Background/Purpose: The LFA REAL^TM is designed as two complimentary disease activity measures in order to integrate clinician and patient input. The current report updates progress of the LFA REAL^TM patient-reported outcome (PRO).

Methods: The PRO was developed in accordance with FDA guidance. After preliminary concept identification work, a qualitative study was performed with 25 adult participants with SLE, including 10 who participated in concept elicitation (Phase 1) and 15 for cognitive debriefing interviews (Phase 2). A semi-structured guide was employed by trained interviewers. Qualitative data were analyzed using ATLAS.ti software v7.5. A coding dictionary was developed based on the interview guide and concepts of interest. At the completion of the interviews, participants completed the draft PRO and measures to characterize the sample (SF-36, socio-demographic, clinical data questionnaires).

Results: Mean age of participants was 45.6 [22-69], 88% were female and all had SLE diagnosis confirmed by their rheumatologists. The mean SF-36 physical component score (PCS) for the sample was 29.8 (±9.1), and mental component scores MCS was 46.4 (±11.6). Phase 1 elicited symptom saturation (detailed in Table 1) and mapping of the draft PRO while Phase 2 debriefed instructions, items, response options for content clarity, comprehensiveness and content validity of the draft PRO. With a recall period of 4 weeks, the PRO asks patients to evaluate their overall progress and severity of symptoms associated with current lupus activity along a series of visual analogue scales. Instructions are brief and guide the patient to active as opposed to longstanding symptoms that are more likely due to damage. The PRO allows for global, organ-based or symptom specific disease assessments from the patient’s perspective.

Conclusion: Results of this qualitative study address the content validity of the LFA-REAL PRO. As expected, fatigue or tiredness was spontaneously reported by 90% of patients. 100% of patients spontaneously brought up arthritis, which may be more important to this group than previously estimated and substantiates the approach to break down arthritis into joint pain, stiffness and swelling in this PRO. Shortness of breath and fever was also more common than expected. Quantitative validation of the PRO will be performed to characterize the psychometric properties of the PRO against other PROs used in lupus trials. After validation, the LFA-REAL system is intended for clinical practice and clinical trial use.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-development-of-the-lupus-foundation-of-america-rapid-evaluation-of-activity-in-lupus-lfa-real-patient-reported-outcome-pro-to-evaluate-lupus-disease-activity/