The objective of the EXAMINE-AF study was to record and compare antithrombotic treatment in patients with atrial fibrillation (AF) in daily clinical practice of general practitioners, internists and cardiologists in the Netherlands. Eighty-six general practitioners, 93 internists and 99 cardiologists responded to postal questionnaires and enrolled 1596 patients: 365, 351 and 880 respectively. A cardiologist was indicated to be the main treating physician for AF in 82% of all patients; current antithrombotic treatment was initiated in 80% by a cardiologist. Of all patients, 84% were at high risk for stroke and therefore were eligible for oral anticoagulation treatment, but only 64% actually received this. Cardiologists instituted appropriate antithrombotic treatment best, compared with general practitioners and internists (70% vs. 58% and 55%; p < 0.001). Positive predictive factors for oral anticoagulation prescription were previous stroke/transient ischaemic attack (OR, 2.31; 95% CI, 1.33-4.02) and heart failure (OR, 1.72; 95% CI, 1.23-2.42). Contraindications for oral anticoagulation (OR, 0.46; 95% CI, 0.32-0.68), treatment by a general practitioner (OR, 0.29; 95% CI, 0.20-0.42) or internist (OR, 0.24; 95% CI, 0.15-0.39) were important factors for withholding treatment. Antithrombotic treatment in AF patients is well instituted in primary and secondary care in the Netherlands. Cardiologists play a key role in the diagnosis and management of the majority of AF patients, even in those regularly attending other physicians. Factors for oral anticoagulation prescription are heart failure, physician specialty and contraindications. Availability of guidelines seems instrumental for application of appropriate antithrombotic treatment.
BackgroundPreterm birth is in quantity and in severity the most important contributor of perinatal morbidity and mortality both in well- and low-resource countries. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for preterm birth. We aim to evaluate whether a cervical pessary can replace cervical cerclage for preventing recurrent preterm birth in women with a prior preterm birth due to cervical insufficiency or in women with a prior preterm birth and a short cervix in the current pregnancy.Methods/designA nationwide open-label multicentre randomised clinical trial will be set up to study women with a singleton pregnancy and a prior preterm birth before 34 weeks of gestation. Women are eligible in case of previous preterm birth based on cervical insufficiency (primary intervention, <16 weeks) or in case of previous preterm birth and a short cervical length in current pregnancy ≤25 mm (secondary intervention, <24 weeks). Eligible women will be randomised to either cervical pessary or cervical cerclage. Both interventions will be removed at labour or at 36 weeks of gestational age, whatever comes first. The primary outcome will be delivery before 32 weeks. Secondary outcomes will be gestational age at birth, preterm birth rate before 24, 28, 34 and 37 weeks of gestation (overall and stratified by spontaneous or indicated delivery), premature rupture of membranes, use of tocolysis and/or corticosteroids during pregnancy, mode of delivery, maternal infections, maternal side effects, neonatal and maternal hospital admissions, and a composite of adverse perinatal outcomes including both morbidity and mortality. We assume an event rate of 20% preterm birth before 32 weeks for cerclage and use a non-inferiority margin of 10% for the cervical pessary. Using an alpha of 0.05 and power of 0.80 we need 2 groups of 200 women each.DiscussionThe outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.Trial registrationNetherlands Trial Registry, NTR 4415. Date registered: 29th of January 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-017-1393-6) contains supplementary material, which is available to authorized users.
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