A 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, Rebecca Mercieca-bebber, Melanie Calvert, Madeleine King, Michael Brundage, Jo Armes

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Emerging evidence suggests that 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 endpoint is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary endpoints.
Methods and Analysis:
Completed NIHR Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO endpoint. 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 31/12/2000 and 01/03/2014 (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: (i) determine the completeness of their PRO-specific protocol content; (ii) determine the proportion and completeness of PRO reporting in UK Cancer trials; (iii) model factors associated with PRO protocol and reporting completeness, and with PRO reporting proportion.
Ethics and Dissemination
Study was approved by 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/cpror). Trial registered with Prospero at: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016036533.
Strengths and limitations of this study
• Our review will assist the scientific community in determining how best to improve the way PROs are assessed, managed and reported in future cancer trials.
• Our review will provide original data regarding the potential factors associated with PRO protocol quality and PRO reporting.
• The review will be limited to UK-led studies adopted to the National Institute for Health Research (NIHR) portfolio, which may limit generalizability of the results.
• Our selection criteria may lead to a cohort of studies that are not fully representative of the field as the trials may, on average, be of a higher quality than those found in the field (they are studies that have successfully completed) and they are more likely to be trials that have yielded a positive result (due to publication bias by journals).
• Our search criteria may be more likely to identify and obtain the required documents for non-industry sponsored trials, as the protocols of industry trials may be more likely to be confidential due to commercially sensitive information being included in them.
Original languageEnglish
Article numbere012863
JournalBMJ open
Publication statusPublished - 1 Sept 2016


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