Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. Patients' perceptions of fatigue in rheumatoid arthritis: overwhelming, uncontrollable, ignored. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. The Effect of Exercise on Sleep and Fatigue in Rheumatoid Arthritis: A Randomized Controlled Study Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis. Responsiveness of patient reported outcomes including fatigue, sleep quality, activity limitation, and quality of life following treatment with abatacept for rheumatoid arthritis Perceived work ability, quality of life, and fatigue in patients with rheumatoid arthritis after a 6‐month course of TNF inhibitors: prospective intervention study and partial economic evaluation Radiographic outcome of recent-onset rheumatoid arthritis: a 19-year study of radiographic progression. Interrelationship of outcome measures and process variables in early rheumatoid arthritis. A comparison of radiologic damage, physical disability, joint counts, and acute phase reactants. Sensitivity of a health status measure to short-term clinical changes in arthritis. Decreases in health care resource utilization in patients with rheumatoid arthritis following a cognitive behavioral intervention Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. Identifying Preliminary Domains to Detect and Measure Rheumatoid Arthritis Flares: Report of the OMERACT 10 RA Flare Workshop Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity. Predictors of productivity loss in early rheumatoid arthritis: a 5 year follow up study.
OBJECTIVE This study vali date d a brief measure of fatigue in rheumatoid arthritis ( RA ) , the Functional Assessment of Chronic Illness Therapy ( FACIT ) Fatigue Scale . METHODS The FACIT Fatigue was tested along with measures previously vali date d in RA : the Multidimensional Assessment of Fatigue ( MAF ) and Medical Outcomes Study Short-Form 36 ( SF-36 ) Vitality . The sample included 636 patients with RA enrolled in a 24 week double blind , r and omized clinical trial ( RCT ) of adalimumab versus placebo . RESULTS The FACIT Fatigue showed good internal consistency ( alpha = 0.86 to 0.87 ) , strong association with SF-36 Vitality ( r = 0.73 to 0.84 ) and MAF ( r = -0.84 to -0.88 ) , and the ability to differentiate patients according to clinical change using the American College of Rheumatology ( ACR ) response criteria ( ACR 20/50/70 ) . Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures . A minimally important difference in FACIT Fatigue change score of 3 - 4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo . CONCLUSION The FACIT Fatigue is a brief , valid measure for monitoring this important symptom and its effects on patients with RA OBJECTIVE Fatigue is commonly reported by patients with rheumatoid arthritis ( RA ) but is rarely a treatment target . The aim of this study was to explore the concept of fatigue as experienced by patients with RA . METHODS Fifteen patients with RA and fatigue ( > or = 7 on a 10-cm visual analog scale ) were individually interviewed and asked about the description , cause , consequence , and management of fatigue . Transcripts were systematic ally analyzed by 2 research ers independently , relevant phrases were coded , and earlier transcripts were checked for the emerging codes . A r and om sample of analyses were independently review ed . A total of 191 codes arising from the data were grouped into 46 categories and overarching themes . RESULTS Vivid descriptions reflect 2 types of fatigue : severe weariness and dramatic overwhelming fatigue . RA fatigue is different from normal tiredness because it is extreme , often not earned , and unresolving . Participants described physical , cognitive , and emotional components and attributed fatigue to inflammation , working the joints harder , and unrefreshing sleep . Participants described far-reaching effects on physical activities , emotions , relationships , and social and family roles . Participants used self-management strategies but with limited success . Most did not discuss fatigue with clinicians but when they did , they felt it was dismissed . Participants held negative views on the management of fatigue . CONCLUSION The data show that RA fatigue is important , intrusive , and overwhelming , and patients struggle to manage it alone . These data on the complexity of fatigue experiences will help clinicians design measures , interventions , and self-managment guidance OBJECTIVES Fatigue is an important aspect of rheumatoid arthritis ( RA ) . The objective was to assess fatigue levels and its determinants over the first 4 months of tocilizumab ( TCZ ) treatment in RA patients . METHODS We performed a multicentre prospect i ve study of RA patients treated with intravenous TCZ in open-label prescription conditions . The first 5 infusions ( 4 months ) were assessed . The primary endpoint was the percentage of patients with variation of the FACIT fatigue scale from inclusion to 4 months , above the minimal clinical ly important difference ( MCID ) of 4 points . Fatigue was also assessed by the patient acceptable symptom state for fatigue ( PASS ) question . Variables related with fatigue and with fatigue improvement including other patient reported outcomes , depression and anxiety , and disease activity , were assessed before and after treatment . ANALYSES univariate and multivariate logistic regressions . RESULTS Of 719 patients , 610 had evaluable data : mean age 56±13 years , disease duration 12±10 years , 490 ( 81 % ) women . At baseline , fatigue levels were high : 73 % patients had unacceptable fatigue . At 4 months , 378 patients ( 62 % ) reached MCID improvement for fatigue . Fatigue reduction was rapid , seen as early as after 2 weeks . Fatigue was mainly related to functional status ( HAQ score ) , depression and anxiety , both before and after TCZ treatment . Moderate predictors of fatigue improvement were evidence d. CONCLUSIONS In these long-st and ing RA patients  , fatigue levels were high and mainly explained by HAQ and psychological distress but improved with treatment indicating a link with disease activity . The pathophysiological basis of RA fatigue should be further explored Objective . Sleep disturbance and chronic fatigue are common in rheumatoid arthritis ( RA ) and contribute to disability , symptomatology , and healthcare use . It has long been recognized in other population s that exercise can improve sleep and diminish fatigue . The effect of exercise on sleep quality and fatigue in RA has not been evaluated . Methods . Ours is a r and omized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue . These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale .  Patients were r and omized to either a 12-week , home-based exercise intervention or usual care . The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Question naire ( HAQ ) with cardiovascular work as per the guidelines . The intervention group was evaluated on a 3-week basis . Full evaluation was carried out at baseline and at 12 weeks . Results . Forty patients were r and omized to the intervention with 38 controls . In the exercise intervention group , there was a statistically significant improvement in HAQ ( p = 0.00 ) , pain ( p = 0.05 ) , stiffness ( p = 0.05 ) , sleep quality ( p = 0.04 ) , and fatigue ( p = 0.04 ) . In our control group , there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise , but none of the other variables . Conclusion . Our study demonstrates that an exercise program result ed in significant improvement in sleep quality and fatigue . This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population Background The primary aim of rheumatoid arthritis ( RA ) treatment is to induce remission , the absence of disease activity . The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life , fatigue , and physical function in RA patients treated with secukinumab in a phase 2 r and omized controlled trial ( RCT ) . Method Adult RA patients ( n = 237 ) with incomplete responses to methotrexate were r and omized equally to receive monthly s.c . injections of secukinumab 25 mg , 75 mg , 150 mg , 300 mg or placebo . Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score . Patient-reported outcomes ( PRO ) included Health Assessment Question naire-Disability Index ( HAQ-DI ) , Medical Outcomes Study Short Form-36 [ SF-36 ] Survey , and Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) . Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint . Definitions of minimal important differences [ MID ] in each clinical endpoint were used to categorize patients , as well as thresholds beyond MID . Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint . Analyses were limited to patients r and omized to secukinumab treatment . All dose groups were combined ( n = 187 ) . Results Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction . With few exceptions , there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinical ly meaningful . More importantly , results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL , fatigue , and physical function . Conclusion Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures OBJECTIVE In patients with longst and ing severe rheumatoid arthritis ( RA ) receiving chronic treatment with adalimumab  , health related quality of life ( HRQOL ) was assessed using new instruments [ Functional Assessment of Chronic Illness Therapy-Fatigue scale ( FACIT-Fatigue ) and Health Utilities Index Mark 3 ( HUI3 ) ] and a more conventional instrument [ Medical Outcomes Study Short Form-36 Health Survey ( SF-36 ) ] . METHODS Different measures for collecting patient-reported outcomes were applied simultaneously during the 3-year study period . Sociodemographic and medical history data were assessed at the baseline visit . Clinical examinations ( e.g. , joint examination and morning stiffness ) , disease assessment s , and HRQOL data  were recorded every 8 weeks . For dichotomous and categorical variables , absolute and relative frequencies were calculated . Metric measures were described using mean and st and ard deviation and /or st and ard error of the mean . HRQOL data were analyzed using observed cases . RESULTS All assessed measures ( FACIT-Fatigue , HUI3 , SF-36 ) showed a rapid and statistically significant improvement from baseline following initiation of adalimumab therapy . This effect was maintained over the study period for a mean of 1.6 years in all applied measures . HRQOL data from all tested instruments were significantly correlated with each other . CONCLUSION Chronic therapy with adalimumab improved measures of fatigue and HRQOL  in patients with longst and ing RA Objective : To evaluate the responsiveness of patient reported outcomes ( PROs ) , including fatigue , sleep , activity limitation , and quality of life , in patients with rheumatoid arthritis ( RA ) . Methods : Data were considered from a r and omised controlled trial comparing  abatacept ( n = 258 )  with placebo ( n = 133 ) on a background of DMARD treatment in RA patients who were inadequate responders to anti-TNF therapy ( ATTAIN study ) . PROs assessed included SF-36 , activity limitation , fatigue , and sleep . For each outcome the treatment difference , relative per cent improvement , st and ardised response mean ( SRM ) , and relative efficiency for assessing an outcome ’s ability to detect a treatment effect relative to tender joint count ( TJC ) were calculated . A relative efficiency > 1 suggests a measure that is more efficient than TJC in detecting treatment effect . Results : Moderate to large SRMs ( ⩾0.6 ) were observed for the PRO measures . In particular , SRMs ( 95 % confidence interval ) were : physician global , 0.72 ( 0.51 to 0.94 ) ; HAQ , 0.63 ( 0.42 to 0.85 ) ; SF-36 physical component score , 0.62 ( 0.40 to 0.83 ) ; SF-36 bodily pain , 0.68 ( 0.46 to 0.90 ) ; and fatigue , 0.59 ( 0.38 to 0.81 ) . Relative efficiencies for physician global ( 1.6 ) , SF-36 bodily pain domain ( 1.4 ) , pain intensity ( 1.4 ) , HAQ ( 1.2 ) , SF-36 physical component score ( 1.2 ) , fatigue ( 1.1 ) , and patient global assessment ( 1.04 ) were all more responsive than TJC . The SF-36 mental component score ( 0.3 ) , swollen joint count ( 0.6 ) , activity limitation ( 0.8 ) , sleep ( 0.7 ) , and C reactive protein ( 0.9 ) were less responsive . Conclusions : Using PROs for evaluating treatments for RA can detect improvements and will identify changes that are important to patients . In general , physical assessment s are more responsive to an effective treatment than mental assessment Objective : The objective of this exploratory study was to evaluate the effects and costs of a 6‐month course of tumour necrosis factor ( TNF ) inhibitors on work ability , quality of life , and fatigue in patients with rheumatoid arthritis ( RA ) . Methods : In this prospect i ve single‐arm intervention study 59 consecutive patients of working age with established RA were recruited from an outpatient clinic in Amsterdam , the Netherl and s. All patients received fortnightly subcutaneous injections of 40 mg adalimumab . The three outcomes at baseline and 6 months were : perceived work ability [ Work Ability Index ( WAI ) ] , quality of life [ Rheumatoid Arthritis Quality of Life instrument ( RAQoL ) ] , and fatigue [ Checklist Individual Strength ( CIS ) , Need for Recovery ( NFR ) scale ] . Cost data of the preceding 6 months were collected using a self‐administered patient question naire at baseline and follow‐up . Results : At 6 months , all outcomes showed a statistically significant improvement in mean scores from baseline , ranging from 10.0 % ( WAI ) , to 11.7 % ( RAQoL ) , to 15 % ( NFR ) ( subgroup paid work , n = 26 ) . The total mean costs showed a twofold increase in mean costs per week per patient [ difference EUR 169 , 95 % confidence interval ( CI ) EUR 113–226 ] . Conclusions : In this short‐term exploratory evaluation , a 6‐month course of TNF inhibitors  improved work ability and quality of life , and reduced fatigue in patients with established RA . These effects are associated with an increase in total healthcare costs , attributable to the costs of TNF inhibitors . R and omized controlled trials with a longer follow‐up are needed to show a long‐term effect on work disability and the potential cost‐effectiveness of TNF inhibitors OBJECTIVE To describe the longitudinal radiographic course of rheumatoid arthritis ( RA ) , and to identify and quantitate predictors of radiographic progression . METHODS This prospect i ve , longitudinal study of radiographic progression and clinical predictors of RA involved 256 patients with RA who were seen within the first 2 years of disease ( mean 0.77 years ) and were followed up for up to 19 years . Participants underwent a total of 6,278 clinical assessment s  ( mean 24.5 ) and 934 paired radiographs ( mean 3.1 , range 2 - 6 ) . Clinical assessment s at every visit included determination of the erythrocyte sedimentation rate ( ESR ) , grip strength , pain scores , tender joint counts , and anxiety and depression measurements . Regression analyses utilized time-integrated predictors . RESULTS Overall , radiographic progression rates , as measured by the summary Sharp scores , appeared constant over the course of RA . The strongest correlate of progression was the time-integrated ESR ( rho=0.53 ) . This association grew stronger with time . At 0 - 5 years , 5 - 10 years , 10 - 15 years , and 15 - 20 years , correlations were 0.40 , 0.50 , 0.65 , and 0.74 , respectively , and for the period 10 - 20 years , the correlation was 0.67 . In multivariate models , the mean ESR , mean grip strength , rheumatoid factor positivity , and tender joint count were independent predictors of radiographic progression . CONCLUSION Radiographic damage occurs at a constant rate in RA , and is not greater early in RA or reduced later in the course of the illness . Acute-phase reactants are , by far , the strongest determinants of progression OBJECTIVE To investigate the relationship between different outcome and process measures in early rheumatoid arthritis ( RA ) . METHODS A 3-year prospect i ve study of 149 patients with early RA ( symptoms < 1 year at entry ) . Results of serial measurements of process variables were transformed into time integrated values for comparison with the outcome measures . RESULTS A highly significant correlation was found between the acute phase response , swollen joints , and radiological progression whereas none of these measures correlated with joint tenderness . Physical disability as estimated by the Health Assessment Question naire ( HAQ ) however , appeared to be determined by joint tenderness rather than by joint swelling . CONCLUSION In early RA , joint swelling and acute phase reactants appear to be the most appropriate process variables for the prediction of radiological outcome , whereas joint tenderness is a strong determinant of physical disability ( HAQ ) To assess the sensitivity of the Arthritis Impact Measurement Scales ( AIMS ) , we analyzed data from 3 clinical trials . One trial involving 255 patients with rheumatoid arthritis ( RA ) was a 12-week , r and omized controlled trail of diclofenac , naproxen , and aspirin . Two trials were open-label studies of 24 weeks duration that included 165 RA and 355 osteoarthritis ( OA ) patients , all of whom were treated with diclofenac .  In addition to the AIMS , tender joint count , morning stiffness , and erythrocyte sedimentation rate were used as outcome measures in the trials . The AIMS results showed substantial improvements in Physical Function , Psychological Status , and Pain , as well as in overall Arthritis Impact . These improvements were detected by the time of the initial outcome assessment at 4 weeks or 8 weeks , and were detected in patients with either OA or RA . These AIMS results closely parallel improvements shown by traditional clinical measures , and demonstrate that the AIMS health status measure is sensitive to improvements in OA as well as in RA . The AIMS also detects responses produced by therapy with nonsteroidal antiinflammatory drugs ( NSAIDs ) , and these improvements can be demonstrated in as short a treatment time as 4 weeks . These findings confirm the utility of the AIMS for assessing outcome in rheumatic disease studies , and they have implication s for the design of future clinical trials of NSAIDs We previously reported the efficacy of a multicomponent cognitive-behavioral intervention including biofeedback to decrease pain , affective distress , and objective measures of disease activity in patients with rheumatoid arthritis ( RA ) . In the present article we report evidence that this intervention is associated with reductions in RA-related clinic visits and days hospitalized as well as reductions in the costs of these medical services . Data were independently and objective ly collected over an 18-month interval as part of a controlled group outcome study . The importance of documenting economic as well as clinical benefits of our treatments in specific patient population s is noted OBJECTIVE To determine the minimal clinical ly important differences ( MCID ) in the patient-reported outcomes of activity ( 0 - 30 , number of days of limitation ) , fatigue ( 0 = none , 100 = complete ) , and sleep quality ( 0 = no problems , 100 = worst case ) for patients with rheumatoid arthritis ( RA ) . METHODS Two r and omized controlled trials comparing abatacept to placebo  in RA patients were considered : ATTAIN ( n = 391 ) and AIM ( n = 652 ) . An internal anchor-based approach was used to derive the MCID using the Health Assessment Question naire , patient global assessment , and pain as anchors . Minimal important change in activity , fatigue , and sleep were determined by estimating mean changes in these outcomes in patients showing change in a narrow range about the MCID of the internal anchor . Correlation analysis was used to determine the consistency of the changes in the outcomes and anchors , and a Delphi process was used to determine the final MCID values . RESULTS For the 2 trials , consistent patterns of change for activity , fatigue , and sleep and the internal anchors were found with correlations in the range of 0.5 , 0.7 , and 0.4 , respectively . The mean changes for activity , fatigue , and sleep in a narrow range about the MCID of the 3 internal anchors corresponding to the 2 trials were : 3.4 to 4.3 for activity ; 6.7 to 17.0 for fatigue ; and 4.1 to 7.3 for sleep . Following the Delphi process the MCID determined were 4 for activity , 10 for fatigue , and 6 for sleep . CONCLUSION These MCID for activity limitation , fatigue , and sleep problems can be used in design ing clinical trials and providing benchmarks in assessing patient improvement OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS )  were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT Background . While disease flares in rheumatoid arthritis ( RA ) are a recognized aspect of the disease process , there is limited formative research to describe them . Methods . The Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) RA Flare Definition Working Group is conducting an international research project to underst and the specific characteristics and impact of episodic disease worsening , or “ flare , ” so that outcome measures can be developed or modified to reflect this uncommonly measured , but very real and sometimes disabling RA disease feature . Patient research partners provided critical insights into the multidimensional nature of flare . The perspectives of patients and healthcare and research professionals are being integrated to ensure that any outcome measurement to detect flares fulfills the first OMERACT criteria of Truth . Through an iterative data -driven Delphi process , a preliminary list of key domains has been identified to evaluate flare . Results . At OMERACT 10 , consensus was achieved identifying features of flare in addition to the existing core set for RA , including fatigue , stiffness , symptom persistence , systemic features , and participation . Patient self-report of flare was identified as a component of the research agenda needed to establish criterion validity for a flare definition ; this can be used in prospect i ve studies to further evaluate the Discrimination and Feasibility components of the OMERACT filter for a flare outcome measure . Conclusion . Our work to date has provided better underst and ing of key aspects of the RA disease process as episodic , potentially disabling disease worsening even when a patient is in low disease activity . It also highlights the importance of developing ways to enhance communication between patients and clinicians and improve the ability to achieve “ tight control ” of disease OBJECTIVE To investigate the validity of the 28-joint count for assessment of joint involvement in patients with rheumatoid arthritis ( RA ) . METHODS Joint involvement as determined by the 28- and the 66/68-joint count was compared using data from 735 prospect ively studied RA patients . RESULTS The joints included in the 28-joint count were more commonly involved than other joints , and findings from the 28-joint count correlated highly with those from the 66/68-joint count in all analyses . CONCLUSION The 28-joint count is a reliable and valid measure for joint assessment . It is easier to perform than the 66/68-joint count , and it addresses the joints that are critically involved OBJECTIVE To explore baseline risk factors for productivity loss and work disability over 5 years in patients with early , active RA . PATIENTS AND METHODS In the FIN-RACo trial , 195 patients with recent onset RA were r and omised to receive either a combination of DMARDs with prednisolone or a single DMARD for 2 years . At baseline , 162 patients were working or available for work . After 5 years ' follow up , data on sick leave and retirement were obtained from social insurance registers or case records . The cumulative duration of sick leaves and RA related disability pensions was counted for each patient . To analyse predictors of productivity loss , the patients were divided into four groups according to duration of work disability per patient year . RESULTS Patient 's and physician 's global assessment of RA severity > or = 50 and HAQ score > or = 1.0 were risk factors for extension of productivity loss ( OR ( 95 % ( CI ) 1.77 ( 1.00 to 3.16 ) , 1.85 ( 1.03 to 3.32 ) , and 1.78 ( 1.01 to 3.14 ) , respectively ) . Additional risk factors were low education level ( 2.40 ( 1.18 to 4.88 ) ) and older age ( 1.03 ( 1.00 to 1.06 ) ) ; combination treatment was a protective factor ( 0.59 ( 0.35 to 0.99 ) ) . CONCLUSION At baseline , the risk of future productivity loss is best predicted by education level , age , global assessment s of RA severity , and HAQ score
However , the 4 generic scales would benefit from further validation in patients with RA , the VAS requires st and ardization , and the MAF would benefit from further sensitivity data .
OBJECTIVE Fatigue is an important outcome for patients with rheumatoid arthritis ( RA ) .
The purpose of this study was to identify the scales being used to measure RA fatigue , and to systematic ally examine the evidence for their validation .