Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Khaled Ahmed; Derek Kyte; Thomas Keeley; Fabio Efficace; Jo Armes; Julia M Brown; Lynn Calman; Chris Copland; Anna Gavin; Adam Glaser; Diana M Greenfield; Anne Lanceley; Rachel Taylor; Galina Velikova; Michael Brundage; Rebecca Mercieca-Bebber; Madeleine T King; Melanie Calvert

doi:10.1136/bmjopen-2016-012863

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

BMJ Open. 2016 Sep 21;6(9):e012863. doi: 10.1136/bmjopen-2016-012863.

Authors

Khaled Ahmed¹, Derek Kyte¹, Thomas Keeley¹, Fabio Efficace², Jo Armes³, Julia M Brown⁴, Lynn Calman⁵, Chris Copland⁶, Anna Gavin⁷, Adam Glaser⁸, Diana M Greenfield⁹, Anne Lanceley¹⁰, Rachel Taylor¹¹, Galina Velikova¹², Michael Brundage¹³, Rebecca Mercieca-Bebber¹⁴, Madeleine T King¹⁵, Melanie Calvert¹

Affiliations

¹ Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
³ King's College London, London, UK.
⁴ UKCRC Registered CTU Network, University of Leeds, Leeds, UK.
⁵ Department of Heath Sciences, University of Southhampton, Southampton, UK.
⁶ NCRI Psychosocial Oncology and Survivorship CSG Consumer member, York, UK.
⁷ Queen's University Belfast, Centre for Public Health, Belfast, UK.
⁸ Leeds Institute of Cancer & Pathology, University of Leeds, Leeds, UK.
⁹ Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.
¹⁰ University College London, UCL EGA Institute for Women's Health, London, UK.
¹¹ University College London Hospital (UCLH), London, UK.
¹² University of Leeds, Leeds, UK.
¹³ Queen's Department of Oncology School of Medicine, Queen's Cancer Research Institute, Kingston, Ontario, Canada.
¹⁴ 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.
¹⁵ Faculties of Science and Medicine, University of Sydney, Sydney, New South Wales, Australia.

Abstract

Introduction: 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.

Hypothesis: 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 and analysis: 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.

Ethics and dissemination: 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).

Trial registration number: PROSPERO CRD42016036533.

Keywords: CONSORT PRO; Cancer trials; Evaluation; PROs; Quality of life; SPIRIT Checklist.

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