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Acquired brain injury (ABI), primarily caused by stroke and traumatic brain injury (TBI), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. The lack of dedicated guidelines and regular treatment re-evaluation increases the risk of adverse drug reactions (ADRs).
Retrospective, bicentric study in two rehabilitation centers in Normandy, France, from November 1, 2020, to October 31, 2023, to describe prescription patterns of antidepressants, antiepileptics, and analgesics, as well as potential drug-related complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group | Patients with Acquired Brain Injury (ABI) receiving prescribed antidepressants, antiepileptics, and analgesics during hospitalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Observation of pharmacological prescriptions in patients with ABI |
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| Measure | Description | Time Frame |
|---|---|---|
| Prescription Paterns and rates of antidepressants, antiepileptics and analgesics | Proportion of patients with at least one prescription of antidepressants, antiepileptics, or analgesics retrieved from medical records, described at three time points: (1) pre-existing usual prescriptions prior to acute care hospitalization, (2) prescriptions at discharge from acute care, and (3) prescriptions at discharge from rehabilitation. This outcome is purely descriptive. No clinical events are measured. No measurement tools are used. Data are extracted retrospectively from medical records. | From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of drugs listed per prescription type | To analyze the average number of drugs per prescription, categorized into three types: usual prescription, discharge from acute care, and discharge from rehabilitation. Unit of Measure: Number of drugs per prescription Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients diagnosed with acquired brain injury (ABI) who were hospitalized in two rehabilitation centers in Normandy, France, between November 1, 2020, and October 31, 2023. Eligible patients were required to have passed through an acute care department before being admitted to the rehabilitation center. Only patients with ABI as the primary diagnosis, according to the PMSI (French medical information system), were included.
The study focused on patients who received new prescriptions for specific pharmacological classes (antidepressants, antiepileptics, and analgesics) either during acute care or within the first month of rehabilitation hospitalization. Patients were excluded if they had pre-existing prescriptions for these drugs prior to ABI, or if they did not receive new prescriptions for these drugs during the study period.
The final study population was selected based on these inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen (Centre Hospitalier Universitaire de Caen, France) | Caen | 14000 | France |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days). |
| Most frequently prescribed drug classes per prescription type | To identify the top prescribed pharmacological classes (e.g., using ATC classification) within usual prescriptions, acute discharge prescriptions, and rehabilitation discharge prescriptions. Unit of Measure: Number of prescriptions per drug class Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions. | From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days). |
| Analysis of specific drugs, their indications, and therapeutic management | To describe the most frequently prescribed drugs in the three target classes, assess whether their indications comply with official labelling, and detail any therapeutic adjustments during the rehabilitation stay (e.g., dosage changes, discontinuation). Unit of Measure: Number of prescriptions assessed for compliance and change Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions. | From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days) |
| Number of potential drug-drug interactions identified | To identify and count potential pharmacokinetic or pharmacodynamic drug-drug interactions involving antidepressants, antiepileptics, or analgesics, in the context of all prescribed medications. Unit of Measure: Number of potential drug-drug interactions per patient Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions. | From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days). |
| Rate of suspected Adverse Drug Reactions (ADRs) and therapeutic consequences | To identify suspected Adverse Drug Reactions (ADRs) reported in medical records and describe the related clinical decisions (e.g., discontinuation, switch, dose adjustment). Unit of Measure: Number of ADRs reported and management decisions documented Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions. | From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days). |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D064419 | Chemically-Induced Disorders |