An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial

Pincus, Theodore; Strand, Vibeke; Koch, Gary G.; Amara, Ingrid A.; Crawford, Bruce; Wolfe, Frederick; Cohen, Stanley; Felson, David T.

doi:10.1002/art.10824

Cited by 125 publications

(85 citation statements)

References 12 publications

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“…Self-reported measures of functional status are known to be significant predictors of adverse outcomes in RA such as work disability, joint replacement surgery, and premature death when compared to laboratory tests, joint counts, or radiographic scores (32,33). These outcomes discriminate active treatment from placebo in randomized controlled trials equally as well as, if not better than, physician-reported variables such as the ACR criteria for 20% improvement in disease activity or the DAS28 (34,35). Hispanic patients in the Arthritis, Rheumatism, and Aging Medical Information System database (2) exhibited worse functional, pain, and global assessment scores compared to whites and African Americans.…”

Section: Discussionmentioning

confidence: 99%

Correlates and predictors of disability in vulnerable US Hispanics with rheumatoid arthritis

Karpouzas¹,

Dolatabadi²,

Moran³

et al. 2012

Arthritis Care & Research

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Objective. US Hispanics with rheumatoid arthritis experience worse functional outcomes compared to whites. The determinants of disability, however, are not well established in large Hispanic cohorts. In the present report, we identified factors associated with disability in a cross-sectional design, and evaluated their individual contributions to disability over time. Methods. Two hundred fifty-one Hispanic subjects from a single center were evaluated. Disease activity, serologies, radiographs, treatments, irreversible articular damage (defined as subluxation, arthrodesis, fusion, or prosthesis), and joint replacement surgeries were recorded. Self-reported disability (Health Assessment Questionnaire disability index), patient pain by a visual analog scale, and depression assessments were collected. Cross-sectional factors associated with disability were identified, and their effects on future disability were evaluated in a subgroup of 114 patients assessed 6 months later. Results. Six parameters were independently related to disability cross-sectionally: pain was the strongest (P < 0.0001), followed by irreversible articular damage, disease activity, depression, age, and fibromyalgia (P < 0.03 for all). Baseline parameters predicting disability 6 months later included, in decreasing significance, irreversible articular damage (P ‫؍‬ 0.004), depression, disease activity, age, and pain (all P < 0.04). Conclusion. In cross-sectional analysis, self-reported pain had the strongest relationship with disability; however, factors such as irreversible articular damage, depression, and disease activity were more important in predicting future disability. Most of these factors are amenable to targeted interventions and should be addressed in an effort to improve functional outcomes.

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Section: Discussionmentioning

confidence: 99%

Correlates and predictors of disability in vulnerable US Hispanics with rheumatoid arthritis

Karpouzas¹,

Dolatabadi²,

Moran³

et al. 2012

Arthritis Care & Research

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“…Recent data from studies in RA suggest that patient-reported outcomes perform as well as physician-assessed outcomes, and that they should be given priority in clinical trials (29)(30)(31). The data from the present study in adult and juvenile IIM, however, do not support a heavy emphasis on patient-reported outcomes or a requirement for improvements in parent's global assessment and physical function in these preliminary definitions of improvement.…”

Section: Discussionmentioning

confidence: 99%

International consensus on preliminary definitions of improvement in adult and juvenile myositis

Rider

Giannini

Brunner

et al. 2004

Arthritis & Rheumatism

214

164

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Objective. To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials.Methods. Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation.Results. The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >20%, with no more than 2 worse by >25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials.Conclusion. Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now proposed for use as end points in all myositis trials.

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“…An index of only the 3 patient self-report RA core data set measures, the Routine Assessment of Patient Index Data 3 (RAPID3) without joint counts, is correlated significantly with the DAS28 and CDAI in clinical trials (23) and in clinical settings (24,25). RAPID3 distinguishes active from control treatments at levels similar to the DAS28 and CDAI in clinical trials of leflunomide (26,27), methotrexate (26,27), adalimumab (28), and abatacept (23). RAPID3 on a Multidimensional Health Assessment Questionnaire (MDHAQ) (see Supplementary Appendix A, available in the online version of this article at http://www3.interscience.wiley.…”

Section: Introductionmentioning

confidence: 99%

RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): Agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds

Pincus¹,

Swearingen²,

Bergman³

et al. 2010

Arthritis Care & Research

101

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, and time to score. Methods. Four rheumatologists each assessed 50 patients with rheumatoid arthritis in "real-time" clinical care. Patients completed an MDHAQ. The rheumatologist then calculated RAPID3 (physical function, pain, patient global estimate), performed a 28-joint count, assigned a physician global estimate, and scored a CDAI, each timed by an observer. Erythrocyte sedimentation rate (ESR) was tested on the same date, and the DAS28-ESR was computed later, again timed by an observer. Spearman's rank-order correlations and comparisons of patients classified as high activity, moderate activity, low activity, and remission according to the DAS28, CDAI, and RAPID3 were computed and compared with kappa statistics. A second study of 25 "paper patients" was also performed to compare time to score the DAS28, CDAI, and RAPID3 on a 0 -10 versus 0 -30 scale. Mean and median times to score each index were computed. Results. The 3 indices were correlated significantly, including agreement for >80% of patients for high/moderate activity. The mean time to perform a 28-joint count was 94 seconds, and the mean times to score the DAS28, CDAI, RAPID3 on a 0 -10 scale, and RAPID3 on a 0 -30 scale were 114, 106, 9.6, and 4.6 seconds, respectively. Conclusion. RAPID3 scores provide similar quantitative information to DAS28 and CDAI, while calculated on a 0 -30 scale in about 5% of the time.

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An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial

Cited by 125 publications

References 12 publications

Correlates and predictors of disability in vulnerable US Hispanics with rheumatoid arthritis

Correlates and predictors of disability in vulnerable US Hispanics with rheumatoid arthritis

International consensus on preliminary definitions of improvement in adult and juvenile myositis

RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): Agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds

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