Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

Gladman, Dafna; Nash, Peter; Gotō, Hitoshi; Birt, Julie; Cai, Lin; Orbai, Ana‐Maria; Kvien, Tore K

doi:10.1136/rmdopen-2019-000928

Cited by 40 publications

(33 citation statements)

References 40 publications

(58 reference statements)

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“…However, the fatigue question was part of the RAID questionnaire which has been developed by patients and should thus be relevant for exploring fatigue. In addition, a numeric rating scale of 0-10 (as also used for RAID fatigue) has been validated for fatigue in psoriatic arthritis [42]. Another potential weakness is that this is a single-centre study, which may reduce the generalizability of our findings.…”

Section: Discussionmentioning

confidence: 98%

Fatigue is cross-sectionally not associated with objective assessments of inflammation, but changes in fatigue are associated with changes of disease activity assessments during biologic treatment of patients with established rheumatoid arthritis

et al. 2020

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Objective The associations between fatigue and disease activity in patients with rheumatoid arthritis (RA) have not been defined. The present objectives were to explore in RA patients the cross-sectional and longitudinal relation of fatigue with subjective as well as objective assessments of disease activity. Methods RA patients were consecutively included when initiating biologic disease-modifying anti-rheumatic drugs (DMARDs) and assessed at baseline, 1, 2, 3, 6, and 12 months with investigation of fatigue, patient-reported outcome measures (PROMs; joint pain and patient’s global disease activity, MHAQ, pain catastrophizing, Mental Health score), clinical examinations (examiner’s global disease activity, 28 tender and swollen joint counts), and laboratory variables (ESR, CRP, calprotectin). Ultrasound examinations (semi-quantitative scoring (0–3)) with grey scale and power Doppler were performed of 36 joints and 4 tendons. Statistics included one-way analysis of variance, Pearson’s correlations, and multiple linear and logistic regression analysis. Results A total of 208 RA patients (mean (SD) age 53.2 (13.2) years, disease duration 9.8 (8.5) years) were included. Fatigue levels diminished during follow-up (mean (SD) baseline/12 months; 4.8 (2.8)/3.0 (2.5) (p < 0.001)). Substantial correlations were cross-sectionally found between fatigue and PROMs (median (IQR) r=0.61 (0.52-0.71)) but not with the objective inflammatory assessments. During follow-up, baseline fatigue was associated with PROMs (p < 0.001) but not with objective inflammatory assessments. However, change of fatigue was associated with change in all variables. Higher baseline fatigue levels were associated with lower clinical composite score remission rates. Conclusion Fatigue was cross-sectionally associated to subjective but not to objective disease assessments. However, change of fatigue during treatment was associated to all assessments of disease activity. Trial registration number Anzctr.org.au identifier ACTRN12610000284066, Norwegian Regional Committee for Medical and Health Research Ethics South East reference number 2009/1254 Key Points• In this longitudinal study of patients with established RA, fatigue was associated with patient reported outcome measures at each visit, but not with objective assessments of inflammation including calprotectin and comprehensive ultrasound examinations.• Changes in fatigue during biological treatment were associated with changes in patient reported outcome measures, clinical, laboratory and ultrasound assessments.• Baseline fatigue was associated with all patient reported outcome measures, but not objective assessments of inflammation at all the prospective visits.• Higher baseline fatigue levels were associated with lower remission rates as assessed by clinical composite scores.

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Section: Discussionmentioning

confidence: 98%

Fatigue is cross-sectionally not associated with objective assessments of inflammation, but changes in fatigue are associated with changes of disease activity assessments during biologic treatment of patients with established rheumatoid arthritis

et al. 2020

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Section: Discussionmentioning

confidence: 99%

“…Numerous scales have been used to measure fatigue [ 20 , 33 – 37 ]. The FACIT-Fatigue scale [ 20 ] and the Fatigue Numeric Rating Scale [ 37 ] have the advantage of being validated for PsA. Several controlled studies of biologics for PsA have evaluated fatigue using these validated scales, as well as more general scales [ 12 , 38 – 43 ].…”

Section: Discussionmentioning

confidence: 99%

Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response—results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis

et al. 2021

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Background The interleukin-23p19-subunit inhibitor guselkumab effectively treats signs and symptoms of psoriatic arthritis (PsA). We evaluated the effect of guselkumab on fatigue. Methods Across two phase 3 trials of guselkumab (DISCOVER-1, DISCOVER-2), patients with active PsA despite standard therapy were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W, N = 373); guselkumab 100 mg at week 0, week 4, and then Q8W (N = 375); or placebo (N = 372) through week 24, after which patients in the placebo group crossed over to guselkumab Q4W. Fatigue was measured as a secondary endpoint using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument (range 0–52, higher scores indicate less fatigue). Least-squares mean changes in FACIT-Fatigue scores were compared between treatments using a mixed-effect model for repeated measures. Mediation analysis was used to adjust for indirect effects on fatigue deriving from improvement in other outcomes, including ≥20% improvement in American College of Rheumatology criteria (ACR20; prespecified), minimal disease activity (MDA; post hoc), or C-reactive protein (CRP; post hoc). Results Baseline mean (SD) FACIT-Fatigue scores in DISCOVER-1 (N = 381) and DISCOVER-2 (N = 739), ranging from 29.1 (9.5) to 31.4 (10.1), indicated substantial levels of fatigue relative to the United States general population (43.6 [9.4]). Across studies, mean improvements, and proportions of patients with ≥4-point improvements, in FACIT-Fatigue scores at week 24 with guselkumab Q4W and Q8W (5.6–7.6 and 54–63%, respectively) were larger vs placebo (2.2–3.6 and 35–46%). Improvement in FACIT-Fatigue scores with guselkumab was sustained from week 24 to week 52, with moderate-to-large effect sizes (Cohen’s d = 0.52–0.81 at week 24; 0.66–0.91 at week 52). Mediation analyses demonstrated that substantial proportions of the effects of guselkumab vs placebo on fatigue were direct effect, after adjusting for achievement of ACR20 (Q4W 69–70%, Q8W 12–36% direct effect) or MDA (72–92% across dosing regimens) response or for change in serum CRP concentrations (82–88% across dosing regimens). Conclusions In patients with active PsA, guselkumab 100 mg Q4W or Q8W led to clinically meaningful and sustained improvements in fatigue through 1 year. A substantial portion of the improvement in FACIT-Fatigue scores induced by guselkumab was independent of effects on the achievement of other select outcomes. Trial registration Name of the registry: ClinicalTrials.gov Trial registrations: DISCOVER-1, NCT03162796; DISCOVER-2, NCT03158285 Date of registration: DISCOVER-1, May 22, 2017; DISCOVER-2, May 18, 2017 URLs of the trial registry record: DISCOVER-1, https://clinicaltrials.gov/ct2/show/NCT03162796?term=NCT03162796&draw=1&rank=1 DISCOVER-2, https://clinicaltrials.gov/ct2/show/NCT03158285?term=NCT03158285&draw=2&rank=1

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“…The mean value of the two scores was calculated for use in the analyses. NRS are widely used to rate pain intensity, 41,42 and have also been validated for use in research regarding other subjective health concerns, [43][44][45][46][47] allowing parametric statistical approaches.…”

Section: Goal Achievementmentioning

confidence: 99%

Rehabilitation Goals and Effects of Goal Achievement on Outcome Following an Adapted Physical Activity-Based Rehabilitation Intervention

Preede¹,

Søberg²,

Dalen³

et al. 2021

PPA

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Purpose: To explore the goal-setting process carried out at a rehabilitation facility providing adapted physical activity, by 1) identifying goals set by individuals with chronic disabilities, 2) comparing these goals to the negotiated goals set in collaboration with the rehabilitation team and 3) assessing goal achievement and its association with self-reported functioning after 12 months. Methods: A prospective observational study where adults (18-67 years) admitted to Beitostølen Healthsports Centre (n=151) reported mental and physical functioning measured by the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) administered at baseline (eight weeks before rehabilitation), admission, discharge and follow-up 12 months after rehabilitation. The participants provided their individual goals for rehabilitation in the admission questionnaire. Individual goals were compared to negotiated goals set by the participants and the rehabilitation team together as part of the goal-setting process at the facility. The goals were linked to The International Classification of Functioning, Disability and Health (ICF) for comparison. Goal achievement was assessed on a 10-point numeric rating scale (NRS) in the discharge questionnaire. The association between SF-12 physical and mental functioning at longterm follow-up and goal achievement was explored. Results: The 293 individual goals and the 407 negotiated goals were most frequently linked to the ICF-component Body Functions. When comparing negotiated to individual goals, negotiated goals were more frequently linked to activities and participation. Goals to wide to be linked to the ICF were less frequent. For 76% of the participants, content of individual goals was captured in negotiated goals. Goal achievement with NRS scores ≥9 points was reported by 66% of the included participants. Goal achievement was a significant predictor for long-term mental functioning (p=0.04). Conclusion:Collaboration between participants and health professionals resulted in more specific goals directed towards the activities and participation component. Goal achievement predicted long-term mental functioning following rehabilitation.

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Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

Cited by 40 publications

References 40 publications

Fatigue is cross-sectionally not associated with objective assessments of inflammation, but changes in fatigue are associated with changes of disease activity assessments during biologic treatment of patients with established rheumatoid arthritis

Fatigue is cross-sectionally not associated with objective assessments of inflammation, but changes in fatigue are associated with changes of disease activity assessments during biologic treatment of patients with established rheumatoid arthritis

Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response—results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis

Rehabilitation Goals and Effects of Goal Achievement on Outcome Following an Adapted Physical Activity-Based Rehabilitation Intervention

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