Mitochondrial Disease

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments

Mitochondrial Disease Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Mitochondrial Disease study start-up

Mitochondrial Disease Highlight Summary: Overview of all Mitochondrial Disease-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

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Search Term(s)
NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
Mitochondrial Disease CDE Summary N/A
Biomarkers Working Group Summary Document N/A
Cognitive/Behavioral/Psychological Working Group Summary Document N/A
Endocrinology/Diabetes/Gastrointestinal/Nutrition Working Group Summary Document N/A
Exercise Physiology Working Group Summary Document N/A
Genetics Working Group Summary Document N/A
Imaging Working Group Summary Document N/A
Neurological Assessments Working Group Summary Document N/A
Patient Reported Outcome/Quality of Life Working Group Summary Document N/A
Vision Working Group Summary Document N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Diabetes-Related Medical History CDE Details
Dietary Supplements CDE Details
Reproductive and Hormonal History CDE Details
Assessments and Examinations
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Holter Examination CDE Details
Electrocardiogram (ECG) CDE Details
Physical Examinations
CRF Module/Guidance CDEs
Mitochondrial and Gastrointestinal Diseases Assessment CDE Details
Automated Self-Administered 24-hour Dietary Recall (ASA 24) N/A
Vision
CRF Module/Guidance CDEs
Mitochondrial Disease OCT Guidelines N/A
Mitochondrial Disease Test Guidelines N/A
Mitochondrial Disease Visual Electrophysiology Guidelines N/A
Mitochondrial Disease Visual Fields Guidelines N/A
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Laboratory Tests and Non-Imaging Diagnostics (Diabetes) CDE Details
Genetics Testing Short Form CDE Details
Genetics Testing Clinical Diagnostics CDE Details
Biomarkers Guidelines Mitochondrial Disease N/A
Biomarkers in Mitochondrial Disease CDE Details
Imaging Diagnostics
CRF Module/Guidance CDEs
Imaging - Mitochondrial Disease CDE Details
Imaging Guidelines and Definitions N/A
Brain Magnetic Resonance Imaging (MRI) CDE Details
Brain Perfusion Magnetic Resonance Imaging CDE Details
Cardiac Magnetic Resonance Imaging (MRI) CDE Details
Echocardiogram CDE Details
Phosphorus Magnetic Resonance Spectroscopy (31PMRS) CDE Details
Two Dimensional Speckle Tracking Echocardiography Imaging CDE Details
Outcomes and End Points
Motor Function
CRF Module/Guidance CDEs
2 Minute Walk Test N/A
6 Minute Walk Test N/A
Alberta Infant Motor Scale N/A
Barry Albright Dystonia Scale (BADS) N/A
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) CDE Details
Borg Rating of Perceived Exertion (RPE) Scale N/A
Burke-Fahn-Marsden Movement Scale (BFMMS) N/A
Gross Motor Function Measure (GMFM-88, GMFM-66) N/A
International Pediatric Mitochondrial Disease Score (IPMDS) N/A
Modified Hammersmith Functional Motor Scale for Children with Spinal Muscular Atrophy (MHFMS-SMA/MHFMS-Extend) N/A
Motor Function Measure (MFM) N/A
Newcastle Mitochondrial Disease Adult Scale N/A
Newcastle Pediatric Mitochondrial Disease Scale (NPMDS) N/A
Peabody Developmental Motor Scale Second Edition (PDMS-2) N/A
Physical Activity Questionnaire for Adolescents (PAQ-A) N/A
Physical and Neurological Examination for Subtle Signs (PANESS) N/A
Unified Dystonia Rating Scale (UDRS) N/A
Adaptive
CRF Module/Guidance CDEs
Adaptive Behavior Assessment Scale (ABAS-II) CDE Details
Delis-Kaplan Executive Function System (D-KEFS) N/A
Vineland Adaptive Behavior Scales, second edition (Vineland-II) N/A
Emotional/Behavioral
CRF Module/Guidance CDEs
ALS Depression Inventory (ADI-12) CDE Details
Apathy Evaluation Scale N/A
Apathy Scale (AS) CDE Details
Autism Diagnostic Interview (ADI) N/A
Autism Diagnostic Observation Schedule (ADOS) N/A
Beck Anxiety Inventory (BAI) CDE Details
Brief Infant Toddler Social Emotional Assessment (BITSEA) N/A
Brief Psychiatric Rating Scale (BPRS) CDE Details
Cambridge Behavioral Inventory - Revised CDE Details
Center for Epidemiologic Studies-Depression Scale (CES-D) CDE Details
Child Behavior Checklist (CBCL) N/A
Child Depression Inventory (CDI) N/A
Children's Depression Inventory - 2 (CDI-2) CDE Details
Columbia - Suicide Severity Rating Scale (C-SSRS) N/A
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) N/A
Generalized Anxiety Disorder (GAD-7) CDE Details
Hamilton Anxiety Rating Scale (HAM-A) CDE Details
Hamilton Depression Rating Scale (HDRS) CDE Details
Irritability Scale N/A
Modified Overt Aggression Scale (MOAS) N/A
Montgomery-Asberg Depression Scale (MADRS) N/A
Mood Disorder Questionnaire (MDQ) N/A
Problem Behaviours Assessment HD - Short Version (PBA-s) CDE Details
Social Responsiveness Scale (SRS) N/A
Academic Achievement
CRF Module/Guidance CDEs
American National Adult Reading Test (AmNART) CDE Details
Cognitive
CRF Module/Guidance CDEs
Automated Neuropsychological Assessment Metrics (ANAM) CDE Details
Axon Sports Computerized Cognitive Assessment Tool (CCAT) CDE Details
Brief Test of Adult Cognition by Telephone (BTACT) CDE Details
Cambridge Cognitive Assessment-Revised (CAMCOG-R) N/A
Neuropsychological Testing
CRF Module/Guidance CDEs
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Executive Functioning
CRF Module/Guidance CDEs
Behavior Rating Inventory of Executive Function (BRIEF) ? Second Edition (BRIEF-2) CDE Details
Behavior Rating Inventory of Executive Function- Preschool Version (BRIEF-P) N/A
Language
CRF Module/Guidance CDEs
Boston Diagnostic Aphasia Exam (BDAE-III) N/A
Boston Naming Test (BNT) - 30-item version N/A
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5) N/A
Comprehensive Assessment of Spoken Language (CASL) N/A
Expressive One-Word Picture Vocabulary Test N/A
New Reynell Developmental Language Scale (NRDLS) N/A
Peabody Picture Vocabulary Test 4th Edition (PPVT?-4) N/A
Preschool Language Scales ? Fifth Edition (PLS-5) N/A
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Child and Adolescent Scale of Environment (CASE) CDE Details
Child and Adolescent Scale of Participation (CASP) CDE Details
Craig Handicap and Assessment Reporting Technique (CHART-SF) - Interview version CDE Details
Craig Handicap and Assessment Reporting Technique (CHART-SF) - Paper version CDE Details
EuroQoL-5 Dimension Questionnaire (EQ-5D) CDE Details
Family Strain Questionnaire Assessment of Preschooled Children's Participation N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Pediatric Quality of Life Inventory (PEDSQL) CDE Details
Pediatric Quality of Life Inventory, Multidimensional Fatigue Scale N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Short Form 36-Item Health Survey (SF-36) CDE Details
World Health Organization Quality of Life Assessment (WHOQOL-BREF) CDE Details
Attention
CRF Module/Guidance CDEs
Conners Continuous Performance Test 3rd Edition (Conners CPT 3) CDE Details
Delis-Kaplan Executive Function System (D-KEFS) N/A
National Institutes of Health (NIH) Toolbox N/A
Test of Variables of Attention (TOVA) N/A
Dementia
CRF Module/Guidance CDEs
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) CDE Details
Montreal Cognitive Assessment (MoCA) N/A
Ataxia and Performance Measures
CRF Module/Guidance CDEs
International Cooperative Ataxia Rating Scale (ICARS) N/A
Scale for the Assessment and Rating of Ataxia N/A
Visual-Spatial Processing
CRF Module/Guidance CDEs
Judgment of Line Orientation (Benton JLO) N/A
Intellectual Functioning
CRF Module/Guidance CDEs
Kaufman Assessment Battery for Children N/A
Leiter International Performance Scale-3 (Leiter-3) N/A
Reynolds Intellectual Assessment Scale (RIAS) N/A
Wechsler Abbreviated Scale of Intelligence (WASI) N/A
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) CDE Details
Wechsler Intelligence Scale for Children-V (WISC-V) N/A
Wechsler Memory Scale IV (WMS-IV) CDE Details
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) N/A
Muscle Strength Testing
CRF Module/Guidance CDEs
Manual Muscle Testing-Using the Medical Research Council Muscle Grading Scale CDE Details
Maximum Voluntary Isometric Contraction Testing (MVICT) N/A
Memory
CRF Module/Guidance CDEs
Memory Assessment Scale N/A
Pulmonary Function Testing/Respiratory Status
CRF Module/Guidance CDEs
Pulmonary Function CDE Details

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at http://www.cssrs.columbia.edu).

Accessibility Statement

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guideline’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

Overview

The first set of Common Data Elements (CDEs) for Mitochondrial Disease was developed in 2014-2015.

To develop the Mitochondrial Disease CDEs, the Mitochondrial Disease CDE Working Groups are divided into subgroups to focus on identifying and defining data elements in the domains of:

 

• Biomarkers

• Cognitive/Behavioral/Psychological

• Endocrinology/Diabetes/GI/Nutrition

• Exercise Physiology

• Genetics

• Imaging

• Neurological Assessments

• Patient Reported Outcomes/Quality of Life

• Vision

 

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.

Roster

The Mitochondrial CDE Working Group is comprised of nine different subgroups. The Working Group members have developed the CDEs for their specific subgroups. The Mitochondrial CDE Working Group is supported by the NINDS CDE Team. The subgroups began meeting by teleconference in April 2014 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for mitochondrial disease research.

Complete Mitochondrial CDE Roster

The complete Mitochondrial Disease CDE Working Group roster and the rosters by Subgroup are shown below.

Oversight Committee Members

  • Michio Hirano, MD
    Columbia University Medical Center, New York, New York
    Co-Chair
  • Lynne A. Wolfe, MS, PNP, BC
    National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland
    Co-Chair
  • Marni Falk, MD
    The Children's Hospital of Philadelphia, Philadelphia, Pennslyvania
  • Danuta Krotoski, PhD
    National Institutes of Health, Bethesda, Maryland
  • Russel Saneto, DO, PhD
    Seattle Children's Hospital, Seattle, Washington
  • John Shoffner, MD
    Atlanta, Georgia
  • Johan Van Hove, MD, PhD, MBA
    University of Colorado, Aurora, Colorado
  • Jerry Vockley, MD, PhD
    University of Pittsburgh, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
  • Philip Yeske, PhD
    United Mitochondrial Disease Foundation, Pittsburgh, Pennsylvania

Biomarkers Working Group

  • John Shoffner, MD
    Atlanta, Georgia
    Chair
  • Mark Bamberger, PhD
    Stealth Peptides, Inc, Newton, Massachusetts
  • Yasutoshi Koga, MD, PhD
    Kurume University, Fukuoka-ken, Japan
  • Anne Lombes, MD, PhD
    INSERM, Paris, France
  • Fernando Scaglia, MD
    Baylor College of Medicine, Houston, Texas

Cognitive/Behavioral/Psychological Outcomes Working Group

  • Lisa Emrick, MD
    Baylor College of Medicine, Houston, Texas
    Chair
  • Rebecca Vaurio, PhD
    Kennedy Krieger Institute, Baltimore, Maryland

Endocrinology/Diabetes/GI/Nutrition Working Group

  • Shana McCormack, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    Chair
  • Jose E. Abdenur, MD
    Children's Hospital of Orange County, Orange, California
  • Bret Goodpaster, PhD
    Sanford Burnham Prebys Medical Discovery Instititute, Orlando, Florida
  • Robert O. Heuckeroth, MD, PhD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Robert McFarland, DoH, HEFCE
    Newcastle University, Newcastle upon Tyne, United Kingdom
  • Philip Morgan, MD
    Mitochondrial Research Guild, Seattle, Washington
  • Fernando Scaglia, MD
    Baylor College of Medicine, Houston, Texas
  • Charles A. Stanley, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Steven M. Willi, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Exercise Physiology Working Group

  • Tanja Taivassalo, PhD
    McGill University, Montreal, Canada
    Chair
  • Amy Goldstein, MD
    Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
  • Ronald Haller, MD
    Southwestern Medical Center, Dallas, Texas
  • Mark Tarnopolsky, MD, PhD
    McMaster University, Hamilton, Ontario, Canada
  • Karim Wahbi, MD, PhD
    Institute of Myology, Paris, France

Genetics Working Group

  • David Dimmock, MD
    Medical College of Wisconsin, Milwaukee, Wisconsin
    Co-Chair
  • Marn J. Falk, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    Co-Chair
  • Xiaowu Gai, PhD
    Ocular Genomics Institute, Boston, Massachusetts
  • Michio Hirano, MD
    Columbia University Medical Center, New York, New York
  • Anne Lombes, MD, PhD
    INSERM, Paris, France
  • Shamima Rahman, PhD, FRCP(C), FRCPCH
    UCL Institute of Child Health, London, United Kingdom
  • Fernando Scaglia, MD
    Baylor College of Medicine, Houston, Texas
  • Curt Scharfe, MD, PhD
    Stanford University School of Medicine, Stanford, California
  • David Thorburn, PhD, FHGSA, FFSC (RCPA)
    Murdoch Children's Research Institute, Victoria, Australia
  • Stephan Zuchner, MD, PhD
    Dr. John T. Macdonald Foundation, Miami, Florida

Imaging Working Group

  • David M. Mirsky, MD
    Children's Hospital Colorado, Aurora, Colorado
    Chair
  • Abigail Collins, MD
    Children's Hospital Colorado, Aurora, Colorado
  • Andrea L. Gropman, MD
    Children's National Medical Center, Washington, District of Columbia
  • Edward Yang, MD
    Boston Children's Hospital, Boston, Massachusetts

Neurological Assessments Working Group

  • Bruce Cohen, MD, FAAN
    Akron Children's Hospital, Akron, Ohio
    Co-Chair
  • Ingrid Tein, MD, FRCP
    University of Toronto, Toronto, Canada
    Co-Chair
  • Laurence Bindoff, MD, PhD
    University of Bergen, Bergen, Norway
  • Michio Hirano, MD
    Columbia University Medical Center, New York, New York
  • Matthew Klein, MD, MS, FACS
    Edison Pharmaceuticals, Mountain View, California
  • Thomas Klopstock, MD
    Ludwig Maximilian University of Munich, Munchen, Germany
  • Saskia Koene, MD
    Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  • Pascal Laforet, MD, PhD
    Assistance Publique-Hopitaux de Paris, Paris, France
  • Margherita Milone, MD, PhD
    Mayo School of Graduate Medical Education, Rochester, Minnesota
  • Jan Smeitink, MD, PhD
    Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

Patient Reported Outcomes/QOL Working Group

  • Mary Kay Koenig, MD
    University of Texas Health Science Center, Houston, Texas
    Co-Chair
  • Sumit Parikh, MD
    Cleveland Clinic, Cleveland, Ohio
    Co-Chair
  • Cristy Balcells, RN, MSN
    Mito Action, Medford, Massachusetts
  • Michio Hirano, MD
    Columbia University Medical Center, New York, New York
  • Amel Karaa, MD
    Massachusetts General Hospital, Boston, Massachusetts
  • Robert McFarland, DoH, HEFCE
    Newcastle University, Newcastle upon Tyne, United Kingdom
  • Russel Saneto, DO, PhD
    Seattle Children's Hospital, Seattle, Washington
  • Peter W. Stacpoole, MD, PhD
    University of Florida, Gainesville, Florida
  • Philip Yeske, PhD
    United Mitochondrial Disease Foundation, Pittsburgh, Pennsylvania

Vision Working Group

  • Patrick Yu-Wai-Man, MBBS, PhD, FRCOphth
    Newcastle University, Newcastle upon Tyne, United Kingdom
    Chair
  • Piero Barboni, MD
    University of Bologna, Bologna, Italy
  • Valerio Carelli, MD, PhD
    University of Bologna School of Medicine, Bologna, Italy
  • Patrick Chinnery, PhD, MRCPath, MRCP
    Newcastle University, Newcastle upon Tyne, United Kingdom
  • Graham E. Holder, PhD
    Moorfields Eye Hospital, London, United Kingdom
  • John L. Keltner, MD
    UC Davis School of Medicine, Sacramento, California
  • Tony Moore, MA, FRCS, FCROphth, FMedSci
    Moorfields Eye Hospital, London, United Kingdom
  • Alfredo A. Sadun, MD, PhD
    University of California Los Angeles, Los Angeles, California
  • Claire Sheldon, MD, PhD
    University of Pennsylvania, Philadelphia, Pennsylvania
  • Marcela Votruba, PhD, FRCOphth
    Cardiff University, Cardiff, United Kingdom

NIH Coordinating Team

  • Vernon Anderson, PhD
    National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), Bethesda, Maryland
  • Kathryn Camp MS, RD, CSP
    National Institutes of Health (NIH), Bethesda, Maryand
  • William C. Copeland, PhD
    National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Research Triangle Park, North Carolina
  • Kerry Goetz, MS
    National Eye Institute (NEI), National Institutes of Health (NIH), Bethesda, Maryland
  • Katrina A. Gwinn, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Adam Hartman, MD, FAAP, FANA, FAES
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Petra Kaufmann, MD, MSc
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Danuta Krotoski, PhD
    National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland
  • Elizabeth McNeil, MD, MSc
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Lynne A. Wolfe, MS, PNP, BC
    National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland
  • Steven Zullo, PhD
    National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH), Bethesda, Maryland

NINDS CDE Team

  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Ilar Edun, BA (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Sherita Ala'i Hansen, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Elias R. Feldman
    The Emmes Company, LLC, Rockville, Maryland
  • Robin Feldman, BS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Ayanna Garland
    The Emmes Company, LLC, Rockville, Maryland
  • Marybeth Montoro, MPH, CPH (Until 2015)
    The Emmes Company, LLC, Rockville, Maryland
  • Divya Nigam, BS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Amanda Suller, BS (Until 2015)
    The Emmes Company, LLC, Rockville, Maryland

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Mitochondrial CDE Revision History Document