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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03135-50 | Other Identifier | ANSM |
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Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.
The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.
Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included.
Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected.
Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit.
At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (<7 days), by a committee of adjudication composed of 2 examiners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prognostic evaluation | Experimental | Questionnaire at Day1, Day7 and 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the quality of the prognostic assessment of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score. | Comparison of the area under the ROC curve of the IMPACT model score for the prediction of the 6-month Glasgow Outcome Scale (GOS) ≤ 3 to the area under the ROC curve of the first day clinician's prediction. | At 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in prognosis between clinicians based on their experience and specialty. | Evaluation of the effect of the clinician's experience (number of years of neuro-ICU exercise) and specialty on the clinician's prognosis ROC curve. | At 6 months |
| To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémy BERNARD, MD | Assistance Publique Hoptiaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Comparison between the clinician's ROC curves at D1 (between the 6th and the 24th hour) and at D7 of the trauma for the prognosis of the patient. |
| At 6 months |
| Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis. | Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve. | At 6 months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |