Naseem Raasti, Howe Nicola, Pretorius Sara, Williams Cameron, Lendrem Clare, Pallmann Philip, Carrol Enitan D
Health Innovation North East and North Cumbria, England, NE4 5PL, UK.
NIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, NE2 4HH, UK.
NIHR Open Res. 2025 Jan 17;4:35. doi: 10.3310/nihropenres.13568.2. eCollection 2024.
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.
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.
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.
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.
PROTECT（利用新型技术优化抗菌治疗的临床结局平台随机评估）汇集了一组研究人员，旨在设计一项平台试验，以快速评估并将多种诊断技术应用于临床护理，从而为患者带来直接益处。快速诊断测试将用于在患者病情严重恶化之前，识别有严重感染恶化风险的患者。该平台将评估这些技术相对于当前护理标准的比较临床有效性和成本效益。在一项卫生技术评估应用加速奖的资助下开展的初步工作，为优化PROTECT平台的设计提供了关键证据。
采用定性方法，咨询严重感染领域的关键利益相关者，以确定关键优先事项。一项针对二级护理中严重感染的高级护理路径分析，梳理了与患者护理相关的接触点、行动、决策和潜在结果。
确定了两种用于严重感染的快速诊断测试用例；（1）在急性急诊医学中用于决定抗菌药物的起始使用和/或护理升级，以及（2）在住院患者中用于监测治疗反应。“理想”的测试应具备快速、即时检测、采购成本低、高度易用且所有工作人员都能操作和解读的能力。采用感染诊断测试的促进因素是临床需求，而主要潜在障碍是变革管理不善和行为改变。
任何新测试都应提供有力的临床有效性证据，并有潜力加速确诊或排除严重感染，这对患者、临床医生和整个医院的临床路径均有益，才有可能被考虑作为新的护理标准采用。
