Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001520820
Ethics application status
Approved
Date submitted
18/09/2021
Date registered
9/11/2021
Date last updated
23/02/2024
Date data sharing statement initially provided
9/11/2021
Date results information initially provided
4/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnosis of vocal cord dysfunction / inducible laryngeal obstruction – a Delphi study
Scientific title
Diagnosis of vocal cord dysfunction / inducible laryngeal obstruction – a Delphi study
Secondary ID [1] 305346 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vocal cord dysfunction 323672 0
Condition category
Condition code
Respiratory 321212 321212 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Currently there is no consistent and widely accepted approach to the diagnosis of vocal cord dysfunction/inducible laryngeal obstruction(s) (VCD/ILO). Harmonised diagnostic methods are vital to enable facilitate optimal diagnosis, advance management and enable research.

This is an online two-round Delphi aiming to understand how expert clinicians diagnose VCD/ILO. Participation will involve two 15 minute surveys approximately 2-4 months apart.
Intervention code [1] 321754 0
Diagnosis / Prognosis
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328996 0
The primary outcome is to understand how expert clinicians diagnose VCD/ILO using a modified two-round Delphi method. Round 1 will assess consensus quantitatively using 5-point likert rating scales.
Timepoint [1] 328996 0
Following Round 1
Primary outcome [2] 329456 0
Disagreement will be assessed quantitatively using a 5-point likert scale.
Timepoint [2] 329456 0
Following Round 2
Secondary outcome [1] 401117 0
Thematic qualitative text analysis (e.g. NVivo) will be applied to free text fields concerning advantages, disadvantages, caveats etc of diagnostic techniques.
Timepoint [1] 401117 0
After both round 1 and 2 of the modified Delphi survey.

Eligibility
Key inclusion criteria
Experts in VCD/ILO diagnosis as identified by scientific publication record and steering committee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
commercial conflict of interest

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Agreement will be defined as >= 70% of the expert panel rating Likert 4 or 5 (out of 5) or alternatively Likert 1 or 2 (out of 5)

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/11/2021
Actual
7/12/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
21/12/2021
Date of last data collection
Anticipated
24/06/2024
Actual
Sample size
Target
40
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24133 0
United States of America
State/province [1] 24133 0
Country [2] 24134 0
United Kingdom
State/province [2] 24134 0
Country [3] 24135 0
Denmark
State/province [3] 24135 0

Funding & Sponsors
Funding source category [1] 309716 0
Self funded/Unfunded
Name [1] 309716 0
Country [1] 309716 0
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 310736 0
None
Name [1] 310736 0
Address [1] 310736 0
Country [1] 310736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309479 0
Monash Health HREC
Ethics committee address [1] 309479 0
246 Clayton Rd
Clayton VIC 3168
Ethics committee country [1] 309479 0
Australia
Date submitted for ethics approval [1] 309479 0
13/10/2021
Approval date [1] 309479 0
04/11/2021
Ethics approval number [1] 309479 0

Summary
Brief summary
Introduction
Currently there is no consistent and widely accepted approach to the diagnosis of vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO). Harmonised diagnostic methods are vital to enable facilitate optimal diagnosis, advance management and enable research.

Aim
To obtain consensus on how expert clinicians diagnose VCD/ILO.

Methods and analysis
Two-round modified Delphi.

Ethics and dissemination
Ethics will be obtained from the Monash Health Human Research Ethics Committee. The dissemination plan is for presentation and publication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114286 0
Dr Paul Leong
Address 114286 0
Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168
Country 114286 0
Australia
Phone 114286 0
+61 3 9594 2045
Fax 114286 0
Email 114286 0
[email protected]
Contact person for public queries
Name 114287 0
Dr Paul Leong
Address 114287 0
Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168
Country 114287 0
Australia
Phone 114287 0
+61 3 9594 2045
Fax 114287 0
Email 114287 0
[email protected]
Contact person for scientific queries
Name 114288 0
Dr Paul Leong
Address 114288 0
Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168
Country 114288 0
Australia
Phone 114288 0
+61 3 9594 2045
Fax 114288 0
Email 114288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Study data will be available from the researcher upon reasonable request.
When will data be available (start and end dates)?
After trial completion, anticipated mid to end 2022. Full data set (anonymised) available for 5 years following study conclusion. All (anonymised) data will be included in publication.
Available to whom?
Readers of the publication
Available for what types of analyses?
Qualitative
How or where can data be obtained?
Study data will be available from study PI Paul Leong ([email protected]) upon reasonable request for a 5 year period after study conclusion..


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13261Study protocol    planned publication



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo results are being analyzed and will be available i... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDiagnosis of vocal cord dysfunction / inducible laryngeal obstruction-A Delphi study protocol.2022https://dx.doi.org/10.1371/journal.pone.0279338
EmbaseDiagnosis of vocal cord dysfunction/inducible laryngeal obstruction: An International Delphi Consensus Study.2023https://dx.doi.org/10.1016/j.jaci.2023.06.007
N.B. These documents automatically identified may not have been verified by the study sponsor.