Testing of the OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage in Rheumatoid Arthritis: A Systematic Literature Search on 5 Candidate Biomarkers

2009 ◽  
Vol 36 (8) ◽  
pp. 1769-1784 ◽  
Author(s):  
SILJE W. SYVERSEN ◽  
ROBERT LANDEWE ◽  
DÉSIRÉE van der HEIJDE ◽  
JOAN M. BATHON ◽  
MAARTEN BOERS ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Structural Damage ◽  
Animal Studies ◽  
Literature Search ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Systematic Literature Search ◽  
Strength Of Evidence ◽  
Validation Criteria ◽  
Individual Criterion

Objective.To test the OMERACT 8 draft validation criteria for soluble biomarkers by assessing the strength of literature evidence in support of 5 candidate biomarkers.Methods.A systematic literature search was conducted on the 5 soluble biomarkers RANKL, osteoprotegerin (OPG), matrix metalloprotease (MMP-3), urine C-telopeptide of types I and II collagen (U-CTX-I and U CTX-II), focusing on the 14 OMERACT 8 criteria. Two electronic voting exercises were conducted to address: (1) strength of evidence for each biomarker as reflecting structural damage according to each individual criterion and the importance of each individual criterion; (2) overall strength of evidence in support of each of the 5 candidate biomarkers as reflecting structural damage endpoints in rheumatoid arthritis (RA) and identification of omissions to the criteria set.Results.The search identified 111 articles. The strength of evidence in support of these biomarkers reflecting structural damage was low for all biomarkers and was rated highest for U-CTX-II [score of 6.5 (numerical rating scale 0–10)]. The lowest scores for retention of specific criteria in the draft set went to criteria that refer to the importance of animal studies, correlations with other biomarkers reflecting damage, and an understanding of the metabolism of the biomarker.Conclusion.Evidence in support of any of the 5 tested biomarkers (MMP-3, CTX-I, CTX-II, OPG, RANKL) was inadequate to allow their substitution for radiographic endpoints in RA. Three of the criteria in the draft criteria set might not be required, but few omissions were identified.

scholarly journals Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report

2017 ◽  
Vol 44 (10) ◽  
pp. 1536-1543 ◽  
Author(s):  
Susan J. Bartlett ◽  
Skye P. Barbic ◽  
Vivian P. Bykerk ◽  
Ernest H. Choy ◽  
Rieke Alten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Construct Validity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Field Testing ◽  
Sensitivity Factor ◽  
Instrument Selection ◽  
Item Functioning ◽  
Numerical Rating ◽  
The Rasch Model

Objective.The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016.Methods.Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores.Results.People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity, and responsiveness. Factor analysis supported unidimensionality. Rasch analysis showed acceptable fit to the Rasch model, with items and people covering a broad measurement continuum and evidence of appropriate targeting of items to people, ordered thresholds, minimal differential item functioning by language, sex, or age. A summative score across items is defensible, yielding an interval score (0–50) where higher scores reflect worsening flare. The RA-FQ received endorsement from 88% of attendees that it passed the OMERACT Filter 2.0 “Eyeball Test” for instrument selection.Conclusion.The RA-FQ has been developed to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials.

scholarly journals Safety and efficiency of therapy by gene-engineering-biological preparations of rheumatoid arthritis

2018 ◽  
Vol 9 (3) ◽  
pp. 44-49
Author(s):  
E. A. Strel’tsov
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Search ◽  
Randomized Trials ◽  
Web Of Science ◽  
Genetically Engineered ◽  
Systematic Literature Search ◽  
Efficacy And Safety ◽  
Review Of The Literature ◽  
Gene Engineering

In this review of the literature, questions of the efficacy and safety of therapy with genetically engineered biological preparations for rheumatoid arthritis are discussed. The results of randomized trials of recent years are described in detail. Systematic literature search was conducted on the databases Scopus, Web of Science, MedLine, elibrary and others.

Efficacy of Intra-Articular Injection of 10 mg and 20 mg Triamcinolone for Rheumatoid Arthritis of the Wrist: A Prospective, Randomized, Pilot Study

2021 ◽  
Vol 26 (03) ◽  
pp. 490-493
Author(s):  
Takeshi Mochizuki ◽  
Koichiro Yano ◽  
Katsunori Ikari ◽  
Ken Okazaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Pilot Study ◽  
Scale Score ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Wrist Joint ◽  
Power Doppler ◽  
Total Study Population ◽  
Entire Study ◽  
Study Population

Background: To compare the efficacy of intra-articular injection (IA) with 10 mg and 20 mg triamcinolone for treatment of rheumatoid arthritis (RA) of the wrist joint. Methods: We enrolled 20 patients with swelling and pain in wrist due to RA in the present prospective, randomized, pilot study. Patients were randomly assigned in a 1:1 ratio to either the 20 mg or 10 mg group, and received IA of the appropriate dose of triamcinolone. Efficacy was assessed by recording Numerical Rating Scale (NRS) for pain and improvement in power doppler (PD) scale score at weeks 1, 4, and 12 of treatment compared with baseline. The shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) was recorded at baseline and week 12. Results: The NRS was found to be significantly improved at weeks 4 (p = 0.006) and 12 (p = 0.036) among the total study population. Neither the change in NRS nor the improvement PD scale score from baseline were significantly different between the two groups at any week (NRS: week 1, p = 0.617; week 4, p = 0.727; and week 12, p = 0.878; PD scale score: week 1, p = 0.370; week 4, p = 1.000; and week 12, p = 0.179). Among the entire study population, the QuickDASH was not significantly improved at week 12 nor was the change from baseline significantly different between the two groups at week 12 (p = 0.592). Conclusions: IA of triamcinolone was effective for pain relief in context of RA in the wrist joint. However, in terms of NRS, improvement of PD scale score, and QuickDASH score, the efficacies of 10 mg and 20 mg triamcinolone were not significantly different. Thus, IA of 10 mg triamcinolone may be sufficient for the treatment of RA in the wrist joint.

scholarly journals Evidence for treating rheumatoid arthritis to target: results of a systematic literature search update

2015 ◽  
Vol 75 (1) ◽  
pp. 16-22 ◽  
Author(s):  
Michaela A Stoffer ◽  
Monika M Schoels ◽  
Josef S Smolen ◽  
Daniel Aletaha ◽  
Ferdinand C Breedveld ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Search ◽  
Systematic Literature Search

Predictors of Clinical Response and Radiographic Progression in Patients with Rheumatoid Arthritis Treated with Methotrexate Monotherapy

2010 ◽  
Vol 37 (7) ◽  
pp. 1405-1410 ◽  
Author(s):  
JULIE DROUIN ◽  
BOULOS HARAOUI
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Literature Search ◽  
Radiographic Progression ◽  
Statistical Tests ◽  
Patient Characteristics ◽  
Cochrane Central Register ◽  
Systematic Literature Search ◽  
American College Of Rheumatology

Objective.To determine through a systematic literature search the predictors of clinical response and radiographic progression in adult patients with rheumatoid arthritis (RA) treated with methotrexate (MTX) monotherapy.Methods.A systematic literature search using Medline, Embase, and the Cochrane Central Register of Controlled Trials, in May 2008, and review of abstracts of the annual congresses of the American College of Rheumatology (2006–2007) and the European League Against Rheumatism (2002–2007) was performed, as part of a national initiative to develop guidelines for the use of MTX in RA.Results.Nine studies fulfilled the criteria set for this literature search. Male sex, low disease activity measured by composite scores (DAS or SDAI), and nonutilization of prior DMARD were predictive of good clinical response to MTX. Patients with early RA who are rheumatoid factor-positive and smokers tend to have lower response. However, this last association has not been found for patients with established disease. High disease activity before introduction of MTX monotherapy and higher activity during followup at 3 months is a predictor of more severe radiographic progression.Conclusion.Among factors found to be predictive of clinical and radiographic outcomes of patients with RA treated with MTX, no factor was found to have a high predictive value. Variability in efficacy measures and statistical tests made it difficult to compare results. Followup of disease activity after 3 to 6 months of treatment seems to be a better and more useful predictor than baseline patient characteristics.

scholarly journals Pain Predicts Function One Year Later: A Comparison across Pain Measures in a Rheumatoid Arthritis Sample

2016 ◽  
Vol 2016 ◽  
pp. 1-8
Author(s):  
Vivian Santiago ◽  
Karen Raphael ◽  
Betty Chewning
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Intensity ◽  
Severe Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Functional Limitations ◽  
Measurement Scale ◽  
Impact Measurement ◽  
Patient Reported ◽  
One Year

Background. Guidance is limited on best measures and time periods to reference when measuring pain in order to predict future function. Objective. To examine how different measures of pain predict functional limitations a year later in a sample of rheumatoid arthritis patients. Methods. Logistic regression analyses were conducted using baseline and one-year data (n=262). Pain intensity in the last 24 hours was measured on a 0–10 numerical rating scale and in the last month using an item from the Arthritis Impact Measurement Scale 2 (AIMS2). AIMS2 also provided frequency of severe pain, pain composite scores, and patient-reported limitations. Physician-rated function was also examined. Results. Composite AIMS2 pain scale performed best, predicting every functional outcome with the greatest magnitude, a one-point increase in pain score predicting 21% increased odds of limitations (combined patient and physician report). However, its constituent item—frequency of severe pain in the last month—performed nearly as well (19% increased odds). Pain intensity measures in last month and last 24 hours yielded inconsistent findings. Conclusion. Although all measures of pain predicted some functional limitations, predictive consistency varied by measure. Frequency of severe pain in the last month provided a good balance of brevity and predictive power.

scholarly journals Need for Palliative Care in Patient with Rheumatoid Arthritis: A Cross-sectional Observational Study

2021 ◽  
Vol 27 ◽  
pp. 275-280
Author(s):  
Kiran Mahendru ◽  
Nishkarsh Gupta ◽  
Manish Soneja ◽  
Rajeev Kumar Malhotra ◽  
Vinod Kumar ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Palliative Care ◽  
Observational Study ◽  
Disease Activity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Short Form ◽  
Emotional Problem ◽  
Well Being ◽  
Cross Sectional

Objectives: Rheumatoid arthritis (RA) is a chronic disorder causing inflammation in the joints and achieving remission is often the primary goal of physicians. We evaluated the suffering from RA and assessed the need for palliative care services in these patients. Materials and Methods: This cross-sectional observational study was done in 100 adult RA cases who attended the outpatient department. The Disease Activity Score 28 (DAS28), Health Assessment Questionnaire Disability Index, depression, anxiety and stress score, Short Form 36 Health Survey and numeric rating scale were assessed. The relationship between DAS28 with the other parameters and scores was assessed using Spearman’s rho correlation coefficient. Results: About 90% of patients in our study were female and majority (50%) had a moderate disease activity. The DAS28 showed a positive correlation with the degree of depression (r = 0.671, P = 0.000), anxiety (r = 0.609, P = 0.000) and stress levels (r = 0.474, P = 0.000). The patients with severe disease had a poor quality of life (QoL) [physical functioning (r = –0.737, P = 0.000); role limitation (r = –0.662, P = 0.000); emotional problem (r = –0.676, P = 0.000); energy/fatigue (r = –0.638, P = 0.000); social functioning (r = –0.658, P = 0.000); emotional well-being (r = –0.605, P = 0.000); general health (r = –0.643, P = 0.000); health change (r = –0.376, P = 0.000) and numerical rating scale score for pain (r = 0.656, P = 0.000)]. Conclusion: RA patients with high disease activity suffer from depression, anxiety, stress and poor QoL. Palliative care physicians and rheumatologists must be vested with the power to provide comprehensive care to these patients.

Reappraisal of OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Spondyloarthritis: The OMERACT 9 v2 Criteria

2009 ◽  
Vol 36 (8) ◽  
pp. 1785-1791 ◽  
Author(s):  
WALTER P. MAKSYMOWYCH ◽  
ROBERT LANDEWÉ ◽  
PAUL-PETER TAK ◽  
CHRISTOPHER J. RITCHLIN ◽  
MIKKEL ØSTERGAARD ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Working Group ◽  
Structural Damage ◽  
Group Discussion ◽  
Delphi Consensus ◽  
Validation Process ◽  
Essential Requirement ◽  
Validation Criteria ◽  
New Framework

Objectives.A draft set of criteria for the validation of soluble biomarkers reflecting damage endpoints was proposed at OMERACT 8. At OMERACT 9 we aimed to scrutinize the necessity for each of these criteria according to the objectives of the working group.Methods.The OMERACT 8 draft criteria and the principle objectives of the validation process were clarified at a meeting of the working group in London, December 2007. A new framework was proposed after the following steps were conducted: (A) A systematic review of the literature focusing on the draft criteria and a preselected group of biomarkers (MMP3, CTX-II, RANKL, OPG, CTX-I) followed by a Delphi consensus exercise addressing the importance of individual criteria and identification of omissions in the draft set. (B) Formal debate as well as group discussion centered on the key arguments for inclusion/exclusion of specific criteria. (C) Onsite interactive electronic voting on the importance of specific criteria. The framework was presented and discussed at OMERACT 9 in both breakout and plenary sessions followed by a vote on its acceptance.Results.The objectives of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis biomarkers in relation to their predictive validity for damage endpoints was clarified and supported by OMERACT 9 participants. The OMERACT 8 draft validation criteria were reformulated into an essential category focused on criteria addressing the OMERACT Filter elements of discrimination (incorporating truth) and feasibility, and a desirable but nonessential category of other criteria addressing truth. This revised draft set was endorsed by participants at OMERACT 9.Conclusion.A revised set of validation criteria has been drafted by consensus at OMERACT 9 that focuses on the performance characteristics of biomarker assays, the importance of addressing potential confounders, and the essential requirement for clinical validation studies.

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