Clinical trial NCT04183439: Modeling Technical Error and Adverse Outcomes
Official title: A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Errors
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Surgical teacher

Exclusion Criteria:

* None

Primary outcomes:
measure: Model of the relationship between minute, technical motions by a surgeon and intraoperative adverse events, and eventually adverse patient outcomes
timeFrame: approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Missouri Kansas City
name: Gary Sutkin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang B, Hanna GB, Joice P, Cuschieri A. Identification and categorization of technical errors by Observational Clinical Human Reliability Assessment (OCHRA) during laparoscopic cholecystectomy. Arch Surg. 2004 Nov;139(11):1215-20. doi: 10.1001/archsurg.139.11.1215.