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

Svobodova, Martina ORCID: https://orcid.org/0000-0001-7949-4039, Keating, Liza, Gager, Melanie, Waldron, Cherry-Ann ORCID: https://orcid.org/0000-0001-8465-2492, Ainsworth, Sammy, Carman, Julie, Jones, Sarah, Ogden, Margaret and Prestwich, Graham 2024. Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT). NIHR Open Research 4 , 52. 10.3310/nihropenres.13591.1

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Centre for Trials Research (CNTRR)
Publisher:	Taylor and Francis
ISSN:	2633-4402
Date of First Compliant Deposit:	25 September 2024
Date of Acceptance:	September 2024
Last Modified:	18 Oct 2024 15:09
URI:	https://orca.cardiff.ac.uk/id/eprint/172366

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