title: Common Data Elements for Muscle Biopsy Reporting.
abstract: BACKGROUND
  There is no current standard among myopathologists for reporting muscle biopsy findings. The National Institute of Neurological Disorders and Stroke has recently launched a common data element (CDE) project to standardize neuromuscular data collected in clinical reports and to facilitate their use in research.
  
  
  OBJECTIVE
  To develop a more-uniform, prospective reporting tool for muscle biopsies, incorporating the elements identified by the CDE project, in an effort to improve reporting and educational resources.
  
  
  METHODS
  The variation in current biopsy reporting practice was evaluated through a study of 51 muscle biopsy reports from self-reported diagnoses of genetically confirmed or undiagnosed muscle disease from the Congenital Muscle Disease International Registry. Two reviewers independently extracted data from deidentified reports and entered them into the revised CDE format to identify what was missing and whether or not information provided on the revised CDE report (complete/incomplete) could be successfully interpreted by a neuropathologist.
  
  
  RESULTS
  Analysis of the data highlighted showed (1) inconsistent reporting of key clinical features from referring physicians, and (2) considerable variability in the reporting of pertinent positive and negative histologic findings by pathologists.
  
  
  CONCLUSIONS
  We propose a format for muscle-biopsy reporting that includes the elements in the CDE checklist and a brief narrative comment that interprets the data in support of a final interpretation. Such a format standardizes cataloging of pathologic findings across the spectrum of muscle diseases and serves emerging clinical care and research needs with the expansion of genetic-testing therapeutic trials.
authors.affiliation: From the Neuromuscular and Neurogenetic Disorders of Childhood Section, Neurogenetics Branch, National Institutes of Neurological Disorders and Stroke, Bethesda, Maryland (Drs Dastgir and Bonnemann); the Department of Pediatric Neurology, Division of Pediatric Neuromuscular Medicine, Columbia University Medical Center, New York, New York (Dr Dastgir); Cure CMD, Olathe, Kansas (Dr Rutkowski and Mss Alvarez and Cossette); the Department of Pediatrics, Quantitative Health Sciences Section (Drs Yan and Hoffmann), and the Department of Pathology and Laboratory Medicine, Division of Pediatric Pathology (Dr Lawlor and Ms Cossette); Medical College of Wisconsin, Milwaukee; the Dubowitz Neuromuscular Centre (Dr Sewry), the Institute of Child Health (Dr Sewry), and Great Ormond Street Hospital (Dr Sewry), University College of London, London, United Kingdom; the Wolfson Centre for Inherited Neuromuscular Diseases, RJAH Orthopaedic Hospital, Oswestry, United Kingdom (Dr Sewry); the Department of Neurophysiology, Tokyo Medical University, Tokyo, Japan (Dr Hayashi); and the Department of Neuropathology, University Medical Center, Johannes Gutenberg University, Mainz, Germany (Dr Goebel).
authors.forename: Jahannaz
authors.initials: J
authors.lastname: Dastgir
authors.forename: Anne
authors.initials: A
authors.lastname: Rutkowski
authors.forename: Rachel
authors.initials: R
authors.lastname: Alvarez
authors.forename: Stacy A
authors.initials: SA
authors.lastname: Cossette
authors.forename: Ke
authors.initials: K
authors.lastname: Yan
authors.forename: Raymond G
authors.initials: RG
authors.lastname: Hoffmann
authors.forename: Caroline
authors.initials: C
authors.lastname: Sewry
authors.forename: Yukiko K
authors.initials: YK
authors.lastname: Hayashi
authors.forename: Hans-Hilmar
authors.initials: HH
authors.lastname: Goebel
authors.forename: Carsten
authors.initials: C
authors.lastname: Bonnemann
authors.forename: Michael W
authors.initials: MW
authors.lastname: Lawlor
mesh_terms: D001706:Biopsy; D065709:Common Data Elements; D006801:Humans; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D009468:Neuromuscular Diseases / Q000175:diagnosis*; D010340:Pathology, Surgical / Q000592:standards*; D012107:Research Design / Q000592:standards*; D014481:United States