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- Ederle, Joerg, et al.
(författare)
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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial
- 2010
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Ingår i: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
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Tidskriftsartikel (refereegranskat)abstract
- Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
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| 3. |
- Hagger, Martin S., et al.
(författare)
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Predicting alcohol consumption and binge drinking in company employees: An application of planned behaviour and self-determination theories
- 2012
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Ingår i: British Journal of Health Psychology. - : Wiley. - 1359-107X. ; 17, s. 379-407
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Tidskriftsartikel (refereegranskat)abstract
- Objectives. This study tested an integrated model of the psychosocial determinants of alcohol-related behaviour among company employees from four nations. A motivational sequence was proposed in which motivational orientations from selfdetermination theory influenced intentions to consume alcohol within guideline limits and alcohol-related behaviour via the mediation of the theory of planned behaviour variables of attitude, subjective norms, and perceived behavioural control (PBC). Design. A three-wave prospective design using self-reported psychological and behavioural measures. Methods. Company employees (N = 486, males = 225, females = 261; M age = 30.41, SD = 8.31) from four nations (Estonia, Finland, Sweden, and UK) completed measures of autonomous and controlled motivation from self-determination theory,attitudes, subjective norms, PBC, intentions from the theory of planned behaviour, and self-reported measures of past alcohol consumption and binge-drinking occasions at the first time point (time 1). Follow-up psychological and behavioural measures were taken one month later (time 2) and follow-up behavioural measures taken a further 2 months later (time 3). Results. Path analyses supported the motivational sequence with identified regulation (time 1), predicting intentions (time 1), and alcohol units consumed (time 2). The effects were indirect via the mediation of attitudes and PBC (time 1). A similar pattern of effects was found for the effect of time 2 psychological variables on time 3 units of alcohol consumed. There was little support for the effects of the psychological variables on binge-drinking behaviour. Conclusions. Findings provide new information on the psychosocial determinants of alcohol behaviour in company employees and the processes involved. Results may provide impetus for the development of interventions to reduce alcohol consumption.
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