针对内窥镜初学者的基于模拟器的培训课程的效果如何? (EFFEKTRA)
研究概览
详细说明
介入医学的培训,包括手术和内窥镜检查,通常仍然在或多或少合格的监督下对患者进行。 以前在模型或模拟器上进行的练习仍然是个例外,在具有明确课程和指南的国家/地区中,只有大约 40% 的同事参与。然而,基于模拟器的培训提供了一个保护区,在这个保护区内,患者可以在没有风险的情况下获得初步学习成功可根据“试错法”原则实现软性内窥镜检查。 各种研究表明,在模拟器上进行初始培训是有益的:在模拟器上接受过培训的医生在对患者进行首次检查时需要的支持更少,检查时间更短,可以更好地到达和识别解剖标志,并且手眼协调性更好。如果模拟器培训嵌入结构化课程中,与非结构化培训相比似乎取得了更大的成功。 培训期间的反馈也是一个积极的影响因素;这最好在每个单元结束时进行。 也可以使用模拟器来训练定义的部分表演并以所需的数量重复这些表演。 在掌握学习的意义上,具有明确中间目标的逐步结构也提高了有效性。关于模拟器训练中的最佳持续时间或学习曲线饱和度的数据很少。 在一项研究中,学习曲线在 60 次模拟结肠镜检查后变平。 另一项研究表明,在模拟器上最多可以增加 6 小时。 它还使用绩效评分的阈值来定义过渡到基于患者的培训的最佳时间点。
目前德国胃肠病学会 (DGVS) 对全国内窥镜培训课程的标准化认证,提供 4 小时的模拟器培训,包括 1 小时的介绍。 还建议每个模拟器的最大团体人数为 4 名参与者,这相当于每个受训者的有效模拟器培训持续时间仅为 1 小时。 没有关于构建模拟器培训或使用的模拟器类型的建议。
本研究的主要目的是找出是否有可能在不不切实际地延长培训和课程时间的情况下改善这种情况。
学员将随机参加常规培训或扩展模拟器培训。 课程结束后,根据 DGVS 指南,立即对两组进行相同内容的考试,以询问理论知识。 1-5 完成培训课程几周后,将对参与者的内窥镜技能进行评估。 这是在监督下对患者进行的,这是目前日常临床培训中的惯例。 通过常规胃镜检查进行为期一天的介绍后,再进行两次胃镜检查。 两名内窥镜医师根据检查视频记录独立评估性能。 所有参与监督或评估的内镜医师都不知道受训者的小组成员身份。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Hamburg、德国、20246
- University Hospital Eppendorf
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Hamburg、德国、22457
- Albertinen Krankenhaus
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
学员:
- 内科、外科或胃肠病学的执业医师,
- 没有内窥镜或腹腔镜经验
- 知情同意
患者的内窥镜检查:
- 所有年龄 > 18 岁且能够被告知并具有食管胃十二指肠镜检查临床指征的患者
- 知情同意
- 预计进行简单检查
排除标准:
患者的内窥镜检查:
- 预计会有困难的考试
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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常规胃镜培训课程
医生接受 DGVS 推荐的培训,包括为期 2 天的课程和 1 小时的模拟器培训
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往上看
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扩展模拟课程
医生接受为期两天的模拟器课程,每个受训者至少接受 6 小时的模拟器培训,按渐进或掌握学习的方式分阶段进行。
培训的初始部分将是部分任务培训。
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往上看
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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胃肠内窥镜技能全球评估 (GAGES) 能力得分能力得分
大体时间:培训课程结束后一到五周
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比较前两次患者检查的基于视频的观察的 GAGES 能力得分,每项检查均由两名内窥镜医师评估。
评价对象:食管插管、内窥镜导航、保持内镜视野清晰的能力、器械、检查质量。
每题最好5分,最差1分。
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培训课程结束后一到五周
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新训练程序的非劣效性
大体时间:通过学习完成,大约1年
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根据 DGVS 标准,期末考试中新培训程序的非劣效性
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通过学习完成,大约1年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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胃肠内窥镜检查联合咨询小组 (JAG) 对程序技能 (DOPS) 的直接观察能力评估
大体时间:培训课程结束后一到五周
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比较前两次患者检查的基于视频的 JAG DOPS 能力水平,每次检查均由两名内窥镜医师评估。
评估受训者在手术前后、插入和取出、可视化、结果管理和非技术技能方面所需的监督水平。
每个都有 4 个值,最好的是“有能力独立实践”,最差的是“最大监督”
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培训课程结束后一到五周
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内窥镜检查能力评估 (ACE)
大体时间:培训课程结束后一到五周
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前两次患者检查的基于视频的观察结果的 ACE 能力评估比较,每项检查均由两名内窥镜医师进行评估。
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培训课程结束后一到五周
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平均视觉模拟量表 (VAS) 的自我评估
大体时间:培训课程结束后一到五周
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前两次患者检查后的 VAS。
这使得能够评估压力水平并最终测量受试者的认知负荷。
在从“完全不同意”到“完全同意”的非标度线上进行评估。
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培训课程结束后一到五周
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合作者和调查者
调查人员
- 首席研究员:Thomas Rösch, Prof. Dr.、Universitätsklinikum Hamburg-Eppendorf
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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