ArticleLupus science & medicine2022
Generation of evidence supporting the content validity of SF-36, FACIT-F, and LupusQoL, and novel patient-reported symptom items for use in patients with systemic lupus erythematosus (SLE) and SLE with lupus nephritis (LN).
Article in Lupus science & medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 10 citations in OpenAlex.
- Qualitative interview study in patients with SLE to assess patient perception of fatigue and skin-related symptoms.Lupus science & medicine · 2026Article
- Renal Flares and Health-Related Quality of Life Among Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from the LUNAR Phase 3 Clinical Trial.Rheumatology and therapy · 2026Article
- Lupus nephritis.Nature reviews. Disease primers · 2025Review
- Towards a minimal core dataset for systemic lupus erythematosus studies.Lupus science & medicine · 2025Article
- Patient-reported outcome measures for lupus nephritis: content validity of LupusQoL and FACIT-Fatigue.Journal of patient-reported outcomes · 2024Article
- German Translation and Linguistic Validation of the LIMB‑Q: A Patient-reported Outcome Measure for Lower Extremity Trauma.Plastic and reconstructive surgery. Global open · 2024Article
- Content validation of the SF-36v2® Health Survey Acute for use in hypoparathyroidism.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
Corrections and comments
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Authors and funding
14 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSLE and lupus nephritis (LN) have significant impacts on the health-related quality of life of patients living with the condition, which are important to capture from the patient's perspective using patient-reported outcomes (PROs). The objectives of this study were to evaluate the content validity of PROs commonly used in SLE and LN (36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Lupus Quality of Life (LupusQoL), as well as novel PRO symptom severity items measuring skin rash, joint pain, joint stiffness and swelling of the legs and/or feet, in both populations.
methodsQualitative, semi-structured, cognitive interviews were conducted with 48 participants (SLE=28, LN=20). Understanding and relevance of symptom and impact PRO concepts from existing PROs were assessed, alongside novel PRO symptom severity items with different recall periods (24 hours vs 7 days) and response scales (Numerical Rating Scale (NRS) vs Verbal Rating Scale). Interviews were conducted in multiple rounds to allow for modifications to the novel PRO items. Analysis of verbatim interview transcripts was performed.
resultsSymptom and impact concepts assessed by the SF-36, FACIT-F, and LupusQoL were well understood by both participants with SLE and LN (≥90.0%), with most considered relevant by over half of the participants asked (≥51.9%). All participants asked (100%) understood the novel PRO symptom severity items, and the majority (≥90.0%) considered the symptoms relevant. Minor modifications to the novel PRO items were made between rounds to improve clarity based on participant feedback. The selected 7-day recall period and NRS in the final iteration of the PRO items were understood and relevant. No differences in interview findings between the SLE and LN samples were identified.
conclusionsFindings provide evidence of content validity for concepts assessed by the SF-36, FACIT-F, LupusQoL and the novel PRO symptom severity items, supporting use of these PROs to comprehensively assess disease impact in future SLE and LN clinical trials.
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