Evaluation of the Clinical Performance and Multi-Setting Application of an AI-Based Medical Image Verification System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reader Performance With and Without DeepMedFake Assistance: Sensitivity of the Final Verification Decision in the Hospital Clinical Cohort
研究概览
简要总结
This prospective randomized controlled trial will evaluate whether DeepMedFake improves the identification of medical images that require further verification. DeepMedFake is an artificial intelligence-based medical image analysis system that provides an image-authenticity risk assessment, a patient-image consistency risk assessment and a recommendation regarding further verification. Hospital physicians and healthcare audit professionals will participate in a randomized two-period crossover design. Each participant will assess one case set with DeepMedFake assistance and the other without AI assistance. The primary outcome in each cohort is the sensitivity of the final verification decision, evaluated separately in the hospital clinical and healthcare audit cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older.
- •Able to complete reading periods and all required electronic study procedures.
- •Completed the standardized study training and practice cases.
- •Provided written informed consent before participation.
- •（1）Hospital clinical cohort participants must also meet the following criteria:
- •Hold a valid physician qualification.
- •Currently practice in ophthalmology, radiology, ultrasound medicine, or a clinical specialty in which imaging of the neurological or cerebrovascular, cardiovascular, thoracic, abdominal, or musculoskeletal domain is routinely reviewed.
- •Have direct professional experience reviewing all imaging modalities and clinical imaging domains assigned to them in the study.
- •Routinely use the assigned medical images for image interpretation, image verification or clinical decision-making.
- •（2）Healthcare audit cohort participants must also meet the following criteria:
- •Currently work in healthcare audit, medical reimbursement review, medical-cost review or medical-material verification.
- •Have experience reviewing medical imaging materials as part of their routine work.
- •Have knowledge required to interpret the medical images and patient information presented in the study and to determine whether further verification is required.
排除标准
- •Direct involvement in development of the locked DeepMedFake model, determination of model weights or selection of decision thresholds.
- •Direct involvement in selection or construction of the formal case library or adjudication of the reference standard.
- •Direct involvement in generation or implementation of the reader randomization sequence.
- •Previous participation as a reader in the pilot study.
- •Previous access to any formal study case, case-construction record or reference-standard label.
- •Access to undisclosed study information that could permit advance identification of case type or image-generation method.
- •A financial, professional or other conflict of interest considered likely to compromise independent case assessment.
研究组 & 干预措施
Crossover Sequence A
Participants undergo unassisted review of case set S1 during Period 1, followed by DeepMedFake-assisted review of case set S2 during Period 2.
干预措施: DeepMedFake (Device)
Crossover Sequence B
Participants undergo DeepMedFake-assisted review of case set S1 during Period 1, followed by unassisted review of case set S2 during Period 2.
干预措施: DeepMedFake (Device)
Crossover Sequence C
Participants undergo unassisted review of case set S2 during Period 1, followed by DeepMedFake-assisted review of case set S1 during Period 2.
干预措施: DeepMedFake (Device)
Crossover Sequence D
Participants undergo DeepMedFake-assisted review of case set S2 during Period 1, followed by unassisted review of case set S1 during Period 2.
干预措施: DeepMedFake (Device)
结局指标
主要结局
Reader Performance With and Without DeepMedFake Assistance: Sensitivity of the Final Verification Decision in the Hospital Clinical Cohort
时间窗: During both reading periods, up to 4 weeks after randomization
The percentage of reference-standard abnormal cases assigned to further verification by hospital physicians will be estimated under DeepMedFake-assisted and unassisted review. The effect measure is the absolute percentage-point difference between review conditions.
Reader Performance With and Without DeepMedFake Assistance: Sensitivity of the Final Verification Decision in the Healthcare Audit Cohort
时间窗: During both reading periods, up to 4 weeks after randomization
The percentage of reference-standard abnormal cases assigned to further verification by healthcare audit professionals will be estimated under DeepMedFake-assisted and unassisted review. The effect measure is the absolute percentage-point difference between review conditions.
次要结局
- Reader Performance With and Without DeepMedFake Assistance: Specificity of the Final Verification Decision in the Hospital Clinical Cohort(During both reading periods, up to 4 weeks after randomization)
- Reader Performance With and Without DeepMedFake Assistance: Specificity of the Final Verification Decision in the Healthcare Audit Cohort(During both reading periods, up to 4 weeks after randomization)
- Sensitivity of the Final Verification Decision for Synthetic Medical Image Cases(During both reading periods, up to 4 weeks after randomization)
- Sensitivity of the Final Verification Decision in Discordant Cases(During both reading periods, up to 4 weeks after randomization)
- Sensitivity of the Image-Authenticity Judgment(During both reading periods, up to 4 weeks after randomization)
- Specificity of the Image-Authenticity Judgment(During both reading periods, up to 4 weeks after randomization)
- Sensitivity of the Patient-Image Consistency Judgment(During both reading periods, up to 4 weeks after randomization)
- Specificity of the Patient-Image Consistency Judgment(During both reading periods, up to 4 weeks after randomization)
- Case-Level Workflow Time(During both reading periods, up to 4 weeks after randomization)
研究者
Lv, Han
Professor
Beijing Friendship Hospital