Evidence map›Paper›PMID 38321701›Full record

ArticleClinical trials (London, England)2024

Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2-related schwannomatosis: Recommendations for clinical trials.

Heather L Thompson, Jane Grabowski, Barbara Franklin, Kimberley S Koetsier, D Bradley Welling

Open access · hybridAbstract read
In one paragraph

Article in Clinical trials (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

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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

5 authors at 4 institutions in 3 countries.

Heather L ThompsonDepartment of Communication Sciences and Disorders, California State University, Sacramento, Sacramento, CA, USA.ORCID 0000-0002-4205-239X
Jane GrabowskiMimi Hearing Technologies, Charité, Universitätsmedizin Berlin, Berlin, Germany.
Barbara FranklinREiNS Patient Representative for NF2, New York, NY, USA.
Kimberley S KoetsierOtorhinolaryngology and Head & Neck Surgery, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-2918-4750
D Bradley WellingHarvard Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital, Boston, MA, USA.
California State University, Sacramento · USCharité - Universitätsmedizin Berlin · DELeiden University Medical Center · NLMassachusetts Eye and Ear Infirmary · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeurofibromatosis type 2-related schwannomatosis is a genetic disease characterized by the development of bilateral vestibular schwannomas, ependymomas, meningiomas, and cataracts. Mild to profound hearing loss and tinnitus are common symptoms reported by individuals with neurofibromatosis type 2. While tinnitus is known to have a significant and negative impact on the quality of life of individuals from the general population, the impact on individuals with neurofibromatosis type 2 is unknown. Consensus regarding the selection of suitable patient-reported outcome measures for assessment could advance further research into tinnitus in neurofibromatosis type 2 patients. The purpose of this work is to achieve a consensus recommendation by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration for patient-reported outcome measures used to evaluate quality of life in the domain of tinnitus for neurofibromatosis type 2 clinical trials.

methodsThe Response Evaluation in Neurofibromatosis and Schwannomatosis Patient-Reported Outcomes Communication Subgroup systematically evaluated patient-reported outcome measures of quality of life in the domain of tinnitus for individuals with neurofibromatosis type 2 using previously published Response Evaluation in Neurofibromatosis and Schwannomatosis rating procedures. Of the 19 identified patient-reported outcome measures, 3 measures were excluded because they were not validated as an outcome measure or could not have been used as a single outcome measure for a clinical trial. Sixteen published patient-reported outcome measures for the domain of tinnitus were scored and compared on their participant characteristics, item content, psychometric properties, and feasibility for use in clinical trials.

resultsThe Tinnitus Functional Index was identified as the most highly rated measure for the assessment of tinnitus in populations with neurofibromatosis type 2, due to strengths in the areas of item content, psychometric properties, feasibility, and available scores. DISCUSSION: Response Evaluation in Neurofibromatosis and Schwannomatosis currently recommends the Tinnitus Functional Index for the assessment of tinnitus in neurofibromatosis type 2 clinical trials.

Indexed as

NeurilemmomaNeurofibromatosesNeurofibromatosis 2Skin NeoplasmsTinnitusHumansPatient Reported Outcome MeasuresQuality of Lifehearing disorderNeurofibromatosis type 2tinnitustinnitus distressTinnitus Functional Indextinnitus severity

Identifiers

PMID38321701
PMCPMC10865763
OpenAlexW4391610158

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Registered trials

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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.