Focus of Study: Surgeons' Non-technical SkillsNCT01562054
Evaluation of a Rating Tool for Measuring General Surgeons' Non-technical Performance in the Operating Room
An observational study of Focus of Study: Surgeons' Non-technical Skills, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The operating room, OR, is a high-tech and complex domain in which clinicians' possession of clinical knowledge and good technical skills are essential, but not sufficient. Retrospective studies have shown that a large proportion of the mistakes that occur during surgery are not caused by lack of clinical skills but… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Surgeons' Non-technical Skills
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General surgeons from eight hospitals in Denmark will be recruited to participate as raters. We wish to recruit consultant surgeons (n=10) and senior residents in surgery (n=10) who have an interest in education and supervision. Once recruited background information such as age, gender, position, years of surgical experience and prior experience with assessment of others will be collected.
Who may be able to join
- general surgeons either at consultant or trainee level
Who cannot join
- involvement in the development of NOTSSdk (the behavioral marker system used in the study)
Trial locations and contacts
1 site in 1 country.
About this study
The operating room, OR, is a high-tech and complex domain in which clinicians' possession of clinical knowledge and good technical skills are essential, but not sufficient. Retrospective studies have shown that a large proportion of the mistakes that occur during surgery are not caused by lack of clinical skills but rather by insufficient communication and teamwork. Prospective studies have shown that insufficient teamwork in the OR causes a higher risk of complications and that communication failure in the surgical team causes procedural errors and delays. It is therefore evident, that surgeons and the surgical teams need skills in communication, teamwork, decision making and leadership (so called non-technical skills) to ensure a good outcome for surgical patients.
Internationally different behavioural marker systems have been developed to aid training and assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula for surgical trainees, but no formal training or assessment occurs at this point.
Read more
The investigators developed a behavioural marker system for general surgeons adapted to the Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists of four categories: leadership, situation awareness, decision making and communication \& teamwork. Each category has between 3 and 4 elements underpinning it and each element has several behavioural examples illustrating good and poor behaviour.
The system needs evaluation to ensure that it is valid and can be used reliably to observe and rate surgeons' intra operative performance.
Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation to it's construct validity, reliability, and usability in a simulated setting.
Research questions:
- What is the inter rater reliability among raters?
- Are these ratings consistent with expert ratings (= "gold standard ratings")?
- Can a one day training session improve novice raters' agreements (construct validity)?
METHODS The study is designed to explore the reliability of the ratings made by surgeons as well as to examine whether the reliability improves with training. The study setting will be a one day course in which surgeons are asked to rate the non-technical performance of surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The first at the beginning of the day when the surgeons have had no prior training in or knowledge of rating non-technical skills and at the end of the day after 5 hours of training.
Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited to participate as raters after the heads of the departments have been contacted and informed about the project. The investigators wish to recruit consultant surgeons (n=10) and senior residents in surgery (n=10) who have an interest in education and supervision. Once recruited background information such as age, gender, position, years of surgical experience and prior experience with assessment of others will be collected.
Training and rating session The surgeons will attend a one day course. The course will consist of three parts: first a rating session to get baseline-ratings from participants of 6 video scenarios, then a teaching and training session and then another rating session with 4 new and 2 of the baseline-videos. During the first rating session the surgeons will only have the NOTSSdk rating form and will not be allowed to discuss with each other. The second rating session will be like the first but in addition to the rating form the participants will also be allowed to look in the full NOTSSdk behavioral marker system. The teaching will include an introduction to Human Factors and non-technical skills in surgery, and a short description of the development and intended use of NOTSSdk. The following training will allow participants to practice the rating of surgeons' non-technical skills on 4 video recorded scenarios and then discuss their ratings.
Ratings of the lead surgeons' performance will be obtained at the category level of each scenario.
Video recordings 14 simulated video recordings will be made showing general surgeons "acting" in their own roles during surgery. The scenarios will be scripted to display various scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy) and non-routine situations (such as unexpected bleeding during open surgery). The scenarios will be designed after a specific structure aiming at a specific variation in the surgeons' non-technical performance according to the four categories of NOTSSdk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of non-technical performance
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Surgeons' Non-technical SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Spanager, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562054
- Sponsor's protocol ID
- LS-DIMS-2
- Status last verified
- Aug 2012
- First submitted
- 6 Mar 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rating Tool for Measuring General Surgeons' Non-technical Performance in the Operating Room
- ClinicalTrials.gov ID
- NCT01562054
- Acronym / sponsor ID
- LS-DIMS-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Study completion
- Apr 2012 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The operating room, OR, is a high-tech and complex domain in which clinicians' possession of clinical knowledge and good technical skills are essential, but not sufficient. Retrospective studies have shown that a large proportion of the mistakes that occur during surgery are not caused by lack of clinical skills but rather by insufficient communication and teamwork. Prospective studies have shown that insufficient teamwork in the OR causes a higher risk of complications and that communication failure in the surgical team causes procedural errors and delays. It is therefore evident, that surgeons and the surgical teams need skills in communication, teamwork, decision making and leadership (so called non-technical skills) to ensure a good outcome for surgical patients.
Internationally different behavioural marker systems have been developed to aid training and assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula for surgical trainees, but no formal training or assessment occurs at this point.
The investigators developed a behavioural marker system for general surgeons adapted to the Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists of four categories: leadership, situation awareness, decision making and communication \& teamwork. Each category has between 3 and 4 elements underpinning it and each element has several behavioural examples illustrating good and poor behaviour.
The system needs evaluation to ensure that it is valid and can be used reliably to observe and rate surgeons' intra operative performance.
Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation to it's construct validity, reliability, and usability in a simulated setting.
Research questions:
- What is the inter rater reliability among raters?
- Are these ratings consistent with expert ratings (= "gold standard ratings")?
- Can a one day training session improve novice raters' agreements (construct validity)?
METHODS The study is designed to explore the reliability of the ratings made by surgeons as well as to examine whether the reliability improves with training. The study setting will be a one day course in which surgeons are asked to rate the non-technical performance of surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The first at the beginning of the day when the surgeons have had no prior training in or knowledge of rating non-technical skills and at the end of the day after 5 hours of training.
Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited to participate as raters after the heads of the departments have been contacted and informed about the project. The investigators wish to recruit consultant surgeons (n=10) and senior residents in surgery (n=10) who have an interest in education and supervision. Once recruited background information such as age, gender, position, years of surgical experience and prior experience with assessment of others will be collected.
Training and rating session The surgeons will attend a one day course. The course will consist of three parts: first a rating session to get baseline-ratings from participants of 6 video scenarios, then a teaching and training session and then another rating session with 4 new and 2 of the baseline-videos. During the first rating session the surgeons will only have the NOTSSdk rating form and will not be allowed to discuss with each other. The second rating session will be like the first but in addition to the rating form the participants will also be allowed to look in the full NOTSSdk behavioral marker system. The teaching will include an introduction to Human Factors and non-technical skills in surgery, and a short description of the development and intended use of NOTSSdk. The following training will allow participants to practice the rating of surgeons' non-technical skills on 4 video recorded scenarios and then discuss their ratings.
Ratings of the lead surgeons' performance will be obtained at the category level of each scenario.
Video recordings 14 simulated video recordings will be made showing general surgeons "acting" in their own roles during surgery. The scenarios will be scripted to display various scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy) and non-routine situations (such as unexpected bleeding during open surgery). The scenarios will be designed after a specific structure aiming at a specific variation in the surgeons' non-technical performance according to the four categories of NOTSSdk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General surgeons from eight hospitals in Denmark will be recruited to participate as raters. We wish to recruit consultant surgeons (n=10) and senior residents in surgery (n=10) who have an interest in education and supervision. Once recruited background information such as age, gender, position, years of surgical experience and prior experience with assessment of others will be collected.
Key inclusion criteria (1 listed)
- general surgeons either at consultant or trainee level
Key exclusion criteria (1 listed)
- involvement in the development of NOTSSdk (the behavioral marker system used in the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rating of non-technical performance
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study: Surgeons' Non-technical Skills, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating of non-technical performance (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.