1. Development and content validity of the Lupus Foundation of America rapid evaluation of activity in lupus (LFA-REAL™): a patient-reported outcome measure for lupus disease activity
- Author
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Leslie Hanrahan, Kayla Neville, R Paola Daly, Anca D. Askanase, Miya Okado, Joan T. Merrill, and Avery Pong
- Subjects
Adult ,Male ,PRO ,medicine.medical_specialty ,Visual Analog Scale ,Visual analogue scale ,Population ,SLE ,Lupus ,lcsh:Computer applications to medicine. Medical informatics ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Surveys and Questionnaires ,medicine ,Content validity ,Humans ,Lupus Erythematosus, Systemic ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Disease activity ,education ,Qualitative Research ,Experience ,education.field_of_study ,Systemic lupus erythematosus ,Lupus erythematosus ,business.industry ,Research ,030503 health policy & services ,Public Health, Environmental and Occupational Health ,Chronic pain ,Reproducibility of Results ,General Medicine ,Middle Aged ,medicine.disease ,Measure ,Quality of Life ,Physical therapy ,lcsh:R858-859.7 ,Female ,Patient-reported outcome ,0305 other medical science ,business - Abstract
Background/purpose The LFA REAL™ is a measurement system for evaluating lupus disease activity from both clinician and patient perspectives. Patients’ viewpoints are captured using a patient-reported outcome (PRO) questionnaire. A series of visual analog scales are designed to rate disease severity and progress over the past 4 weeks. Brief instructions guide the patient to distinguish between active, potentially reversible symptoms and chronic pain or discomfort that are more likely due to damage. Beyond its simplicity and efficiency, the PRO can provide versatile assessments from a global, organ-based, and symptom-specific level. This paper describes the patient-centered approach used to evaluate the content validity of the LFA-REAL PRO. Methods The PRO was developed in accordance with FDA guidance. A two-phase qualitative study was performed with 25 lupus patients, 10 who participated in concept elicitation (Phase 1) and 15 in cognitive debriefing interviews (Phase 2). Qualitative data were analyzed using ATLAS.ti software v7.5. Upon completion of the interviews, participants completed the draft PRO and additional measures to characterize the sample. Results The mean age of participants was 45.6 and 88% were female, as expected in a lupus population. The mean SF-36 physical component score was 29.8 and the mean mental component score was 46.4. Phase 1 elicited symptom saturation and mapping of the draft PRO. Fatigue was reported by 100% of patients, highlighting its importance as a measurable domain. Additionally, 100% of patients spontaneously mentioned arthritis, which may be more important to this group than previously estimated, substantiating the approach of this PRO to break down components of arthritis into joint pain, stiffness, and swelling. Shortness of breath and fever were reported more frequently than expected. Phase 2 data demonstrated that participants found the instrument easy to use and offered recommendations to improve clarity, leading to adjustments in wording and formatting. Conclusions Results suggest that the LFA-REAL PRO has content validity and, with some modifications suggested by participants, is ready for quantitative validation, including tests of reliability, validity, responsiveness to change, and performance relative to other PROs used in lupus trials. After validation, the LFA-REAL system is intended for use in clinical practice and research. Electronic supplementary material The online version of this article (10.1186/s12955-019-1151-8) contains supplementary material, which is available to authorized users.
- Published
- 2019
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