The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials.
Identifieur interne : 002970 ( PubMed/Curation ); précédent : 002969; suivant : 002971The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials.
Auteurs : Gillian Mead [Royaume-Uni] ; Maree L. Hackett [Australie] ; Erik Lundström [Suède] ; Veronica Murray [Suède] ; Graeme J. Hankey [Australie] ; Martin Dennis [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2015.
Descripteurs français
- KwdFr :
- Accident vasculaire cérébral (), Accident vasculaire cérébral (diagnostic), Accident vasculaire cérébral (physiopathologie), Accident vasculaire cérébral (économie), Analyse coût-bénéfice, Australie, Coûts des médicaments, Examen neurologique, Facteurs temps, Fluoxétine (effets indésirables), Fluoxétine (usage thérapeutique), Fluoxétine (économie), Humains, Inhibiteurs de la capture de la sérotonine (effets indésirables), Inhibiteurs de la capture de la sérotonine (usage thérapeutique), Inhibiteurs de la capture de la sérotonine (économie), Méta-analyse comme sujet, Nouvelle-Zélande, Plan de recherche, Protocoles cliniques, Royaume-Uni, Récupération fonctionnelle, Résultat thérapeutique, Suède, Études prospectives, Évaluation de l'incapacité.
- MESH :
- diagnostic : Accident vasculaire cérébral.
- effets indésirables : Fluoxétine, Inhibiteurs de la capture de la sérotonine.
- physiopathologie : Accident vasculaire cérébral.
- usage thérapeutique : Fluoxétine, Inhibiteurs de la capture de la sérotonine.
- économie : Accident vasculaire cérébral, Fluoxétine, Inhibiteurs de la capture de la sérotonine.
- Accident vasculaire cérébral, Analyse coût-bénéfice, Australie, Coûts des médicaments, Examen neurologique, Facteurs temps, Humains, Méta-analyse comme sujet, Nouvelle-Zélande, Plan de recherche, Protocoles cliniques, Royaume-Uni, Récupération fonctionnelle, Résultat thérapeutique, Suède, Études prospectives, Évaluation de l'incapacité.
English descriptors
- KwdEn :
- Australia, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Drug Costs, Fluoxetine (adverse effects), Fluoxetine (economics), Fluoxetine (therapeutic use), Humans, Meta-Analysis as Topic, Neurologic Examination, New Zealand, Prospective Studies, Recovery of Function, Research Design, Serotonin Uptake Inhibitors (adverse effects), Serotonin Uptake Inhibitors (economics), Serotonin Uptake Inhibitors (therapeutic use), Stroke (diagnosis), Stroke (economics), Stroke (physiopathology), Stroke (therapy), Sweden, Time Factors, Treatment Outcome, United Kingdom.
- MESH :
- chemical , adverse effects : Fluoxetine, Serotonin Uptake Inhibitors.
- chemical , economics : Fluoxetine, Serotonin Uptake Inhibitors.
- chemical , therapeutic use : Fluoxetine, Serotonin Uptake Inhibitors.
- diagnosis : Stroke.
- economics : Stroke.
- physiopathology : Stroke.
- therapy : Stroke.
- Australia, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Drug Costs, Humans, Meta-Analysis as Topic, Neurologic Examination, New Zealand, Prospective Studies, Recovery of Function, Research Design, Sweden, Time Factors, Treatment Outcome, United Kingdom.
Abstract
Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome.
DOI: 10.1186/s13063-015-0864-1
PubMed: 26289352
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Hackett</name><affiliation wicri:level="1"><nlm:affiliation>The George Institute for Global Health, University of Sydney, Sydney, Australia. mhackett@georgeinstitute.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>The George Institute for Global Health, University of Sydney, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Lundstrom, Erik" sort="Lundstrom, Erik" uniqKey="Lundstrom E" first="Erik" last="Lundström">Erik Lundström</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Karolinska University Hospital, Solna, Sweden. erik.lundstrom@gmail.com.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Neurology, Karolinska University Hospital, Solna</wicri:regionArea></affiliation></author><author><name sortKey="Murray, Veronica" sort="Murray, Veronica" uniqKey="Murray V" first="Veronica" last="Murray">Veronica Murray</name><affiliation wicri:level="1"><nlm:affiliation>Karolinska Institutet, Stockholm, Solna, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Karolinska Institutet, Stockholm, Solna</wicri:regionArea></affiliation></author><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J" last="Hankey">Graeme J. 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thérapeutique</term><term>Suède</term><term>Études prospectives</term><term>Évaluation de l'incapacité</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Fluoxetine</term><term>Serotonin Uptake Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="economics" xml:lang="en"><term>Fluoxetine</term><term>Serotonin Uptake Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Fluoxetine</term><term>Serotonin Uptake Inhibitors</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Stroke</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Accident vasculaire cérébral</term></keywords><keywords scheme="MESH" qualifier="economics" xml:lang="en"><term>Stroke</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Fluoxétine</term><term>Inhibiteurs de la capture 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Studies</term><term>Recovery of Function</term><term>Research Design</term><term>Sweden</term><term>Time Factors</term><term>Treatment Outcome</term><term>United Kingdom</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Accident vasculaire cérébral</term><term>Analyse coût-bénéfice</term><term>Australie</term><term>Coûts des médicaments</term><term>Examen neurologique</term><term>Facteurs temps</term><term>Humains</term><term>Méta-analyse comme sujet</term><term>Nouvelle-Zélande</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Royaume-Uni</term><term>Récupération fonctionnelle</term><term>Résultat thérapeutique</term><term>Suède</term><term>Études prospectives</term><term>Évaluation de l'incapacité</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26289352</PMID><DateCreated><Year>2015</Year><Month>08</Month><Day>20</Day></DateCreated><DateCompleted><Year>2016</Year><Month>05</Month><Day>02</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2015</Year><Month>Aug</Month><Day>20</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials.</ArticleTitle><Pagination><MedlinePgn>369</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-015-0864-1</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">The three trial investigator teams have collaboratively developed a core protocol. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (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 subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients. The trials include patients ≥18 years old with a clinical diagnosis of stroke, persisting focal neurological deficits at randomisation between 2 and 15 days after stroke onset. Patients are randomised centrally via web-based randomisation systems using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Our primary outcome measure is the modified Rankin scale (mRS) at 6 months. Secondary outcomes include the Stroke Impact Scale, EuroQol (EQ5D-5 L), the vitality subscale of the Short-Form 36, diagnosis of depression, adherence to medication, adverse events and resource use. Outcomes are collected at 6 and 12 months. The methods of collecting these data are tailored to the national setting. If FOCUS, AFFINITY and EFFECTS combined enrol 6000 participants as planned, they would have 90 % power (alpha 5 %) to detect a common odds ratio of 1.16, equivalent to a 3.7 % absolute difference in percentage with mRS 0-2 (44.0 % to 47.7 %). This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">If fluoxetine is safe and effective in promoting functional recovery, it could be rapidly, widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND"></AbstractText><AbstractText Label="FOCUS" NlmCategory="OBJECTIVE">ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011).</AbstractText><AbstractText Label="EFFECTS" NlmCategory="UNASSIGNED">ISRCTN13020412 (19/12/2014).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mead</LastName><ForeName>Gillian</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building FU303h, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. Gillian.E.Mead@ed.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hackett</LastName><ForeName>Maree L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>The George Institute for Global Health, University of Sydney, Sydney, Australia. mhackett@georgeinstitute.org.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lundström</LastName><ForeName>Erik</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Neurology, Karolinska University Hospital, Solna, Sweden. erik.lundstrom@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Murray</LastName><ForeName>Veronica</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Karolinska Institutet, Stockholm, Solna, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hankey</LastName><ForeName>Graeme J</ForeName><Initials>GJ</Initials><AffiliationInfo><Affiliation>School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia. Graeme.Hankey@health.wa.gov.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dennis</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building FU303h, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. martin.dennis@ed.ac.uk.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ISRCTN</DataBankName><AccessionNumberList><AccessionNumber>ISRCTN13020412</AccessionNumber><AccessionNumber>ISRCTN83290762</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>08</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D017367">Serotonin Uptake Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>01K63SUP8D</RegistryNumber><NameOfSubstance UI="D005473">Fluoxetine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2005 Feb 26-Mar 4;365(9461):755-63</RefSource><PMID Version="1">15733716</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Stroke. 1993 Jan;24(1):35-41</RefSource><PMID Version="1">7678184</PMID></CommentsCorrections><CommentsCorrections 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