Calibration of a multidimensional item bank to measure fatigue in rheumatoid arthritis patients (original) (raw)

Applying Item Response Theory Methods to Improve the Measurement of Fatigue in a Clinical Trial of Rheumatoid Arthritis Patients Treated with Secukinumab*

Open Journal of Rheumatology and Autoimmune Diseases, 2013

Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to patients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT-Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.

Validation of the Danish versions of the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaires (BRAFs)

Scandinavian Journal of Rheumatology, 2021

Objectives: To validate the Danish versions of the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) and BRAF numerical rating scales version 2 (NRSv2) Methods: We tested a) face and content validity, b) internal consistency, c) criterion validity, d) construct validity and e) reproducibility for the BRAF-MDQ, and face-and criterion validity and reproducibility for the BRAF-NRS. Results: In all, 224/236 patients completed the questionnaires (95%); 70% female, mean age (SD) 59 (13.04) years, disease duration 11.2 (9.49) years, health assessment questionnaire (HAQ) 0.724 (0.70) and Disease Activity Score, DAS28-CRP 2.55 (1.24). The uni-dimensionality for the physical and cognitive fatigue subscales was confirmed, whereas the subscales living with fatigue and emotional fatigue were found not to be uni-dimensional. Cronbach's α was 0.94 for the BRAF-MDQ total and 0.78-0.92 for the four subscales. The correlation between BRAF-MDQ and respectively, SF-36 vitality subscale: 0.75; The Hospital Anxiety and Depression scale (HADS) anxiety subscale: 0.65; HADS depression subscale: 0.62; Visual Analogue Scale (VAS) pain: 0.62; VAS global: 0.73 and MDHAQ: 0.62. Intra class correlation for agreement was 0.995. A Bland-Altman plot showed a mean difference of-1.9 and SD of 3.62 for BRAF-MDQ. Correlation coefficients between BRAF-NRSv2 subscales and respectively, BRAF-MDQ subscales: 0.57-0.93; SF-36 vitality subscale: 0.54-0.68 and to VASfatigue: 0.66-0.82. Conclusions: The Danish BRAFs are considered valid and reliable for use among Danish patients with rheumatoid arthritis, even though the subscales living with fatigue and emotional fatigue are not uni-dimensional, as they are in the original version.

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale: validation in six countries

Rheumatology, 2017

Objective. To evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries. Methods. We surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach's a and construct validity by Spearman's correlation. Results. A total of 1276 patients participated (76% female, 25% with a disease duration <5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with 566% of variation in items explained by each factor and all item factor loadings of 0.710.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach's a of 0.750.96 and for RAID, 0.930.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.630.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.460.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original. Conclusion. Across six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderategood construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original.

Selection of items for a computer-adaptive test to measure fatigue in patients with rheumatoid arthritis: a Delphi approach

2012

Abstract Purpose Computer-adaptive tests (CATs) can measure precisely at individual level with few items selected from an item bank. Our aim was to select fatigue items to develop a CAT for rheumatoid arthritis (RA) and include expert opinions that are important for content validity of measurement instruments. Methods Items were included from existing fatigue questionnaires and generated from interview material. In a Delphi procedure, rheumatologists, nurses, and patients evaluated the initial pool of 294 items.

Faculty of 1000 evaluation for A Multidimensional Model of Fatigue in Patients with Rheumatoid Arthritis

F1000 - Post-publication peer review of the biomedical literature, 2012

Objective-To evaluate a multidimensional model testing disease activity, mood disturbance, and poor sleep quality as determinants of fatigue in patients with rheumatoid arthritis (RA). Method-The data of 106 participants were drawn from baseline of a randomized comparative efficacy trial of psychosocial interventions for RA. Sets of reliable and valid measures were used to represent model constructs. Structural equation modeling was used to test the direct effects of disease activity, mood disturbance, and poor sleep quality on fatigue, as well as the indirect effects of disease activity as mediated by mood disturbance and poor sleep quality. Results-The final model fit the data well, and the specified predictors explained 62% of the variance in fatigue. Higher levels of disease activity, mood disturbance, and poor sleep quality had direct effects on fatigue. Further, disease activity was indirectly related to fatigue through its effects on mood disturbance, which, in turn, was related to poor sleep quality. Mood disturbance also indirectly influenced fatigue through poor sleep quality. Conclusion-The findings from this study confirmed the importance of a multidimensional framework in evaluating the contribution of disease activity, mood disturbance, and sleep quality to fatigue in RA using a structural equation approach. Mood disturbance and poor sleep quality played major roles in explaining fatigue along with patient-reported disease activity.

Predictors of fatigue over 1 year among people with rheumatoid arthritis. Treharne, G. J., Lyons, A. C., Hale, E. D., Goodchild, C. E., Booth, D. A., & Kitas, G. D. (2008). Psychology, Health & Medicine, 13, 494-504.

Psychology, Health & Medicine, 2008

Explanatory factors and predictors of fatigue in persons with rheumatoid arthritis: A longitudinal study

Journal of rehabilitation medicine, 2016

To investigate the impact of disease-related aspects on long-term variations in fatigue in persons with rheumatoid arthritis. Observational longitudinal study. Sixty-five persons with rheumatoid arthritis, age range 20-65 years, were invited to a clinical examination at 4 time-points during the 4 seasons. Outcome measures were: general fatigue rated on visual analogue scale (0-100) and aspects of fatigue assessed by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire. Disease-related variables were: disease activity (erythrocyte sedimentation rate), pain threshold (pressure algometer), physical capacity (six-minute walk test), pain (visual analogue scale (0-100)), depressive mood (Hospital Anxiety and Depression scale, depression subscale), personal factors (age, sex, body mass index) and season. Multivariable regression analysis, linear mixed effects models were applied. The strongest explanatory factors for all fatigue outcomes, when recorded at the same time-p...

Measuring fatigue among women with Sjögren's syndrome or rheumatoid arthritis: a comparison of the Profile of Fatigue (ProF) and the Multidimensional Fatigue Inventory (MFI). Goodchild, C. E., Treharne, G. J., Booth, D. A., Kitas, G. D., & Bowman, S. J. (2008). Musculoskeletal Care, 6, 31-48.

Musculoskeletal Care, 2008

Background: Fatigue is common in both Sjögren's syndrome (SS) and rheumatoid arthritis (RA) and can restrict functioning. Aims: We tested the convergent validity of the Profi le of Fatigue (ProF) using the Multidimensional Fatigue Inventory (MFI) in SS and RA. Methods: The 16-item ProF and the 20-item MFI were completed by 82 White-British women aged 35-79 years (mean 60.4 years). Thirty-four had been diagnosed with SS for a mean of 7.0 years and 48 had been diagnosed with RA for a mean of 14.5 years. The ProF measures four somatic facets of fatigue and two mental facets; the MFI contains one mental and four somatic facets. The structures of the items from both measures were tested by principal component factor analysis using varimax rotation. Results: No signifi cant differences in fatigue were found between the women with SS or RA. Five factors explained a total of 76% of the variance of the MFI; six factors explained 94% of the variance of the ProF. Mental fatigue items from both questionnaires loaded onto separate factors from somatic fatigue items; the two original facets of mental fatigue in the ProF were replicated. The four somatic fatigue facets of the ProF were generally replicated but the somatic facets of the MFI did not replicate as clearly. Equivalent facets correlated well between the two questionnaires (r ≥ 0.65). Conclusions: Both the ProF and the MFI distinguish between somatic and mental fatigue in SS and RA but the ProF appears better at resolving somatic facets of fatigue.