Abstract
IntroductionEmerging 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 analysisCompleted 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 disseminationThe 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 numberPROSPERO CRD42016036533.
Highlights
Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that patient-reported outcomes (PROs) results are poorly reported, limiting the use of PRO data to inform cancer care
▪ Our review will provide original data regarding the potential factors associated with PRO protocol quality and PRO reporting
This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications
Summary
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. Patients with cancer value PRO information and may use it to inform complex healthcare decisions.[9 10] For instance, PRO trial results can help patients to assess whether survival benefits of a new drug outweigh potential side effects or may assist patients and their clinicians in choosing between treatment options offering similar survival rates.[11,12,13,14,15] Given their importance: (1) details regarding PRO assessment should be included in the trial protocol, to ensure appropriate data collection and management;[16 17] and (2) PRO results should be fully reported in arising trial publications, to enable timely access by patients, clinicians and policymakers and facilitate integration of findings into clinical practice.[18] our recent review of 75 National Institute for Health Research (NIHR) Health Technology Assessment trials[19] suggests important PRO information is frequently omitted from trial protocols, even where a PRO is the primary outcome of the study This may lead to impaired data collection and result in poor quality PRO data, limiting the potential of PRO findings to effectively inform patient care.[20] international research suggests PRO results are poorly reported in trial publications or may not be reported at all.[18 21 22] valuable information that may have a significant impact on treatment decision-making and outcomes may not be available to patients, clinicians and researchers. This would represent a waste of limited healthcare and research resources, which is unethical, and devalues the contribution of trial participants who spend time and effort providing PRO data.[23]
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