Meningococcal disease is a rare but serious infection mainly caused by the bacterium Neisseria meningitides. It is a major cause of serious bloodstream infection (septicaemia) and meningitis (acute inflammation of the protective membranes covering the brain and spinal cord, known as the meninges) worldwide and is associated with significant mortality as well as serious long-term complications (sequelae) that will impact the survivors quality of life such as amputations, hearing loss and neurodevelopmental disabilities. This study aims to investigate the annual healthcare resource utilisation (primary care consultation & hospital care consultations) attributable to meningococcal disease in the United Kingdom (UK) during the period 2008-2017, through analysis of data collected in the Clinical Practice Research Datalink (CPRD), linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) death registration data. The study will describe the number of General Practitioners (GP) and hospital visits, the treatment received either due to meningitis / septicaemia or to their related complications and sequelae.
Objectives: This study aims to describe the annual healthcare resource utilisation attributable to meningococcal disease in the UK during the period 2008-2017, through analysis of data collected in CPRD, linked to hospital care consultations and death records.
Methods: A matched case control study will be conducted. Patients with an event of meningococcal disease will be identified between January 2009 and December 2016, and will be individually matched with up to four randomly selected controls on: age, gender, region, and index date for meningococcal. The index date will be defined as the first meningococcal episode during this period. Baseline period will be defined by 12-month (for patients aged ? 1 year) pre-index date and follow-up period by 12 months after index date. Continuous enrolment of 1 year over baseline and follow-up and HES eligibility will be required to be eligible for inclusion.
Analysis: Descriptive analysis will be conducted on demographics, Charlson comorbidities, high-risk conditions, sequelae, treatment patterns, and healthcare utilisation. All these parameters will be described in case and control cohorts and stratified by age groups. Meningococcal-attributable resource utilisation will be assessed based on the incremental differences between the cases and controls using multivariate analysis.
Demography
- High-risk conditions
- Complications / long term sequelae
- Medication
- Meningococcal-attributable healthcare utilisation
Caroline Amand - Chief Investigator - Sanofi Winthrop Industrie (France)
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement (France)
Alexia Kieffer - Collaborator - SANOFI
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data