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Objective : The 10th International brain computer interface (BCI) Society Meeting, 'Balancing Innovation and Translation', was held from the 6th to 9th of June 2023 in Brussels, Belgium. This report provides a summary of the workshop ' Building Consensus on Clinical Outcome Assessments (COAs) for BCI Devices '. This workshop was intended to give participants an overview of the current state of BCI, future opportunities, and how different countries and regions provide regulatory oversight to support the BCI community to develop safe and effective devices for patients. Approach : Five presentations and a panel discussion including representatives from regulators, industry, and clinical research stakeholders focused on how various stakeholders and the BCI community might best work together to ensure studies provide data that is useful for evaluating safety and effectiveness, including reaching consensus on COAs that represent clinically meaningful benefits and support regulatory and payor requirements. This report focuses on the regulatory and reimbursement requirements for medical devices and how to best measure safety and effectiveness and summarizes the presentations from five experts and the discussion between the panel and the audience. Main results : Consensus was reached on the following items specifically related to BCI: (i) the importance of and need for a new generation of COAs, (ii) the challenges facing the development of appropriate clinical outcome assessments, and (iii) that improvements in COAs should demonstrate obvious and clinically meaningful benefit(s). There was discussion on: (i) clinical trial design for BCIs and (ii) considerations for payor reimbursement and other funding. Significance : Whilst the importance of building community consensus on COAs was apparent, further collaboration will be required to reach consensus on which specific current and/or novel COAs could be used for the BCI field to evolve from research to market., (© 2025 IOP Publishing Ltd. All rights, including for text and data mining, AI training, and similar technologies, are reserved.)

Despite growing popularity and potential advantages of robotics in general surgery, there is very little published data regarding robotic inguinal hernia repair. This study examines a single surgeon's early experience with robotic TAPP inguinal hernia repair compared with laparoscopic TAPP repair in terms of feasibility and cost. We performed a retrospective review of 63 consecutive patients (24 laparoscopic and 39 robotic) who underwent inguinal hernia repair between December 2012-December 2014 at a single institution by a single surgeon. Data examined included gender, age, BMI, operative times, recovery room times, pain scale ratings, and cost. Patient groups were the same in terms of age and BMI. The mean operative time (77.5 vs 60.7 min, p = 0.001) and room time (109.3 vs 93.0 min, p = 0.001) were significantly longer for the robotic vs the laparoscopic patients. Recovery room time (109.1 vs 133.5 min, p = 0.026) and average pain scores in recovery (2.5 vs 3.8, p = 0.02) were significantly less for the robotic group. The average direct cost of the laparoscopic group was $3216 compared with $3479 for the robotic group. The average contribution margin for the laparoscopic group was $2396 compared with $2489 for the robotic group. Robotic TAPP inguinal hernia repair had longer operative times, but patients spent less time in recovery and noted less pain than patients who underwent laparoscopic TAPP inguinal hernia repair. The direct cost and contribution margin are nearly equivalent. These results should allow the continued investigation of this technique without concern over excess cost.

The objective of the study was to investigate the sociodemographic and psychological factors which are associated with choice or refusal of regional anesthesia for lower segment Caesarean section. A semi-structured questionnaire was administered preoperatively to consecutive women presenting for elective operation at two hospital sites in the same health authority. The questionnaires were administered to 39 pregnant women by two anesthetists, one at each site. Sociodemographic and past and present obstetric and anesthetic details were obtained. The Hospital Anxiety and Depression scale and the FEAR questionnaire were used with an additional visual analog scale to assess fearfulness associated with the proposed operation. A 'panic checklist' of ten items was also constructed to identify procedures associated with feelings of panic. Ten women requested general anesthesia. These women had a similar level of anxiety to the others, but were significantly more depressed, had had more pregnancies overall and more without live babies. There were also more aspects of the procedure at which they thought they might panic. Women who have suffered the loss of a conception with its associated grief and often obstetric intervention are more reluctant to be conscious during an operative delivery for a subsequent baby. Preventive measures should be considered at the time of fetal loss to avoid this. However, preoperatively a simple visual analog scale for fearfulness would identify these women so that any unresolved fears could receive full psychological assessment.