Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop

Beard, David J; Campbell, Marion K; Blazeby, Jane M; Carr, Andrew J; Weijer, Charles; Cuthbertson, Brian H; Buchbinder, Rachelle; Pinkney, Thomas; Bishop, Felicity L; Pugh, Jonathan; Cousins, Sian; Harris, Ian; Lohmander, L Stefan; Blencowe, Natalie; Gillies, Katie; Probst, Pascal; Brennan, Carol; Cook, Andrew; Farrar-Hockley, Dair; Savulescu, Julian; Huxtable, Richard; Rangan, Amar; Tracey, Irene; Brocklehurst, Peter; Ferreira, Manuela L; Nicholl, Jon; Reeves, Barnaby C; Hamdy, Freddie; Rowley, Samuel CS; Lee, Naomi; Cook, Jonathan A

doi:10.3310/hta25530

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This report provides a framework for best practice for those considering the use of a placebo control in a surgical randomised controlled trial.

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David J Beard ^1,^*, Marion K Campbell ², Jane M Blazeby ³, Andrew J Carr ¹, Charles Weijer ⁴, Brian H Cuthbertson ⁵, Rachelle Buchbinder ⁶, Thomas Pinkney ⁷, Felicity L Bishop ⁸, Jonathan Pugh ⁹, Sian Cousins ³, Ian Harris ¹⁰, L Stefan Lohmander ¹¹, Natalie Blencowe ³, Katie Gillies ², Pascal Probst ¹², Carol Brennan ¹³, Andrew Cook ¹⁴, Dair Farrar-Hockley ¹³, Julian Savulescu ⁹, Richard Huxtable ³, Amar Rangan ^1,¹⁵, Irene Tracey ¹⁶, Peter Brocklehurst ¹⁷, Manuela L Ferreira ¹⁸, Jon Nicholl ¹⁹, Barnaby C Reeves ²⁰, Freddie Hamdy ²¹, Samuel CS Rowley ²², Naomi Lee ²³, Jonathan A Cook ¹

¹ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
² Health Services Research Unit, University of Aberdeen, Aberdeen, UK
³ Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK
⁴ Departments of Medicine, Epidemiology and Biostatistics, and Philosophy, Western University, London, ON, Canada
⁵ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
⁶ Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
⁷ Academic Department of Surgery, University of Birmingham, Queen Elizabeth Hospital Birmingham, Birmingham, UK
⁸ Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK
⁹ The Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK
¹⁰ Faculty of Medicine, South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
¹¹ Department of Clinical Sciences Lund, Orthopedics, Clinical Epidemiology Unit, Lund University, Lund, Sweden
¹² Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany
¹³ Patient representative, Oxford, UK
¹⁴ Wessex Institute, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK
¹⁵ Department of Health Sciences, University of York, York, UK
¹⁶ Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK
¹⁷ Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
¹⁸ Faculty of Medicine and Health, Institute of Bone and Joint Research, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia
¹⁹ School of Health and Related Research, University of Sheffield, Sheffield, UK
²⁰ Clinical Trials Evaluation Unit Bristol Medical School, University of Bristol, Bristol Royal Infirmary, Bristol, UK
²¹ Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK
²² Medical Research Council, London, UK
²³ Editorial Department, The Lancet, London, UK
^* Corresponding author Email: david.beard@ndorms.ox.ac.uk

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