Inclusive and acceptable patient-reported outcome collection

Status: Ongoing

Patient-reported outcomes (PROs) provide essential safety and tolerability data to inform patient-centred clinical care and regulatory decisions. However, trials using PROs often fail to address cultural and health specificities of populations underserved by research. An underserved group refers to individuals whose inclusion within research falls lower than expected from population estimates, their high healthcare burden is not matched by the volume of research designed for them, or their response or engagement with healthcare interventions is neglected compared to other groups. The Birmingham BRC serves covers a region of 5.7 million people, and is socially diverse, multi-ethnic with significant health inequalities and life expectancy lower than the UK average. While there is a substantial evidence base relating to the willingness of groups underrepresented in research to participate in research and growing awareness of the need to implement PROs equitably, research to explore public attitudes towards PRO research specifically, in a manner that is inclusive of underserved groups, is lacking.

Project aims

This mixed methods study aims to:

• explore the barriers and facilitators of collecting PRO data in research and routine care settings, with particular focus on the inclusivity, accessibility and acceptability of PRO collection
• identify the specific experiences and views of those groups underserved by research, in relation to the collection of PRO data in research and routine care settings and explore potential solutions
• formulate guidance outlining how to promote accessible and acceptable PRO collection that is inclusive of the experience of groups underserved by research

Patient and public involvement

This research is being supported by a patient and public advisory panel convened for the purpose of the study. The eleven individuals have provided input into the study design and the study documents. Ongoing involvement will include helping to anticipate and address any issues as they arise (e.g. recruitment), interpreting findings, and formulating public communication and dissemination strategies.