None listed
Conditions
Brief summary
This is an exploratory study to collect preliminary clinical performance data of Bio Concepts Pathology Interpretation Assistant (PIA) software to guide further product development and future pivotal study design. The trial is designed to investigate the effectiveness of using PIA for improving the users’ pathology reading performance. The primary hypotheses of this study are: using PIA is not inferior to the standard practice in terms of accuracy of identifying health conditions and using PIA reduces the time required to interpret pathology reports compared to standard practice.
Interventions
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
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.
Sponsors
Bio Concepts Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed