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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 trialsand for the individual patient data meta-analysis

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Show simple item record Graham, Catriona Lewis, Steff Forbes, John F. Mead, Gillian Elizabeth Hackett, Maree L. Hankey, Graeme J. Gommans, John Nguyen, Huy Thang Lundström, Erik Isaksson, Eva Näsman, Per Rudberg, Ann-Sofie Dennis, Martin 2018-01-03T09:17:24Z 2018-01-03T09:17:24Z 2017
dc.description peer-reviewed en_US
dc.description.abstract 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. Trial registration: FOCUS: ISRCTN, ISRCTN83290762. Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Registered on 22 July 2011. EFFECTS: ISRCTN, ISRCTN13020412. Registered on 19 December 2014., NCT02683213. Registered on 2 February 2016. EudraCT, 2011-006130-16. Registered on 8 August 2014. en_US
dc.language.iso eng en_US
dc.publisher BioMed Central en_US
dc.relation.ispartofseries Trials;18:627
dc.subject ischaemic stroke en_US
dc.subject haemorrhagic stroke en_US
dc.subject antidepressants en_US
dc.subject SSRI en_US
dc.subject fluoxetine en_US
dc.subject recovery en_US
dc.subject depression en_US
dc.title 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 trialsand for the individual patient data meta-analysis en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.identifier.doi 10.1186/s13063-017-2385-6
dc.contributor.sponsor UK Stroke Association en_US
dc.contributor.sponsor NIHR Health Technology Assessment Programme en_US
dc.contributor.sponsor National Health and Medical Research Council (NHMRC) en_US
dc.contributor.sponsor University of Sydney en_US
dc.contributor.sponsor Konung Gustaf V:s och Drottning Victorias Frimurare, Hjärt-Lungfonden en_US
dc.contributor.sponsor Stroke Riksförbundet en_US
dc.contributor.sponsor Vetenskapsrådet the Swedish Research Council en_US
dc.relation.projectid TSA 2011101 en_US
dc.relation.projectid 13/04/30 en_US
dc.relation.projectid APP1013612 en_US
dc.relation.projectid APP1059094 en_US
dc.relation.projectid 921-2014-7072 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.rssid 2735932

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