title: Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.
abstract: No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures.
  
  
  
  This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy.
  
  
  
  Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included.
  
  
  
  Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. Muscle Nerve 55: 366-372, 2017.
authors.affiliation: University of Rochester, Rochester, New York, USA.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.affiliation: LORA Group, LLC, Royal Oak, Maryland, USA.
authors.forename: Laurie
authors.initials: L
authors.lastname: Burke
authors.affiliation: University of Milano-Bicocca, Monza, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Cavaletti
authors.affiliation: University of Rochester, Rochester, New York, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.affiliation: Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Gibbons
authors.affiliation: U.S. Army Medical Research and Materiel Command, Fort Detrick, Maryland, USA.
authors.forename: Tony D
authors.initials: TD
authors.lastname: Gover
authors.affiliation: University of Rochester, Rochester, New York, USA.
authors.forename: David N
authors.initials: DN
authors.lastname: Herrmann
authors.affiliation: Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Justin C
authors.initials: JC
authors.lastname: Mcarthur
authors.affiliation: University of Rochester, Rochester, New York, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.affiliation: Arlington, Virginia, USA.
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.affiliation: University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: University of Maryland and Veterans Administration Maryland Health Care System, Baltimore, Maryland, USA.
authors.forename: James W
authors.initials: JW
authors.lastname: Russell
authors.affiliation: University of Utah, Salt Lake City, Utah, USA.
authors.forename: A Gordon
authors.initials: AG
authors.lastname: Smith
authors.affiliation: University of Rochester, Rochester, New York, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.affiliation: University of Washington, Seattle, Washington, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Eastern Virginia Medical School, Norfolk, Virginia, USA.
authors.forename: Aaron I
authors.initials: AI
authors.lastname: Vinik
authors.affiliation: Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Roy
authors.initials: R
authors.lastname: Freeman
mesh_terms: D003929:Diabetic Neuropathies / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology
keywords: content validity; drug development; measure development; outcome measures; peripheral neuropathy; systematic review