Factors associated with treatment intensification in patients with axial spondyloarthritis and high disease activity in clinical practice.

OBJECTIVE: To investigate which factors are associated with treatment intensification (TI) in axial spondylarthritis (axSpA) patients with high disease activity (HDA). METHODS: Patients with axSpA and HDA (Ankylosing Spondylitis Disease Activity Score [ASDAS]≥2.1) from the Dutch SpA-Net registry were included. TI was defined as: 1) higher dose or shorter interval of the same drug, 2) switch from current drug to another due to inefficacy, or 3) addition of a new drug. Only anti-inflammatory drugs were considered. Primary determinants considered were ASDAS, Assessment of SpondyloArthritis international Society Health Index (ASAS HI) and physician global (PhGA). Acceptable symptom state according to patient (PASS-patient) or physician (PASS-physician) were included in sensitivity analyses. Patient-centered and physician-centered logistic regression models were used to investigate the association between potential determinants and TI. RESULTS: In total, 121 patients with HDA were included. TI was conducted in a minority (41/121, 33.9%), and mainly involved a switch or addition of a drug. In multivariable regression analyses, a higher ASDAS was associated with TI in the patient-centered model (ORASDAS = 1.94, [95%CI 1.00-3.74]). However, in the physician-centered model, this association attenuated, and PhGA or PASS-physician were the primary factors associated with TI (ORPhGA = 1.71 [1.24-2.34]; ORPASS-physician = 94.95). Interestingly, patient-centered factors (ASAS HI/PASS-patient/education level) did not contribute to TI. CONCLUSION: In practice, treatment is intensified in a minority of axSpA patients with HDA. Physician-centered factors are associated with the decision to change treatment, independently of disease activity or patient perspective. Further research is needed to better understand these decisions.

Fatigue in patients with rheumatic and musculoskeletal diseases: a scoping review on definitions, measurement instruments, determinants, consequences and interventions.

OBJECTIVES: To scope published reviews addressing fatigue in rheumatoid arthritis (RA), spondyloarthritis, osteoarthritis and fibromyalgia in areas relevant for clinical practice: (1) definition, (2) measurement instruments and diagnosis, (3) determinants, (4) consequences and (5) effectiveness of interventions. METHODS: A systematic literature search of reviews was performed in five bibliographical databases. A hierarchical data extraction was applied based on review type (Cochrane reviews (CRs), followed by non-Cochrane systematic reviews (SRs) and narrative reviews (NRs)) and year of publication. Extracted data were summarised in elaborated narrative syntheses. Results were discussed with a patient panel. RESULTS: One hundred and thirty-four reviews were included (19 CRs, 44 SRs, 71 NRs). No agreed on definition was reported for general fatigue, nor for types of fatigue. Twenty-five measurement instruments were found, all self-reported. Five instruments proposed a threshold for excessive fatigue. Pain, physical function and depressive symptoms were the most frequently studied disease-related determinants of fatigue; female sex and stress the most frequent contextual determinants. Work performance, followed by impact on pain, physical activity and social roles were the most frequently studied consequences. Whenever quantified, associations between fatigue with determinants and consequences were on average small. For non-pharmacological interventions, if effect sizes were reported, these were negligible to small and for pharmacological interventions negligible to moderate. Patients recommended actions for research and practice. CONCLUSION: Syntheses of reviews point to the complexity of fatigue. The extensive amount of evidence could be used to offer tailored management plans to patients in clinical practice and inform future research agendas.

Development of a web-based decision aid for initiating biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in axial spondyloarthritis.

OBJECTIVES: To develop a web-based evidence-based decision aid to support shared decision-making in patients with axial spondyloarthritis (axSpA) who face a treatment decision to initiate or switch a biological or targeted synthetic disease modifying antirheumatic drug (b/tsDMARDs). METHODS: Through an iterative process, we systematically developed a decision aid based on evidence from the literature, explorative needs assessment interviews among patients and care providers, and input from experts of the SpA working group of the Dutch Society for Rheumatology and professionals on patient information employed at the Dutch Arthritis Society. The usability, ease of use and feasibility of the pilot version were tested among stakeholders and feedback was used to adapt the decision aid. Finally, a multifaceted strategy was used to introduce the decision aid in clinical practice. RESULTS: The decision aid consists of (1) consultation support instructions in the context of disease control and treatment needs, (2) an overview of available treatment options for axSpA, (3) detailed information on b/tsDMARDs and an interactive option grid that facilitates comparison of characteristics and (4) a final check supporting patients to deliberate on the decision to initiate or switch a b/tsDMARD. Rheumatologists introduced the decision aid in several Dutch rheumatology settings and the Dutch Arthritis Society posted it on their website, social media and in their monthly newsletter. CONCLUSION: We developed an evidence-based decision aid to support axSpA patients who face a treatment decision to initiate or switch a b/tsDMARD and introduced this in clinical practice.

Performance of 3 Composite Measures for Disease Activity in Peripheral Spondyloarthritis.

OBJECTIVE: To investigate concurrent validity and discrimination of the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, Psoriatic Arthritis Disease Activity Score (PASDAS), and Ankylosing Spondylitis Disease Activity Score (ASDAS) in peripheral spondyloarthritis (pSpA) in clinical practice. METHODS: Data from a Dutch registry for SpA (SpA-Net) were used. Predefined hypotheses on concurrent validity of the composite measures with 15 other outcome measures of disease activity, physical function, and health-related quality of life were tested. Concurrent validity was considered acceptable if ≥ 75% of the hypotheses were confirmed. Discrimination was assessed by stratifying patients in DAPSA, PASDAS, and ASDAS predefined disease activity states and studying mean differences in health outcomes by 1-way ANOVA. Further, the concordance in disease activity states was determined. All analyses were repeated in subgroups with and without psoriasis (PsO). RESULTS: DAPSA, PASDAS, and ASDAS scores were available for 191, 139, and 279 patients with pSpA, respectively. The concurrent validity and discrimination of all composite measures were acceptable, as the strength of correlations were as hypothesized in ≥ 75% of the studied correlations. With increasing disease activity states, scores in nearly all outcome measures worsened significantly. The DAPSA, PASDAS, and ASDAS classified 22%, 56%, and 48% of the patients, respectively, in the 2 highest disease activity states. Stratified analyses for concomitant PsO revealed no relevant subgroup differences. CONCLUSION: The performance of DAPSA, PASDAS, and ASDAS in pSpA was acceptable, and independent of concomitant PsO. Due to discrepancy in classification, the validity of existing thresholds for disease activity states warrants further study in pSpA.

Treat-to-target in axial spondyloarthritis: an observational study in daily practice.

OBJECTIVES: To evaluate the extent to which internationally agreed treat-to-target recommendations were applied in clinical practice in patients with axial spondyloarthritis. METHODS: Data were used from a web-based patient registry for monitoring SpA in daily practice in the Netherlands. The extent to which treat-to-target was applied was evaluated through four indicators: the proportion of patients (i) with ≥1 Ankylosing Spondylitis Disease Activity Score (ASDAS) assessed during a 1-year period, (ii) having inactive disease/low disease activity (i.e. ASDAS < 2.1), (iii) in whom re-evaluation of ASDAS within recommended intervals occurred, and (iv) with high disease activity (HDA, i.e. ASDAS ≥ 2.1) in whom treatment was adapted ≤6 weeks after obtaining ASDAS ≥ 2.1. Patients with HDA with treatment adaptations were compared with patients with HDA without treatment adaptations. RESULTS: In 185 out of 219 patients (84%), disease activity was monitored with ≥1 ASDAS during a 1-year period, of whom 71 (38%) patients had a score below the target (ASDAS < 2.1) at first measurement. Re-evaluation of ASDAS ≤3 months occurred in 11% and 23% of the patients with inactive disease/low disease activity and HDA, respectively. Treatment adaptation occurred in 19 out of 114 patients (17%) with HDA. Patients in whom treatment was adapted had significantly higher ASDAS (P < 0.01), CRP levels (P < 0.05) and physician global assessment (P < 0.05) compared with patients without treatment adaptations. CONCLUSIONS: Treat-to-target was applied to a limited extent in clinical practice in patients with axial spondyloarthritis. Available disease activity scores seemed not to be used for determining the frequency of re-evaluation nor treatment adaptation.

Validation and implementation of a patient-reported experience measure for patients with rheumatoid arthritis and spondyloarthritis in the Netherlands.

OBJECTIVES: To test the psychometric properties of the United Kingdom's Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) in patients with spondyloarthritis (SpA) and rheumatoid arthritis (RA) and to implement this questionnaire in daily practice in the Netherlands. METHODS: After a forward-backward translation procedure into Dutch, the CQRA-PREM was tested into two quality registries in daily practice. Face validity was assessed with focus group interviews. Feasibility was evaluated through completion times and interpretability of domain scores through floor and ceiling effects. Internal consistency (Cronbach's α coefficients) and homogeneity (corrected item-total correlations) were determined. Divergent validity was assessed by Spearman's rank correlation coefficients (rs) between the average scores of domains and outcome measures. The CQRA-PREM was implemented in daily practice, and the results were used in quality improvement cycles. RESULTS: Face validity of the CQRA-PREM was good. The CQRA-PREM was completed by 282 patients with SpA and 376 with RA. Median time to complete the CQRA-PREM was 4.7 min. Ceiling effects were found in three out of seven domains. Internal consistency of nearly all domains was considered good (0.65 ≤ α ≤ 0.95). Thresholds for homogeneity were exceeded within three domains (rp > 0.7), suggesting item redundancy. Divergent validity showed that nearly all domains of the CQRA-PREM were at most weakly correlated with outcomes measures (- 0.3 ≤ rs ≤ 0.3). The CQRA-PREM could identify areas of improvement for providing patient-centered care. CONCLUSION: The CQRA-PREM has acceptable psychometric properties and has shown to be a useful tool in evaluating quality of care from the patients' perspective in the Netherlands. TRIAL REGISTRATION: SpA-Net is registered in the Netherlands Trial Registry (NTR6740). KEY POINTS: • The Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) is a valid measure for assessing patient-centeredness of rheumatology care. • The Dutch version of the CQRA-PREM shows acceptable psychometric properties. • The CQRA-PREM shows to be a useful tool in Plan-Do-Check-Act quality improvement cycles in the Netherlands. • The CQRA-PREM can be used for benchmarking and quality improvement of rheumatology services.

Development, usability and acceptability of an integrated eHealth system for spondyloarthritis in the Netherlands (SpA-Net).

Objective: To develop and test the usability and acceptability of a disease-specific integrated electronic health (eHealth) system for spondyloarthritis (SpA) in the Netherlands ('SpA-Net'). Methods: SpA-Net was developed in four phases. First, content and design were discussed with experts on SpA and patients. Second, the database, electronic medical record (EMR) and quality management system were developed. Third, multiple rounds of testing were performed. Fourth, the eHealth system was implemented in practice and feasibility was tested among patients through semistructured focus interviews (n=16 patients) and among care providers through feedback meetings (n=11 rheumatologists/fellows and 5 nurses). Results: After completion of the first three steps of development in 2015, SpA-Net was implemented in 2016. All patients included have a clinical diagnosis of SpA. Information on domains relevant to clinical record-keeping is prospectively collected at routine outpatient consultations and readily available to care providers, presented in a clear dashboard. Patients complete online questionnaires prior to outpatient visits. In February 2019, 1069 patients were enrolled (mean [SD] age 54.9 [14.1] years, 52.4% men). Patients interviewed (n=16) considered SpA-Net an accessible system that was beneficial to disease insight and patient-physician communication, and had additional value to current care. Care providers appreciated the additional information for (preparing) consultations. Barriers were the initial time required to adopt the EMR and the quantity of data entry. Conclusion: SpA-Net enables monitoring of patients with SpA and real-life data collection, and could help improve knowledge and optimise communication between patients and care providers. Both considered SpA-Net a valuable addition to current care. Trial registration number: NTR6740.