SynthesisLupus science & medicine2020
Measurement properties of selected patient-reported outcome measures for use in randomised controlled trials in patients with systemic lupus erythematosus: a systematic review.
Synthesis in Lupus science & medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 50 citations in OpenAlex.
- Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial.Lupus science & medicine · 2025Trial
- Article
- New efforts to incorporate patient-reported outcomes into lupus clinical trials: report of the community meeting convened by the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), 16-17 October 2024.Lupus science & medicine · 2025Article
- Holistic approaches in systemic lupus erythematosus: do physicians avoid addressing difficult-to-treat but highly relevant symptoms?RMD open · 2025Article
- Social Determinants of Health Among Pregnant Hispanic Women and Associated Psychological Outcomes.Journal of racial and ethnic health disparities · 2025Article
- The Short Form 6 Dimensions (SF-6D): Development and Evolution.Applied health economics and health policy · 2025Review
- Predicting higher risk factors for COVID-19 short-term reinfection in patients with rheumatic diseases: a modeling study based on XGBoost algorithm.Journal of translational medicine · 2024Article
- Patient-reported outcome measures for lupus nephritis: content validity of LupusQoL and FACIT-Fatigue.Journal of patient-reported outcomes · 2024Article
- Patients with NPSLE experience poorer HRQoL and more fatigue than SLE patients with no neuropsychiatric involvement, irrespective of neuropsychiatric activity.Rheumatology (Oxford, England) · 2024Article
- Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity.BMC rheumatology · 2024Article
- Development of the American College of Rheumatology Patient-Reported Outcome Quality Measures for Systemic Lupus Erythematosus.Arthritis care & research · 2024Article
- 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).Lupus science & medicine · 2022Article
- Discordance in patient and physician global assessment in relapsing polychondritis.Rheumatology (Oxford, England) · 2022Article
- The Patient Experience of Fatigue in Systemic Lupus Erythematosus: A Conceptual Model.Rheumatology and therapy · 2022Article
- Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?Journal of patient-reported outcomes · 2022Article
- Patient-Reported Outcomes in Systemic Lupus Erythematosus. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring?Journal of clinical medicine · 2022Review
- State of the art and future directions in assessing the quality of life in rare and complex connective tissue and musculoskeletal diseases.Frontiers in medicine · 2022Review
- Article
- EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus.Rheumatology (Oxford, England) · 2021Article
- Interferon-directed therapies for the treatment of systemic lupus erythematosus: a critical update.Clinical rheumatology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe heterogeneous multisystem manifestations of SLE include fatigue, pain, depression, sleep disturbance and cognitive dysfunction, and underscore the importance of a multidimensional approach when assessing health-related quality of life. The US Food and Drug Administration has emphasised the importance of patient-reported outcomes (PROs) for approval of new medications and Outcome Measures in Rheumatology has mandated demonstration of appropriate measurement properties of selected PRO instruments.
methodsPublished information regarding psychometric properties of the Medical Outcomes Survey Short Form 36 (SF-36), Lupus Quality of Life Questionnaire (LupusQoL) and Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), and their suitability as end points in randomised controlled trials (RCTs) and longitudinal observational studies (LOS) were assessed. A search of English-language literature using MEDLINE and EMBASE identified studies related to development and validation of these instruments. Evidence addressed content validity, reliability (internal consistency and test-retest reliability), construct validity (convergent and divergent) and longitudinal responsiveness, including thresholds of meaning and discrimination.
resultsAll instruments demonstrated strong internal consistency, reliability and appropriate face/content validity, indicating items within each instrument that measure the intended concept. SF-36 and LupusQoL demonstrated test-retest reliability; although not published with FACIT-F in SLE supported by evidence from other rheumatic diseases. All instruments demonstrated convergent validity with other comparable PROs and responsivity to treatment.
conclusionThe measurement properties of PRO instruments with published data from RCTs including: SF-36, LupusQoL and FACIT-F indicate their value as secondary end points to support labelling claims in RCTs and LOS evaluating the efficacy of SLE treatments.
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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.