Change in the Proportion of Correct Interpretations of Pulmonary Opacities by General Practitioners Using an Expert System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of globally correct interpretations of pulmonary opacities
研究概览
简要总结
This randomized crossover clinical trial will evaluate whether an artificial intelligence-based expert system improves the interpretation of chest radiographs by final-year medical students, rural physicians, and general practitioners with less than two years of clinical experience.
Participants will interpret chest radiographs containing normal findings or pulmonary opacities classified as alveolar, interstitial, or mixed. Each participant will review the same set of radiographs twice: once without assistance from the expert system and once with assistance from the artificial intelligence system. The order of these two reading conditions will be randomly assigned, with a six-week interval between sessions to reduce memory effects.
The main outcome will be the proportion of correct interpretations compared with a previously established reference standard based on radiologist interpretation supported by chest computed tomography findings. The study will also assess diagnostic confidence and agreement with the reference standard.
This study does not involve treatment decisions or direct patient care. It is intended to determine whether artificial intelligence support may improve the accuracy and confidence of less-experienced physicians when interpreting pulmonary opacities on chest radiographs.
详细描述
Study Design
A randomized, controlled, two-period crossover trial with a six-week washout period will be conducted to evaluate the change in the proportion of correct interpretations of pulmonary opacities on chest radiographs by final-year medical students, physicians in mandatory rural or social service, and general practitioners with less than two years of clinical experience, before and after assistance from an artificial intelligence-based image-recognition expert system.
Each participant serves as their own control, allowing direct comparison of interpretation performance with and without assistance from the expert system. Each participant evaluates a set of chest radiographs under two conditions: Phase A, interpretation without expert-system assistance, and Phase B, interpretation with expert-system assistance. The order of the phases is randomized. Sequence 1 begins with Phase A and, after a six-week washout period, proceeds to Phase B; Sequence 2 begins with Phase B and, after the washout period, proceeds to Phase A. The six-week interval is considered sufficient to reduce memory or learning effects. During this period participants have no access to the previously evaluated images and receive no feedback about their responses.
Expert System
The expert system is a freely available, open-source deep-learning model for computer-aided interpretation of chest radiographs that reports the presence of pulmonary opacities. Its output is displayed together with each image during Phase B only. The system is used exclusively as a reading aid for study participants; it is not used for clinical care, and no diagnostic, treatment or management decision for any patient is based on its output.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Final-year undergraduate medical students.
- •Physicians completing mandatory rural or social service.
- •Licensed general practitioners with less than two years of clinical experience.
- •Willingness to participate as a chest radiograph reader.
- •Ability to complete both study reading sessions.
排除标准
- •Corrected visual acuity worse than 20/60 in the better-seeing eye.
- •Visual-field restriction, impaired contrast perception, binocular vision abnormalities, or another visual condition that prevents adequate interpretation of chest radiographs.
- •Inability to complete the visual acuity assessment before the reading session.
结局指标
主要结局
Proportion of globally correct interpretations of pulmonary opacities
时间窗: Each of the two reading sessions, separated by a 6-week washout period
Proportion of chest radiographs interpreted correctly by the participant, compared with a previously established reference standard. An interpretation is counted as globally correct only when both criteria are met: (1) the participant correctly identifies whether a pulmonary opacity is present or absent, and (2) when an opacity is present, the participant correctly classifies the pattern as alveolar, interstitial or mixed. The outcome is expressed as the percentage of correct interpretations out of the 16 radiographs read in each condition, and is compared between the reading condition without expert-system assistance and the reading condition with expert-system assistance.
次要结局
- Sensitivity and specificity for the detection of pulmonary opacities(Each of the two reading sessions, separated by a 6-week washout period)
- Proportion of correctly classified pulmonary opacity patterns(Each of the two reading sessions, separated by a 6-week washout period)
- Diagnostic confidence score(Each of the two reading sessions, separated by a 6-week washout period)
- Agreement between participant interpretation and the reference standard (Cohen's kappa)(Each of the two reading sessions, separated by a 6-week washout period)