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Objective: To compare a 0-10 physician subglobal estimate of inflammatory activity (DOCINF) on a RheuMetric checklist to a formal swollen joint count (SJC) and other rheumatoid arthritis (RA) Core data set measures in a disease activity score 28 (DAS28), clinical disease activity index (CDAI), and simplified disease activity index (SDAI) in patients with RA, recognizing that RA measures, index scores and physician global assessment (DOCGL) may be elevated by joint damage and patient distress, independent of inflamamtory activity, and that formal joint counts are not recorded at most routine care visits., Methods: A cross-sectional study at a routine care visit included a RheuMetric checklist completed by a rheumatologist, with four 0-10 visual numeric scales (VNS) for DOCGL, and three sub-global estimates for inflammatory activity (DOCINF), joint damage (DOCDAM), and patient distress (DOCDIS), e.g., anxiety, depression, and/or fibromyalgia, etc. Variation in SJC according to other individual measures in the DAS28, CDAI, and SDAI, and in the indices was analyzed using Spearman correlation coefficients and regressions with and without DOCINF as an independent variable., Results: In 173 patients with long disease duration, regressions which included individual DAS28, CDAI or SDAI measures and added DOCINF as an independent variable explained 46 % of variation in SJC, compared to 23 % if DOCINF was not included. DOCINF was more explanatory of SJC than even the DAS28 or CDAI indices themselves, although SJC is a component of these indices., Conclusion: In routine care RA patients with long disease duration, DOCINF depicts SJC as effectively as RA indices which require 90-100 seconds to record, and may provide a feasible, informative quantitative clinical measure without recording formal joint counts., Competing Interests: Declaration of competing interest Dr. Pincus holds a copyright and trademark on MDHAQ (multidimensional health assessment questionnaire) and RAPID3 (Routine Assessment of Patient Index Data 3), for which he receives royalties and license fees from for-profit entities but none from physicians for patient care, all of which are used to support further development of quantitative questionnaire measurements for patients and doctors in clinical rheumatology care. Dr. Gibson has received honoraria from UCB, Novartis and Janssen and grant support from Novartis. She is a part-time employee and stockholder of Eli Lilly, but no financial or other support was received from Eli Lilly in the creation of this article., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: More than 20% of rheumatoid arthritis (RA) patients have comorbid fibromyalgia (FM+), which may elevate DAS28-ESR (disease activity score 28-erythrocyte sedimentation rate) and other indices, resulting in challenges to assess inflammatory disease activity. Although several reports indicate that elevated patient global assessment (PATGL) may elevate DAS28 in the absence of inflammatory activity, less information is available concerning the other three components, tender joint count (TJC), swollen joint count (SJC), and erythrocyte sedimentation rate (ESR), to possibly elevate DAS28 in FM+ vs. FM- RA patients., Methods: A PubMed search identified 14 reports which presented comparisons of DAS28-ESR and its four components in RA FM+ vs. FM- groups. Median DAS28, component arithmetic differences, pooled effect sizes and 95% confidence intervals were analysed in the FM+ vs. FM- groups., Results: In FM+ vs. FM- groups, median DAS28 was 5.3 vs. 4.2, SJC 4.0 vs. 3.0, TJC 13.2 vs. 5.3, PATGL 61.6 vs. 39.9, ESR 26.3 vs. 26.5. DAS28-ESR was classified as "high" (>5.1) in 11/14 FM+ groups and "moderate" (3.2-5.1) in all 14 FM- groups. Effect sizes in FM+ vs. FM- groups for DAS28-ESR, SJC, TJC, PATGL, and ESR were large (≥0.8) in 10/14, 1/13, 12/13, 7/13, and 1/13 comparisons, respectively, and pooled effect sizes 0.84 (0.3, 1.4), 0.33 (-0.4, 1.0), 1.27 (0.01, 2.5), 0.91 (-0.6, 2.4), and 0.07 (-0.6, 0.7), respectively., Conclusions: DAS28-ESR is elevated significantly in FM+ vs. FM- RA patients; pooled effect sizes were highest for TJC, followed by PATGL, SJC and ESR. The findings appear relevant to response and remission criteria, treat-to-target, and general management of RA.

Objective: To analyze disease burden in osteoarthritis (OA) according to Multidimensional Health Assessment Questionnaire (MDHAQ)/Routine Assessment of Patient Index Data 3 (RAPID3) scores at the initial visit and the 6-month follow-up visit, compared with rheumatoid arthritis (RA) as a benchmark for high disease burden., Methods: All patients with all diagnoses at the Rush University Medical Center Division of Rheumatology complete a paper MDHAQ at all visits, saved as a PDF in the electronic health record. MDHAQ 0-10 scores for physical function, pain, and patient global assessment (compiled into RAPID3 0-30 scores) and additional scales at the initial and 6-month follow-up visits, for new OA and RA patients seen from 2011 to 2017, were compared. OA and RA patients were classified as self-referred or physician-referred, and RA patients were classified as disease-modifying antirheumatic drug (DMARD)-naive or having prior-DMARD treatment. Patient groups were compared using t-tests and analysis of variance, adjusted for age, disease duration, body mass index (BMI), education, and ethnicity., Results: Compared with RA patients, OA patients had higher age, BMI, and disease duration. At initial visit, the mean RAPID3 did not differ significantly in OA versus DMARD-naive RA patients, whether self- or physician-referred (range 14.8-16.4 [P = 0.38]), or in all OA patients versus DMARD-naive RA patients versus prior-DMARD RA patients (15.0, 15.7, and 15.8, respectively [P = 0.49]). After 6 months, RAPID3 was improved to 13.3, 10.3, and 10.8, respectively, which represented substantially greater improvement in RA patients than OA patients (P < 0.001). Similar results were seen for most self-reported measures and in adjusted analyses., Conclusion: MDHAQ/RAPID3 scores are similar in OA and RA patients at the initial visit, but higher in OA patients than in RA patients 6 months later, reflecting superior RA treatments. The same MDHAQ/RAPID3 allows comparisons of disease burdens in different diseases., (© 2019, American College of Rheumatology.)

Objective: To analyze discordance between global estimates by patients (PATGL) and their physicians (DOCGL) according to demographic and self-report variables on a Multidimensional Health Assessment Questionnaire (MDHAQ) in patients with many rheumatic diseases seen in usual care., Methods: Each patient completed an MDHAQ at each visit, which includes scores for physical function, pain, and PATGL, each found on the traditional Health Assessment Questionnaire (HAQ), and scores for sleep quality, anxiety, depression, self-report joint count, and fatigue, which are not found on the HAQ. A random visit of 980 patients with any rheumatic diagnosis was analyzed in 3 categories: PATGL=DOCGL (within 2 of 10 units), PATGL>DOCGL (by ≥2 of 10 units), and DOCGL>PATGL (by ≥2 of 10 units), using descriptive statistics and multinomial logistic regression models., Results: Patients included 145 with rheumatoid arthritis, 57 with systemic lupus erythematosus, 173 with osteoarthritis, 348 with other inflammatory diseases, and 257 with other noninflammatory diseases. Overall, PATGL=DOCGL in 509 (52%), PATGL>DOCGL in 371 (38%), and DOCGL>PATGL in 100 (10%). PATGL>DOCGL was associated significantly with older age, female sex, low formal education, Hispanic ethnicity, not working, high MDHAQ physical function and pain scores, and high scores for fatigue, poor sleep, anxiety, depression, and self-report joint count, which are not available on the HAQ. Pain and fatigue were significant in a final multinomial logistic regression; the other variables may raise awareness of discordance to clinicians., Conclusion: Global estimates of patients indicated significantly poorer status than estimates of their physicians in 38% of 980 patients with rheumatic conditions, and were associated with demographic and MDHAQ scores, 5 of which are not available on the HAQ., (Copyright © 2014 by the American College of Rheumatology.)

Objective: To analyze whether MDHAQ (Multidimensional Health Assessment Questionnaire) scores for physical function (FN), pain, Patient Global Estimate (PATGL), and RAPID3 (Routine Assessment of Patient Index Data, a composite of these 3 measures) document improvement in patients with osteoarthritis, systemic lupus erythematosus, spondyloarthropathy, and gout, similarly to rheumatoid arthritis., Methods: In a solo rheumatology practice, every patient completes an MDHAQ/RAPID3 and is assigned a Physician Global Estimate (DOCGL) at every visit. Mean and median FN (0-10 scale), pain (0-10), PATGL (0-10), RAPID3 (0-30), and DOCGL (0-10) were computed at first visit and 2 months later in 141 new patients with 5 diagnoses. Proportions with RAPID3 high (>12), moderate (6.1-12), and low (3.1-6) severity and remission (≤3) were computed. Differences between baseline and 2-month follow-up for each diagnosis were analyzed using paired t tests. Mean changes over 2 months across 5 diagnoses were compared using analysis of variance., Results: Mean baseline scores for all measures were in narrow ranges for all 5 diagnoses: FN 1.5 to 2.5, pain 4.2 to 5.9, PATGL 4.3 to 5.6, RAPID3 10.1 to 13.7, and DOCGL 2.4 to 4.0. Improvement for FN was 9.4% to 26.8% in all diagnoses but osteoarthritis, for pain 20.2% to 35.3% in all diagnoses, PATGL 11.3% to 30.4%, RAPID3 16.8% to 27.5%, and for DOCGL 23.8% to 36.4%, similar in 5 diagnostic groups., Conclusions: MDHAQ, RAPID3, and DOCGL document similar baseline and improvement scores in patients with 5 diagnoses. These quantitative data may supplement traditional narrative, "gestalt" descriptions in usual care of patients with any rheumatic disease.

Objective: To analyze a patient self-report joint count from the Rheumatoid Arthritis Disease Activity Index (RADAI) on a Multidimensional Health Assessment Questionnaire (MDHAQ) in a cohort of consecutive patients seen in usual rheumatology care with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), osteoarthritis (OA), psoriatic arthritis (PsA), and gout., Methods: Each patient completed an MDHAQ, which included a RADAI, at each visit in one usual care setting. In order to include a physician measure, a random visit at which there was a recorded physician global estimate was selected for each of 465 patients (174 patients with RA, 75 with SLE, 113 with OA, 53 with PsA, and 50 patients with gout). The RADAI was analyzed for total scores (range 0-48), number of involved joint groups (range 0-16), and each specific joint group, and then compared in the 5 diagnostic groups to one another and to other MDHAQ measures and the Routine Assessment of Patient Index Data 3 (RAPID3)., Results: In patients with RA, SLE, OA, PsA, and gout, mean RADAI scores (range 0-48) were 12.4, 6.5, 10.1, 6.7, and 2.7, respectively. The mean numbers of involved joint groups (range 0-16) were 6.9, 3.8, 4.8, 4.5, and 1.7, respectively, and the median numbers were 6, 2, 4, 4, and 1, respectively. RADAI scores were correlated significantly with the physician global estimate, except in SLE, and at higher levels with the MDHAQ and RAPID3 scores in all diagnostic groups., Conclusion: The RADAI self-report joint counts can be used to record self-report involvement of specific joints and joint groups in patients with SLE, OA, PsA, and gout, with minimal effort on the part of the rheumatologist., (Copyright © 2013 by the American College of Rheumatology.)

The patient history often provides the most important information in diagnosis and management of rheumatoid arthritis (RA) and other rheumatic diseases. A multidimensional health assessment questionnaire (MDHAQ)-with templates to score RAPID3 (routine assessment the patient index data), an index of three patient self-report measures, physical function, pain, and patient global estimate-pro- vides a "scientific" patient history. MDHAQ/RAPID3 scores meet criteria for the scientific method seen for laboratory tests: standard format, quantitative data, protocol for col- lection, and recognition of prognostic implications of levels for management decisions. Extensive evidence supports a scientific rationale for MDHAQ/RAPID3 scores, which are as efficient as joint counts, laboratory tests, DAS28, and CDAI to distinguish active from control treatments in clinical trials and correlated significantly with DAS28 and CDAI scores in clinical trials and usual clinical care, including categories for high, moderate, low severity, and remission. Pragmatic advantages of MDHAQ/RAPID3 include that the patient does almost all the work and prepares for the encounter to focus on concerns to discuss with the doctor. MDHAQ/RAPID3 improves doctor-patient communication and saves time for the doctor with a 10 to 15 second overview of medical history data that otherwise would require 10 to 15 minutes of conversation. RAPID3 is scored in 5 seconds, compared to almost 2 minutes for a CDAI or DAS28, and can be used effectively for treat-to-target in RA. MDHAQ/ RAPID3 is informative in all rheumatic diseases, including systemic lupus erythematosus, osteoarthritis, ankylosing spondylitis, psoriatic arthritis, fibromyalgia, gout, and others. All rheumatologists may include MDHAQ/RAPID3 in all patients in the infrastructure of clinical care.

Background: An index is needed to assess the status of patients with rheumatoid arthritis (RA), as none of the existing measures are applicable to all individual patients. The 28-joint Disease Activity Score (DAS28) is the most specific and widely used index. Routine Assessment of Patient Index Data (RAPID3) is an index containing only the 3 patient self-report core dataset measures, without a laboratory test or formal joint count, and with simple scoring. RAPID3 is correlated significantly with DAS28, but calculated in 5-10 seconds on a Multidimensional Health Assessment Questionnaire (MDHAQ), compared to 114 seconds for DAS28., Methods: DAS28 (0-10 scale) categories for high, moderate, and low activity, and remission (≤ 2.6, 2.6-3.2, 3.21-5.1, and > 5.1, respectively) and proposed RAPID3 (0-30 scale) categories for severity (0 ≤ 3, 3.1-6, 6.1-12, and > 12) were compared in patients taking abatacept and control-treated patients at the endpoint of the Abatacept in Inadequate Response to Methotrexate (AIM) and the Abatacept Trial in Treatment of Anti-TNF INadequate Responders (ATTAIN) clinical trials, using cross-tabulations and kappa statistics., Results: Overall, 92%-99% of patients classified as having high DAS28 activity had high or moderate RAPID3 severity, while 64%-83% in DAS28 remission had RAPID3 low severity or remission; 50%-82% of patients with good or poor EULAR responses had good or poor RAPID3 responses. Kappa values ranged from 0.25 to 0.48, and weighted kappas from 0.32 to 0.52, indicating fair to moderate agreement for the 2 indices., Conclusion: Proposed RAPID3 severity and response categories yield comparable results to DAS28 and EULAR criteria in AIM and ATTAIN. DAS28 is more specific for clinical trials. RAPID3 does not preclude also scoring DAS28, and may be informative in the infrastructure of routine care.

Objective: To analyze quantitative data in patients with systemic lupus erythematosus (SLE), seen in usual care, from a patient Multidimensional Health Assessment Questionnaire (MDHAQ) with routine assessment of patient index data (RAPID3) scores and from a physician global estimate of noninflammatory symptoms; and to compare results to self-report Systemic Lupus Activity Questionnaire (SLAQ) scores and 4 SLE indices: SLE Disease Activity Index-2K (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG), Systemic Lupus Activity Measure (SLAM), and European Consensus Lupus Activity Measurement (ECLAM)., Methods: Fifty consecutive patients with SLE were studied in usual care of one rheumatologist. All patients completed an MDHAQ/RAPID3 in this setting. Each patient also completed a SLAQ. The rheumatologist scored SLEDAI-2K, BILAG, SLAM, ECLAM, and 2 physician global estimates, one for overall status and one for noninflammatory symptoms. Patients were classified into 2 groups: "few" or "many" noninflammatory symptoms. Scores and indices were compared using correlations, cross-tabulations and t tests., Results: The patients included 45 women and 5 men. MDHAQ/RAPID3 and SLAQ scores were significantly correlated. RAPID3 scores were significantly higher in patients with SLE index scores above median levels, and in 34 patients scored by the rheumatologist as having "few" noninflammatory symptoms. MDHAQ/RAPID3 and SLAQ were significantly higher in 16 patients scored as having many noninflammatory symptoms., Conclusion: MDHAQ/RAPID3 and SLAQ subscale scores appear to reflect disease activity in patients with SLE, but not in patients with many noninflammatory symptoms. A physician scale for noninflammatory symptoms is useful to interpret MDHAQ/RAPID3, SLAQ, and SLE index scores.

Objective: To compare the Routine Assessment of Patient Index Data 3 (RAPID3) on a Multidimensional Health Assessment Questionnaire (MDHAQ) with the Disease Activity Score (DAS28), Clinical Disease Activity Index (CDAI), and individual core data set measures for correlations, agreement of activity levels, and time to score., Methods: Four rheumatologists each assessed 50 patients with rheumatoid arthritis in "real-time" clinical care. Patients completed an MDHAQ. The rheumatologist then calculated RAPID3 (physical function, pain, patient global estimate), performed a 28-joint count, assigned a physician global estimate, and scored a CDAI, each timed by an observer. Erythrocyte sedimentation rate (ESR) was tested on the same date, and the DAS28-ESR was computed later, again timed by an observer. Spearman's rank-order correlations and comparisons of patients classified as high activity, moderate activity, low activity, and remission according to the DAS28, CDAI, and RAPID3 were computed and compared with kappa statistics. A second study of 25 "paper patients" was also performed to compare time to score the DAS28, CDAI, and RAPID3 on a 0-10 versus 0-30 scale. Mean and median times to score each index were computed., Results: The 3 indices were correlated significantly, including agreement for >80% of patients for high/moderate activity. The mean time to perform a 28-joint count was 94 seconds, and the mean times to score the DAS28, CDAI, RAPID3 on a 0-10 scale, and RAPID3 on a 0-30 scale were 114, 106, 9.6, and 4.6 seconds, respectively., Conclusion: RAPID3 scores provide similar quantitative information to DAS28 and CDAI, while calculated on a 0-30 scale in about 5% of the time.

RAPID3 (routine assessment of patient index data 3) is a pooled index of the 3 patient-reported American College of Rheumatology rheumatoid arthritis (RA) Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = moderate; 3.1-6 = low; < or =3 = remission. RAPID3 scores are correlated with the disease activity score 28 (DAS28) and clinical disease activity index (CDAI) in clinical trials and clinical care, and are comparable to these indices in capacity to distinguish active from control treatments in clinical trials. RAPID3 on a multidimensional health assessment questionnaire (MDHAQ) is scored in 5 to 10 seconds, versus 90 to 94 seconds for a formal 28-joint count, 108 seconds for a CDAI, and 114 seconds for a DAS28. An MDHAQ can be completed by each patient at each visit in the waiting room in 5 to 10 minutes, as a component of the infrastructure of routine care, with minimal effort of the rheumatologist and staff, to provide RAPID3 scores as well as additional data including a self-report joint count, fatigue, review of systems, and recent medical history. In all rheumatic diseases RAPID3 is able to provide a baseline quantitative value, and to quantitatively monitor and document improvement or worsening over time.

A joint examination is prerequisite to a diagnosis of rheumatoid arthritis (RA), and quantitative counts of swollen and tender joints are the most specific of the 7 RA Core Data Set measures for patient assessment. Therefore, joint counts are weighted of greater importance than the other 5 Core Data Set measures in American College of Rheumatology response criteria and all RA indices in which it is included. Nonetheless, several limitations to the joint count have been recognized: (1) poor reproducibility with a requirement to be performed by the same observer at each visit; (2) likelihood to improve with placebo treatment as much or more than the other 5 RA Core Data Set measures; (3) similar or lower relative efficiencies than global and patient measures to document differences between active and control treatments in clinical trials; (4) improvement over 5 years while joint damage and functional disability may progress; (5) lower sensitivity in detecting inflammatory activity than ultrasound and magnetic resonance imaging. Most visits to a rheumatologist do not include a formal quantitative joint count. Quantitative patient self-report data are as sensitive to change and as informative about prognosis and outcomes as joint counts. It may be suggested that a careful qualitative (nonquantitative) joint examination, supplemented by quantitative self-report questionnaire scores to interpret physical examination findings, may be adequate to monitor patients and document changes in status in busy clinical settings.

Objective: To analyze baseline erythrocyte sedimentation rates (ESR) in cohorts of patients with rheumatoid arthritis (RA), which had been included in a review concerning longterm mortality, in reports published between 1973 and 2008, with baseline observations between 1954 and 2000., Methods: A computer search and complementary review of the literature had identified 84 unique cohorts with RA for which mortality over 5-40 years was reported. Baseline ESR data were available for 23 of the 84 cohorts. Mean and median ESR, age, disease duration, and rheumatoid factor (RF) status were compiled and analyzed in tertiles according to first year of patient recruitment., Results: Among 7 cohorts recruited initially between 1954 and 1980, median ESR at baseline was 47 mm/h (mean 50 mm/h, range 43-66), compared to median 38 mm/h (mean 41 mm/h, range 34-64) among 8 cohorts recruited between 1981 and 1984, and median 36 mm/h (mean 35 mm/h, range 28-42) among 8 cohorts recruited between 1985 and 1996. The lowest mean ESR among 7 cohorts with baseline in 1980 or earlier was 43 mm/h, and the highest reported mean ESR among 8 cohorts recruited after 1985 was 42 mm/h. In 3 cohorts recruited after 1985 from Sweden, Finland, and Spain, mean baseline ESR was < 30 mm/h., Conclusion: Mean ESR fell by 30% in cohorts of patients with RA recruited before 1981 compared to cohorts recruited after 1984. This decline may reflect changes in both the natural history and approaches to therapy of RA.

Objective: To compare 4 categories (high, moderate, and low severity, and near-remission) of RAPID3 (Routine Assessment of Patient Index Data 3), an index without formal joint counts, which is scored in < 10 seconds to 4 categories of the Disease Activity Score (DAS28) and Clinical Disease Activity Index (CDAI) in patients with rheumatoid arthritis (RA)., Methods: All patients complete a Multidimensional Health Assessment Questionnaire (MDHAQ) at each visit. A physician/assessor 28-joint count and erythrocyte sedimentation rate (ESR) were completed in 285 patients with RA in usual care by 3 rheumatologists to score DAS28, CDAI, and RAPID3. RAPID3 includes the 3 MDHAQ patient self-report RA Core Data Set measures for physical function, pain, and patient global estimate. Proposed RAPID3 (range 0-10) severity categories of high (> 4), moderate (2.01-4), low (1.01-2), and near-remission (< or = 1) were compared to DAS (0-10) activity categories of high (> 5.1), moderate (3.21-5.1), low (2.61-3.2), and remission (< or = 2.6), and CDAI (0-76) categories of > 22, 10.1-22.0, 2.9-10.0, and < or = 2.8. Additional RAPID scores, which add to RAPID3 a physician/assessor or patient self-report joint count and/or assessor global estimate, were also analyzed. Statistical significance was analyzed using Spearman correlations, cross-tabulations, and kappa statistics., Results: All RAPID scores were correlated significantly with DAS28 and CDAI (rho > 0.65, p < 0.001). Overall, 78%-84% of patients who met DAS28 or CDAI moderate/high activity criteria met similar RAPID severity criteria, and 68%-77% who met DAS28 or CDAI remission/low activity criteria also met similar RAPID criteria. RAPID3 was as informative as other indices., Conclusion: RAPID3 provides a feasible, informative quantitative index for busy clinical settings.

Objective: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR)., Methods: The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007)., Results: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue., Conclusions: These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

Objective: To analyze the time required to score different measures used to assess patients with rheumatoid arthritis (RA), as a guide to feasibility in standard care. The measures studied were a 28-Joint Count, Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ), Multidimensional HAQ (MDHAQ), and various Routine Assessment of Patient Index Data (RAPID) scores derived from the MDHAQ., Methods: Three rheumatologists at 3 sites performed and timed 28-joint counts in 20 different patients at each site. Each rheumatologist scored and timed identical data in 5 groups of 10 from the same 50 patients seen in standard clinical care, including 50 DAS28 indices using the DAS Website, 50 identical HAQ, and 50 identical MDHAQ from the same patients. The MDHAQ includes 10 activities self-assessed for physical function, 21 circle visual analog scales (VAS) (rather than 10 cm lines), and scoring templates on the questionnaire for physical function, patient self-report joint count and RAPID composite scores. RAPID3 includes the 3 Core Data Set measures, RAPID4 adds the self-report joint count to RAPID3, and RAPID5 adds a physician global estimate to RAPID4., Results: The median number of seconds to complete a 28-joint count was 90, compared to 41.9 s for a HAQ, 9.6 s for an MDHAQ RAPID3, and 19.4 s for RAPID5., Conclusion: MDHAQ RAPID3 scores can be calculated in considerably less time than other RA measures, using scoring templates on the MDHAQ, to provide informative, feasible, quantitative measures for standard rheumatology clinical care.

Objective: To estimate relative efficiencies of the 7 rheumatoid arthritis (RA) Core Data Set measures to distinguish adalimumab from control treatments in 4 clinical trials., Methods: Four adalimumab clinical trials were analyzed for arithmetic and percentage changes for each Core Data Set measure from baseline to endpoint: 3 assessor/physician measures -- swollen joints, tender joints, and global estimate; 1 laboratory test -- C-reactive protein; and 3 patient measures -- physical function, pain, and global estimate. Relative efficiencies of each measure to distinguish adalimumab from control group responses were assessed, with tender joint count as the referent measure., Results: Relative efficiencies were in a similar range for physician/assessor, patient, and laboratory measures, with some variation between trials. Among physician/assessor measures, relative efficiencies for global estimates were greater than for swollen and tender joint counts in 8/8 comparisons. Among patient measures, relative efficiencies for global estimates were greater than for physical function and pain scores in at least 6/8 comparisons. Among all measures, relative efficiencies for patient global estimates were greater than for swollen joint counts in 5/8 comparisons, and for tender joint counts in 8/8 comparisons., Conclusion: Patient and physician/assessor measures distinguished adalimumab from control treatment groups in similar ranges. Among all measures, physician/assessor global estimate was most efficient, and tender joint count least efficient, in all 4 trials. This information suggests that while joint counts are the most specific measure to assess RA, their sensitivity to detect treatment effects in patients with RA is generally no greater, and usually less, than other measures.

Objective: To carry out a meta-analysis designed to compare the discriminant capacities of American College of Rheumatology 50% (ACR50) with 20% (ACR20) responses in clinical trials on rheumatoid arthritis reported after 1997 and to analyse whether ACR50 can be as informative as ACR20 in distinguishing active from control treatments in more recent trials., Methods: Clinical trials on rheumatoid arthritis reported since 1997 were identified, which included aggressive combinations of disease-modifying antirheumatic drugs and glucocorticoids, as well as powerful new agents-leflunomide, etanercept, infliximab, anakinra, adalimumab, abatacept, tacrolimus and rituximab. A meta-analysis of ACR20 compared with ACR50 responses for 21 clinical trials was carried out on differences in proportions of responders for active and control treatments and corresponding odds ratios (ORs)., Results: In all but one clinical trial on rheumatoid arthritis published since 1997 with data available on ACR20 and ACR50, more than 50% of patients who were ACR20 responders among those randomised to active treatment were also ACR50 responders. This phenomenon was seen for control groups in 38% of trials, many of which included treatment with methotrexate. A meta-analysis of the clinical trials indicated a slight advantage to ACR50 for quantifying treatment comparisons, not significant for differences in proportions but significant for ORs., Conclusion: ACR20 and ACR50 seem to be similar in distinguishing active from control treatments in clinical trials on rheumatoid arthritis reported since 1997. As ACR50 represents a considerably stronger clinical response, ACR50 may be a preferred end point for contemporary clinical trials on rheumatoid arthritis.

Objective: To analyze 2 indices composed of the 3 patient reported outcomes (PRO) in the American College of Rheumatology (ACR) Core Data Set--physical function, pain, and global estimate--without joint count or laboratory data, for capacities to distinguish active from control treatments in 4 pivotal clinical trials., Methods: Data from 4 clinical trials involving adalimumab, in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARD) or as monotherapy, versus control treatment were made available to analyze properties of various indices. A categorical PRO-Index M was defined as "majority" improvement in 2 of the 3 PRO measures at 20%, 50%, and 70% levels; results were evaluated to analyze agreement with ACR20, ACR50, ACR70 responses and an "all Core Data Set measures" index based on 4 of the 7 measures having such levels of improvement. A continuous PRO-Index C was defined as the median or 2nd highest of 3 percentage differences from baseline to endpoint; results were evaluated to analyze agreement with a continuous ACR-N, "all Core Data Set measures" index, and Disease Activity Score 28 (DAS28)., Results: All indices distinguished active versus control treatment at similar levels, including PRO-Index M versus ACR20, ACR50, and ACR70 responses, and PRO-Index C versus DAS28., Conclusion: PRO indices based only on patient questionnaire data, without joint counts or laboratory tests, may be useful quantitative measures of therapeutic efficacy for use in standard rheumatology clinical care.

A proposed approach is presented to recognise a status of "near-remission" in a patient with rheumatoid arthritis (RA) on the basis of patient self-report questionnaire data without formal joint counts or laboratory tests. Indices of patient-reported outcome (PRO) measures distinguish active from control treatments in RA clinical trials at levels similar to American College of Rheumatology (ACR) or disease activity score (DAS) 28 improvement levels. PRO measures on a multidimensional health assessment questionnaire (MDHAQ) can be compiled into a routine assessment of patient index data (RAPID) score. RAPID 3 includes the three PRO measures from the ACR Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count from a rheumatoid arthritis disease activity index (RADAI). RAPID 5 adds a physician estimate of global status. RAPID cores may be classified into four preliminary proposed categories, as "near-remission" (0-1), "low severity" (1.01-2), "moderate severity" (2.01-4), and "high severity" (> 4), analogous to the four categories of the DAS28 of "remission" (< 2.6), as well as "low" (2.6-3.19), "moderate" (3.2-5.1), and "high" (> 5.1) disease activity. RAPID scores are correlated significantly with DAS28 (rho = 0.64-0.67, p < 0.001), and about 75% of patients with DAS < 2.6 have RAPID scores < 2, while about 75% of patients with DAS > 5.1 have RAPID scores > 4. RAPID data are available on one side of one page, and are feasible to collect in standard clinical care. RAPID 3 scores may be calculated in about 10 seconds, and RAPID 4 and RAPID 5 scores in 20 to 30 seconds. RAPID scores every 3 months or more on simple flowsheets can be a basis for a "continuous quality improvement" strategy in standard clinical care to recognise a need for aggressive therapy, an inadequate response to a therapy, and "near- remission" status.

The prevalence of ischemic heart disease and atherosclerosis is increased in patients with rheumatoid arthritis (RA). In the general population, but not in patients with systemic lupus erythematosus, the Framingham risk score identifies patients at increased cardiovascular risk and helps determine the need for preventive interventions. We examined the hypothesis that the Framingham score is increased and associated with coronary-artery atherosclerosis in patients with RA. The Framingham score and the 10-year cardiovascular risk were compared among 155 patients with RA (89 with early disease, 66 with long-standing disease) and 85 control subjects. The presence of coronary-artery calcification was determined by electron-beam computed tomography. The Framingham score was compared in patients with RA and control subjects, and the association between the risk score and coronary-artery calcification was examined in patients. Patients with long-standing RA had a higher Framingham score (14 [11 to 18]) (median [interquartile range]) compared to patients with early RA (11 [8 to 14]) or control subjects (12 [7 to 14], P < 0.001). This remained significant after adjustment for age and gender (P = 0.015). Seventy-six patients with RA had coronary calcification; their Framingham risk score was higher (14 [12 to 17]) than that of 79 patients without calcification (10 [5 to 14]) (P < 0.001). Furthermore, a higher Framingham score was associated with a higher calcium score (odds ratio [OR] = 1.20, 95% confidence interval [CI] 1.12 to 1.29, P < 0.001), and the association remained significant after adjustment for age and gender (OR = 1.15, 95% CI 1.02 to 1.29, P = 0.03). In conclusion, a higher Framingham risk score is independently associated with the presence of coronary calcification in patients with RA.

Objective: To develop and validate a composite patient self-report disease activity scale for use in clinical practice and in observational studies and clinical trials., Methods: A total of 9078 patients with rheumatoid arthritis completed detailed questionnaires that included measure of quality of life in the form of utilities. We evaluated several disease activity scales by measuring their agreement with the utility scales, and also their assessed ability to predict mortality and prescription for anti-tumor necrosis factor therapy., Results: A composite index composed of a visual analog scale (VAS) for pain, a patient global VAS, and the Health Assessment Questionnaire (HAQ) or the HAQ II formed the Patient Activity Scale (PAS) and PAS-II. These scales performed as well as or better than longer, more complex scales., Conclusion: A simple, useful clinical scale, the PAS or PAS-II, can be formed by the use of common clinical variables. It is well correlated with and relevant to a wide range of clinical variables. This scale should be useful for comparative studies, clinical care, and regulatory documentation.

Objective: The Disease Activity Score (DAS) is widely used in clinical trials. A DAS of 5.1 defines the level of severe rheumatoid arthritis (RA) and is the criterion for the initiation of anti-tumor necrosis factor therapy in the UK and The Netherlands. In North America, similar rules are sometimes imposed. However, it is not known how accurately the DAS characterizes RA activity. The present study was undertaken to determine the concordance between DAS scores and physicians' assessments of RA activity, to investigate factors relating to discrepancies, and to assess the suitability of using the DAS in individual patients., Methods: Six hundred sixty-nine RA patients were assessed using the DAS and other clinical measures. A physician's global estimate of RA activity was performed using an 11-point predefined scale and a standard definition of disease activity., Results: The DAS and physician global assessment had substantially different distributions of values. The level of agreement (Kendall's tau-a) between DAS scores and physician global assessments was 49% (95% confidence interval 45-53%), Lin's coefficient of concordance was 0.62, and the Bland-Altman 95% limits of agreement were -3.17 and 3.99. These results suggest poor-to-moderate concordance between the 2 measures of disease activity., Conclusion: The DAS and the physician's assessment of RA activity do not approach, value, and weight RA variables to the same extent, suggesting that RA activity is not evaluated similarly by North American physicians and with the DAS. The scales do not have acceptable levels of concordance. There is too much inherent variability in the DAS and other RA scales (e.g., the Health Assessment Questionnaire) to recommend them as sole determinants of RA activity for clinical or regulatory purposes.

A count of swollen and tender joints is the most specific quantitative clinical measure to assess and monitor the status of patients with rheumatoid arthritis. Many methods have been described to quantitate joint abnormalities, including scoring various numbers of joints (with or without grading of abnormality) for different types of abnormalities, including swelling, tenderness, pain on motion, limited motion, and deformity. This article reviews selected methods for the performance of joint counts, with discussion of their advantages and limitations in the assessment of patients with rheumatoid arthritis.

Physical measures of functional status, including grip strength, walking time and button test, had been used in rheumatology clinical trials for many years, but have been supplanted in recent years by patient questionnaires. While patient questionnaire measures involve minimum professional time and have greater predictive value than physical measures for severe long-term outcomes of rheumatoid arthritis (RA), physical measures bypass socio-cultural differences which may be seen in use of patient questionnaires. Inter-observer and intra-observer reliabilities of these physical measures were excellent when administered according to a standard protocol for instructions. Physical measures of function also were significant predictors of mortality in two cohorts of patients with RA, one monitored between 1973 and 1988, and a second between 1985 and 1990.

The HAQ has become the pre-eminent patient questionnaire used in rheumatology. It is easily completed by patients, but not easily reviewed and scored in standard clinical care and has some minor psychometric limitations, as do all questionnaires. Modifications of the HAQ been made to facilitate use in standard care, particularly to include 8-10 activities of daily living, along with scores for pain and global status and other information on one side of one page for rapid review by the clinician. A patient questionnaire for standard care should be limited to 2 sides of 1 page, in a format amenable to "eyeball" review by the clinician in 5 seconds or less. It can be scored formally in 15-20 seconds or less, and is useful in patients with all rheumatic diseases. The current version of a multi-dimensional HAQ (MDHAQ) includes scoring templates on the questionnaire to allow formal scoring in less than 15 seconds by a rheumatologist or an assistant, for possible entry onto a paper and/or computerized flow sheet. Various versions of the MDHAQ may also include a "constant" region of physical function, pain and patient global status, and "variable" regions of fatigue, morning stiffness, psychological distress, change in status, a review of systems, a rheumatoid arthritis disease activity self-report joint count (RADAI), review of recent health events, and review of medications. The MDHAQ can be used in the infrastructure of rheumatology care to include quantitative data in standard care of all patients with all rheumatic diseases.

Pooled indices of several measures have been developed to assess and monitor patients with rheumatoid arthritis in clinical trials and clinical care, as no single measure can serve as a "gold standard" in all individual patients. Early indices of disease activity include the Steinbrocker "therapeutic scorecard in rheumatoid arthritis," the Lansbury Index, and Paulus criteria. The most widely used indices at this time are the American College of Rheumatology (ACR) Core Data Set and disease activity score (DAS). A simplified disease activity index (SDAI) and clinical disease activity index (CDAI) are derived from the DAS. The ACR Core Data Set includes 7 measures--swollen joint count, tender joint count, patient assessment of global status, an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)], health professional assessment of global status, physical function, and pain; the first four of these measures are included on the DAS. Improvement criteria for the ACR Core Data Set are based on improvement of at least 20% in both tender and swollen joint counts, and three of the five additional measures (ACR 20), and corresponding "ACR 50," and "ACR 70." A pooled index which includes only the three patient self-report questionnaire measures from the Core Data Set, physical function, pain, and patient assessment of global status performs as well as ACR 20 or DAS to discriminate between efficacy of active versus placebo treatment in a clinical trial.

Objective: To describe indices that are continuous counterparts of categorical responses to the American College of Rheumatology 20% improvement criteria (ACR20), ACR50, and ACR70, which extend rheumatoid arthritis (RA) clinical trial results and recognize clinical worsening (as well as improvement) with active and placebo treatments., Methods: Data from a clinical trial of leflunomide, methotrexate, and placebo treatment over 1 year were reanalyzed. Percent change was computed for each of the 7 components of the ACR core set of outcome measures. Four continuous indices were computed: 1) ACR-N (lowest of 3 values: number of swollen joints, number of tender joints, and median of the other 5 measures); 2) composite (median of all 7 measures [3 patient and 3 assessor measures plus erythrocyte sedimentation rate]); 3) patient-only (median of physical function, pain, and global status); and 4) assessor-only (median of number of swollen joints, number of tender joints, and global status). Means, medians, categorical 20%, 50%, and 70% responses, and continuous probability plots were computed according to each index for the 3 treatment groups and were compared with one another and with standard ACR20, ACR50, and ACR70 responses., Results: Mean levels of improvement calculated using the different methods, in patients taking leflunomide, placebo, and methotrexate, respectively, were as follows: ACR-N 20%, -12%, and 13%; composite 43%, 9%, and 33%; patient-only 36%, 0%, and 26%; assessor-only 50%, 20%, and 44%; and ACR20 52%, 26%, and 46%. Differences between leflunomide and placebo were 30-36%, and differences between methotrexate and placebo were 24-26%., Conclusion: Continuous indices may be an informative addition to categorical ACR 20%, 50%, or 70% responses to compare efficacies of various treatments in RA, and to describe lower responses to placebo by recognizing worsening as well as improvement.

Therapies for rheumatoid arthritis (RA) may be assessed according to relative levels of measures to compare efficacy to another therapy or to a placebo, as in the American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR 20 ACR 50 and ACR 70) responses, or by absolute levels of measures, as in disease activity scores (DAS), ACR criteria for remission, or "target values" of specific measures. Regulatory considerations have emphasized primarily relative comparisons to a placebo or standard therapy, derived in part from the weak efficacy of traditional disease modifying anti-rheumatic drugs (DMARDs). While improvement compared to placebo certainly indicates efficacy, it is of concern that measures of inflammatory activity, such as swollen joints and the erythrocyte sedimentation rate (ESR), may be stable or improved over periods of 5-10 years, while measures of damage, such as joint deformity and radiographic changes, may progress over the same period in the same patients. These findings suggest that improvement at a level of 20% or 50% may deter but not prevent severe long-term outcomes of radiographic progression, functional declines, work disability, and premature mortality, seen in most patients until the middle 1990s. Outcomes appear to be improved at this time, associated with aggressive treatment strategies and more powerful therapies, including biologic agents. In the Finnish Rheumatoid Arthritis Combination Therapy Trial (FinRACo), no patient who was in remission after 6 months was receiving work disability payments 4 1/2 years later, compared to 22% of patients who had ACR 20 or 50 responses and 54% of patients who did not have ACR 20 responses after 6 months who were all receiving work disability payments after 5 years. These findings suggest that absolute targets, including remission, may be realistic contemporary goals, with aggressive treatment strategies and more effective DMARDs and biologic agents.

Objective: To analyze quantitative scores for pain, fatigue, functional disability, and the number of symptoms on a review of systems on a multidimensional health assessment questionnaire (MDHAQ), including the ratios of scores for pain to physical function and fatigue to physical function, and to further study how these scores can help to identify patients with fibromyalgia., Methods: All consecutive patients seen at a rheumatology clinic completed a 2-sided, 1-page MDHAQ at each visit to assess physical function, pain, fatigue, global status, helplessness and review of systems, and had their erythrocyte sedimentation rate (ESR) measured. Scores for these variables were analyzed in 78 consecutive patients with fibromyalgia over a two-year period, and in 149 patients with rheumatoid arthritis (RA) as a "control" group. A subset analysis was conducted in patients with RA who were classified independently according to clinical criteria as having or not having coexistent fibromyalgia. Descriptive statistics, logistic regression, and receiver-operating-characteristic curves were computed for patients with fibromyalgia and compared to patients with RA., Results: Patients with fibromyalgia had high ratios of pain:physical function and fatigue:physical function scores, and a high number of reported symptoms. These quantitative data differed significantly from patients with RA. Patients with fibromyalgia also had a lower ESR than patients with RA, whose scores were similar whether or not there was coexistent fibromyalgia. Patients with fibromyalgia were distinguished equally well from patients with RA by patient questionnaire data as by the ESR., Conclusion: A simple 1-page, 2-sided patient questionnaire provides quantitative information which may contribute to identify patients with fibromyalgia, including patients with RA who may also have coexistent fibromyalgia.

Objective: To evaluate the capacity of a pooled index of only the 3 patient self-report questionnaire measures among the 7 American College of Rheumatology (ACR) core data set (Core Data Set) measures to distinguish efficacy of active treatment of rheumatoid arthritis (RA) with leflunomide or methotrexate versus placebo in a randomized, controlled clinical trial, and to compare the results with those obtained using the ACR 20% response criteria (ACR20), Disease Activity Score (DAS), and other pooled indices., Methods: The 7 ACR Core Data Set measures of 1) joint swelling, 2) joint tenderness, 3) physician global assessment, 4) erythrocyte sedimentation rate (ESR), 5) functional disability, 6) pain, and 7) patient global assessment were combined into the following 5 pooled indices: "All Core Data Set" (all 7 measures), "Assessor Only" (measures 1-3), "Assessor + ESR" (measures 1-4), "Patient Only" (measures 5-7), and "Patient + ESR" (measures 4-7). The capacity of each of these 5 indices to detect differences between active treatment and placebo treatment was compared with that of the ACR20 and the DAS using 4 different analytic methods, each of which presented advantages and limitations. Agreement of the indices with one another and with the ACR20 and the DAS was analyzed according to pairwise kappa statistics and Z scores in multivariate logistic regression models., Results: Each of the 5 indices, including "Patient Only," had a similar capacity to detect greater efficacy of leflunomide and methotrexate versus placebo in this clinical trial, according to each of 4 methods, at similar levels of statistical and clinical significance., Conclusion: A pooled index of patient self-report questionnaire Core Data Set measures appears to be as informative as ACR20 responses, DAS scores, and pooled indices of all and assessor-derived Core Data Set measures for distinguishing between active treatment and placebo treatment in this RA clinical trial.

Several reports concerning outcomes of rheumatoid arthritis (RA) document that measures of inflammatory activity [such as swollen joint count, tender joint count, and acute phase reactant, which are included in the Core Data Set or Disease Activity Score (DAS)] may be stable or improved over 5-10 years, while measures of damage (such as radiographic progression and joint deformity) may show contemporaneous progression. Therefore, studies which include only improvement in measures of disease activity cannot document overall improvement in patient status over 5-10 years. Studies designed to document favorable long-term effects of therapy in RA must include, at baseline and later follow-up evaluation, measures of damage, such as a radiograph, joint deformity, comorbidities, and extra-articular disease, in addition to measures of disease activity. The one prognostic measure which appears to detect both activity and damage in RA over short, intermediate, and long periods is a disability score on a patient questionnaire, which might be used by all rheumatologists at all patient encounters. The need for inclusion of accurate and relevant measures of damage appears of particular importance in the current era of biological drugs, in which the slowing or prevention of damage now appears a realistic goal in most patients with RA.

To determine in clinical practice which rheumatoid arthritis (RA) clinical status variables are most associated with a change in disease modifying antirheumatic drug (DMARD) therapy, we studied 26,240 observations from 1905 RA patients occurring over 25 years. Variables included tender joint count, erythrocyte sedimentation rate (ESR), grip strength, visual analog scale for pain, global severity, fatigue and sleep, Health Assessment Question functional disability scale (HAQ), anxiety, depression and morning stiffness. Only the tender joint count required a physician. Observations at which a change in DMARD therapy occurred were compared to those where a change did not occur using generalized estimating equations (GEE) and classification and regression tree analysis (CART). Tender joint count, pain, global severity, and ESR were the 4 variables most strongly predictive of DMARD change. CART modeling indicated a special role for fatigue and sleep disturbance in some patients. These data add support in clinical practice for the ACR core set and the DAS set of variables. In addition, they validate the use of these variables in a practice setting. We suggest a minimum set of evaluations comprising: joint count, ESR or CRP, measures of pain and/or severity, a fatigue scale (fatigue being a surrogate for sleep disturbance), and a measure of function such as the HAQ or modified HAQ. Because only joint count requires physician participation, these evaluations are practical for the clinic, and allow quantitative measurement of RA status. With the use of quantile charts, the comparative status of RA and the change in RA status can be determined easily.

Predictors of longterm mortality in rheumatoid arthritis (RA) include patient questionnaire measures, grip strength, walk time, physician and patient assessment of global status, joint examination abnormalities, erythrocyte sedimentation rate (ESR), and morning stiffness. In the rheumatology literature, these measures have been analyzed primarily according to mean values in groups or regression analyses, which are valuable to recognize that mortality in RA is predicted by more severe disease, but do not provide the clinician with specific goals of therapy. Goals for therapeutic intervention are often expressed either as complete remission or as statistically significant differences versus a placebo, as in a 20% or even 50% response of a measure such as the American College of Rheumatology Core Data Set. Remission may be too stringent, while statistically significant efficacy of a drug compared to placebo may not necessarily indicate effectiveness to control longterm damage. An alternative approach might be to identify possible target values for therapeutic efficacy that markers of a poor prognosis be "near normal" rather than necessarily at normal or remission levels, as has been explored in management of hypertension and diabetes. However, it remains uncertain whether the goal of therapy should be a "near normal" or entirely normal values for a clinical marker. Better control of quantitative markers that predict early mortality could provide a valuable approach to improving outcomes in RA.

There is general agreement regarding the most appropriate examinations and methods to use to evaluate change in status in randomized controlled trials (RCT). However, no guidelines exist to aid in determining and evaluating actual status rather than change in status, particularly when applied to individual patients with rheumatoid arthritis (RA). In addition, methods appropriate for clinical trials may not be useful in evaluating individual patients because of time constraints. This report reviews current methods of evaluation and develops modified methods, based on data bank research that will be useful in clinical practice and in the evaluation of RCT and observational studies. Using data from longitudinal observational data banks, further reduction in the number of joints examined is evaluated to reconcile the time constraints of clinical practice with the need to maintain reliability and validity. Percentile methods to determine severity status are applied to the variables used in RCT and extended further to observational studies and routine clinical practice. Shortened joint counts, based on modifications of the Ritchie method, are identified that allow for examination of groups of 18 (clinical-18) and 16 (clinical-16) joints, the clinical-16 omitting the metatarsophalangeal joints. Using percentile charts, actual severity valuations are given to the variables evaluated in the clinic as well as in RCT. Disease activity status of clinic patients can be determined quantitatively thus allowing clinicians further insight into the status and prognosis of their patients. By quantifying disease activity severity, clinicians and 3rd party payers can better evaluate the appropriateness of and response to disease modifying antirheumatic drugs and biologic therapies. Further, RCT can be evaluated as to severity status of patients participating, and the generalizability of RCT can be better evaluated.

Objective: To develop components of a multidimensional Health Assessment Questionnaire (MDHAQ) through the addition of new items in the "patient-friendly" HAQ format, including advanced activities of daily living (ADL), designed to overcome "floor effects" of the HAQ and modified HAQ (MHAQ) in which patients may report normal scores although they experience meaningful functional limitations, and psychological items, designed to screen efficiently for psychological distress in routine care., Methods: The new MDHAQ items, as well as scales for pain, fatigue, helplessness, and global health status on a 2-page questionnaire, were completed by 688 consecutive patients with various rheumatic diseases, including 162 with rheumatoid arthritis (RA), 114 with fibromyalgia, 63 with osteoarthritis, 34 with systemic lupus erythematosus, 20 with vasculitis, 18 with psoriatic arthritis, 16 with scleroderma, and 261 with various other rheumatic diseases, over 2 years at a weekly academic rheumatology clinic., Results: The new MDHAQ items have good test-retest reliability and face validity. MHAQ scores were highest in patients with RA, and scores for other scales were highest in patients with fibromyalgia. On the advanced ADL, 58% of patients reported difficulty with errands, 68% with climbing stairs, 79% with walking two miles, 87% with participating in sports and games, and 94% with running or jogging two miles. On the psychological items, 75% of patients reported difficulty with sleep, 63% with stress, 61% with anxiety, and 57% with depression. Normal MHAQ scores were reported by 23% of patients and normal HAQ scores by 16% of patients who completed these questionnaires, while fewer than 5% had normal scores on the MDHAQ., Conclusion: The MDHAQ items overcome in large part the "floor effects" seen on the HAQ and MHAQ, and are useful to screen for problems with sleep, stress, anxiety, and depression in the "patient-friendly" HAQ format. These data support the value of completion of a simple 2-page patient questionnaire by each patient at each visit to a rheumatologist.

Objective: To compare 3 quantitative hand radiograph scores, Steinbrocker stage, Larsen score, and Sharp score modified by Kaye, to one another and to other measures of clinical status in a cross sectional analysis of hand radiographs of 173 patients with rheumatoid arthritis (RA)., Methods: Radiographs were scored and compared to other measures of clinical status according to correlation and cross tabulation analyses., Results: In these cross sectional studies, radiographic scores according to all 3 methods were correlated at high levels (r(s) > 0.5) with one another and duration of disease, as well as with scores for physical joint deformity and limited motion; at lower levels (0.3 < r(s) < 0.5) with physical joint swelling scores, functional status, and age; and at low levels of marginal or no clinical importance (r(s) < 0.3) with physical joint tenderness scores, laboratory data, and pain scores., Conclusion: The 3 scoring methods give similar quantitative information concerning hand radiographs of patients with RA. The Larsen and modified Sharp scores are preferred measures, as the detailed information facilitates comparison of different patients and monitoring of individual patients over time.

Objective: To determine if quantitative assessment of a reduced number of joints provides information equivalent to that obtained by the traditional 60-joint evaluation in detecting changes in patients participating in clinical trials of rheumatoid arthritis (RA)., Methods: The changes in quantitative joint scores of patients from 3 previously reported clinical trials were compiled and compared with changes in quantitative scores derived using a reduced number of joints. Effect sizes were calculated (mean change in joint score/standard deviation of joint score) and compared for the different joint indices., Results: The effect sizes of the joint scores derived using a reduced number of joints were similar to those of the original 60-joint score. The reduced joint count scores revealed significant changes for clinical trials involving as few as 15 patients., Conclusion: Reduced joint count scores may be used to evaluate the results of clinical trials without decreasing the ability to detect change over time. Quantitative assessment of a reduced number of joints may also facilitate assessment of responses to treatment in the routine care of patients with RA.

The use of quantitative measures to analyse the long-term course of RA appears to have provided new insights into the severe morbidity and increased mortality rates of this disease. Quantitative assessment of RA may be viewed as an expression of clinical rheumatology as a quantitative science designed to assess accurately the long-term course of disease. The description of the joint count, radiographic scores, laboratory tests, questionnaire measures and physical measures of functional status, as well as the importance of socio-economic status, may provide new insights into the pathogenesis, prevalence, morbidity and mortality of RA.

Study Objective: To assess whether scores on a simple self-report questionnaire to depict the clinical status of patients with rheumatoid arthritis are correlated with traditional measures of physical, radiographic, laboratory, functional, and global status., Design: The self-report questionnaire was administered at the same time the following variables were assessed: American Rheumatism Association functional class, joint count, hand radiograph, erythrocyte sedimentation rate, rheumatoid factor titer, walking time, grip strength, button test, and global self-assessment., Setting: University rheumatology clinic, the rheumatology clinic of a Veterans Administration hospital, and a private rheumatology practice., Patients: The study included 259 patients who met the criteria of the American Rheumatism Association for a diagnosis of definite or classic rheumatoid arthritis., Interventions: Standard rheumatologic care for patients with rheumatoid arthritis., Measurements and Main Results: Self-report questionnaire scores were significantly correlated with the joint count, radiographic score, erythrocyte sedimentation rate, grip strength, button test, walking time, American Rheumatism Association functional class, and global self-assessment. Patients were categorized into five questionnaire score categories of 1.00, indicating no dysfunction, and 1.01 to 1.50, 1.51 to 2.00, 2.01 to 3.00, and 3.01 to 4.00, indicating progressive dysfunction. In these five categories, more than ten involved joints were seen in 11%, 37%, 67%, 79%, and 100% of patients, respectively, and erythrocyte sedimentation rates greater than 20 mm/h in 29%, 49%, 64%, 74%, and 85% of patients, respectively. Similar results were seen for other physical and radiographic measures. The questionnaire score was as effective in explaining other measures of clinical status as was any other available measure., Conclusions: A simple self-report questionnaire provides information similar to many traditional measures in rheumatoid arthritis and appears to be an attractive, cost-effective approach to assessing and monitoring quantitatively the status of an individual patient.