Am I doing this right? Structured self-assessment during simulation training of mastoidectomy improves cadaver dissection performance: a prospective educational study.

PURPOSE: Temporal bone surgery requires excellent surgical skills and simulation-based training can aid novices' skills acquisition. However, simulation-based training is challenged by early stagnation of performance after few performances. Structured self-assessment during practice might enhance learning by inducing reflection and engagement in the learning task. In this study, structured self-assessment was introduced during virtual reality (VR) simulation of mastoidectomy to investigate the effects on subsequent performance during cadaveric dissection. METHODS: A prospective educational study with comparison with historical controls (reference cohort). At a temporal bone dissection course, eighteen participants performed structured self-assessment during 3 h of VR simulation mastoidectomy training before proceeding to cadaver dissection (intervention cohort). At a previous course, eighteen participants received identical VR simulation training but without the structured self-assessment (reference cohort). Final products from VR simulation and cadaveric dissection were recorded and assessed by two blinded raters using a 19-point modified Welling Scale. RESULTS: The intervention cohort completed fewer procedures (average 4.2) during VR simulation training than the reference cohort (average 5.7). Nevertheless, the intervention cohort achieved a significantly higher average performance score both in VR simulation (11.1 points, 95% CI [10.6-11.5]) and subsequent cadaveric dissection (11.8 points, 95% CI [10.7-12.8]) compared with the reference cohort, who scored 9.1 points (95% CI [8.7-9.5]) during VR simulation and 5.8 points (95% CI [4.8-6.8]) during cadaveric dissection. CONCLUSIONS: Structured self-assessment is a valuable learning support during self-directed VR simulation training of mastoidectomy and the positive effect on performance transfers to subsequent cadaveric dissection performance.

Standard Setting in Simulation-based Training of Surgical Procedures: A Systematic Review.

OBJECTIVE: This systematic review aims to examine the use of standard-setting methods in the context of simulation-based training of surgical procedures. SUMMARY OF BACKGROUND: Simulation-based training is increasingly used in surgical education. However, it is important to determine which level of competency trainees must reach during simulation-based training before operating on patients. Therefore, pass/fail standards must be established using systematic, transparent, and valid methods. METHODS: Systematic literature search was done in 4 databases (Ovid MEDLINE, Embase, Web of Science, and Cochrane Library). Original studies investigating simulation-based assessment of surgical procedures with the application of a standard setting were included. Quality of evidence was appraised using GRADE. RESULTS: Of 24,299 studies identified by searches, 232 studies met the inclusion criteria. Publications using already established standard settings were excluded (N = 70), resulting in 162 original studies included in the final analyses. Most studies described how the standard setting was determined (N = 147, 91%) and most used the mean or median performance score of experienced surgeons (n = 65, 40%) for standard setting. We found considerable differences across most of the studies regarding study design, setup, and expert level classification. The studies were appraised as having low and moderate evidence. CONCLUSION: Surgical education is shifting toward competency-based education, and simulation-based training is increasingly used for acquiring skills and assessment. Most studies consider and describe how standard settings are established using more or less structured methods but for current and future educational programs, a critical approach is needed so that the learners receive a fair, valid, and reliable assessment.

The cutting edge of customized surgery: 3D-printed models for patient-specific interventions in otology and auricular management-a systematic review.

PURPOSE: 3D-printing (three-dimensional printing) is an emerging technology with promising applications for patient-specific interventions. Nonetheless, knowledge on the clinical applicability of 3D-printing in otology and research on its use remains scattered. Understanding these new treatment options is a prerequisite for clinical implementation, which could improve patient outcomes. This review aims to explore current applications of 3D-printed patient-specific otologic interventions, including state of the evidence, strengths, limitations, and future possibilities. METHODS: Following the PRISMA statement, relevant studies were identified through Pubmed, EMBASE, the Cochrane Library, and Web of Science. Data on the manufacturing process and interventions were extracted by two reviewers. Study quality was assessed using Joanna Briggs Institute's critical appraisal tools. RESULTS: Screening yielded 590 studies; 63 were found eligible and included for analysis. 3D-printed models were used as guides, templates, implants, and devices. Outer ear interventions comprised 73% of the studies. Overall, optimistic sentiments on 3D-printed models were reported, including increased surgical precision/confidence, faster manufacturing/operation time, and reduced costs/complications. Nevertheless, study quality was low as most studies failed to use relevant objective outcomes, compare new interventions with conventional treatment, and sufficiently describe manufacturing. CONCLUSION: Several clinical interventions using patient-specific 3D-printing in otology are considered promising. However, it remains unclear whether these interventions actually improve patient outcomes due to lack of comparison with conventional methods and low levels of evidence. Further, the reproducibility of the 3D-printed interventions is compromised by insufficient reporting. Future efforts should focus on objective, comparative outcomes evaluated in large-scale studies.

Assessing competence in cochlear implant surgery using the newly developed Cochlear Implant Surgery Assessment Tool.

PURPOSE: To develop and gather validity evidence for a novel tool for assessment of cochlear implant (CI) surgery, including virtual reality CI surgery training. METHODS: Prospective study gathering validity evidence according to Messick's framework. Four experts developed the CI Surgery Assessment Tool (CISAT). A total of 35 true novices (medical students), trained novices (residents) and CI surgeons performed two CI-procedures each in the Visible Ear Simulator, which were rated by three blinded experts. Classical test theory and generalizability theory were used for reliability analysis. RESULTS: The CISAT significantly discriminated between the three groups (p < 0.001). The generalizability coefficient was 0.76 and most of the score variance (53.3%) was attributable to the participant and only 6.8% to the raters. When exploring a standard setting for CI surgery, the contrasting groups method suggested a pass/fail score of 36.0 points (out of 55), but since the trained novices performed above this, we propose using the mean CI surgeon performance score (45.3 points). CONCLUSION: Validity evidence for simulation-based assessment of CI performance supports the CISAT. Together with the standard setting, the CISAT might be used to monitor progress in competency-based training of CI surgery and to determine when the trainee can advance to further training.

Use of simulation-based training of surgical technical skills among ENTs: an international YO-IFOS survey.

PURPOSE: The aim of this study was to investigate and compare the use of simulation-based technical skills training (SBTST) in the otolaryngology curriculum in different countries, and to explore the needs and opinions about the use of simulation among young otolaryngologists. METHODS: An e-survey conducted among Young Otolaryngologists of the International Federation of Oto-rhino-laryngological Societies (Yo-IFOS) members. RESULTS: 139 Yo-IFOS members from 51 countries completed the survey. During residency training, 82.7% of respondents have used SBTST on cadavers, 51.8% on physical simulators, and 43.8% on virtual reality simulators. High costs (65.5%), lack of availability (49.2%) and lack of time (25.5%) were the main barriers limiting the practice of SBTST. These barriers also limited teaching using simulation. Sinonasal surgery (72.7%), temporal bone surgery (67.6%), and head/neck surgery (44.6%) were significantly more frequently taught using SBTST than suspension microlaryngoscopy (25.9%) and pediatric surgery (22.3%) (p < 0.001). The procedures rated as the most important to learn through SBTST were tracheotomy (50.4%), emergency cricothyroidotomy (48.9%), and rigid bronchoscopy (47.5%). On an analogic visual scale (0-100) for the question "how important will simulation be for future ENTs in surgical training?", the mean score was 79.5/100 (± 23.3), highlighting the positive attitude toward the use of SBTST in otorhinolaryngology training. CONCLUSION: SBTST is an attractive learning and teaching method in otorhinolaryngology, but associated costs, lack of access, and lack of time are the main barriers limiting its use. Emergency procedures are key technical skills to be learned using simulation but in some cases, lack relevant simulators for training.

Content validity evidence for a simulation-based test of handheld otoscopy skills.

PURPOSE: At graduation from medical school, competency in otoscopy is often insufficient. Simulation-based training can be used to improve technical skills, but the suitability of the training model and assessment must be supported by validity evidence. The purpose of this study was to collect content validity evidence for a simulation-based test of handheld otoscopy skills. METHODS: First, a three-round Delphi study was conducted with a panel of nine clinical teachers in otorhinolaryngology (ORL) to determine the content requirements in our educational context. Next, the authenticity of relevant cases in a commercially available technology-enhanced simulator (Earsi, VR Magic, Germany) was evaluated by specialists in ORL. Finally, an integrated course was developed for the simulator based on these results. RESULTS: The Delphi study resulted in nine essential diagnoses of normal variations and pathologies that all junior doctors should be able to diagnose with a handheld otoscope. Twelve out of 15 tested simulator cases were correctly recognized by at least one ORL specialist. Fifteen cases from the simulator case library matched the essential diagnoses determined by the Delphi study and were integrated into the course. CONCLUSION: Content validity evidence for a simulation-based test of handheld otoscopy skills was collected. This informed a simulation-based course that can be used for undergraduate training. The course needs to be further investigated in relation to other aspects of validity and for future self-directed training.

Cognitive load and performance in immersive virtual reality versus conventional virtual reality simulation training of laparoscopic surgery: a randomized trial.

BACKGROUND: Virtual reality simulators combined with head-mounted displays enable highly immersive virtual reality (VR) for surgical skills training, potentially bridging the gap between the simulation environment and real-life operating room conditions. However, the increased complexity of the learning situation in immersive VR could potentially induce high cognitive load thereby inhibiting performance and learning. This study aims to compare cognitive load and performance in immersive VR and conventional VR simulation training. METHODS: A randomized controlled trial of residents (n = 31) performing laparoscopic salpingectomies with an ectopic pregnancy in either immersive VR or conventional VR simulation. Cognitive load was estimated by secondary-task reaction time at baseline, and during nonstressor and stressor phases of the procedure. Simulator metrics were used to evaluate performance. RESULTS: Cognitive load was increased by 66% and 58% during immersive VR and conventional VR simulation, respectively (p < 0.001), compared to baseline. A light stressor induced a further increase in cognitive load by 15.2% and a severe stressor by 43.1% in the immersive VR group compared to 23% (severe stressor) in the conventional VR group. Immersive VR also caused a significantly worse performance on most simulator metrics. CONCLUSION: Immersive VR simulation training induces a higher cognitive load and results in a poorer performance than conventional VR simulation training in laparoscopy. High extraneous load and element interactivity in the immersive VR are suggested as mechanisms explaining this finding. However, immersive VR offers some potential advantages over conventional VR such as more real-life conditions but we only recommend introducing immersive VR in surgical skills training after initial training in conventional VR.

Ultra-high-fidelity virtual reality mastoidectomy simulation training: a randomized, controlled trial.

PURPOSE: Ultra-high-fidelity (UHF) graphics in virtual reality (VR) simulation might improve surgical skill acquisition in temporal bone training. This study aims to compare UHF VR simulation training with conventional, screen-based VR simulation training (cVR) with respect to performance and cognitive load (CL). METHODS: In a randomized trial with a cross-over design, 24 students completed a total of four mastoidectomies in a VR temporal bone surgical simulator: two performances under UHF conditions using a digital microscope and two performances under conventional conditions using screen-based VR simulation. Performances were assessed by two blinded raters using an established assessment tool. In addition, CL was estimated as the relative change in secondary-task reaction time during simulation when compared with individual baseline measurements. Data were analyzed using linear mixed model analysis for repeated measurements. RESULTS: The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR simulation [mean difference 1.0 points out of 17 points, 95% CI (0.2-1.7), p = 0.02]. The most important factor for performance during UHF simulation was the ability to achieve stereovision (mean difference = 3.4 points, p < 0.001). Under the UHF VR condition, CL was significantly higher than during cVR (28% vs. 18%, respectively, p < 0.001). CONCLUSION: UHF graphics in VR simulation training reduced performance and induced a higher CL in novices than conventional, screen-based VR simulation training. Consequently, UHF VR simulation training should be preceded by cVR training and might be better suited for the training of intermediates or experienced surgeons.

Developing a national e-learning course in otorhinolaryngology: the Danish experience.

PURPOSE: E-learning provides a flexible and effective approach to learning and is increasingly used in otorhinolaryngology (ORL). We developed a national theoretical e-learning course for ORL trainees and describe our experiences with implementation as well as piloting the e-learning course. METHODS: E-learning course content was developed as structured multiple choice quizzes for the European core curriculum textbook. An open-source learning management system was adapted for a self-paced e-learning course. We piloted the e-learning course as a non-mandatory option for the 15 residents participating in the Danish 4-day national training course in rhinology in February 2019. A post-course survey was sent out to the participants and used in the evaluation along with activity data from the learning management system. RESULTS: Fourteen out of 15 trainees participated in the e-learning course. Nine participants completed > 95% of the course. The activity data demonstrated that participants with the highest completion rate typically began well in advance of the course (> 2 months). Overall the e-learning course was rated positively in relation to learning and as preparation for the national training course. Participants responded that the level of the e-learning course was higher than and also at times in slight incongruity with the content of the national curriculum. Participants would like protected study time for e-learning activities in their residency program. All participants responded that they would use e-learning in relation to future national training courses. CONCLUSIONS: Developing a national e-learning course is feasible and is well-received by trainees as well as other educational stakeholders.

Identifying and prioritizing technical procedures in otorhinolaryngology for simulation-based training: a national needs assessment in Denmark.

PURPOSE: To conduct a national needs assessment using a structured approach to identify and prioritize technical skills and procedures in otorhinolaryngology (ORL) for simulation-based training. METHODS: The study was designed as a national Danish survey of key educational stakeholders in ORL. A Delphi methodology with three rounds was used: the first round constituted a brainstorming phase to identify relevant procedures; the second round was a survey of importance, frequency, number of physicians needed to train, and patient safety/discomfort of the procedures, and feasibility of simulation-based training; and a final third round for prioritization. RESULTS: A total of 62 key opinion leaders were identified and 50 responded in the first round, constituting our panel. Fifty technical skills and procedures were identified in the brainstorming phase and were sent out for assessment, with responses from 56.5% of still eligible panellists. Thirty-six procedures were found important in ORL residency training by the panel. After final prioritization by the panel (response rate 43.4%), there was broad consensus (> 75%) on the need for simulation-based training of 13 technical skills and procedures, with the most highly ranking procedures being emergency cricothyroidotomy, flexible fibre pharyngo-laryngoscopy, and basic surgical skills. CONCLUSIONS: As educational decisions are increasingly required to be evidence-based, this study represents a structured approach to identifying procedures for simulation-based training in ORL. This information can be valuable in the development and implementation of simulation-based training programmes in the ORL residency training curriculum.

Performance metrics in mastoidectomy training: a systematic review.

OBJECTIVE: To investigate validity evidence, and strengths and limitations of performance metrics in mastoidectomy training. METHODS: A systematic review following the PRISMA guidelines. Studies reporting performance metrics in mastoidectomy/temporal bone surgery were included. Data on design, outcomes, and results were extracted by two reviewers. Validity evidence according to Messick's framework and level of evidence were assessed. RESULTS: The search yielded a total of 1085 studies from the years 1947-2018 and 35 studies were included for full data extraction after abstract and full-text screening. 33 different metrics on mastoidectomy performance were identified and ranked according to the number of reports. Most of the 33 metrics identified had some amount of validity evidence. The metrics with most validity evidence were related to drilling time, volume drilled per time, force applied near vital structures, and volume removed. CONCLUSIONS: This review provides an overview of current metrics of mastoidectomy performance, their validity, strengths and limitations, and identifies the gap in validity evidence of some metrics. Evidence-based metrics can be used for performance assessment in temporal bone surgery and for providing integrated and automated feedback in virtual reality simulation training. The use of such metrics in simulation-based mastoidectomy training can potentially address some of the limitations in current temporal bone skill assessment and ease assessment in repeated practice. However, at present, an automated feedback based on metrics in VR simulation does not have sufficient empirical basis and has not been generally accepted for use in training and certification. LEVEL OF EVIDENCE: 2a.

The effect of structured self-assessment in virtual reality simulation training of mastoidectomy.

PURPOSE: Virtual reality (VR) simulation surgical skills training is well established, but self-directed practice is often associated with a learning curve plateau. In this study, we investigate the effects of structured self-assessment as a means to improve performance in mastoidectomy training. METHODS: The study was a prospective, educational study. Two cohorts of novices (medical students) were recruited for practice of anatomical mastoidectomy in a training program with five distributed training blocks. Fifteen participants performed structured self-assessment after each procedure (intervention cohort). A reference cohort of another 14 participants served as controls. Performances were assessed by two blinded raters using a modified Welling Scale and simulator-recorded metrics. RESULTS: The self-assessment cohort performed superiorly to the reference cohort (mean difference of final product score 0.87 points, p = 0.001) and substantially reduced the number of repetitions needed. The self-assessment cohort also had more passing performances for the combined metrics-based score reflecting increased efficiency. Finally, the self-assessment cohort made fewer collisions compared with the reference cohort especially with the chorda tympani, the facial nerve, the incus, and the malleus. CONCLUSIONS: VR simulation training of surgical skills benefits from having learners perform structured self-assessment following each procedure as this increases performance, accelerates the learning curve thereby reducing time needed for training, and induces a safer performance with fewer collisions with critical structures. Structured self-assessment was in itself not sufficient to counter the learning curve plateau and for continued skills development additional supports for deliberate practice are needed.

Validity evidence for procedural competency in virtual reality robotic simulation, establishing a credible pass/fail standard for the vaginal cuff closure procedure.

BACKGROUND: The use of robotic surgery for minimally invasive procedures has increased considerably over the last decade. Robotic surgery has potential advantages compared to laparoscopic surgery but also requires new skills. Using virtual reality (VR) simulation to facilitate the acquisition of these new skills could potentially benefit training of robotic surgical skills and also be a crucial step in developing a robotic surgical training curriculum. The study's objective was to establish validity evidence for a simulation-based test for procedural competency for the vaginal cuff closure procedure that can be used in a future simulation-based, mastery learning training curriculum. METHODS: Eleven novice gynaecological surgeons without prior robotic experience and 11 experienced gynaecological robotic surgeons (> 30 robotic procedures) were recruited. After familiarization with the VR simulator, participants completed the module 'Guided Vaginal Cuff Closure' six times. Validity evidence was investigated for 18 preselected simulator metrics. The internal consistency was assessed using Cronbach's alpha and a composite score was calculated based on metrics with significant discriminative ability between the two groups. Finally, a pass/fail standard was established using the contrasting groups' method. RESULTS: The experienced surgeons significantly outperformed the novice surgeons on 6 of the 18 metrics. The internal consistency was 0.58 (Cronbach's alpha). The experienced surgeons' mean composite score for all six repetitions were significantly better than the novice surgeons' (76.1 vs. 63.0, respectively, p < 0.001). A pass/fail standard of 75/100 was established. Four novice surgeons passed this standard (false positives) and three experienced surgeons failed (false negatives). CONCLUSION: Our study has gathered validity evidence for a simulation-based test for procedural robotic surgical competency in the vaginal cuff closure procedure and established a credible pass/fail standard for future proficiency-based training.

The effect of distributed virtual reality simulation training on cognitive load during subsequent dissection training.

BACKGROUND: Complex tasks such as surgical procedures can induce excessive cognitive load (CL), which can have a negative effect on learning, especially for novices. AIM: To investigate if repeated and distributed virtual reality (VR) simulation practice induces a lower CL and higher performance in subsequent cadaveric dissection training. METHODS: In a prospective, controlled cohort study, 37 residents in otorhinolaryngology received VR simulation training either as additional distributed practice prior to course participation (intervention) (9 participants) or as standard practice during the course (control) (28 participants). Cognitive load was estimated as the relative change in secondary-task reaction time during VR simulation and cadaveric procedures. RESULTS: Structured distributed VR simulation practice resulted in lower mean reaction times (32% vs. 47% for the intervention and control group, respectively, p < 0.01) as well as a superior final-product performance during subsequent cadaveric dissection training. CONCLUSIONS: Repeated and distributed VR simulation causes a lower CL to be induced when the learning situation is increased in complexity. A suggested mechanism is the formation of mental schemas and reduction of the intrinsic CL. This has potential implications for surgical skills training and suggests that structured, distributed training be systematically implemented in surgical training curricula.

European status on temporal bone training: a questionnaire study.

PURPOSE: In otorhinolaryngology training, introduction to temporal bone surgery through hands-on practice on cadaveric human temporal bones is the gold-standard training method before commencing supervised surgery. During the recent decades, the availability of such specimens and the necessary laboratory facilities for training seems to be decreasing. Alternatives to traditional training can consist of drilling artificial models made of plaster or plastic but also virtual reality (VR) simulation. Nevertheless, the integration and availability of these alternatives into specialist training programs remain unknown. METHODS: We conducted a questionnaire study mapping current status on temporal bone training and included responses from 113 departments from 23 countries throughout Europe. RESULTS: In general, temporal bone training during residency in ORL is organized as in-house training, or as participation in national or international temporal bone courses or some combination hereof. There are considerable differences in the availability of training facilities for temporal bone surgery and the number of drillings each ORL trainee can perform. Cadaveric dissection is still the most commonly used training modality. CONCLUSIONS: VR simulation and artificial models are reported to be used at many leading training departments already. Decreasing availability of cadavers, lower costs of VR simulation and artificial models, in addition to established evidence for a positive effect on the trainees' competency, were reported as the main reasons. Most remaining departments expect to implement VR simulation and artificial models for temporal bone training into their residency programs in the near future.

The good lecture.

Postgraduate medical education often relies on the traditional lecture model with low knowledge retention rates of 5-20%. Cognitive overload from excessive information during lectures diminishes learning efficacy. To optimise learning, evidence suggests prioritising active engagement, streamlining visual aids, introducing clinical scenarios, and incorporating audience response systems may further enhance retention and comprehension. In conclusion, the traditional lecture must evolve into more interactive and engaging modalities to facilitate increased participant long-term learning as summarised in this review.

Further Validity Evidence for Patient-Specific Virtual Reality Temporal Bone Surgical Simulation.

OBJECTIVE: Patient-specific virtual reality (VR) simulation of cochlear implant (CI) surgery potentially enables preoperative rehearsal and planning. We aim to gather supporting validity evidence for patient-specific simulation through the analysis of virtual performance and comparison with postoperative imaging. METHODS: Prospective, multi-institutional study. Pre- and postoperative cone-beam CT scans of CI surgical patients were obtained and processed for patient-specific VR simulation. The virtual performances of five trainees and four attendings were recorded and (1) compared with volumes removed during actual surgery as determined in postoperative imaging, and (2) assessed using the Copenhagen Cochlear Implant Surgery Assessment Tool (CISAT) by two blinded raters. The volumes compared were cortical mastoidectomy, facial recess, and round window (RW) cochleostomy as well as violation of the facial nerve and chorda. RESULTS: Trainees drilled more volume in the cortical mastoidectomy and facial recess, whereas attendings drilled more volume for the RW cochleostomy and made more violations. Except for the cochleostomy, attendings removed volumes closer to that determined in postoperative imaging. Trainees achieved a higher CISAT performance score compared with attendings (22.0 vs. 18.4 points) most likely due to lack of certain visual cues. CONCLUSION: We found that there were differences in performance of trainees and attendings in patient-specific VR simulation of CI surgery as assessed by raters and in comparison with actual drilled volumes. The presented approach of volume comparison is novel and might be used for further validation of patient-specific VR simulation before clinical implementation for preoperative rehearsal in temporal bone surgery. LEVEL OF EVIDENCE: n/a Laryngoscope, 134:1403-1409, 2024.

Variability in Manual Segmentation of Temporal Bone Structures in Cone Beam CT Images.

PURPOSE: Manual segmentation of anatomical structures is the accepted "gold standard" for labeling structures in clinical images. However, the variability in manual segmentation of temporal bone structures in CBCT images of the temporal bone has not been systematically evaluated using multiple reviewers. Therefore, we evaluated the intravariability and intervariability of manual segmentation of inner ear structures in CBCT images of the temporal bone. METHODS: Preoperative CBCTs scans of the inner ear were obtained from 10 patients who had undergone cochlear implant surgery. The cochlea, facial nerve, chorda tympani, mid-modiolar (MM) axis, and round window (RW) were manually segmented by five reviewers in two separate sessions that were at least 1 month apart. Interreviewer and intrareviewer variabilities were assessed using the Dice coefficient (DICE), volume similarity, mean Hausdorff Distance metrics, and visual review. RESULTS: Manual segmentation of the cochlea was the most consistent within and across reviewers with a mean DICE of 0.91 (SD = 0.02) and 0.89 (SD = 0.01) respectively, followed by the facial nerve with a mean DICE of 0.83 (SD = 0.02) and 0.80 (SD = 0.03), respectively. The chorda tympani had the greatest amount of reviewer variability due to its thin size, and the location of the centroid of the RW and the MM axis were also quite variable between and within reviewers. CONCLUSIONS: We observed significant variability in manual segmentation of some of the temporal bone structures across reviewers. This variability needs to be considered when interpreting the results in studies using one manual reviewer.