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: 3.19). 05/2012; 39(6):1139-45. DOI: 10.3899/jrheum.111543
Source: PubMed


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.

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    • "The literature reflects that clinical trial conditions are different from routine clinical practice and that patients may score PGH differently depending on their original disease activity [12]. Modification of PGH subcriteria to PGH ≤2 has been proposed to allow more patients to reach ACR/EULAR remission [25]. The limitation in clinical application of the new remission criteria is that patients may score a high PGH for reasons other than RA disease activity, raising the opportunity for overtreatment; in contrast, minimisation of latent disease activity may ensure better long-term radiographic outcomes. "
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    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. DOI:10.1186/ar4421 · 3.75 Impact Factor
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    • "For the assessment of remission in RA, the American College of Rheumatology (ACR)/EULAR have suggested that the patient global assessment uses the following phrasing: 'Considering all of the ways your arthritis has affected you, how do you feel your arthritis is today?' (Anchors: very well–very poor) (Felson et al., 2011). This version of the question is very important for future clinical practice, but may affect remission rates because it could capture non-inflammatory issues such as low back pain and functional limitations (Masri et al., 2012). The PG-VAS is also an important component of the RA core set (Felson et al., 1995), indices such as the Clinical Disease Activity Index (CDAI) (Aletaha et al., 2005) and may be used independently by clinicians to assess patient status; whenever it is used, the same limitations apply. "
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    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.
    Musculoskeletal Care 12/2013; 11(4). DOI:10.1002/msc.1046
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    • "They are infrequently used in practice and have limitations, including reliance on subjective measures with frequent discordance between physician and patient assessments.[9] Patient global assessment and its contribution to the ACR/European League Against Rheumatism remission criteria are affected by non-inflammatory factors.[10] Moreover, individual variability in therapeutic responses and lack of objective biomarkers for identification of active disease can lead to variability in patient care that may affect the management of RA [11]–[15]. "
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    ABSTRACT: Variability exists in the assessment of disease activity in rheumatoid arthritis (RA) patients that may affect quality of care. To measure the impact on quality of care of a Multi-Biomarker Disease Activity (MBDA) test that quantitatively assesses RA disease activity. Board-certified rheumatologists without prior experience with the MBDA test (N = 81) were randomized into an intervention or control group as part of a longitudinal randomized-control study. All physicians were asked to care for three simulated RA patients, using Clinical Performance and Value (CPV™) vignettes, in a before and after design. CPV™ vignettes have been validated to assess the quality of clinical practice and identify variation in care. The vignettes covered all domains of a regular patient visit; scores were determined as a percentage of explicit predefined criteria completed. Three vignettes, representing typical RA cases, were administered each round. In the first round, no physician received information about the MBDA test. In the second round, only physicians in the intervention group were given educational materials about the test and hypothetical test results for each of the simulated patients. The outcome measures were the overall quality of care, disease assessment and treatment. The overall quality scores in the intervention group improved by 3 percent (p = 0.02) post-intervention compared with baseline, versus no change in the control group. The greatest benefit in the intervention group was to the quality of disease activity assessment and treatment decisions, which improved by 12 percent (p<0.01) compared with no significant change in the control group. The intervention was associated with more appropriate use of biologic and/or combination DMARDs in the co-morbidity case type (p<0.01). Based on these results, use of the MBDA test improved the assessment and treatment decisions for simulated cases of RA and may prove useful for rheumatologists in clinical practice.
    PLoS ONE 05/2013; 8(5):e63215. DOI:10.1371/journal.pone.0063215 · 3.23 Impact Factor
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