Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Valid informed consent
- •Patient information available in the hospital information system or Health Data Platform (HDP)
- •Enrollment in the hepatobiliary tumor conference
- •Diagnosis of any of the following entities: Colorectal liver metastasis, Gallbladder carcinoma, Hepatocellular carcinoma (HCC), mixed cell carcinoma, or fibrolamellar carcinoma, Perihilar cholangiocarcinoma (Klatskin tumors), Intrahepatic cholangiocarcinoma (iCC)
排除标准
- •Patient does not consent / incapable of giving consent
- •Missing findings in the hospital information system
- •Patient is seeking for a second opinion and is not being treated at the study institution
结局指标
主要结局
Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation
时间窗: Through study completion, average of 30 months
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.
The reproducibility of the therapy recommendations made by ADBoard (yes/no)
时间窗: Through study completion, average of 30 months
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.
次要结局
- Completeness of the patient information with regard to decision-relevant parameters(Through study completion, average of 30 months)
- Quality of the explainability of the tumor conference protocols (ADBoard)(Through study completion, average of 30 months)
- Time between primary presentation and start of diagnostics/therapy as recommended(Through study completion, average of 30 months)
研究者
Felix Krenzien
Senior Physician and Advanced Clinician Scientist, Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany