title: Patient-Reported Outcome Measures Related to Laryngopharyngeal Reflux: A Systematic Review of Instrument Development and Validation.
abstract: Patient-reported outcome (PRO) measures are often used to diagnose laryngopharyngeal reflux (LPR) and monitor treatment outcomes in clinical and research settings. The present systematic review was designed to identify currently available LPR-related PRO measures and to evaluate each measure's instrument development, validation, and applicability.
  
  
  
  MEDLINE via PubMed interface, CINAHL, and Health and Psychosocial Instrument databases were searched with relevant vocabulary and key terms related to PRO measures and LPR.
  
  
  
  Three investigators independently performed abstract review and full text review, applying a previously developed checklist to critically assess measurement properties of each study meeting inclusion criteria.
  
  
  
  Of 4947 studies reviewed, 7 LPR-related PRO measures (publication years, 1991-2010) met criteria for extraction and analysis. Two focused on globus and throat symptoms. Remaining measures were designed to assess LPR symptoms and monitor treatment outcomes in patients. None met all checklist criteria. Only 2 of 7 used patient input to devise item content, and 2 of 7 assessed responsiveness to change. Thematic deficiencies in current LPR-related measures are inadequately demonstrated: content validity, construct validity, plan for interpretation, and literacy level assessment.
  
  
  
  Laryngopharyngeal reflux is often diagnosed according to symptoms. Currently available LPR-related PRO measures used to symptomatically identify suspected LPR patients have disparate developmental rigor and important methodological deficiencies. Care should be exercised to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.
authors.affiliation: Department of Otolaryngology, Bill Wilkerson Center, Nashville, Tennessee, USA david.o.francis@vanderbilt.edu.|Center for Surgical Quality and Outcomes Research, Nashville, Tennessee, USA.|Vanderbilt Evidence-Based Practice Center, Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: David O
authors.initials: DO
authors.lastname: Francis
authors.affiliation: Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Dhyanesh A
authors.initials: DA
authors.lastname: Patel
authors.affiliation: Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Rohit
authors.initials: R
authors.lastname: Sharda
authors.affiliation: Department of Otolaryngology, Bill Wilkerson Center, Nashville, Tennessee, USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Hovis
authors.affiliation: Vanderbilt Evidence-Based Practice Center, Vanderbilt University Medical Center, Nashville, TN, USA.|Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Nila
authors.initials: N
authors.lastname: Sathe
authors.affiliation: Center for Surgical Quality and Outcomes Research, Nashville, Tennessee, USA.|Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Geriatric Research and Education Coordination Center, Veteran's Administration Tennessee Valley Health System, Nashville, Tennessee, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Penson
authors.affiliation: Center for Surgical Quality and Outcomes Research, Nashville, Tennessee, USA.|Departments of Surgery and Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Irene D
authors.initials: ID
authors.lastname: Feurer
authors.affiliation: Vanderbilt Evidence-Based Practice Center, Vanderbilt University Medical Center, Nashville, TN, USA.|Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Center for Population Health Sciences, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Melissa L
authors.initials: ML
authors.lastname: McPheeters
authors.affiliation: Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.|Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Vaezi
mesh_terms: D057189:Checklist / Q000379:methods; D061827:Dimensional Measurement Accuracy; D019317:Evidence-Based Medicine; D005764:Gastroesophageal Reflux / Q000150:complications; D006801:Humans; D057045:Laryngopharyngeal Reflux / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy; D000071066:Patient Reported Outcome Measures; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
keywords: developmental properties; extraesophageal reflux; laryngopharyngeal reflux; measurement; patient-reported outcome measures; systematic review; validation