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. Validity of the MACTAR questionnaire as a functional index in a rheumatoid arthritis clinical trial. The McMaster Toronto Arthritis. Rehabilitation in rheumatoid arthritis: a critical review. A randomised controlled trial of occupational therapy for people with early rheumatoid arthritis. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand Cigarette smoking and radiographic progression in rheumatoid arthritis A randomized, pilot study to assess the efficacy and safety of curcumin in patients with active rheumatoid arthritis. Does disease activity add to functional disability in estimation of utility for rheumatoid arthritis patients on biologic treatment? French validation of the Foot Function Index (FFI). Development and validation of a multivariate predictive model for rheumatoid arthritis mortality using a machine learning approach MRI of the wrist in early rheumatoid arthritis can be used to predict functional outcome at 6 years. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey Vitamin D intake is inversely associated with rheumatoid arthritis: results from the Iowa Women's Health Study. Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials The value of a continuous ambulatory activity monitor to quantify the amount and intensity of daily activity in patients with rheumatoid arthritis. A genome-wide screen of gene–gene interactions for rheumatoid arthritis susceptibility Clinical Response Within 12 Weeks as a Predictor of Future Low Disease Activity in Patients with Early RA: Results from the TEAR Trial Revalidation of the original Cedars-Sinai health-related quality of life in rheumatoid arthritis questionnaire. Development and evaluation of a patient self-report case-finding method for rheumatoid arthritis. Validation of a novel satisfaction questionnaire for patients with rheumatoid arthritis receiving outpatient clinical nurse specialist care, inpatient care, or day patient team care. Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review
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 The McMaster Toronto Arthritis patient preference question naire ( MACTAR ) is a functional index that measures change in impaired activities selected by each patient in a baseline interview , and change in rheumatoid arthritis ( RA ) disease activity . In addition , it contains questions on the state of physical , social and emotional function and overall health , and their relation to RA . We evaluated MACTAR 's feasibility and validity ( content validity , construct validity , and responsiveness ) . METHODS A r and omized trial of combined treatment in 155 patients with early RA ; patients ' mean age at baseline was 50 years and median disease duration since diagnosis was 4 months . RESULTS Feasibility : MACTAR requires trained interviewers . In the trial , interviews took about 15 min . In longer term followup , activities selected at baseline may become less relevant as the pattern of disability changes . Followup from 153 patients ( 99 % ) was available . At least 5 impaired activities were identified and ranked by 147 patients ( 95 % ) ; interviewers could follow 99 % of these . The scoring system proved complex and required amendments . Content validity : Although its main focus is physical function , the MACTAR also contains generic questions ; 75 % of the patients named at least one impaired activity from the category " mobility . " Only 48 % were covered by Health Assessment Question naire ( HAQ ) items . Construct validity : MACTAR scores correlate highly with other functional indices and with measures of disease activity . Responsiveness : At 16 weeks the st and ardized response mean for the total MACTAR score in the combined-treatment group was excellent , at 2.2 . Items that directly address change were even more responsive . CONCLUSION The MACTAR interview is a valid and highly responsive instrument to assess change in functional ability of patients with early RA with active disease . It provides insight into problems -- mainly of physical function -- that really matter to patients . For st and ard clinical trials and clinical care , feasibility of the MACTAR is limited and the simpler HAQ remains the instrument of choice This article considers the evidence for effectiveness and timing of rehabilitation  for people with rheumatoid arthritis ( RA ) . The Cochrane Library , DARE , Medline , Embase , CINAHL and AMED were search ed to identify systematic review s and r and omized controlled trials evaluating rehabilitation interventions for people with rheumatoid arthritis . Many trials identified had method ological limitations ( e.g. short follow-up periods , small sample sizes ) . Evidence to date is that symptomatic relief results from thermotherapy , laser therapy , acupuncture and assistive devices . In the short-term , comprehensive occupational therapy ( in established rheumatoid arthritis ) , orthoses , and mind-body approaches can help maintain function . Over at least a one-year period , the following are effective in reducing pain and maintaining function :  patient education and joint protection training using behavioural approaches ; dynamic exercise therapy , h and exercises and hydrotherapy ; and cognitive-behavioural therapy ( in people with poorer psychological status ) . Many trials have recruited people with moderate to severe , established RA and relatively little is known about the long-term effectiveness of early rehabilitation , although this is becoming much more common in practice . Despite the increased availability of guidelines and systematic review s , most conclude there is insufficient evidence for many areas of rheumatology rehabilitation . Further well- design ed clinical trials are needed recruiting people with early disease using patient-centred outcomes BACKGROUND Occupational therapy ( OT ) aims at improving performance of daily living tasks , facilitating successful adjustments in lifestyle , and preventing losses of function . OBJECTIVE To evaluate the effects of a pragmatic , comprehensive OT programme on self management and health status of people with early rheumatoid arthritis ( RA ) ( < 2.5 years ) . METHODS A r and omised , controlled " assessor blinded " trial was conducted with assessment s made at entry , 6 , 12 , and 24 months . Main outcomes were AIMS 2 : physical function ( PF ) , pain visual analogue scale ( VAS ) , and Arthritis Self-Efficacy Scale ( ASES ) . RESULTS Groups had similar disease duration ( 9 months OT ( n = 162 ) v 10 months control ( n = 164 ) ) . The OT group received 7.57 ( SD 3.04 ) hours of therapy . Self management significantly increased in the OT group . Otherwise , there were no significant differences in any outcome measures , or between groups , by ACR functional class : AIMS 2 : PF ( F = 0.04 ; p = 0.96 ) ; pain VAS ( F = 0.29 ; p = 0.74 ) ; total ASES score ( F = 0.93 ; p = 0.39 ) . CONCLUSIONS OT improved self management but not health status in early RA . Functional ability remains reasonably good for many in the first five years , so preventive benefits of self management may not yet be apparent and longer follow up is needed . Although many considered the education and therapy useful , insufficient numbers in the OT group used self management sufficiently to make a difference . Behavioural approaches can improve adherence and , potentially , the long term benefits . Future research should evaluate OT as a complex intervention and develop programmes from a theoretical and evidence base OBJECTIVE To vali date the European League Against Rheumatism ( EULAR ) , the American College of Rheumatology ( ACR ) , and the World Health Organization (WHO)/International League Against Rheumatism ( ILAR ) response criteria for rheumatoid arthritis ( RA ) . METHODS EULAR response criteria were developed combining change from baseline and level of disease activity attained during follow up . In a trial comparing hydroxychloroquine and sulfasalazine , we studied construct ( radiographic progression ) , criterion ( functional capacity ) , and discriminant validity . RESULTS EULAR response criteria had good construct , criterion , and discriminant validity , ACR and WHO/ILAR criteria showed only good criterion validity . CONCLUSION EULAR response criteria showed better construct and discriminant validity than did the ACR and the WHO/ILAR response criteria for RA Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose Background : Smoking is a well-established environmental risk factor for the development of rheumatoid arthritis ( RA ) . However , it remains unclear whether smoking influences RA disease progression and whether smokers have more radiographic damage progression than non-smokers over time . Objective : To compare the rates of radiographic damage progression in current smokers and non-smokers in a large prospect i ve RA cohort . Methods : The SCQM-RA is a population -based registry monitoring disease activity , radiographic damage and symptoms at regular intervals . All patients in the SCQM-RA data base with sequential plain radiographs were included .  Joint erosions were assessed in 38 h and and foot joints with a vali date d scoring method . The rate of erosion progression was analysed using multivariate longitudinal regression models and adjusted for potential confounders . Results : 2004 RA patients with a mean of 3.6 sequential radiographs and 3.1 years of follow-up were included . The 545 ( 27 % ) current smokers smoked on average 16 cigarettes per day and had a mean past smoking exposure of 20.6 pack-years . Radiographic joint damage progressed at a similar rate in current smokers and non-smokers ( p = 0.26 ) . However , smoking intensity was associated with a significant inverse dose – response ; heavy smokers ( > 1 pack-day ) progressed significantly less than non-smokers or moderate smokers ( p<0.001 ) . Conclusion : Radiographic joint damage progressed at an equivalent rate in smokers and non-smokers . Furthermore , a significant trend was observed for reduced radiographic progression and generally more favourable functional scores among heavy smokers , suggesting that cigarette smoke does not accelerate RA disease progression Curcumin is known to possess potent antiinflammatory and antiarthritic properties . This pilot clinical study evaluated the safety and effectiveness of curcumin alone , and in combination with diclofenac sodium in patients with active rheumatoid arthritis ( RA ) . Forty-five patients diagnosed with RA were r and omized into three groups with patients receiving curcumin ( 500 mg ) and diclofenac sodium ( 50 mg ) alone or their combination . The primary endpoints were reduction in Disease Activity Score ( DAS ) 28 . The secondary endpoints included American College of Rheumatology ( ACR ) criteria for reduction in tenderness and swelling of joint scores . Patients in all three treatment groups showed statistically significant changes in their DAS scores . Interestingly , the curcumin group showed the highest percentage of improvement in overall DAS and ACR scores ( ACR 20 , 50 and 70 ) and these scores were significantly better than the patients in the diclofenac sodium group . More importantly , curcumin treatment was found to be safe and did not relate with any adverse events . Our study provides the first evidence for the safety and superiority of curcumin treatment in patients with active RA , and highlights the need for future large-scale trials to vali date these findings in patients with RA and other arthritic conditions OBJECTIVE Treatment in general is mostly directly aim ed at disease activity , and measures such as the DAS28 might therefore present important additional information . Our aim was to develop and vali date a model that uses a combination of disease activity ( DAS28 ) and HAQs to estimate EuroQoL 5-dimension scale ( EQ5D ) utilities . METHODS Longitudinal data from a cohort study in RA patients from the Utrecht Rheumatoid Arthritis Cohort study Group ( Stichting Reumaonderzoek Utrecht ) who started treatment with a biologic drug  were used for mapping and validation . All 702 observations , including DAS28 , HAQ and EQ5D assessed at the same time points , were used . The observations were r and omly divided into a subset for development of the model ( n = 428 observations ) and a subset for validation ( n = 274 ) . A stepwise multivariable regression analysis was used to test the association of DAS28 ( components ) and HAQ ( domains ) with EQ5D . Model performance was assessed using the explained variance ( R(2 ) ) and root mean square errors . Observed and predicted utility scores were compared to check for under- or overestimation of the scores . Finally , the performance of the model was compared with published mapping models . RESULTS Lower DAS28 score and HAQ items dressing and grooming , arising , eating , walking and activities were associated with higher EQ5D scores . The final model had an explained variance of 0.35 and a lower root mean square error as compared with other models tested . The agreement between predicted and observed scores was fair . CONCLUSION HAQ components estimate EQ5D better than total HAQ . Adding DAS28 to HAQ components does not result in better utility estimations OBJECTIVE French validation of the Foot Function Index ( FFI ) , self- question naire design ed to evaluate rheumatoid foot according to 3 domains : pain , disability and activity restriction . METHODS The first step consisted of translation/back translation and cultural adaptation according to the vali date d methodology . The second stage was a prospect i ve validation on 53 patients with rheumatoid arthritis who filled out the FFI . The following data were collected :  pain ( Visual Analog Scale ) , disability ( Health Assessment Question naire ) and activity restrictions ( McMaster Toronto Arthritis question naire ) . A test/retest procedure was performed 15 days later . The statistical analyses focused on acceptability , internal consistency ( Cronbach 's alpha and Principal Component Analysis ) , test-retest reproducibility ( concordance coefficients ) , external validity ( correlation coefficients ) and responsiveness to change . RESULTS The FFI-F is a culturally acceptable version for French patients with rheumatoid arthritis . The Cronbach 's alpha ranged from 0.85 to 0.97 . Reproducibility was correct ( correlation coefficients>0.56 ) . External validity and responsiveness to change were good . CONCLUSION The use of a rigorous methodology allowed the validation of the FFI in the French language ( FFI-F ) . This tool can be used in routine practice and clinical research for evaluating the rheumatoid foot . The FFI-F could be used in other pathologies with foot-related functional impairments We developed and independently vali date d a rheumatoid arthritis ( RA ) mortality prediction model using the machine learning method R and om Survival Forests ( RSF ) . Two independent cohorts from Madrid ( Spain ) were used : the Hospital Clínico San Carlos RA Cohort ( HCSC-RAC ; training ; 1,461 patients ) , and the Hospital Universitario de La Princesa Early Arthritis Register Longitudinal study ( PEARL ; validation ; 280 patients ) .  Demographic and clinical -related variables  collected during the first two years after disease diagnosis were used . 148 and 21 patients from HCSC-RAC and PEARL  died during a median follow-up time of 4.3 and 5.0 years , respectively . Age at diagnosis , median erythrocyte sedimentation rate , and number of hospital admissions showed the higher predictive capacity . Prediction errors in the training and validation cohorts were 0.187 and 0.233 , respectively . A survival tree identified five mortality risk groups using the predicted ensemble mortality . After 1 and 7 years of follow-up , time-dependent specificity and sensitivity in the validation cohort were 0.79–0.80 and 0.43–0.48 , respectively , using the cut-off value dividing the two lower risk categories . Calibration curves showed overestimation of the mortality risk in the validation cohort . In conclusion , we were able to develop a clinical prediction model for RA mortality using RSF , providing evidence for further work on external validation OBJECTIVES To determine whether magnetic resonance ( MR ) scans of the dominant wrist of patients with early rheumatoid arthritis ( RA ) can be used to predict functional outcome at 6 years ' follow up . METHODS  Dominant wrist MR scans were obtained in 42 patients with criteria for RA at first presentation . Patients were followed up prospect ively for 6 years , and further scans obtained at 1 year ( 42 patients ) and 6 years ( 31 patients ) . Two radiologists scored scans for synovitis , tendonitis , bone oedema , and erosions . The Stanford Health Assessment Question naire ( HAQ ) score , indicating functional outcome , and st and ard measures of disease activity were assessed at 0 , 1 , 2 , and 6 years . The physical function component of the SF-36 score ( PF-SF36 ) was also used as a functional outcome measure at 6 years . RESULTS Baseline MR parameters , including bone oedema score and the total baseline MR score , were predictive of the PF-SF36 at 6 years ( R2 = 0.22 , p = 0.005 and R2 = 0.16 , p = 0.02 , respectively ) . The PF-SF36 score correlated strongly with the HAQ score at 6 years ( rs = -0.725 , p<0.0001 ) ; none of the baseline MR parameters predicted the 6 year HAQ score . The total MR score obtained at 1 year was predictive of the 6 year HAQ ( R2 = 0.04 , p = 0.01 ) . St and ard clinical and radiographic measures at baseline were not predictive of the 6 year PF-SF36 , but when combined in a model with baseline MR oedema score , prediction increased from 0.09 to 0.23 , or 23 % of the 6 year variance . CONCLUSION MR imaging of the wrist  in patients with early RA can help to predict function at 6 years and could be used to plan aggressive management at an earlier stage OBJECTIVE The objective of the EPISER study was to estimate the prevalence of rheumatoid arthritis ( RA ) , low back pain , h and and knee osteoarthritis ( OA ) , and fibromyalgia in the adult Spanish population , and to assess the impact of these diseases on function and quality of life , and use of health and social re sources . METHODS 2998 subjects aged 20 years or above were r and omly selected by stratified multistage cluster sampling from the censuses of 20 municipalities .  Trained rheumatologists carried out structured visits at which subjects were asked about rheumatic symptoms and sociodemographic characteristics , completed vali date d instruments for measuring function ( HAQ ) and  quality of life  ( SF-12 ) , and underwent a st and ardised physical examination . Cases were defined by previously vali date d criteria . RESULTS The estimated prevalences with 95 % confidence intervals were as follows : RA lifetime cumulative : 0.5 % ( 0.3 to 0.9 ) ; low back pain : 14.8 % ( 12.2 to 17.4 ) ; symptomatic knee OA : 10.2 % ( 8.5 to 11.9 ) ; h and OA : 6.2 % ( 5.9 to 6.5 ) ; fibromyalgia : 2.4 % ( 1.5 to 3.2 ) . Most conditions significantly impaired function and quality of life . CONCLUSIONS The EPISER study has internal and external validity for application of the results to the adult Spanish population . The diseases studied affect a significant proportion of the population , with various degrees of impact on disability and quality of life result ing in a significant number of physician visits , work disability , and medication use OBJECTIVE Vitamin D is a potent regulator of calcium homeostasis and may have immunomodulatory effects . The influence of vitamin D on human autoimmune disease has not been well defined . The purpose of this study was to evaluate the association of dietary and supplemental vitamin D intake with rheumatoid arthritis ( RA ) incidence . METHODS We analyzed data from a prospect i ve cohort study of 29,368 women of ages 55 - 69 years without a history of RA at study baseline in 1986 . Diet was ascertained using a self-administered , 127-item vali date d food frequency question naire that included supplemental vitamin D use . Risk ratios ( RRs ) and 95 % confidence intervals ( 95 % CIs ) were estimated using Cox proportional hazards regression , adjusting for potential confounders . RESULTS Through 11 years of followup , 152 cases of RA were vali date d against medical records . Greater intake ( highest versus lowest tertile ) of vitamin D  was inversely associated with risk of RA ( RR 0.67 , 95 % CI 0.44 - 1.00 , P for trend = 0.05 ) . Inverse associations were apparent for both dietary ( RR 0.72 , 95 % CI 0.46 - 1.14 , P for trend = 0.16 ) and supplemental ( RR 0.66 , 95 % CI 0.43 - 1.00 , P for trend = 0.03 )  vitamin D.  No individual food item high in vitamin D content and /or calcium was strongly associated with RA risk , but a composite measure of milk products was suggestive of an inverse association with risk of RA ( RR 0.66 , 95 % CI 0.42 - 1.01 , P for trend = 0.06 ) . CONCLUSION Greater intake of vitamin D may be associated with a lower risk of RA in older women , although this finding is hypothesis generating Background Joint damage is an important outcome in trials of rheumatoid arthritis ( RA ) , usually assessed by Total Sharp Score ( TSS ) . It is currently unknown how it translates numerically into disability by the Health Assessment Question naire ( HAQ ) . Objective To determine the units of HAQ score corresponding to one TSS unit . Methods A short-term observational trial of  glucocorticoids in RA ( the ‘ BEst LIfe with Rheumatoid Arthritis ’ ( BELIRA ) trial ) was evaluated , using r and omised controlled clinical trial ( RCT ) data for confirmation . For each trial arm HAQ , TSS and the Simplified Disease Activity Index ( SDAI ) were assessed . Based on the hypothesis that short-term HAQ changes will mostly be due to changes of disease activity , activity HAQ ( ACT-HAQ ) at end point ( EP ) was determined and remaining disability defined as damage related ( DAM-HAQ ) . Using TSS at EP , the HAQ units corresponding to a TSS unit were estimated . Results In BELIRA , one TSS unit corresponded to a mean of 0.017 HAQ units ; to account for other causes of irreversible disability , the 25th percentile was used : 0.011 HAQ units/TSS unit . In RCT trial arms , the HAQ/TSS were similar ( 0.013 and 0.015 in established and early RA , respectively ; 25th percentile : 0.010 ) . The correlation between DAM-HAQEP and TSS was r=0.829 . Over 5 years , damage would amount to an increase of irreversible HAQ of 0.33 on placebo , 0.13 on disease-modifying antirheumatic drugs ( DMARDs ) and 0.03 on TNF inhibitors+methotrexate ( MTX ) . Conclusion An approach to estimate the numerical relationship between HAQ and damage as 0.01 HAQ points/TSS unit is presented , although the linear relationship may not be generally valid . This allows the assessment of functional correlates of radiographic changes in trials OBJECTIVE To examine the reliability , validity , and responsiveness of a continuous ambulatory activity monitor in patients with rheumatoid arthritis ( RA ) . METHODS Forty-one patients with RA , participating in a r and omized controlled trial examining the effect of an intensive exercise program  , were assessed by means of the  Dynaport ADL ( activities of daily living ) monitor ( AM ) .  The time spent on activities ( locomotion , st and ing , and active sitting ) during 24 hours and the intensity of trunk movement during these activities were recorded . To determine test-retest reliability 20 patients were reassessed with the AM one week after the first assessment . Construct validity of the AM was determined by comparing the AM results with physical fitness measures ( muscle strength , endurance , joint mobility ) , disease activity , and functional status . As well , 37 patients were assessed 18 months after the first assessment to determine responsiveness . RESULTS All AM measurements showed satisfactory test-retest reliability ( ICC 0.63 - 0.76 ) . AM measures were significantly associated with physical fitness , functional status , and disease activity , indicating construct validity of the AM . The AM could discriminate between patients with improvement and deterioration in physical fitness , indicating sufficient responsiveness of AM variables . CONCLUSION This study shows the value of an ambulatory activity monitor to quantify both the amount and intensity of physical activity of patients with RA during a day in their own environment . The ambulatory activity monitor seems to be a promising instrument for research into rehabilitation of patients with RA The objective of the study was to identify interacting genes contributing to rheumatoid arthritis ( RA ) susceptibility and identify SNPs that discriminate between RA patients who were anti-cyclic citrullinated protein positive and healthy controls . We analyzed two independent cohorts from the North American Rheumatoid Arthritis Consortium . A cohort of 908 RA cases and 1,260 controls was used to discover pairwise interactions among SNPs and to identify a set of single nucleotide polymorphisms ( SNPs ) that predict RA status , and a second cohort of 952 cases and 1,760 controls was used to vali date the findings . After adjusting for HLA-shared epitope alleles , we identified and replicated seven SNP pairs within the HLA class II locus with significant interaction effects . We failed to replicate significant pairwise interactions among non-HLA SNPs . The machine learning approach “ r and om forest ” applied to a set of SNPs selected from single-SNP and pairwise interaction tests identified 93 SNPs that distinguish RA cases from controls with 70 % accuracy . HLA SNPs provide the most classification information , and inclusion of non-HLA SNPs improved classification . While specific gene – gene interactions are difficult to vali date using genome-wide SNP data , a stepwise approach combining association and classification methods identifies c and i date interacting SNPs that distinguish RA cases from healthy controls Objective . Rapidly predicting future outcomes based on short-term clinical response would be helpful to optimize rheumatoid arthritis ( RA ) management in early disease . Our aim was to derive and vali date a clinical prediction rule to predict low disease activity ( LDA ) at 1 year among patients participating in the Treatment of Early Aggressive Rheumatoid Arthritis ( TEAR ) trial escalating RA therapy by adding either etanercept or sulfasalazine + hydroxychloroquine [ triple therapy ( TT ) ] after 6 months of methotrexate ( MTX ) therapy . Methods . Eligible subjects included in the derivation cohort ( used for model building , n = 186 ) were participants with moderate or higher disease activity [ Disease Activity Score 28-erythrocyte sedimentation rate ( DAS-ESR ) > 3.2 ] despite 24 weeks of MTX monotherapy who added either etanercept or sulfasalazine + hydroxychloroquine . Clinical characteristics measured within the next 12 weeks were used to predict LDA 1 year later using multivariable logistic regression . Validation was performed in the cohort of TEAR patients r and omized to initially receive either MTX + etanercept or  TT . Results . The derivation cohort yielded 3 prediction models of varying complexity that included age , DAS28 at various timepoints , body mass index , and ESR ( area under the receiver-operator characteristic curve up to 0.83 ) . Accuracy of the prediction models ranged between 80 % and 95 % in both derivation and validation cohorts , depending on the complexity of the model and the cutpoints chosen for response and nonresponse . About 80 % of patients could be predicted to be responders or nonresponders at Week 12 . Conclusion . Clinical data collected early after starting or escalating disease-modifying antirheumatic drug/biologic treatment could accurately predict LDA at 1 year in patients with early RA . For patients predicted to be nonresponders , treatment could be changed at 12 weeks to optimize outcomes OBJECTIVE To assess the psychometric characteristics of the original 33-item Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis Question naire ( O-CSHQ-RA ) and 11-item CSHQ-RA Short Form ( SF ) using a representative population of patients with rheumatoid arthritis ( RA ) from 55 sites across the United States . METHODS Data were from a 24-week multicenter , open-label , single-arm study of 312 RA patients receiving anakinra .  Cronbach 's alpha coefficient was used to indicate the internal consistency . Test-retest reliability was assessed by establishing the intraclass correlation coefficient ( ICC ) for screening and baseline visit responses . Convergent validity was tested with the Pearson correlation coefficient . Analysis of variance was performed to determine discriminant validity . A Wilcoxon signed-rank test and analysis of covariance were used to assess the responsiveness . A discriminant function was generated to determine the clinical ly meaningful change . RESULTS Test-retest reliability was demonstrated for both versions of the CSHQ-RA , with ICC ranging from 0.82 to 0.94 . Cronbach 's alpha coefficients were > or = 0.9 , indicating good internal consistency . Pearson correlations between health-related quality of life instruments and CSHQ-RA measures ranged from -0.33 to -0.73 and 0.39 to 0.76 , demonstrating good convergent validity . Scores on both versions of the CSHQ-RA differed significantly ( p < 0.0001 ) for patients with different levels of physical disability as measured by the Stanford Health Assessment Question naire . Both instruments were responsive to differences in patient health as measured by the general health question ( p < 0.0001 ) . Clinical ly meaningful changes were calculated for all 5 domains of the O-CSHQ-RA ( 6.9 - 14.0 ) and the overall O-CSHQ-RA SF ( 12.7 ) . CONCLUSION These results support the validity and reliability of both the original CSHQ-RA and the 11-item CSHQ-RA SF when tested in a representative patient population OBJECTIVE To describe the development and evaluation of a patient self-report case-finding method for rheumatoid arthritis ( RA ) not dependent on direct contact with the treating physicians . METHODS The American College of Rheumatology criteria for RA diagnosis were adapted for patient self-report using a question naire , and alternative scoring algorithms were evaluated to balance case-finding sensitivity and specificity . Positive rheumatoid factor tests were used to identify 1053 individuals in 2 large healthcare organizations ; 440 agreed to receive study material s. Case-finding results were vali date d by medical record review ( MRR ) for a r and om sample of 90 patients . Three scoring algorithms were compared with MRR for likelihood of RA diagnosis . Cases not classifiable by algorithm were flagged and review ed by 2 expert physicians for likelihood of RA diagnosis . RESULTS Pilot testing demonstrated that patients comprehended the question naire and were willing to answer the questions . Completed question naires were returned by 265 ( 60 % ) of the 440 patients contacted . Following expert physician review of 16 flagged cases in the 90-patient MRR sub sample , the most accurate scoring algorithm demonstrated 80 % sensitivity , 67 % specificity , 74 % accuracy , and 77 % positive predictive value for detecting early RA . CONCLUSION The case-finding method represents a promising tool for identifying RA patients , with potential application in research and quality -assurance activities . RELEVANCE This case-finding method should be useful in research and quality -assurance efforts requiring identification of RA patients treated by all types of providers in healthcare organizations in which central ized laboratory data are available OBJECTIVES To develop and vali date a question naire for measuring satisfaction with different forms of complex multidisciplinary care in patients with rheumatoid arthritis ( RA ) . METHODS The satisfaction question naire ( score range 0 - 100 ) comprised 28 items covering 11 domains . Together with a visual analog scale ( VAS , range 0 - 100 ) on overall satisfaction , the question naire was applied in 210 RA patients who participated in a r and omized trial comparing 3 types of multidisciplinary care . RESULTS The question naire was returned by 174 patients ( 83 % ) . The question naire and VAS scores in the total group were 75 ( SD 12 ) and 83 ( SD 20 ) , respectively . Reliability analysis showed Cronbach 's alpha of the question naire was 0.91 . Spearman 's correlation coefficient between the satisfaction question naire score and VAS score was 0.58 ( P < 0.01 ) . Mean total satisfaction question naire scores were 72 ( SD 9 ) , 76 ( SD 14 ) , and 78 ( SD 11 ) , in the nurse specialist , inpatient and day patient groups , respectively ( nurse specialist versus day patient , P = 0.004 ) . Significant differences between nurse specialist and day patients were seen in the following domains : waiting time during the treatment , autonomy , coordination , non-financial access , and quality of general information ( all P < 0.05 ) . CONCLUSION Overall , patients were highly satisfied with the multidisciplinary care they received . Major differences regarding the organization of care were reflected in the results of the question naire scores . The satisfaction question naire appears to be a useful instrument for measuring satisfaction with complex multidisciplinary care in RA patients Background The quality of reporting of harms data in r and omised controlled trials ( RCTs ) has been reported to be suboptimal . Rheumatoid arthritis ( RA ) has seen a massive growth in novel pharmacotherapies in the last decade . Objective The aim of this study was to assess the quality of reporting of harms-related data  in RCTs evaluating pharmacological interventions for RA according to the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement on harms reporting extension . Study selection RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included . Reports of secondary , supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded . Two review ers independently extracted data using a structured , pilot-tested , 18-item question naire developed based on CONSORT harms extension recommendations . Findings 68 RCTs were included in the review . Out of a maximum harms reporting score of 18 , the mean ( SD ) score was 8.51 ( 3.5 ) ( range=0–15 ) . More than half ( 56.5 % ) of the RCTs reported ≤50 % of items and only three ( 4.3 % ) RCTs reported more than 70 % ( score ≥14 ) of the items . Multilinear regression analyses found that region of trial origin ( p=0.01 ) , sample size ( p=0.001 ) and whether the study was a long-term extension of a trial or not ( p=0.04 ) were independent predictors associated with higher total harms reporting score . Conclusions The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA . There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making
Conclusion Based on this literature review , the disease-specificHAQ and the generic SF-36 can currently be most confidently recommended to measure PF in RA for most research purpose s. The HAQ , however , was frequently associated with considerable ceiling effects while the SF-36 has limited content coverage .
Background The aim of this study was to systematic ally review the content validity and measurement properties of all physical function ( PF ) scales which are currently vali date d for use with patients with rheumatoid arthritis ( RA ) .