New technology for data-driven improvement of effectiveness, quality, and safety in the operating room.

With a synchronised data capture and analysis platform, comprehensive data can be collected from the operating room (OR), like in most high-risk industries. This review summarises the various benefits from capturing data from every procedure in the OR. From every surgery there are millions of data which, when synchronised and analysed, can help us to identify, understand and mitigate safety threats. Data can be used to increase efficiency, to identify and predict adverse events, and to increase the quality of teaching in the OR. The rapid advances in modern technology and the introduction of high-reliability culture in healthcare will result in more data-driven, precise, and safer surgical care.

Implementation of an Innovative Technology Called the OR Black Box: A Feasibility Study.

Introduction. The operating room (OR) Black Box is an innovative technology that captures and compiles extensive real-time data from the OR, allowing identification and analysis of factors that influence intraoperative procedures and performances - ultimately improving patient safety. Implementation of this kind of technology is still an emerging research area and prone to face challenges. Methods. Observational study running from May 2017 to May 2021 conducted at Copenhagen University Hospital - Rigshospitalet, Denmark, involving 152 OR staff and 306 patients. Feasibility of the OR Black Box was assessed in accordance with Bowen's framework with 8 focus areas. Results. The OR Black Box had a high level of acceptability among stakeholders with 100% participation from management, 93% from OR staff, and 98% from patients. The implementation process improved over time, and an average of 80% of the surgeries conducted were captured. The practical aspects such as numerous formal and informal meetings, ethical and legal approval, recruitment of patients were acceptable, albeit time-consuming. The OR Black Box was adopted without any changes in scheduled surgery program, but capturing hours were adjusted to match the surgery program and relocation of OR staff declining to provide consent was possible. Conclusions. Implementation of the OR Black Box was feasible yet challenging. Management, nearly all staff, and patients embraced the initiative; however, ongoing evaluation, information meetings, and commitment from stakeholders are required and crucial to sustain momentum, continue implementation and expansion. Ideas from this study can be useful in the implementation of similar initiatives.

Healthcare professionals' perception of safety culture and the Operating Room (OR) Black Box technology before clinical implementation: a cross-sectional survey.

INTRODUCTION: Comprehensive data capture systems such as the Operating Room Black Box (OR Black Box) are becoming more widely implemented to access quality data in the complex environment of the OR. Prior to installing an OR Black Box, we assessed perceptions on safety attitudes, impostor phenomenon and privacy concerns around digital information sharing among healthcare professionals in the OR. A parallel survey was conducted in Canada, hence, this study also discusses cultural and international differences when implementing new technology in healthcare. METHODS: A cross-sectional survey using three previously validated questionnaires (Safety Attitudes Questionnaire (SAQ), Clance Impostor Phenomenon Scale, Dispositional Privacy Concern) was distributed through Research Electronic Data Capture to 145 healthcare professionals from the OR (July to December 2019). Analysis of variance and analysis of covariance were used to test for differences. RESULTS: 124 responded (86%): 100 completed the survey (69%) (38 nurses, 10 anaesthesiologists, 36 obstetricians/gynaecologists, 16 residents). Significant variability in all six SAQ domains, safety climate and teamwork being the lowest ranked and job satisfaction ranked highest for all groups. The SAQ varied in all domains in Canada. Moderate to frequent impostor phenomenon was experienced by 71% predominantly among residents (p=0.003). 72% in the Canadian study. Residents were most comfortable with digital information sharing (p<0.001), only 13% of all healthcare professionals were concerned/heavy concerned compared with 45% in Canada. CONCLUSIONS: The different healthcare professional groups had diverse perceptions about safety culture, but were mainly concerned about safety climate and teamwork in the OR. Impostor phenomenon decreased with age. All groups were unconcerned about digital information sharing. The Canadian study had similar findings in terms of impostor phenomenon, but a variety within the SAQ and were more concerned about data safety, which could be due to medical litigation per se and is not widespread in Scandinavia compared with North America.

Perceptions of safety culture and recording in the operating room: understanding barriers to video data capture.

OBJECTIVE: Recording in the operating room is an important tool to help surgical teams improve their performance. This is becoming more feasible using the Operating Room Black Box, a comprehensive data capture platform. Operating room (OR) staff, however, may voice reasonable concerns as recording initiatives are implemented. The objective of this study was to assess pre-implementation attitudes of OR staff toward operative recording and explore the relationship of these attitudes to the themes of (1) safety culture, (2) impostor syndrome, and (3) privacy concerns. METHODS: This cross-sectional survey study measured staff members' beliefs and opinions of operative recording and used three previously validated tools (safety attitudes questionnaire, clance impostor phenomenon scale, and dispositional privacy concern) to assess personal and professional factors. Concepts were correlated using Pearson's correlation coefficient. RESULTS: Forty-three staff members participated in this study, with a response rate of 45% (n = 43/96, 20/22 nurses, 9/11 gynecologists, 14/63 anesthesiologists). Opinions of operative data capture were generally positive (5-point Likert scale, mean = 3.81, SD = 0.91). Nurses tended to have more favorable opinions of the OR Black Box as compared to gynecologists and anesthesiologists, though this did not reach statistical significance (4.15 vs. 3.67 vs 3.43, p = 0.06). Impostor syndrome characteristics correlated with concerns about litigation related to recording (r = - 0.32, p = 0.04). CONCLUSION: There are personal and professional attributes of the OR team that impact perceptions of the OR Black Box and implications around privacy and litigation. Addressing these concerns may facilitate successful implementation of the OR Black Box and improve team communication and patient safety in the OR.

Six Sigma in surgery: how to create a safer culture in the operating theatre using innovative technology.

Safe delivery of patient care in the operating theatre is complex and co-dependent of many individual, organisational, and environmental factors, including patient, task and technology, individual, and human factors. The Six Sigma approach aims to implement a data-driven strategy to reduce variability and consequently improve safety. Analytical data platforms such as a Black Box ought to be embraced to support process optimisation and ultimately create a higher level of Six Sigma safety performance of the operating theatre team.

Tools for measuring technical skills during gynaecologic surgery: a scoping review.

BACKGROUND: Standardised assessment is key to structured surgical training. Currently, there is no consensus on which surgical assessment tool to use in live gynaecologic surgery. The purpose of this review is to identify assessment tools measuring technical skills in gynaecologic surgery and evaluate the measurement characteristics of each tool. METHOD: We utilized the scoping review methodology and searched PubMed, Medline, Embase and Cochrane. Inclusion criteria were studies that analysed assessment tools in live gynaecologic surgery. Kane's validity argument was applied to evaluate the assessment tools in the included studies. RESULTS: Eight studies out of the 544 identified fulfilled the inclusion criteria. The assessment tools were categorised as global rating scales, global and procedure rating scales combined, procedure-specific rating scales or as a non-procedure-specific error assessment tool. CONCLUSION: This scoping review presents the current different tools for observational assessment of technical skills in intraoperative, gynaecologic surgery. This scoping review can serve as a guide for surgical educators who want to apply a scale or a specific tool in surgical assessment.

[Failed epidural analgesia during birth].

Epidural analgesia is regarded as the most effective pain relief option, and it is used in 25% of all child births in Denmark. Despite the large number of epidural blocks, there is no consensus on, how failed epidural analgesia (FEA) should be defined. There are several different definitions and probably therefore a wide incidence (8.5-23%). In this review, we attempt to provide an overview of the many definitions of FEA and to identify the risk factors. In addition, we suggest recommendations on how to reduce the number of FEA in the future.

Twelve tips for assessing surgical performance and use of technical assessment scales.

Using validated assessment scales for technical competence can help structure and standardize assessment and feedback for both the trainee and the supervisor and thereby avoid bias and drive learning. Correct assessment of operative skills can establish learning curves and allow adequate monitoring. However, the assessment of surgical performance is not an easy task, since it includes many proxy parameters, which are hard to measure. Although numerous technical assessment scales exist, both within laparoscopic and open surgery, the validity evidence is often sparse, and this can raise doubts about reliability and educational outcome. Furthermore, the implementation of technical assessment scales varies due to several obstacles and doubts about accurate use. In this 12-tips article, we aim to give the readers a critical and useful appraisal of some of the common questions and misunderstandings regarding the use of surgical assessment scales and provide tips to ease and overcome potential pitfalls.

Evaluation of Procedural Simulation as a Training and Assessment Tool in General Surgery-Simulating a Laparoscopic Appendectomy.

BACKGROUND: Laparoscopic appendectomy is a commonly performed surgical procedure, but few training models have been described for it. We examined a virtual reality module for practising a laparoscopic appendectomy. METHODS: A prospective cohort study with the following 3 groups of surgeons (n = 45): novices (0 procedures), intermediates (10-50 procedures), and experienced (>100 procedures). After being introduced to the simulator and 1 familiarization attempt on the procedural module, the participants practiced the module 20 times. Movements, task time, and procedure-specific parameters were compared over time. RESULTS: The time and movement parameters were significantly different during the first attempt, and more experienced surgeons used fewer movements and less time than novices (p < 0.01), although only 2 parameters were significantly different between novices and intermediates. All 3 groups improved significantly over 20 attempts (p < 0.0001). The intraclass correlation coefficient varied between 0.55 and 0.68 and did not differ significantly between the 3 groups (p > 0.05). When comparing novices with experienced surgeons, novices had a higher risk of burn damage to cecum (odds ratio [OR] = 3.0 [95% CI: 1.3; 7.0] p = 0.03), pressure damage to appendix (OR = 3.1 [95% CI: 2.0; 4.9] p < 0.0001), and grasping of the appendix (OR = 2.9 [95% CI: 1.8; 4.7] p < 0.0001). The risk of causing a perforation was not significantly different among the different experience levels (OR = 1.9 [95% CI: 0.9; 3.8] p = 0.14). Only 3 out of 5 error parameters differed significantly when comparing novices and experienced surgeons. Similarly, when comparing intermediates and novices, it was only 2 of the parameters that differed. DISCUSSION: The simulator module for practising laparoscopic appendectomy may be useful as a training tool, but further development is required before it can be used for assessment purposes. Procedural simulation may demonstrate more variation for movement parameters, and future research should focus on developing better procedure-specific parameters.

Take-home training in a simulation-based laparoscopy course.

BACKGROUND: Simulation training can prepare trainees for clinical practice in laparoscopic surgery. Training on box trainers allows for simulation training at home, which studies have shown to be a feasible method of training. However, little research has been conducted into how to make it a more efficient method of training. Our aim was to investigate how box trainers are used in take-home training to help guide the design of take-home training courses. METHODS: This study was designed using a mixed methods approach. Junior doctors participating in a laparoscopy curriculum, which included practising at home on box trainers, were invited. Quantitative data on training patterns was collected from logbooks. Qualitative data on the use of box trainers was retrieved from focus groups and individual interviews. RESULTS: From logbooks, we found that 14 out of 18 junior doctors mixed their training modalities, and four practised first on box trainers then on virtual reality simulators. Twelve practised only at home, while five practised at both places and one practised solely at the simulation centre. After a delayed start, most practised for some time, then had a period without training and then started training again towards the end of the course. We found that the themes of the interviews were: training method, training pattern, feedback and self-regulation. Participants identified the lack of feedback as challenging but described how self-rating provided direction during unsupervised training. Mandatory training elements affected when and how much participants practised. CONCLUSIONS: When participants practised at home, they took an individualised approach to training. They mixed their training at home with training at the simulation centre. Participants practised at the beginning and towards the end of the course. Self-rating helped to guide unsupervised training where feedback was not accessible. Curricular requirements and testing determined when and how much participants practised.

Ensuring Competency of Novice Laparoscopic Surgeons-Exploring Standard Setting Methods and their Consequences.

OBJECTIVE: Simulation-based assessment tools have been developed to allow for proficiency-based simulator training in laparoscopy. However, few studies have examined the consequences of different standard setting methods or examined what level of proficiency is considered adequate for trainees. The objectives of the present study were to explore the consequences of different standard setting methods and to examine the proficiency level that surgical trainees are expected to reach, before performing supervised surgery on patients. DESIGN: Study participants undertook the Training and Assessment of Basic Laparoscopic Techniques test. The tests were video-recorded and rated using a simple scoring system based on number of errors and time. Participants were then asked to assess how high a score a novice should reach before performing supervised surgery on a patient. We then compared 3 methods of standard setting: expert performance level, contrasting groups method, and a modified Angoff method. SETTING: The study was conducted at the Copenhagen Academy for Medical Education and Simulation. The academy provides surgical simulation training in laparoscopy for trainees at the hospitals in the Capital Region and the Zealand Region of Denmark. PARTICIPANTS: Participants were recruited among surgical trainees in their first year of specialty training from surgery, gynecology, and urology departments. A total of 40 participants were included and completed the trial. RESULTS: The different standard setting methods resulted in different pass/fail levels. At the expert performance level, the pass/fail level was 474 points-the contrasting groups method resulted in 358 points and the modified Angoff method resulted in 311 points among experienced surgeons, and 386 points among trainees. The different proficiency levels resulted in a failure rate of 0% to 50% of experienced surgeons and a pass rate of 0% to 25% of novices. Novice laparoscopic surgeons set a higher pass/fail level than experienced surgeons did (p = 0.008). CONCLUSION: Required proficiency levels varies depending on the standard setting method used, which highlights the importance of using an established standard setting method to set the pass/fail level.

Off-site training of laparoscopic skills, a scoping review using a thematic analysis.

BACKGROUND: The focus of research in simulation-based laparoscopic training has changed from examining whether simulation training works to examining how best to implement it. In laparoscopic skills training, portable and affordable box trainers allow for off-site training. Training outside simulation centers and hospitals can increase access to training, but also poses new challenges to implementation. This review aims to guide implementation of off-site training of laparoscopic skills by critically reviewing the existing literature. METHODS: An iterative systematic search was carried out in MEDLINE, EMBASE, ERIC, Scopus, and PsychINFO, following a scoping review methodology. The included literature was analyzed iteratively using a thematic analysis approach. The study was reported in accordance with the STructured apprOach to the Reporting In healthcare education of Evidence Synthesis statement. RESULTS: From the search, 22 records were identified and included for analysis. A thematic analysis revealed the themes: access to training, protected training time, distribution of training, goal setting and testing, task design, and unsupervised training. The identified themes were based on learning theories including proficiency-based learning, deliberate practice, and self-regulated learning. CONCLUSIONS: Methods of instructional design vary widely in off-site training of laparoscopic skills. Implementation can be facilitated by organizing courses and training curricula following sound education theories such as proficiency-based learning and deliberate practice. Directed self-regulated learning has the potential to improve off-site laparoscopic skills training; however, further studies are needed to demonstrate the effect of this type of instructional design.

Implementation of a Cross-specialty Training Program in Basic Laparoscopy.

BACKGROUND AND OBJECTIVES: Several surgical specialties use laparoscopy and share many of the same techniques and challenges, such as entry approaches, equipment, and complications. However, most basic training programs focus on a single specialty. The objective of this study was to describe the implementation of a regional cross-specialty training program for basic laparoscopy, to increase the flexibility of educational courses, and to provide a more efficient use of simulation equipment. METHODS: Using a regional training program in basic laparoscopy for gynecology as a model, we developed a cross-specialty training program for residents in surgery, gynecology, urology, and thoracic surgery. We reviewed data on training for the first year of the program and evaluated the program by using a scoring system for quality criteria for laparoscopic curricula and skills. RESULTS: We held 6 full-day theoretical courses involving 67 residents between September 1, 2013, and August 31, 2014. In the weeks following each course, residents practiced in a self-directed, distributed, and proficiency-based manner at a simulation center and in local hospital departments. A total of 57 residents completed the self-practice and a subsequent practical animal laboratory-based course. The structure of the training program was evaluated according to identified quality criteria for a skills laboratory, and the program scored 38 of a maximum 62 points. DISCUSSION: Implementation of a regional cross-specialty training program in basic laparoscopy is feasible. There are several logistic benefits of using a cross-specialty approach; however, it is important that local departments include specialty-specific components, together with clinical departmental follow-up.

Effect of instructor feedback on skills retention after laparoscopic simulator training: follow-up of a randomized trial.

BACKGROUND: Instructor feedback reduces the number of repetitions and time to reach proficiency during laparoscopic simulator training. The objective of this study was to examine the effect of instructor feedback on long-term skill retention. METHODS: A 6-month follow-up of a randomized trial. Participants were surgical novices (medical students). All participants (n = 99) initially practiced a laparoscopic salpingectomy on the LapSim virtual reality simulator to proficiency. The intervention group could request instructor feedback, whereas the control group could not. After 6 months, the participants (n = 65) practiced on the simulator until they reached proficiency again. The primary outcomes were the total time and the number of repetitions. RESULTS: Initially, the intervention group used significantly fewer repetitions (29 vs 65, p < 0.0005) and less total training time (162 vs 342 min, p < 0.0005) than the control group to reach the proficiency level. At follow-up, both the groups used an equal number of repetitions (21 vs 20, p = 0.72) and time (83 vs 73 min, p = 0.37) to reach the same proficiency level. CONCLUSIONS: Instructor feedback during proficiency-based laparoscopic simulator training does not affect the long-term retention of skills.

Medical students as facilitators for laparoscopic simulator training.

BACKGROUND: Teaching basic clinical skills to student peers and residents by medical students has previously been shown effective. This study examines if medical students can facilitate laparoscopic procedural tasks to residents using a virtual reality simulator. METHODS: This was a retrospective study comparing 2 groups of gynecology residents. One group was instructed by 2 student facilitators, and a resident facilitator instructed the other group. Facilitators in both the groups were experienced in laparoscopic simulator training. The outcome measures were time and repetitions to complete a laparoscopic simulator training program. RESULTS: A total of 51 residents participated: 15 in the student-facilitated group and 36 in the resident-facilitated group after 18 and 7 residents dropped out, respectively. The student-facilitated group averaged 230 minutes, while the resident-facilitated group averaged 200 minutes (p = 0.724). To complete the final examination module, the student-facilitated group required 19.5 repetitions vs 39.2 in the resident-facilitated group (p = 0.007). CONCLUSION: Our findings suggest that students can be used as facilitators as an alternative to residents when practicing on a laparoscopic virtual reality simulator.

Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial.

BACKGROUND: The use of structured curricula for minimally invasive surgery training is becoming increasingly popular. However, many laparoscopic training programs still use basic skills and isolated task training, despite increasing evidence to support the use of training models with higher functional resemblance, such as whole procedural modules. In contrast to basic skills training, procedural training involves several cognitive skills such as elements of planning, movement integration, and how to avoid adverse events. The objective of this trial is to investigate the specificity of procedural practice in laparoscopic simulator training. METHODS/DESIGN: A randomised single-centre educational superiority trial. Participants are 96 surgical novices (medical students) without prior laparoscopic experience. Participants start by practicing a series of basic skills tasks to a predefined proficiency level on a virtual reality laparoscopy simulator. Upon reaching proficiency, the participants are randomised to either the intervention group, which practices two procedures (an appendectomy followed by a salpingectomy) or to the control group, practicing only one procedure (a salpingectomy) on the simulator. 1:1 central randomisation is used and participants are stratified by sex and time to complete the basic skills. Data collection is done at a surgical skills centre.The primary outcome is the number of repetitions required to reach a predefined proficiency level on the salpingectomy module. The secondary outcome is the total training time to proficiency. The improvement in motor skills and effect on cognitive load are also explored. DISCUSSION: The results of this trial might provide new knowledge on how the technical part of surgical training curricula should be comprised in the future. To examine the specificity of practice in procedural simulator training is of great importance in order to develop more comprehensive surgical curricula. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02069951.

A structured four-step curriculum in basic laparoscopy: development and validation.

OBJECTIVE: The objective of this study was to develop a four-step curriculum in basic laparoscopy consisting of validated modules integrating a cognitive component, a practical component and a procedural component. DESIGN: A four-step curriculum was developed. The methodology was different for each step. Step 1: A 1-day course in basic laparoscopy developed on the background of a regional needs analysis. Step 2: A multiple-choice test, developed and validated through interviews with experts in laparoscopy and subsequently through a Delphi audit involving regional chief physicians. Step 3: A procedural training task (a salpingectomy) on a validated virtual reality simulator. Step 4: An operation on a patient (a salpingectomy) with following formative assessment based on a validated assessment scale. SETTING: University hospital, Copenhagen, Denmark. POPULATION: Fifty-two first-year residents in obstetrics and gynecology from 2009 to 2011. METHOD: Observational cohort study. MAIN OUTCOME MEASURE: Completion rate. RESULTS: All participants completed step 1 and improved post-course test scores compared with pre-course test scores, p = 0.001. Step 2 was completed by 75% (37/52); all improved test scores after 6 months, p = 0.001. Step 3 was completed by 75%. Participants used 238 min (range 75-599) and 38 repetitions (range 8-99) to reach proficiency level on a virtual reality simulator. Step 4 was completed by 55%. There was no correlation between test scores and simulator training time. Protected training time was correlated with increasing completion rate. CONCLUSION: A four-step curriculum in basic laparoscopy is applicable in residency training. Protected training time correlated with increasing completion rate.

Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial.

OBJECTIVE: To investigate the impact of instructor feedback versus no instructor feedback when training a complex operational task on a laparoscopic virtual reality simulator. BACKGROUND: : Simulators are now widely accepted as a training tool, but there is insufficient knowledge about how much feedback is necessary, which is useful for sustainable implementation. METHODS: A randomized trial complying with CONSORT Statement. All participants had to reach a predefined proficiency level for a complex operational task on a virtual reality simulator. The intervention group received standardized instructor feedback a maximum of 3 times. The control group did not receive instructor feedback. Participants were senior medical students without prior laparoscopic experience (n = 99). Outcome measures were time, repetitions, and performance score to reach a predefined proficiency level. Furthermore, influence of sex and perception of own surgical skills were examined. RESULTS: Time (in minutes) and repetitions were reduced in the intervention group (162 vs 342 minutes; P < 0.005) and (29 vs 65 repetitions; P < 0.005). The control group achieved a higher performance score than the intervention group (57% vs 49%; P = 0.004). Men used less time (in minutes) than women (P = 0.037), but no sex difference was observed for repetitions (P = 0.20). Participants in the intervention group had higher self-perception regarding surgical skills after the trial (P = 0.011). CONCLUSIONS: Instructor feedback increases the efficiency when training a complex operational task on a virtual reality simulator; time and repetitions used to achieve a predefined proficiency level were significantly reduced in the group that received instructor feedback compared with the control group. TRIAL REGISTRATION NUMBER: NCT01497782.

Development and validation of a theoretical test in basic laparoscopy.

BACKGROUND: Testing of knowledge is an important component in a successful skills curriculum. Nonetheless, structured testing of basic procedure-relevant knowledge in the surgical domains is not ordinary practice. A regional need assessment showed insufficient knowledge regarding basic laparoscopy for first-year residents in obstetrics and gynecology. This study therefore aimed to develop and validate a framework for a theoretical knowledge test, a multiple-choice test, in basic theory related to laparoscopy. METHODS: The content of the multiple-choice test was determined by conducting informal conversational interviews with experts in laparoscopy. The subsequent relevance of the test questions was evaluated using the Delphi method involving regional chief physicians. Construct validity was tested by comparing test results from three groups with expected different clinical competence and knowledge levels: senior medical students, first-year residents, and chief physicians. RESULTS: The four conversational interviews resulted in the development of 47 test questions, which were narrowed down to 37 test questions after two Delphi rounds involving 12 chief physicians. Significant differences were found between the test scores from the senior medical students (n = 14) and the first-year residents (n = 52) (median test scores, 18 vs. 24, respectively; p = 0.001), and between the first-year residents and the chief physicians (n = 12) (median test scores, 24 vs. 33, respectively; p = 0.001). Internal consistency (Cronbach's alpha) was 0.82. There was no evidence of differential item functioning between the three groups tested. CONCLUSIONS: A newly developed knowledge test in basic laparoscopy proved to have content and construct validity. The formula for the development and validation of a theoretical test could potentially be used for any topics that require structured testing of knowledge.