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| Name | Class |
|---|---|
| German Research Center for Artificial Intelligence | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants' cases discussed in tumor conference without ADBoard | No Intervention | Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice. | |
| Participants' cases discussed in tumor conference with ADBoard | Experimental | Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADBoard | Other | Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, average of 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, average of 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Krenzien | Contact | +4930450552001 | felix.krenzien@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Felix Krenzien | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37684688 | Derived | Ng SST, Oehring R, Ramasetti N, Roller R, Thomas P, Chen Y, Moosburner S, Winter A, Maurer MM, Auer TA, Kamali C, Pratschke J, Benzing C, Krenzien F. Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer-a study protocol for a randomized controlled trial. Trials. 2023 Sep 9;24(1):577. doi: 10.1186/s13063-023-07610-8. |
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The ADBoard study is a monocentric, prospective, parallel randomized controlled trial with a non-inferiority framework. Participants will be randomized 1:1 into one of two groups: either a) tumor conference with ADBoard, or b) tumor conference without ADBoard.
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| 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. | 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. | Through study completion, average of 30 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| C537258 | Fibrolamellar hepatocellular carcinoma |
| D018285 | Klatskin Tumor |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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