Informed consent through 3D virtual reality: a randomized clinical trial.

BACKGROUND: The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients' anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor. METHODS: In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images. RESULTS: Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group. CONCLUSIONS: 3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients' comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts. TRAIL REGISTRATION: ClinicalTrials.gov NCT03503487.

Propofol and sevoflurane affect intra-operative memory formation of words differently: A prospective cohort study.

BACKGROUND: Memory priming seems possible even during apparently adequate anaesthesia. However, the effects of different anaesthetics and type of stimuli, by virtue of their specific neural underpinnings, have not been considered. OBJECTIVE: To determine if intra-operative implicit memory is affected by the type of anaesthesia (propofol or sevoflurane) or by the type of stimuli (abstract or concrete words). DESIGN: Two consecutive, randomised controlled experiments. SETTING: Neurological institute in Milan, Italy. PATIENTS: Forty-three patients undergoing anaesthesia with propofol (experiment 1) and 32 patients undergoing anaesthesia with sevoflurane (experiment 2). Patients were ASA I or II, age 18 to 65 years, native Italian speakers, right-handed and without any condition affecting memory or hearing. INTERVENTION: During anaesthesia, the patients heard a list of either concrete or abstract words or no words at all (controls). Explicit memory was tested with an explicit recall task and the Brice Interview; implicit memory was assessed through a word stem completion test. OUTCOME MEASURES: The number of explicitly recalled words, positivity to the Brice Interview, the proportion of target and nontarget hits, and a derived implicit memory score. RESULTS: With propofol, the proportion of target hits was significantly greater than the proportion of nontarget hits for the concrete word experimental group (P = 0.018). The implicit memory score of the concrete word experimental group was significantly higher than the score of both the abstract word experimental group (P  = 0.000) and the concrete word control group (P = 0.023). With sevoflurane, the proportion of target hits was significantly higher than the proportion of nontarget hits for the abstract word experimental group only (P = 0.027). No patients had a BIS above 60 and no one could recall intra-operative events or words. CONCLUSION: Intra-operative memory for words can form during apparently adequate BIS-guided anaesthesia but is modified by propofol or sevoflurane acting on different brain targets. Further studies on larger samples and using neuroimaging techniques are needed. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03727464.

EANS Basic Brain Course (ABC): combining simulation to cadaver lab for a new concept of neurosurgical training.

BACKGROUND: Neurosurgical training has traditionally been based on an apprenticeship model that requires considerable time and exposure to surgeries. Unfortunately, nowadays these requirements are hampered by several limitations (e.g., decreased caseload, worktime restrictions). Furthermore, teaching methods vary among residency programs due to cultural differences, monetary restrictions, and infrastructure conditions, with the possible consequence of jeopardizing residents' training. METHODS: The EANS Basic Brain Course originated from a collaboration between the Besta NeuroSim Center in Milano and the Swiss Foundation for Innovation and Training in Surgery in Geneva. It was held for 5 neurosurgical residents (PGY1-3) who participated to this first pilot experience in January 2019. The main goal was to cover the very basic aspects of cranial surgery, including both technical and non-technical skills. The course was developed in modules, starting from the diagnostic paths and communication with patients (played by professional actors), then moving to practical simulation sessions, rapid theoretical lessons, and discussions based on real cases and critical ethical aspects. At the end, the candidates had cadaver lab sessions in which they practiced basic emergency procedures and craniotomies. The interaction between the participants and the faculties was created and maintained using role plays that smoothly improved the cooperation during debriefs and discussions, thus making the sessions exceedingly involving. RESULTS: At the end of the course, every trainee was able to complete the course curriculum and all the participants expressed their appreciation for this innovative format, with a particular emphasis on the time spent learning non-technical skills, confirming that they feel this to be a fundamental aspect of a comprehensive training in neurosurgery. CONCLUSIONS: It is possible that this combined concept of training on technical and non-technical skills, using emerging technologies along with pedagogic techniques and cadaver dissection, may become the state-of-the-art for European Neurosurgical training programs in the next future.

Filling the gap between the OR and virtual simulation: a European study on a basic neurosurgical procedure.

BACKGROUND: Currently available simulators are supposed to allow young neurosurgeons to hone their technical skills in a safe environment, without causing any unnecessary harm to their patients caused by their inexperience. For this training method to be largely accepted in neurosurgery, it is necessary to prove simulation efficacy by means of large-scale clinical validation studies. METHODS: We correlated and analysed the performance at a simulator and the actual operative skills of different neurosurgeons (construct validity). We conducted a study involving 92 residents and attending neurosurgeons from different European Centres; each participant had to perform a virtual task, namely the placement of an external ventricular drain (EVD) at a neurosurgical simulator (ImmersiveTouch). The number of attempts needed to reach the ventricles and the accuracy in positioning the catheter were assessed. RESULTS: Data suggests a positive correlation between subjects who placed more EVDs in the previous year and those who get better scores at the simulator (p = .008) (fewer attempts and better surgical accuracy). The number of attempts to reach the ventricle was also analysed; senior residents needed fewer attempts (mean = 2.26; SD = 1.11) than junior residents (mean = 3.12; SD = 1.05) (p = .007) and staff neurosurgeons (mean = 2.89, SD = 1.23). Scoring results were compared by using the Fisher's test, for the analysis of the variances, and the Student's T test. Surprisingly, having a wider surgical experience overall does not correlate with the best performance at the simulator. CONCLUSION: The performance of an EVD placement on a simulator correlates with the density of the neurosurgical experience for that specific task performed in the OR, suggesting that simulators are able to differentiate neurosurgeons according to their surgical ability. Namely this suggests that the simulation performance reflects the surgeons' consistency in placing EVDs in the last year.

Validation of the italian version of the 15-item Myasthenia Gravis Quality-of-Life questionnaire.

INTRODUCTION: In this study we assess the Italian version of the 15-item Myasthenia Gravis Quality-of-Life questionnaire (MG-QOL15). METHODS: The validation protocol included the MG-QOL15, the 36-item Short Form (SF-36), the Besta Neurological Institute Rating Scale for Myasthenia Gravis, and the MG-Composite. We used the Cronbach α to test reliability, the Spearman correlation to test short-term test-retest, the Kruskal-Wallis test to assess differences in MG-QOL15 between patients with different disease severity, and the Wilcoxon signed-rank test to assess sensitivity to change. RESULTS: Seventy-two patients were enrolled in the study. The mean MG-QOL15 score was 15.2 ± 12.2, with α = 0.93 and test-retest correlation = 0.93. Compared with the SF-36, the MG-QOL15 was superior in differentiating patients with different MG types (P = 0.041) and severity (P = 0.004), showed higher sensitivity to change (P = 0.003 for improved and P = 0.024 for worsened patients), and had higher correlations with the MG-Composite (rho = 0.367 vs. -0.213 and -0.154). CONCLUSION: The Italian version of the MG-QOL15 is valid, reliable, stable, and sensitive to changes. Muscle Nerve 56: 716-720, 2017.

Clinical and psychosocial features of frequent relapsers (FR) among patients with chronic migraine and medication overuse.

The objective was to characterize frequent relapsers (FR)-i.e. those requiring two or more withdrawals in a 3-year period-in a sample of 188 patients with chronic migraine with medication overuse (CM-MO). We tested differences between FR and non-FR for age, gender, employment status, days with headache, headache severity, type of overused medication, BDI-II, WHODAS 2.0 and MSQ. 30.8% of participants were FR: they were more frequently treated as inpatients and living alone, had a lower education, higher disability and lower QoL, higher frequency and intensity of headaches, and higher depression scores. Clinicians should address whether CM-MO patients submitted to withdrawal had recently underwent other similar interventions.

Simulation to become a better neurosurgeon. An international prospective controlled trial: The Passion study.

Introduction: Surgical training traditionally adheres to the apprenticeship paradigm, potentially exposing trainees to an increased risk of complications stemming from their limited experience. To mitigate this risk, augmented and virtual reality have been considered, though their effectiveness is difficult to assess. Research question: The PASSION study seeks to investigate the improvement of manual dexterity following intensive training with neurosurgical simulators and to discern how surgeons' psychometric characteristics may influence their learning process and surgical performance. Material and methods: Seventy-two residents were randomized into the simulation group (SG) and control group (CG). The course spanned five days, commencing with assessment of technical skills in basic procedures within a wet-lab setting on day 1. Over the subsequent core days, the SG engaged in simulated procedures, while the CG carried out routine activities in an OR. On day 5, all residents' technical competencies were evaluated. Psychometric measures of all participants were subjected to analysis. Results: The SG demonstrated superior performance (p < 0.0001) in the brain tumour removal compared to the CG. Positive learning curves were evident in the SG across the three days of simulator-based training for all tumour removal tasks (all p-values <0.05). No significant differences were noted in other tasks, and no meaningful correlations were observed between performance and any psychometric parameters. Discussion and conclusion: A brief and intensive training regimen utilizing 3D virtual reality simulators enhances residents' microsurgical proficiency in brain tumour removal models. Simulators emerge as a viable tool to expedite the learning curve of in-training neurosurgeons.

The "STARS-CT-MADE" Study: Advanced Rehearsal and Intraoperative Navigation for Skull Base Tumors.

BACKGROUND: Skull base meningiomas represent a challenge for neurosurgeons, and the procedures are typically performed by experienced neurosurgeons, thus limiting resident training. A new simulation and rehearsal device can be used as an aid for senior surgeons during these operations and serve as a training tool for junior surgeons. METHODS: Forty patients harboring an anterior/middle fossa meningioma were recruited. Surgical Theater, a rehearsal/simulation platform, was used for preoperative planning and intraoperative 3D navigation on 20 patients (CT-MADE group), while the remaining (control group) underwent a traditional navigation. Qualitative comparisons between the 2 groups were made with regard to surgical procedure and patient outcome. Satisfaction questionnaires were completed by expert neurosurgeons and residents to assess the overall usefulness of the platform. Furthermore, the surface of the simulated craniotomy performed during the planning was compared with the one actually performed during surgery in order to evaluate the reliability of the planning. RESULTS: No differences between the 2 groups were found (surgery duration: P = 0.4; visual impairment: P = 0.56). Both residents and senior neurosurgeons enjoyed using the platform for intraoperative navigation and planning; simulated craniotomies were significantly smaller as compared with the real ones (P = 0.009), probably because it was not intuitive to depict the exact margins of the operculum with the platform. CONCLUSION: Surgical Theater helped residents to improve their anatomic and procedural comprehension and was deemed as a useful aid to safely perform some demanding neurosurgical procedures, by both senior and junior surgeons.

The "STARS-CASCADE" Study: Virtual Reality Simulation as a New Training Approach in Vascular Neurosurgery.

OBJECTIVE: Surgical clipping has become a relatively rare procedure in comparison to endovascular exclusion of cerebral aneurysms. Consequently, there is a declining number of cases where young neurosurgeons can practice clipping. For this reason, we investigated the application of a new 3-dimensional (3D) simulation and rehearsal device, Surgical Theater, in vascular neurosurgery. METHODS: We analyzed data of 20 patients who underwent surgical aneurysm clipping. In 10 cases, Surgical Theater was used to perform the preoperative 3D planning (CASCADE group), while traditional imaging was used in the other cases (control group). Preoperative 3D simulation was performed by 4 expert and 3 junior neurosurgeons (1 fellow, 2 residents). During postoperative debriefings, expert surgeons explained the different aspects of the operation to their younger colleagues in an interactive way using the simulator. Questionnaires were given to the surgeons to get qualitative feedback about the simulator, and the junior surgeons' performance at simulator was also analyzed. RESULTS: There were no differences in surgery outcomes, complications, and surgical duration (P > 0.05) between the 2 groups. Senior neurosurgeons performed similarly when operating at the simulator as compared with in the operating room, while junior neurosurgeons improved their performance at the simulator after the debriefing session (P < 0.005). CONCLUSIONS: Surgical Theater proved to be realistic in replicating vascular neurosurgery scenarios for rehearsal and simulation purposes. Moreover, it was shown to be useful for didactic purposes, allowing young neurosurgeons to take full advantage and learn from senior colleagues to become familiar with this demanding neurosurgical subspecialty.