Evidence map›Paper›PMID 31666263›Full record

ArticleBMJ open2019

Study protocol to develop a patient-reported outcome measuring disability associated with unilateral vocal fold paralysis: a mixed-methods approach with the CoPE collaborative.

Sara Fernandes-Taylor, Cara Damico Smith, Natalia Arroyo, Kemberlee Bonnet, David Schlundt, Margarete Wichmann, Irene Feurer, David O Francis

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Job Accommodations and Job Loss From Unilateral Vocal Fold Paralysis.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Sara Fernandes-TaylorDepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USA fernandes-taylor@surgery.wisc.edu.
Cara Damico SmithDepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USA.
Natalia ArroyoDepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USA.
Kemberlee BonnetDepartment of Psychology, Vanderbilt University, Nashville, Tennessee, USA.
David SchlundtDepartment of Psychology, Vanderbilt University, Nashville, Tennessee, USA.
Margarete WichmannUniversity of Wisconsin Survey Center, University of Wisconsin, Madison, Wisconsin, USA.
Irene FeurerDepartment of Biostatistics, Vanderbilt University, Nashville, Tennessee, USA.
David O FrancisDivision of Otolaryngology, Department of Surgery, University of Wisconsin, Madison, Wisconsin, USA.
University of Wisconsin–Madison · USVanderbilt University · US

Funding

Developing an Outcome Measuring Unilateral Vocal Fold Paralysis DisabilityK23DC013559 · NIDCD · VANDERBILT UNIVERSITY MEDICAL CENTER · PI FRANCIS, DAVID O. · 2014 to 2018
$990k
ECR Application: Unilateral Vocal Fold Paralysis-Related Disability Outcome: Development And ValidationR21DC016724 · NIDCD · UNIVERSITY OF WISCONSIN-MADISON · PI FRANCIS, DAVID O. · 2018 to 2019
$427k
NIDCD NIH HHS K23 DC013559NIDCD NIH HHS R21 DC016724
6 · The paper itself

Abstract

introductionPatient-reported outcome (PRO) measures are increasingly developed with multisite, representative patient populations so that they can serve as a primary endpoint in clinical trials and longitudinal studies. Creating multisite infrastructure during PRO measure development can facilitate future comparative effectiveness trials. We describe our protocol to simultaneously develop a PRO measure and create a collaborative of tertiary care centres to address the needs of patients with unilateral vocal fold paralysis (UVFP). We describe the stakeholder engagement, information technology and regulatory foundations for PRO measure development and how the process enables plans for multisite trials comparing treatments for this largely iatrogenic condition. METHODS AND ANALYSIS: The study has three phases: systematic review, measure development and measure validation. Systematic reviews and qualitative interviews (n=75) will inform the development of a conceptual framework. Qualitative interviews with patients with UVFP will characterise the lived experience of the condition. Candidate PRO measure items will be derived ETHICS AND DISSEMINATION: Our study is approved by the University of Wisconsin Health Sciences Institutional Review Board. Findings from this project will be published in open-access journals and presented at international conferences. Subsequent use of the PRO measure will include comparative effectiveness trials of treatments for UVFP at CoPE Collaborative sites.

Indexed as

Patient Reported Outcome MeasuresFemaleHumansMalePatient ParticipationPersons with DisabilitiesProgram DevelopmentQualitative ResearchReproducibility of ResultsVocal Cord Paralysislaryngologypatient-reported outcome measureprotocols & guidelinesunilateral vocal fold paralysis

Identifiers

PMID31666263
PMCPMC6830693
OpenAlexW2982478047

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.