The Vocal Cord Paralysis Experience (CoPE), led by David Francis, MD, MS, is a collaborative of voice centers across the United States committed to understanding and improving patients’ experience with vocal cord paralysis.
The CoPE collaborative analyzes patient experiences to enhance clinical practices and develop personalized treatment plans aligned with each patient’s unique characteristics and treatment goals.
To help clinicians track symptoms and treatment effectiveness over time, the University of Wisconsin research team has developed and validated a patient-reported outcome measurement tool (PROM). The CoPE PROM tool is intended to act as a primary endpoint in clinical trials, comparing the effectiveness and durability of treatments including behavioral (e.g., speech therapy), temporary (e.g., injection augmentation), and permanent surgical treatments for unilateral vocal fold paralysis (UVFP). Reliability and validity of the CoPE PROM tool was established in a large, nationally representative sample of adult patients with UVFP from voice centers in the CoPE Collaborative.
The CoPE PROM tool was developed with funding from the National Institutes of Health.
The CoPE team is part of the Wisconsin Surgical Outcomes Research program (WiSOR).
Vocal Cord Paralysis Experience
UW Clinical Sciences Center
K6/100 block of University Hospital
600 Highland Ave., Madison, WI 53792
608-263-6927
cope@med.wisc.edu
Licensing
Wisconsin Alumni Research Foundation (WARF) licenses the CoPE PROM tool free of charge for educational or nonprofit use.
Commercial licenses are also available for use by surgical clinics, researchers interested in UVFP epidemiology and treatment, and testing a drug, medical intervention, or other potential for-profit use.
Any unlicensed or unauthorized commercial use, commercial distribution, or other unlicensed or unauthorized use of the CoPE PROM tool constitutes copyright infringement. Fines and criminal penalties under federal law may apply.
CoPE PROM Uses
Clinicians
- Understand the benefits of using patient-reported measures, including enhanced monitoring, quality of care, and personalized treatment
- Administer, access and interpret patient scores to detect signs of change and support patient engagement
- Recognize the limitations in assessing patient-reported health and treatment outcomes
Researchers
- In a clinical setting, assess how treatments affect patients’ symptoms, quality of life and functioning, from their perspective
- Interpret individual and population-level longitudinal data for insights into UVFP epidemiology
- Prepare to use the tool as a primary endpoint in clinical trials
Industry Partners
- Enhance industry clinical trials with patient perspectives that complement traditional endpoints
- Evaluate and inform improvements to medical devices, pharmaceuticals, or other therapies
- Identify unmet patient needs
Unilateral Vocal Fold Paralysis
Unilateral vocal fold paralysis (UVFP) is an increasingly common and debilitating neurological condition caused by injury to one recurrent laryngeal nerve. More head, neck, spine, and cardiothoracic surgeries lead to more people at risk for UVFP, with these procedures accounting for 50% of UVFP cases. UVFP complicates up to 15% of thyroidectomies and 11% of anterior spine procedures. In recent decades, these procedures have increased threefold and eightfold, with a corresponding rise in UVFP incidence.
UVFP can have debilitating quality of life consequences that include disordered communication, swallowing and breathing, substantial losses in work productivity, and decreased psychosocial function, which may result in anxiety, isolation and fear. Treatments for UVFP vary widely due to the degree of spontaneous recovery and the timing of intervention, which depend on the severity of the neurological injury. While some interventions benefit patients, the optimal type and timing of treatment remain undetermined due to a lack of high-quality comparative evidence.
Translation
The CoPE PROM was developed in English.
For information on translations in progress or to submit translations, contact us at cope@med.wisc.edu.
Translation Steps
- Find a vendor to perform a forward-backward translation
- Submit the forward and backward translations to us for approval
- Provide us with the final translation and translation certificate
Active Patient Studies
Our ongoing CoPE study aims to personalize the assessment of treatment effectiveness using patient-reported outcome measures at the point of care. We use an innovative statistical machine-learning approach that incorporates the value each patient places on outcomes related to voice, psychosocial well-being, and swallowing.
To achieve this, we are conducting a study, funded by the National Institutes of Health, consisting of two user-friendly surveys completed within a three-month period. These surveys ask patients about their medical history and how the symptoms of vocal cord paralysis have affected their lives before and after treatment. Launched in fall 2024, the surveys are being conducted across the CoPE Collaborative.
Our Team
David O. Francis
Credentials: MD, MS
Position title: CoPE Study Principal Investigator, Director of Outcomes Research
Jiwei Zhao
Credentials: PhD
Position title: CoPE Study Principal Investigator; Associate Professor, Department of Biostatistics and Medical Informatics
Miranda Rasmussen
Position title: CoPE Study Coordinator
Peter Nordby
Credentials: MA
Position title: CoPE Study Project Manager
CoPE Collaborative Sites
Augusta University
Baylor College of Medicine
Boston University
Brigham and Women’s Hospital
Cleveland Clinic
Cornell University
Duke University
Eastern Virginia Medical School
Emory University
Indiana University
Johns Hopkins University
Loma Linda University
Massachusetts Eye and Ear
Mayo Clinic
Mayo Clinic Arizona
Medical College of Wisconsin
Medical University of South Carolina
Memorial Sloan Kettering Cancer Center
New York University
Northwestern University
Ochsner Medical Center
The Ohio State University
Oregon Health & Science University
Tufts Medical Center
University of Alabama at Birmingham
University of California, Los Angeles
University of California, San Diego
University of Cincinnati
University of Colorado
University of Iowa
University of Kansas
University of Miami
University of Michigan
University of Minnesota
University of Missouri
University of North Carolina at Chapel Hill
University of Pittsburgh Medical Center
University of Rochester Medical Center
University of Southern California
University of Texas at San Antonio
University of Texas Southwestern Medical Center
University of Utah
University of Virginia
University of Washington
University of Wisconsin–Madison
Vanderbilt University
Washington University in St. Louis