Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy

Jennifer S. Gewandter, Laurie Burke, Guido Cavaletti, Robert H. Dworkin, Christopher Gibbons, Tony D. Gover, David N. Herrmann, Justin Charles McArthur, Michael P. Mcdermott, Bob A. Rappaport, Bryce B. Reeve, James W. Russell, A. Gordon Smith, Shannon M. Smith, Dennis C. Turk, Aaron I. Vinik, Roy Freeman

Research output: Contribution to journalArticle

Abstract

Introduction: 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. Methods: This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Results: 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. Conclusions: 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.

Original languageEnglish (US)
JournalMuscle and Nerve
DOIs
StateAccepted/In press - 2016

Keywords

  • Content validity
  • Drug development
  • Measure development
  • Outcome measures
  • Peripheral neuropathy
  • Systematic review

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Cellular and Molecular Neuroscience
  • Physiology (medical)

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    Gewandter, J. S., Burke, L., Cavaletti, G., Dworkin, R. H., Gibbons, C., Gover, T. D., Herrmann, D. N., McArthur, J. C., Mcdermott, M. P., Rappaport, B. A., Reeve, B. B., Russell, J. W., Smith, A. G., Smith, S. M., Turk, D. C., Vinik, A. I., & Freeman, R. (Accepted/In press). Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy. Muscle and Nerve. https://doi.org/10.1002/mus.25264