SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.

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Summary Background Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. Funding British Heart Foundation.

People living with human immunodeficiency virus infection (HIV) are at increased risk for developing cardiovascular disease (CVD). Safe and effective interventions for lowering CVD risk in HIV are high priorities.Objective-We conducted a prospective, randomized, controlled study to evaluate whether a yoga lifestyle intervention improves CVD risk factors, virologic or immunologic status, or quality of life in HIV-infected adults more than in a matched control group.Methods-Sixty HIV-infected adults with mild-moderate CVD risk were assigned to 20 wks of supervised yoga practice or standard of care treatment. Baseline and week 20 measures were; 2hr-oral glucose tolerance test with insulin monitoring, body composition, fasting serum lipid/lipoprotein profile, resting blood pressures, CD4+ T-cell number and plasma HIV RNA, and the Medical Outcomes Study SF-36 health-related quality of life inventory.Results-Resting systolic and diastolic blood pressures were reduced more (p=0.04) in the yoga group (−5±2 and −3±1 mmHg) than in the standard of care group (+1±2 and +2±2 mmHg), despite no greater reduction in body weight, fat mass, proatherogenic lipids, or improvements in glucose tolerance or overall quality of life after yoga. Immune and virologic status was not adversely affected.Conclusion-Among traditional lifestyle modifications, yoga is a low cost, simple to administer, non-pharmacological, popular behavioral intervention that can lower blood pressure in prehypertensive HIV-infected adults with mild-moderate CVD risk factors.

Good to high short-term (3-week) stability and convergent and discriminant validity of the Job Descriptive Index (JDI) were established using multitraitmultimethod matrices. Two groups (n = 50 each) responded twice to the same JDI, one with the yes/?/no format and one with a 5-point Likert-type format. Test-retest coefficients ranged from .68 to .88 and from .70 to .78, respectively. Corresponding coefficients alpha ranged from .75 to ,91 and from .80 to .93. Times 1 and 2 were treated as methods, and subscales were treated as traits in two matrices (« = 50, each format). Analyses of variance (Kavanagh, Mac-Kinney, & Wolins, 1971) showed slightly greater discriminant validity, but greater method bias, for the Likert-type method. Two additional groups (n = 50 each) were given the two response formats in counterbalanced order, thus forming a third matrix. Similar analysis (treating formats as methods and subscales as traits) showed significant convergent validities and a small, but significant, method bias. The three matrices met the criterion for convergent validity and all three criteria for discriminant validity (Campbell & Fiske, 1959). Both methods yielded acceptable reliabilities and validities; differences were trivial. For several practical reasons, we recommend continued use of the original format unless research requires extreme sensitivity at the favorable end of the Supervision and Co-workers subscales or the unfavorable end of the Promotion subscale.

Local and national attention is needed to prevent 'drift' into activities that both support workers and registered practitioners consider outside their remit. Barriers to training and further qualification need to be addressed.

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