A mixed-methods study investigating PRO protocol content and reporting in UK cancer clinical trials.
Background
Patient-Reported Outcomes (PROs) are increasingly selected as outcomes within cancer clinical trials to provide the patient perspective on physical, functional and psychological consequences of treatment and the degree and impact of disease symptoms. Cancer patients value PRO trial results, such as quality of life, as they can enhance clinician-patient communication regarding treatment options, helping patients to feel more involved/empowered in decisions around their care.
Despite their importance, recent international evidence suggests (i) PRO information is commonly omitted from protocols, leading to impaired data collection; and (ii) PRO results are poorly reported in trial publications, or may not be reported at all. This means that PRO data may be less likely to effectively inform patient and clinician decision-making at the point of diagnosis and beyond, and represents a waste of limited healthcare and research resources.
Research is needed to determine if these 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.
Aim of study
To develop an online training resource to facilitate improvements in the availability and quality of PRO trial results, thereby providing a better information base for future patients, clinicians and researchers to inform patient-centred healthcare decisions.
Patient-Reported Outcomes (PROs) are increasingly selected as outcomes within cancer clinical trials to provide the patient perspective on physical, functional and psychological consequences of treatment and the degree and impact of disease symptoms. Cancer patients value PRO trial results, such as quality of life, as they can enhance clinician-patient communication regarding treatment options, helping patients to feel more involved/empowered in decisions around their care.
Despite their importance, recent international evidence suggests (i) PRO information is commonly omitted from protocols, leading to impaired data collection; and (ii) PRO results are poorly reported in trial publications, or may not be reported at all. This means that PRO data may be less likely to effectively inform patient and clinician decision-making at the point of diagnosis and beyond, and represents a waste of limited healthcare and research resources.
Research is needed to determine if these 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.
The EPiC study is funded by MacMillan Cancer Support
EPiC phases of research
- Phase I - Empirical review of UK cancer trials to review UK cancer trial protocols and their arising publications and model the potential factors influencing completeness of PRO specific protocol content and published results.
- Phase 2 - Qualitative study to determine the potential barriers/enablers to optimal PRO protocol content, implementation and reporting.
- Phase 3 - Development of an online PRO training resource.