BMJ Open (Nov 2020)
Feasibility of reporting results of large randomised controlled trials to participants: experience from the Fluoxetine Or Control Under Supervision (FOCUS) trial
- Martin Dennis,
- D Cohen,
- A Thompson,
- M Smith,
- A Naqvi,
- Graham Ellis,
- A Khan,
- L Hunt,
- X Huang,
- J Andrews,
- J Foot,
- J Smith,
- S Wong,
- A Stevens,
- D Bailey,
- S Johnston,
- S Jones,
- R Robinson,
- A Johnson,
- S Williams,
- T Smith,
- A Ahmed,
- S Bloom,
- L Sekaran,
- D Singh,
- F Smith,
- R Greenwood,
- A Singh,
- R Brown,
- J White,
- S Smith,
- S Arif,
- S Ross,
- S Trippier,
- S Levy,
- B Patel,
- M Khan,
- A Thomas,
- S Brown,
- V Jones,
- D Wood,
- S Maguire,
- U Khan,
- P Nair,
- A Smith,
- G Hann,
- R Williams,
- M Cooper,
- S Jackson,
- M Hassan,
- P Kumar,
- A Metcalf,
- R Patel,
- A Wright,
- S Khan,
- A Bell,
- C Williams,
- M Robinson,
- K Jones,
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- R Shah,
- J Simpson,
- K Ali,
- K Miller,
- K Kennedy,
- S Ahmed,
- J Francis,
- L Thomas,
- M Scott,
- S Nelson,
- S Clayton,
- L Zhang,
- B Charles,
- P Lopez,
- A Fleming,
- C Lambert,
- A Shah,
- J Wong,
- David Burgess,
- L Wilson,
- A Siddiqui,
- S Kumar,
- A Hassan,
- D Cooke,
- M Williams,
- P Cooper,
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- S Crothers,
- B Wroath,
- G Douris,
- D Vahidassr,
- B Gallen,
- C McGoldrick,
- M Bhattad,
- J Putteril,
- R Gallifent,
- E Makanju,
- M Lepore,
- C McRedmond,
- L Arundell,
- A Goulding,
- K Kawafi,
- P Jacob,
- L Turner,
- N Saravanan,
- L Johnson,
- D Morse,
- R Namushi,
- S Humphrey,
- M Salehin,
- S Tinsley,
- T Jones,
- L Garcia-Alen,
- L Kalathil,
- N Gautam,
- J Horton,
- J Meir,
- E Margerum,
- A Ritchings,
- K Amor,
- V Nadarajan,
- J Laurence,
- S Fung Lo,
- S Melander,
- P Nicholas,
- E Woodford,
- G McKenzie,
- V Le,
- J Crause,
- P OMahony,
- C Orefo,
- C McDonald,
- E Osikominu,
- G Appiatse,
- A Wardale,
- M Augustin,
- R Luder,
- M Bhargava,
- G Bhome,
- V Johnson,
- D Chesser,
- H Bridger,
- E Murali,
- A Burns,
- J Graham,
- M Duffy,
- E Pitcher,
- J Gaylard,
- J Newman,
- S Punnoose,
- S Oakley,
- V Murray,
- C Bent,
- R Walker,
- K Purohit,
- A Rees,
- S Besley,
- O Chohan,
- L Argandona,
- L Cuenoud,
- H Hassan,
- E Erumere,
- A OCallaghan,
- O Redjep,
- G Auld,
- P Gompertz,
- A Song,
- R Hungwe,
- H Kabash,
- T Tarkas,
- G Livingstone,
- F Butler,
- S Bradfield,
- L Gordon,
- J Schmit,
- A Wijewardane,
- C Medcalf,
- T Edmunds,
- R Wills,
- C Peixoto
Affiliations
- Martin Dennis
- Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
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- 7AstraZeneca, Gaithersburg, MD, USA
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- Improvement Hub, Healthcare Improvement Scotland, Edinburgh, UK
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- 2Imorphics
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- 5Pfizer Inc, New York, NY
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- 1Hamburg Center for Pediatric Rheumatology, Hamburg
- D Bailey
- S Johnston
- 4VirTus Respiratory Research, Ltd, London, UK
- S Jones
- 5Cardiff and Vale University Health Board, Cardiff, UK
- R Robinson
- A Johnson
- S Williams
- Department of Pediatrics, Medical Center of Central Georgia, Macon, GA
- T Smith
- 5Pfizer Inc, New York, NY, United States
- A Ahmed
- 1Internal Medicine, Rheumatology & Clinical Immunology Subspeciality, Kasr Alainy
- S Bloom
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- 12Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK
- F Smith
- R Greenwood
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- Wyeth Research, Collegeville, Pennsylvania, USA
- R Brown
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- 1North Middlesex University Hospital, London, UK
- S Smith
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- B Patel
- M Khan
- A Thomas
- 18Neurosurgery, Cooper University Health Care, Camden, NJ, USA
- S Brown
- 3Neurocritical Care, The Queen’s Medical Center, Honolulu, HI, USA
- V Jones
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- U Khan
- University of Mississippi, Jackson, MS
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- A Smith
- 1Epidemiology and Cancer Statistics Group, Health Sciences, University of York, York, UK
- G Hann
- R Williams
- 4Radiology, Medical Imaging of Lehigh Valley, Allentown, PA, USA
- M Cooper
- S Jackson
- 1Department of Paediatrics, University of Oxford, Oxford, UK
- M Hassan
- 2Alexandria University, Alexandria, Egypt
- P Kumar
- 2University Hospitals of Leicester NHS Trust, UK, Leicester, United Kingdom
- A Metcalf
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- 10University College London Hospitals NHS Foundation Trust, London, UK of Great Britain and UK
- A Wright
- 1School of Physiotherapy and Exercise Science
- S Khan
- 1Rheumatology
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- Department of Neurology, School of Veterinarian Medicine, University of California Davis, Davis, California, 95618, USA
- M Robinson
- South Western Ambulance Service NHS Foundation Trust, UK
- K Jones
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- R Shah
- 2Rheumatology Department, East Surrey Hospital, Redhill, United Kingdom
- J Simpson
- 1Population Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
- K Ali
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- S Ahmed
- Clinical Immunology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India
- J Francis
- Medical College Calicut, Kerala, India
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- 7Department of Pharmaceutical/Medicinal Chemistry
- M Scott
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- 1Department of Pulmonary and Critical Care Medicine, Department of Physiology
- S Clayton
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- 1Reumatologia, Hospital Regional Universitario Jose Maria Cabral y Baez
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- 2The London School of Hygiene and Tropical Medicine, London, UK of Great Britain and UK
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- 2 Service user representative, Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
- L Wilson
- 1Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
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- Neurosurgery, University at Buffalo Neurosurgery, Buffalo, NY, USA
- S Kumar
- 4Child Health, Christian Medical College, Vellore, Tamil Nadu, Vellore, India
- A Hassan
- 4Neurology, Valley Baptist Medical Center, Harlingen, TX, USA
- D Cooke
- 1Department of Neuroendovascular Surgery, University of California, San Francisco, San Francisco, CA, USA
- M Williams
- P Cooper
- S Graham
- 3University of Tennessee Health Science Center, College of Medicine, Memphis, TN, USA
- S Morrison
- M Holland
- C Green
- 2Institute of Health Research, University of Exeter Medical School, Exeter, UK
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- K Subramanian
- K Patel
- Department of Respiratory Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK
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- Samumed, LLC, San Diego, CA, United States
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- 4Galen Research, Manchester, United Kingdom
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- 7University of Auckland, Auckland, New Zealand
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- 2North Tees and Hartlepool NHS Foundation Trust, North Tees, UK
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- 3Asthma and Lung UK, London, UK
- S Lewis
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- 1 Centre for Health Sciences Research, University of Salford, Salford, UK
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- Centre for Longitudinal Studies, UCL Social Research Institute, University College London, London, UK
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- 4VirTus Respiratory Research, Ltd, London, UK
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- 1Northumbria University, Newcastle upon Tyne, UK
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- 1Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
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- 3Sidney Kimmel Medical College, Philadelphia, PA
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- Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
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- Mid and South Essex NHS Trust, Chelmsford, UK
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- Tallaght University Hospital, Dublin Ireland
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- 1University of Manchester, Manchester, United Kingdom
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- Department of Rheumatology, University College London NHS Trust, London, United Kingdom
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- Neurology, University of Toledo, Toledo, OH
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- 1Department of Rheumatology
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- 1Kettering General Hospital, Kettering, UK
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- 3Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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- 16 University of Queensland, Brisbane, Queensland, Australia
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- 4University of Birmingham, Birmingham
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- 1Imperial College, London, UK
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- M Hussain
- 1Cleveland Clinic, Cleveland, OH, USA
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- 2Department of Rheumatology, William Harvey Hospital, Ashford, United Kingdom
- J Roberts
- 6Pfizer Inc, Tadworth, United Kingdom
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- C McInnes
- Department of International Politics, Aberystwyth University, Penglais, Aberystwyth, UK
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- 4John Taylor Hospice, UK
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- Samuel Lunenfeld Research Institute and University of Toronto, Toronto, Ontario, Canada
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- 1Innovation Agency, Daresbury, UK
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- 1POLARIS, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK
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- 1University of South Carolina School of Medicine Greenville, Greenville, SC, USA
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- 2Data and Insights, Aberdeen City Council, Aberdeen, UK
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- 1Adult and Pediatric Rheumatology, Allergy and Immunology, Al-Mafraq Hospital, Abu Dhabi, United Arab Emirates
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- 2Department of Neurosurgery, Prisma Richland Hospital, University of South Carolina School of Medicine Columbia, Columbia, SC
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- 1University of Cincinnati College of Medicine, Cincinnati, OH, USA
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- 3Dept of Public Health and Clinical Medicine, Umeå
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- 3 Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK
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- Imperial College London, London, UK
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- 2School of Medicine, University of St Andrews, St Andrews, UK
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- 1 Research Center on Cognitive Sciences, Faculty of Psychology, Universidad de Talca, Talca, Chile
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- 1University of Manchester, Manchester, UK
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- DOI
- https://doi.org/10.1136/bmjopen-2020-040492
- Journal volume & issue
-
Vol. 10,
no. 11
Abstract
Objectives Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.Design In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.Setting UK stroke services.Participants 3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.Results Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.Conclusion It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.Trial registration number ISRCTN83290762; Post-results.
