Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study With Accurate Gold-standard Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Accuracy of the diagnosis established by the resident physician
研究概览
简要总结
Single-center, unblinded, 2:1 parallel pseudo-randomized efficacy trial.
In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.
In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard diagnosis of the senior physician.
详细描述
Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.
A single-center, unblinded, 2:1 parallel pseudo-randomized efficacy trial will be performed. A consultation follow-up is organized at 4-6 weeks, were the gold-standard diagnosis is established by the senior physician. The study will take place in the emergency outpatient unit of La Colline Hospital (Geneva, Switzerland) and include patients suffering from symptoms covered by Diaana.
Patients in the intervention group will fulfill Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fulfill case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard diagnosis. In the control group, the residents will directly establish a differential diagnosis, without the help of Diaana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the emergency outpatient unit of La Colline hospital (Geneva, Switzerland)
- •Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.
排除标准
- •Strictly dermatologic concerns
- •Toes trauma (because the diagnosis of those conditions is generally obvious)
- •Medical condition considered as urgent
- •Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)
结局指标
主要结局
Accuracy of the diagnosis established by the resident physician
时间窗: At day 0
The resident physician will select up to 5 diagnose in an exhaustive list, from the most to the least relevant. The accuracy of the diagnosis established will be measured as following: * 100% if the gold-standard diagnosis is in position#1 into the resident diagnosis list * 80% if the gond-standard diagnosis is in position#2 * 60% in position #3 * 40% in position #4 * 20% in position #5 * 0% if the gold-standard diagnosis absent of the resident diagnosis list A higher percentage is considered as a better outcome.
次要结局
- Patient satisfaction: Likert 1-4 scale(At day 0)
- Consultation time(At day 0)
- Differential diagnosis established by Diaana(At day 0)
研究者
Adrien Schwitzguebel
Medical doctor & principal investigator
Hôpital de la Providence, Switzerland