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1.
RMD Open ; 7(1)2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33790049

RESUMO

BACKGROUND: The CHIC study (COVID-19 High-intensity Immunosuppression in Cytokine storm syndrome) is a quasi-experimental treatment study exploring immunosuppressive treatment versus supportive treatment only in patients with COVID-19 with life-threatening hyperinflammation. Causal inference provides a means of investigating causality in non-randomised experiments. Here we report 14-day improvement as well as 30-day and 90-day mortality. PATIENTS AND METHODS: The first 86 patients (period 1) received optimal supportive care only; the second 86 patients (period 2) received methylprednisolone and (if necessary) tocilizumab, in addition to optimal supportive care. The main outcomes were 14-day clinical improvement and 30-day and 90-day survival. An 80% decline in C reactive protein (CRP) was recorded on or before day 13 (CRP >100 mg/L was an inclusion criterion). Non-linear mediation analysis was performed to decompose CRP-mediated effects of immunosuppression (defined as natural indirect effects) and non-CRP-mediated effects attributable to natural prognostic differences between periods (defined as natural direct effects). RESULTS: The natural direct (non-CRP-mediated) effects for period 2 versus period 1 showed an OR of 1.38 (38% better) for 14-day improvement and an OR of 1.16 (16% better) for 30-day and 90-day survival. The natural indirect (CRP-mediated) effects for period 2 showed an OR of 2.27 (127% better) for 14-day improvement, an OR of 1.60 (60% better) for 30-day survival and an OR of 1.49 (49% better) for 90-day survival. The number needed to treat was 5 for 14-day improvement, 9 for survival on day 30, and 10 for survival on day 90. CONCLUSION: Causal inference with non-linear mediation analysis further substantiates the claim that a brief but intensive treatment with immunosuppressants in patients with COVID-19 and systemic hyperinflammation adds to rapid recovery and saves lives. Causal inference is an alternative to conventional trial analysis, when randomised controlled trials are considered unethical, unfeasible or impracticable.

2.
Ann Rheum Dis ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33832966

RESUMO

BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. OBJECTIVES: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain. METHODS: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously. RESULTS: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9). CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

3.
Artigo em Inglês | MEDLINE | ID: mdl-33775461

RESUMO

OBJECTIVE: Towards developing an instrument to measure knee and hip osteoarthritis (KHOA) flare, the Outcome Measures in Rheumatology (OMERACT) Flares in OA Working Group first sought to identify and define relevant domains of flare in KHOA. METHODS: Guided by OMERACT Filter 2.1, candidate domains were identified from data generated in interviews, in English or French, with persons with KHOA and health professionals (HPs) who treat OA. The first and second rounds of an online Delphi process with patients and HPs, including researchers, selected relevant domains. The third round provided agreement on the selected domains and their definitions. At the virtual OMERACT 2020 workshop, the proposed domains and their definitions were discussed in facilitated breakout groups with patients and HPs. Participants then voted, with consensus set at ≥70%. RESULTS: Qualitative interviews characterizing OA flare were completed with 29 persons with KHOA and 16 HPs. Content was analyzed and grouped into nine clusters. These candidate domains were included in two Delphi rounds, completed by 91 patients and 165 HPs then 50 patients and 116 HPs, per round, respectively. This resulted in selecting five relevant domains. A final Delphi round, completed by 38 patients and 89 HPs, provided agreement on these domains and their definitions. The OMERACT virtual vote included 27 patients and 106 HPs. The domains and their definitions were endorsed with ≥98% agreement. Domains include: Pain, Swelling, Stiffness, Psychological aspects, and Impact of symptoms, all defined "during flare". CONCLUSION: Using OMERACT methodology, we have developed five domains of KHOA flare that were highly endorsed by patients and HPs.

4.
Arthritis Rheumatol ; 2021 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-33538097

RESUMO

AIM: To investigate whether TNF inhibitors (TNFi) impact spinal radiographic progression in patients with axial spondyloarthritis (axSpA) and whether this is coupled to their effect on inflammation. METHODS: Patients with axSpA fulfilling the modified New York criteria were included in this prospective cohort (ALBERTA FORCAST). Spine radiographs, done every 2 years up to 10 years, were scored by 2 central readers, using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The indirect effect of TNFi on mSASSS was evaluated with generalized estimating equations by testing the interaction between TNFi and ASDAS at the start of each 2-year interval (t). If significant, the association between ASDAS at t and mSASSS at the end of the interval (t+1) was assessed in: i. patients treated with TNFi in all visits; ii. some visits and iii. never treated. In addition, the association between TNFi at t and mSASSS at t+1 (adjusting for ASDAS at t) was also tested (direct effect). RESULTS: In total, 314 patients were included. A gradient was seen for the effect of ASDAS at t on mSASSS at t+1 (interaction p-value 0.10), with a higher progression in patients never treated with TNFi [ß (95% CI): 0.41 (0.13; 0.68)] compared to those continuously treated [0.16 (0.00;0.31)] (indirect effect). However, TNFi also directly slowed progression as treated patients had on average 0.85 mSASSS-units less on t+1 compared to those not treated [-0.85 (-1.35; -0.35)]. CONCLUSION: TNFi reduce spinal radiographic progression in patients with radiographic axSpA which might be partially uncoupled from their effects on ASDAS inflammation.

7.
RMD Open ; 7(1)2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33542048

RESUMO

OBJECTIVE: To summarise the methodological aspects in studies with work participation (WP) as outcome domain in inflammatory arthritis (IA) and other chronic diseases. METHODS: Two systematic literature reviews (SLRs) were conducted in key electronic databases (2014-2019): search 1 focused on longitudinal prospective studies in IA and search 2 on SLRs in other chronic diseases. Two reviewers independently identified eligible studies and extracted data covering pre-defined methodological areas. RESULTS: In total, 58 studies in IA (22 randomised controlled trials, 36 longitudinal observational studies) and 24 SLRs in other chronic diseases were included. WP was the primary outcome in 26/58 (45%) studies. The methodological aspects least accounted for in IA studies were as follows (proportions of studies positively adhering to the topic are shown): aligning the studied population (16/58 (28%)) and sample size calculation (8/58 (14%)) with the work-related study objective; attribution of WP to overall health (28/58 (48%)); accounting for skewness of presenteeism/sick leave (10/52 (19%)); accounting for work-related contextual factors (25/58 (43%)); reporting attrition and its reasons (1/58 (2%)); reporting both aggregated results and proportions of individuals reaching predefined meaningful change or state (11/58 (16%)). SLRs in other chronic diseases confirmed heterogeneity and methodological flaws identified in IA studies without identifying new issues. CONCLUSION: High methodological heterogeneity was observed in studies with WP as outcome domain. Consensus around various methodological aspects specific to WP studies is needed to improve quality of future studies. This review informs the EULAR Points to Consider for conducting and reporting studies with WP as an outcome in IA.

8.
RMD Open ; 7(1)2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33514672

RESUMO

INTRODUCTION: Although patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries. METHODS: A multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still's disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18-35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups. RESULTS: Fifty-three patients (21 with RA/JIA/Still's, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons. CONCLUSIONS: Despite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease.

9.
RMD Open ; 6(3)2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33310864

RESUMO

OBJECTIVE: To investigate if in radiographic axial Spondyloarthritis (r-axSpA) low vertebral bone mineral density (BMD) is associated with development of new syndesmophytes at the same vertebral level. METHODS: In a post-hoc analysis from the ASSERT trial (infliximab vs placebo), dual-energy X-ray absorptiometry was used to measure baseline BMD (g/cm2) of the lumbar spine L1 to L4. Syndesmophyte formation was assessed in the same vertebrae on conventional radiographs defined as an increase in modified Stoke Ankylosing Spondylitis Spine Score from 0 or 1 to 2 or 3 after 2 years. Radiographs were scored by two readers. Generalised estimating equations (GEE) adjusted for within-patient correlation across multiple vertebrae, taking potential confounders into account. RESULTS: We analysed 599 vertebrae in 165 r-axSpA patients (78% male, mean (SD) age 38 (10) years, 67% with at least one syndesmophyte anywhere in the spine). In total, 24 to 74 new syndesmophytes developed in 9 (5%) to 30 (18%) patients and 13 (2%) to 39 (7%) vertebrae, if either a syndesmophyte was seen by both or only one of the readers (ie, specific and sensitive definitions) respectively. In multivariable analyses, no association was found between baseline local vertebral BMD and new syndesmophyte formation after 2 years: adjOR (95% CI): 0.56 (0.01, 44.45) (specific definition) and 0.26 (0.03, 2.63) (sensitive definition). CONCLUSION: In patients with active and established r-axSpA, with an observed low incidence of lumbar spine syndesmophyte formation over 2 years, no relationship was found between baseline BMD and new radiographic syndesmophyte formation at the same vertebra.

11.
Clin Exp Rheumatol ; 38(6): 1056-1067, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33253107

RESUMO

OBJECTIVES: Despite availability of efficacious treatments, unmet needs still exist, preventing optimal and comprehensive management of rheumatoid arthritis (RA). Evolving the management of RA (eRA) is a European-wide educational initiative aiming to support improved patient care through practical and educational tools addressing specific unmet needs. METHODS: A multidisciplinary Steering Committee (17 members, 12 countries) identified unmet needs within the management of RA and prioritised those with the greatest impact on patient outcomes. Practical educational tools addressing priority needs were then developed for dissemination and implementation by the rheumatology community across Europe. RESULTS: Five areas of priority need were identified: increasing early recognition of RA and treatment initiation; treating RA to target; optimal, holistic approach to selection of treatment strategy, including shared decision-making; improving identification and management of comorbidities; and non-pharmacological patient management. A suite of 14 eRA tools included educational slides, best-practice guidance, self­assessment questionnaires, clinical checklists, a multidisciplinary team training exercise, an interactive patient infographic, and case scenarios. By April 2020, rheumatology professionals in 17 countries had been actively engaged in the eRA programme; in 11 countries, eRA tools were selected by national leaders in rheumatology and translated for local dissemination. A web platform, with country-specific pages, was developed to support access to the translated tools (https://www.evolvingthemanagementofra.com/). CONCLUSIONS: The eRA programme supports comprehensive management of RA across Europe through development and dissemination of practical educational tools. The eRA tools address priority needs and are available free of charge to the rheumatology community.

13.
Artigo em Inglês | MEDLINE | ID: mdl-33026713

RESUMO

OBJECTIVES: To identify and describe health literacy profiles of patients with rheumatic diseases and explore whether the identified health literacy profiles can be generalized to a broader rheumatology context. METHODS: Patients with rheumatoid arthritis, spondyloarthritis and gout from three hospitals in different regions in the Netherlands completed the Health Literacy Questionnaire (HLQ). Hierarchical cluster analysis was used to identify patients' health literacy profiles based on nine HLQ domains. A multinomial regression model with the identified health literacy profiles as the dependent variable was fitted to assess whether patients with a given disease type or attending a given hospital were more likely to belong to a specific profile. RESULTS: Among 895 participating patients, lowest mean HLQ domain scores (indicating most difficulty) were found for "Critical appraisal", "Navigating the health system" and "Finding good health information". The ten identified profiles revealed substantial diversity in combinations of strengths and weaknesses. While 42% of patients scored moderate to high on all nine domains (profiles 1 and 3), another 42% of patients (profiles 2, 4, 5 and 6) clearly struggled with one or several aspects of health literacy. Notably, 16% (profiles 7 to 10) exhibited difficulty across a majority of health literacy domains. The probability of belonging to one of the profiles was independent of hospital attended or type of rheumatic disease. CONCLUSION: Ten distinct health literacy profiles were identified among patients with rheumatic diseases, independent of disease type and treating hospital. These profiles can be used to facilitate health literacy intervention development in rheumatology.

18.
Artigo em Inglês | MEDLINE | ID: mdl-32986932

RESUMO

OBJECTIVES: To investigate determinants of the physician global assessment of disease activity (PhGA) and the influence of the contextual factors on this relationship in patients with early axial spondyloarthritis (axSpA). METHOD: Five-year data of DESIR, a cohort of early axSpA, were analyzed. Univariable generalized estimating equations (GEE) were used to investigate contributory explanatory effects of various potential determinants of PhGA. Effect modification by contextual factors (age, gender and educational level) was tested and, if significant, models were stratified. Autoregressive GEE models (i.e., models adjusted for PhGA at the previous time point) were used to confirm a longitudinal relationship. RESULTS: A total of 708 patients were included. Higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) individual questions, swollen joint count in 28 joints (SJC28), tender joint count in 53 joints, Maastricht Ankylosing Spondylitis Enthesitis Score, C-reactive protein (CRP) and Bath Ankylosing Spondylitis Metrology Index were associated with a higher PhGA. Gender and age were effect modifiers of SJC28; the contributory effect of SJC28 was largest in the younger male stratum (ß [95% CI]; 1.07 [0.71-1.43]), and the smallest in the older female stratum (0.13 [0.04-0.22]). Autoregressive GEE models revealed the same determinants as having a longitudinal association with PhGA and the same pattern of effect modification. CONCLUSIONS: Patient's subjective symptoms, peripheral arthritis and enthesitis, higher CRP and impaired spinal mobility contribute to explaining PhGA in patients with early axSpA irrespective of gender and age. Intriguingly, physicians consider the presence of swollen joints as more important in males than in females.

19.
Artigo em Inglês | MEDLINE | ID: mdl-32976683

RESUMO

OBJECTIVE: To compare the sensitivity to change of different imaging scoring methods in patients with early axial spondyloarthritis (axSpA). METHODS: Patients from the DESIR cohort fulfilling the ASAS axSpA criteria were included. Radiographs and MRI of the sacroiliac joints (SIJ) and spine were obtained at baseline, 1, 2 and 5 years. Each image was scored by 2 or 3 readers in 3 separate 'reading-waves'. The rate of change of outcomes measuring spinal and SIJ inflammation (e.g. SPARCC score) and structural damage on MRI (e.g. ≥3 fatty lesions) and radiographs (e.g. mNY grading) was assessed using multilevel generalized estimating equations (GEE) models (taking all readers and waves into account). To allow comparisons across outcomes, rates were standardized (difference between the individual's value and the population mean divided by the standard deviation). RESULTS: In total, 345 patients were included. Inflammation on MRI-SIJ (standardized rate range: -0.278; -0.441) was more sensitive to change compared to spinal inflammation (range: -0.030; -0.055). Structural damage in the SIJ showed a higher standardized rate of change on MRI-SIJ (range: 0.015-0.274) compared to X-SIJ (range: 0.043-0.126). MRI-SIJ damage defined by ≥3 fatty lesions showed the highest sensitivity to change (0.274). Spinal structural damage slowly progressed over time with no meaningful difference between radiographic (range: 0.037-0.043) and MRI structural outcomes (range: 0.008-0.027). CONCLUSION: Structural damage assessed in pelvic radiographs has low sensitivity to change, while fatty lesions detected on MRI-SIJ are a promising alternative. In contrast, MRI-spine is not better than X-spine in detecting structural changes in early axSpA patients.

20.
RMD Open ; 6(2)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32883720

RESUMO

OBJECTIVE: To summarise the literature on the assessment of competences in postgraduate medical training. METHODS: A systematic literature review was performed within a EULAR taskforce on the assessment of competences in rheumatology training and other related specialities (July 2019). Two searches were performed: one search for rheumatology and one for related medical specialities. Two reviewers independently identified eligible studies and extracted data on assessment methods. Risk of bias was assessed using the medical education research study quality instrument. RESULTS: Of 7335 articles in rheumatology and 2324 reviews in other specialities, 5 and 31 original studies were included, respectively. Studies in rheumatology were at variable risk of bias and explored only direct observation of practical skills (DOPS) and objective structured clinical examinations (OSCEs). OSCEs, including clinical, laboratory and imaging stations, performed best, with a good to very good internal consistency (Cronbach's α=0.83-0.92), and intrarater reliability (r=0.80-0.95). OSCEs moderately correlated with other assessment tools: r=0.48 vs rating by programme directors; r=0.2-0.44 vs multiple-choice questionnaires; r=0.48 vs DOPS. In other specialities, OSCEs on clinical skills had a good to very good inter-rater reliability and OSCEs on communication skills demonstrated a good to very good internal consistency. Multisource feedback and the mini-clinical evaluation exercise showed good feasibility and internal consistency (reliability), but other data on validity and reliability were conflicting. CONCLUSION: Despite consistent data on competence assessment in other specialities, evidence in rheumatology is scarce and conflicting. Overall, OSCEs seem an appropriate tool to assess the competence of clinical skills and correlate well with other assessment strategies. DOPS, multisource feedback and the mini-clinical evaluation exercise are feasible alternatives.

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