15 research outputs found

    Testing devices for the prevention and treatment of stroke and its complications

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    We are entering a challenging but exciting period when many new interventions may appear for stroke based on the use of devices. Hopefully these will lead to improved outcomes at a cost that can be afforded in most parts of the world. Nevertheless, it is vital that lessons are learnt from failures in the development of pharmacological interventions (and from some early device studies), including inadequate preclinical testing, suboptimal trial design and analysis, and underpowered studies. The device industry is far more disparate than that seen for pharmaceuticals; companies are very variable in size and experience in stroke, and are developing interventions across a wide range of stroke treatment and prevention. It is vital that companies work together where sales and marketing are not involved, including in understanding basic stroke mechanisms, prospective systematic reviews, and education of physicians. Where possible, industry and academics should also work closely together to ensure trials are designed to be relevant to patient care and outcomes. Additionally, regulation of the device industry lags behind that for pharmaceuticals, and it is critical that new interventions are shown to be safe and effective rather than just feasible. Phase IV postmarketing surveillance studies will also be needed to ensure that devices are safe when used in the ‘real-world’ and to pick up uncommon adverse events

    Very Early Rehabilitation in SpEech (VERSE): Progress report

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    Background: Little is known about the relationship between ambient temperature and the severity of perihematomal oedema.We aimed to determine the association of ambient temperature with oedema volume in acute intracerebral haemorrhage (ICH) among Chinese participants in INTERACT 1. Method: INTERACT 1 was a randomised controlled trial of intensive blood pressure (BP) lowering in 404 patients with acute ICH. Among 250 Chinese participants, data on ambient temperature (mean, minimum, maximum and range) on the day of ICH onset obtained from China Meteorological Data Sharing Service System were linked to each patient's oedema volume. Crude linear regression and multivariable regression analyses were performed to evaluate the relationship of ambient temperature with oedema volume. Results: There were positive associations between mean temperature and minimum temperature at baseline, 24 hour and 72 hour time points after hospital admission (all P < 0.05). All temperature parameters with the exception of diurnal temperature range were positively associated after adjusting for confounding factors (all P < 0.02). Conclusion: There is an evidence of relationship between ambient temperature with the severity of perihematomal oedema in acute ICH.1 page(s
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