title: Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation.
abstract: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties.
  
  
  
  MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables.
  
  
  
  A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling.
  
  
  
  PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications.
authors.affiliation: Vanderbilt Voice Center, Department of Otolaryngology, Bill Wilkerson Center, Vanderbilt University Medical Center, Nashville, TNCenter for Surgical Quality and Outcomes Research, Nashville, TNVanderbilt Evidence-Based Practice Center, Nashville, TN.
authors.forename: David O
authors.initials: DO
authors.lastname: Francis
authors.affiliation: Center for Voice and Swallowing, University of Virginia, Charlottesville.
authors.forename: James J
authors.initials: JJ
authors.lastname: Daniero
authors.affiliation: Vanderbilt University School of Medicine, Nashville, TN.
authors.forename: Kristen L
authors.initials: KL
authors.lastname: Hovis
authors.affiliation: Vanderbilt Evidence-Based Practice Center, Nashville, TNVanderbilt University Medical Center, Nashville, TNDepartment of Health Policy, Vanderbilt University Medical Center, Nashville, TN.
authors.forename: Nila
authors.initials: N
authors.lastname: Sathe
authors.affiliation: Department of Hearing and Speech Sciences, Bill Wilkerson Center, Vanderbilt University Medical Center, Nashville, TN.
authors.forename: Barbara
authors.initials: B
authors.lastname: Jacobson
authors.affiliation: Center for Surgical Quality and Outcomes Research, Nashville, TNVanderbilt Evidence-Based Practice Center, Nashville, TNDepartment of Health Policy, Vanderbilt University Medical Center, Nashville, TNDepartments of Urology and Medicine, Vanderbilt University Medical Center, Nashville, TNGeriatric Research and Education Coordination Center, Veteran's Administration Tennessee Valley Health System, Geriatric Research and Education Coordination Center, Nashville, TN.
authors.forename: David F
authors.initials: DF
authors.lastname: Penson
authors.affiliation: Center for Surgical Quality and Outcomes Research, Nashville, TNDepartments of Surgery and Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
authors.forename: Irene D
authors.initials: ID
authors.lastname: Feurer
authors.affiliation: Vanderbilt Evidence-Based Practice Center, Nashville, TNDepartment of Health Policy, Vanderbilt University Medical Center, Nashville, TN.
authors.forename: Melissa L
authors.initials: ML
authors.lastname: McPheeters
mesh_terms: D006801:Humans; D000071066:Patient Reported Outcome Measures; D054928:Validation Studies as Topic; D014831:Voice; D014832:Voice Disorders / Q000175:diagnosis / Q000628:therapy