American Registry for Migraine Research

Imagine the power and value of an enormous database of information about unlimited numbers of patients who are diagnosed with migraine. Packed with information - including age, gender, type of migraine, severity and frequency of attacks, treatment history, family history, and other medical information. Add a biorepository to this database with a collection of physical samples of saliva, blood or other fluids from each patient for genetic analysis, and brain images from each patient, and scientists will finally be able to unlock the keys to understanding the causes of this disease and rapidly move us closer to finding safer and more effective treatments and eventually, a cure.

The United States spends more per capita on healthcare than any other country.1 According to the Centers for Medicare and Medicaid Services, health spending is projected to grow at an average rate of 5.8% from 2012–2022, which is 1% higher than the projected gross domestic product.2 Numerous strategies and efforts have been discussed to improve the benefits per dollar spent on healthcare.3

One such effort is a disease registry, which is a collection of information about individuals, usually focused around a specific diagnosis or condition. The registry provides an organized program for the collection, storage, retrieval, and dissemination of a defined set of data— collected from individuals, minus their personal information. The rationale for registries is to provide healthcare professionals and researchers first- hand information about a disease or condition and treatments. There are numerous examples of registries for both rare and common conditions.4

The benefits of a registry are:

  • Rapid collection of data from a large number of patients
  • The ability to study a broad population
  • Increase knowledge about a specific condition
  • Helps healthcare providers improve patient outcomes
  • Provides information about physician’s adherence to treatment guidelines
  • Compare a physician’s own population with that of other clinicians
  • Enable researchers to design better studies
  • Patients can become aware in real time to ongoing clinical studies

The registry provides real world, long-term outcomes and may even provide comparative data between multiple treatments. In some instances, existing databases capture physical samples for genetic characterization. As such, a biorepository is added to the existing database.

Disease registries may also fill a data gap by complementing information from Medicare and large insurance databases, which collect administrative data, such as age, race, and gender that can be useful in estimating disease incidence and prevalence. But disease registries tend to capture many clinical details not typically collected for an administrative dataset.

Registries can also be used to help improve patient care by contributing to the development of standards of care and tracking adherence to formalized treatment guidelines.

Primary headache disorders (e.g. episodic migraine, chronic migraine, chronic tension-type headache, new daily persistent headache, trigeminal autonomic cephalalgias, cranial neuralgias) and secondary headache disorders (e.g. post-traumatic headache, medication overuse headache) are highly prevalent and cause substantial individual and societal burden. Although progress has been made in characterizing the phenotype of many primary headache disorders, large-scale longitudinal studies are required for the
- elucidation of headache pathophysiology that will drive molecular pharmacology and drug discovery, identification of genetic endophenotypes and biochemical and imaging biomarkers for primary headache disorders, and predictors of treatment response/resistance.

The AMF proposes to develop a large-scale, longitudinal, publicly accessible headache registry and repository containing clinical, biologic, and neuroimaging data that will allow the clinical and scientific community to accomplish these goals.

The specific aims of this program are:

  1. Establish repositories and collection methods for phenotypic data, imaging data, genetic data and biologic samples.
  2. Enroll subjects with primary headache disorders and secondary headache disorders, collecting phenotypic data, biologic samples (i.e. blood, saliva, buccal swab, cerebrospinal fluid, consent for post- mortem brain tissue), and magnetic resonance imaging (MRI) data. Data will be used to test several of the major scientific aims proposed during recent NIH summits on headache research priorities in the United States, including:
    1. Phenotype – Use phenotypic data to test the value of individual International Classification of Headache Disorders diagnostic criteria (ICHD), compare the specificity and sensitivity of ICHD- II vs. ICHD-III Beta diagnostic criteria, and inform future revisions of the classification to allow for more accurate diagnosis
    2. Genetics – Use (epi)genetic data, biochemical data, gene expression data to identify gene mutations/variants, (nc-)RNA expression profiles and epigenetic profiles for diagnostic purposes, and to increase molecular insight into pathophysiological mechanisms of migraine that will guide design of novel treatment options
    3. Imaging – Utilize structural and functional magnetic resonance imaging (MRI) data to compare brain structure and function among patients with different headache types and to correlate imaging findings with phenotypic and genetic data.
    4. Develop and evaluate mathematical models of imaging data that best differentiate headache types
  3. Establish and train a larger network of investigative sites (e.g. participating sites in the American Migraine Foundation Academic Headache Center Initiative) to enroll subjects, submit data, and access all collected data for specific research investigations.
  4. Make data accessible to all scientists. Grant applications will also be accepted for review and high-value, high-yield projects will be funded.

Establishment and utilization of a large, longitudinal, publicly assessable headache repository would transform headache research by facilitating collaborations amongst investigators from numerous institutions, pooling physical and intellectual resources from national and international experts, allowing for analyses of large cohorts of patients with primary and secondary headache disorders, linking phenotypic data with biologic specimens and imaging data, and allowing for longitudinal analyses. Our team of principal investigators and core leaders has considerable experience in headache science, genetics, neuroimaging, neuropathology, identification and utilization of biomarkers, biostatistics, and informatics, making the team ideal for oversight of these collaborative efforts.

 

 

References

  1. Kaiser Family Foundation. Snapshots: Healthcare Spending in the United States and Selected OECD Countries. Available at: http://kff.org/health-costs/issue-brief/snapshots-health-care-spending-in-the-united-states-selected-oecd-countries/. Accessed September 12, 2014.
  2. Centers for Medicare and Medicaid Services. Research statistics, data and systems. National Healthcare Expenditure Date 2012. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/proj2012.pdf. Accessed September 12, 2014.
  3. Institute of Medicine (US) Roundtable on Value & Science-Driven Health Care; Yong PL, Olsen LA, McGinnis JM, editors. Value in Health Care: Accounting for Cost, Quality, Safety, Outcomes, and Innovation. Washington (DC): National Academies Press(US); 2010.
  4. US Department of Health & Human Services. National Institutes of Health. List of Registries. Available at: http://www.nih.gov/health/clinicaltrials/registries.htm. Accessed September 12, 2014.
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