Clinical Decision Rule for Pediatric Intracranial Pathology



Status:Recruiting
Conditions:Migraine Headaches, Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 18
Updated:4/21/2016
Start Date:September 2015
End Date:July 2016
Contact:Meghan Cain, MD
Email:meghan.cain@childrensmn.org
Phone:6128136843

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Development of a Clinical Decision Rule to Identify Pediatric Patients With Headache at Low Risk for Intra-cranial Pathology

The purpose of this study is to develop a clinical decision rule for patients seen in the
pediatric emergency department for possible intracranial pathology. This a prospective study
evaluating patients presenting with headache and migraine. The study is observational and
does not impact patient care.

Background/Question: A significant number of children who present to the Emergency
Department (ED) with headache or migraine undergo head imaging with Computed Tomography (CT)
or Magnetic Resonance Imaging (MRI). However, there is relatively low yield in imaging
neurologically normal patients based on prior studies. The goal of this study is to describe
the utilization of head CT or MRI among pediatric ED patients with headache and migraine.
The investigators plan to evaluate clinical and examination characteristics of these
patients, and use this information to develop a clinical decision rule to help providers
predict the risk of finding an abnormality that affects patient treatment.

Design: The investigators will perform a study of all children between 6 and 18 years of age
who present to the ED with headache or migraine. At the time of the visit providers will be
asked to complete a questionnaire regarding exam and history without making any changes to
patient care. The investigators will also contact a sub-group of patients who do not undergo
MRI or CT, 12-14 weeks after discharge to ask about subsequent headache care after leaving
our facility.

Methods: All children age 6-18 years who present to the ED with a chief complaint of
headache or migraine will be eligible for the study. Patients will be excluded if they meet
any of the following criteria: trauma within 48 hours, previous neurosurgery (shunt
included), known tumor, history of cerebral hemorrhage/ischemia, Sickle Cell Disease,
thrombophilia, bleeding disorder or non-English speaker. ED Research Assistants and ED staff
physicians and nurse practitioners will screen potential candidates and ask providers to
review the inclusion criteria. If the eligibility criteria are met, the provider will
complete a standardized data collection form regarding exam and history findings. Patient
care will not be impacted or altered. Research Assistants will also provide a Parent
Information Sheet (either during the visit, or by mail following the ED visit) to the family
of those patients who are enrolled informing them they may be contacted following discharge.
Medical records will be reviewed for all eligible patients to obtain information on patient
demographics, course of treatment and diagnosis. For those patients who do not have any head
CT or MRI performed at their visit, the family will be contacted 12-14 weeks later to
determine if they have had subsequent care for their headache. If the family is unable to be
reached by phone, the patient chart will be reviewed for any other pertinent visits.

Analysis: For each patient characteristic examined, the investigators will look for a
statistically significant difference between those patients who have normal head imaging,
and those with abnormal imaging. Using the characteristics that are significantly different,
the investigators will develop a clinical decision rule to help providers assess the risk of
significant findings in an individual patient. The investigators will also develop a
decision tree to help aid providers when deciding which patients need head imaging. A sample
of patients will have two independent assessments to allow us to look for evidence of
inter‐rater reliability in our questionnaires.

Inclusion Criteria:

- Age 6-18 years

- Chief complaint of headache or migraine

Exclusion Criteria:

- Exclusion criteria

- Head trauma within 48 hours

- Previous neurosurgery (shunt included)

- Personal history of brain tumor

- History of stroke or vascular abnormality

- Sickle Cell Disease

- Fever (temperature over 38 degrees C)
We found this trial at
1
site
St. Paul, Minnesota 55102
Principal Investigator: Meghan Cain, MD
Phone: 612-813-6843
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mi
from
St. Paul, MN
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