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 : 000D16 ( Pmc/Curation ); précédent : 000D15; suivant : 000D17The 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 ; Graeme J. Hankey ; Martin Dennis [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2015.
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.
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.
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.
FOCUS:
The online version of this article (doi:10.1186/s13063-015-0864-1) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-015-0864-1
PubMed: 26289352
PubMed Central: 4545865
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Veronica Murray<affiliation><nlm:aff id="Aff4">Karolinska Institutet, Stockholm, Solna Sweden</nlm:aff><wicri:noCountry code="subfield">Solna Sweden</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff5">School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia Australia</nlm:aff><wicri:noCountry code="subfield">Western Australia Australia</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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</title><author><name sortKey="Mead, Gillian" sort="Mead, Gillian" uniqKey="Mead G" first="Gillian" last="Mead">Gillian Mead</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building FU303h, 49 Little France Crescent, Edinburgh, EH16 4SB UK</nlm:aff><orgName type="university">Université d'Édimbourg</orgName><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Hackett, Maree L" sort="Hackett, Maree L" uniqKey="Hackett M" first="Maree L." last="Hackett">Maree L. Hackett</name><affiliation wicri:level="1"><nlm:aff id="Aff2">The George Institute for Global Health, University of Sydney, Sydney, Australia</nlm:aff><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:aff id="Aff3">Department of Neurology, Karolinska University Hospital, Solna, Sweden</nlm:aff><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><nlm:aff id="Aff4">Karolinska Institutet, Stockholm, Solna Sweden</nlm:aff><wicri:noCountry code="subfield">Solna Sweden</wicri:noCountry></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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Hackett</name><affiliation wicri:level="1"><nlm:aff id="Aff2">The George Institute for Global Health, University of Sydney, Sydney, Australia</nlm:aff><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:aff id="Aff3">Department of Neurology, Karolinska University Hospital, Solna, Sweden</nlm:aff><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><nlm:aff id="Aff4">Karolinska Institutet, Stockholm, Solna Sweden</nlm:aff><wicri:noCountry code="subfield">Solna Sweden</wicri:noCountry></affiliation></author><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name><affiliation><nlm:aff id="Aff5">School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia Australia</nlm:aff><wicri:noCountry code="subfield">Western Australia Australia</wicri:noCountry></affiliation></author><author><name sortKey="Dennis, Martin" sort="Dennis, Martin" uniqKey="Dennis M" first="Martin" last="Dennis">Martin Dennis</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building FU303h, 49 Little France Crescent, Edinburgh, EH16 4SB UK</nlm:aff><orgName type="university">Université d'Édimbourg</orgName><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/Design</title><p>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.</p><p>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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>FOCUS: <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN83290762">ISRCTN83290762</ext-link> (23/05/2012), AFFINITY: <ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000774921">ACTRN12611000774921</ext-link> (22/07/2011). EFFECTS: <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN13020412">ISRCTN13020412</ext-link> (19/12/2014).</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-015-0864-1) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Strong, K" uniqKey="Strong K">K Strong</name></author><author><name sortKey="Mathers, C" uniqKey="Mathers C">C Mathers</name></author><author><name sortKey="Bonita, R" uniqKey="Bonita R">R Bonita</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Shin, Tk" uniqKey="Shin T">TK Shin</name></author><author><name sortKey="Kang, Ms" uniqKey="Kang M">MS Kang</name></author><author><name sortKey="Lee, Hy" uniqKey="Lee H">HY Lee</name></author><author><name sortKey="Seo, Ms" uniqKey="Seo M">MS 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26289352</article-id><article-id pub-id-type="pmc">4545865</article-id><article-id pub-id-type="publisher-id">864</article-id><article-id pub-id-type="doi">10.1186/s13063-015-0864-1</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>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</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Mead</surname><given-names>Gillian</given-names></name><address><email>Gillian.E.Mead@ed.ac.uk</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hackett</surname><given-names>Maree L.</given-names></name><address><email>mhackett@georgeinstitute.org.au</email></address><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Lundström</surname><given-names>Erik</given-names></name><address><email>erik.lundstrom@gmail.com</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Murray</surname><given-names>Veronica</given-names></name><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Hankey</surname><given-names>Graeme J.</given-names></name><address><email>Graeme.Hankey@health.wa.gov.au</email></address><xref ref-type="aff" rid="Aff5"></xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Dennis</surname><given-names>Martin</given-names></name><address><phone>+44(0)1314659617</phone><email>martin.dennis@ed.ac.uk</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><aff id="Aff1"><label></label>Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building FU303h, 49 Little France Crescent, Edinburgh, EH16 4SB UK</aff><aff id="Aff2"><label></label>The George Institute for Global Health, University of Sydney, Sydney, Australia</aff><aff id="Aff3"><label></label>Department of Neurology, Karolinska University Hospital, Solna, Sweden</aff><aff id="Aff4"><label></label>Karolinska Institutet, Stockholm, Solna Sweden</aff><aff id="Aff5"><label></label>School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia Australia</aff></contrib-group><pub-date pub-type="epub"><day>20</day><month>8</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>20</day><month>8</month><year>2015</year></pub-date><pub-date pub-type="collection"><year>2015</year></pub-date><volume>16</volume><elocation-id>369</elocation-id><history><date date-type="received"><day>18</day><month>3</month><year>2015</year></date><date date-type="accepted"><day>14</day><month>7</month><year>2015</year></date></history><permissions><copyright-statement>© Mead et al. 2015</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold> This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/Design</title><p>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.</p><p>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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>FOCUS: <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN83290762">ISRCTN83290762</ext-link> (23/05/2012), AFFINITY: <ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000774921">ACTRN12611000774921</ext-link> (22/07/2011). EFFECTS: <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN13020412">ISRCTN13020412</ext-link> (19/12/2014).</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-015-0864-1) contains supplementary material, which is available to authorized users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Ischaemic stroke</kwd><kwd>Haemorrhagic stroke</kwd><kwd>Antidepressants</kwd><kwd>SSRI</kwd><kwd>Fluoxetine</kwd><kwd>Recovery</kwd><kwd>Depression</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2015</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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