Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000288426p
Ethics application status
Not yet submitted
Date submitted
13/02/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of a pathology interpretation assistance software
Scientific title
Exploratory Study for An Interpretation Assistance Software on Pathology Report Reading Performance – A Remote Randomised Crossover Trial
Secondary ID [1] 313288 0
None
Universal Trial Number (UTN)
U1111-1315-2211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pathology 335702 0
Condition category
Condition code
Public Health 332270 332270 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a fully-remote, prospective randomised 2x2 cross-over trial, with Bio Concepts Pathology Interpretation Assistant (PIA) as the investigational intervention, compared to standard practice as a control, which is reading plain PDF pathology reports with naked eyes. This is an exploratory study with the purpose of collecting preliminary clinical data on pathology report reading performance to guide further product development and future study design.

PIA is intended to be utilised by complementary medicine health professional as a software that supports the screening of health conditions, visually displaying reference ranges and trends and flagging referrals for further clinical investigation when required. This trial is a fully-remote, prospective randomised 2x2 cross-over trial, with Bio Concepts Pathology Interpretation Assistant (PIA) as the investigational intervention, compared to standard practice as a control, which is reading plain PDF pathology reports with naked eyes. This is an exploratory study with the purpose of collecting preliminary clinical data on pathology report reading performance to guide further product development and future study design. The trial will span 8 weeks, structured with two reading sessions per arm, separated by a 6-week washout period.

Participants will complete each reading session, involving 10 pre-defined pathology reports. In each session, participants will review the reports and provide responses related to condition screening, confidence levels, and referral decisions. The time taken to review each report and submit responses will also be recorded. In the PIA session, participants will use the PIA tool to assist with interpretation. In the control session, participants will review the same reports in raw PDF format, without access to PIA. Each reading session is expected to take approximately 15 minutes to 1 hour and will be administered via web application, supervised remotely by the clinical investigation team.
Intervention code [1] 329932 0
Early detection / Screening
Comparator / control treatment
The trial control group will be active control with the health professionals using current methods of analysing blood pathology reports by reading report with naked eye and using their own reference materials.
Control group
Active

Outcomes
Primary outcome [1] 340731 0
Accuracy in health condition detection by complementary medicine health professionals with the use of PIA compared to without PIA.
Assessment method [1] 340731 0
Average percentage of health conditions identified by the participants across the 10 pre-defined pathology reports at the end of each reading session.
Timepoint [1] 340731 0
Comparing reading using PIA software to without with a 6 week washout period between reading session. Where participants will have 1 week to complete a reading.
Primary outcome [2] 340732 0
To compare the speed of interpreting pathology reports by complementary medicine health professionals with the use of PIA compared to without PIA.
Assessment method [2] 340732 0
The average time required to complete interpretation of the 10 pathology reports at each reading session, assessed through digital session timing.
Timepoint [2] 340732 0
Comparing reading using PIA software to without with a 6 week washout period between reading session. Where participants will have 1 week to complete a reading.
Secondary outcome [1] 444880 0
To compare the accuracy of referral decisions made by health professionals when using PIA and standard practice.
Assessment method [1] 444880 0
Proportion of correct referral decisions out of the 10 pre-defined pathology cases at each reading session.
Timepoint [1] 444880 0
Comparing reading using PIA software to without with a 6 week washout period between reading session. Where participants will have 1 week to complete a reading.
Secondary outcome [2] 444881 0
To test the clinical usability of the PIA.
Assessment method [2] 444881 0
Clinical usability data will be collected using the System Usability Scale (SUS) at the end of PIA-assisted reading session.
Timepoint [2] 444881 0
Comparing reading using PIA software to without with a 6 week washout period between reading session. Where participants will have 1 week to complete a reading.
Secondary outcome [3] 444882 0
To collect feasibility and outcome parameters to inform the design of future confirmatory studies. Parameters to inform future study design - recruitment
Assessment method [3] 444882 0
Recruitment - assessed via an audit of study recruitment records and processes.
Timepoint [3] 444882 0
Upon conclusion of the study
Secondary outcome [4] 445926 0
To collect feasibility and outcome parameters to inform the design of future confirmatory studies. Parameters to inform future study design - consent/retention
Assessment method [4] 445926 0
Consent and retention rates assessed via an audit of consent processes/records and retention rate records.
Timepoint [4] 445926 0
Upon conclusion of study.
Secondary outcome [5] 445927 0
To collect feasibility and outcome parameters to inform the design of future confirmatory studies. Parameters to inform future study design - workflow and quality of data collection
Assessment method [5] 445927 0
Workflows and quality of data collection assessed through an audit of data records and workflow gaps.
Timepoint [5] 445927 0
Upon conclusion of data analysis.
Secondary outcome [6] 445928 0
To collect feasibility and outcome parameters to inform the design of future confirmatory studies. Parameters to inform future study design - effect size estimates to refine power calculation.
Assessment method [6] 445928 0
Effect size estimates to refine power calculation through an audit of data analysis outcomes.
Timepoint [6] 445928 0
Upon conclusion of data analysis.
Secondary outcome [7] 445929 0
To collect feasibility and outcome parameters to inform the design of future confirmatory studies. Parameters to inform future study design - cost estimation for future clinical investigation
Assessment method [7] 445929 0
Cost estimations for future clinical investigation informed through an analysis of cost incurred for exploratory trial.
Timepoint [7] 445929 0
Upon conclusion of study.

Eligibility
Key inclusion criteria
Complementary medicine health professionals with current registration (e.g., Australian Health Practitioner Regulation Agency, Dietitian Australia, NHAA, ANTA, ATMS Nutrition Society of Australia, Australian Register of Naturopaths and Herbalists)

Practice in a clinical setting.

Provide a signed and dated informed consent form.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Do not review patient's blood pathology in clinic.

Do not have sufficient self-efficacy with computer and internet.

Do not have a stable internet connection at the workplace.

Inability or unwillingness to commit to the minimum of a 8-week study period and time to review 10 patients pathology reports.

Unable to complete the onboarding testing.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
20/06/2025
Actual
Date of last data collection
Anticipated
15/08/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317738 0
Commercial sector/Industry
Name [1] 317738 0
Bio Concepts Pty. Ltd
Country [1] 317738 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bio Concepts Pty Ltd
Country
Australia
Secondary sponsor category [1] 320052 0
None
Name [1] 320052 0
Country [1] 320052 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316426 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316426 0
Ethics committee country [1] 316426 0
Australia
Date submitted for ethics approval [1] 316426 0
18/04/2025
Approval date [1] 316426 0
Ethics approval number [1] 316426 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 137854 0
Dr Michael Osiecki
Address 137854 0
Bio Concepts Pty Ltd, 19a Guardhouse Road, Banyo, QLD 4014
Country 137854 0
Australia
Phone 137854 0
+61 7 3868 0615
Email 137854 0
ceo@bioconcepts.com.au
Contact person for public queries
Name 137855 0
Emma Boreland
Address 137855 0
Bio Concepts Pty Ltd, 19a Guardhouse Road, Banyo, QLD 4014
Country 137855 0
Australia
Phone 137855 0
+61 7 38680699
Email 137855 0
piatrial@bioconcepts.com.au
Contact person for scientific queries
Name 137856 0
Michael Osiecki
Address 137856 0
Bio Concepts Pty Ltd, 19a Guardhouse Road, Banyo, QLD 4014
Country 137856 0
Australia
Phone 137856 0
+61 7 38680699
Email 137856 0
piatrial@bioconcepts.com.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.