Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01773525 |
| Other study ID # |
NTS-2_LS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 14, 2013 |
| Last updated |
August 23, 2013 |
| Start date |
January 2013 |
| Est. completion date |
May 2013 |
Study information
| Verified date |
August 2013 |
| Source |
Herlev Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: The Regional Committee on Biomedical Research Ethics |
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to test the use of a tool (NOTSSdk)to assess and provide
feedback to trainee surgeons' non-technical skills. It focuses on two aspects: reliability
of ratings of trainee surgeons using NOTSSdk; and the content and quality of feedback given
to trainees based on observations using NOTSSdk.
Description:
The specific research questions are:
- How many situations (=operations) are necessary to assess using NOTSSdk, to get
reliable ratings of trainee surgeons' NTS?
- What is the impact of the NOTSSdk feedback tool on the content of feedback
conversations regarding NTS?
- How do trainees perceive the usefulness of the feedback session?
- How do raters perceive the usefulness of the ratings and the feedback session?
Materials and methods
We aim for a sample of 15 trainees in one hospital.
Demographic data will be collected regarding: gender, age, postgraduate experience
(years/months), surgical experience (years/months), specialist training level for both
assessors and trainees.
Procedure The head of the surgical department will be informed about the project and will be
asked permission to recruit trainees and assessors.
Participants will be informed about the project orally and in writing prior to commencement.
Surgeon assessors and trainees will be given the NOTSSdk handbook to familiarize themselves
with the system before the study.
The assessors will receive a short guidance on how to provide assessments and give feedback
using NOTSSdk immediately before the first operation. After the first assessment and
feedback session, the assessor will be offered a further short structured guidance on how to
fill in the assessment form and how to provide structured feedback. It will also be allowed
for the assessor to solve ambiguities, ask questions and to get further explanation of the
categories and elements of NOTSSdk.
Eligible operations: laparoscopic cholecystectomy, hernia repair, laparoscopic appendectomy,
small bowel obstruction, hemicolectomy - depending on the trainee's competence.
Reliability study Each trainee will be assessed by one surgeon assessor using NOTSSdk during
an operation. Each trainee will be assessed on two occasions. Assessors will vary according
to availability. This will produce app. 30 assessments in total.
Feedback study Data will be collected in connection with data gathering in the reliability
study that is, data will be provided by the same assessors and the same trainees on the same
occasions. After the operation the surgeon will provide feedback to the trainee based on
his/her observations. This feedback session will be observed and audio recorded by the
primary investigator. After each feedback session the trainee and the surgeon will be
individually surveyed exploring their perception of the feedback session and its usefulness.
After the last feedback session the assessors will be surveyed about their perceptions of
NOTSSdk feasibility.
Data analysis
Reliability study Generalizability theory will be applied to analyze how many operations are
necessary to observe for reliable assessment. First the different variance components
(trainees, assessors, cases etc.) will be estimated (three facet, balanced design with
trainees nested within assessors and nested within operations). These will be used to
generate Generalizability coefficients to estimate overall reliability of the use of NOTSSdk
depending on number of assessors and operations observed.
Feedback study
We will use qualitative content analysis of emergent themes to explore the contents of the
feedback sessions with special focus on:
- Frequency of NTS topics discussed over time
- Frequency of TS topics discussed over time Descriptive statistics will be used to
present trainees' perceptions of the usefulness of the feedback and to present
assessors' perceptions of the usefulness and feasibility of the ratings and the
feedback.
