Evidence map›Paper›PMID 36863737›Full record

ArticleBMJ open2023

Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial.

Carl Christian Pedersen, Ellen Raben Pedersen, Søren Laugesen, Raul Sanchez-Lopez, Jacob Nielsen, Chris Bang Sørensen, Christos Sidiras, René Gyldenlund Pedersen, Jesper Hvass Schmidt

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05043207 (A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT05043207 naunknown statusnot on this map

A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.

TypeinterventionalSponsorUniversity of Southern DenmarkRan2022 to 2024Enrolled250ConditionsHearing Loss, Sensorineural, Hearing Impairment, SensorineuralArmsuAud, Traditional audiometry
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 2 institutions in 3 countries.

Carl Christian PedersenResearch Unit for ORL - Head & Neck Surgery and Audiology, University of Southern Denmark, Odense, Denmark pede@sdu.dk.ORCID 0000-0002-8262-3185
Ellen Raben PedersenThe Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark.
Søren LaugesenInteracoustics Research Unit, Lyngby, Denmark.
Raul Sanchez-LopezInteracoustics Research Unit, Lyngby, Denmark.ORCID 0000-0002-5239-2339
Jacob NielsenThe Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark.
Chris Bang SørensenThe Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-2279-2091
Christos SidirasThe Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark.
René Gyldenlund PedersenThe Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark.ORCID 0000-0001-8589-2930
Jesper Hvass SchmidtResearch Unit for ORL - Head & Neck Surgery and Audiology, University of Southern Denmark, Odense, Denmark.
University of Southern Denmark · DKUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is a worldwide need to enhance the capacity of audiometry testing. The objective of this study is to compare the User-operated Audiometry (UAud) system with traditional audiometry in a clinical setting, by investigating if hearing aid effectiveness based on UAud is non-inferior to hearing aid effectiveness based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility. METHODS AND ANALYSIS: The design will be a blinded non-inferiority randomised controlled trial. 250 adults referred for hearing aid treatment will be enrolled in the study. Study participants will be tested using both traditional audiometry as well as the UAud system and they will answer the questionnaire Speech, Spatial and Qualities of Hearing Scale (SSQ12) at baseline. Participants will be randomly divided to receive hearing aids fitted based on either UAud or traditional audiometry. Three months after participants have started using their hearing aids, they will undergo a hearing in noise test with hearing aids to measure their speech-in-noise performance and answer the following questionnaires: SSQ12, the Abbreviated Profile of Hearing Aid Benefit and the International Outcome Inventory for Hearing Aids. The primary outcome is a comparison of the change in SSQ12 scores from baseline to follow-up between the two groups. Participants will undergo the user-operated ACT test of spectro-temporal modulation sensitivity as part of the UAud system. The ACT results will be compared with measures of speech intelligibility from the traditional audiometry session and follow-up measurements. ETHICS AND DISSEMINATION: The project was evaluated by the Research Ethics Committee of Southern Denmark and judged not to need approval. The findings will be submitted to an international peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05043207.

Indexed as

Hearing AidsAdultAudiometryEquivalence Trials as TopicHearingHearing TestsHumansRandomized Controlled Trials as TopicSpeech IntelligibilityAudiologyHealth informaticsQuality in health care

Identifiers

PMID36863737
PMCPMC9990669
OpenAlexW4323035478

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.