BMC research notes
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Randomized Controlled Trial
Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.
We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. ⋯ Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).
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Observational Study
National report on aggressions to physicians in Spain 2010-2015: violence in the workplace-ecological study.
Aggressions against health staff is a phenomenon that is not widely studied worldwide. To date, there is no national study analyzing this situation in Spain. Our objective is to describe and analyze aggressions to physicians of the whole Spanish territory in the period 2010-2015, through an observational analytical study by conglomerates (ecological) with all aggressions to physicians identified by the 52 official medical associations of Spain over 6 years of study. ⋯ There were 2419 aggressions on physicians, 51% on men. Primary care is the area that concentrates more incidents (54%) and the public sector is the most affected (89%). A third of the assaults were concentrated on professionals aged 46-55 years old. Cumulative incidence decreased from 20 aggressions × 10,000 physicians in 2010 to 15 × 10,000 physicians in 2015. The importance and seriousness of the problem of aggressions against physicians is verified through notifications to the registry. The collection method is different from others based on surveys, and therefore the figures are significantly lower than other studies. The scant denunciation by attacked physicians in Spain makes deceiving the real dimensions of the phenomenon.