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The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: Statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis
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2017 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 627Article in journal (Refereed) Published
Abstract [en]

Background: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. Methods/Design: The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. Discussion: Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020.

Place, publisher, year, edition, pages
BioMed Central Ltd. , 2017. Vol. 18, no 1, article id 627
Keywords [en]
Antidepressants, Depression, Fluoxetine, Haemorrhagic stroke, Ischaemic stroke, Recovery, SSRI, acute coronary syndrome, algorithm, Article, automutilation, brain hemorrhage, brain ischemia, cerebrovascular accident, clinical protocol, cognition, death, drug effect, falling, fracture, functional status, gastrointestinal hemorrhage, health economics, health status, human, hyperglycemia, hypoglycemia, hyponatremia, medication compliance, meta analysis, mood, neurologic disease, outcome assessment, quality of life, Rankin scale, recurrent disease, seizure, Short Form 36, side effect, suicide attempt, survival, treatment duration, treatment outcome, upper gastrointestinal bleeding
National Category
Neurology
Identifiers
URN: urn:nbn:se:kth:diva-227107DOI: 10.1186/s13063-017-2385-6ISI: 000419147400010PubMedID: 29282099Scopus ID: 2-s2.0-85039552548OAI: oai:DiVA.org:kth-227107DiVA, id: diva2:1205904
Funder
Swedish Research Council
Note

QC 20180515

Available from: 2018-05-15 Created: 2018-05-15 Last updated: 2019-02-07Bibliographically approved

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