Trial Review

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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 2346 0
Condition category
Condition code
Respiratory 2451 2451 0 0
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] 2068 0
Other interventions
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 3375 0
Intraclass correlation coefficient (ICC) for apnoea hypopnoea index (AHI)
Timepoint [1] 3375 0
Baseline, 3 and 6 months
Secondary outcome [1] 5569 0
ICC for Arousal Index (ArI), ICC for Total Sleep Time (TST), event by event agreement for sleep stages, arousals and respiratory events.
Timepoint [1] 5569 0
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
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 423 0
NA
Recruitment outside Australia
Country [1] 600 0
New Zealand
State/province [1] 600 0
NA

Funding & Sponsors
Funding source category [1] 2603 0
Other Collaborative groups
Name [1] 2603 0
Australasian Sleep Trials Network
Country [1] 2603 0
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] 2355 0
None
Name [1] 2355 0
Address [1] 2355 0
Country [1] 2355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4524 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 4524 0
Studley Rd
Heidelberg, 3084
Ethics committee country [1] 4524 0
Australia
Date submitted for ethics approval [1] 4524 0
Approval date [1] 4524 0
22/12/2006
Ethics approval number [1] 4524 0
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 28039 0
Address 28039 0
Country 28039 0
Phone 28039 0
Fax 28039 0
Email 28039 0
Contact person for public queries
Name 11196 0
Peter Rochford
Address 11196 0
Austin Health
Studley rd
Heidelberg
Vic 3084
Country 11196 0
Australia
Phone 11196 0
0394963673
Fax 11196 0
Email 11196 0
[email protected]
Contact person for scientific queries
Name 2124 0
Peter Rochford
Address 2124 0
Austin Health
Studley rd
Heidelberg
Vic 3084
Country 2124 0
Australia
Phone 2124 0
0394963673
Fax 2124 0
Email 2124 0
[email protected]

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.