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Update to the FOCUS...
Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke : statistical analysis plan for the trials and for the individual patient data meta-analysis
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- Mead, Gillian Elizabeth (författare)
- Univ Edinburgh, Royal Infirm, Usher Inst, Room S1642, Edinburgh EH16 4SA, SA, Scotland.
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- Graham, Catriona (författare)
- Western Gen Hosp, Welcome Trust Clin Res Facil, Crewe Rd, Edinburgh EH4 2XU, Midlothian, Scotland.
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- Billot, Laurent (författare)
- Univ Sydney, George Inst Global Hlth, Sydney, NSW, Australia.
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- Näsman, Per, Docent, 1954- (författare)
- KTH,Fastighetsekonomi och finans,Säkerhetsforskning,KTH Royal Inst Technol, Ctr Safety Res, Stockholm, Sweden
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- Lundström, Erik, 1964- (författare)
- Uppsala universitet,Landtblom: Neurovetenskap
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- Lewis, Steff (författare)
- Univ Edinburgh, Nine Edinburgh BioQuarter, Level 2,9 Little France Rd, Edinburgh EH16 4UX, Midlothian, Scotland.
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- Hankey, Graeme J. (författare)
- Univ Western Australia, Fac Hlth & Med Sci, Med Sch, Crawley, WA, Australia.
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- Hackett, Maree L. (författare)
- Univ Sydney, George Inst Global Hlth, Sydney, NSW, Australia.
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- Forbes, John (författare)
- Univ Limerick, Hlth Res Inst, Limerick, Ireland.
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- Dennis, Martin (författare)
- Univ Edinburgh, Ctr Clin Brain Sci, Chancellors Bldg, Edinburgh EH16 4SA, Midlothian, Scotland.
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Univ Edinburgh, Royal Infirm, Usher Inst, Room S1642, Edinburgh EH16 4SA, SA, Scotland Western Gen Hosp, Welcome Trust Clin Res Facil, Crewe Rd, Edinburgh EH4 2XU, Midlothian, Scotland. (creator_code:org_t)
- 2020-11-25
- 2020
- Engelska.
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Ingår i: Trials. - : Springer Nature. - 1745-6215. ; 21:1
- Relaterad länk:
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https://doi.org/10.1...
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https://trialsjourna...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- BackgroundThree large trials of fluoxetine for stroke recovery (FOCUS (fluoxetine or control under supervision), AFFINITY (the Assessment oF FluoxetINe In sTroke recovery) and EFFECTS (Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke)) have been collaboratively designed with the same basic protocol to facilitate an individual patient data analysis (IPDM). The statistical analysis plan for the three individual trials has already been reported in Trials, including a brief description of the IPDM. In this protocol, we describe in detail how we will perform the IPDM.Methods/designData from EFFECTS and AFFINITY will be transferred securely to the FOCUS statistician, who will perform a one-stage IPDM and a two-stage IPDM. For the one-stage IPDM, data will be combined into a single data set and the same analyses performed as described for the individual trials. For the two-stage IPDM, the results for the three individual trials will be combined using fixed effects meta-analyses.The primary and secondary outcome domains for the IPDM are the same as for individual trials. We will also perform analyses according to several subgroups including country of recruitment, ethnicity and trial. We will also explore the effects of fluoxetine on our primary and secondary outcomes in subgroups defined by combinations of characteristics.We also describe additional research questions that will be addressed using the combined data set, and published subsequently, including predictors of important post-stroke problems such as seizures, low mood and bone fractures.DiscussionAn IPDM of our three large trials of fluoxetine for stroke recovery will allow us to provide the most precise estimates of any risks and benefits of fluoxetine vs placebo, to detect reliably a smaller overall effect size than those detectable by the individual trials, to better determine the effects of fluoxetine vs placebo in subgroups of patients and outcomes and to broaden the generalisability of the results. Also, we may identify differences in treatment effects between studies.Trial registrationFOCUS: 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. ClinicalTrials.gov NCT02683213. Registered on 2 February 2016. EudraCT 2011-006130-16. Registered on 8 August 2014.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap -- Övrig annan medicin och hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences -- Other Medical and Health Sciences not elsewhere specified (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Nyckelord
- Stroke
- Recovery
- Individual patient data meta-analysis
- FOCUS
- AFFINITY
- EFFECTS
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Mead, Gillian El ...
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Graham, Catriona
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Billot, Laurent
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Näsman, Per, Doc ...
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Lundström, Erik, ...
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Lewis, Steff
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Hankey, Graeme J ...
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Hackett, Maree L ...
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Forbes, John
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Dennis, Martin
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