Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop

Cook, Jonathan A; Julious, Steven A; Sones, William; Hampson, Lisa V; Hewitt, Catherine; Berlin, Jesse A; Ashby, Deborah; Emsley, Richard; Fergusson, Dean A; Walters, Stephen J; Wilson, Edward CF; MacLennan, Graeme; Stallard, Nigel; Rothwell, Joanne C; Bland, Martin; Brown, Louise; Ramsay, Craig R; Cook, Andrew; Armstrong, David; Altman, Douglas; Vale, Luke D

doi:10.3310/hta23600

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This document provides advice to improve practice and reporting regarding the target difference and sample size calculation in randomised controlled trials.

Jonathan A Cook
[Image - ORCID logo], Steven A Julious
[Image - ORCID logo], William Sones, Lisa V Hampson, Catherine Hewitt, Jesse A Berlin, Deborah Ashby, Richard Emsley, Dean A Fergusson
[Image - ORCID logo], Stephen J Walters, Edward CF Wilson, Graeme MacLennan, Nigel Stallard, Joanne C Rothwell
[Image - ORCID logo], Martin Bland, Louise Brown, Craig R Ramsay, Andrew Cook, David Armstrong
[Image - ORCID logo], Douglas Altman & Luke D Vale.

Detailed Author information
Detailed Author information

Jonathan A Cook ^1,^*, Steven A Julious ², William Sones ¹, Lisa V Hampson ³, Catherine Hewitt ⁴, Jesse A Berlin ⁵, Deborah Ashby ⁶, Richard Emsley ⁷, Dean A Fergusson ⁸, Stephen J Walters ², Edward CF Wilson ^9,¹⁰, Graeme MacLennan ¹¹, Nigel Stallard ¹², Joanne C Rothwell ², Martin Bland ¹³, Louise Brown ¹⁴, Craig R Ramsay ¹⁵, Andrew Cook ¹⁶, David Armstrong ¹⁷, Douglas Altman ^1,^†, Luke D Vale ¹⁸

¹ Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
² Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK
³ Statistical Methodology and Consulting, Novartis Pharma AG, Basel, Switzerland
⁴ York Trials Unit, Department of Health Sciences, University of York, York, UK
⁵ Johnson & Johnson, Titusville, NJ, USA
⁶ Imperial Clinical Trials Unit, Imperial College London, London, UK
⁷ Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
⁸ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
⁹ Cambridge Centre for Health Services Research, Cambridge Clinical Trials Unit University of Cambridge, Cambridge, UK
¹⁰ Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, UK
¹¹ Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
¹² Warwick Medical School, Statistics and Epidemiology, University of Warwick, Coventry, UK
¹³ Department of Health Sciences, University of York, York, UK
¹⁴ MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
¹⁵ Health Services Research Unit, University of Aberdeen, Aberdeen, UK
¹⁶ Wessex Institute, University of Southampton, Southampton, UK
¹⁷ School of Population Health and Environmental Sciences, King’s College London, London, UK
¹⁸ Health Economics Group, Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
^* Corresponding author Email: jonathan.cook@ndorms.ox.ac.uk

Funding: {{metadata.Funding}}

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