19 research outputs found

    Rheumatoid Arthritis:Strategies that Work

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    Lems, W.F. [Promotor]Boers, M. [Promotor]Voskuijl, A.E. [Copromotor]Schaardenburg, D. van [Copromotor

    Methodological aspects of design, analysis and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis : results of two systematic literature reviews informing EULAR points to consider

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    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

    Great saves or near misses? Severe maternal outcome in Metro East, South Africa: a region-wide population-based case-control study

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    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 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.Research into fetal development and medicin

    Vitamin D and metabolic disturbances in polycystic ovary syndrome (PCOS): A cross-sectional study

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    Objective To compare vitamin D status in women with PCOS versus fertile women and subsequently evaluate the association between vitamin D status and metabolic disturbances in PCOS women. Methods We conducted a cross-sectional comparison study of 639 women with PCOS and 449 fertile women. Serum 25-hydroxyvitamin D (25(OH)D) was stratified into a severe deficient ( 75 nmol/l) status. The main outcome measures were the difference in vitamin D status between PCOS and fertile women, and the association between serum 25(OH)D and metabolic disturbances in PCOS women only. Results Serum 25(OH)D was significantly lower in PCOS women compared to fertile controls (mean 25(OH)D of 49.0 nmol/l versus 64.5 nmol/l). An adjusted significant difference was seen between serum 25(OH)D and homeostasis model assessment (HOMA-IR) (β = 0.76; 95% CI: 0.63–0.91; p < 0.01), HDL-cholesterol (β = 0.20; 95% CI: 0.05–0.60, p < 0.01) and apolipoprotein A1 (β = 26.2; 95% CI: 7.5–45.0, p < 0.01) between the highest vitamin D group compared to the lowest vitamin D group. Conclusions This study demonstrates that women

    Effect of vitamin D supplementation on health status in non-vitamin D deficient people with type 2 diabetes mellitus

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    Objective Increased levels of depressive symptoms, fatigue or pain (all dimensions of reduced health-related quality of life (HRQOL)) are common in people with type 2 diabetes mellitus (DM). Earlier studies have reported associations between low vitamin D status and fatigue and depressive symptoms. The aim of the present study was to examine the effects of vitamin D supplementation on dimensions of HRQOL in people with type 2 DM. Design Randomised, double-blind, placebo-controlled trial. Methods The effect of monthly cholecalciferol 50,000 IU vs placebo on HRQOL was assessed in 275 adults with type 2 DM derived from general practices. HRQOL at baseline and after six months using the Short Form 36 Health Survey (SF-36) was collected. Linear regression analyses were used to compare the change in HRQOL over time between the vitamin D and placebo group. Results 187/275 (68%) completed baseline and follow-up SF-36 and were included in the analysis. Median serum 25-hydroxyvitamin D almost doubled in the intervention group compared to that in the placebo group (58.5–106.0 nmol/L vs 60.0–61.5 nmol/L, respectively). A small significant difference (adjusted B: −8.90; 95% CI: −17.16 to −0.65) between both groups was seen concerning the SF-36 domain role limitations due to physical problems in disadvantage of the vitamin D group. Conclusions Six months of vitamin D supplementation did not improve HRQOL in non-vitamin D-deficient people with type 2 DM managed on oral antidiabetic therapy. Keywords: RCT vitamin D health-related quality of life type 2 diabetes mellitu

    Effect of Vitamin D Supplementation on Glycemic Control in Patients With Type 2 Diabetes (SUNNY Trial): A Randomized Placebo-Controlled Trial

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    OBJECTIVE Low Vitamin D status has been associated with impaired glycemic control in patients with type 2 diabetes. The purpose of our study was to evaluate the effect of Vitamin D supplementation on glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This randomized, double-blind, placebo-controlled trial was conducted in 275 adult patients with type 2 diabetes without insulin treatment. Patients were randomly assigned to receive either Vitamin
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