The Clinical Need for New Diagnostics in the Identification and Management of Patients with Suspected Sepsis in UK NHS Hospitals: A Survey of Healthcare Professionals.

Amanda Winter,Sara Graziadio,William Stephen Jones,A Joy Allen,Raffaele Filieri,Anthony Rostron,D Ashley Price

doi:10.3390/antibiotics9110737

Abstract

Development of a new diagnostic is ideally driven by an understanding of the clinical need that the test addresses and the optimal role the test will have within a care pathway. This survey aimed to understand the clinical need for new sepsis diagnostics and to identify specific clinical scenarios that could be improved by testing. An electronic, cross-sectional survey was circulated to UK National Health Service (NHS) doctors and nurses who care for patients with suspected sepsis in hospitals. Two hundred and sixty-five participants completed the survey, representing 64 NHS Trusts in England. Sixty-seven percent of respondents suggested that the major cause of delay was during the initial identification of sepsis and the subsequent recognition of patients who were deteriorating. Existing blood tests did not enhance the confidence of consultants making their diagnoses. Those surveyed identified a role for a near-patient test to “rule out” suspected sepsis and, thereby, stop or postpone use of antibiotics. Current diagnostic tests are slow, non-specific, and do not reliably identify patients with a high suspicion of sepsis. As a result, they have a limited use in patient management and antibiotic stewardship. Future development of sepsis diagnostics should focus on overcoming these limitations.

Highlights

The Third International Consensus Definitions for Sepsis and Septic Shock define sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” [1]
To develop diagnostics that are fit for purpose, it is important to have a comprehensive understanding of the current care pathway for the disease in question
Articulating an unmet clinical need will identify the optimal patient population and the role for a new diagnostic, i.e., as triage, add-on, or replacement test; this information is crucial for the technical development of the new diagnostic and in planning for further evidence generation, attaining regulatory approvals, and facilitating adoption in the healthcare system of interest [4,5,6]

Summary

Introduction

The Third International Consensus Definitions for Sepsis and Septic Shock define sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” [1]. Antibiotics 2020, 9, 737 figures, it is unsurprising that many companies, and academics alike, are interested in developing in vitro diagnostics for sepsis, even though this is challenging, as sepsis is a syndrome, not a disease. Understanding the current diagnostic pathway can help to identify any current unmet clinical needs, which can drive innovation. Articulating an unmet clinical need will identify the optimal patient population and the role for a new diagnostic, i.e., as triage, add-on, or replacement test; this information is crucial for the technical development of the new diagnostic and in planning for further evidence generation, attaining regulatory approvals, and facilitating adoption in the healthcare system of interest [4,5,6]. The last of these, surveys, can help to gather attitudes, opinions, and elicit descriptive data from large cohorts of experts, and, through online dissemination, can be administered across wide geographical areas quickly [7]

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Conclusion