Developing a Construct to Evaluate Flares in Rheumatoid Arthritis: A Conceptual Report of the OMERACT RA Flare Definition Working Group: Table 1.

2011 ◽  
Vol 38 (8) ◽  
pp. 1745-1750 ◽  
Author(s):  
RIEKE ALTEN ◽  
CHRISTOF POHL ◽  
ERNEST H. CHOY ◽  
ROBIN CHRISTENSEN ◽  
DANIEL E. FURST ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Conceptual Framework ◽  
Working Group ◽  
Activity Index ◽  
Disease Activity Index ◽  
Self Report ◽  
Patient Treatment ◽  
Conceptual Approach ◽  
Patient Reported

Rheumatoid arthritis (RA) patients and healthcare professionals (HCP) recognize that episodic worsening disease activity, often described as a “flare,” is a common feature of RA that can contribute to impaired function and disability. However, there is no standard definition to enable measurement of its intensity and impact. The conceptual framework of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Definition Working Group includes an anchoring statement, developed at OMERACT 9 in 2008: “flare in RA” is defined as worsening of signs and symptoms of sufficient intensity and duration to lead to change in therapy. Subsequently, domains characterizing flare have been identified by comprehensive literature review, patient focus groups, and patient/HCP Delphi exercises. This led to a consensus regarding preliminary domains and a research agenda at OMERACT 10 in May 2010. The conceptual framework of flare takes into account validated approaches to measurement in RA: (1) various disease activity indices (e.g., Disease Activity Score, Clinical Disease Activity Index, Simplified Disease Activity Index); (2) use of patient-reported outcomes (PRO); and (3) characterization of minimally clinically detectable and important differences (MCDD, MCID). The measurement of RA flare is composed of data collection assessing a range of unique domains describing key features of RA worsening at the time of patient self-report of flare, and then periodically for the duration of the flare. The components envisioned are: (1) Patient self-report using a “patient global question” with well characterized and validated anchors; (2) Patient assessment using a flare questionnaire and PRO available at the time of each self-report; (3) Physician/HCP assessment of disease activity status; and (4) Physician’s determination whether to change treatment. In randomized controlled trials and observational studies, such a conceptual approach is intended to lead to a valid measure of this outcome/response, thus expanding an understanding of the true impact of a therapy to limit disease activity. Clinically, this approach is intended to enhance patient-HCP communication. This article describes the conceptual framework being used by the OMERACT RA Flare Definition Working Group in developing a standardized method for description and measurement of “flare in RA” to guide individual patient treatment.

scholarly journals Patient Acceptable Symptom State in Self-Report Questionnaires and Composite Clinical Disease Index for Assessing Rheumatoid Arthritis Activity: Identification of Cut-Off Points for Routine Care

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Fausto Salaffi ◽  
Marina Carotti ◽  
Marwin Gutierrez ◽  
Marco Di Carlo ◽  
Rossella De Angelis
Keyword(s):  
Rheumatoid Arthritis ◽  
Logistic Regression ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
State Level ◽  
Clinical Disease ◽  
Self Report ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Objective. To provide information on the value of Patient Acceptable Symptom State (PASS) in rheumatoid arthritis (RA) by the identification of PASS thresholds for patient-reported outcomes (PROs) composite scores.Methods. The characteristics of RA patients with affirmative and negative assignment to PASS were compared. Contributors to physician response were estimated by logistic regression models and PASS thresholds by the 75th percentile and receiver-operating characteristic (ROC) curve methods.Results. 303 RA patients completed the study. All PROs were different between the PASS (+) and PASS (−) groups (p<0.0001). The thresholds with the 75th percentile approach were 2.0 for the RA Impact of Disease (RAID) score, 2.5 for the PRO-CLinical ARthritis Activity (PRO-CLARA) index, and 1.0 for the Recent-Onset Arthritis Disability (ROAD) questionnaire. The cut-off values for Clinical Disease Activity Index (CDAI) were in the moderate range of disease activity. Assessing the size of the logistic regression coefficients, the strongest predictors of PASS were the disease activity (p=0.0007) and functional state level (0.006).Conclusion. PASS thresholds were relatively high and many patients in PASS had moderate disease activity states according to CDAI. Factors such as disease activity and physical function may influence a negative PASS.

Can Remission in Rheumatoid Arthritis Be Assessed Without Laboratory Tests or a Formal Joint Count? Possible Remission Criteria Based on a Self-report RAPID3 Score and Careful Joint Examination in the ESPOIR Cohort

2013 ◽  
Vol 40 (4) ◽  
pp. 386-393 ◽  
Author(s):  
Isabel Castrejón ◽  
Maxime Dougados ◽  
Bernard Combe ◽  
Francis Guillemin ◽  
Bruno Fautrel ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Self Report ◽  
Tender Joint Count ◽  
Kappa Statistics ◽  
Global Estimate ◽  
Remission Criteria ◽  
Joint Examination

Objective.To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test.Methods.The ESPOIR early RA cohort of 813 French patients recruited in 2002–2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed — Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: “RAPID3R” (RAPID3 ≤ 3.0); “RAPID3R+SJ1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint); “RAPID3R+SJ1+D1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); “RAPID3R+SJ0” (RAPID3 ≤ 3.0, 0 swollen joints); and “RAPID3R+SJ0+D1” (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed.Results.Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%–94.7%, kappa 0.67–0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%–85.8%, kappa 0.46–0.55).Conclusion.Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.

scholarly journals “From Where I Stand”: Using Multiple Anchors Yields Different Benchmarks for Meaningful Improvement and Worsening in the Rheumatoid Arthritis Flare Questionnaire (RA-FQ)

2021 ◽  
Author(s):  
Susan J. Bartlett ◽  
Vivian P. Bykerk ◽  
Orit Schieir ◽  
Marie-France Valois ◽  
Janet E Pope ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Early Arthritis ◽  
Meaningful Change ◽  
Meaningful Improvement ◽  
Patient Reported ◽  
New Evidence

Abstract Purpose The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) is a patient-reported measure of disease activity in RA. We estimated minimal and meaningful change from the perspective of RA patients, physicians, and using a disease activity index. Methods Data were from 3- and 6-month visits of adults with early RA enrolled in the Canadian Early Arthritis Cohort. Participants completed the RA-FQ, the Patient Global Assessment of RA, and Patient Global Change Impression at consecutive visits. Rheumatologists recorded joint counts and MD Global. Clinical Disease Activity Index (CDAI) scores were computed. We compared mean RA-FQ change across categories using patients, physicians, and CDAI anchors. Results The 808 adults were mostly white (84%) women (71%) with a mean age of 55 and moderate-high disease activity (85%) at enrollment. At V2, 79% of patients classified their RA as changed; 59% were better and 20% were worse. Patients reporting they were a lot worse had a mean RA-FQ increase of 8.9 points whereas those who were a lot better had a -6.0 decrease. Minimal worsening and improvement were associated with a mean 4.7 and -1.8 change in RA-FQ, respectively, while patients rating their RA unchanged had stable scores. Physician and CDAI classified more patients as worse than patients, and minimal and meaningful RA-FQ thresholds differed by group. Conclusion Thresholds to identify meaningful change vary by anchor used. These data offer new evidence demonstrating robust psychometric properties of the RA-FQ and offer guidance about improvement or worsening, supporting its use in RA care, research and decision-making.

Remission in Rheumatoid Arthritis: A Comparison of the 2 Newly Proposed ACR/EULAR Remission Criteria with the Rheumatoid Arthritis Disease Activity Index-5, a Patient Self-report Disease Activity Index

2013 ◽  
Vol 40 (4) ◽  
pp. 394-400 ◽  
Author(s):  
Bernhard Rintelen ◽  
Judith Sautner ◽  
Pia Haindl ◽  
Harsono Mai ◽  
Hans-Peter Brezinschek ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Self Report ◽  
Kappa Statistics ◽  
Predictive Values ◽  
Rheumatoid Arthritis Disease Activity ◽  
Rheumatoid Arthritis Disease ◽  
Definition Of

Objective.We analyzed whether a patient self-report remission criterion, such as that according to the Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), meets the criteria of the 2011 proposed American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission.Methods.The 2 approaches of the ACR/EULAR proposal [Boolean- and Simplified Disease Activity Index (SDAI)-based] as well as the RADAI-5 were used to assess whether patients with RA are in remission. Sensitivity, specificity, positive and negative predictive values (PPV, NPV), and kappa analyses were performed to illustrate the relationship among the different approaches defining remission at a group level.Results.In total, 705 patients' assessments were included. Eighty-nine patients were classified as being in remission according to the Boolean-based and 169 according to the SDAI-based definition of the ACR/EULAR proposals, and 154 according to the RADAI-5. Sixty-eight assessments were classified as being in remission according to all 3 definitions. In the case of RADAI-5 remission, sensitivity was 78%, specificity 86%, PPV 45%, and NPV 96%, indicating remission according to the Boolean-based definition; and 60%, 92%, 66%, and 90%, respectively, indicating remission according to the SDAI-based definition. In the case of remission according to the SDAI-based ACR/EULAR definition, sensitivity was 52%, specificity 100%, PPV 98%, and NPV 87%, also indicating remission according to the Boolean definition; while according to the Boolean definition the values were 98%, 87%, 52%, and 100%, respectively. Kappa statistics showed fair to good agreement for all 3 definitions.Conclusion.Nearly twice as many assessments were classified as being in remission using the SDAI-based or the RADAI-5 definitions when compared to the Boolean-based definition. Remission according to the RADAI-5 also was highly specific for both ACR/EULAR criteria. Sensitivity for the RADAI-5 criterion was even better for the Boolean-based definition than that for the SDAI-based definition.

scholarly journals Impact of assessing patient-reported outcomes with mobile apps on patient–provider interaction

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001566
Author(s):  
Yomei Shaw ◽  
Delphine S Courvoisier ◽  
Almut Scherer ◽  
Adrian Ciurea ◽  
Thomas Lehmann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Mobile Apps ◽  
Disease Activity Index ◽  
Discussion Group ◽  
Patient Reported ◽  
Physician Awareness

ObjectiveTo explore the effect of apps measuring patient-reported outcomes (PROs) on patient–provider interaction in the rheumatic diseases in an observational setting.MethodsPatients in the Swiss Clinical Quality Management in Rheumatic Diseases Registry were offered mobile apps (iDialog and COmPASS) to track disease status between rheumatology visits using validated PROs (Rheumatoid Arthritis Disease Activity Index-5 score, Bath Ankylosing Spondylitis Disease Activity Index score, Routine Assessment of Patient Index Data-3 score and Visual Analogue Scale score for pain, disease activity and skin symptoms). We assessed two aspects of patient–provider interaction: shared decision making (SDM) and physician awareness of disease fluctuations. We used logistic regressions to compare outcomes among patients who (1) used an app and discussed app data with their physician (app+discussion group), (2) used an app without discussing the data (app-only group) or (3) did not use any app (non-app users).Results2111 patients were analysed, including 1799 non-app users, 150 app-only users and 162 app+discussion users (43% male; with 902 patients with rheumatoid arthritis, 766 patients with axial spondyloarthritis and 443 patients with psoriatic arthritis). App users were younger than non-app users (mean age of 47 vs 51 years, p<0.001). Compared with non-app users, the app+discussion group rated their rheumatologist more highly in SDM (OR 1.7, 95% CI 1.1 to 2.4) and physician awareness of disease fluctuations (OR 2.0, 95% CI 1.3 to 3.1). This improvement was absent in the app-only group.ConclusionApp users who discussed app data with their rheumatologist reported more favourably on patient–provider interactions than app users who did not and non-app users. Apps measuring PROs may contribute little to patient–provider interactions without integration of app data into care processes.

scholarly journals Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001017 ◽  
Author(s):  
Gerd R Burmester ◽  
Vibeke Strand ◽  
Andrea Rubbert-Roth ◽  
Howard Amital ◽  
Tatiana Raskina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Normative Values ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Patient Reported ◽  
Open Label Extension

ObjectiveEvaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).MethodsDuring the 48-week OLE, patients received sarilumab 200 mg subcutaneously once every 2 weeks. Safety (March 2017 cut-off) and efficacy, including patient-reported outcomes, were evaluated.ResultsIn the double-blind phase, patients receiving sarilumab or adalimumab monotherapy showed meaningful improvements in disease activity; sarilumab was superior to adalimumab for improving signs, symptoms and physical function. Overall, 320/369 patients completing the 24-week double-blind phase entered OLE (155 switched from adalimumab; 165 continued sarilumab). Sarilumab safety profile was consistent with previous reports. Treatment-emergent adverse events were similar between groups; no unexpected safety signals emerged in the first 10 weeks postswitch. Among switch patients, improvement in disease activity was evident at OLE week 12: 47.1%/34.8% had changes ≥1.2 in Disease Activity Score (28 joints) (DAS28)-erythrocyte sedimentation rate/DAS28-C-reactive protein. In switch patients achieving low disease activity (LDA: Clinical Disease Activity Index (CDAI) ≤10; Simplified Disease Activity Index (SDAI) ≤11) by OLE week 24, 70.7%/69.5% sustained CDAI/SDAI LDA at both OLE weeks 36 and 48. Proportions of switch patients achieving CDAI ≤2.8 and SDAI ≤3.3 by OLE week 24 increased through OLE week 48. Improvements postswitch approached continuation-group values, including scores ≥normative values.ConclusionsDuring this OLE, there were no unexpected safety issues in patients switching from adalimumab to sarilumab monotherapy, and disease activity improved in many patients. Patients continuing sarilumab reported safety consistent with prolonged use and had sustained benefit.

scholarly journals High Disease Activity Is Associated with Self-reported Depression and Predicts Persistent Depression in Early Rheumatoid Arthritis: Results from the Ontario Best Practices Research Initiative

2018 ◽  
Vol 45 (8) ◽  
pp. 1101-1108 ◽  
Author(s):  
Bindee Kuriya ◽  
Raman Joshi ◽  
Mohammad Movahedi ◽  
Emmanouil Rampakakis ◽  
John S. Sampalis ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Best Practices ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Self Report ◽  
High Disease Activity ◽  
Research Initiative ◽  
Persistent Depression

Objective.We sought to determine if initial high disease activity or changes in disease activity contribute to persistent depression in early rheumatoid arthritis (ERA). We also determined if disease activity and depression is modified by sex.Methods.Depression was ascertained by self-report among patients enrolled in the Ontario Best Practices Research Initiative. The association between baseline disease activity, measured by the Clinical Disease Activity Index (CDAI), and persistent depression was evaluated with multivariate regression models, and effect modification by sex was tested. A general estimating equation assessed the association between change in CDAI over time and risk of depression.Results.The sample of 469 ERA subjects was predominantly female (73%). At baseline, the prevalence of depression was 26%, and 23% reported persistent depression. After adjusting for potential confounders, higher baseline CDAI was associated with both baseline and persistent depression (OR 1.03, 95% CI 1.01–1.05). Female sex was an effect modifier of this relationship (OR 1.04, 95% CI 1.01–1.06). Maintaining a moderate or high CDAI score over 2 years also increased the risk of future depression.Conclusion.Depression in ERA is common and initial high disease activity is associated with the probability of depression and its persistence. This risk seems particularly modified in women with active disease and represents an area for targeted focus and screening. Future studies in ERA are needed to determine if intervening during the “window of opportunity” to control disease activity has the potential to mitigate the development and maintenance of adverse mental health outcomes, including depression.

The Rheumatoid Arthritis Disease Activity Index-5 in Daily Use. Proposal for Disease Activity Categories

2009 ◽  
Vol 36 (5) ◽  
pp. 918-924 ◽  
Author(s):  
BERNHARD RINTELEN ◽  
PIA M. HAINDL ◽  
JUDITH SAUTNER ◽  
BARBARA A. LEEB ◽  
CHRISTOPH DEUTSCH ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Disease Status ◽  
Self Report ◽  
Mild Disease ◽  
The Third ◽  
Rheumatoid Arthritis Disease ◽  
Moderate Disease

Objective.To establish thresholds for rheumatoid arthritis (RA) activity categories according to the RA Disease Activity Index-5 (RADAI-5).Methods.Three hundred ninety-two patients with RA were categorized according to Disease Activity Score 28-joint count (DAS28), Clinical Disease Activity Index (CDAI), and their satisfaction (PATSAT) with disease status. These measures built the basis for the calculation of disease activity limits for the RADAI-5. Patient assessments simultaneously meeting the identical DAS28, CDAI, and PATSAT categories were taken as the references to establish the thresholds for the respective RADAI-5 categories by calculating the third quartile of the corresponding RADAI-5 values. Subsequently, these new thresholds were applied to all assessments.Results.Seven hundred fifty-eight assessments in 392 patients (2 assessments median/patient) could be obtained, most patients having mild to moderate disease according to DAS28 and CDAI. Calculating the third quartile, the RADAI-5 thresholds were as follows: 0.0–1.4 for a remission-like state, 1.6–3.0 for mild disease activity, 3.2–5.4 for moderate, and 5.6–10.0 for high disease activity. Categorization according to the RADAI-5 showed a normal distribution, while DAS28 and CDAI were somewhat shifted to the left. DAS28 and CDAI levels, as well as tender and swollen joint counts and physician’s global assessment and erythrocyte sedimentation rate, proved to be highly significantly different within the different RADAI-5 categories (Kruskal-Wallis test p < 0.001).Conclusion.RADAI-5 thresholds for RA activity could be elaborated. Patient self-report questionnaires may substitute composite disease activity scores and may contribute significantly to improving documentation in routine patient care.

scholarly journals Impact of the COVID-19 pandemic on the disease course of patients with inflammatory rheumatic diseases: results from the Swiss Clinical Quality Management cohort

2020 ◽  
pp. annrheumdis-2020-218705 ◽  
Author(s):  
Adrian Ciurea ◽  
Eleftherios Papagiannoulis ◽  
Kristina Bürki ◽  
Isabell von Loga ◽  
Raphael Micheroli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Quality Management ◽  
Disease Activity ◽  
Activity Index ◽  
Statistical Significance ◽  
Disease Activity Index ◽  
Inflammatory Rheumatic Diseases ◽  
Disease Course ◽  
Clinical Quality ◽  
Patient Reported

ObjectivesTo investigate whether the transient reduction in rheumatology services imposed by virus containment measures during the COVID-19 pandemic was associated with disease worsening in axial spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA).MethodsPatient-reported disease activity assessed during face-to-face visits and/or via a smartphone application were compared between three periods of each 2 months duration (before, during and after the COVID-19-wave) from January to June 2020 in 666 patients with axSpA, RA and PsA in the Swiss Clinical Quality Management cohort.ResultsThe number of consultations dropped by 52%, whereas the number of remote assessments increased by 129%. The proportion of patients with drug non-compliance slightly increased during the pandemic, the difference reaching statistical significance in axSpA (19.9% vs 13.2% before the pandemic, p=0.003). The proportion of patients with disease flares remained stable (<15%). There was no increase in mean values of the Bath Ankylosing Disease Activity Index, the Rheumatoid Arthritis Disease Activity Index-5 and the Patient Global Assessment in patients with axSpA, RA and PsA, respectively.ConclusionA short interruption of in-person patient–rheumatologist interactions had no major detrimental impact on the disease course of axSpA, RA and PsA as assessed by patient-reported outcomes.

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