Analysis of the Clinical Practice Research Datalink (CPRD Gold + Aurum) and Hospital Episode Statistics (HES) to provide real world evidence on disease progression and the burden of uncomplicated urinary tract infection (uUTI)

Date of Approval
Application Number
21_000492
Technical Summary

The study will use retrospective data of English adult and adolescent female patients with linkable Clinical Practice Research Datalink (CPRD)/ Hospital Episode Statistics (HES) data in the period January 1, 2018 through December 31, 2019.The study involves two parts.

Part 1 will use a cohort of adult and adolescent females diagnosed with uUTI caused by E. coli in a community setting (i.e. CPRD) and treated with oral antibiotic and will follow them over their index 28-day uUTI episode. The index uUTI date for the episode will be defined as the date of first uUTI medical code meeting the inclusion/exclusion criteria. This cohort will constitute the main study cohort and is relevant to Objectives 1 and 2.

Part 2 will use a retrospective observational cohort design with matched controls; uUTI patients from Part 1 (cases) will be matched to patients from the general English female population without UTI (controls) to assess the incremental health care burden due to uUTI. This part of the study is relevant to Objective 3.

Health Outcomes to be Measured

The outcomes for the study for Objectives 1 and 2 will be HES hospitalization for E coli sepsis, acute pyelonephritis, or bacteremia during the 28-day uUTI episode.

Outcomes for Objective 3 will cover the burden of illness of community-acquired uUTI captured over the 28-day uUTI episode as well as 12 months post-diagnosis:

• Number of all-cause and UTI-specific hospital admissions
• Number of all-cause and UTI-specific admissions to high dependency/intensive treatment unit
• Number of all-cause and UTI-specific Accident and Emergency (A & E) attendances
• Number of all-cause and UTI-specific specialist consultations
• Number of all-cause and UTI-specific primary care (GP) consultations
• Cost of each component of health care resource utilization

Collaborators

Fanny Mitrani-Gold - Chief Investigator - GlaxoSmithKline - USA
Sue Beecroft - Corresponding Applicant - Harvey Walsh Ltd
Aruni Mulgirigama - Collaborator - GSK
Ashish Joshi - Collaborator - GlaxoSmithKline - USA
Daniel Gibbons - Collaborator - GSK
David Heaton - Collaborator - Harvey Walsh Ltd
David Webb - Collaborator - GlaxoSmithKline - UK
Mark Wilcox - Collaborator - University of Leeds
Viktor Chirikov - Collaborator - OPEN Health Group
Xiaocong Marston - Collaborator - Harvey Walsh Ltd

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Rural-Urban Classification