ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12607000488404

Ethics application status

Approved

Date submitted

7/09/2007

Date registered

21/09/2007

Date last updated

21/09/2007

Type of registration

Retrospectively registered

Titles & IDs

Public title

DOES EXTERNAL PROFICIENCY TESTING AND METHOD INTERVENTION IMPROVE INTER-SCORER AND INTER-LABORATORY POLYSOMNOGRAM SCORING RELIABILITY?

Scientific title

DOES EXTERNAL PROFICIENCY TESTING AND METHOD INTERVENTION IMPROVE INTER-SCORER AND INTER-LABORATORY POLYSOMNOGRAM SCORING RELIABILITY?

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Measurement reliability in Polysomnographic scoring

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. External Proficiency Testing (2 cycles of EPT at 3 and 6 months)
2. External proficiency testing (2 cycles of EPT at 3 and 6 months) plus method alignment (at 1,2,4 and 5 months)

Intervention code [1]

Other interventions

Comparator / control treatment

No intervention

Control group

Active

Outcomes

Primary outcome [1]

Intraclass correlation coefficient (ICC) for apnoea hypopnoea index (AHI)

Timepoint [1]

Baseline, 3 and 6 months

Secondary outcome [1]

ICC for Arousal Index (ArI), ICC for Total Sleep Time (TST), event by event agreement for sleep stages, arousals and respiratory events.

Timepoint [1]

Baseline, 3 and 6 months

Eligibility

Key inclusion criteria

Experienced scorers. Availability for duration of study. Study compatable equipment

Minimum age

N/A

Maximum age

N/A

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Nil.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation schedule was centrally administered

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Recruited laboratories were randomly assigned to the three groups by pulling numbers out of a hat.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/01/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australasian Sleep Trials Network

Address [1]

c/- Adelaide Institute for Sleep Health
Repatriation General Hospital Daws Road, Daw Park,
South Australia 5041

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Australasian Sleep Trials Network

Address

c/- Adelaide Institute for Sleep Health
Repatriation General Hospital Daws Road, Daw Park,
South Australia 5041

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee (HREC)

Ethics committee address [1]

Studley Rd
Heidelberg, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/12/2006

Ethics approval number [1]

H2006/02714

Summary

Brief summary

Polysomnography (PSG) is a clinical test that is used to diagnose breathing disorders that occur during sleep. The most common of this type of disorder is Obstructive Sleep Apnoea (OSA). People with OSA experience periods of partial or complete obstruction of the throat during sleep. It is a serious disorder when severe, with good treatments available. Accurate diagnostic tests are therefore very important.

The main outcome measures from the PSG test are the number of obstructions per hour of sleep, the number of arousals from sleep and the amount and quality of sleep. Scoring these features from PSG recordings relies heavily on visual pattern recognition by trained observers applying pre-defined rules. The recognition of features and application of the rules is therefore subject to interpretation by individual scorers and this has the potential to affect measurement reliability. Inter-scorer variations in PSG outcome measures may affect the accuracy of clinical evaluation of individual patients and also decrease statistical power in research studies, particularly multicentre research studies. 

Several studies have examined the reliability of scoring PSGs. All have demonstrated significant variability in scoring of PSGs and there is therefore a strong incentive to investigate sources of inter-scorer variability and to develop methods aimed at achieving improvements. 

Our group has recently developed methods that allow measurement of PSG scoring reliability to be assessed and potentially improved through external proficiency testing (EPT). They rely on distributing test PSGs to participating laboratories and determining the consistency of scoring using a purpose-written computer application. However, there are no studies that evaluate whether applying the principles of EPT to PSG scoring is effective in improving scoring consistency. If EPT proves to be ineffective, then it is likely that an active process that aims to align scorer technique will be necessary.

The purposes of this study are therefore to:

1.	Evaluate whether a program of EPT improves scorer consistency
2.	Evaluate whether an active process for identifying and correcting causes of discordance (alignment process) in addition to EPT further improves scorer consistency

The demonstration of effective methods for improving scorer consistency will have important benefits for both patient care and research.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Peter Rochford

Address

Austin Health
Studley rd
Heidelberg
Vic 3084

Country

Australia

Phone

0394963673

Fax

peter.rochford@austin.org.au

Contact person for scientific queries

Name

Peter Rochford

Address

Austin Health
Studley rd
Heidelberg
Vic 3084

Country

Australia

Phone

0394963673

Fax

peter.rochford@austin.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically