The goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'ADBoard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. The main questions it aims to answer are: Can ADBoard achieve a high level of similar recommendations as physicians' tumor conferences? Can ADBoard consider a more complete set of patient-related data than in physicians' tumor conferences? Can ADBoard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? Participants will have their hepatobiliary tumor treatments determined by either tumor conference with ADBoard, or tumor conference without ADBoard.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,200
Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors
Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Berlin, Germany
Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation
Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation. The interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.
Time frame: Through study completion, average of 30 months
The reproducibility of the therapy recommendations made by ADBoard (yes/no)
The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.
Time frame: Through study completion, average of 30 months
Completeness of the patient information with regard to decision-relevant parameters
For each type of tumor examined, a series of relevant parameters is defined by the medical staff. The objective is achieved if complete documentation, defined as documentation status 'present' or 'detected as missing', is present in more than or equal to 75% of all ADBoard-assisted decisions.
Time frame: Through study completion, average of 30 months
Quality of the explainability of the tumor conference protocols (ADBoard)
The System Causability Scale will be reviewed by 3 specialist physicians. The score ranges from 0 to 1. A higher score means greater suitability of the user interface, explanation, or explanation process itself for the intended purpose of tumor conference treatment recommendations.
Time frame: Through study completion, average of 30 months
Time between primary presentation and start of diagnostics/therapy as recommended
The time between the initial presentation of the case to the tumor conference and the time of recommendation implementation will be recorded.
Time frame: Through study completion, average of 30 months
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