are less commonly used in practice and clinical trials as measures of lupus activity, despite their increasingly recognized importance.
The LFA-REAL integrates both patient and physician assessments for a holistic, partnered approach to lupus disease assessment, and improved evaluations of treatment efficacy. The LFA-REAL clinician- and patient-reported ratings were developed in parallel. By including both the physician and patient in disease assessment, the LFA-REAL may also be a better way for clinicians and patients to communicate about symptoms and support patient-centered care.
The development process of the LFA-REAL PRO was recently published in the journal of Health and Quality of Life Outcome. This two-part study first asked 10 of the 25 participants to discuss their personal experiences and perspectives on lupus symptoms, the qualitative part of the study. Their responses guided the development of the PRO questionnaire. In the second phase of the study, the other 15 participants were asked to give feedback on the questionnaire to ensure that the instrument was easy to use and understand, comprehensive in content, and appropriately structured. Participants found the questionnaire easy to use; they offered recommendations to improve clarity, leading to adjustments in wording and formatting. The average age of participants was 45.7 years, 88% were female, and 44% identified themselves as “White.”
Anca D. Askanase, MD, MPH, Director, Columbia University Lupus Center at Columbia University College of Physicians and Surgeons, Lupus Foundation of America, Medical-Scientific Advisory Council member and lead researcher comments, “we hope the LFA-REAL will soon be used to measure lupus disease activity in both clinical care and trials and improve the care of lupus patients everywhere.”
LFA-REAL is currently included in a phase III global clinical trial. The Lupus Foundation of America is also working with the US Food and Drug Administration to qualify the LFA-REAL as an outcome measure in lupus trials and to help bring new drugs to market for people with lupus.