Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?

NCT03009656 | Unknown

• 1 other identifier: 2016-01819
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Syndrome; Stroke Hemorrhagic; Stroke, Acute; Strokes Thrombotic; Emergencies; Diagnostic Self Evaluation

Keywords

Stroke; Emergency; Focal Neurological Deficits; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits

  Primary endpoint is the proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits, calculated by comparing the initial assessment with the final diagnosis at discharge. If the initial assessment was correct, the diagnosis of the emergency physician will be rated as correct (correct answer = Ac), if it was incorrect, it will be rated as incorrect (incorrect answer = Ai). The proportion of accurate initial diagnoses will be calculated as: Ac / (Ac + Ai)

  7 days +/- 7 days

Interventions

No study specific interventions OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Thrombotic Stroke; Emergencies; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Schankin, PD Dr. med.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schankin, PD Dr. med.

CONTACT

christoph.schankin@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 4, 2017
• Study Start: January 10, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)