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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01739-34 | Other Identifier | IDRCB |
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absence of inclusion within two years of obtaining the CPP notice
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Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire
Every year, subarachnoid hemorrhage affects 9.1 people per 100,000 worldwide, with a peak between the ages of 50 and 60. Its frequency and relatively young age of onset make it a major source of decline in healthy life years.
Progress over the past thirty years has led to a 57% reduction in mortality, but these figures do not always reflect the day-to-day reality of these patients, for whom recovery remains incomplete in almost half of cases. For example, a third of patients have not returned to work at one year, and of those who have, only half have returned to work full-time. In 2020, a Norwegian team showed that, at one year, a third of patients suffer from a "post-HSA syndrome", as yet little described, but which seems very similar to the post-concussion syndrome experienced by patients after head trauma. In their study, only 3% of patients with this syndrome returned to work at one year. A better understanding of the incidence of this syndrome, as well as its evolution and determinants, is therefore essential.
With this in mind, the investigators chose to assess the presence of post-SAH syndrome at 3 months and its repercussions on return to work, using the Rivermead questionnaire.
Secondly, in view of the prevalence of post-traumatic stress syndrome at 3 years (a quarter of patients), the investigators wished to study the factors determining the presence of post-HSA syndrome and an inability to return to work at 3 months, 6 months, 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with subarachnoid hemorrhage | Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire | Other | self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome. | The Rivermead questionnaire is a 16-item self-administered questionnaire, rated from 0 to 4, giving a total of 0 to 52 points. This scale was created to assess post-concussion syndrome, which in many ways is similar to what patients experience after a SAH. The higher the score, the greater the difficulties experienced by the patient. A score of 3 or 4 for any of the responses indicates that the patient is incapacitated. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year | Quality of life assessed using the SS-QoL questionnaire, specific to stroke patients. Self-questionnaire with 49 questions covering 12 domains (including work/productivity, mood, social roles, family roles, personality). | 3 months, 6 months and 1 year, |
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Inclusion Criteria:
Patient aged 18 to 65
Exclusion Criteria:
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Patients aged 18 to 65 who had presented with an episode of spontaneous subarachnoid haemorrhage or aneurysmal rupture, excluding meningeal haemorrhage due to trauma,
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| C000728118 | Coping Orientation to Problems Experienced Questionnaire |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| SS-QoL | Other | 49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.). |
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| SF-36 | Other | multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment |
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| CIQ-R | Other | 16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration |
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| BREFF | Diagnostic Test | rapid frontal efficiency battery, 6 tests from 0 to 3 on each side |
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| MoCA | Diagnostic Test | MoCA is a screening test for neurocognitive impairment. It comprises 11 categories scored from 0 to 6 for a total of 0 to 30 points. |
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| IADL | Other | 8 questions rated from 0 to 1 to assess functional outcome |
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| mMRS | Other | mMRS score from 0 to 4 to assess functional outcome |
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| PCL-5 | Other | To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire. |
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| Brief-Cope | Other | 28-question self-questionnaires to study patients' coping strategies |
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| To study the prevalence of post-traumatic stress in this population | Assess the prevalence of post-traumatic stress in this population using the PCL-5 self-questionnaire. PCL-5 is a 20-question self-questionnaire. | 3 months, 6 months and 1 year, |
| Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire | Brief-Cope self-questionnaire (28-question self-questionnaires). | 3 months, 6 months and 1 year, |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |