Trends in direct oral anticoagulant (DOAC) use:Health benefits and patient preference

In 2012, the Dutch Health Council published a report addressing barriers for an early and broad introduction of direct oral anticoagulants (DOACs). The report raised concerns about the lack of an antidote, adherence, lack of monitoring in the case of overdose and the increased budget impact at DOAC introduction. In the past decade, international studies have shown that DOACs can provide healthcare benefits for a large number of patients. This has led to an increase in the prescription of DOACs, as they are an effective and user-friendly alternative to vitamin K antagonists (VKAs). Unlike VKAs, DOACs do not need monitoring of the international normalized ratio due to more predictable pharmacokinetics. However, the number of prescriptions of DOACs in the Netherlands is still lagging, compared to other European countries. This article highlights the potential health gains in the Netherlands if the use of DOACs were to increase, based on current international experience

Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk:Rationale and design of the ODYSSEY DM-INSULIN trial

Aims: The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk. Methods: ODYSSEY DM-INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients. Participants had low-density lipoprotein cholesterol (LDL-C) levels at screening. ≥. 70. mg/dL (1.81. mmol/L) with stable maximum tolerated statin therapy or were statin-intolerant, and taking (or not) other lipid-lowering therapy; they also had established CV disease or at least one additional CV risk factor. Eligible patients were randomized 2:1 to 24. weeks of alirocumab 75. mg every 2. weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C. ≥. 70. mg/dL at week 8 underwent a blinded dose increase to 150. mg Q2W at week 12. Primary endpoints were the difference between treatment arms in percentage change of calculated LDL-C from baseline to week 24, and alirocumab safety. Results: This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017. Conclusion: The ODYSSEY DM-INSULIN study will provide information on the efficacy and safety of alirocumab in insulin-treated individuals with T1 or T2 DM who are at high CV risk and have hypercholesterolaemia not adequately controlled by the maximum tolerated statin therapy

Who among patients with acquired brain injury returned to work after occupational rehabilitation?:The rapid-return-to-work-cohort-study

Background:  Acquired brain injury (ABI) is known to be severely disabling. On average, 40% of employees return to work (RTW) within two years after injury. There is, however, limited research on what might contribute to successful RTW.  Aim:  To examine factors that might impact the time-to first RTW for patients with ABI, participating in a RTW-program.  Methods:  The study was designed as a cohort study of patients on sick leave due to mild or moderate ABI (n = 137). The mean age of the patients was 51 years, and 58% were men. The most common diagnoses were stroke (75%) and traumatic brain injury (12%). Data were collected through questionnaires, and combined with register data on sickness absence. Survival analyses were used to analyse the effect of different variables on time to first RTW (full or partial), at one- and two-year follow-up.  Results:  Generally, women (HR = 0.447; CI: 0.239-0.283) had higher RTW-rates than men, and patients with non-comorbid impairments returned to work earlier than patients with multiple impairments. Although not statistically significant, receiving individual consultations and participating in group-sessions were generally associated with a delayed RTW at both follow-up-times. The only service-related factor significantly associated with delayed RTW was meetings with the social insurance office (HR = 0.522; CI: 0.282-0.965), and only at one-year follow-up.  Conclusions:  Women and patients with non-comorbid impairments returned to work earlier than men and patients with multiple impairments. There seems to be an association between intense and long-lasting participation in the RTW program and prolonged time-to first-RTW, even after controlling for level of cognitive impairments and comorbidity

Development of a Vitality Scan related to workers' sustainable employability: a study assessing its internal consistency and construct validity

BACKGROUND: Most validated sustainable employability questionnaires are extensive and difficult to obtain. Our objective was to develop a usable and valid tool, a Vitality Scan, to determine possible signs of stagnation in one’s functioning related to sustainable employability and to establish the instrument’s internal consistency and construct validity. METHODS: A literature review was performed and expert input was obtained to develop an online survey of 31 items. A sample of 1722 Dutch employees was recruited. Internal consistency was assessed by Cronbach’s alpha. The underlying theoretical concepts were extracted by factor analysis using a principal component method. For construct validity, a priori hypotheses were defined for expected differences between known subgroups: 1) older workers would report more stagnation than younger workers, and 2) less educated workers would report more problems than the highly educated ones. Both hypotheses were statistically tested using ANOVA. RESULTS: Internal consistency measures and factor analysis resulted in five subscales with acceptable to good reliability (Cronbach’s alpha 0.72-0.87). These subscales included: balance and competence, motivation and involvement, resilience, mental and physical health, and social support at work. Three items were removed following these analyses. In accordance with our a priori hypothesis 1, the ANOVA showed that older workers reported the most problems, while younger workers reported the least problems. However, hypothesis 2 was not confirmed: no significant differences were found for education level. CONCLUSIONS: The developed Vitality Scan - with the 28 remaining items - showed good measurement properties. It is applicable as a user-friendly, evaluative instrument for worker’s sustainable employability. The scan’s value for determining whether or not the employee is at risk for a decrease in functioning during present and future work, should be further tested