Abstract
To the Editor:
Historically, comparing data across studies has been challenging due to variations in data collection tools (1). Headache clinical research has much to gain by accepting and adopting standardized instruments and case report forms.
The updated National Institute of Neurological Disorders and Stroke (NINDS) Headache Common Data Elements (CDE) aim to promote the efficiency of clinical research studies, improve the quality of clinical data, increase the feasibility of data sharing and interoperability, significantly reduce study start-up time and, lastly, support new investigators by providing standardized case report forms and instruments recommendations (2).
The Headache Version 2.0 CDEs include five (5) working group summary documents, 26 Case Report Forms (CRFs), and 41 instrument recommendations. A CDE details report, describing additional information such as definitions, accompanies each CRF. CDE recommendations are classified according to the strength of the recommendation. The four classification categories are as follows: Core, Supplemental-Highly Recommended, Supplemental, and Exploratory (3).
All documents can be downloaded and accessed on the NINDS CDEs website (4). The Headache specific CDEs are located on the “Data Standards” tab on the Headache CDE landing page (5). A CDE video tutorial is also available for new users (6).
The use of Headache CDEs will promote consistent data collection, facilitate comparisons across trials by way of meta-analyses, and allow for greater clinical trial data utility. By eliminating variability between data collection, the field of headache research can advance expeditiously.
Utilization of the Headache CDEs is a logical step forward in improving data quality and integrity. Reliable research relies on replicable data; the implementation of headache CDEs into clinical trials is a logical step forward in improving data quality and integrity.
Refining the Headache CDEs is an ongoing process, and these will be updated based on advancements in the field.
Footnotes
Declaration of conflicting interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Michael L Oshinsky reports no relevant disclosures apart from being an NIH employee. Sarah Tanveer reports no relevant disclosures apart from being an NIH employee.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: HHSN271201200034C and HHSN271201700064C contracts.
The Headache V2.0 working group members are listed below. Biomarkers subgroup
Michael G Harrington (Huntington Medical Research Institutes, Pasadena, California, Co-Chair); B Lee Peterlin (Lancaster General Health, Lancaster, Pennsylvania, Co-Chair); Angel L Guerrero (University Clinical Hospital of Valladolid, Valladolid, Spain); Andrew Hershey (Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio); Timothy Houle (Wake Forest University School of Medicine, Winston-Salem, North Carolina); Gisela M Terwindt (Leiden University Medical Center, Leiden, The Netherlands); Gretchen Tietjen (University of Toledo, Toledo, Ohio); Arn MJM van den Maagdenberg (Leiden University Medical Center, Leiden, The Netherlands); Gerrit LJ Onderwater (Leiden University Medical Center, Leiden, The Netherlands – ad hoc member); Robin M van Dongen (Leiden University Medical Center, Leiden, The Netherlands – ad hoc member); Irene de Boer, MD (Leiden University Medical Center, Leiden, The Netherlands – ad hoc member).
Demographics subgroup
Ann Scher (Uniformed Services University of the Health Sciences, Bethesda, Maryland, Chair); Lenore J Launer (National Institute of Aging, National Institute of Health, Bethesda, Maryland); Kathleen Merikangas (National Institute of Mental Health, Bethesda, Maryland); Elizabeth Seng (Yeshiva University, Bronx, New York); Todd Smitherman (University of Mississippi, University, Mississippi).
Diagnostics and characteristics subgroup
David Dodick (Mayo Clinic, Phoenix, Arizona, Co-Chair); Stephen Silberstein (Thomas Jefferson University, Philadelphia, Pennsylvania, Co-Chair); Andrew Ahn (Eli Lilly and Company, Indianapolis, Indiana); Sheena Aurora (Eli Lilly and Company, Indianapolis, Indiana); Michel Lanteri-Minet (C.H.U. Hôpital Pasteur, Nice, France); Sagar Munjal (Dr. Reddy’s Laboratories Inc, Princeton, New Jersey); Eric M Pearlman (Eli Lilly and Company, Indianapolis, Indiana); Donald Penzien (University of Mississippi Medical Center, Jackson, Mississippi); Caryn Seebach (Jefferson Headache Center, Philadelphia, Pennsylvania); Nicole M Spare (Jefferson Headache Center, Philadelphia, Pennsylvania); Christina Szperka (Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania); Hsiangkuo Scott Yuan (Jefferson Headache Center, Philadelphia, Pennsylvania).
Imaging and neurophysiology subgroup
Todd J Schwedt (Mayo Clinic, Phoenix, Arizona, Chair); Hans-Christoph Diener (University Duisburg-Essen, Essen, Germany); Manjit Matharu (National Hospital for Neurology and Neurosurgery, London, United Kingdom); Scott Powers (Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio); Jean Schoenen (University of Liège, Liège, Wallonia, Belgium); Jing Xiang (Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio).
Therapies and interventions subgroup
David Dodick (Mayo Clinic, Phoenix, Arizona, Co-Chair); Stephen Silberstein (Thomas Jefferson University, Philadelphia, Pennsylvania, Co-Chair); Aftab Alam (Dr. Reddy’s Laboratories Inc, Princeton, New Jersey); Ernesto Aycardi (Teva Pharmaceuticals, Cambridge, Massachusetts); David Borsook (Boston Children’s Hospital, Boston, Massachusetts); Mitchell Brin (Allergan and University of California Irvine, Irvine, California); Roger Cady (Alder BioPharmaceuticals Inc, Bothell, Washington); Benjamin Friedman (Montefiore Medical Center, Bronx, New York); Peter Goadsby (University of California San Francisco, San Francisco, California); Scott Powers (Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio); Michael Rapoff (University of Kansas Medical Center, Kansas City, Kansas); Uwe Reuter (The Headache Clinic of the Charité, Berlin, Germany); William Young (Thomas Jefferson University, Philadelphia, Pennsylvania).
NINDS CDE team
Claudia Moy (NINDS CDE Project Officer, Division of Clinical Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland); Carolina Mendoza-Puccini (Scientific Program Specialist, Division of Clinical Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland); Michael L Oshinsky (Program Director, Pain and Migraine, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland); Joy Esterlitz (The Emmes Corporation, Rockville, Maryland); Sherita Ala’i-Hansen (The Emmes Corporation, Rockville, Maryland); Sarah Tanveer (The Emmes Corporation, Rockville, Maryland); Katelyn Gay (The Emmes Corporation, Rockville, Maryland).