A REtrospective Study to discOver the economic impLications of Vasospasm and delayed cErebral ischaemia (RESOLVE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, nationwide, multi-centre observational study

Study drug and medical condition

• Medical condition to be studied:
  Subarachnoid haemorrhage
• Additional medical condition(s):
  Aneurysmal subarachnoid hemorrhage

Population studied

• Short description of the study population:
  Patients with subarachnoid haemorrhage identified from the medical charts and the Système National des Données de Santé (SNDS), the French national healthcare database.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with subarachnoid haemorrhage
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To assess and compare hospital length of stay in patients with and without delayed cerebral ischaemia following aneurysmal subarachnoid haemorrhage
• Outcomes:
  The following patient outcomes will be assessed and compared: - Overall hospital length of stay - Intensive care unit length of stay - Length of stay in acute and subacute hospital settings (excluding inpatient rehabilitation centre stays) length of stay - Inpatient rehabilitation centre length of stay, The following patient outcomes will be assessed: - All-cause re-admissions to hospital - Imaging/diagnostic tests undertaken - Recue therapy requirements - Discharge location - Outpatient rehabilitation centre visits - All cause mortality - Direct costs - Indirect costs
• Data analysis plan:
  Descriptive statistics will be used to describe and compare patient demographic and clinical characteristics according to patient DCI status. Propensity score methods will be used to balance differences between patients who did and did not develop DCI. Propensity scores will be derived for each patient using a logistic regression model including pre-specified confounders such as age, World Federation of Neurosurgical Societies grade, Modified Fisher scale, aneurysm size, aneurysm-securing procedure. Thereafter, the groups will be balanced using the Inverse Probability of Treatment Weighting (IPTW). Appropriate models (mixed effects logistic regression for binary variables, mixed effects linear regression model for continuous variables and count or rate variables) will be used to compare healthcare resource utilization and patient outcomes according to DCI status, accounting for IPTW.