Validity and Reliability Problems with Patient Global as a Component of the ACR/EULAR Remission Criteria as Used in Clinical Practice
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.
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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. Copyright © 2013 John Wiley & Sons, Ltd. Copyright © 2013 John Wiley & Sons, Ltd.Musculoskeletal Care 12/2013; 11(4). DOI:10.1002/msc.1046
- Nature Reviews Rheumatology 07/2012; 8(8):445-7. DOI:10.1038/nrrheum.2012.111 · 10.25 Impact Factor
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ABSTRACT: OBJECTIVE: To compare the performance of the preliminary American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) remission criteria with the 28-joint count Disease Activity Score (DAS28) remission in unselected 'real-life' patients. METHODS: Remission was calculated according to the DAS28 and to both versions of the ACR/EULAR criteria (Boolean or Simplified Disease Activity Index (SDAI)-based) for 6864 patients with rheumatoid arthritis (RA) who were enrolled in the national database of the German Collaborative Arthritis Centres between 2007 and 2009. Logistic regression analyses identified factors that were responsible for patients in DAS28 remission to miss the new criteria. In addition, the functional status of patients who fulfilled the different remission criteria was compared with that of an age- and sex-matched population sample. RESULTS: Of all patients, 28% were in DAS28, 7% in Boolean and 11% in SDAI remission. Of those in DAS28 remission, 21.0% were also in Boolean and 34% also in SDAI remission. Higher scores for pain and fatigue, the presence of degenerative spine disease, longer disease duration and male gender were significantly associated with missing the new criteria despite being in DAS28 remission. Compared with age- and sex-matched samples from the general population, patients in DAS28 remission had a similar functional ability while patients in remission according to the new criteria had better functional scores. CONCLUSIONS: Patients fulfilling the new remission criteria tend to be not only free from active RA, but also from other disabling diseases. If these criteria are applied in clinical practice to guide treatment decisions, the impact of comorbidity should be taken into account.Annals of the rheumatic diseases 08/2012; 72(7). DOI:10.1136/annrheumdis-2012-201821 · 9.27 Impact Factor