Objective The randomised placebo-controlled GLORIA (Glucocorticoid LOw-dose in RheumatoId Arthritis) trial evaluated the benefits and harms of prednisolone 5 mg/day added to standard care for 2... Show moreObjective The randomised placebo-controlled GLORIA (Glucocorticoid LOw-dose in RheumatoId Arthritis) trial evaluated the benefits and harms of prednisolone 5 mg/day added to standard care for 2 years in patients aged 65+ years with rheumatoid arthritis (RA). Here, we studied disease activity, flares and possible adrenal insufficiency after blinded withdrawal of study medication.Methods Per protocol, patients successfully completing the 2-year trial period linearly tapered and stopped blinded study medication in 3 months. We compared changes in disease activity after taper between treatment groups (one-sided testing). Secondary outcomes (two-sided tests) comprised disease flares (DAS28 (Disease Activity Score 28 joints) increase >0.6, open-label glucocorticoids or disease-modifying antirheumatic drug (DMARD) increase/switch after week 4 of tapering) and symptoms/signs of adrenal insufficiency. In a subset of patients from 3 Dutch centres, cortisol and ACTH were measured in spot serum samples after tapering.Results 191 patients were eligible; 36 met treatment-related flare criteria and were only included in the flare analysis. Mean (SD) DAS28 change at follow-up: 0.2 (1.0) in the prednisolone group (n=76) vs 0.0 (1.2) in placebo (n=79). Adjusted for baseline, the between-group difference in DAS28 increase was 0.16 (95% confidence limit –0.06, p=0.12). Flares occurred in 45% of prednisolone patients compared with 33% in placebo, relative risk (RR) 1.37 (95% CI 0.95 to 1.98; p=0.12). We found no evidence for adrenal insufficiency.Conclusions Tapering prednisolone moderately increases disease activity to the levels of the placebo group (mean still at low disease activity levels) and numerically increases the risk of flare without evidence for adrenal insufficiency. This suggests that withdrawal of low-dose prednisolone is feasible and safe after 2 years of administration. Show less
Background Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses... Show moreBackground 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. Show less
Heitkamp, A.; Vollmer, L.; Akker, T. van den; Gebhardt, G.S.; Sandberg, E.M.; Roosmalen, J. van; ... ; Theron, G. 2021
Objective To assess the incidence of severe maternal outcome (SMO), comprising maternal mortality (MM) and maternal near miss (MNM), in Metro East health district, Western Cape Province, South... Show moreObjective To assess the incidence of severe maternal outcome (SMO), comprising maternal mortality (MM) and maternal near miss (MNM), in Metro East health district, Western Cape Province, South Africa between November 2014 and November 2015 and to identify associated determinants leading to SMO with the aim to improve maternity care.Methods Region-wide population-based case-control study. Women were included in the study, if they were maternal deaths or met MNM criteria, both as defined by WHO. Characteristics of women with SMO were compared with those of a sample of women without SMO, matched for age and parity, taken from midwifery-led obstetrical units from two residential areas in Metro East, using multivariate regression analysis.Results Incidence of SMO was 9.1 per 1000 live births, and incidence of MNM was 8.6 per 1000 live births. Main causes of SMO were obstetrical hemorrhage and hypertensive disorders. Factors associated with SMO were HIV (adjusted odds ratio [aOR] 24.8; 95% confidence interval [CI] 10.0-61.6), pre-eclampsia (aOR 17.5; 95% CI 7.9-38.7), birth by cesarean section (aOR 8.4; 95% CI 5.8-12.3), and chronic hypertension (aOR 2.4; 95% CI 1.1-5.1).Conclusion Evaluation of SMO incidence and associated determinants supports optimizing tailored guidelines in Metro-East health district to improve maternal health. Show less
Bentum, R.E. van; Vodnizza, S.E.I.; Fuente, M.P.P. de la; Aldridge, F.V.; Navarro-Compan, V.; Rusman, T.R.; ... ; Horst-Bruinsma, I.E. van der 2020
Objective. Physical function in patients with axial spondyloarthritis (axSpA) is currently evaluated through questionnaires. The Ankylosing Spondylitis Performance Index (ASPI) is a performance... Show moreObjective. Physical function in patients with axial spondyloarthritis (axSpA) is currently evaluated through questionnaires. The Ankylosing Spondylitis Performance Index (ASPI) is a performance-based measure for physical functioning, which has been validated in Dutch patients with radiographic (r-) axSpA. The interrater reliability has not yet been determined. To our knowledge, this study is the first to evaluate the validity, reliability, and feasibility of the ASPI in another patient population, including both r- and nonradiographic (nr-) axSpA patients.Methods. Patients with axSpA were recruited from rheumatology clinics in Santiago, Chile. Dutch instructions were translated to Spanish by a forward-backward procedure. Study visits were performed at baseline and 1-4 weeks later. Four ASPI observers were involved, measuring the performance times of the 3 ASPI tests. Validity was assessed through a patient questionnaire (numeric rating scale 0-10: >= 6 sufficient). For reliability, intraclass correlation coefficients (ICC) were calculated (with 95% CI). Correlations between the ASPI and disease variables were tested with regression analyses.Results. Sixty-eight patients were included (57% male, 52% r-axSpA). All patients understood the Spanish instructions and considered the ASPI to reach its aim (84%) and representativeness (85%) for physical functioning. The overall interrater (n = 62) and test-retest (n = 39) reliability (ICC) of the 3 tests combined were 0.93 (0.88-0.96) and 0.94 (0.87-0.97), respectively. Eighty-two percent of the patients completed all tests and 94% finished in < 15 min (feasibility).Conclusion. This study demonstrated a high validity and feasibility in an entirely different population, with both r-axSpA and nr- axSpA. The interrater and test-retest reliability was excellent. The ASPI instructions are now available for Spanish-speaking patients. Show less
