Use this URL to cite or link to this record in EThOS: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.636865
Title: The methodological and ethical issues associated with patient-reported outcome measurement in clinical trials
Author: Kyte, Derek Glenn
ISNI:       0000 0004 5359 5562
Awarding Body: University of Birmingham
Current Institution: University of Birmingham
Date of Award: 2015
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Abstract:
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.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID: uk.bl.ethos.636865  DOI: Not available
Keywords: R Medicine (General)
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