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

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dc.contributor.authorCook, Jonathan A.
dc.contributor.authorJulious, Steven A.
dc.contributor.authorSones, William
dc.contributor.authorHampson, Lisa V.
dc.contributor.authorHewitt, Catherine
dc.contributor.authorBerlin, Jesse A.
dc.contributor.authorAshby, Deborah
dc.contributor.authorEmsley, Richard
dc.contributor.authorFergusson, Dean A.
dc.contributor.authorWalters, Stephen J.
dc.contributor.authorWilson, Edward C.F.
dc.contributor.authorMaclennan, Graeme
dc.contributor.authorStallard, Nigel
dc.contributor.authorRothwell, Joanne C.
dc.contributor.authorBland, Martin
dc.contributor.authorBrown, Louise
dc.contributor.authorRamsay, Craig R.
dc.contributor.authorCook, Andrew
dc.contributor.authorArmstrong, David
dc.contributor.authorAltman, Douglas
dc.contributor.authorVale, Luke D.
dc.contributor.institutionUniversity of Aberdeen.Centre for Healthcare Randomised Trials (CHaRT)en
dc.contributor.institutionUniversity of Aberdeen.Aberdeen Centre for Evaluationen
dc.contributor.institutionUniversity of Aberdeen.Other Applied Health Sciencesen
dc.contributor.institutionUniversity of Aberdeen.Institute of Applied Health Sciencesen
dc.date.accessioned2020-01-07T16:15:01Z
dc.date.available2020-01-07T16:15:01Z
dc.date.issued2019-10-30
dc.descriptionAcknowledgements This project was funded by the MRC NIHR Methodology Research Programme in the UK in response to a commissioned call to lead a workshop on this topic in order to produce guidance. The members of the original DELTA2 group were Associate Professor Jonathan Cook, Professor Douglas Altman, Dr Jesse Berlin, Professor Martin Bland, Professor Richard Emsley, Dr Dean Fergusson, Dr Lisa Hampson, Professor Catherine Hewitt, Professor Craig Ramsay, Miss Joanne Rothwell, Dr Robert Smith, Dr William Sones, Professor Luke Vale, Professor Stephen Walters and Professor Steve Julious. As part of the process of developing this document, a 2-day workshop was held in Oxford in September 2016. The workshop participants were Professor Douglas Altman, Professor David Armstrong, Professor Deborah Ashby, Professor Martin Bland, Dr Andrew Cook, Professor Jonathan Cook, Dr David Crosby, Professor Richard Emsley, Dr Dean Fergusson, Professor Andrew Grieve, Dr Lisa Hampson, Professor Catherine Hewitt, Professor Steve Julious, Professor Graeme MacLennan, Professor Tim Maughan, Professor Jon Nicholl, Dr José Pinheiro, Professor Craig Ramsay, Miss Joanne Rothwell, Dr William Sones, Professor Nigel Stallard, Professor Luke Vale, Professor Stephen Walters and Dr Ed Wilson. The authors would like to acknowledge and thank the participants in the Delphi exercise and the one-off engagement sessions with various groups, including the SCT, PSI and JSM conference session attendees, along with the other workshop participants who kindly provided helpful input and comments on the scope and content of this document. We would also like to thank, in particular, Dr Robert Smith in his role as a member of the public who provided a helpful public perspective during the workshop and in the development and revision of this document. Finally, the authors would like to thank Stefano Vezzoli for in-depth comments that helped to refine this document, helpful feedback from the MRC Methodological Research Programme Advisory Group, and representatives of the Medicines and Healthcare products Regulatory Agency and Health and Social Care, Northern Ireland. Dedication This work is dedicated to Douglas Altman, an inspirational researcher, friend and colleague. Contributions of authors Jonathan A Cook (Professor) drafted the initial version of the manuscript, and read and approved the final version. Steven A Julious (Professor) drafted the initial version of the manuscript and read and approved the final version. William Sones (Statistician) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Lisa V Hampson (Associate Director) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Catherine Hewitt (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Jesse A Berlin (Vice President and Global Head of Epidemiology) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Deborah Ashby (Co-Director) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Richard Emsley (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Dean A Fergusson (Senior Scientist and Director) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Stephen J Walters (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Edward CF Wilson (Senior Research Associate in Health Economics) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Graeme MacLennan (Director and Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Nigel Stallard (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Joanne C Rothwell (PhD student) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Martin Bland (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Louise Brown (Senior Statistician) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Craig R Ramsay (Director and Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Andrew Cook (Consultant in Public Health Medicine and Fellow in Health Technology Assessment) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. David Armstrong (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Douglas Altman (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version. Luke D Vale (Professor) contributed to the development of the document, commented on the draft manuscript, and read and approved the final version.en
dc.description.statusPeer revieweden
dc.format.extent118
dc.format.extent1013685
dc.identifier153094439
dc.identifier6cdfe5a2-b593-4140-90aa-cd0d16702536
dc.identifier85074259328
dc.identifier31661431
dc.identifier.citationCook, J A, Julious, S A, Sones, W, Hampson, L V, Hewitt, C, Berlin, J A, Ashby, D, Emsley, R, Fergusson, D A, Walters, S J, Wilson, E C F, Maclennan, G, Stallard, N, Rothwell, J C, Bland, M, Brown, L, Ramsay, C R, Cook, A, Armstrong, D, Altman, D & Vale, L D 2019, 'Practical help for specifying the target difference in sample size calculations for RCTs : The DELTA 2 five-stage study, including a workshop', Health Technology Assessment, vol. 23, no. 60. https://doi.org/10.3310/hta23600en
dc.identifier.doi10.3310/hta23600
dc.identifier.iss60en
dc.identifier.issn1366-5278
dc.identifier.otherORCID: /0000-0003-4043-7349/work/84131500
dc.identifier.otherORCID: /0000-0002-1039-5646/work/98038664
dc.identifier.urihttps://hdl.handle.net/2164/13466
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85074259328&partnerID=8YFLogxKen
dc.identifier.vol23en
dc.language.isoeng
dc.relation.ispartofHealth Technology Assessmenten
dc.subjectSDG 3 - Good Health and Well-beingen
dc.subjectR Medicineen
dc.subjectHealth Policyen
dc.subjectNational Institute for Health Research (NIHR)en
dc.subjectMRC NIHR Methodology Research Programmeen
dc.subject.lccRen
dc.titlePractical help for specifying the target difference in sample size calculations for RCTs : The DELTA2 five-stage study, including a workshopen
dc.typeJournal articleen

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