PROTECT

The NIHR-funded PROTECT project comprised preparatory work to develop a multi-arm, multi-stage platform study to evaluate rapid diagnostic tests in emergency departments (EDs), with the aim of supporting faster, more informed decisions about antibiotic prescribing.

Introduction

Antimicrobial resistance is a critical global health issue, driven in part by the overuse of antibiotics. To ensure the design and delivery of this complex trial reflected public needs and expectations, the PROTECT team embedded patient and public involvement (PPI) from the outset.

Our Key Question

How can inclusive and sustained public involvement contribute meaningfully to the design and development of a complex platform trial?

Methodology

The PPI strategy followed best practice guidance, with a focus on inclusion, continuity, and impact. A formal NIHR equality impact assessment was undertaken, alongside use of the NIHR INCLUDE guidance to reflect on the characteristics of the population the trial is intended to serve.

Recruitment targeted individuals with relevant lived experience — people with serious infections, ED service users, parents, older adults, and individuals from ethnically and socioeconomically diverse communities. The team worked with three established PPI groups:

• GenerationR Liverpool Young People’s Advisory Group
• Talking Trials, an ethnically diverse, community-based advisory group at Cardiff University
• Reading ED PPI group, comprising patients and carers with ED experience

Three virtual sessions were held between September 2023 and February 2024, lasting 60 to 90 minutes. Sessions were recorded, transcribed, and thematically analysed. Participants received written summaries and were shown how their input had shaped the trial design. To support continuity, contributors were invited to join a dedicated PPI Forum with a role in trial governance, offering further opportunities to influence trial materials, communications, and implementation.

Overarching Methodological Findings

Acceptability and feasibility

Contributors supported the trial’s overall design and welcomed the use of rapid testing to inform antibiotic decisions. They endorsed the use of deferred and electronic consent, with suggestions to improve clarity and accessibility — such as translated materials, easy-read versions, and formats appropriate for older adults.

Prioritising outcomes

PPI input helped shape decisions on outcome measures most important to patients. Priorities included time to diagnosis, hospital stay duration, side effects, antibiotic use, readmissions, and quality of life — ensuring that the trial captures what matters most to participants.

Inclusive approaches

Working with trusted PPI groups allowed the team to access a wide range of perspectives, particularly from underserved communities. This supported a more inclusive design and helped ensure the trial reflected broader public concerns and values.

Ongoing involvement

Public contributors remain actively engaged in trial development. They have reviewed participant materials, supported communication strategies, and contributed to training resources — ensuring the trial remains accessible and relevant.

Conclusion

Involving diverse public contributors through established PPI groups enabled the trial to benefit from varied lived experience and long-term trusting relationships. This case offers a good practice example of how researchers and PPI groups can collaborate to deliver meaningful, inclusive involvement across complex research designs.