Identification of sepsis cases: a validation study
Research type
Research Study
Full title
Identification of sepsis cases: a validation study
IRAS ID
362580
Contact name
Sarah Gerver
Contact email
Sponsor organisation
UK Health Security Agency
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Infections are a common and costly reason for emergency hospital attendance and admissions in England, responsible for half of total NHS bed days. Sepsis is a life-threatening condition which occurs when the body’s immune response to an infection damages its organs. Sepsis does not have a gold-standard test, it is complex and non-specific, with cases identified from a combination of physiological scores, multiple diagnostic tests and clinical judgement. Surveillance of sepsis and estimates of incidence are typically drawn from “diagnosis codes” in administrative healthcare datasets; these codes translate clinical diagnoses recorded in patient records into structured data for administration and payment. However, changes in the agreed definitions of sepsis over time and variation in the way in which sepsis is recorded in patient records, as well as the translation into diagnosis codes, can artificially alter the number of sepsis cases recorded over time. Various methods exist to evaluate the accuracy of diagnosis codes in identifying “true” sepsis cases which would allow accurate estimates of incidence. Evaluation of sepsis coding in England has typically favoured an assessment of mortality and other severe outcomes rather than validating case ascertainment against a “gold-standard” clinical notes review that would provide accuracy metrics; these metrics could be used to determine the reliability of estimates. Consequently, there is currently no reliable estimate of sepsis incidence in England. This study aims to address this gap by confirming whether diagnosis codes from administrative data truly identify confirmed sepsis cases and, therefore, whether sepsis incidence can be accurately and robustly estimated using administrative healthcare datasets. By identifying the necessary data to produce a standardised sepsis surveillance definition, UKHSA and the NHS can then robustly and confidently monitor the number of current, historical and prospective sepsis cases in England.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
25/LO/0894
Date of REC Opinion
8 Dec 2025
REC opinion
Favourable Opinion