ArticleRheumatology and therapy2021
Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies.
Article in Rheumatology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Instruments for measuring fatigue in people with rheumatic and musculoskeletal diseases: a systematic review of measurement properties.RMD open · 2025Pooled it
- Measurement properties of the FATIGUE-PRO in patients with SLE in real-world settings.Lupus science & medicine · 2026Observational
- Measuring Satisfaction with Minimally Invasive Aesthetic Treatments with the SKIN-Q Treatment Outcome Scale.Aesthetic surgery journal · 2025Article
- Psychometric Validation of the FACE-Q Dental Module in Patients With Malocclusions.Community dentistry and oral epidemiology · 2025Article
- Measuring Outcomes Relevant to the Décolletage From the Patient Perspective: Development and Validation of the BODY-Q Décolletage Scale.Aesthetic surgery journal · 2025Article
- "I Want It to Look Natural": Development and Validation of the FACE-Q Aesthetics Natural Module.Aesthetic surgery journal · 2024Article
- Extending the Range of Measurement for Minimally Invasive Treatments by Adding New Concepts to FACE-Q Aesthetics Scales.Plastic and reconstructive surgery. Global open · 2024Article
- Traceability and comparability through crosswalks with the NeuroMET Memory Metric.Scientific reports · 2023Article
- The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus.Rheumatology (Oxford, England) · 2022Article
- Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia.Innovations in pharmacy · 2022Article
- The SKIN-Q: An Innovative Patient-Reported Outcome Measure for Evaluating Minimally Invasive Skin Treatments for the Face and Body.Facial plastic surgery & aesthetic medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFatigue is one of the most important symptoms reported by patients with systemic lupus erythematosus (SLE) and a key concept of interest in SLE clinical trials. Despite this, fatigue remains poorly understood and sub-optimally measured by existing patient-reported outcome (PRO) instruments and scales. Here, we psychometrically evaluated the measurement properties of three PRO scales that purport to measure fatigue, using data from two SLE clinical trials.
methodsData were pooled from two completed phase 3 SLE trials: EMBODY1 (NCT01262365) and EMBODY2 (NCT01261793). FACIT-F, SF-36 Vitality and LupusQoL Fatigue data were selected for post hoc Rasch Measurement Theory psychometric analysis in two stages: (1) scale-to-sample targeting, thresholds for item response options, item fit statistics, and reliability; and (2) proposal and evaluation of pooled fatigue items based on the best-performing items. Responsiveness analyses on group-level (two effect size [ES] calculations and relative efficiency) and individual level (within person statistically significant difference), were conducted to compare original scales and pooled item sets.
resultsScale-to-sample targeting was good for FACIT-F, but suboptimal for SF-36 Vitality and LupusQoL Fatigue. Thresholds for item response options were ordered for all three scales. Item misfit was found in all three scales (FACIT-F 10/13; SF-36 Vitality 4/4; LupusQoL Fatigue 1/4). Reliability statistics were good for FACIT-F (0.93) and LupusQoL Fatigue (0.80) but low for SF-36 Vitality (0.53). The pooled fatigue items improved some psychometric properties despite persisting misfit issues (2/10) and were more sensitive in detecting change at week 24 compared with un-pooled data (ES 0.41 vs. 0.26-0.25).
conclusionsFACIT-F, SF-36 Vitality, and LupusQoL Fatigue were found to have important limitations in the EMBODY1 and EMBODY2 SLE clinical trials. Findings from pooled fatigue items support the need for further research to improve conceptual underpinnings of fatigue PROs and make them fit for purpose for drug development.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.