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Objective: To develop feasible indices as clues to comorbid fibromyalgia (FM) in routine care of patients with various rheumatic diseases based only on self-report multidimensional Health Assessment Questionnaire (MDHAQ) scores, which are informative in all rheumatic diagnoses studied., Methods: All patients with all diagnoses complete an MDHAQ at each visit; the 2011 FM criteria questionnaire was added to the standard MDHAQ between February 2013 and August 2016. The proportion of patients who met 2011 FM criteria or had a clinical diagnosis of FM was calculated. Individual candidate MDHAQ measures were compared to 2011 FM criteria using receiver-operating characteristic (ROC) curves; cutpoints to recognize FM were selected from the area under the curve (AUC) for optimal tradeoff between sensitivity and specificity. Cumulative indices of 3 or 4 MDHAQ measures were analyzed as fibromyalgia assessment screening tools (FAST)., Results: In 148 patients, the highest AUC in ROC analyses versus 2011 FM criteria were seen for MDHAQ symptom checklist, self-report painful joint count, pain visual analog scale (VAS), and fatigue VAS. The optimal cutpoints were ≥ 16/60 for symptom checklist, ≥ 16/48 for self-report painful joint count, and ≥ 6/10 for both pain and fatigue VAS. Cumulative FAST indices of 2/3 or 3/4 MDHAQ measures correctly classified 89.4-91.7% of patients who met 2011 FM criteria., Conclusion: FAST3 and FAST4 cumulative indices from only MDHAQ scores correctly identify most patients who meet 2011 FM criteria. FAST indices can assist clinicians in routine care as clues to FM with a general rheumatology rather than FM-specific questionnaire.

Objective: To estimate minimal clinically important improvement (MCII) of RAPID-3 (Routine Assessment of Patient Index Data 3) in rheumatoid arthritis (RA)., Methods: RAPID-3 was computed before and after treatment escalation in a prospective study of adults with active RA. Patient judgment of improvement was used as the standard for a receiver-operating characteristic curve, from which MCII was estimated., Results: Mean RAPID-3 improved from 16.3 to 11.1 between visits. MCII was -3.8 based on simultaneously optimized sensitivity and specificity, -3.5 using the 0.80 specificity criterion, and -4.1 using the Youden index., Conclusion: RAPID-3 improvement of 3.8/30 units appears clinically meaningful.

Objective: To identify baseline variables that predict remission according to different criteria in rheumatoid arthritis (RA) in a comprehensive French ESPOIR early arthritis database., Methods: Individual variables and indices at baseline were analyzed in 664 patients for capacity to predict remission either 6 or 12 months later according to 4 criteria that require a formal joint count: the American College of Rheumatology/European League Against Rheumatism Boolean criteria, the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the 28-joint Disease Activity Score; and 2 remission criteria that do not require a formal joint count: the Routine Assessment of Patient Index Data 3 (RAPID3) and the RAPID3 ≤ 3 + swollen joint, using univariate and multivariate logistic regressions., Results: Remission was predicted significantly 6 and/or 12 months later in 26.8%-51.4% of patients, according to all 6 criteria by younger age, low index scores, and better status for the 6/7 clinical RA core dataset measures: tender joint count, swollen joint count (SJC), physician's global estimate, patient self-report Health Assessment Questionnaire (HAQ) physical function, pain, and patient's global estimate. Remission was not predicted by the absence of "poor prognosis RA" indicators, rheumatoid factor (RF), anticitrullinated protein antibodies (ACPA), or radiographic erosions. In multivariate regressions that included only 3 variables, low HAQ function predicted remission by all criteria as effectively as SJC, erythrocyte sedimentation rate, or C-reactive protein., Conclusion: Younger age and 6 core dataset clinical measures, but not the absence of traditional "poor prognosis RA" indicators, RF, ACPA, or radiographic erosions, predicted remission according to 6 criteria, including 2 without a formal joint count.

Objective: To assess the frequency of discordance in patient's (PtGA) and physician's (PGA) global assessment, and to investigate whether higher discordance in female patients compared with male patients is associated with the physician's sex in patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA)., Methods: PtGA, PGA, and other patient-related variables were retrieved from the Danish DANBIO registry, used nationwide to monitor patients with RA, axSpA, and PsA. A questionnaire was sent to all physicians registering in DANBIO (n = 265) regarding individual physician characteristics including sex and age. Discordance was defined as PtGA > 20 mm higher (or lower) than PGA. First encounters between patients and physicians were analyzed using descriptive statistics and mixed model regression analysis., Results: Ninety physicians (34%) returned the questionnaire and were pairwise matched with 10,282 first patient encounters (8300 patients with RA, 524 axSpA, and 1458 PsA). The frequency of discordant (PtGA > PGA) encounters (not including PGA > PtGA seen in < 2%) in RA, axSpA, and PsA was 49.0%, 48.3%, and 56.5%, respectively. Discordance was more common in female patients with high scores on functional disability, pain, and fatigue across the 3 diseases, whereas it was independent of the physician's sex., Conclusion: In this study on Danish patients with RA, axSpA, and PsA, the PtGA was > 20 mm higher than the PGA in about half of the encounters, and more common in female patients of both female and male physicians. This finding highlights one of the challenges in shared decision making.

Objective: To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test., Methods: The ESPOIR early RA cohort of 813 French patients recruited in 2002-2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed - Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: "RAPID3R" (RAPID3 ≤ 3.0); "RAPID3R+SJ1" (RAPID3 ≤ 3.0, ≤ 1 swollen joint); "RAPID3R+SJ1+D1" (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); "RAPID3R+SJ0" (RAPID3 ≤ 3.0, 0 swollen joints); and "RAPID3R+SJ0+D1" (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed., Results: Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%-94.7%, kappa 0.67-0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%-85.8%, kappa 0.46-0.55)., Conclusion: Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.

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: Patients with rheumatoid arthritis (RA) are at increased risk of atherosclerosis, but routine lipid measurements differ little from those of people without RA. We examined the hypothesis that lipid subclasses determined by nuclear magnetic resonance spectroscopy (NMR) differed in patients with RA compared to controls and are associated with disease activity and the presence of coronary-artery atherosclerosis., Methods: We measured lipoprotein subclasses by NMR in 139 patients with RA and 75 control subjects. Lipoproteins were classified as large low-density lipoprotein (LDL; diameter range 21.2-27.0 nm), small LDL (18.0-21.2 nm), large high-density lipoprotein (HDL; 8.2-13.0 nm), small HDL (7.3-8.2 nm), and total very low-density lipoprotein (VLDL; >or= 27 nm). All subjects underwent an interview and examination; disease activity was quantified by the 28-joint Disease Activity Score (DAS28) and coronary artery calcification (CAC) was measured with electron-beam computed tomography., Results: Concentrations of small HDL particles were lower in patients with RA (18.2 +/- 5.4 nmol/l) than controls (20.0 +/- 4.4 nmol/l; p = 0.003). In patients with RA, small HDL concentrations were inversely associated with DAS28 (rho = -0.18, p = 0.04) and C-reactive protein (rho = -0.25, p = 0.004). Concentrations of small HDL were lower in patients with coronary calcification (17.4 +/- 4.8 nmol/l) than in those without (19.0 +/- 5.8 nmol/l; p = 0.03). This relationship remained significant after adjustment for the Framingham risk score and DAS28 (p = 0.025). Concentrations of small LDL particles were lower in patients with RA (1390 +/- 722 nmol/l) than in controls (1518 +/- 654 nmol/l; p = 0.05), but did not correlate with DAS28 or CAC., Conclusion: Low concentrations of small HDL particles may contribute to increased coronary atherosclerosis in patients with RA.

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 analyze erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and rheumatoid factor (RF) tests in 2 databases of consecutive patients with rheumatoid arthritis (RA) over 25 years between 1980 and 2004, in Finland and the USA., Methods: Databases of 1892 patients of 7 rheumatologists in Jyväskylä, Finland, and 478 of one author in Nashville, TN, USA, seen in usual care, were reviewed for the first recorded ESR and CRP, and all RF tests., Results: Median ESR at presentation was 30 mm/h at both sites. Mean ESR was 36 mm/h in Jyväskylä and 35 mm/h in Nashville. ESR was < 28 mm/h in 45% and 47% of patients at the 2 sites, respectively. CRP was normal in 44% and 58%, and all RF tests were negative in 38% and 37%, respectively. Both ESR and CRP were normal in 33% and 42% of patients, and all 3 tests were normal in 15% and 14% of patients in whom they were assessed. All 3 tests were abnormal in only 28% in Jyväskylä and 23% in Nashville., Conclusion: A majority of patients with RA seen between 1980 and 2004 had abnormal ESR, CRP, or RF. However, more than 37% of patients had ESR < 28 mm/h, normal CRP, or all negative RF tests. Similarities of laboratory test data at 2 sites on different continents with different duration of disease suggest generalizability of the findings. Normal ESR, CRP, and RF are seen in a substantial proportion of patients with RA at this time.

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 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.

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: To analyze a further version of the Multidimensional Health Assessment Questionnaire (MDHAQ) with 10 activities of daily living (ADL), which is more easily completed by patients and scored by health professionals than a 14-ADL MDHAQ; and to determine if the 10-ADL MDHAQ would be as informative as the 14-ADL MDHAQ, the 20-ADL HAQ, and the 8-ADL modified HAQ (MHAQ), which is more easily reviewed and scored than the HAQ, but scores are routinely 0.3-0.5 units lower than HAQ scores., Methods: In standard care, 144 consecutive patients completed a HAQ, which includes a MHAQ, and 14-ADL MDHAQ, which includes a 10-ADL MDHAQ subscale, all scored 0-3. These scales were analyzed for mean and median scores, Cronbach's alpha to estimate internal consistency, factor analysis to estimate construct validity, and cumulative percentile scores., Results: Mean (median) scores for the HAQ, MHAQ, 14-ADL MDHAQ, and 10-ADL MDHAQ physical function scales were 0.80 (0.75), 0.48 (0.38), 0.83 (0.79), and 0.73 (0.70), respectively. Internal consistency of each scale was very good. The lowest 25 percentile score was 0.16 on the HAQ, 0.0 on the MHAQ, 0.36 on the 14-ADL MDHAQ, and 0.20 on the 10-ADL MDHAQ., Conclusion: The MDHAQ physical function scale of 10 ADL is more easily completed and scored than the 14-ADL MDHAQ or 20-ADL HAQ, while providing similar information.

Objective: Key outcomes in rheumatoid arthritis (RA) are evaluated with multi-item ratings scales such as the Health Assessment Questionnaire (HAQ) and visual analog scales (VAS) such as pain and patient and physician global. As VAS scales are easy to use and particularly effective in research and patient care, we studied the characteristics, association, and psychometric properties of a VAS function scale (VAS-F) to determine if it could be used in RA studies and clinical practice., Methods: A total of 394 patients with RA completed the HAQ, the HAQ-II, and a VAS functional scale. In addition, they completed standard assessments of pain, global, fatigue, sleep problems, joint count, and the Medical Outcome Study Short-Form 36 (SF-36) physical component summary score (PCS) and vitality and total pain scores., Results: The HAQ-II was correlated with VAS-F at 0.76, but distributional characteristics of the HAQ and VAS-F differed, as the VAS-F scale results contained more higher scores as well as more lower scores compared with the HAQ-II and HAQ. Kendall's tau concordance analyses indicated that VAS scales were more concordant with other VAS than with non-VAS scales. Concordance of VAS-F was greatest with VAS global and was similar overall with VAS pain, sleep disturbance, fatigue, and quality of life. By contrast, the PCS, a multi-item scale, was more concordant with HAQ-II and HAQ. There was little to no difference between the VAS-F and the 2 HAQ with regard to concordance with the multi-item joint count, SF-36 vitality, and SF-36 total pain., Conclusion: The distribution differences between HAQ and HAQ-II and the VAS-F suggest that patients do not see minor limitations as problematic, but rate major limitations as being particularly limiting and worthy of high ratings. A VAS functional scale represents a patient-weighted functional assessment in which additional interpretation is given to the meaning of the limitations by the patient. VAS-F scales may be suitable for use in the clinic and in research. However, studies to assess sensitivity to change are required to determine the appropriate role of this scale.

Objective: To analyze correlational validity of self-report responses regarding patient preference between 2 drugs at the conclusion of a crossover double-blind clinical trial in patients with osteoarthritis (OA) of the knee or hip., Methods: Patients were randomized to 6 weeks' treatment of diclofenac/misoprostol or acetaminophen, followed by crossover to 6 weeks of the other drug. Patient preference was queried at the final visit: "Please compare control of your arthritis during the first and second periods as 'much better' or 'better' in the first period, 'no different' or 'better' or 'much better' in the second period." Patient preference ratings were evaluated in comparisons with 4 independent self-report measures within each treatment period: (1) change in Western Ontario McMaster (WOMAC) questionnaire scores; (2) change in pain visual analog scale (VAS) on a multidimensional Health Assessment Questionnaire (MDHAQ); (3) patient ratings of drug efficacy; and (4) patient report of change in arthritis status, as well as investigator ratings of the more efficacious drug., Results: Among 173 patients, diclofenac/misoprostol was rated as "much better" by 54 and "better" by 45, acetaminophen was rated as "better" by 18 and "much better" by 17, and "no difference" by 39 patients. Spearman rank correlations for patient preferences were significant for changes in WOMAC scores, pain VAS, and independent patient ratings of drug efficacy and changes in arthritis status within each treatment period, as well as with physician ratings of the more efficacious drug (p < 0.001)., Conclusion: Significant correlational validity is documented for patient self-report of preferences between 2 drugs compared to independent measures within each treatment period in this crossover clinical trial in patients with OA of the knee or hip.

Objective: To compare the level of morning stiffness in a cohort of patients with early rheumatoid arthritis (RA), assessed on a self-report questionnaire, to levels of patient self-report scores and clinical and laboratory variables., Methods: A total of 337 patients with recent onset RA since 1998 were assessed for tender and swollen joint counts, erythrocyte sedimentation rate (ESR), physician global assessment, and radiographs of the hands and feet, as well as Multidimensional Health Assessment Questionnaire (MDHAQ) scores for functional disability, pain, fatigue, global status, morning stiffness, and number of symptoms. Regression models were used to estimate possible associations between these variables and morning stiffness., Results: At study entry, 70 patients (21%) reported no morning stiffness, 52 (15%) reported morning stiffness < 15 minutes, 52 (15%) for 16-59 minutes, and 163 (49%) for >/= 1 one hour. At baseline and in longitudinal analyses, morning stiffness was significantly associated with functional disability scores on the MDHAQ and with other patient self-report data, and was associated at lower levels with swollen and tender joint counts and erythrocyte sedimentation rate (ESR)., Conclusion: The degree of morning stiffness appears to reflect functional disability and pain more than traditional markers of inflammation such as joint counts and ESR in patients with early RA. Inclusion of morning stiffness as a marker of inflammatory activity in classification criteria for RA, inclusion criteria for most clinical trials in RA, and RA remission criteria, may be open to reassessment.

Objective: To prospectively analyze patient questionnaire scores concerning functional disability as well as formal education level as potential predictors of premature mortality over 10 years in 1416 patients with rheumatoid arthritis (RA) from 15 private practice rheumatology settings in 11 diverse cities in the United States., Methods: At baseline in 1985 and periodically over 10 years, patients completed mailed self-report multidimensional health assessment questionnaires (MDHAQ) that included functional disability scores, formal education level, and other demographic and clinical data. Vital status was determined 10 years after baseline. Potential predictors of 10 year mortality were analyzed using descriptive statistics and Cox proportional hazards models., Results: Vital status was accounted for in 1378 patients, 97.3% of the cohort. The standard mortality ratio was 1.6, similar to most reported series of patients with RA, as 401 patients died versus 251 expected over 10 years. Evidence of "dose-response" relations was seen for age, formal education level, functional disability scores, and helplessness scores as predictors of mortality. In Cox proportional hazards models, age, sex, formal education level, functional disability, and helplessness scores remained significant independent predictors of 10 year mortality., Conclusion: Functional disability and low formal education level are significant predictors of premature mortality in people with RA under care in US private practice settings, as in most reported cohorts of patients with RA. This study shows that it is possible to account for more than 95% of patients over 10 years using mailed questionnaires to monitor patient status.

Objective: To determine the proportion of 2 cohorts of patients with rheumatoid arthritis (RA) in Nashville, Tennessee, who met 4 common criteria for inclusion in clinical trials: > or = 6 swollen joints, > or = 6 tender joints, erythrocyte sedimentation rate > or = 28 mm/h, and/or morning stiffness > or = 45 min., Methods: Two cohorts of patients with RA, all of whom had met American Rheumatism Association (ARA) [now American College of Rheumatology (ACR)] criteria for RA at some time, were studied. Cohort L (late) included 146 consecutive patients whose mean disease duration was 14.0 years and who had been under care at a weekly academic rheumatology clinic for a mean of 6.2 years when seen in 1998-2001. Cohort E (early) included 232 patients of 5 private practice rheumatologists whose symptoms began in 1998 or later and whose mean disease duration was 1.8 years when seen in 2001. Patients were reviewed for the 4 inclusion criteria as well as 6 ARA remission criteria., Results: In Cohort L, on a 28 joint count, 42.5% of patients had > or = 6 swollen joints, 25.3% had > or = 6 tender joints, 19.9% had both > or = 6 swollen and > or = 6 tender joints, 25.0% had ESR > or = 28, and 45.9% had morning stiffness > or = 45 min. In Cohort E, on a 42 joint count, 63.4% of patients had > or = 6 swollen joints, 50.4% had > or = 6 tender joints, 38.8% had both > or = 6 swollen and > or = 6 tender joints, 49.3% had ESR > or = 28, and 50.9% had morning stiffness > or = 45 min. Overall, 15.3% of Cohort L and 34.1% of Cohort E patients had > or = 6 swollen and tender joints, as well as an ESR > or = 28 or morning stiffness > or = 45 min. Only 4.1% of Cohort L and no patient in Cohort E met ARA criteria for remission., Conclusion: The majority of patients seen in routine care in these 2 cohorts did not meet criteria for inclusion in most contemporary RA clinical trials, including clinical trials sponsored by pharmaceutical companies to introduce new drugs or biological agents. Few of these patients met ARA criteria for remission. Controlled trial data are not available concerning results of treatment with new biological agents or disease modifying antirheumatic drugs in a large proportion, if not a majority, of patients with RA at this time.

Objective: To describe therapies with disease modifying antirheumatic drugs (DMARD) and biological agents in patients with early rheumatoid arthritis (RA) who were receiving routine clinical care in 2001 in a private practice of 5 rheumatologists in Nashville, TN, USA., Methods: A cohort of 232 patients with initial symptoms of RA in 1998 or later were enrolled between February and October 2001 into a longterm observational study, designed to evaluate treatments and longterm outcomes of RA. The baseline evaluation included review of all DMARD that had been taken since disease onset, clinical measures on a multidimensional health assessment questionnaire, joint counts, and laboratory measures., Results: Among the 232 patients, methotrexate (MTX) was the first DMARD used in 192 patients (82.8%), including 3 in combinations. Since initiation of the first DMARD to the study visit, over a median interval of 12.1 months, 125 (66.1%) patients of the 189 whose initial DMARD was MTX as a single DMARD continued MTX as a single DMARD, 43 (22.8%) had another DMARD or biological agent added in combination with MTX, and 21 (11.1%) discontinued MTX. Since the onset of RA, 89.2% of the patients had taken MTX, 15.9% hydroxychloroquine, 3.9% sulfasalazine, 22.0% leflunomide, 9.5% etanercept, 4.3 infliximab, and 87.0% prednisone., Conclusion: After a median duration of 12.1 months of DMARD therapy, almost 90% of patients with recent onset RA took MTX as the anchor drug. More than 60% took MTX as a single DMARD or in combination with traditional DMARD, while 30% took leflunomide, etanercept, or infliximab, usually in combination with MTX.