Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

• Melanie Calvert ,

  * E-mail: M.Calvert@bham.ac.uk

  Affiliations Primary Care and Clinical Sciences, University of Birmingham, Birmingham, United Kingdom, MRC Midland Hub for Trials Methodology Research, Birmingham, United Kingdom

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• Derek Kyte,

  Affiliations Primary Care and Clinical Sciences, University of Birmingham, Birmingham, United Kingdom, School of Sport, Exercise & Rehabilitation, University of Birmingham, Birmingham, United Kingdom

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• Helen Duffy,

  Affiliation Primary Care and Clinical Sciences, University of Birmingham, Birmingham, United Kingdom

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• Adrian Gheorghe,

  Affiliation Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, United Kingdom

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• Rebecca Mercieca-Bebber,

  Affiliation Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, Australia

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• Jonathan Ives,

  Affiliation Medicine. Ethics, Society and History, University of Birmingham, Birmingham, United Kingdom

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• Heather Draper,

  Affiliations MRC Midland Hub for Trials Methodology Research, Birmingham, United Kingdom, Medicine. Ethics, Society and History, University of Birmingham, Birmingham, United Kingdom

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• Michael Brundage,

  Affiliation Queens University, Kingston, Ontario, Canada

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• Jane Blazeby,

  Affiliation MRC ConDuCT II Hub for Trials Methodology Research, School of Social & Community Medicine, University of Bristol, Bristol, United Kingdom

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• Madeleine King

  Affiliation Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, Australia

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