"There is something you must see": breaking down the remission concept in rheumatoid arthritis from a rheumatologist's perspective.

OBJECTIVES: To explore the remission concept in rheumatoid arthritis (RA) and the implications of the existing definitions when applied to clinical practice among rheumatologists with different profiles. METHODS: A qualitative study through focus groups was conducted. Three focus groups were organised from February to March 2016. Each group was composed of rheumatologists with extensive clinical experience with different profiles; experts in basic research (RBR), experts in imaging techniques research (RIR), and experts in clinical research (RCR). The data was collected with audio recording. Verbatim transcriptions of the audio files were made, and a subsequent reflexive thematic analysis assisted by ATLAS.ti (GmbH, Berlin, v. 7) software was performed. RESULTS: From the reflexive thematic analysis, three main themes were generated: (1) remission limitations, (2) instruments or measures to assess remission, and (3) a new definition of remission. Rheumatologists mentioned frequently that the following variables should be considered when developing a new remission definition: inflammatory activity, calprotectin, psychological variables, sex, disease stage, and sociocultural factors. Contrary to what could be expected, all groups acknowledged that their research field could contribute with domains for a gold standard remission instrument, but not in a hierarchical arrangement of importance. The dissonance existing in the entire remission evaluation process was outlined: remission in clinical practice versus remission in clinical trials, remission following the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean versus Musculoskeletal Ultrasound (US) remission, and remission from the rheumatologist's point of view versus the patient's point of view. CONCLUSIONS: Currently, rheumatologists would not accept a domain as more important than others in remission. Our suggestion is, not to generate a universal definition of remission - one that could cover all aspects - but rather to develop definitions of remission for the different settings that could be pondered by the patient's perspective.

Magnetic resonance imaging assessment in patients with axial spondyloarthritis: development of checklists for use in clinical practice.

The objective of our study was to standardize magnetic resonance imaging (MRI) assessment of spine and sacroiliac joints in patients with axial spondyloarthritis (axSpA) and/or inflammatory spinal pain, by creating checklists and templates based on the opinions of rheumatologists and radiologists. A scientific committee developed a series of questionnaires with multiple items regarding MRI in patients with axial inflammatory pain and/or axSpA. Then an expert panel of rheumatologists and radiologists rated all items in a 9-point Likert scale. Finally, the scientific committee and the expert panel met to create the definitive documents. Several definitive checklists and templates were generated for rheumatologist-requested MRI and for radiologist-requested MRI reports of sacroiliac joint and spinal examinations. A technical requirement protocol was also agreed on. Our results could be useful in increasing understanding between rheumatologists and radiologists regarding MRI in axSpA diagnosis and follow-up.

Exploring the remission concept in rheumatoid arthritis with patients and rheumatologists: time for a new approach?

OBJECTIVES: To explore the remission concept in rheumatoid arthritis (RA) and to compare remission definitions and related concepts between rheumatologists and patients with the purpose of identifying similarities and disparities to comprehend the different perspectives of the disease. METHODS: This was a qualitative study of discourse and content analysis through focus groups, conducted from February to March 2016. Four focus groups were set up, each one with different interests: rheumatologists involved in basic research (BR), rheumatologists with high specialisation in imaging techniques (IR), clinical rheumatologists (CR), and patients (PA). RESULTS: There is no consensus in a remission definition in RA; differences exist between-groups, rheumatologists and patients value remission differently, and there are discrepancies within the group of rheumatologists. Rheumatologists highlight quantifiable objective parameters, in contrast, patients did not consider objective measures as the best instruments, and they prefer subjective measures of remission. The data confirmed the existence of two sources of knowledge of the disease, technical (physicians) and experiential (patients). These sources of knowledge should concur in order to establish new remission criteria well-adjusted to reality. CONCLUSIONS: The lack of consensus between key groups implicated in defining remission and remission criteria suggests a new strategy for its operational definition. Our group proposes that subjects with a balance between experiential and technical knowledge, should be the ones in charge of this assignment.

Standards of care for patients with spondyloarthritis.

To define and give priory to standards of care in patients with spondyloarthritis (SpA). A systematic literature review on SpA standards of care and a specific search in relevant and related sources was performed. An expert panel was established who developed the standards of care and graded their priority (high, mild, low, or no priority) following qualitative methodology and Delphi process. An electronic survey was sent to a representative sample of 167 rheumatologists all around the country, who also gave priority to the standards of care (same scale). A descriptive analysis is presented. The systematic literature review retrieved no article specifically related to SpA patients. A total of 38 standards of care were obtained-12 related to structure, 20 to process, and 6 to result. Access to care, treatment, and safety standards of care were given a high priority by most of rheumatologists. Standards not directly connected to daily practice were not given such priority, as standards which included a time framework. The standards generated for the performance evaluation (including patient and professionals satisfaction) were not considered especially important in general. This set of standards of care should help improve the quality of care in SpA patients.

Recommendations for the use of ultrasound and magnetic resonance in patients with rheumatoid arthritis. / Recomendaciones para el uso de la ecografía y la resonancia magnética en pacientes con artritis reumatoide.

OBJECTIVE: To develop evidence-based recommendations on the use of ultrasound (US) and magnetic resonance imaging (MRI) in patients with rheumatoid arthritis (RA). METHODS: Recommendations were generated following a nominal group technique. A panel of experts, consisting of 15 rheumatologists and 3 radiologists, was established in the first panel meeting to define the scope and purpose of the consensus document, as well as chapters, potential recommendations and systematic literature reviews (we used and updated those from previous EULAR documents). A first draft of recommendations and text was generated. Then, an electronic Delphi process (2 rounds) was carried out. Recommendations were voted from 1 (total disagreement) to 10 (total agreement). We defined agreement if at least 70% of experts voted ≥7. The level of evidence and grade or recommendation was assessed using the Oxford Centre for Evidence-based Medicine Levels of Evidence. The full text was circulated and reviewed by the panel. The consensus was coordinated by an expert methodologist. RESULTS: A total of 20 recommendations were proposed. They include the validity of US and MRI regarding inflammation and damage detection, diagnosis, prediction (structural damage progression, flare, treatment response, etc.), monitoring and the use of US guided injections/biopsies. CONCLUSIONS: These recommendations will help clinicians use US and MRI in RA patients.

Recommendations for the Use of Ultrasound and Magnetic Resonance in Patients With Spondyloarthritis, Including Psoriatic Arthritis, and Patients With Juvenile Idiopathic Arthritis. / Recomendaciones para el uso de la ecografía y la resonancia magnética en pacientes con espondiloartritis, incluyendo la artritis psoriásica, y en pacientes con artritis idiopática juvenil.

OBJECTIVE: To develop evidence-based recommendations on the use of ultrasound (US) and magnetic resonance imaging in patients with spondyloarthritis, including psoriatic arthritis, and juvenile idiopathic arthritis. METHODS: Recommendations were generated following a nominal group technique. A panel of experts (15 rheumatologists and 3 radiologists) was established in the first panel meeting to define the scope and purpose of the consensus document, as well as chapters, potential recommendations and systematic literature reviews (we used and updated those from previous EULAR documents). A first draft of recommendations and text was generated. Then, an electronic Delphi process (2 rounds) was carried out. Recommendations were voted from 1 (total disagreement) to 10 (total agreement). We defined agreement if at least 70% of participants voted≥7. The level of evidence and grade or recommendation was assessed using the Oxford Centre for Evidence Based Medicine levels of evidence. The full text was circulated and reviewed by the panel. The consensus was coordinated by an expert methodologist. RESULTS: A total of 12 recommendations were proposed for each disease. They include, along with explanations of the validity of US and magnetic resonance imaging regarding inflammation and damage detection, diagnosis, prediction (structural damage progression, flare, treatment response, etc.), monitoring and the use of US guided injections/biopsies. CONCLUSIONS: These recommendations will help clinicians use US and magnetic resonance imaging in patients with spondyloarthritis and juvenile idiopathic arthritis.

Development of a checklist for patients with axial spondyloarthritis and psoriatic arthritis in daily practice: ONLY TOOLS project. / Desarrollo de un cuadro de actuación para la evaluación de pacientes con espondiloartritis axial y artritis psoriásica en la práctica diaria: proyecto ONLY TOOLS.

OBJECTIVE: To standardize clinical evaluation of patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) using a checklist. METHODS: Qualitative study that included: 1) nominal group (18 experts); 2) literature reviews of measures used in the assessment of patients with axial SpA or PsA; and 3) focus groups, one with rheumatologists and another with patients, organized to become familiar with their opinion on medical assistance. Taking this into account, the experts selected the measures to be included in the checklist based on their relevance, feasibility, and the outcome type. RESULTS: The checklist includes measures for the evaluation of personal history, physical examination, activity and function, laboratory tests, imaging studies and treatments. It also defines risk factors of radiographic progression, predictors of the response to biological therapies, and comprises measures of excellence. CONCLUSIONS: This checklist for patients with axial SpA and PsA could help standardize daily clinical practice and improve clinical management and patient prognosis.

Strategy to improve the request of uric acid in primary care: preliminary results and evaluation through process and outcome appropriateness indicators.

INTRODUCTION: Alerted by the high rates of request of serum uric acid (UA) in primary care patients, we aimed to design a strategy to improve such an indicator, and to monitor such an intervention through process and outcome appropriateness indicators. METHODS: To design the strategy, several meetings were held between the Laboratory, Rheumatology and Primary Care. The intervention consisted of discharging UA from two laboratory profiles ("Health Check" and "Rheumatology"), making it only possible to request the test in an individualized manner. To assess the intervention effectiveness, the ratio of UA/glucose requests, the quantity of allopurinol prescription and the resulting economic savings were calculated and compared for pre- and post-intervention 12 month periods. RESULTS: There was a 70% decrease in the number of UA requests in the post-intervention period, as compared to the pre-intervention interval. The ratio of UA/glucose requests experienced a significant commensurate drop in the post-intervention period (p<0.01). There was a significant reduction in the prescription of allopurinol (p<0.01). From an economic perspective, the strategy resulted in a savings of 8190 €. CONCLUSION: The strategy resulted in a dramatic drop in the number of UA requests and in the prescription of allopurinol. This highlights a likely existence of prior unnecessary treatment of patients with hyperuricemia in the absence of clinical symptoms.

[Economic evaluation of tramadol/paracetamol in the management of pain in patients with osteoarthritis in Spain]. / Evaluación económica de tramadol/paracetamol en el manejo del dolor en pacientes con osteoartrosis en España.

OBJECTIVE: To compare the costs of treating osteoarthritis (OA) pain using combination tramadol/paracetamol tablets, Non-Steroidal Anti-Inflammatory Agents (NSAID) alone or NSAID plus proton pump inhibitors (PPI) from the perspective of the Spanish National Health System. METHODS: A decision-analytical model was constructed to analyze the cost associated with three treatment strategies over 6 months. A cost-minimization approach was used, which considered data related to resource use, medication costs and costs for the treatment of adverse events. RESULTS: In the base-case analysis, costs for 6 months of treatment of OA pain using tramadol/paracetamol were €232.86, compared with €274.60 for NSAID + PPI and €133.75 for NSAID alone. This provided a savings of €41.74 per patient over 6 months for tramadol/paracetamol compared with NSAID + PPI and a cost increase of €99.11 compared with NSAID alone. When renal adverse events associated with NSAID were considered, tramadol/paracetamol was cost saving compared with all NSAID-based regimens (saving €140.02 vs NSAID alone, €280.86 vs NSAID + PPI). CONCLUSION: Based on the results of a theoretical decision-analytic model, the data obtained may suggest that tramadol/paracetamol is cost saving compared with NSAID + PPI for the treatment of OA pain over a period of 6 months. Tramadol/paracetamol is also cost saving compared with treatment with NSAID alone if considering renal adverse events.

Prevalence of vertebral fractures by semiautomated morphometry in patients with ankylosing spondylitis.

OBJECTIVE: Ankylosing spondylitis (AS) is a chronic inflammatory disease mainly affecting the axial skeleton and characterized by ossification of the spinal disc, joints, and ligaments leading to progressive ankylosis. Vertebral osteoporosis is a recognized feature of AS. Studies have confirmed a moderate to high prevalence of vertebral fractures with extremely varying ranges in patients with AS. Our objective was to estimate the prevalence of vertebral fractures in a representative Spanish population of patients with AS using a validated semiquantitative method, MorphoXpress(®). METHODS: Patients were randomly selected from the 10 initial participating centers of the Spanish National Registry of Spondyloarthropathies (REGISPONSER) by consecutive sampling. All patients fulfilled the New York modified criteria for AS and had a baseline thoracolumbar radiograph. A prevalent vertebral fracture was defined according to the Genant classification criteria. RESULTS: The estimated prevalence of vertebral fractures was 32.4% (95% CI 25.5%-39.3%). The majority of fractures were localized in the thoracic segment (n = 100; 82.%) and were mild (n = 79; 64.8%). In logistic regression analysis, age (odds ratio per year 1.05, 95% CI 1.03-1.08, p < 0.001), disease duration (OR per year 1.03, 95% CI 1.01-1.06, p = 0.011), Bath Ankylosing Spondylitis Functional Index score (OR per score 1.16, 95% CI 1.03-1.30, p = 0.015), Bath Ankylosing Spondylitis Radiographic Index-TS (OR per score 1.25, 95% CI 1.12-1.39, p < 0.001), and wall-occiput distance (OR per cm 1.15, 95% CI 1.08-1.23, p < 0.001) were all associated with prevalent fracture. CONCLUSION: Semiquantitative methods are needed to improve the diagnosis of vertebral fractures in AS in order to start early treatment and to avoid complications arising from osteoporosis.

[Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients]. / Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas.

OBJECTIVE: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. RESULTS: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. CONCLUSIONS: We present the SER recommendations related to biologic therapy risk management.

Work disability in patients with ankylosing spondylitis.

OBJECTIVE: To determine the prevalence of work disability in Spanish patients with ankylosing spondylitis (AS) and to identify factors related to it. METHODS: A cross-sectional study based on data from Regisponser (National Spanish Registry of Patients with Spondyloarthropathy). Demographic and disease-related variables were collected. AS patients were classified as work-disabled according to the Spanish Social Security System criteria. Variables that discriminated between AS patients with and those without work disability were identified using chi-square test or unpaired t test when appropriate. Multiple logistic regression was performed. RESULTS: In total 699 AS patients, age 48.7 +/- SD 12.7 years and with disease duration 14.1 +/- 10.1 years, were analyzed; 179 patients (25.6%) had permanent work disability. Several variables had significantly different values in patients with compared to those without work disability. In the regression model (pseudo R(2) = 0.26, p < 0.0001), age (p = 0.001), sex (p = 0.04), disease duration (p = 0.006), total Bath AS Radiological Index (p = 0.007), Bath AS Functional Index (BASFI; p = 0.007), and chest expansion (p = 0.03) retained an independent association with work disability. When BASFI was excluded from the model the independent association with sex did not remain, and a significant association with finger to floor distance was found (p = 0.040). CONCLUSION: The prevalence of permanent work disability in Spanish patients with AS is significant, and the main factors related to it are age, disease duration, structural damage, and physical functioning. Longitudinal studies are needed to confirm these results.