Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]

Background PROTECT (Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy) has brought together a team of researchers to design a platform trial to rapidly evaluate and adopt into care multiple diagnostic technologies, bringing immediate benef...

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Main Authors: Raasti Naseem, Sara Pretorius, Nicola Howe, Clare Lendrem, Cameron Williams, Enitan D Carrol, Philip Pallmann
Format: Article
Language:English
Published: F1000 Research Ltd 2025-01-01
Series:NIHR Open Research
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Online Access:https://openresearch.nihr.ac.uk/articles/4-35/v2
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author Raasti Naseem
Sara Pretorius
Nicola Howe
Clare Lendrem
Cameron Williams
Enitan D Carrol
Philip Pallmann
author_facet Raasti Naseem
Sara Pretorius
Nicola Howe
Clare Lendrem
Cameron Williams
Enitan D Carrol
Philip Pallmann
author_sort Raasti Naseem
collection DOAJ
description Background PROTECT (Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy) has brought together a team of researchers to design a platform trial to rapidly evaluate and adopt into care multiple diagnostic technologies, bringing immediate benefit to patients. Rapid diagnostic tests will be used to identify patients at risk of deterioration from severe infection, before they become critically unwell. The platform will assess their comparative clinical effectiveness and cost-effectiveness relative to current standard of care. Preliminary work, conducted under a Health Technology Assessment Application Acceleration Award, provided key evidence to optimise the design of the PROTECT platform. Methods Qualitative methods which involved consulting key stakeholders in the field of serious infection addressed the key priorities. A high-level care pathway analysis focusing on serious infection in secondary care, captured the points of contact, actions, decisions, and potential outcomes associated with a patient’s care. Results Two use cases of rapid diagnostic tests for serious infection were identified; (1) in acute emergency medicine to decide on antimicrobial initiation and/or escalation of care, and (2) in hospitalised patients to monitor treatment response. The “ideal” test should be rapid, point-of-care, cheap to procure, have capacity for high usability, and ability to be performed and interpreted by all staff. Facilitators to the adoption of infection diagnostic tests is their clinical need, and the main potential barrier is poor change management and behavioural change. Conclusions Any new test should provide robust evidence of its clinical effectiveness and have the potential to accelerate ruling in or out serious infection which benefits the clinical pathway for patients, clinicians, and hospitals as a whole, to be considered for adoption as a new standard of care.
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spelling doaj-art-6c5ed23079d6409088a6386eda8865662025-01-23T01:00:00ZengF1000 Research LtdNIHR Open Research2633-44022025-01-01415085Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]Raasti Naseem0https://orcid.org/0000-0003-1978-4370Sara Pretorius1https://orcid.org/0000-0001-8277-711XNicola Howe2https://orcid.org/0000-0001-9446-8314Clare Lendrem3Cameron Williams4Enitan D Carrol5https://orcid.org/0000-0001-8357-7726Philip Pallmann6https://orcid.org/0000-0001-8274-9696Health Innovation North East and North Cumbria, England, NE4 5PL, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, NE2 4HH, UKInstitute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, England, L69 7BE, UKCentre for Trials Research, Cardiff University, Cardiff, Wales, CF14 4YS, UKBackground PROTECT (Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy) has brought together a team of researchers to design a platform trial to rapidly evaluate and adopt into care multiple diagnostic technologies, bringing immediate benefit to patients. Rapid diagnostic tests will be used to identify patients at risk of deterioration from severe infection, before they become critically unwell. The platform will assess their comparative clinical effectiveness and cost-effectiveness relative to current standard of care. Preliminary work, conducted under a Health Technology Assessment Application Acceleration Award, provided key evidence to optimise the design of the PROTECT platform. Methods Qualitative methods which involved consulting key stakeholders in the field of serious infection addressed the key priorities. A high-level care pathway analysis focusing on serious infection in secondary care, captured the points of contact, actions, decisions, and potential outcomes associated with a patient’s care. Results Two use cases of rapid diagnostic tests for serious infection were identified; (1) in acute emergency medicine to decide on antimicrobial initiation and/or escalation of care, and (2) in hospitalised patients to monitor treatment response. The “ideal” test should be rapid, point-of-care, cheap to procure, have capacity for high usability, and ability to be performed and interpreted by all staff. Facilitators to the adoption of infection diagnostic tests is their clinical need, and the main potential barrier is poor change management and behavioural change. Conclusions Any new test should provide robust evidence of its clinical effectiveness and have the potential to accelerate ruling in or out serious infection which benefits the clinical pathway for patients, clinicians, and hospitals as a whole, to be considered for adoption as a new standard of care.https://openresearch.nihr.ac.uk/articles/4-35/v2Antimicrobial resistance care pathway analysis platform trial adaptive design bacterial infection implementationeng
spellingShingle Raasti Naseem
Sara Pretorius
Nicola Howe
Clare Lendrem
Cameron Williams
Enitan D Carrol
Philip Pallmann
Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
NIHR Open Research
Antimicrobial resistance
care pathway analysis
platform trial
adaptive design
bacterial infection
implementation
eng
title Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
title_full Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
title_fullStr Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
title_full_unstemmed Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
title_short Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection [version 2; peer review: 2 approved]
title_sort mapping decision making pathways determination of intervention entry points for diagnostic tests in suspected serious infection version 2 peer review 2 approved
topic Antimicrobial resistance
care pathway analysis
platform trial
adaptive design
bacterial infection
implementation
eng
url https://openresearch.nihr.ac.uk/articles/4-35/v2
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AT enitandcarrol mappingdecisionmakingpathwaysdeterminationofinterventionentrypointsfordiagnostictestsinsuspectedseriousinfectionversion2peerreview2approved
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