<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009656</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01819</org_study_id>
    <nct_id>NCT03009656</nct_id>
  </id_info>
  <brief_title>Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?</brief_title>
  <acronym>HOGAN</acronym>
  <official_title>Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The emergency setting for acute neurological conditions, such as stroke, is peculiar due to&#xD;
      time pressure and limited resources for further diagnostics. Clinical skills are essential&#xD;
      for swift and accurate bedside diagnosis and thus are the basis for early and correct&#xD;
      treatment. This is especially evident in the context of computed tomography being the&#xD;
      standard neuroimaging method world-wide with its limitations for detecting smaller infarcts,&#xD;
      strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic&#xD;
      seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by&#xD;
      neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not&#xD;
      been studied in detail. In order to improve clinical diagnosing and future treatment it is&#xD;
      essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting&#xD;
      (&quot;how good are neurologists?&quot;) and to assesses whether there are any differences between&#xD;
      experienced staff neurologists and junior physicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      The emergency setting for acute neurological conditions, such as stroke, is peculiar due to&#xD;
      time pressure and limited resources for further diagnostics. Clinical skills are essential&#xD;
      for swift and accurate bedside diagnosis and thus are the basis for early and correct&#xD;
      treatment. This is especially evident in the context of computed tomography being the&#xD;
      standard neuroimaging method world-wide with its limitations for detecting smaller infarcts,&#xD;
      strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic&#xD;
      seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by&#xD;
      neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not&#xD;
      been studied in detail. Management of acute stroke patients is a main interest of the&#xD;
      neurovascular research group at Inselspital Bern. For example, the investigators analysed the&#xD;
      prediction of large vessel occlusion in acute stroke patients by clinical examination and&#xD;
      found a significant association of stroke severity measured with the NIHSS score and location&#xD;
      of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving&#xD;
      symptoms demonstrated that three of four of these patients had a favourable outcome, but&#xD;
      those with a central vessel occlusion were likely to deteriorate with poor outcome. These&#xD;
      studies showed that there is a correlation of clinical symptoms with the mechanism of stroke,&#xD;
      which is important for the outcome after treatment. Importantly, however, the quality of&#xD;
      clinical assessment itself is likely highly variable, for example depending on the experience&#xD;
      of the treating physician. Factors influencing this clinical assessment, which needs to be&#xD;
      done under high temporal and emotional pressure in the emergency setting have not been&#xD;
      investigated so far but might be crucial for rapid and successful treatment (&quot;time is&#xD;
      brain&quot;).In order to improve clinical diagnosing and future treatment it is essential to&#xD;
      quantify the accuracy of clinical diagnosis of stroke in the emergency setting (&quot;how good are&#xD;
      neurologists?&quot;) and to assesses whether there are any differences between experienced staff&#xD;
      neurologists and junior physicians.&#xD;
&#xD;
      Rationale:&#xD;
&#xD;
      By assessing whether prediction of aetiology of acute neurological deficits is&#xD;
      experience-based the investigators aim to understand what symptoms/signs impede the&#xD;
      in-experienced from swiftly making the correct diagnosis in the emergency setting. This&#xD;
      should help to improve resident training and with this treatment of patients with acute&#xD;
      neurological deficits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits</measure>
    <time_frame>7 days +/- 7 days</time_frame>
    <description>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).&#xD;
The proportion of accurate initial diagnoses will be calculated as:&#xD;
Ac / (Ac + Ai)</description>
  </primary_outcome>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Stroke Syndrome</condition>
  <condition>Stroke Hemorrhagic</condition>
  <condition>Stroke, Acute</condition>
  <condition>Strokes Thrombotic</condition>
  <condition>Emergencies</condition>
  <condition>Diagnostic Self Evaluation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No study specific interventions</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Non-refusal of &quot;general consent&quot;&#xD;
&#xD;
          -  Patients with focal clinical neurological deficits with symptom onset of &lt; 6 hours or&#xD;
             wake-up strokes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Interval from symptom onset to clinical examination of &gt; 6 hours.&#xD;
&#xD;
          -  Patients who do not have focal clinical neurological deficit at examination will not&#xD;
             be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Schankin, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christoph Schankin, PD Dr. med.</last_name>
    <email>christoph.schankin@insel.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bern University Hospital - Inselspital</name>
      <address>
        <city>Bern</city>
        <state>BE</state>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Schankin, PD Dr. med.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Emergency</keyword>
  <keyword>Focal Neurological Deficits</keyword>
  <keyword>Diagnostic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Thrombotic Stroke</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009656
org study id: 2016-01819
nct id: NCT03009656
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits
time frame: 7 days +/- 7 days
description: 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)
intervention type: Other
intervention name: No study specific interventions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Schankin, PD Dr. med.
role: Principal Investigator
affiliation: Insel Gruppe AG, University Hospital Bern
last name: Christoph Schankin, PD Dr. med.
email: christoph.schankin@insel.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hemorrhagic Stroke
mesh term: Thrombotic Stroke
mesh term: Emergencies
sharing ipd: No