Background/Purpose: The goal of this study is to better understand how people with systemic lupus erythematosus (SLE) in the United States experience the disease. Results will be used to develop a patient reported outcome instrument that will form half of the LFA-REAL™ system. The LFA-REAL™ will be a comprehensive system, comprised of complimentary clinician reported outcome (ClinRO) and patient reported outcome measures (PRO).  This will be the first system that will allow, from both a physician and patient perspective, both global and organ-specific disease assessment, without complex forms and scoring algorithms. The LFA-REAL™ is undergoing qualification reviews by the United States Food and Drug Administration (FDA) in order to become accepted by the FDA for use in SLE clinical trials. This abstract describes the aims, methods and preliminary findings of the qualitative research used in development of this PRO.  

Methods: This exploratory study was designed in two phases. During Phase I, a literature review was conducted, identifying common themes in the experiences of people with lupus. In-depth interviews were then completed with 11 participants, including three men and eight women from a diverse range of demographic and experiential backgrounds, including health history and lupus severity. All study participants were 18 years of age or older and confirmed formal lupus diagnosis by a rheumatologist. The interviews covered the following topics: diagnosis and current treatment, symptoms, experience receiving clinical care, and ideal tool development.  Analysis of in-depth interviews was conducted using grounded theory analysis; subsequently a conceptual framework was created to capture emerging codes and themes. This framework was iteratively refined, through a stepwise analytical review. During phase 2, the resulting conceptual framework will be used to create a draft PRO instrument. The conceptual framework and draft PRO will be evaluated through patient and physician focus group discussions, iteratively refined, and finally, tested in tandem with the LFA-REAL™ ClinRO, through a pilot study and large scale validation trial.   

Results: Our initial data confirm that, in addition to physical indicators of wellbeing, such as physical functioning, pain, fatigue, and acute and chronic symptoms, mental and emotional indicators of wellbeing are also important to people with lupus. Disease-related factors that cause anxiety or interfere with activities of daily living may be perceived as equally or more limiting than symptoms that indicate severe disease to an MD. Additionally, study subjects indicated that the ideal PRO should be able to track and rate symptoms with visual aids, assess symptoms over time and should also encourage open communication with their healthcare providers. 

Conclusion: Findings show that patients view factors that cause anxiety and interfere with daily living as equally or more limiting than symptoms of severe disease. A two part system that addresses both physicians’ and patients’ views is likely to contribute to reconciling the discordance between physician and patient assessments of disease, improving short and long term outcomes in lupus.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-real-life-with-lupus-study-developing-a-patient-reported-outcome-measure-for-use-in-clinical-trials-and-clinical-care/