title: Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol.
abstract: BACKGROUND
  Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported.
  
  
  OBJECTIVE
  Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.
  
  
  METHODS
  Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.
  
  
  BACKGROUND
  The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).
  
  
  BACKGROUND
  PROSPERO CRD42016036533.
authors.affiliation: Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
authors.forename: Khaled
authors.initials: K
authors.lastname: Ahmed
authors.affiliation: Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
authors.forename: Derek
authors.initials: D
authors.lastname: Kyte
authors.affiliation: Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Keeley
authors.affiliation: Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.affiliation: King's College London, London, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Armes
authors.affiliation: UKCRC Registered CTU Network, University of Leeds, Leeds, UK.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
authors.affiliation: Department of Heath Sciences, University of Southhampton, Southampton, UK.
authors.forename: Lynn
authors.initials: L
authors.lastname: Calman
authors.affiliation: NCRI Psychosocial Oncology and Survivorship CSG Consumer member, York, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Copland
authors.affiliation: Queen's University Belfast, Centre for Public Health, Belfast, UK.
authors.forename: Anna
authors.initials: A
authors.lastname: Gavin
authors.affiliation: Leeds Institute of Cancer & Pathology, University of Leeds, Leeds, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Glaser
authors.affiliation: Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Greenfield
authors.affiliation: University College London, UCL EGA Institute for Women's Health, London, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Lanceley
authors.affiliation: University College London Hospital (UCLH), London, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Taylor
authors.affiliation: University of Leeds, Leeds, UK.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.affiliation: Queen's Department of Oncology School of Medicine, Queen's Cancer Research Institute, Kingston, Ontario, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.affiliation: Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Faculties of Science and Medicine, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Mercieca-Bebber
authors.affiliation: Faculties of Science and Medicine, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Madeleine T
authors.initials: MT
authors.lastname: King
authors.affiliation: Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
authors.forename: Melanie
authors.identifier: http://orcid.org/0000-0002-1856-837X
authors.initials: M
authors.lastname: Calvert
keywords: CONSORT PRO; Cancer trials; Evaluation; PROs; Quality of life; SPIRIT Checklist