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.
Evaluated 40 low back pain patients by a multidisciplinary team (orthopedic surgeons, nursing staff and a medical psychologist) to identify the behavioral characteristics associated with functional and organic determinants of pain. Significant relationships were found between orthopedists' clinical judgments and higher scores on MMPI scales F, Hs, and MA, between nurses' ratings and higher scores on MMPI scales D, PA, PT, and SI, and on the Zung Depression Scale and STAI Trait‐Anxiety scale. Physicians and nurses consensually agreed on 27 cases. Behavioral observations of the orthopedists and the nursing staff revealed contrasting patterns of behavior for those patients classified as organic or functional. The power of the consensual rating method and its usefulness in clinical appraisals were discussed.
The present generation of those past age 70 grew up with the idea that a fractured hip meant "the beginning of the end" for the elderly. The results reported here on the treatment of 50 consecutive patients over 70 years of age who had sustained a fractured hip indicate that in this situation the orthopedic surgeon can be an important partner in geriatric medicine. He can improve the functioning and health of this special group of elderly trauma victims through reassuring them that the fracture usually can be successfully treated without undue risk to life. The present improved state of the art of anesthesiology, surgery, and pre- and postoperative medical care makes the surgical risk tolerable, and helps to prevent many of the complications that used to occur in elderly patients confined to bed for long periods following hip fracture.
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