2018 Section 6 - Laryngology, Voice Disorders, and Bronchoesophalogy

Reprinted by permission of Otolaryngol Head Neck Surg. 2016; 155(6):923-935.

Systematic Review/Meta-analysis

Otolaryngology– Head and Neck Surgery 2016, Vol. 155(6) 923–935 American Academy of Otolaryngology—Head and Neck

Patient-Reported Outcome Measures Related to Laryngopharyngeal Reflux: A Systematic Review of Instrument Development and Validation David O. Francis, MD, MS 1,2,3 , Dhyanesh A. Patel, MD 4,5 , Rohit Sharda, MD 4,5 , Kristen Hovis, MD 1 , Nila Sathe, MA, MLIS 3,6 , David F. Penson, MD, MPH 2,5,6,7,8 , Irene D. Feurer, PhD 2,9 , Melissa L. McPheeters, PhD, MPH 3,6,10 , and Michael F. Vaezi, MD, PhD 4,5

Surgery Foundation 2016 Reprints and permission:

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relevance before applying these PRO measures for clinical, research, or quality initiatives.

Sponsorships or competing interests that may be relevant to content are dis- closed at the end of this article.

Abstract Objectives. Patient-reported outcome (PRO) measures are often used to diagnose laryngopharyngeal reflux (LPR) and monitor treatment outcomes in clinical and research set- tings. The present systematic review was designed to iden- tify currently available LPR-related PRO measures and to evaluate each measure’s instrument development, validation, and applicability. Data Sources. 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. Review Methods. Three investigators independently per- formed abstract review and full text review, applying a previ- ously developed checklist to critically assess measurement properties of each study meeting inclusion criteria. Results. Of 4947 studies reviewed, 7 LPR-related PRO mea- sures (publication years, 1991-2010) met criteria for extrac- tion 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: con- tent validity, construct validity, plan for interpretation, and literacy level assessment. Conclusion. 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

Keywords laryngopharyngeal reflux, extraesophageal reflux, measure- ment, patient-reported outcome measures, developmental properties, validation, systematic review

Received April 22, 2016; revised June 22, 2016; accepted July 25, 2016.

1 Department of Otolaryngology, Bill Wilkerson Center, Nashville, Tennessee, USA 2 Center for Surgical Quality and Outcomes Research, Nashville, Tennessee, USA 3 Vanderbilt Evidence-Based Practice Center, Vanderbilt University Medical Center, Nashville, TN, USA 4 Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee, USA 5 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA 6 Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA 7 Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee, USA 8 Geriatric Research and Education Coordination Center, Veteran’s Administration Tennessee Valley Health System, Nashville, Tennessee, USA 9 Departments of Surgery and Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA 10 Center for Population Health Sciences, Vanderbilt University Medical Center, Nashville, Tennessee, USA This work was presented at Digestive Disease Week 2016; May 21, 2016; San Diego, California. Corresponding Author: David O. Francis, MD, MS, Department of Otolaryngology, Vanderbilt Bill Wilkerson Center, Medical Center East, South Tower 7302, 1215 21st Avenue South, Nashville, TN 37232, USA. Email: david.o.francis@vanderbilt.edu

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