AbstractsMedical & Health Science

The doctoral research forming this thesis used mixed-methods to explore methodological and ethical issues associated with patient-reported outcome (PRO) measurement in clinical trials. A qualitative study of trial staff suggested there are perceived inconsistencies in the administration and management of PROs in some UK trials which could undermine PRO trial results and introduce bias. In addition, the study found that staff reported intermittently encountering ‘concerning’ PRO data in trials, but were unsure how it should be managed. A large-scale survey of UK-based trial staff and management demonstrated the genralisiability of these findings. A systematic review of PRO literature for front-line data collection staff found guidance was lacking. A large-scale review of PRO-specific literature for trial protocol developers suggested guidelines were inconsistent and difficult to access. Finally, using a novel PRO protocol checklist, a systematic review of trial protocols found that PRO information was commonly absent, even where a PRO was the primary outcome. In conclusion, the thesis highlights a need for the development of comprehensive consensus-based PRO guidelines addressing protocol development, training and the management of ‘concerning’ PRO data in trials; aiming to facilitate improvements in PRO protocol content and PRO assessment, whilst protecting the interests of trial participants.