A Prospective Study to Assess the Impact of an Artificial Intelligence System on Reporting of Chest X-rays, Evaluate the Ability of AI Driven Worklists to Improve Reporting Times and Improve Same Day CT Pathway for Suspected Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20,000
- 主要终点
- Radiologist performance review
研究概览
简要总结
The study has an initial short retrospective component but is predominately a prospective study with two main parts.
Initially during a 1 month period whilst reporters are familiarising themselves with the software two local databases will be reviewed by the AI software:
- A training set of 100 chest X-rays (CXR) some of which contain nodules and is used as a training tool with previously documented radiologist performance.
- A set of previously reported radiographs in patients referred by the reporter for CT, ground truth created from the prior CT report and review by two radiologists if required.
This will allow comparison of stand-alone radiologist and AI performance
This is followed by a 6 month period involving multiple groups of reporters and approximately 20,000 cases looking at the impact of an AI system which assesses 10 abnormalities on chest X-ray and reporting on the sensitivity for detection of lesions and its impact on reporter confidence. Specifically the investigators would look at:
- Missed finding by AI, but detected by reporter
- Correctly detected finding by AI
- Missed finding by the reporter but detected by AI
- Finding detected by AI but disputed by the reporter
■ AI's impact on
- Radiological report
- Further recommended imaging
- Altering patient management
- improvement in report confidence as perceived by reporter
A subsequent 3 month period looking at the impact of AI produced worklists on report turnaround times and the patient pathway from chest X-ray to CT. the investigators would specifically look at:
- number of nodules detected
- number of CXRs recommended for follow up CT
- time taken from CXR to CT
- number of lung cancers detected after CT[1]
- Time to report, measured as previously from PACS and reporting software data
The population to be studied will be all patients over 16 years of age referred by their General Practitioner to Hull University Hospitals NHS Trust for a chest radiograph and any chest radiograph performed in the Hull Royal Infirmary ED radiology for patients over 16 years of age during the 6 month study period. The ED department images patients from the emergency department and in-patients within the hospital.
All radiographs will be reviewed initially without review of the AI information and then using the additional images. Reporters will mark the effect of the AI on their decision. All disagreements between the reporter and the AI will be reviewed by senior reporters and a consensus decision made.
详细描述
A single centre prospective study, in which data will be collected from Hull University Teaching Hospitals NHS Trust (HUTH).
GP chest X-rays take place in the two main hospital sites of the Trust but also at satellite units in the local community. All of these use the same radiology information system (RIS) and chest X-rays are automatically stored on the HUTH picture archiving and communication system (PACS).
The radiology unit in the Emergency Department at Hull Royal Infirmary undertakes chest X-rays for the emergency patients but also in-patients within the hospital.
All chest X-rays will be booked into the RIS, performed and sent to the PACS system as normal. Any chest X-ray performed on a patient of 16 years of age or older from either of the above sets will be automatically transferred to the AI server and once processed the AI report will automatically transfer into the same PACS folder as the original film.
Reporting of the chest X-ray and review of the AI information will take place in the normal reporting sessions undertaken within the radiology department by all grades of staff.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient 16 years or older
- •Posterior-anterior and Anterior-posterior chest radiographs
- •Requested by General Practitioners or performed in the Emergency Department radiology unit
排除标准
- •Patients under 16 years of age
- •lateral films
- •Chest radiographs which are of suboptimal quality, to an extent that it is deemed uninterpretable by the reporter
结局指标
主要结局
Radiologist performance review
时间窗: six months
To demonstrate AI can help to improve the radiologist performance in terms of missed finding by radiologist detected by AI ( as a percentage error rate)
次要结局
- Lung cancer pathway improvement(three months)
- Lung cancer detection(six months)
- Report turnaround times improvement(three months)
