Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice - the vertAIdo Project (Vertebral Fracture AI Detection for Better Osteoporosis Care)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,500
- 试验地点
- 1
- 主要终点
- Vertebral fractures (ICD coded)
研究概览
简要总结
The aim of this study is to evaluate clinical effectiveness and cost-effectiveness after implementing a medically approved and commercially available AI support system for opportunistic vertebral fracture screening in CT examinations within an adapted fracture care pathway (integrated care process) in clinical routine. Data will be compared to historical data (same period the previous year).
The main question it aims to answer is: Does opportunistic AI-supported vertebral fracture screening in CT examinations integrated to a fracture care pathway increase the numbers of diagnosed vertebral fractures compared to usual care?
CT scans in the clinical routine care will be opportunistically screened for vertebral fractures by the AI for 4 months. All positive findings will be confirmed by a radiologist and triaged by the FLS (Fracture Liaison Service).
详细描述
Objective
This study aims to compare a 4-month period during which AI support was integrated into the clinical fracture pathway (AI-cohort) with a historical cohort from the same period one year earlier (control-cohort). The prevalence of vertebral fractures on CT scans is expected to remain constant during this period.
The two cohorts include:
- The AI-cohort where an AI algorithm was installed and integrated into the clinical workflow to automatically analyze CT images of the thoracic or lumbar spine for vertebral fractures, i.e. opportunistic screening. The AI algorithm operates on local regional servers, ensuring that no images are sent externally. A worklist of positive findings, indicating the presence of vertebral fractures, is automatically generated in the radiology PACS (Picture Archiving and Communication System). This list is reviewed and verified by dedicated radiologists to confirm the AI findings. Confirmed fractures are then linked to the fracture liaison service (FLS), where the fracture coordinator and osteoporosis specialist care for further patient management according to clinical routine, i.e. based on a medical review, writes a referral to primary care, which will be responsible for further patient investigation and treatment of osteoporosis (i.e. usual care in the region).
- The control cohort (i.e. routine care), includes historical data from the same period the year before the AI-screening was introduced. In clinical routine, radiologists are expected to report incidental findings, such as vertebral fractures. The referring physician, who sends the referral to radiology, is then expected to act on the incidental finding of a vertebral fracture and is responsible for ensuring that the patient is managed further according to clinical routine for osteoporosis investigation and treatment.
Timeframe: Data from the AI-intervention period, spanning 4 months (20 October 2024-19 February 2025), will be analyzed. The same timeframe will be used for the historical cohort from the previous year (2023-2024).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Vertebral fractures (ICD coded)
时间窗: Within 3 months from CT scan
Numbers of ICD-coded vertebral fractures within 3 months from the CT scan.
次要结局
- Medical treatment (anti-osteoporotic)(Within 12 months after the CT scan)
- Cost-effectiveness(Two time frames: Within 12 months after the CT scan and long-term using a decision-analytic model to assess outcome in 10 years)
- Reported vertebral fractures (radiology report)(Within 2 months after the CT scan)
- DXA screened patients(Within 12 months after the CT scan)
研究者
Anna Spangeus
Assoc Prof MD
University Hospital, Linkoeping