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, clinical trials using PROs often fail to reflect the experiences, cultures or health needs of people from communities that are underserved by research.

Underserved groups are members of the population who take little part in research. This could be for several reasons, for example where the research being conducted does not match the healthcare needs in a population, or where established working practices disadvantage certain groups. The NIHR Biomedical Research Centre: Birmingham serves a population of around 5.7 million people across a socially diverse and multi‑ethnic region, where health inequalities are significant and life expectancy is lower than the UK average.

There is good evidence about the willingness of underrepresented groups to take part in research – and awareness among researchers of the need to implement PROs equitably. However, there is a lack of evidence of public attitudes to PRO research, especially among underserved groups.

This research aims to address that gap, helping to ensure that patient‑reported outcomes are collected and used in ways that are inclusive, acceptable and meaningful for everyone.

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.

Survey findings

The first phase of this project is now complete. This involved exploring what helps and what hinders people from completing health questionnaires. To do this, we ran a survey, involving over 1,000 participants across outpatient clinics in Birmingham.

As part of this, we explored where people would prefer to complete PRO questionnaires. Our survey results indicate that participants want flexibility, with the majority preferring to complete health questionnaires at home (68% of 950 participants).

Participants also identified a number of considerations to support their completion of PROs:

• PROs should be accessible, clear, relevant and non-ambiguous
• Participants should receive clear instructions, training and support on how to use electronic PROs from the research team
• Participants should understand why their input is wanted and how their data is used
• Researchers should be clear with PRO results and how they affect people
• Increased awareness of PROs, for example via primary care, is important

“Allow the participant to understand why their opinion and views are so valued. Clear instructions”

“Explaining what will happen to the information I give and how it will be used”

Inclusive PRO collection requires flexibility, transparency, and co-design with patients. When done well, it helps ensures that patient-reported evidence reflects all patients, not just the easiest to reach.

Outputs

Read our article for best practice guidance on inclusive PRO collection

Read the paper