Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT)

Abstract

Background: Our patient and public involvement activities were part of a project aiming to develop a master protocol and National Institute for Health and Care research application for the PROTECT trial aiming to assess the effectiveness, implementation, and efficiency of antimicrobial stewardship interventions, to safely reduce unnecessary antibiotic usage by excluding severe bacterial infection in acutely unwell patients.

Methods: Three public involvement sessions were held with representation from young people and parents, people from diverse backgrounds and people with experience of presenting to the emergency department with undifferentiated illness. The teleconference meetings lasted between 60-90 minutes, were recorded, notes were subsequently taken, and findings summarised. The data was collected on September 13, 2023, October 14, 2023 and February 28, 2024.

Results: Working with public involvement contributors and public involvement groups at the protocol development stage provided an opportunity for the public to shape and influence the trial. We were able to establish the feasibility of the trial in the proposed setting and gain insights into how it would be perceived by potential trial participants. Antibiotic resistance was viewed as an urgent problem and research evaluating new technologies was deemed timely and important. The platform design was considered appropriate, time and cost-effective. Deferred and electronic methods of consent were viewed as acceptable if a clear and inclusive explanation is provided.

Conclusions: Having access to public contributors with relevant lived experience was an important resource for the trial team. Identification and recruitment of public contributors via working with existing public involvement groups across the UK enabled the trial team to involve public members with varied life experiences and from diverse backgrounds. This project was a good practice example of how public involvement groups and practitioners across the UK can work together to deliver public involvement that is inclusive of relevant groups.

Keywords: clinical trial; inclusive patient and public involvement; inclusivity; patient and public involvement; platform trial design; underserved populations.