ANZCTR - Registration

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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 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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

vocal cord dysfunction

Condition category

Condition code

Respiratory

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]

Diagnosis / Prognosis

Comparator / control treatment

n/a

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Following Round 1

Primary outcome [2]

Disagreement will be assessed quantitatively using a 5-point likert scale.

Timepoint [2]

Following Round 2

Secondary outcome [1]

Thematic qualitative text analysis (e.g. NVivo) will be applied to free text fields concerning advantages, disadvantages, caveats etc of diagnostic techniques.

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Country [2]

United Kingdom

State/province [2]

Country [3]

Denmark

State/province [3]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Rd
Clayton VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

246 Clayton Rd
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/10/2021

Approval date [1]

04/11/2021

Ethics approval number [1]

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

Dr Paul Leong

Address

Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2045

Fax

[email protected]

Contact person for public queries

Name

Paul Leong

Address

Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2045

Fax

[email protected]

Contact person for scientific queries

Name

Paul Leong

Address

Monash Lung Sleep Allergy & Immunology
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2045

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
13261	Study protocol				planned publication

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Diagnosis of vocal cord dysfunction / inducible laryngeal obstruction-A Delphi study protocol.	2022	https://dx.doi.org/10.1371/journal.pone.0279338
Embase	Diagnosis of vocal cord dysfunction/inducible laryngeal obstruction: An International Delphi Consensus Study.	2023	https://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.

Trial Review

Documents added manually

Documents added automatically