Inclusive PRO Study
Research type
Research Study
Full title
Inclusive and acceptable patient-reported outcome collection: A mixed methods study
IRAS ID
331274
Contact name
Melanie Calvert
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
Background and rationale
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. In research, the result of populations being underserved is that they may not benefit from the valuable PRO data that evidences the risks and benefits of treatment from the patients’ own perspective. When this happens systematically, health data poverty occurs, resulting in the absence of vital evidence relating to these groups when informing clinical care, regulatory decisions, and health policy.Aims and objectives
We are conducting a programme of research to:
1. Explore the accessibility and acceptability of PRO data collection in research and routine care settings
2. Explore the barriers and facilitators for PRO data collection in research and routine care settings from the perspective of those who are underserved by research
3. Formulate solutions to address barriers to patient-reported outcome data collection from groups underserved by research.Methods
We plan to meet these objectives by delivering a survey and carrying out interviews and group discussions with members of the public accessing the main entrance foyers, public spaces, and outpatient clinics in University Hospitals Birmingham (UHB) and Sandwell and West Birmingham Hospitals (SWBH). This can include patients, staff, friends and family of patients.Funding
This study is funded by the National Institute for Health and Care Research Birmingham Biomedical Research Centre (NIHR Birmingham BRC).REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/PR/1551
Date of REC Opinion
12 Jan 2024
REC opinion
Favourable Opinion