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Modeling Technical Error and Adverse Outcomes

2019年12月2日 更新者:Gary Sutkin、University of Missouri, Kansas City

A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study

The investigators' objective was to develop a theoretical model exploring the relationship between technical errors and adverse patient outcomes. To achieve this aim, the investigators interviewed surgeons from a diverse group of surgical specialties, asking them about their adverse outcomes from surgery and their most granular surgical techniques. the investigators' focus was on adverse outcomes that could be predictably associated with imperfect surgical technique and therefore prevented with proper technique.

研究概览

地位

完全的

详细说明

Background:

Minute technical errors performed by the surgeon have the potential to lead to adverse patient outcomes. The objective was to gain a deeper understanding of this relationship through the development of an intraoperative model.

Materials and Methods:

The investigators used Constructivist Grounded Theory methodology, including a comprehensive review of the literature and interviews with surgeons, focusing on avoidance of technical errors. The investigators used the Observational Clinical Human Reliability Assessment system, which categorizes granular, technical intraoperative errors, as their conceptual framework. The investigators iteratively interviewed surgeons, from multiple adult and pediatric surgical specialties, refined our semi-structured interview, and developed a model. The model remained stable after interviewing 11 surgeons, and it was reviewed it with earlier interviewed surgeons.

研究类型

观察性的

注册 (实际的)

11

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We recruited surgeons from two University academic health centers, one specializing in adults and the other in children. The surgeons were selected through a snowball technique and emailed to participate. DK and GS interviewed eleven surgical attendings representing 10 surgical specialties. Each subject had at least 10 years of experience in their respective fields and regularly taught residents.

描述

Inclusion Criteria:

  • Surgical teacher

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:其他

队列和干预

团体/队列
Surgeons Interviewed
We recruited surgeons from two University academic health centers, one specializing in adults and the other in children. The surgeons were selected through a snowball technique and emailed to participate. DK and GS interviewed eleven surgical attendings representing 10 surgical specialties. (Table 2) Each subject had at least 10 years of experience in their respective fields and regularly taught residents.

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
Model of the relationship between minute, technical motions by a surgeon and intraoperative adverse events, and eventually adverse patient outcomes
大体时间:approximately 2 years
This is a qualitative study interviewing surgeons about the link between technical motions and adverse patient outcomes. Our primary outcome will be a model, developed from their answers.
approximately 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gary Sutkin、University Missouri Kansas City

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月30日

初级完成 (实际的)

2019年1月7日

研究完成 (实际的)

2019年1月7日

研究注册日期

首次提交

2019年11月26日

首先提交符合 QC 标准的

2019年11月27日

首次发布 (实际的)

2019年12月3日

研究记录更新

最后更新发布 (实际的)

2019年12月4日

上次提交的符合 QC 标准的更新

2019年12月2日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 17-076

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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