Paving the way for patient centricity in real-world evidence (RWE): Qualitative interviews to identify considerations for wider implementation of patient-reported outcomes in RWE generation.

Objectives: Real-world evidence (RWE) generation can be enhanced by including patient-reported outcomes (PROs). Methods for collecting and using PRO data in the real-world setting are currently underdeveloped and there is no international guidance specific to its use in this context. This study explored stakeholders' perspectives and needs for using PROs in RWE generation. Barriers, facilitators, and opportunities for wider use of PROs in real-world studies were also investigated.
Methods: Online semi-structured interviews were conducted with international stakeholders: patients, patient advocates, regulators, payers, clinicians, academic researchers, and industry experts. Interviews were recorded, transcribed verbatim and analysed using NVivo 20. Thematic analysis was conducted based on the updated Consolidated Framework for Implementation Research (CFIR).
Results: Twenty-three interviews were conducted. Participants confirmed that the use of PROs in RWE generation is not yet well established. Participants expressed a mixed level of confidence in the value of PROs collected in a real-world setting. Operational challenges associated with collecting routine PRO data to inform care delivery at the individual level (e.g., setting up infrastructure) need to be addressed. Methodological and other challenges (e.g., financing research) associated with collecting prospective de novo data in a real-world setting should be considered to facilitate PRO utilisation in real-world studies.
Conclusions: Several opportunities and challenges were identified regarding the broader use of PROs in RWE research. Joint efforts from different stakeholders are needed to maximise PRO implementation, with consideration given to each stakeholders' specific needs (e.g., by developing good practices).
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Konrad Maruszczyk reports financial support was provided by GSK plc. Melanie Calvert reports financial support was provided by GSK plc. Christel McMullan reports financial support was provided by GSK plc. Olalekan Lee Aiyegbusi reports financial support was provided by GSK plc. Melanie Calvert reports a relationship with NIHR Birmingham Biomedical Research Centre that includes: funding grants. Melanie Calvert reports a relationship with Health Data Research UK that includes: funding grants. Melanie Calvert reports a relationship with Innovate UK that includes: funding grants. Melanie Calvert reports a relationship with Macmillan Cancer Support that includes: funding grants. Melanie Calvert reports a relationship with GSK plc that includes: consulting or advisory and funding grants. Melanie Calvert reports a relationship with UCB Pharma SA that includes: funding grants. Melanie Calvert reports a relationship with Research England that includes: funding grants. Melanie Calvert reports a relationship with European Commission and EFPIA that includes: funding grants. Melanie Calvert reports a relationship with Brain Tumor Charity that includes: funding grants. Melanie Calvert reports a relationship with Gilead Sciences Inc that includes: funding grants. Melanie Calvert reports a relationship with Janssen Pharmaceuticals Inc that includes: funding grants. Melanie Calvert reports a relationship with National Institute for Health and Care Research that includes: funding grants. Melanie Calvert reports a relationship with UK Research and Innovation that includes: funding grants. Melanie Calvert reports a relationship with Aparito that includes: consulting or advisory. Melanie Calvert reports a relationship with CIS Oncology that includes: consulting or advisory. Melanie Calvert reports a relationship with Takeda UK Ltd that includes: consulting or advisory. Melanie Calvert reports a relationship with Merck & Co Inc that includes: consulting or advisory. Melanie Calvert reports a relationship with Daiichi Sankyo Inc that includes: consulting or advisory. Melanie Calvert reports a relationship with Glaukos Corporation that includes: consulting or advisory. Melanie Calvert reports a relationship with Patient-Centered Outcomes Research Institute that includes: consulting or advisory. Melanie Calvert reports a relationship with Genentech that includes: consulting or advisory. Melanie Calvert reports a relationship with Vertex that includes: consulting or advisory. Melanie Calvert reports a relationship with Icon plc that includes: consulting or advisory. Melanie Calvert reports a relationship with University of Maastricht that includes: speaking and lecture fees. Melanie Calvert reports a relationship with Cochrane Portugal that includes: speaking and lecture fees. Melanie Calvert reports a relationship with South-Eastern Norway Regional Health Authority that includes: paid expert testimony. Melanie Calvert reports a relationship with Singapore National Medical Research Council that includes: paid expert testimony. Melanie Calvert reports a relationship with PROTEUS Consortium that includes: board membership. Catherine Bottomley reports a relationship with Vitaccess Limited that includes: employment. Olalekan Lee Aiyegbusi reports a relationship with GSK plc that includes: consulting or advisory and funding grants. Olalekan Lee Aiyegbusi1 reports a relationship with Merck & Co Inc that includes: consulting or advisory. Christel McMullan reports a relationship with National Institute for Health and Care Research that includes: funding grants. Christel McMullan reports a relationship with CIS Oncology that includes: funding grants. Christel McMullan reports a relationship with Aparito that includes: consulting or advisory. Thomas Keeley reports a relationship with GSK plc that includes: employment and equity or stocks.
(© 2023 The Authors.)