Construct and Criterion Validity of the Euro Qol-5D in Patients with Systemic Lupus Erythematosus

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 known-group validity and reliability among generic instruments; however, data on its responsiveness have not been published. Across measures, standardised response means were generally indicative of poor-moderate sensitivity to longitudinal change. In RCTs, clinically important improvements were reported in SF36 scores from baseline; however, between-arm differences were frequently non-significant and non-important. SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties, but few measures aside from the SF36 have been incorporated into clinical trials. This review highlights the importance of incorporating a broader range of SLE-specific HRQoL measures in RCTs and warrants further research that focuses on longitudinal responsiveness of newer instruments.

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“…EQ5D was shown to have good construct and criterion validity in a group of Chinese-speaking patients with SLE. 56 …”

Section: Resultsmentioning

confidence: 99%

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

et al. 2018

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“…The EuroQol (EQ-5D) is a generic health index which comprises a five-part questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) to calculate a ‘utility’ or health index value between “0” and “1”, and a visual analogue self-rating scale (EQ-VAS) which ranges from 0 (minimum score) to 100 (maximum score). The EQ-5D is a reliable and valid instrument for measure quality of life [ 25 , 26 ].…”

Section: Methodsmentioning

confidence: 99%

Measurement properties of the brief resilient coping scale in patients with systemic lupus erythematosus using rasch analysis

López‐Pina

Meseguer-Henarejos

Gascón-Cánovas

et al. 2016

Health Qual Life Outcomes

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BacgroundResilience has been defined as the capacity or the ability to rebound from and positively adapt to significant stressors, despite experiences of significant adversity or trauma. To capture to what extent an individual copes with stress in a resilient fashion the Brief Resilient Coping Scale (BRCS) was developed. This tool was validated in people with chronic disease, such as rheumatoid arthritis using standard psychometric techniques of classical test theory, but not yet in patients with Systemic lupus erythematosus (SLE). The aim of this study was to explore the psychometric properties of the Brief Resilient Coping Scale in patients with SLE using Rasch analysis.MethodThis study used cross-sectional data. The BRCS was administered to 232 patients with systemic lupus erythematosus. The aspects analyzed were unidimensionality, local independence and differential item functioning (DIF) to construct an interpretative scale of scores with the Rasch model.ResultsRating scale mode (RSM) showed that the four categories used in the items of the BRCS are properly ordered. The four items provided a good fit to the polytomous Rasch model. Moreover, the parameters were sufficiently separated to measure resilience in patients with SLE. BRCS is a unidimensional scale (eigenvalue = 1.843) of resilience and the items were locally independent. There was no DIF between males and females in the sample. Only marginally significant differences depending on the level of education were found. The BRCS showed adequate discriminant validity between groups of scores.ConclusionsBRCS is a suitable scale for measuring resilience in patients with SLE. This scale might be useful for clinicians to obtain information concerning the degree of resilience that each patient has, allowing individuals with low resilience to be identified who need interventions aimed at developing coping skills.

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“…The EQ-5D summary score was sensitive to change over time when compared to EQ-5D VAS and self-reported improvements, but the overall effect size was small. More recently, construct validity was established in a Chinese sample of SLE-patients when compared to the Lupus Quality of Life Questionnaire (LupusQoL), and discriminant validity was seen with both SLE disease activity and damage scores [46]. Additionally, significant ceiling effects were detected in the EQ-5D, with almost half of participants reporting no problems in some disability domains including self-care.…”

Section: Generic Pro Instrumentsmentioning

confidence: 99%

Patient-Reported Outcomes in Systemic Lupus Erythematosus

Mahieu

Yount

Ramsey‐Goldman

2016

Rheumatic Disease Clinics of North America

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Successful management of complex conditions such as systemic lupus erythematosus, SLE, and comorbid conditions benefit significantly from patient-reported outcomes (PRO) instruments that validly and precisely measure relevant aspects of health status (e.g., symptoms) and health related quality of life. Measuring health related quality of life and other aspects of health status (e.g., symptoms, functioning) with PROs provides SLE patients with an opportunity to participate in their treatment and to facilitate better communication with the multi-disciplinary team of health professionals involved in their care. Health outcomes research has produced a number of well-validated instruments that can be used across diseases whereas some have been specifically developed for SLE. The use of either a generic and SLE-specific PRO depends on the particular needs of a variety of clinical applications including population monitoring, treatment decision-making in clinical practice, clinical trials research, and for evaluating and comparing the effect of therapies across conditions, therapies, trials and patients in clinical research studies.

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Construct and Criterion Validity of the Euro Qol-5D in Patients with Systemic Lupus Erythematosus

Cited by 28 publications

References 20 publications

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

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

Measurement properties of the brief resilient coping scale in patients with systemic lupus erythematosus using rasch analysis

Patient-Reported Outcomes in Systemic Lupus Erythematosus

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