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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

Declared competing interests of authors: David J Beard reports grants from the National Institute for Health Research (NIHR) and Versus Arthritis (Chesterfield, UK) outside the submitted work. Marion K Campbell reports former NIHR Clinical Trials Unit (CTU) Standing Advisory Committee membership (2014–17). Jane M Blazeby reports current NIHR CTU Standing Advisory Committee membership (2015–19). Andrew J Carr reports grants from NIHR and the Wellcome Trust (London, UK) outside the submitted work, has a patent issued with BioPatch and is a member of Novartis Musculoskeletal Advisory Board and UK Research and Innovation Advanced Pain Discovery programme (January 2020–present). Charles Weijer reports personal fees from Cardialen, Inc. (Minneapolis, MN, USA), Eli Lilly & Company (Indianapolis IN, USA) and RTI International (Research Triangle, Park, NC, USA) outside the submitted work. Thomas Pinkney reports Health Technology Assessment (HTA) Clinical Evaluation and Trials Committee membership (November 2017–present). Jonathan Pugh reports grants from Wellcome Trust during the conduct of the study. Katie Gillies reports HTA Clinical Evaluation and Trials Committee membership (November 2020–present). Andrew Cook reports membership of the Efficacy and Mechanism Evaluation (EME) Funding Committee, EME Funding Committee Sub-Group Remit & Comp Check, HTA Prioritisation Committee B Methods Group (former) (October 2019–present), PHR Prioritisation Group (former) and Prioritisation Strategy Group (2006–9). Andrew Cook also declares membership of the secretariat of various committees for the HTA, EME and PHR programmes (2006–present). Richard Huxtable reports grants from NIHR during the conduct of the study. In addition, Richard Huxtable reports grants from the Wellcome Trust, the European Union, the Engineering and Physical Sciences Research Council (Swindon, UK), the Elizabeth Blackwell Institute for Health Research (Bristol, UK) and the National Research Foundation of Korea (Daejeon, Republic of Korea), and personal fees from the Wellcome Trust, outside the submitted work. Natalie Blencowe reports trainee membership to the HTA Clinical Evaluation and Trials Committee (January–December 2020). Amar Rangan reports grants from NIHR, Orthopaedic Research UK (London, UK) and Horizon 2020, and grants and personal fees from DePuy Synthes (Raynham, MA, USA) outside the submitted work. Irene Tracey is a member of a Medical Research Council (MRC) Council (2017–present), a member of the Guarantors of Brain (London, UK) (2016–present), is a trustee of MQ: Transforming Mental Health (London, UK) (2016–present) and is a Lundbeck Brain Prize Committee Member (2015–present). Peter Brocklehurst reports personal fees from MRC and AG Biotest (Dreieich, Germany) and grants from MRC, Wellcome Trust and NIHR outside the submitted work. In addition, Peter Brocklehurst reports clinical trial units funded by NIHR, and HTA Efficient Study Designs Board (former) (2016) and HTA Maternal, Neonatal and Child Health Panel (former) membership (2014–18). Manuela L Ferreira reports grants from the National Health and Medical Research Council of Australia (Canberra, ACT, Australia) during the conduct of the study. Barnaby C Reeves reports former membership of the Health Technology Assessment Commissioning Board (January 2012–31 March 2016) and the Health Technology Assessment Efficient Study Designs Board (October–December 2014). He also reports current membership of the Health Technology Assessment Interventional Procedures Committee B Methods Group and Systematic Reviews Programme Advisory Group (Systematic Reviews National Institute for Health Research Cochrane Incentive Awards and Systematic Review Advisory Group). Freddie Hamdy reports being an editor-in-chief of the BJU International journal (John Wiley & Sons, Inc., Hoboken, NJ, USA) (February 2020–present) and Advisory Board Member for Intuitive (Sunnyvale, CA, USA) (January 2020–present). Samuel CS Rowley reports personal fees from MRC and UK Research and Innovation during the conduct of the study. Jonathan A Cook reports Methodology State-of-the-Art Workshops (MSAW) grant funding from the MRC and NIHR for the project. Naomi Lee reports an annual salary from Elsevier (Amsterdam, the Netherlands)/The Lancet, during the conduct of the study.

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