BackgroundTrials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to determine if daily fluoxetine for 6 months after stroke improves functional outcome in Australasian and Vietnamese patients. MethodsAFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial conducted in 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10). Eligible patients were adults with a clinical diagnosis of stroke in the previous 2-15 days and a persisting neurological deficit. Patients were randomised via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20mg or matching placebo for 6 months. Patients, investigators and outcome assessors were masked to the treatment allocation. The primary outcome was functional outcome, measured by the modified Rankin scale (mRS), at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Analyses were according to the patient's treatment allocation. The trial is registered with the ACTRN registry, number 12611000774921. FindingsPowered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation 1280 patients were recruited in Australia (n=532), New Zealand (n=42) and Vietnam (n=706) between 11 January 2013 and 30 June 2019; 642 were allocated fluoxetine and 638 placebo. Adherence to trial medication (mean 167 [SD 48] days) was similar between groups. At 6 months, mRS data were available in 624 (97.2%) patients allocated fluoxetine and 632 (99.1%) placebo. The distribution of mRS categories at 6 months was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0.936, 95% CI 0.762-1.150; p=0.53), and consistent among all pre-defined subgroups. Compared to placebo, patients allocated fluoxetine had more falls (20 [3.12%] vs 7 [1.10%]; p=0.02), bone fractures (19 [2•96%] vs 6 [0.94%]; p=0.01) and epileptic seizures (10 [1.56%] vs 2 [0.31%]; p=0.04) at 6 months. InterpretationFluoxetine 20mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. These results do not support the use of fluoxetine to improve outcome after stroke.
Background and Purpose: Conditions associated with frailty are common in people experiencing stroke and may explain differences in outcomes. We assessed associations between a published, generic frailty risk score, derived from administrative data, and patient outcomes following stroke/transient ischemic attack; and its accuracy for stroke in predicting mortality compared with other measures of clinical status using coded data. Methods: Patient-level data from the Australian Stroke Clinical Registry (2009–2013) were linked with hospital admissions data. We used International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes with a 5-year look-back period to calculate the Hospital Frailty Risk Score (termed Frailty Score hereafter) and summarized results into 4 groups: no-risk (0), low-risk (1–5), intermediate-risk (5–15), and high-risk (>15). Multilevel models, accounting for hospital clustering, were used to assess associations between the Frailty Score and outcomes, including mortality (Cox regression) and readmissions up to 90 days, prolonged acute length of stay (>20 days; logistic regression), and health-related quality of life at 90 to 180 days (quantile regression). The performance of the Frailty Score was then compared with the Charlson and Elixhauser Indices using multiple tests (eg, C statistics) for predicting 30-day mortality. Models were adjusted for covariates including sociodemographics and stroke-related factors. Results: Among 15 468 adult patients, 15% died ≤90 days. The frailty scores were 9% no risk; 23% low, 45% intermediate, and 22% high. A 1-point increase in frailty (continuous variable) was associated with greater length of stay (OR adjusted , 1.05 [95% CI, 1.04 to 1.06), 90-day mortality (HR adjusted , 1.04 [95% CI, 1.03 to 1.05]), readmissions (OR adjusted , 1.02 [95% CI, 1.02 to 1.03]; and worse health-related quality of life (median difference, −0.010 [95% CI −0.012 to −0.010]). Adjusting for the Frailty Score provided a slightly better explanation of 30-day mortality (eg, larger C statistics) compared with other indices. Conclusions: Greater frailty was associated with worse outcomes following stroke/transient ischemic attack. The Frailty Score provides equivalent precision compared with the Charlson and Elixhauser indices for assessing risk-adjusted outcomes following stroke/transient ischemic attack.
To reduce barriers to rt-PA utilisation in rural facilities physicians require education on the calculated risk of ICH as well as exposure and experience to improve their ability to confidently diagnose stroke patients who are eligible for rt-PA treatment. Education for nurses on symptoms of stroke and rt-PA utilisation and administration is recommended.
Background and Purpose— Readmissions after stroke are common and appear to be associated with comorbidities or disability-related characteristics. In this study, we aimed to determine the patient and health-system level factors associated with all-cause and unplanned hospital readmission within 90 days after acute stroke or transient ischemic attack (TIA) in Australia. Methods— We used person-level linkages between data from the Australian Stroke Clinical Registry (2009–2013), hospital admissions data and national death registrations from 4 Australian states. Time to first readmission (all-cause or unplanned) for discharged patients was examined within 30, 90, and 365 days, using competing risks regression to account for deaths postdischarge. Covariates included age, stroke severity (ability to walk on admission), stroke type, admissions before stroke/TIA and the Charlson Comorbidity Index (derived from International Statistical Classification of Diseases and Related Health Problems, Tenth Revision , [Australian modified] coded hospital data in the preceding 5 years). Results— Among the 13 594 patients discharged following stroke/TIA (45% female; 65% ischemic stroke; 11% intracerebral hemorrhage; 4% undetermined stroke; and 20% TIA), 25% had an all-cause readmission and 15% had an unplanned readmission within 90 days. In multivariable analyses, the factors independently associated with a greater risk of unplanned readmission within 90 days were being female (subhazard ratio, 1.13 [95% CI, 1.03–1.24]), greater Charlson Comorbidity Index scores (subhazard ratio, 1.11 [95% CI, 1.09–1.12]) and having an admission ≤90 days before the index event (subhazard ratio, 1.85 [95% CI, 1.59–2.15]). Compared with being discharged to rehabilitation or aged care, those who were discharged directly home were more likely to have an unplanned readmission within 90 days (subhazard ratio, 1.44 [95% CI, 1.33–1.55]). These factors were similar for readmissions within 30 and 365 days. Conclusions— Apart from comorbidities and patient-level characteristics, readmissions after stroke/TIA were associated with discharge destination. Greater support for transition to home after stroke/TIA may be needed to reduce unplanned readmissions.
Background and Purpose— Despite evidence to support the prescription of antihypertensive medications before hospital discharge to promote medication adherence and prevent recurrent events, many patients with stroke miss out on these medications at discharge. We aimed to examine patient, clinical, and system-level differences in the prescription of antihypertensive medications at hospital discharge after stroke. Methods— Adults with acute ischemic stroke or intracerebral hemorrhage alive at discharge were included (years 2009–2013) from 39 hospitals participating in the Australian Stroke Clinical Registry. Patient comorbidities were identified using the International Statistical Classification of Diseases and Related Health Problems (Tenth Edition, Australian Modification ) codes from the hospital admissions and emergency presentation data. The outcome variable and other system factors were derived from the Australian Stroke Clinical Registry dataset. Multivariable, multilevel logistic regression was used to examine factors associated with the prescription of antihypertensive medications at hospital discharge. Results— Of the 10 315 patients included, 79.0% (intracerebral hemorrhage, 74.1%; acute ischemic stroke, 79.8%) were prescribed antihypertensive medications at discharge. Prescription varied between hospital sites, with 6 sites >2 SDs below the national average for provision of antihypertensives at discharge. Prescription was also independently associated with patient and clinical factors including history of hypertension, diabetes mellitus, management in an acute stroke unit, and discharge to rehabilitation. In patients with acute ischemic stroke, females (odds ratio, 0.85; 95% CI, 0.76–0.94), those who had greater stroke severity (odds ratio, 0.81; 95% CI 0.72–0.92), or dementia (odds ratio, 0.65; 95% CI, 0.52–0.81) were less likely to be prescribed. Conclusions— Prescription of antihypertensive medications poststroke varies between hospitals and according to patient factors including age, sex, stroke severity, and comorbidity profile. Implementation of targeted quality improvement initiatives at local hospitals may help to reduce the variation in prescription observed.
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