Patient-reported outcome measures for use in clinical trials of SLE: a review

Lupus Science & Medicine
Zara IzadiJinoos Yazdany

Abstract

Inclusion of patient-reported outcomes is important in SLE clinical trials as they allow capture of the benefits of a proposed intervention in areas deemed pertinent by patients. We aimed to compare the measurement properties of health-related quality of life (HRQoL) measures used in adults with SLE and to evaluate their responsiveness to interventions in randomised controlled trials (RCTs). A systematic review was undertaken using full original papers in English identified from three databases: MEDLINE, EMBASE and PubMed. Studies describing the validation of HRQoL measures in English-speaking adult patients with SLE and SLE drug RCTs that used an HRQoL measure were retrieved. Twenty-five validation papers and 26 RCTs were included in the indepth review evaluating the measurement properties of 4 generic (Medical Outcomes Study Short-Form 36 (SF36), Patient Reported Outcomes Measurement Information System (PROMIS) item-bank, EuroQol-5D, and Functional Assessment of Chronic Illness Therapy-Fatigue) and 3 disease-specific (Lupus Quality of Life (LupusQoL), Lupus Patient Reported Outcomes, Lupus Impact Tracker (LIT)) instruments. All measures had good convergent and discriminant validity. PROMIS provided the strongest evidence for ...Continue Reading

Citations

Nov 7, 2019·Clinical Rheumatology·Sandra V NavarraMa Theresa M Collante
Jun 18, 2021·Orphanet Journal of Rare Diseases·Massimo RadinDario Roccatello
Aug 28, 2021·Journal of Clinical Medicine·Matthew H NguyenSean G O'Neill
Oct 9, 2021·Rheumatology and Therapy·Sophie CleanthousThomas Morel

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