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Introduction of a surgical Black Box system in a hybrid angiosuite: Challenges and opportunities
Abstract
Purpose
In laparoscopy, the Operating Room Black Box® (ORBB) provides insights into operative performance to improve patient safety. This technology may also enhance endovascular surgical practice; however, the use of a C-arm and X-rays pose important challenges, hindering transferability to an endovascular context. We describe the first implementation of ORBB technology in a hybrid angiosuite and illustrate its value in evaluating surgeons’ radiation safety, technical and non-technical performance.
Methods
Team members (surgeons, nurses, anaesthesiologists) and stakeholders were informed during several information sessions. Together with teams from Surgical Safety Technologies (Toronto, Canada), an implementation plan was developed, and video-evaluation frameworks were chosen.
Radiation safety was assessed using dose measurements and video-evaluation of safety-related behaviours. Technical performance was assessed using ‘global’ (GRS) and ‘procedure-specific’ (PRS) rating scales and the ‘EndoVascular Aortic Repair Assessment of Technical Expertise’ (EVARATE) framework. Surgeons’ non-technical skills were assessed with the NOTSS framework.
Results
The system captures Audio-visual data from four ceiling-mounted cameras, three ceiling-array microphones, the fluoroscopy screen and anaesthesia monitor. After patient and team consent, an elective endovascular aneurysm repair was successfully analysed. Dose-Area-Product and Air Kerma were 71094 mGy.cm² and 270 mGy, respectively. Behavioural analysis revealed deficiencies in stepping back and radiation safety communication. Technical skill assessment was feasible: GRS: 29/40; ‘PRS’: 27/35; EVARATE: 29/35. Non-technical analysis highlighted surgeons’ leadership qualities.
Conclusion
An innovative data capture platform has been successfully installed to evaluate overall performance during endovascular procedures. This technology may facilitate identification of (radiation) safety-related errors and instigate educational interventions based on real-world issues.
... Some of the primary concerns that participating staff had, especially among those who declined to provide consent, were data security, deidentification, and legal issues. These concerns, mainly verbally expressed during formal information meetings held by the research group but also informal encounters with staff and management, are in line with findings at other OR Black Box sites in North America and Europe, [24][25][26] as well as from other initiatives with audio-and video recordings. 27,28 To expand knowledge on these perceptions, qualitative studies should be designed and carried out. ...
... Furthermore, the study lacks external validation of the results; however, our results are in line with similar studies looking at OR Black Box implementation in a clinical setting. 22,24 Perspectives The major advantages of implementing the OR Black Box include the opportunity to identify intraoperative factors that, independently or in combination, influence intraoperative performance and/or procedures, as well as factors that the OR staff does not necessarily notice or report. 35,36 Videorecordings, which are a part of the OR Black Box set up, are a powerful tool for documenting in a transparent, real time, manner, what happens in the clinical setting. ...
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.
Background and Aims: The Hawthorne effect-the alteration of behavior by subjects due to their awareness of being observed-is evident in both research and clinical settings involving different forms of observation. However, the role of the Hawthorne effect on healthcare professionals and their practice are poorly understood. A systematic review of primary studies that examined the role of the Hawthorne effect on healthcare professionals was performed. Materials and Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL were searched. Studies that discussed any changes in healthcare professionals' performance or behavior due to observation or awareness of being studied were included. A quality assessment tool for observational cohort and cross-sectional studies was used to assess risk of bias. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to report this review. Results and Conclusions: In total, 23 studies were analyzed. 18 out of 23 (78%) studies showed behavioral change among observed healthcare professionals, and all behavioral changes led to increased productivity, compliance, or adherence to best practice guidelines or protocols. From 13 studies that observed only physicians as subjects, 8 (62%) studies reported a positive Hawthorne effect. 86% of studies using "direct" observation methods demonstrated positive Hawthorne effect in comparison to 67% using "indirect" observation. Of the five studies with post-intervention follow-up, four studies (80%) reported either diminished or decreasing Hawthorne effect within three months once observation ceased. Of the three studies with continued observation, two studies reported diminished Hawthorne effect. This systematic review demonstrated that healthcare professionals were affected by the Hawthorne effect. They tended to exhibit short-lived positive behavior change when observed.
Background
Systematically observing clinical performance in the operating room (OR) to support patient safety initiatives faces numerous logistical and methodological challenges. These may be solved by new audio-video recording technologies like the OR Black Box, which is a tool similar to black boxes in aviation. This study aimed to identify barriers and enablers that may influence patients’, clinicians’ and senior leadership team members’ support of the OR Black Box in order to guide its future implementation.
Methods
Patients, clinicians and senior leadership team members were recruited to participate in semistructured interviews informed by the theoretical domains framework (TDF) to identify factors relevant to planning OR Black Box implementation. Deidentified interview transcripts were analysed in duplicate following a TDF coding structure.
Results
Data saturation was achieved at 15 patients, 17 clinicians and 9 senior leadership team members. Seven domains were relevant for patients, nine for clinicians and four for senior leadership. Knowledge and Beliefs about consequences were barriers and enablers for all three groups. Memory, attention and decision processes and Social influences were enablers for both clinicians and senior leadership. Environmental context and resources, Emotion and Behavioural regulation were found to be barriers and enablers for both clinicians and patients. Social/professional role and identity and Reinforcement were enablers for patients only and Optimism and Intentions were barriers and enablers to clinicians.
Conclusions
While most stakeholders were supportive of the OR Black Box, we identified many key areas that need to be addressed during its implementation. It is critical to ensure all stakeholders have adequate and accurate information about the OR Black Box system and research goals, and that the OR Black Box is positioned as a patient safety initiative for learning from and improving practice.
Inadequate staff behaviors in an operating room (OR) may lead to environmental contamination and increase the risk of surgical site infection. In order to assess this statement objectively, we have developed an approach to analyze OR staff behaviors using a motion tracking system. The present article introduces a solution for the assessment of individual displacements in the OR by: (1) detecting human presence and quantifying movements using a motion capture (MOCAP) system and (2) observing doors’ movements by means of a wireless network of inertial sensors fixed on the doors and synchronized with the MOCAP system. The system was used in eight health care facilities sites during 30 cardiac and orthopedic surgery interventions. A total of 119 h of data were recorded and analyzed. Three hundred thirty four individual displacements were reconstructed. On average, only 10.6% individual positions could not be reconstructed and were considered undetermined, i.e., the presence in the room of the corresponding staff member could not be determined. The article presents the hardware and software developed together with the obtained reconstruction performances.
Objective:
Patient specific rehearsal (PsR) prior to endovascular aneurysm repair (EVAR) enables the endovascular team to practice and evaluate the procedure prior to treating the real patient. This multicentre trial aimed to evaluate the utility of PsR prior to EVAR as a pre-operative planning and briefing tool.
Material and methods:
Patients with an aneurysm suitable for EVAR were randomised to pre-operative or post-operative PsR. Before and after the PsR, the lead implanter completed a questionnaire to identify any deviation from the initial treatment plan. All team members completed a questionnaire evaluating realism, technical issues, and human factor aspects pertinent to PsR. Technical and human factor skills, and technical and clinical success rates were compared between the randomised groups.
Results:
100 patients were enrolled between September 2012 and June 2014. The plan to visualise proximal and distal landing zones was adapted in 27/50 (54%) and 38/50 (76%) cases, respectively. The choice of the main body, contralateral limb, or iliac extensions was adjusted in 8/50 (16%), 17/50 (34%), and 14/50 (28%) cases, respectively. At least one of the abovementioned parameters was changed in 44/50 (88%) cases. For 100 EVAR cases, 199 subjective questionnaires post-PsR were completed. PsR was considered to be useful for selecting the optimal C-arm angulation (median 4, IQR 4-5) and was recognised as a helpful tool for team preparation (median 4, IQR 4-4), to improve communication (median 4, IQR 3-4), and encourage confidence (median 4, IQR 3-4). Technical and human factor skills and technical and initial clinical success rates were similar between the randomisation groups.
Conclusion:
PsR prior to EVAR has a significant impact on the treatment plan and may be useful as a pre-operative planning and briefing tool. Subjective ratings indicate that this technology may facilitate planning of optimal C-arm angulation and improve non-technical skills.
Trial registration:
URL://www.clinicaltrials.gov. Unique identifier: NCT01632631.
PurposeKnowledge of medical radiation exposure permits application of radiation protection principles. In our center, the first dedicated real-time, automated patient and staff dose monitoring system (DoseWise Portal, Philips Healthcare) was installed. Aim of this study was to obtain insight in the procedural and occupational doses. Materials and Methods
All interventional radiologists, vascular surgeons, and technicians wore personal dose meters (PDMs, DoseAware, Philips Healthcare). The dose monitoring system simultaneously registered for each procedure dose-related data as the dose area product (DAP) and effective staff dose (E) from PDMs. Use and type of shielding were recorded separately. All procedures were analyzed according to procedure type; these included among others cerebral interventions (n = 112), iliac and/or caval venous recanalization procedures (n = 68), endovascular aortic repair procedures (n = 63), biliary duct interventions (n = 58), and percutaneous gastrostomy procedure (n = 28). ResultsMedian (±IQR) DAP doses ranged from 2.0 (0.8–3.1) (percutaneous gastrostomy) to 84 (53–147) Gy cm2 (aortic repair procedures). Median (±IQR) first operator doses ranged from 1.6 (1.1–5.0) μSv to 33.4 (12.1–125.0) for these procedures, respectively. The relative exposure, determined as first operator dose normalized to procedural DAP, ranged from 1.9 in biliary interventions to 0.1 μSv/Gy cm2 in cerebral interventions, indicating large variation in staff dose per unit DAP among the procedure types. Conclusion
Real-time dose monitoring was able to identify the types of interventions with either an absolute or relatively high staff dose, and may allow for specific optimization of radiation protection.
Purpose:
To investigate the total fluoroscopy time and radiation exposure dose during endovascular aortic repairs using mobile, fixed, or fixed C-arms with 3-dimensional image fusion (3D-IF).
Methods:
A systematic search was performed to identify original articles reporting fluoroscopy time (FT) and the kerma area product (KAP) during endovascular aortic repairs. Data were grouped by noncomplex or complex (fenestrated, branched, or chimney) repairs and stratified by type of C-arm. The search identified 27 articles containing 51 study groups (35 noncomplex and 16 complex) that included 3444 patients. Random-effects meta-analysis and meta-regression models were used to calculate the pooled mean estimates of KAP and FT, as well as any effect of equipment or type of intervention. Results are presented with the 95% confidence interval and the statistical heterogeneity (I(2)).
Results:
Within the noncomplex procedure studies, a significant (p<0.001) increase was found in the pooled mean KAP estimate in the fixed C-arm group (181 Gy·cm(2), 95% CI 129 to 233; I(2)=99.7) compared with the mobile C-arm (78 Gy·cm(2), 95% CI 59.6 to 97.3; I(2)=99.6). For complex cases, use of 3D-IF showed a significantly (p<0.001) lower mean KAP (139 Gy·cm(2), 95% CI 85 to 191; I(2)=94%) compared to using fixed C-arms without 3D-IF (487 Gy·cm(2), 95% CI 331 to 643; I(2)=94%).
Conclusion:
For equivalent fluoroscopy times, the use of a fixed C-arm in noncomplex procedures leads to higher patient radiation doses compared to a mobile C-arm. Complex procedures, which are predominantly performed using fixed C-arms, are associated with the highest radiation dose per intervention. Using fixed C-arms combined with 3D-IF techniques during complex cases might seem an adequate method to compensate for the higher radiation doses measured when a fixed C-arm is used.
Interventional radiology and hemodynamic procedures have rapidly grown in number in the past decade, increasing the importance of personnel dosimetry not only for patients but also for medical staff. The optimization of the absorbed dose during operations is one of the goals that fostered the development of real-time dosimetric systems. Indeed, introducing proper procedure optimization, like correlating dose rate measurements with medical staff position inside the operating room, the absorbed dose could be reduced. Real-time dose measurements would greatly facilitate this task through real-time monitoring and automatic data recording. Besides real-time dose monitoring could allow automatic data recording.
In this work, we will describe the calibration and validation of a wireless real-time prototype dosimeter based on a new sensor device (CMOS imager). The validation measurement campaign in clinical conditions has demonstrated the prototype capability of measuring dose-rates with a frequency in the range of few Hz, and an uncertainty smaller than 10%.
An increasing number of medical specialists are using fluoroscopy outside imaging departments, but there has been general neglect of radiological protection coverage of fluoroscopy machines used outside imaging departments. Lack of radiological protection training of those working with fluoroscopy outside imaging departments can increase the radiation risk to workers and patients. Procedures such as endovascular aneurysm repair, renal angioplasty, iliac angioplasty, ureteric stent placement, therapeutic endoscopic retrograde cholangio-pancreatography,and bile duct stenting and drainage have the potential to impart skin doses exceeding Gy. Although tissue reactions among patients and workers from fluoroscopy procedures have, to date, only been reported in interventional radiology and cardiology,the level of fluoroscopy use outside imaging departments creates potential for such injuries.A brief account of the health effects of ionising radiation and protection principles is presented in Section 2. Section 3 deals with general aspects of the protection of workers and patients that are common to all, whereas specific aspects are covered in Section 4 for vascular surgery, urology, orthopaedic surgery, obstetrics and gynaecology,gastroenterology and hepatobiliary system, and anaesthetics and pain management.Although sentinel lymph node biopsy involves the use of radio-isotopic methods rather than fluoroscopy, performance of this procedure in operating theatres is covered in this report as it is unlikely that this topic will be addressed in another ICRP publication in coming years. Information on radiation dose levels to patients and workers, and dose management is presented for each speciality.
Intraoperative adverse events are a common and important cause of surgical morbidity.¹,2 Strategies to reduce adverse events and mitigate their consequences have traditionally focused on surgical education, structured communication, and adverse event management. However, until now, little could be done to anticipate these events in the operating room. Advances in both data capture in the operating room and explainable artificial intelligence (XAI) techniques to process these data open the way for real-time clinical decision support tools that can help surgical teams anticipate, understand, and prevent intraoperative events.
Background:
Despite recent investments into reducing errors and adverse events in health care, methods for quality improvement in surgery are outdated and ineffective. Most current efforts in this field are centred around morbidity and mortality
conferences (MMCs), which have remained unchanged for over 100 years. The present study aimed to quantify the recall bias associated with details from surgical cases.
Methods:
We gathered immediate postoperative questionnaires from 1 surgeon, 1 fellow and 11 trainees following 25 routine surgical cases. Information elicited included their perceived level of concentration, mental preparedness and assessment
of whether the procedure deviated from its expected course, including any intraoperative adverse events. We readministered the questionnaire 7−9 days later to assess participants’ ability to recall important aspects of the procedure.
Results:
After 1 week, members of the surgical team were universally inaccurate in their recollection of even major details from the operating room. Although most participants felt mentally prepared and perceived no issues with concentration during the case, all participants misclassified operations as having been performed with or without adverse events in almost every included case.
Conclusion:
Our findings show that recall bias regarding surgical safety events is exceedingly common. This likely has a major impact on the integrity of data presented at MMCs.
Objective:
Video motion analysis (VMA) uses fluoroscopic sequences to derive information on catheter and guidewire movement and is able to calculate two-dimensional catheter tip path length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to evaluate the effect of anatomic complexity on the efficiency of completion of defined stages of simulated carotid artery stenting as measured by VMA.
Methods:
Twenty interventionists each performed a standardized easy, medium, and difficult carotid artery stenting case in random order on an ANGIO Mentor (Simbionix, Airport City, Israel) simulator. Videos of all procedures were analyzed using VMA software, and performance was expressed in terms of two-dimensional guidewire tip trajectory distance (PL). Comparisons of PL were used to identify differences in cannulation performance of the participants between the three cases of varying difficulty. The procedure was subdivided into four procedural phases: arch navigation, common carotid artery (CCA) cannulation, external carotid manipulation, and carotid lesion crossing. Comparisons of PL were used to identify differences in performance between the three cases of varying difficulty for each of the procedural phases.
Results:
There were significant differences in PL in relation to anatomic complexity, with a stepwise increase in PL from easy to difficult cases: easy, median of 5000 pixels (interquartile range, 4075-5403 pixels); intermediate, 9059 (5974-14,553) pixels; difficult, 17,373 (11,495-26,594) pixels (P < .001). Similarly, during CCA cannulation, there was a stepwise increase in PL from easy to difficult cases: easy, 749 (603-1403) pixels; intermediate, 3274 (1544-8142) pixels; difficult, 8845 (5954-15,768) pixels (P < .001). There were no observed differences across the groups of anatomic difficulty for the phases of arch navigation, external carotid manipulation, and carotid lesion crossing.
Conclusions:
Increasing anatomic complexity leads to significant increases in PL of endovascular tools, in particular during CCA cannulation. This increase in tool movement may have a bearing on clinical outcome.
Objective:
To characterize intraoperative errors, events, and distractions, and measure technical skills of surgeons in minimally invasive surgery practice.
Background:
Adverse events in the operating room (OR) are common contributors of morbidity and mortality in surgical patients. Adverse events often occur due to deviations in performance and environmental factors. Although comprehensive intraoperative data analysis and transparent disclosure have been advocated to better understand how to improve surgical safety, they have rarely been done.
Methods:
We conducted a prospective cohort study in 132 consecutive patients undergoing elective laparoscopic general surgery at an academic hospital during the first year after the definite implementation of a multiport data capture system called the OR Black Box to identify intraoperative errors, events, and distractions. Expert analysts characterized intraoperative distractions, errors, and events, and measured trainee involvement as main operator. Technical skills were compared, crude and risk-adjusted, among the attending surgeon and trainees.
Results:
Auditory distractions occurred a median of 138 times per case [interquartile range (IQR) 96-190]. At least 1 cognitive distraction appeared in 84 cases (64%). Medians of 20 errors (IQR 14-36) and 8 events (IQR 4-12) were identified per case. Both errors and events occurred often in dissection and reconstruction phases of operation. Technical skills of residents were lower than those of the attending surgeon (P = 0.015).
Conclusions:
During elective laparoscopic operations, frequent intraoperative errors and events, variation in surgeons' technical skills, and a high amount of environmental distractions were identified using the OR Black Box.
Objective:
To evaluate radiation exposure in standard endovascular aneurysm repair (EVAR) using intra-operative guidance with pre-operative computed tomographic angiography (CTA) fusion and strict ALARA guidelines in a modern hybrid room.
Material and methods:
Between February and November 2016, consecutive patients with AAA undergoing EVAR with a bifurcated device in a hybrid room under fusion imaging guidance were prospectively enrolled in six aortic centres from the United States (n = 1), Europe (n = 4), and Japan (n = 1). Demographic data including body mass index (BMI), indirect dose area product (DAP), cumulative air kerma (CAK), variables influencing dose delivery, and contrast media volume were collected.
Results:
85 patients (90.4% males) were included. The median age was 75 (IQR 69-81), with a median BMI of 27.4 (IQR 24.7-30.6). Median DAP and CAK were 14.7 (IQR 10.0-27.7) Gy·cm2 and 107 (IQR 68.0-189.0) mGy, respectively. The median contrast volume was 47 mL (IQR 35-70) (equivalent to 14.1g of iodine [IQR 10.5-21.0]). Median DAP per centre was 28.1 (n = 16, IQR 12.6-47.1), 15.9 (n = 11, IQR 11.9-22.5), 14.2 (n = 12, IQR 10.9-25.7), 20.2 (n = 18, IQR 7.0-39.5), 10.3 (n = 27, IQR 8.2-14.7) and 26.5 (n = 1) Gy·cm2. In multivariable analysis, collimation was the only factor that was significantly associated with DAP reduction, (coefficient = -0.014 per percentage of collimation, 95% CI -0.019 to -0.008, p < .001).
Conclusions:
With adherence to the ALARA principle and routine application of fusion imaging guidance for EVAR, low radiation exposure compared with the published literature can be achieved in a real world setting.
Background:
Endovascular procedures come with a potential risk of radiation hazards both to patients and to the vascular staff. Classically, most endovascular interventions took place in regular operating rooms using a fluoroscopy C-arm unit controlled by a third party. Hybrid operating rooms (HOR) provide an optimal surgical suit with all the qualities of a fixed C-arm device, while allowing the device to be controlled by the surgical team. The latest studies suggest that an operator-controlled system may reduce the radiation dose. The purpose of the present study is to determine the amount of absorbed radiation using a HOR in comparison with a portable C-arm unit and to assess whether the radioprotection awareness of the surgical team influences the radiation exposure. The primary endpoint was the effective dose in miliSievert (mSv) for the surgical team and the average dose-area-product (ADAP) in Gray-meters squared (Gym2) for patients.
Methods:
The values of absorbed radiation of the surgical team's dosimeters were collected from January 2015 to May 2016. The HOR was installed in June 2015 and a radioprotection seminar was given in October 2015. The HOR issued radiation, measured by the maximum dose-area-product (MDAP), average dose-area-product (ADAP), average dose per procedure (AD), maximum dose per procedure per month (MD), maximum fluoroscopy time (MFT) average fluoroscopic time (AFT), peak skin dose (PSD) and average skin dose (ASD), was collected monthly from September 2015 to July 2016. The timeline was divided into three periods: 5 months pre-HOR (Pre-HOR), 5 months after the HOR installation (PreS-HOR) and 5 months after a radioprotection seminar (PostS-HOR).
Results:
The average number of procedures per month was 22,55 (±4,9), including EVAR/TEVAR, carotid, visceral and upper and lower limb endovascular revascularization The average amount of absorbed radiation by the surgeons during PreS-HOR was 1,07±0,4mSv, which was higher than the other periods (Pre-HOR 0,06±0,03mSv, p=0,002; PostS-HOR 0,14±0,09mSv, p=0,000, respectively). The ADAP during PreS-HOR was 0,016±0,01Gym2, which was lower than the PostS-HOR (0,001±0,002Gym2) (p=0,034). The AD during PreS-HOR was 0,78±0,3Gy and 0,39±0,3Gy during PostS-HOR (p=0,098). The ASD during PreS-HOR was 0,40±0,2Gy and 0,20±0,1Gy during PostS-HOR (p=0,099).
Conclusions:
In our experience, the HOR increases the amount of absorbed radiation for both patients and surgeons. The radioprotection seminars are of utmost importance to provide a continued training and optimize the use of ionizing radiation while using and HOR. Despite the awareness of the surgical team in the radioprotection field, the amount of absorbed radiation using an HOR is higher than the one using a C-Arm unit.
OBJECTIVE: Patient specific rehearsal (PsR) prior to endovascular aneurysm repair (EVAR) enables the endovascular team to practice and evaluate the procedure prior to treating the real patient. This multicentre trial aimed to evaluate the utility of PsR prior to EVAR as a pre-operative planning and briefing tool. MATERIAL AND METHODS: Patients with an aneurysm suitable for EVAR were randomised to pre-operative or post-operative PsR. Before and after the PsR, the lead implanter completed a questionnaire to identify any deviation from the initial treatment plan. All team members completed a questionnaire evaluating realism, technical issues, and human factor aspects pertinent to PsR. Technical and human factor skills, and technical and clinical success rates were compared between the randomised groups. RESULTS: 100 patients were enrolled between September 2012 and June 2014. The plan to visualise proximal and distal landing zones was adapted in 27/50 (54%) and 38/50 (76%) cases, respectively. The choice of the main body, contralateral limb, or iliac extensions was adjusted in 8/50 (16%), 17/50 (34%), and 14/50 (28%) cases, respectively. At least one of the abovementioned parameters was changed in 44/50 (88%) cases. For 100 EVAR cases, 199 subjective questionnaires post-PsR were completed. PsR was considered to be useful for selecting the optimal C-arm angulation (median 4, IQR 4-5) and was recognised as a helpful tool for team preparation (median 4, IQR 4-4), to improve communication (median 4, IQR 3-4), and encourage confidence (median 4, IQR 3-4). Technical and human factor skills and technical and initial clinical success rates were similar between the randomisation groups. CONCLUSION: PsR prior to EVAR has a significant impact on the treatment plan and may be useful as a pre-operative planning and briefing tool. Subjective ratings indicate that this technology may facilitate planning of optimal C-arm angulation and improve non-technical skills. TRIAL REGISTRATION: URL://www.clinicaltrials.gov. Unique identifier: NCT01632631.
Errors resulting in adverse events are a common cause of morbidity in hospitalized patients. A significant portion of these errors occurs in the operating room (OR) and may be avoidable. A successful operative outcome reflects more than disease factors and postoperative management in isolation. Comprehensive assessment of operative quality is not possible with traditional postevent analysis. In response to this, our group developed and pilot tested a multiport synchronized data capture and analytic platform called the OR Black Box. Previous recording devices have limited the data capture to only video and audio, which restricts the opportunities for automated analysis. The OR Black Box continuously acquires various intraoperative data feeds, such as audiovisual data, physiological parameters from both patients and health care professionals, and multiple other sensors and devices (Figure). Video is captured using in-room wide-angle cameras, and intracorporeal video is collected from the laparoscope or robotic camera or from light-mounted or wearable cameras in open surgical procedures. All inputs are synchronized, encrypted, and stored on a secure server for further analysis. Expert analysts and software-based algorithms populate a procedural timeline using relevant data drawn from these inputs. Data points include procedural steps, disruptive environmental and organizational factors, OR team technical and nontechnical skills, surgeon physiological stress, and intraoperative errors, events, and rectification processes.
Objectives
Healthcare evolution requires optimisation of surgical training to provide safe patient care. Operating room performance after completion of proficiency based training in vascular surgery has not been investigated.
Design
A randomised controlled trial evaluated the impact of a Proficiency based Stepwise Endovascular Curricular Training program (PROSPECT) on the acquisition of endovascular skills and the transferability of these skills to real life interventions.
Materials
All subjects performed two endovascular interventions treating patients with symptomatic iliac and/or superficial femoral artery stenosis under supervision. Primary outcomes were technical performances (Global Rating Scale [GRS]; Examiner Checklist), operative metrics, and patient outcomes, adjusted for case difficulty and trainee experience. Secondary outcomes included knowledge and technical performance after 6 weeks and 3 months.
Methods
Thirty-two general surgical trainees were randomised into three groups. Besides traditional training, the first group (n = 11) received e-learning and simulation training (PROSPECT), the second group (n = 10) only had access to e-learning, while controls (n = 11) did not receive supplementary training.
Results
Twenty-nine trainees (3 dropouts) performed 58 procedures. Trainees who completed PROSPECT showed superior technical performance (GRS 39.36 ± 2.05; Checklist 63.51 ± 3.18) in real life with significantly fewer supervisor takeovers compared with trainees receiving e-learning alone (GRS 28.42 ± 2.15; p = .001; Checklist 53.63 ± 3.34; p = .027) or traditional education (GRS 23.09 ± 2.18; p = .001; Checklist 38.72 ± 3.38; p = .001). Supervisors felt more confident in allowing PROSPECT trained physicians to perform basic (p = .006) and complex (p = .003) procedures. No differences were detected in procedural parameters (such as fluoroscopy time, DAP, procedure time, etc.) or complications. Proficiency levels were maintained up to 3 months.
Conclusions
A structured, stepwise, proficiency based endovascular curriculum including e-learning and simulation based training should be integrated early into training programs to enhance trainee performance.
Aims:
Video-motion analysis (VMA) uses fluoroscopic sequences to derive on catheter and guide-wire movement, and is able to calculate 2D catheter-tip path-length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to validate VMA in coronary angiography as a method of skill assessment.
Methods and results:
47 coronary interventions performed by 10 low- (<1000 cases; group A), 5 medium- (1000-4000; group B) and 6 high- (>4000; group C) experience- volume cardiologists were prospectively recorded and analysed using this software. Total PL was calculated and procedure, fluoroscopy times, and radiation dose were recorded. Comparisons of PL were made between groups of experience. Groups A, B and C performed 24, 14 and 6 paired (right and left coronary) cannulations, respectively. Calculation of PL was possible in all recorded cases and significantly correlated with procedure (p=<0.001, rho=0.827) and fluoroscopy times (p=<0.001, rho=0.888). Median total path-length (combined right and left coronaries) was significantly shorter in group C who used 3836 pixels of movement (IQR; 3003-4484) vs. 10556 (7242-31408) in group A [p=<0.001] and 8725 (5187-15150) in group B [p=0.013].
Conclusions:
VMA in coronary angiography is feasible and PL is able to differentiate level of experience.
Objectives:
This study assessed that the use of real-time monitoring and visualization of peak skin dose could reduce radiation dose during coronary angiography (CAG) and percutaneous coronary intervention (PCI).
Background:
Exposure to ionizing radiation has dose related effects including skin damage. Reducing the radiation exposure is important during CAG and PCI. The skin dose-tracking system (DTS) has a real-time monitor of radiation peak skin dose.
Methods:
A total of 323 consecutive patients who underwent CAG and PCI between September 2014 and June 2015 were enrolled. Patients were classified into with DTS group (CAG alone in 104 and PCI in 57 patients) or without DTS group (CAG alone in 106 and PCI in 56 patients).
Results:
There was no significant difference in reference air kerma between CAG alone with and without DTS groups. Reference air kerma with DTS group during PCI was lower than without DTS group (204.6 ± 141.1 mGy vs. 294.2 ± 237.4 mGy, P = 0.016). Moreover, kerma area product (17.8 ± 13.0 Gycm(2) vs. 25.2 ± 19.3 Gycm(2) , P = 0.019) and number of cine runs (12.8 ± 5.0 vs. 15.5 ± 6.5, P = 0.013) with DTS group were lower than without DTS group. Multiple regression analysis showed increased reference air kerma was associated with male gender, body mass index and type B2/C lesion. Conversely, DTS correlated with decreased reference air kerma.
Conclusions:
The use of DTS could reduce radiation dose during PCI. Real-time radiation monitoring and visualization of peak skin dose was effective for the patients with PCI.
Objective/background:
To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR).
Methods:
A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews. It led to a primary pool of 83 items that were formulated as global rating scale items with tentative anchors. Iterative Delphi rounds were executed. The panellists rated the importance of each item on a 5 point Likert scale. Consensus was defined as 80% of the panel rating an item 4 or 5 in the primary round and 90% in subsequent rounds. Consensus on the final assessment tool was defined as Cronbach's alpha > .8 after a minimum of three rounds.
Results:
Thirty-two of 35 invited experts participated. Three rounds of surveys were completed with a completion rate of 100% in the first two rounds and 91% in round three. The 83 primary assessment items were supplemented with five items suggested by the panel and reduced to seven pivotal assessment items that reached consensus, Cronbach's alpha = 0.82. The seven item rating scale covers key elements of competence in EVAR stent placement and deployment. Each item has well defined grades with explicit anchors at unacceptable, acceptable, and superior performance on a 5 point Likert scale.
Conclusion:
The Delphi methodology allowed for international consensus on a new procedure specific global rating scale for assessment of competence in EVAR. The resulting scale, EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), represents key elements in the procedure. EVARATE constitutes an assessment tool for providing structured feedback to endovascular operators in training.
Interventional radiology and hemodynamic procedures have rapidly grown in number in the past decade, increasing the importance of personnel dosimetry not only for patients but also for medical staff. The optimization of the absorbed dose during operations is one of the goals that fostered the development of real-time dosimetric systems. Indeed, introducing proper procedure optimization, like correlating dose rate measurements with medical staff position inside the operating room, the absorbed dose could be reduced. Real-time dose measurements would greatly facilitate this task through real-time monitoring and automatic data recording. Besides real-time dose monitoring could allow automatic data recording. In this work, we will describe the calibration and validation of a wireless real-time prototype dosimeter based on a new sensor device (CMOS imager). The validation measurement campaign in clinical conditions has demonstrated the prototype capability of measuring dose-rates with a frequency in the range of few Hz, and an uncertainty smaller than 10%.
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Background:
Vascular surgical care has changed dramatically in recent years with little knowledge of the impact of system failures on patient safety. The primary aim of this multicentre observational study was to define the landscape of surgical system failures, errors and inefficiency (collectively termed failures) in aortic surgery. Secondary aims were to investigate determinants of these failures and their relationship with patient outcomes.
Methods:
Twenty vascular teams at ten English hospitals trained in structured self-reporting of intraoperative failures (phase I). Failures occurring in open and endovascular aortic procedures were reported in phase II. Failure details (category, delay, consequence), demographic information (patient, procedure, team experience) and outcomes were reported.
Results:
There were strong correlations between the trainer and teams for the number and type of failures recorded during 88 procedures in phase I. In 185 aortic procedures, teams reported a median of 3 (i.q.r. 2-6) failures per procedure. Most frequent failures related to equipment (unavailability, failure, configuration, desterilization). Most major failures related to communication. Fourteen failures directly harmed 12 patients. Significant predictors of an increased failure rate were: endovascular compared with open repair (incidence rate ratio (IRR) for open repair 0·71, 95 per cent c.i. 0·57 to 0·88; P = 0·002), thoracic aneurysms compared with other aortic pathologies (IRR 2·07, 1·39 to 3·08; P < 0·001) and unfamiliarity with equipment (IRR 1·52, 1·20 to 1·91; P < 0·001). The major failure total was associated with reoperation (P = 0·011), major complications (P = 0·029) and death (P = 0·027).
Conclusion:
Failure in aortic procedures is frequently caused by issues with team-working and equipment, and is associated with patient harm. Multidisciplinary team training, effective use of technology and new-device accreditation may improve patient outcomes.
A statistical pilot study was retrospectively performed to analyze potential changes in occupational radiation exposures to Interventional Radiology (IR) staff at Lawrence General Hospital after implementation of the i2 Active Radiation Dosimetry System (Unfors RaySafe Inc, 6045 Cochran Road Cleveland, OH 44139- 3302). In this study, the monthly OSL dosimetry records obtained during the eight-month period prior to i2 implementation were normalized to the number of procedures performed during each month and statistically compared to the normalized dosimetry records obtained for the 8-mo period after i2 implementation. The resulting statistics included calculation of the mean and standard deviation of the dose equivalences per procedure and included appropriate hypothesis tests to assess for statistically valid differences between the pre and post i2 study periods. Hypothesis testing was performed on three groups of staff present during an IR procedure: The first group included all members of the IR staff, the second group consisted of the IR radiologists, and the third group consisted of the IR technician staff. After implementing the i2 active dosimetry system, participating members of the Lawrence General IR staff had a reduction in the average dose equivalence per procedure of 43.1% ± 16.7% (p = 0.04). Similarly, Lawrence General IR radiologists had a 65.8% ± 33.6% (p=0.01) reduction while the technologists had a 45.0% ± 14.4% (p=0.03) reduction.
Objective:
To assess the effect of patient-specific virtual reality rehearsal (PsR) before endovascular infrarenal aneurysm repair (EVAR) on technical performance and procedural errors.
Background:
Endovascular procedures, including EVAR, are executed in a complex multidisciplinary environment, often treating high-risk patients. Consequently, this may lead to patient harm and procedural inefficiency. PsR enables the endovascular team to evaluate and practice the case in a virtual environment before treating the real patient.
Methods:
A multicenter, prospective, randomized controlled trial recruited 100 patients with a nonruptured infrarenal aortic or iliac aneurysm between September 2012 and June 2014. Cases were randomized to preoperative PsR or standard care (no PsR). Primary outcome measures were errors during the real procedure and technical operative metrics (total endovascular and fluoroscopy time, contrast volume, number of angiograms, and radiation dose).
Results:
There was a 26% [95% confidence interval (CI) 9%-40%, P = 0.004) reduction in minor errors, a 76% (95% CI 30%-92%, P = 0.009) reduction in major errors, and a 27% (95% CI 8.2%-42%, P = 0.007) reduction in errors causing procedural delay in the PsR group. The number of angiograms performed to visualize proximal and distal landing zones was 23% (95% CI 8%-36%, P = 0.005) and 21% (95% CI 7%-32%, P = 0.004) lower in the PsR group.
Conclusions:
PsR before EVAR can be used in different hospital settings by teams with various EVAR experience. It reduces perioperative errors and the number of angiograms required to deploy the stent graft, thereby reducing delays. Ultimately, it may improve patient safety and procedural efficiency.
Background: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. Methods: We reviewed 30 121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. Results: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi(2) = 21.04, p<0.0001). Using weighted totals we estimated that among the 2 671 863 patients discharged from New York hospitals in 1984 there were 98 609 adverse events and 27 179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence. Conclusions: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.
Background: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. Methods: We reviewed 30 121 randomly selected records from 51 randomly selected acute care, non-psychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. Results: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test χ2 = 21.04, p<0.0001). Using weighted totals we estimated that among the 2 671 863 patients discharged from New York hospitals in 1984 there were 98 609 adverse events and 27 179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence. Conclusions: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.
Context
Endovascular procedures, requiring X-ray guidance, are commonly performed in vascular surgery. X-ray exposure is associated with biological risks for both patients and physicians. Medical X-ray use must follow “as low as reasonably achievable” (ALARA) principles, which aim at using the lowest radiation exposure to achieve a procedure safely. This is underlined by European and international recommendations that also suggest that adequate theoretical and practical training is mandatory during the initial education of physicians. However, the content of this education and professional practices vary widely from one country to another.
Objective
This review aims to summarize the basic knowledge required for vascular surgeons on X-ray physics and image production.
Methods
A panel of endovascular therapists (vascular surgeons and radiologists) and physicists dedicated to X-rays was gathered. International recommendations were summarized. A literature review was performed via MEDLINE to identify studies reporting dosages of common endovascular procedures.
Results
The different mechanisms inducing biological risks, and the associated potential effects on health, are described. Details on dose metrics are provided and a common nomenclature to measure, estimate, and report dose is proposed in order to perform accurate comparisons between publications and practices. Key points of the European and international legislation regarding medical X-ray use are summarized, and radiation protection basics for patients and staff, are detailed. Finally, a literature review is proposed for physicians to evaluate their practice.
Conclusions
Today's trainees will be highly exposed to radiation throughout their practice. It is thus compulsory that they undergo dedicated radiation education during their initial training, and regular refresher sessions later. In daily practice, focus on dose reduction and monitoring of patient and staff exposure are mandatory.
The accumulated dose to the skin of the patient during fluoroscopically-guided procedures can exceed the thresholds for tissue reactions. In practice, interventionalists have no direct information about the local procedure-related skin doses in their patient, causing suboptimal or delayed treatment. In current study, the accumulated Kerma-Area-Product (KAP) values were registered, as well as the reference air kerma (Ka,r) values, if available, for almost 200 cases undergoing seven different procedures. A sheet filled with 50 thermoluminescent dosemeters was wrapped around each patient to measure the peak skin dose. In a significant part of the Transjugular Intrahepatic Portosystemic Shunt (TIPSS) procedures, chemo-embolizations of the liver and cerebral embolizations, the threshold values for deterministic skin damage (2 Gy) were attained. Trigger values in terms of KAP, corresponding to a peak skin dose of 2 Gy, were determined. In general, our results comply reasonably well with the values proposed in the NCRP 168 report, with a KAP value of 425 Gy cm² and a Ka,r value of 3 Gy, corresponding to a peak skin dose of 3 Gy. Only for the TIPSS procedure a considerably lower value of 2 Gy was obtained at the published Ka,r and for the RF ablations we obtained a considerably lower value of 250 Gy cm² in terms of KAP.
OBJECTIVES: Accurate assessment and credentialing of physicians is essential. Objective motion analysis of guide-wire/catheter manipulation to assess proficiency during endovascular interventions remains unexplored. This study aims to assess its feasibility and its role in evaluation of technical ability. MATERIALS AND METHODS: A semi-automated catheter-tracking software was developed which allows for frame-by-frame motion analysis of fluoroscopic videos and calculation 2D catheter tip path-length. 21 interventionalists (6 cardiologists, 8 interventional radiologists, 7 vascular surgeons; 14/21 had performed >500 endovascular procedures) performed an identical carotid artery stenting procedure (CAS) on a VIST simulator (Mentice, Gothenburg, Sweden). Operators were sub-divided into four categories according to CAS experience: 6 inexperienced (0 CAS-group A), 3 low-volume (1-20 CAS-group B), 5 moderate-volume (21-50 CAS-group C) and 7 high-volume (>50 CAS-group D) CAS experience. Total PL was calculated for each case and comparisons made between groups. PL was correlated with: quantitative, simulator-derived metrics and qualitative performance scores (generic and procedure-specific) derived from post-hoc video analysis by three blinded observers. RESULTS: Group D used 5160.3 (inter-quartile range- IQR 4046.4-7142.9) pixels of movement, compared to 6856.7 (5914.4-8106.9) for group A (p = 0.046); 10,905.1 (7851.1-14,381.5) for group B (p = 0.017); and 9482.6 (8663.5-13,847.6) for group C (p = 0.003). Statistically significant inverse correlations were seen between total PL and qualitative performance scores (rho = -0.519 for generic (p = 0.027) rho = -0.567 for procedure-specific (p = 0.014) scores). PL did not correlate with any of the simulator-derived metrics (errors, contrast volume, total procedure and fluoroscopy times, cine-loops used). CONCLUSION: Endovascular instrument video motion analysis is feasible and may represent a valuable tool for the objective assessment of endovascular skill.
Debriefing is a process involving the active participation of learners, guided by a facilitator or instructor whose primary goal is to identify and close gaps in knowledge and skills. A review of existing research and a process for identifying future opportunities was undertaken.
A selective critical review of the literature on debriefing in simulation-based education was done. An iterative process of analysis, gathering input from audience participants, and consensus-based synthesis was conducted.
Research is sparse and limited in presentation for all important topic areas where debriefing is a primary variable. The importance of a format for reporting data on debriefing in a research context was realized and a "who, when, where, what, why" approach was proposed. Also, a graphical representation of the characteristics of debriefing studies was developed (Sim-PICO) to help guide simulation researchers in appropriate experimental design and reporting.
A few areas of debriefing practice where obvious gaps that deserve study were identified, such as comparing debriefing techniques, comparing trained versus untrained debriefers, and comparing the effect of different debriefing venues and times. A model for publication of research data was developed and presented which should help researchers clarify methodology in future work.
To develop weighted error-based, generic and procedure-specific rating scales, to validate these scales for video-based assessment during virtual carotid artery stent (CAS) procedures and correlate them with simulator-derived metrics.
A questionnaire was developed to assess the technique during live CAS procedures. Errors were rated from 1 (unimportant) to 5 (life-threatening) by 28 highly experienced CAS (>50 CAS) physicians. Virtual CAS procedure was performed by 21 interventionalists with varied CAS experience. Fluoroscopy screen and hand movements were video-taped, and simulator-derived metrics recorded. Experienced CAS practitioners then rated the video-taped performances using weighted error, generic and procedure-specific rating scales.
Of the 23 errors assessed, 12 were regarded as moderate (score 3), six serious (score 4) and four life-threatening (score 5). The generic rating scale was able to detect significant differences in performance between inexperienced and experienced CAS operators (score 25 vs. 32 respectively, P<0.01). All scoring systems demonstrated good inter-rater reliability (alpha=0.61-0.87). Significant correlations were observed between simulator-derived and video-based scores: weighted error-based score (r: 0.76, P<0.01), generic (r: 0.62, P<0.01) and procedure-specific (r: 0.76, P<0.01) rating scales.
The generic endovascular rating scale differentiated between levels of CAS experience among skilled interventionalists and correlated to simulator-based error scoring.
The technical skill of surgical trainees is not well assessed. This study aimed (1) to compare the reliability of three scoring systems, (2) to compare live and bench formats and (3) to assess construct validity of a test of operative skill.
Parallel examinations of operative skill, one using live animals and one using simulations, were developed. Performance was graded using operation-specific checklists, detailed global rating forms and pass/fail judgements. Twenty surgical residents each took both formats.
Disattenuated correlations between live and bench scores were high (0.69-0.72). Mean interrater reliability across stations ranged from 0.64 to 0.72. Internal consistency was moderate to high (alpha: 0.61-0.74) for the live format using the checklist and for live and bench formats using global ratings. Global ratings discriminated between resident levels for both formats (bench: F(2,17) = 4.45, P < 0.05; live: F(2,17) = 3.55, P < 0.05), checklists did not.
This preliminary study suggests that the Objective Structured Assessment of Technical Skill can reliably and validly assess surgical skills. Global ratings are a better method of assessment than task-specific checklists. Bench model simulation gives equivalent results to use of live animals for this test format.
Complications are common in hospitalized surgical patients. Provider error contributes to a significant proportion of these complications.
Surgical patients were concurrently observed for the development of explicit complications. All complications were reviewed by the attending surgeon and other members of the service and evaluated for the severity of sequelae (major or minor) and for whether the complication resulted from medical error (avoidable) or not.
University teaching hospital with a level I trauma designation.
All inpatients (operative or nonoperative) from 4 different surgical services: general surgery, combined general surgery and trauma, vascular surgery, and cardiothoracic surgery.
Total complication rate (number of complications divided by the number of patients) and the number of patients with complications. Complications were separated into those with major or minor sequelae and the proportion of each type that were due to medical error (avoidable). Rates of complications in a recent Institute of Medicine report were used as a criterion standard.
The data for the respective groups (general surgery, vascular surgery, combined general surgery and trauma, and cardiothoracic surgery) are as follows. The number of patients was 1363, 978, 914, and 1403; number of complications, 413, 409, 295, and 378; total complication rate, 30.3%, 42.4%, 32.3%, and 26.9%; minor complication rate, 13.3%, 19.9%, 13.5%, and 13.0% (percentage of minor complications that were avoidable, 37.4%, 59.0%, 51.2%, and 49.5%); major complication rate, 16.2%, 21.1%, 18.1%, and 12.9% (percentage of major complications that were avoidable, 53.4%, 60.7%, 38.8%, and 38.7%); and mortality rate, 1.83%, 3.33%, 2.28%, and 3.34% (percentage of mortality that was avoidable, 28.0%, 44.1%, 19.0%, and 25.0%).
Despite mortality rates that compare favorably with national benchmarks, a prospective examination of surgical patients reveals complication rates that are 2 to 4 times higher than those identified in an Institute of Medicine report. Almost half of these adverse events were judged contemporaneously by peers to be due to provider error (avoidable). Errors in care contributed to 38 (30%) of 128 deaths. Recognition that provider error contributes significantly to adverse events presents significant opportunities for improving patient outcomes.
Previous research has shown that surgeons' intraoperative non-technical skills are related to surgical outcomes. The aim of this study was to evaluate the reliability of the NOTSS (Non-technical Skills for Surgeons) behavior rating system. Based on task analysis, the system incorporates five categories of skills for safe surgical practice (Situation Awareness, Decision Making, Task Management, Communication & Teamwork, and Leadership).
Consultant (attending) surgeons (n = 44) from five Scottish hospitals attended one of six experimental sessions and were trained to use the NOTSS system. They then used the system to rate consultant surgeons' behaviors in six simulated operating room scenarios that were presented using video. Surgeons' ratings of the behaviors demonstrated in each scenario were compared to expert ratings ("accuracy"), and assessed for inter-rater reliability and internal consistency.
The NOTSS system had a consistent internal structure. Although raters had minimal training, rating "accuracy" for acceptable/unacceptable behavior was above 60% for all categories, with mean of 0.67 scale points difference from reference (expert) ratings (on 4-point scale). For inter-rater reliability, the mean values of within-group agreement (r (wg)) were acceptable for the categories Communication & Teamwork (.70), and Leadership (.72), but below a priori criteria for other categories. Intra-class correlation coefficients (ICC) indicated high agreement using average measures (values were .95-.99).
With the requisite training, the prototype NOTSS system could be used reliably by surgeons to observe and rate surgeons' behaviors. The instrument should now be tested for usability in the operating room.
Recent studies have investigated disruptions to surgical process via observation. We developed the Disruptions in Surgery Index (DiSI) to assess operating room professionals' self-perceptions of disruptions that affect surgical processes.
The DiSI assesses individual issues, operating room environment, communication, coordination/situational awareness, patient-related disruptions, team cohesion, and organizational issues. Sixteen surgeons, 26 nurses, and 20 anesthetists/operating departmental practitioners participated. Participants judged for themselves and for their colleagues how often each disruption occurs, its contribution to error, and obstruction of surgical goals.
We combined the team cohesion and organizational disruptions to improve reliability. All participants judged that individual issues, operating room environment, and communication issues affect others more often and more severely than one's self. Surgeons reported significantly fewer disruptions than nurses or anesthetists.
Although operating room professionals acknowledged disruptions and their impact, they attributed disruptions related to individual performance and attitudes more to their colleagues than to themselves. The cross-professional discrepancy in perceived disruptions (surgeons perceiving fewer than the other two groups) suggests that attempts to improve the surgical environment should always start with thorough assessment of the views of all its users. DiSI is useful in that it differentiates between the frequency and the severity of disruptions. Further research should explore correlations of DiSI-assessed perceptions and other observable measures.
Education and Training in Radiological Protection for Diagnostic and Interventional Procedures. ICRP Publication 113.
- ICRP
ICRP. Education and Training in Radiological Protection for Diagnostic and
Interventional Procedures. ICRP Publication 113. Ann ICRP. 2009;39(5).
European Society of R. Summary of the European Directive 2013/59/Euratom: essentials for health professionals in radiology
European Society of R. Summary of the European Directive 2013/59/Euratom:
essentials for health professionals in radiology. Insights into imaging
2015;6(4):411-7.
/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
European Union Regulation (EU) 2016/679 of the European Parliament and of the
Council of 27 April 2016 on the protection of natural persons with regard to the
processing of personal data and on the free movement of such data, and repealing
Directive 95/46/EC (General Data Protection Regulation). Official Journal of the
European Union L 119 2016;59:1-88.