An international consensus for mitigation of the detrimental effects of the COVID-19 pandemic on laparoscopic training.

AIM: Achieve an international consensus on how to recover lost training opportunities. The results of this study will help inform future EAES guidelines about the recovery of surgical training before and after the pandemic. BACKGROUND: A global survey conducted by our team demonstrated significant disruption in surgical training during the COVID-19 pandemic. This was wide-spread and affected all healthcare systems (whether insurance based or funded by public funds) in all participating countries. Thematic analysis revealed the factors perceived by trainees as barriers to training and gave birth to four-point framework of recovery. These are recommendations that can be easily achieved in any country, with minimal resources. Their implementation, however, relies heavily on the active participation and leadership by trainers. Based on the results of the global trainee survey, the authors would like to conduct a Delphi-style survey, addressed to trainers on this occasion, to establish a pragmatic step-by-step approach to improve training during and after the pandemic. METHODS: This will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with laparoscopic trainers. These will be transcribed and thematic analysis will be applied. A questionnaire will then be proposed; this will be based on both the results of the semi structured interviews and of the global trainee survey. The questionnaire will then be validated by the steering committee of this group (achieve consensus of >80%). After validation, the questionnaire will be disseminated to trainers across the globe. Participants will be asked to consent to participate in further cycles of the Delphi process until more than 80% agreement is achieved. RESULTS: This study will result in a pragmatic framework for continuation of surgical training during and after the pandemic (with special focus on minimally invasive surgery training).

The Role of Shared Decision-Making in Personalised Medicine: Opening the Debate.

Surgeons and cancer patients are starting to open the debate on how personalised medicine could use shared decision-making (SDM) to balance the personal and clinical components and thus improve the quality and value of care. Personalised precision medicine (PPM) has traditionally focused on the use of genomic information when prescribing treatments, which are usually pharmaceutical. However, the knowledge base is considerably scarcer in terms of how clinicians can individualise the information they provide patients about the consequences of different treatments, and in doing so involve them in the decision-making process. To achieve this, the ethical implications of SDM must be addressed from both sides. This paper explores the medical characteristics, the SDM implications in severe and fragile patients, potential risks, and observed benefits within this healthcare approach through four clinical cases. Findings shed light on current needs for clinician and patient training and tools related to SDM in PPM, and also remarks on the way in which this shift in healthcare settings is taking place to include the human component together with the biological and technological advances when designing care processes in colorectal cancer.

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial).

BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.

Towards an Open Medical School without Checkerboards during the COVID-19 Pandemic: How to Flexibly Self-Manage General Surgery Practices in Hospitals?

BACKGROUND: Can we create a technological solution to flexibly self-manage undergraduate General Surgery practices within hospitals? Before the pandemic, the management of clerkships was starting to depend less on checkerboards. This study aims to explore undergraduates' perceptions of doing rotations in teaching hospitals using different teaching styles and elicit their views regarding the options of managing practices to design a mobile app that substitutes for checkerboards. METHODS: In this sequential exploratory mixed methods study, 38 semi-structured interviews at a teaching hospital were conducted. The data was used to survey 124 students doing their rotations in four teaching hospitals during the first wave of COVID-19. RESULTS: 21 themes highlighted concerns related to the practices, the teacher involvement in the students' education, and the students' adaptation to clinical culture. The students reported positive perceptions concerning self-managing and organizing practices via a mobile application. However, problems emerged regarding transparency, the lack of feedback, and the need for new tools. Regarding the teaching styles, the facilitator and personal models were perceived as optimal, but the personal style had no effect on using or not using a tool. CONCLUSIONS: A mobile-learning application designed like an educational opportunities' manager tool can probably promote self-directed learning, flexible teaching, and bidirectional assessments. However, teachers who employ a personal teaching style may not need either checkerboards or a tool. This solution supports teaching at hospitals in pandemic times without checkerboards.

Adipose-derived mesenchymal stromal cells for the treatment of patients with severe SARS-CoV-2 pneumonia requiring mechanical ventilation. A proof of concept study.

BACKGROUND: Identification of effective treatments in severe cases of COVID-19 requiring mechanical ventilation represents an unmet medical need. Our aim was to determine whether the administration of adipose-tissue derived mesenchymal stromal cells (AT-MSC) is safe and potentially useful in these patients. METHODS: Thirteen COVID-19 adult patients under invasive mechanical ventilation who had received previous antiviral and/or anti-inflammatory treatments (including steroids, lopinavir/ritonavir, hydroxychloroquine and/or tocilizumab, among others) were treated with allogeneic AT-MSC. Ten patients received two doses, with the second dose administered a median of 3 days (interquartile range-IQR- 1 day) after the first one. Two patients received a single dose and another patient received 3 doses. Median number of cells per dose was 0.98 × 106 (IQR 0.50 × 106) AT-MSC/kg of recipient's body weight. Potential adverse effects related to cell infusion and clinical outcome were assessed. Additional parameters analyzed included changes in imaging, analytical and inflammatory parameters. FINDINGS: First dose of AT-MSC was administered at a median of 7 days (IQR 12 days) after mechanical ventilation. No adverse events were related to cell therapy. With a median follow-up of 16 days (IQR 9 days) after the first dose, clinical improvement was observed in nine patients (70%). Seven patients were extubated and discharged from ICU while four patients remained intubated (two with an improvement in their ventilatory and radiological parameters and two in stable condition). Two patients died (one due to massive gastrointestinal bleeding unrelated to MSC therapy). Treatment with AT-MSC was followed by a decrease in inflammatory parameters (reduction in C-reactive protein, IL-6, ferritin, LDH and d-dimer) as well as an increase in lymphocytes, particularly in those patients with clinical improvement. INTERPRETATION: Treatment with intravenous administration of AT-MSC in 13 severe COVID-19 pneumonia under mechanical ventilation in a small case series did not induce significant adverse events and was followed by clinical and biological improvement in most subjects. FUNDING: None.