Clinical trial NCT03009656: Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?
Official title: Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Syndrome
Stroke Hemorrhagic
Stroke, Acute
Strokes Thrombotic
Emergencies
Diagnostic Self Evaluation
Keywords: Stroke
Emergency
Focal Neurological Deficits
Diagnostic
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.

Brief summary: The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.

Detailed description: Background:

The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate with poor outcome. These studies showed that there is a correlation of clinical symptoms with the mechanism of stroke, which is important for the outcome after treatment. Importantly, however, the quality of clinical assessment itself is likely highly variable, for example depending on the experience of the treating physician. Factors influencing this clinical assessment, which needs to be done under high temporal and emotional pressure in the emergency setting have not been investigated so far but might be crucial for rapid and successful treatment ("time is brain").In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.

Rationale:

By assessing whether prediction of aetiology of acute neurological deficits is experience-based the investigators aim to understand what symptoms/signs impede the in-experienced from swiftly making the correct diagnosis in the emergency setting. This should help to improve resident training and with this treatment of patients with acute neurological deficits.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Non-refusal of "general consent"
* Patients with focal clinical neurological deficits with symptom onset of \< 6 hours or wake-up strokes.

Exclusion Criteria:

* Interval from symptom onset to clinical examination of \> 6 hours.
* Patients who do not have focal clinical neurological deficit at examination will not be included in the study.

Primary outcomes:
measure: Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits
timeFrame: 7 days +/- 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital - Inselspital
state: BE
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Christoph Schankin, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: