PRospective obsErvational Study to quantify thE buRden of illness of Vasospasm and delayed cErebral ischaemia (PRESERVE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

  Other
• Non-interventional study design, other:
  Prospective, 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 aneurysmal subarachnoid hemorrhage (aSAH) identified from 11 centres across France.
• 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:
  400

Study design details

• Main study objective:
  To assess and compare the humanistic burden of illness associated with the development of delayed cerebral ischaemia following aneurysmal subarachnoid hemorrhage among patients and their caregivers.
• Outcomes:
  The following patient outcomes will be assessed and compared at each follow-up time-point, unless otherwise stated: - Functional impairment - Cognitive impairment - Health-related quality of life - Activities of daily living - Mood - Return to work among employed patients at 12 months - Return to school/education among patients at 12 months - Work productivity/absenteeism at 12 months, The following caregiver outcomes will be assessed and compared at each follow-up time-point, unless otherwise stated: - Health-related quality of life - Caregiver subjective burden - Caregiver objective burden - Mood - Return to work, where relevant at 12 months - Return to school/education, where relevant at 12 months - Work productivity/absenteeism, where relevant at 12 months
• Data analysis plan:
  Descriptive statistics will be used to describe and compare participant demographic and clinical characteristics according to patient DCI status. Propensity score methods will be used to balance differences between patients and the caregivers of patients who did and did not develop DCI. Propensity scores will be derived for each participant 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 patient and caregiver outcomes according to DCI status, accounting for IPTW.