Article

Validity and reliability problems with patient global as a component of the ACR/EULAR remission criteria as used in clinical practice.

University of Kansas School of Medicine, Wichita, KA, USA.
The Journal of Rheumatology (Impact Factor: 3.26). 05/2012; 39(6):1139-45. DOI: 10.3899/jrheum.111543
Source: PubMed

ABSTRACT To investigate what factors influence patient global health assessment (PtGlobal), and how those factors and the reliability of PtGlobal affect the rate, reliability, and validity of recently published American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) rheumatoid arthritis (RA) remission criteria when used in clinical practice.
We examined consecutive patients with RA in clinical practice and identified 77 who met ACR/EULAR joint criteria for remission (≤ 1 swollen joint and ≤ 1 tender joint). We evaluated factors associated with a PtGlobal > 1, because a PtGlobal ≤ 1 defined ACR/EULAR remission in this group of patients who had already met ACR/EULAR joint criteria.
Of the 77 patients examined, only 17 (22.1%) had PtGlobal ≤ 1 and thus fully satisfied ACR/EULAR criteria. A large proportion of patients not in remission by ACR/EULAR criteria had high PtGlobal related to noninflammatory issues, including low back pain, fatigue, and functional limitations, and a number of patients clustered in the range of PtGlobal > 1 and ≤ 2. However, the minimal detectable difference for PtGlobal was 2.3. In addition, compared with a PtGlobal severity score, a PtGlobal activity score was 3.3% less likely to be abnormal (> 1).
Noninflammatory factors contribute to the level of PtGlobal and result in the exclusion of many patients who would otherwise be in "true" remission according to the ACR/EULAR definition. Reliability problems associated with PtGlobal can also result in misclassification, and may explain the observation of low longterm remission rates in RA. As currently constituted, the use of the ACR/EULAR remission criteria in clinical practice appears to be problematic.

0 Bookmarks
 · 
90 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Our objectives were to assess the frequency and sustainability of American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) and Disease Activity Score (DAS)28(4v)-C-reactive protein (CRP) remission 12 months after the initiation of tumour necrosis factor inhibitor (TNFi) therapy in a rheumatoid arthritis (RA) cohort. Data were collected of 273 biologic naive RA patients at baseline, then 3, 6 and 12 months post-TNFi therapy. Remission status was calculated using DAS28(4v)-CRP <2.6 and ACR/EULAR Boolean criteria. Response was scored using EULAR criteria. Mean (range) patient age was 59.9 (7.2-85.4) years with disease duration of 13.4 (1.0-52.0) years. Responder status maintained from 3-12 months (86%, 82.4%), laboratory/clinical parameters (erythrocyte sedimentation rate (ESR), CRP, patient global health (PGH), DAS28(4v)-CRP) also showed sustained improvement (P < 0.05). DAS28 remission was reached by 102 subjects at 1 year, 27 patients were in Boolean remission, but 75 missed it from the DAS28 remission group. Patients in remission were younger (P = 0.041) with lower baseline tender joint count (TJC)28 and PGH than those not in remission (P = 0.001, P = 0.047). DAS28 remission patients were older (P = 0.026) with higher 12 months PGH and subsequently higher DAS28 than Boolean remission patients (P < 0.0001). Patients not achieving Boolean remission due to missing one subcriteria most frequently missed PGH <=1 criteria (79.8%). Only 10% of this TNFi treated cohort achieved remission according to the new ACR/EULAR criteria, which requires lower disease activity. More stringent criteria may ensure further resolution of disease activity and better longterm radiographic outcome, which supports earlier intervention with biologic therapy in RA.
    Arthritis research & therapy 12/2013; 15(6):R221. · 4.27 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE: The Disease Activity Score in 28 joints (DAS28) is a key measure in clinical practice and clinical trials. There are at least five different versions of the 'Patient Global' Visual Analogue Scale (PG-VAS) being used in the DAS28. The developers suggested that the PG-VAS can be an assessment of global health or disease activity, but did not specify the wording of the question. There is no consensus on what the PG-VAS is intended to capture, and the different words and phrases have not been evaluated. The aim of this study was to test if phrasing affects PG-VAS scores and hence yields different results for the DAS28. METHODS: Fifty patients with rheumatoid arthritis taking biologic agents in a rheumatology outpatient department completed a self-administered questionnaire containing five versions of the 100 mm PG-VAS. RESULTS: All PG-VAS versions correlated strongly with each other (rho = 0.67-0.87, p < 0.0001). However, individual scores for each PG-VAS, when compared with the comparator on a Bland-Altman chart had wide limits of agreement-the largest being -42 mm to +45 mm. The five overall DAS28 scores were calculated for each patient using the five different PG-VAS. The largest difference in DAS28 scores was 0.63. CONCLUSION: Different phrasing of the PG-VAS gives different DAS28 results. As the DAS28 is a key outcome measure, such differences have the potential to influence clinical decisions relating to eligibility for biologic agents and evaluation of new therapies. We urgently need to decide on the concept to be measured and the phrasing required to capture this. The PG-VAS phrasing should then be standardized and validated. Copyright © 2013 John Wiley & Sons, Ltd. Copyright © 2013 John Wiley & Sons, Ltd.
    Musculoskeletal Care 02/2013;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objectives: The American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) remission criteria for rheumatoid arthritis (RA) are more stringent than index-based criteria, making it more difficult to achieve a patient's global assessment (PGA) than an evaluator's global assessment (EGA). We investigated the reason for the discrepancy between the PGA and the EGA in a Japanese clinical cohort. Method: We assessed clinical and laboratory variables in our clinical cohort. The frequency of remission achievement according to the ACR/EULAR remission criteria and predictors of the discrepancy between the PGA and EGA were analysed. Results: Of 370 patients with RA, 89 fulfilled PGA criteria and 167 patients fulfilled EGA criteria. The PGA was highly correlated with the visual analogue scale (VAS) pain score and non-inflammatory variables including Steinbrocker class and the Health Assessment Questionnaire Disability Index (HAQ-DI). Conversely, inflammatory variables, including swollen joint count (SJC), tender joint count (TJC), and C-reactive protein (CRP) levels, were significantly associated with the EGA. The main predictors of the discrepancy between the PGA and the EGA were patient's VAS pain score, SJC, and functional disability. Conclusions: Increased pain and functional disability led to a discrepancy towards a worse PGA than EGA, whereas increased SJC led to an accordance towards a worse EGA.
    Scandinavian journal of rheumatology 03/2014; · 2.51 Impact Factor