Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders

Diagnostic Comparison of an Online Questionnaire Versus a Semi-structured Interview for the Diagnosis of Primary Headache Disorders, Using ICHD 3 as the Gold Standard

Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in comparison to a semi-structured interview administered by a trained interviewer.

Study Overview

• Status: Completed
• Conditions: Headache Disorders

Detailed Description

The worldwide current gold standard for diagnosing headaches is the International Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has been problematic for accurately diagnosing patients in the clinic and as for clinical trials. To address these issues, an online instrument was developed that successfully diagnosis common primary and secondary headache disorders. In this research Investigator hopes to demonstrate an on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing different types of headaches (for example: episodic migraine vs. non episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs. non-episodic tension type, chronic tension-type headache vs. non chronic tension-type headache, medication overuse headache vs. non medication overuse headache, post traumatic headache vs. non post traumatic headache).

Participants will be screened by telephone to see if participants meet the criteria for taking part in this research study. Once participant is deemed eligible,the participants will then be randomized in a 1:1 ratio to complete either the semi-structured interview over the phone first and then complete the online questionnaire or vice versa. Study is expected to enroll 500 participants with headache and healthy controls.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All race, gender age between 18-65, English speaking selected from community, clinic.

Description

Inclusion Criteria:

1. Female or male subjects age between age 18-65(inclusive),
2. Subjects must agree to sign online informed consent;
3. Subject must be able to understand and willing to complete both evaluations in English
4. Willing to comply with study instructions.
5. Agree not to Rely or act on any diagnosis given to them in the study

Exclusion Criteria:

1. Presence of Disorders listed in groups 5-13 of The International Headache Society Classification of Head and Facial Pain (Headache Classification Committee of the International Headache Society, 2015 except for post traumatic headache and medication overuse headache);

1a. History of brain tumor, brain surgery

1b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis

1c. History of any significant current or previous brain dysfunction

1d. Regular use of illicit drugs.

2. Known significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.

3. Subjects with - significant cognitive impairment such as dementia, active psychiatric disease such as schizophrenia.

4. Subjects with physical limitations to participate in the on-line or phone interview impossible.

5. Non-English speaking patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Migraineurs; with a migraine
Control; Participants without migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
On-line questionnaire accuracy for Diagnosing episodic migraine	An on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing episodic migraine vs non episodic migraine, chronic migraine vs. non chronic migraine. We will compare the 4 primary (chronic and episodic migraine, chronic and episodic tension-type headache) obtained on each of the two evaluations for reliability using recognized statistical tools: This analysis will be conducted by independent reviewers, not the developers of either instrument	2 -2.5 years

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Robert Cowan, MD, FAAN, Stanford University

Publications and helpful links

General Publications

• DeSouza DD, Woldeamanuel YW, Sanjanwala BM, Bissell DA, Bishop JH, Peretz A, Cowan RP. Altered structural brain network topology in chronic migraine. Brain Struct Funct. 2020 Jan;225(1):161-172. doi: 10.1007/s00429-019-01994-7. Epub 2019 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: John Henry study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No