Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 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
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
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
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
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 the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Readers of the publication

Conditions for requesting access:
• -

What individual participant data might be shared?
• Study data will be available from the researcher upon reasonable request.

What types of analyses could be done with individual participant data?
• Qualitative

When can requests for individual participant data be made (start and end dates)?
From:
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.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Study data will be available from study PI Paul Leong ([email protected]) upon reasonable request for a 5 year period after study conclusion..

Are there extra considerations when requesting access to individual participant data?
No


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
No documents have been uploaded by study researchers.

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.