Adherence to and patient's knowledge of self-management of subcutaneous biologic therapy in chronic inflammatory rheumatic diseases: results of a multicentre cross-sectional study.

OBJECTIVES: Non-adherence to biologic therapy is an issue in chronic inflammatory rheumatic diseases (CIRDs) and might be related to poor patient knowledge of the risk of these therapies. Our aim here was to evaluate the level of patient adherence to and knowledge of self-care safety skills for biologic therapy. METHODS: This was a multicentre, cross-sectional study in which out-patients visited an office- or hospital-based rheumatologist. All the patients received subcutaneous biologic therapy for CIRDs. We collected data on: 1. the level of CIRD patient adherence to current subcutaneous biologic therapy using both the self-administered Compliance Questionnaire Rheumatology 5 items (CQR5) and a simple adherence question; 2. patients' knowledge of self-management of biologic therapy by the self-administered BIOSECURE questionnaire; 3. sources of information related to biologic therapy. RESULTS: In all, 285 patients (rheumatoid arthritis, n=103; spondyloarthritis, n=153; psoriatic arthritis, n=25) were enrolled by 19 rheumatologists. The mean (SD) biologic therapy duration was 5.9 (4.9) years. Adherence to the current biologic therapy was high (79.3% and 57.5% according to the CQR5 questionnaire and the adherence question, respectively). Level of knowledge of self-care safety skills (median BIOSECURE score 71) was in the acceptable range. Level of adherence and level of knowledge of self-care safety skills for biologic therapy were not associated. Patients declared that the main sources of information were their rheumatologist (92.6%) and the rheumatology team (30.5%). CONCLUSIONS: According to the patients' estimation, adherence to biologic therapy and the level of knowledge of self-care safety skills related to biologic therapy are acceptable, and these domains are not related (e.g. level of adherence and level of knowledge of risks).

Spontaneous remission of fully symptomatic visceral leishmaniasis.

BACKGROUND: Visceral leishmaniasis (VL), i.e., infection with Leishmania sp. associated with high fever, weight loss, massive splenomegaly and markedly altered laboratory parameters, is generally fatal if untreated. The possibility of transient spontaneous remission of fully symptomatic visceral leishmaniasis (VL) has been mentioned but, to our knowledge) has never been documented. CASE PRESENTATION: We report the first documented history of a patient with overt, confirmed VL experiencing a complete remission in the absence of any anti-leishmanial therapy. The diagnosis of VL at the time of the self-resolving episode was strongly suspected based on clinical presentation and presence of antileishmanial antibody, then unequivocally confirmed years later by the presence of an amastigote on a stored smear and the positive quantitative PCR with Leishmania-specific primers from the material scraped from this same slide CONCLUSION: This report demonstrates that complete spontaneous remission may occur in patients with overt, fully symptomatic VL. VL should therefore be considered in cases of self-resolving or relapsing episodes of fever of unknown origin. Confirmation should be based on both serological tests and specific PCR on a blood sample.

Assessing structural changes in axial spondyloarthritis using a low-dose biplanar imaging system.

OBJECTIVES: Patients with axial SpA experience repeated spine imaging. EOS is a new low-dose imaging system with significantly lower irradiation than conventional radiography (CR). The objective was to explore the EOS performances compared with CR for the classification and follow-up of SpA. METHODS: We performed an observational, cross-sectional, single-centre study including SpA patients (definite diagnosis by expert opinion) and control patients [definite chronic mechanical low back pain (cLBP)]. All patients underwent pelvic and frontal and lateral CR of the entire spine and two-dimensional (2D) EOS imaging on the same day. Images were blindly assessed for sacroiliitis [modified New York criteria (mNY)] and for ankylosis of the spine [modified Stoke AS Spine Score (mSASSS)]. Global ease of interpretation was rated on a scale of 0-10. The primary outcome was intermodality agreement, with an a priori defined non-inferiority limit of 0.7. Interobserver, intra-observer and intermodality agreement were measured by kappa, weighted kappa, intraclass correlation coefficient and Bland-Altman plots. RESULTS: Forty-eight SpA patients [mean age 47.6 years (s.d. 14.9), symptom duration 21.4 years (s.d. 13.3), 35 (70%) men] and 48 cLBP controls [mean age 49.1 years (s.d. 10.7), 9 (22.5%) men] were included. Intermodality agreement between EOS and CR was 0.50 (95% CI 0.26, 0.75) and 0.97 (95% CI 0.95, 0.98) for sacroiliitis and mSASSS, respectively. Ease of interpretation was greater for CR [8.2 (s.d. 0.9)] compared with EOS [7.2 (s.d. 0.8), P < 0.0001). CONCLUSION: Our results suggest that EOS could replace CR for the follow-up of structural damage of the spine, but its place in the classification of sacroiliitis needs to be further explored.

Elaboration and validation of a questionnaire assessing patient expectations about management of knee osteoarthritis by their physicians: the Knee Osteoarthritis Expectations Questionnaire.

OBJECTIVES: To develop a questionnaire assessing the expectations of patients regarding management of osteoarthritis (OA of the knee. METHODS: A detailed document reporting on a qualitative analysis of interviews of patients with knee OA was sent to experts and a Delphi procedure was adopted for item generation. Eighty physicians (64 general practitioners, 16 rheumatologists) recruited 566 patients with knee OA to test the provisional questionnaire. Items were reduced according to their metric properties and exploratory factor analysis. The reliability of the questionnaire was tested by the Cronbach α coefficient. Construct validity was tested by divergent validity and confirmatory factor analysis. Test-retest reliability was assessed by the intraclass correlation coefficient (ICC) and the Bland-Altman technique. RESULTS: Sixty items were extracted from analysis of the interview data. The experts needed three Delphi rounds to obtain consensus on a 33-item provisional questionnaire. The item reduction process resulted in an 18-item questionnaire. Exploratory factor analysis extracted three main factors: factor 1 represented expectations for education, factor 2 expectations for information on technical and human support, and factor 3 expectations for physician empathy. The Cronbach α coefficient was 0.91 (95% CI 0.89 to 0.92). Expected divergent validity was observed. Confirmation factor analyses confirmed higher intra-factor than inter-factor correlations. Test-retest reliability was good with an ICC of 0.79, and Bland-Altman analysis did not reveal a systematic trend. CONCLUSIONS: A new 18-item questionnaire assessing patient expectations of management of knee OA by their physicians is proposed. The questionnaire has good content and construct validity.

Clinical relevance of C-reactive protein in ankylosing spondylitis and evaluation of the NSAIDs/coxibs' treatment effect on C-reactive protein.

OBJECTIVE: To evaluate the clinical relevance of CRP in AS and investigate the treatment effect of NSAIDs/coxibs on CRP. METHODS: Data of 851 patients with painful axial AS participating in two randomized controlled trials evaluating coxibs (celecoxib) and NSAIDs (naproxen/ketoprofen) were used. The clinical relevance of CRP in AS was studied: the number of patients with abnormal CRP at baseline was expressed as a percentage, and the correlation among CRP, patient (age and gender) and disease [Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI)] characteristics was investigated. The standardized response mean (SRM) over placebo was used to detect the treatment effect of NSAIDs/coxibs on CRP. RESULTS: The 851 enrolled patients (73% of whom were men) had an active disease, as assessed through functional impairment. Mean (s.d.) baseline CRP was 14 (19) (median 7.2) mg/l; 61% of patients had an increased CRP. The CRP levels were correlated positively with male sex, BASDAI and BASFI and negatively with age (multivariate analysis). There was a significant difference in the changes of CRP between placebo and NSAIDs/coxibs group (P = 0.003; SRM over placebo: 0.25). Such a treatment effect was of higher magnitude in the subgroup of patients with increased CRP and usually of lower magnitude than the treatment effect of other outcome variables such as BASDAI and BASFI. CONCLUSIONS: Increased CRP was frequently observed in patients with painful axial AS and was correlated both with activity and functional severity of the disease. The treatment effect of NSAIDs/coxibs was relevant in the subgroup of patients with increased CRP at baseline.

Early referral to the rheumatologist for early arthritis patients: evidence for suboptimal care. Results from the ESPOIR cohort.

OBJECTIVE: To assess the time to access a rheumatologist (TTAR) by early arthritis (EA) patients participating in a nationwide incidental cohort (ESPOIR) and compare it with European League Against Rheumatism (EULAR) recommendations, which recommends rapid referral, ideally within 6 weeks, to a rheumatologist for patients presenting with EA. METHODS: Eight hundred and thirteen patients with EA were included in the cohort between 2002 and 2005. The inclusion criteria were 18-70 years old, two or more swollen joints, symptom duration from 6 weeks to 6 months and possible RA diagnosis. TTAR was defined as the time between the first synovitis and first visit to a rheumatologist. TTAR and satisfaction of the EULAR guidelines were investigated by multiple linear and logistic regressions. RESULTS: Mean TTAR was 76 days; only 46.2% of patients were seen by a rheumatologist within the EULAR-recommended time frame. Patients' patterns of accessing medical care substantially affected access to specialized care: mean TTAR was 58 days for patients who directly scheduled an appointment with the rheumatologist and 78 days for those referred by their general practitioner (P < 0.0007). Only 57.2 and 44.5%, respectively, were able to consult a rheumatologist within 6 weeks. Multivariate analysis confirmed the significant impact of indirect access on TTAR, after adjustment for EA characteristics and medical density in the region. CONCLUSIONS: Significant disparities were identified in the care of EA patients in terms of early access to a rheumatologist. More effort is needed to optimize the physicians' knowledge about EA and to improve the efficiency of medical networks.

Benefits of ultrasonography in the management of early arthritis: a cross-sectional study of baseline data from the ESPOIR cohort.

OBJECTIVE: To assess ultrasonography's (US) performance to detect the structural damage in the initial evaluation of early arthritis (EA) using the Etude et Suivides Polyarthrites Indifférenciées Récentes (ESPOIR) cohort. METHODS: ESPOIR is a French, multi-centric EA cohort. Four centres assessed the structural damage by both X-ray and US examination at baseline. X-rays of hands and feet were read first by the centre's local investigator (usual reading), then in the X-ray coordinating centre (central reading). Four trained examiners performed US blindly from clinical data to detect erosions on the second and fifth MCP (MCP2 and 5) and the fifth MTP (MTP5) joints bilaterally. RESULTS: Patients' characteristics (n = 126) were: female 78%; mean age 50.3 years; disease duration 103 days; disease activity score on 28 joints 5; CRP level 22.7 mg/l; and 79.4% of the patients fulfilling RA ACR criteria. Twelve patients had missing data for X-rays. US revealed 42 (36.8%) patients with erosive disease, whereas radiography revealed only 30 (26%) with central reading and only 11% with usual reading. US missed erosive disease present in X-rays in 10 (8.8%) patients. Combined technique of both revealed 52 (45.6%) patients with erosive diseases. On the targeted joints, US detected erosion on 75 (11%) joints vs X-rays on only 11 (1.5%). Only three joints with erosion(s) detected on X-rays were missed on US. At baseline, the presence of PD activity was not associated with joint erosions. CONCLUSIONS: US on six joints detected 1.4-fold more patients with erosions (3.3-fold more with the usual reading). In clinical practice, US combined with X-rays is of helpful diagnostic value in EA.

Development and validation of a questionnaire assessing fears and beliefs of patients with knee osteoarthritis: the Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ).

OBJECTIVE: We aimed to develop a questionnaire assessing fears and beliefs of patients with knee OA. DESIGN: We sent a detailed document reporting on a qualitative analysis of interviews of patients with knee OA to experts, and a Delphi procedure was adopted for item generation. Then, 80 physicians recruited 566 patients with knee OA to test the provisional questionnaire. Items were reduced according to their metric properties and exploratory factor analysis. Reliability was tested by the Cronbach α coefficient. Construct validity was tested by divergent validity and confirmatory factor analysis. Test-retest reliability was assessed by the intra-class correlation coefficient (ICC) and the Bland and Altman technique. RESULTS: 137 items were extracted from analysis of the interview data. Three Delphi rounds were needed to obtain consensus on a 25-item provisional questionnaire. The item-reduction process resulted in an 11-item questionnaire. Selected items represented fears and beliefs about daily living activities (3 items), fears and beliefs about physicians (4 items), fears and beliefs about the disease (2 items), and fears and beliefs about sports and leisure activities (2 items). The Cronbach α coefficient of global score was 0.85. We observed expected divergent validity. Confirmation factor analyses confirmed higher intra-factor than inter-factor correlations. Test-retest reliability was good, with an ICC of 0.81, and Bland and Altman analysis did not reveal a systematic trend. CONCLUSIONS: We propose an 11-item questionnaire assessing patients' fears and beliefs concerning knee OA with good content and construct validity.

Potential classification criteria for rheumatoid arthritis after two years: results from a French multicenter cohort.

OBJECTIVE: To determine agreement among the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria, a diagnosis of rheumatoid arthritis (RA) by a rheumatologist, and other criteria previously used to classify arthritis. METHODS: We used a nationwide longitudinal prospective cohort of patients with recent-onset arthritis. After 2 years, the patients were classified as receiving disease-modifying antirheumatic drugs (DMARDs), having synovitis, having joint erosions typical of RA, having a rheumatologist diagnosis of RA with >50.0% certainty, having a no better alternative diagnosis with >50.0% certainty, and having a diagnosis of RA using the 1987 ACR criteria and the 2010 ACR/EULAR criteria. Agreement among these criteria was assessed based on Cohen's kappa coefficient, where ≥0.80 = excellent, 0.60-0.79 = good, 0.40-0.59 = moderate, and <0.40 = poor. RESULTS: Of the 692 evaluated patients, 544 (78.6%) had persistent arthritis (defined as synovitis, ongoing DMARD treatment, or both) after 2 years. Among these 544 patients, 496 (91.2%) were receiving DMARDs. Agreement among all criteria was poor (estimated κ = 0.09-0.43), except when including a rheumatologist diagnosis of RA with >50.0% certainty or a no better alternative diagnosis with >50.0% certainty (estimated κ = 0.69-0.81). The strongest associations with a rheumatologist diagnosis of RA with >50.0% certainty were the 2010 ACR/EULAR criteria and the combination of no better alternative diagnosis, persistent arthritis, 1987 ACR criteria, and positive anti-citrullinated protein antibody. CONCLUSION: Rheumatologist diagnosis of RA with >50.0% certainty after 2 years agreed well with the 2010 ACR/EULAR criteria or a combination of items including no better alternative diagnosis, confirming high value as classification criteria after 2 years of followup.

The gap between practice and guidelines in the choice of first-line disease modifying antirheumatic drug in early rheumatoid arthritis: results from the ESPOIR cohort.

OBJECTIVE: To compare rheumatologists' prescription for first disease modifying antirheumatic drug (DMARD) in early rheumatoid arthritis (RA) in real-life settings with 2 clinical practice guidelines (CPG), the French Society of Rheumatology/STPR 2004 and EULAR/ESCISIT 2007, and thus assess the gap between practices and guidelines. Method. ESPOIR was a French multicenter cohort study of 813 patients with early arthritis between 2002 and 2005. "Definite" and "probable" RA were defined according to ACR criteria and the level of diagnostic certainty. The objectives were to assess conformity between the observed first-line DMARD prescribed for those patients and the DMARD recommended in the guidelines; and to conduct a mail survey of patients' usual rheumatologists to investigate the reasons for their nonconformity with guidelines. RESULTS: In total 627 patients with definite or probable RA were identified. Conformity rates were 58% for STPR guidelines and 54% for EULAR guidelines. At 6 months, 83 (34%) patients with early RA did not receive any DMARD. Main determinants associated with conformity to guidelines were disease activity and presence of severity-predictive factors. The main reason leading to a discrepancy between guidelines and daily practice appeared to be diagnostic uncertainty, i.e., the difficulty to reliably assess RA diagnosis as early as the first visits to the rheumatologist. CONCLUSION: There is a substantial gap between CPG and rheumatologists' daily practice concerning the first DMARD to prescribe in early RA. This is explained mainly by diagnostic uncertainty. More attention should be paid in future guidelines to the diagnostic difficulties of early RA.