A qualitative reflexive thematic analysis of innovation and regulation in hearing health care.

BACKGROUND: The hearing health sector is an example of a health sector that is experiencing a period of rapid innovation driven by digital technologies. These innovations will impact the types of interventions and services available to support the communication of deaf and hard-of-hearing individuals. This study explored the perceptions of informed participants on the topic of innovation and regulation within hearing healthcare in Australia and the United Kingdom (UK). METHODS: Participants (N = 29, Australia [n = 16], UK [n = 13]) were purposively sampled and joined one of two online workshops. Participants included adults with hearing loss and family members, hearing health professionals, academics/researchers, representatives of hearing device manufacturers, regulators and policymakers. Workshop data were analysed using reflexive thematic analysis. RESULTS: Participants conceptualised the hearing health sector as a network of organisations and individuals with different roles, knowledge and interests, in a state of flux driven by innovation and regulation. Innovation and regulation were perceived as mechanisms to ensure quality and mitigate risk within a holistic approach to care. Innovations encompassed technological as well as non-technological innovations of potential benefit to consumers. Participants agreed it was essential for innovation and regulation to be congruent with societal values. Critical to ethical congruence was the involvement of consumers throughout both innovation and regulation stages, and the use of innovation and regulation to tackle stigma and reduce health disparities. Participants expressed the desire for accessible and inclusive innovation in the context of fair, transparent and trustworthy commercial practices. CONCLUSIONS: This study explored how stakeholders within the hearing health sector understand and make sense of innovation and the role of regulation. Overall, and despite reservations relating to health care professionals' changing roles and responsibilities, innovation and regulation were conceptualised as beneficial when situated in the context of holistic, whole-person, models of care. The results of this study will inform considerations to support the development and implementation of innovations and regulation within the hearing sector and across other health sectors influenced by technological advances.

Demonstrating the learning and impact of embedding participant involvement in a pandemic research study: the experience of the SARS-CoV-2 immunity & reinfection evaluation (SIREN) study UK, 2020-2023.

BACKGROUND: Participant involvement in research studies is not a new concept, yet barriers to implementation remain and application varies. This is particularly true for pandemic response research studies, where timeframes are condensed, pressure is high and the value and inclusion of participant involvement can be overlooked. The SIREN Participant Involvement Panel (PIP) provides a case study for participant involvement in pandemic research, working in partnership with people who the research is for and about. METHODS: SIREN and the British Society for Immunology (BSI) recruited and ran two phases of the PIP, involving 15 members in total over a 16-month period. Phase 1 ran between January and August 2022 and Phase 2 between October 2022 and March 2023. Activity figures including recruitment interest and PIP meeting attendance were recorded. To evaluate how the PIP has influenced SIREN, feedback was collected from (a) researchers presenting at the PIP and (b) PIP members themselves. Evaluation at the end of Phase 1 informed our approach to Phase 2. Thematic grouping was planned to identify key lessons learned. RESULTS: Applications increased from n = 30 to n = 485 between Phase 1 and Phase 2 of the PIP, a more than 15-fold increase. The SIREN PIP positively impacted the design, implementation and evaluation phases of the study and sub-studies. Feedback from PIP members themselves was positive, with members highlighting that they found the role rewarding and felt valued. Learnings from the PIP have been condensed into five key themes for applying to future pandemic response research studies: the importance of dedicated resources; recruiting the right panel; understanding motivations for participant involvement; providing flexible options for involvement and enabling the early involvement of participants. CONCLUSIONS: The SIREN PIP has demonstrated the value of actively involving people who research is for and about. The PIP has provided an active feedback mechanism for research and demonstrated a positive influence on both SIREN study researchers and PIP members themselves. This paper makes the case for participant involvement in future pandemic research studies. Future work should include improved training for researchers and we would support the development of a national PIP forum as part of future pandemic research preparedness.

The SARS-Cov2 Immunity & Reinfection Evaluation (SIREN) study was set-up at speed during the early stages of the pandemic to help answer key questions about COVID-19 and inform the national pandemic response. It has provided valuable insight into COVID-19 infections, reinfections, and how well the vaccines work. SIREN helped to find these answers by regularly testing over 44,000 healthcare staff working at 135 NHS organisations. To support participant retention, SIREN established a Participant Involvement Panel (PIP) involving 15 SIREN participants to date. PIP members provide guidance and feedback to SIREN researchers on key research priorities, changes to the study and strategies for maximising participant engagement. This paper provides insight into how the PIP was set-up, run and the resources required from the perspective of the PIP and SIREN researchers. Lessons learned from establishing the PIP are summarised to help inform future pandemic response research studies. The paper adds to the evidence base, and makes the case for, the valuable role participant involvement can play in pandemic response research studies.