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Feasibility of reporting results of large randomised controlled trials to participants: experience from the Fluoxetine Or Control Under Supervision (FOCUS) trial
Authors :
Martin Dennis D Cohen A Thompson Graham Ellis A Khan L Hunt X Huang J Andrews J Foot S Wong A Stevens D Bailey S Johnston R Robinson A Johnson S Williams T Smith A Ahmed S Bloom L Sekaran D Singh F Smith R Greenwood R Brown J White S Arif S Ross S Trippier S Levy B Patel M Khan A Thomas S Brown V Jones D Wood 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 M Robinson K Jones S Alam R Shah J Simpson K Ali K Miller K Kennedy S Ahmed 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 S Graham S Morrison M Holland C Green C Edwards K Subramanian K Patel J Mitchell J Stewart S Keenan C Duggan S McKenna M Ward S Walker L Wright M Edwards N Sattar J Mcgee R Butler M Wilkinson C Kelly R Cowan C Brown K Moore L Denny S Patel R Rodriguez J Allen M Kalita Gillian Mead A Bowring A Edwards J Scott J Drew L Dixon K Burton E Brown E Epstein R Miller F Reid A Jones P Murphy A Ali N Ahmad S Noor C Leonard A Nair M Naeem E Douglas J Thompson R Evans C Jenkins J Wilson R Anderson H Wilson H Stone J Ward L Greenhalgh P Walker A Hill K Stagg S Naqvi R Scott M Hughes P Jones M Simpson K Elliott M Davy S Young Karen Innes Pippa Tyrrell A David Steff Lewis A Bwalya C Buckley S Kelly C Thomas I Kane M Hussain S Shah J Roberts D Morales C McInnes N Khan N Weir L Hill K Kavanagh R Clarke P Thompson J Price J Ball L Benton E Walton E Walker L Burgess K McCormick L Wade C Anderson S Stevenson R Blackburn L Brown B Clarke T Khan S Dhar L Harrison S Bell D Buchanan A Deary J Drever R Fraser K Innes C McGill D Perry A Barugh G Blair Y Chun E Maschauer J Forbes M Hackett G Hankey A House E Lundström Peter Sandercock Judith Williamson Graeme Hankey Maree Hackett Veronica Murray Ray French David Stott M MacLeod F Sullivan P Langhorne H Rodgers N Hunter R Parakramawansha A Fazal P Taylor W Rutherford R Buchan A MacRaild R Paulton S Burgess D McGowan J Skwarski F Proudfoot J Perry J Bamford C Bedford D Waugh E Veraque M Kambafwile L Makawa P Smalley M Randall L Idrovo T Thirugnana-Chandran R Vowden J Jackson A Bhalla C Tam A Rudd C Gibbs J Birns L Lee Carbon E Cattermole A Cape L hurley K Marks S Kullane N Smyth E Giallombardo C Eglinton D Dellafera P Reidy M Pitt L Sykes A Frith V Croome J Duffy M Hancevic L Kerwood C Narh C Merritt J Willson T Jackson H Bowler C Kamara J Howe K Stocks G Dunn K Endean F Claydon S Duty K Harkness E Richards M Meegada A Maatouk L Barron K Dakin R Lindert A Majid P Rana C Brighouse-Johnson J Greig M Kyu S Prasad B Mclean I Alam Z Ahmed C Roffe S Brammer A Barry C Beardmore K Finney P Hollinshead J Grocott I Natarajan J Chembala R Sanyal S Lijko N Abano A Remegoso P Ferdinand S Stevens C Stephen P Whitmore A Butler C Causley R Varquez G Muddegowda R Carpio J Hiden H Denic J Sword F Hall J Cageao R Curwen M James P Mudd C Roughan H Kingwell A Hemsley C Lohan S Davenport T Chapter M Hough D Strain K Gupwell A Goff E Cusack S Todd R Partridge G Jennings K Thorpe J Stephenson K Littlewood M Barber F Brodie S Marshall D Esson I Coburn F Ross V Withers E Bowie H Barcroft L Miller P Willcoxson M Keeling M Donninson D Daniel J Coyle M Elliott P Wanklyn J Wightman E Iveson A Porteous N Dyer M Haritakis J Bell C Emms P Wood P Cottrell L Doughty L Carr C Anazodo M O Neill J Westmoreland R Mir C Donne E Bamford P Clark Brown A Stanners I Ghouri A Needle M Eastwood M Carpenter P Datta R Davey F Razik G Bateman J Archer V Balasubramanian L Jackson R Bowers J Ellam K Norton P Guyler S Tysoe P Harman A Kundu T Dowling S Chandler O Omodunbi T Loganathan S Kunhunny D Sinha M Sheppard S Kelavkar K Ng A Ropun L Kamuriwo R Orath Prabakaran E France S Rashmi D Mangion C Constantin S Markova A Hardwick J Borley L De Michele Hock T Lawrence K Netherton R Spencer H Palmer M Soliman S Leach J Sharma C Taylor I Wahishi A Fields S Butler J Hindle E Watson C Hewitt C Cullen D Hamill Z Mellor T Fluskey V Hankin A Keeling R Durairaj J Peters D Shackcloth R Tangney T Hlaing V Sutton J Ewing C Patterson H Ramadan R Bellfield U Hamid M Hooley R Ghulam L Masters W Gaba O Quinn M Tate N Mohammed S Sethuraman L Alwis K Bharaj R Pattni F Justin M Chauhan L Eldridge S Mintias J Palmones C Holmes L Guthrie N Devitt J Leonard M Osborn L Ball A Steele E Dodd A Holloway P Baker I Penwarden S Caine S Clarke L Dow R Wynn-Williams J Kennedy A DeVeciana P Mathieson I Reckless R Teal G Ford P Mccann G Cluckie G Howell J Ayer B Moynihan R Ghatala G Cloud N Al-Samarrai F Watson T Adedoyin N Chopra L Choy N Clarke A Dainty A Blight J Selvarajah W Smith F Moreton A Welch D Kalladka B Cheripelli A Lush S El Tawil N Day K Montgomery H Hamilton D Ritchie S Ramachandra K McLeish B Badiani M Abdul-Saheb A Chamberlain M Mpelembue R Bathula M Lang J Devine L Southworth N Epie E Owoyele F Guo A Oshodi V Sudkeo K Thavanesan D Tiwari C Ovington E Rogers R Bower B Longland O David A Hogan S Loganathan C Cox S Orr M Keltos K Rashed B Williams-Yesson J Board S De Bruijn C Vickers S Board J Allison E Keeling T Duckett D Donaldson C Barron L Balian T England A Hedstrom E Bedford M Harper E Melikyan W Abbott M Goldsworthy M Srinivasan I Mukherjee U Ghani A Yeomans F Hurford R Chapman S Shahzad N Motherwell L Tonks R Young D Dutta P Brown F Davis J Turfrey M Obaid B Cartwright B Topia J Spurway C Hughes S OConnell K Collins R Bakawala K Chatterjee T Webster S Haider P Rushworth F Macleod C Perkins A Nallasivan E Burns S Leason T Carter S Seagrave E Sami S Parkinson L Armstrong S Mawer G Darnbrook C Booth B Hairsine S Williamson F Farquhar B Esisi T Cassidy B McClelland G Mankin M Bokhari D Sproates S Hurdowar N Sukhdeep S Razak N Upton A Hashmi K Osman K Fotherby A Willberry D Morgan G Sahota K Jennings-Preece D Butler K Kauldhar F Harrington A Mate J Skewes K Adie K Bond G Courtauld C Schofield L Lucas A James S Ellis B Maund L Allsop C Brodie E Driver K Harris M Drake E Thomas M Burn A Hamilton S Mahalingam A Benford D Hilton A Misra L Hazell K Ofori M Mathew S Dayal I Burn D Bruce R Burnip R Hayman P Earnshaw P Gamble S Dima M Dhakal G Rogers L Stephenson R Nendick Y Pai K Nyo V Cvoro M Couser A Tachtatzis K Ullah R Cain N Chapman S Pound S McAuley D Hargroves B Ransom K Mears K Griffiths L Cowie T Hammond T Webb I Balogun H Rudenko A Thomson D Ceccarelli A Gillian E Beranova A Verrion N Chattha N Schumacher A Bahk D Sims R Tongue M Willmot C Sutton E Littleton J Khaira S Maiden J Cunningham Y Chin M Bates K Ahlquist J Breeds T Sargent L Latter A Pitt Ford T Levett N Gainsborough A Dunne E Barbon S Hervey S Ragab T Sandell C Dickson S Power J Dube N Evans B Wadams S Elitova B Aubrey T Garcia J Mcilmoyle C Dickinson C Jeffs J Howard C Armer J Frudd A Potter S Donaldson D Collas S Sundayi L Denham D Oza M Bhandari S Ispoglou K Sharobeem A Hayes J Howard-Brown S Shanu S Billingham G Howard E Wood V Pressly P Crawford H Burton A Walters J Marigold R Said C Allen S Evans S Egerton J Hakkak R Lampard S Tsang R Creeden I Gartrell F Price J Pryor A Hedges L Moseley L Mercer E Warburton D Handley S Finlay N Hannon A Espanol H Markus D Chandrasena J Sesay D Hayden H Hayhoe J Macdonald M Bolton C Farron E Amis D Day A Culbert L Whitehead S Crisp J OConnell E Osborne R Beard P Corrigan L Mokoena M Myint R Krishnamurthy A Azim S Whitworth A Nicolson M Krasinska-Chavez J Imam S Chaplin J Curtis L Wood C McGhee A Smart F Donaldson J Blackburn C Copeland P Fitzsimmons G Fletcher A Manoj P Cox L Trainor H Allsop U Sukys S Valentine D Jarrett K Dodsworth M Wands C Watkinson W Golding J Tandy K Yip C James Y Davies A Suttling K Nagaratnam N Mannava N Haque N Shields K Preston G Mason K Short G Uitenbosch G Lumsdale H Emsley S Sultan B Walmsley D Doyle A McLoughlin L Hough B Gregary S Raj A Maney S Blane G Gamble A Hague B Duran R Whiting M Harvey J Homan L Foote L Graham C Lane L Kemp J Rowe H Durman L Brotherton N Hunt A Whitcher C Pawley P Sutton S Mcdonald D Pak A Wiltshire J Balami C Self J Jagger G Healey M Crofts A Chakrabarti C Hmu J Keshet-Price G Ravenhill C Grimmer T Soe I Potter P Tam M Langley M Christie J Irvine A Joyson F Annison D Christie C Meneses V Taylor J Furnace H Gow Y Abousleiman S Goshawk J Purcell T Beadling S Collins S Sangaralingham E Munuswamy Vaiyapuri M Landicho Y Begum S Mutton J Lowe I Wiggam S Tauro S Cuddy B Wells A Mohd Nor N Persad M Weinling S Weatherby D Lashley A Pace A Mucha J Baker M Marner J Westcott N Wilmshurst D Chadha M Fairweather D Walstow R Fong M Krishnan H Thompson Jones C Lynda C Clements T Anjum S Sharon D Lynne S Tucker D Colwill E Vasileiadis A Parry C Mason M Holden K Petrides T Nishiyama H Mehta S Mumani C Almadenboyle S Carson M Stirling E Tenbruck D Broughton A Annamalai D Tryambake A Skotnicka A Sigsworth S Whitehouse J Pagan A Pusalkar H Beadle K Chan P Dangri A Asokanathan A Rana S Gohil K Crabtree A Cook M Massyn P Aruldoss S Dabbagh T Black R Fennelly L Nardone V DiMartino A Anthony D Mead M Tribbeck B Affley C Sunderland E Young L Goldenberg P Wilkinson L Abbott R Nari S Lock A Shakhon R Pereira M DSouza S Dunn N Cron A Mckenna R Sivakumar S Cook J Ngeh R Saksena J Ketley-O'Donel R Needle E Chinery L Howaniec C Watchurst R Erande M Brezitski N Passeron E Elliott N Oji D Austin A Banaras C Hogan T Corbett M Kidd G Hull S Punekar J Nevinson H Penney W Wareing N Hayes K Bunworth L Connell K Mahawish G Drummond N Sengupta M Metiu C Gonzalez J Margalef S Funnell G Peters I Chadbourn H Proeschel P Ashcroft S Sharpe P Cook D Jenkinson D Kelly H Bray G Gunathilagan S Tilbey S Abubakar A Rajapakse A Nasar J Janbieh L Otter I Wynter S Haigh R Boulton J Burgoyne A Boulton J Vassallo A Hasan L Orrell S Qamar D Leonard E Hewitt M Haque J Awolesi E Bradshaw A Kent A Hynes E Nurse S Raza U Pallikona B Edwards G Morgan H Tench R Loosley K Dennett T Trugeon-Smith D Robson R Rayessa A Abdul-Hamid V Lowthorpe K Mitchelson E Clarkson H Rhian R Kirthivasan J Topliffe R Keskeys F McNeela E Bohannan L Cooper G Zachariah F Cairns T James L Fergey S Smolen A Lyle E Cannon S Omer S Mavinamane S Meenakshisundaram L Ranga J Bate M Hargreaves S Dealing S Amlani G Gulli M Hawkes-Blackburn L Francis S Holland A Peacocke J Amero M Burova O Speirs S Brotheridge S Al Hussayni H Lyon C Hare J Featherstone M Goorah J Walford D Rusk D Sutton F Patel S Duberley K Hayes E Ahmed El Nour S Dyer E Temlett J Paterson S Honour C Box R Furness E Orugun H Crowther R Glover C Brewer S Thornthwaite M Sein K Haque L Bailey E Gibson L Brookes K Rotchell K Waltho C Lindley P Harlekar C Culmsee L Booth J Ritchie N Mackenzie J Barker M Haley D Cotterill L Lane D Simmons R Warinton G Saunders H Dymond S Kidd C Little Y Neves-Silva B Nevajda M Villaruel U Umasankar A Man N Gadi N Christmas R Ladner R Rangasamy G Butt W Alvares M Power S Hagan K Dynan 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
Source :
BMJ Open, Vol 10, Iss 11 (2020)
Publication Year :
2020
Publisher :
BMJ Publishing Group, 2020.
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.
Details
Language :
English
ISSN :
20200404 and 20446055
Volume :
10
Issue :
11
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.8dc591ae368b40b580ff5efe89110dfb
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2020-040492