Objective
To develop American College of Rheumatology (ACR) recommendations for patient‐reported Functional Status Assessment Measures (FSAMs) for use in routine clinical practice in patients with ...rheumatoid arthritis (RA).
Methods
We convened a workgroup to conduct a systematic review of published literature through March 16, 2017 and FSAM properties. Based upon initial search results and clinical input, we focused on the following FSAMs appropriate for routine clinical use: the Health Assessment Questionnaire (HAQ) and derived measures and the Patient‐Reported Outcomes Measurement Information System (PROMIS) tool. We used the Consensus‐Based Standards for the Selection of Health Measurement Instruments (COSMIN) 4‐point scoring method to evaluate each FSAM, allowing for overall level of evidence assessment. We identified FSAMs fulfilling a predefined minimum standard and, through a modified Delphi process, selected preferred FSAMs for regular use in most clinic settings.
Results
The search identified 11,835 articles, of which 56 were included in the review. Descriptions of the measures, properties, study quality, level of evidence, and feasibility were ed and scored. Following a modified Delphi process, 7 measures fulfilled the minimum standard for regular use in most clinic settings, and 3 measures were recommended: the PROMIS physical function 10‐item short form (PROMIS PF10a), the HAQ‐II, and the Multidimensional HAQ.
Conclusion
This work establishes ACR recommendations for preferred RA FSAMs for regular use in most clinic settings. These results will inform clinical practice and can support future ACR quality measure development as well as highlight ongoing research needs.
Reaching the therapeutic target of remission or low-disease activity has improved outcomes in patients with rheumatoid arthritis (RA) significantly. The treat-to-target recommendations, formulated in ...2010, have provided a basis for implementation of a strategic approach towards this therapeutic goal in routine clinical practice, but these recommendations need to be re-evaluated for appropriateness and practicability in the light of new insights.
To update the 2010 treat-to-target recommendations based on systematic literature reviews (SLR) and expert opinion.
A task force of rheumatologists, patients and a nurse specialist assessed the SLR results and evaluated the individual items of the 2010 recommendations accordingly, reformulating many of the items. These were subsequently discussed, amended and voted upon by >40 experts, including 5 patients, from various regions of the world. Levels of evidence, strengths of recommendations and levels of agreement were derived.
The update resulted in 4 overarching principles and 10 recommendations. The previous recommendations were partly adapted and their order changed as deemed appropriate in terms of importance in the view of the experts. The SLR had now provided also data for the effectiveness of targeting low-disease activity or remission in established rather than only early disease. The role of comorbidities, including their potential to preclude treatment intensification, was highlighted more strongly than before. The treatment aim was again defined as remission with low-disease activity being an alternative goal especially in patients with long-standing disease. Regular follow-up (every 1-3 months during active disease) with according therapeutic adaptations to reach the desired state was recommended. Follow-up examinations ought to employ composite measures of disease activity that include joint counts. Additional items provide further details for particular aspects of the disease, especially comorbidity and shared decision-making with the patient. Levels of evidence had increased for many items compared with the 2010 recommendations, and levels of agreement were very high for most of the individual recommendations (≥9/10).
The 4 overarching principles and 10 recommendations are based on stronger evidence than before and are supposed to inform patients, rheumatologists and other stakeholders about strategies to reach optimal outcomes of RA.
Interleukin-6 (IL-6) is implicated in rheumatoid arthritis (RA) pathophysiology. Unlike IL-6 receptor inhibitors, sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine. ...The phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group SIRROUND-D study (ClinicalTrials.gov identifier NCT01604343) evaluated the efficacy and safety of sirukumab in patients with active RA refractory to disease-modifying antirheumatic drugs.
Patients were randomised 1:1:1 to treatment with sirukumab 100 mg every 2 weeks, 50 mg every 4 weeks or placebo every 2 weeks subcutaneously. Results through week 52 are reported.
Of 1670 randomised patients, significantly more patients achieved American College of Rheumatology 20% (ACR20) response at week 16 (coprimary endpoint) with sirukumab 100 mg every 2 weeks (53.5%) or 50 mg every 4 weeks (54.8%) versus placebo (26.4%; both p<0.001). Mean (SD) change from baseline in modified Sharp/van der Heijde score at week 52 (coprimary endpoint) was significantly lower with sirukumab (100 mg every 2 weeks: 0.46 (3.26); 50 mg every 4 weeks: 0.50 (2.96)) versus placebo (3.69 (9.25); both p<0.001). All major secondary endpoints (week 24 Health Assessment Questionnaire-Disability Index change from baseline, ACR50 response, 28-joint Disease Activity Score based on C reactive protein and major clinical response (ACR70 for six continuous months by week 52)) were met. The most common adverse events with sirukumab were elevated liver enzymes, upper respiratory tract infection, injection site erythema and nasopharyngitis.
Sirukumab 100 mg every 2 weeks and 50 mg every 4 weeks led to significant reductions in RA symptoms, inhibition of structural damage progression and physical function and quality of life improvements, with an expected safety profile.
NCT01604343; Results.
Objective
Epidemiologic assessments of sufficiently large populations are required in order to obtain robust estimates of disease prevalence and incidence, particularly when exploring the influence ...of various factors (age, sex, calendar time). We undertook this study to describe the epidemiology of rheumatoid arthritis (RA) over the past 15 years.
Methods
We used the Ontario Rheumatoid Arthritis administrative Database (ORAD), a validated population‐based research database of all Ontarians with RA. The ORAD records were linked with census data to calculate crude and age and sex–standardized prevalence and incidence rates from 1996 to 2010. Vital statistics were used to estimate annual all‐cause mortality during the study period.
Results
As of 2010, there were 97,499 Ontarians with RA, corresponding to a cumulative prevalence of 0.9%. Age and sex–standardized RA prevalence increased steadily over time from 473 (95% confidence interval 95% CI 469–478) per 100,000 population (0.49%) in 1996 to 784 (95% CI 779–789) per 100,000 population (0.9%) in 2010. Age and sex–standardized incidence per 100,000 population ranged from 62 (95% CI 60–63) in 1996 to 54 (95% CI 52–55) in 2010. All‐cause mortality decreased by a relative 21.4% since 1996.
Conclusion
Over a 15‐year period, we observed an increase in RA prevalence over time. This rise may be attributed to the increasing time to ascertain cases (which may have been latent in the population during earlier years of the study), increasing survival, and/or an increase in the aging background population. Incidence appears to be stable.
To determine the comparative effectiveness of oral versus subcutaneous methotrexate (MTX) as initial therapy for patients with early rheumatoid arthritis (ERA).
Patients with ERA (symptoms ≤1 year) ...initiating MTX therapy were included from a multicentre, prospective cohort study. We compared the effectiveness between starting with oral versus subcutaneous MTX over the first year. Longitudinal multivariable models, adjusted for potential baseline and time-varying confounders, were used to compare treatment changes due to inefficacy or toxicity and treatment efficacy (Disease Activity Score-28 (DAS-28), DAS-28 remission and Health Assessment Questionnaire-Disability Index (HAQ-DI)).
666 patients were included (417 oral MTX, 249 subcutaneous MTX). Patients prescribed subcutaneous MTX were prescribed a higher dose of MTX (mean dose over first three months 22.3 mg vs 17.2 mg/week). At 1 year, 49% of patients initially treated with subcutaneous MTX had changed treatment compared with 77% treated with oral MTX. After adjusting for potential confounders, subcutaneous MTX was associated with a lower rate of treatment failure ((HR (95% CI) 0.55 (0.39 to 0.79)). Most treatment failures were due to inefficacy with no difference in failure due to toxicity. In multivariable models, subcutaneous MTX was also associated with lower average DAS-28 scores (mean difference (-0.38 (95% CI -0.64 to -0.10)) and a small difference in DAS-28 remission (OR 1.2 (95% CI 1.1 to 1.3)). There was no significant difference in sustained remission or HAQ-DI (p values 0.43 and 0.75).
Initial treatment with subcutaneous MTX was associated with lower rates of treatment changes, no difference in toxicity and some improvements in disease control versus oral MTX over the first year in patients with ERA.
Abstract
Objectives
To investigate whether meticulously following a treat-to-target (T2T)-strategy in daily clinical practice will lead to less radiographic progression in patients with active RA who ...start (new) DMARD-therapy.
Methods
Patients with RA from 10 countries starting/changing conventional synthetic or biologic DMARDs because of active RA, and in whom treatment intensification according to the T2T principle was pursued, were assessed for disease activity every 3 months for 2 years (RA-BIODAM cohort). The primary outcome was the change in Sharp-van der Heijde (SvdH) score, assessed every 6 months. Per 3-month interval DAS44-T2T could be followed zero, one or two times (in a total of two visits). The relation between T2T intensity and change in SvdH-score was modelled by generalized estimating equations.
Results
In total, 511 patients were included mean (s.d.) age: 56 (13) years; 76% female. Mean 2-year SvdH progression was 2.2 (4.1) units (median: 1 unit). A stricter application of T2T in a 3-month interval did not reduce progression in the same 6-month interval parameter estimates (for yes vs no): +0.15 units (95% CI: −0.04, 0.33) for 2 vs 0 visits; and +0.08 units (−0.06; 0.22) for 1 vs 0 visits nor did it reduce progression in the subsequent 6-month interval.
Conclusions
In this daily practice cohort, following T2T principles more meticulously did not result in less radiographic progression than a somewhat more lenient attitude towards T2T. One possible interpretation of these results is that the intention to apply T2T already suffices and that a more stringent approach does not further improve outcome.
Objective
To operationalize and report on nationally endorsed rheumatoid arthritis (RA) performance measures (PMs) using health administrative data for British Columbia (BC), Canada.
Methods
All ...patients with RA in BC ages ≥18 years were identified between January 1, 1997 and December 31, 2009 using health administrative data and followed until December 2014. PMs tested include: the percentage of incident patients with ≥1 rheumatologist visit within 365 days; the percentage of prevalent patients with ≥1 rheumatologist visit per year; the percentage of prevalent patients dispensed disease‐modifying antirheumatic drug (DMARD) therapy; and time from RA diagnosis to DMARD therapy. Measures were reported on patients seen by rheumatologists, and in the total population.
Results
The cohort included 38,673 incident and 57,922 prevalent RA cases. The percentage of patients seen by a rheumatologist within 365 days increased over time (35% in 2000 to 65% in 2009), while the percentage of RA patients under the care of a rheumatologist seen yearly declined (79% in 2001 to 39% in 2014). The decline was due to decreasing visit rates with increasing follow‐up time rather than calendar effect. The percentage of RA patients dispensed a DMARD was suboptimal over follow‐up (37% in 2014) in the total population but higher (87%) in those under current rheumatologist care. The median time to DMARD in those seen by a rheumatologist improved from 49 days in 2000 to 23 days in 2009, with 34% receiving treatment within the 14‐day benchmark.
Conclusion
This study describes the operationalization and reporting of national PMs using administrative data and identifies gaps in care to further examine and address.
Objective
Health inequities exist in chronic diseases for Aboriginal people. This study compared early rheumatoid arthritis (RA) presentation, treatment, and outcomes between Aboriginal and white ...patients in a large Canadian cohort study.
Methods
Longitudinal data from the Canadian Early Arthritis Cohort, a prospective multicenter early RA study, were analyzed for participants who self‐identified as Aboriginal or white ethnicity. Disease characteristics at presentation, prognostic factors, frequency of remission, and disease‐modifying therapy strategies were contrasted between population groups. Linear mixed models were used to estimate rates of change for disease activity measures over a 5‐year period.
Results
At baseline, 2,173 participants (100 Aboriginal and 2,073 white) had similar mean ± SD symptom duration (179 ± 91 days), 28‐joint Disease Activity Scores (DAS28; 4.87 ± 1.48), and Health Assessment Questionnaire (0.88 ± 0.68) scores. Factors associated with poor prognosis were more frequently present in Aboriginal participants, but disease‐modifying therapy selection and frequency of therapy escalation was similar between the 2 groups. DAS28 remission was achieved less frequently in Aboriginal than in white participants (adjusted odds ratio 0.39 95% confidence interval 0.25–0.62). Results were primarily driven by slower improvement in swollen joint counts and nonsignificant improvement in patient global scores in Aboriginal participants. Pain levels remained higher in Aboriginal patients.
Conclusion
Aboriginal early RA patients experienced worse disease outcomes than their white counterparts. This may reflect unmeasured biologic differences and/or disparities in prognostic factors informed by inequities in determinants of health. The appropriateness of current treatment strategies applied in different contexts should be considered.
We have previously validated administrative data algorithms to identify patients with rheumatoid arthritis (RA) using rheumatology clinic records as the reference standard. Here we reassessed the ...accuracy of the algorithms using primary care records as the reference standard.
We performed a retrospective chart abstraction study using a random sample of 7500 adult patients under the care of 83 family physicians contributing to the Electronic Medical Record Administrative data Linked Database (EMRALD) in Ontario, Canada. Using physician-reported diagnoses as the reference standard, we computed and compared the sensitivity, specificity, and predictive values for over 100 administrative data algorithms for RA case ascertainment.
We identified 69 patients with RA for a lifetime RA prevalence of 0.9%. All algorithms had excellent specificity (>97%). However, sensitivity varied (75-90%) among physician billing algorithms. Despite the low prevalence of RA, most algorithms had adequate positive predictive value (PPV; 51-83%). The algorithm of "1 hospitalization RA diagnosis code or 3 physician RA diagnosis codes with ≥1 by a specialist over 2 years" had a sensitivity of 78% (95% CI 69-88), specificity of 100% (95% CI 100-100), PPV of 78% (95% CI 69-88) and NPV of 100% (95% CI 100-100).
Administrative data algorithms for detecting RA patients achieved a high degree of accuracy amongst the general population. However, results varied slightly from our previous report, which can be attributed to differences in the reference standards with respect to disease prevalence, spectrum of disease, and type of comparator group.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To quantify population-level and practice-level encounters with rheumatologists over time.
We conducted a population-based study from 2000 to 2015 in Ontario, Canada, where all residents are covered ...by a single-payer healthcare system. Annual total number of unique patients seen by rheumatologists, the number of new patients seen, and total number of encounters with rheumatologists were identified.
From 2000 to 2015, the percentage of the population seen by rheumatologists was constant over time (2.7%). During this time, Ontario had a stable supply of rheumatologists (0.8 full-time equivalents/75,000). From 2000 to 2015, the number of annual rheumatology encounters increased from 561,452 to 786,061, but the adjusted encounter rates remained stable over time (at 62 encounters per 1000 population). New patient assessment rates declined over time from 10 new outpatient assessments per 1000 in 2000 to 6 per 1000 in 2015. The crude volume of new patients seen annually decreased and an increasing proportion of rheumatology encounters were with established patients. We observed a shift in patient case mix over time, with more assessments for systemic inflammatory conditions. Rheumatologists' practice volumes, practice sizes, and the annual number of days providing clinical care decreased over time.
Over a 15-year period, the annual percentage of the population seen by a rheumatologist remained constant and the volume of new patients decreased, while followup patient encounters increased. Patient encounters per rheumatologist decreased over time. Our findings provide novel information for rheumatology workforce planning. Factors affecting clinical activity warrant further research.
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