Background and Purpose-This prospective, multicenter study was performed to determine the frequency of symptomatic complications up to 30 months after stroke using prespecified definitions of complications. Methods-We recruited 311 consecutive stroke patients admitted to hospital. Research nurses reviewed their progress on a weekly basis until hospital discharge and again at 6, 18, and 30 months after stroke. Results-Complications during hospital admission were recorded in 265 (85%) of stroke patients. Specific complications were as follows: neurological-recurrent stroke (9% of patients), epileptic seizure (3%); infections-urinary tract infection (24%), chest infection (22%), others (19%); mobility related-falls (25%), falls with serious injury (5%), pressure sores (21%); thromboembolism-deep venous thrombosis (2%), pulmonary embolism (1%); pain-shoulder pain (9%), other pain (34%); and psychological-depression (16%), anxiety (14%), emotionalism (12%), and confusion (56%). During follow-up, infections, falls, "blackouts," pain, and symptoms of depression and anxiety remained common. Complications were observed across all 3 hospital sites, and their frequency was related to patient dependency and duration after stroke. Conclusions-Our prospective cohort study has confirmed that poststroke complications, particularly infections and falls, are common. However, we have also identified complications relating to pain and cognitive or affective symptoms that are potentially preventable and may previously have been underestimated.
The results indicate no statistically significant benefit from single agent EPA in the treatment of cancer cachexia. Future studies should concentrate on other agents or combination regimens.
Appropriately resourced ESD services provided for a selected group of stroke patients can reduce long-term dependency and admission to institutional care as well as shortening hospital stays.
The conventional approach to the analysis of a Phase III trial in head injury or stroke takes an ordered scale measuring functional outcome and collapses the scale to a binary outcome of favorable versus unfavorable. This discards potentially relevant information which limits statistical power and moreover is not in accord with clinical practice. We propose an alternative approach where a favorable outcome is defined as better than would be expected, taking account of each individual patient's baseline prognosis. This is illustrated through a worked example based on data from a Phase III trial in head injury. The approach is also compared with the proportional odds model, which is another statistical approach that can exploit an ordered outcome scale. The approach raises issues of clinical, statistical, and regulatory importance, and we initiate what we believe needs to become a widespread debate amongst the community involved in clinical research in head injury and stroke.
Objectives To establish whether providing additional postnatal support during the early postnatal months influences women's physical and psychological health and to identify health service benefits. Design Pragmatic randomised controlled trial with a 2 Â 2 factorial design with two interventions.Setting Community centres, Ayrshire and Grampian, Scotland.Population One thousand and four primiparous women, 83% completed the baseline questionnaire, 71% at six months. Methods (1) An invitation to a local postnatal support group run weekly with a facilitator, starting two weeks postpartum. (2) A postnatal support manual, posted two weeks postpartum. Main outcome measures Data regarding primary outcome postnatal depression (Edinburgh Postnatal Depression Scale, EPDS), secondary outcomes, general health measures (SF-36), social support (SSQ6), use of health services and women's views of interventions were collected at two weeks postpartum and at three and six months. Results There were no significant differences in EPDS scores between the control and trial arms at three and six months, nor were there differences in the SF-36 and the SSQ6 scores. The 95% CI for the difference in EPDS effectively excluded a change in mean score of more than 10% with either intervention. There were no differences in health service attendances in primary or secondary care between the control and trial arms. Of those women who attended the groups, 40% attended six or more. Women reported favourably on the 'pack' with the majority reading it a few times and feeling that it was aimed at them. Conclusions Wide-scale provision by the National Health Service of either support groups or self-help manuals is not appropriate if the aim is to improve measurable health outcomes.
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