Global Assessment of Endoscopic Ultrasound Performance Skills - a New Tool to Measure the Learning Curve and Technical Skills of Endosonografists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- EUS performance
研究概览
简要总结
Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various suspicious malignancies. The learning curve of EUS is regarded long but so far the literature of this topic is minimal. Few studies have been published and there are no standardized or validated methods to perform a systematic assessment of endosonographists in training. This study is an observational study dealing with the matter of assessing endosonographists in training.
详细描述
Sahlgrenska Univeristy Hospital is tertiary university endoscopy center. At our endoscopy unit physicians/endoscopists train EUS under the supervision of an experienced endosonographist. Endosonographists examining patients referred for a routine, clinical EUS at the Sahlgrenska Univeristy hospital are candidates for being study subjects. Patients will not be examined by the study endosonographists if supervision is lacking.
External, collaborating centers will be invited to participte in the study given that the study inclusion criteria and ethical standard will be ensured.
The investigators of this study have developped a score sheet for the assessment of endosonographists in training to be used in a standard clinical setting. The score sheet is to be used by both the endosonographist in training (performer) for self-assessment and by the supervisor (observer) for assessment of the performer.
First, background data of the performer is recorded (pervious endoscopy experience etc). Then the performer starts the examination under the guidance of the observer. The observer performs continuous evaluation and assessment of the performer according to the skill parameters (N=5) of the Observer score sheet. Each parameter is ranked on a 1-5 scale (1=non-satisfactory performance, 5= excellent performance). Finally the observer is taking over, reevaluates the findings of the performer and finishes the examination.
After the examination the performer fullfills the Performer score sheet. Finally, both the performer and the observer record their preliminary diagosis of the lesion examined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EUS-examination with or without sampling performed for clinical reasons at one of the participating centers
- •The EUS-examination is to be performed by a physician in training as endosonographist OR a physician with a completed training as endosonographist
- •The EUS-examination is to be supervised by an experienced endosonographist
- •Oral and written consent of the patients examined (age>18 years)
排除标准
- •Physicians in EUS-traning without adequate supervision
- •Experimental or therapeutic EUS outside the clinical setting
结局指标
主要结局
EUS performance
时间窗: Imediate
The assessment and scoring of the endosonographist in training (Performer) is performed during the EUS-examiantion itself by the supervisor (Observer) in real-time. The total score is a compound of five parameters assessed each on a 1-5 scale (1=non-satisfactory performance, 5=excellent performance). A study unique assessment sheet is developped.
次要结局
- EUS diagnosis(2 months)
- Safety and complications(<48 hours)
研究者
Per Hedenström
Dr
Sahlgrenska University Hospital, Sweden