Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved]
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 in...
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F1000 Research Ltd
2024-09-01
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| Online Access: | https://openresearch.nihr.ac.uk/articles/4-52/v1 |
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| author | Sammy Ainsworth Cherry-Ann Waldron Sarah Jones Julie Carman Martina Svobodova Graham Prestwich Margaret Ogden Melanie Gager Liza Keating |
| author_facet | Sammy Ainsworth Cherry-Ann Waldron Sarah Jones Julie Carman Martina Svobodova Graham Prestwich Margaret Ogden Melanie Gager Liza Keating |
| author_sort | Sammy Ainsworth |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ed789a78dcc546448176bf87ee30c177 |
| institution | Kabale University |
| issn | 2633-4402 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj-art-ed789a78dcc546448176bf87ee30c1772025-01-16T01:00:00ZengF1000 Research LtdNIHR Open Research2633-44022024-09-01414753Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved]Sammy Ainsworth0https://orcid.org/0000-0001-8375-2205Cherry-Ann Waldron1https://orcid.org/0000-0001-8465-2492Sarah Jones2Julie Carman3Martina Svobodova4https://orcid.org/0000-0001-7949-4039Graham Prestwich5Margaret Ogden6Melanie Gager7Liza Keating8https://orcid.org/0000-0001-9028-2520NIHR Clinical Research Facility Alder Hey, University of Liverpool, Liverpool, England, L12 2AP, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKIntensive Care Unit, Royal Berkshire NHS Foundation Trust, Reading, England, RG1 5AN, UKIntensive Care Unit, Royal Berkshire NHS Foundation Trust, Reading, England, RG1 5AN, UKBackground 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.https://openresearch.nihr.ac.uk/articles/4-52/v1patient and public involvement platform trial design inclusivity clinical trial inclusive patient and public involvement underserved populationseng |
| spellingShingle | Sammy Ainsworth Cherry-Ann Waldron Sarah Jones Julie Carman Martina Svobodova Graham Prestwich Margaret Ogden Melanie Gager Liza Keating Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] NIHR Open Research patient and public involvement platform trial design inclusivity clinical trial inclusive patient and public involvement underserved populations eng |
| title | Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] |
| title_full | Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] |
| title_fullStr | Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] |
| title_full_unstemmed | Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] |
| title_short | Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [version 1; peer review: 2 approved] |
| title_sort | patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy protect version 1 peer review 2 approved |
| topic | patient and public involvement platform trial design inclusivity clinical trial inclusive patient and public involvement underserved populations eng |
| url | https://openresearch.nihr.ac.uk/articles/4-52/v1 |
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