Lessons learned from the first 50 COVID-19 critical care transfer missions conducted by a civilian UK Helicopter Emergency Medical Service team

Background The COVID-19 pandemic has placed exceptional demand on Intensive Care Units, necessitating the critical care transfer of patients on a regional and national scale. Performing these transfers required specialist expertise and involved moving patients over significant distances. Air Ambulance Kent Surrey Sussex created a designated critical care transfer team and was one of the first civilian air ambulances in the United Kingdom to move ventilated COVID-19 patients by air. We describe the practical set up of such a service and the key lessons learned from the first 50 transfers. Methods Retrospective review of air critical care transfer service set up and case review of first 50 transfers. Results We describe key elements of the critical care transfer service, including coordination and activation; case interrogation; workforce; training; equipment; aircraft modifications; human factors and clinical governance. A total of 50 missions are described between 18 December 2020 and 1 February 2021. 94% of the transfer missions were conducted by road. The mean age of these patients was 58 years (29–83). 30 (60%) were male and 20 (40%) were female. The mean total mission cycle (time of referral until the time team declared free at receiving hospital) was 264 min (range 149–440 min). The mean time spent at the referring hospital prior to leaving for the receiving unit was 72 min (31–158). The mean transfer transit time between referring and receiving units was 72 min (9–182). Conclusion Critically ill COVID-19 patients have highly complex medical needs during transport. Critical care transfer of COVID-19-positive patients by civilian HEMS services, including air transfer, can be achieved safely with specific planning, protocols and precautions. Regional planning of COVID-19 critical care transfers is required to optimise the time available of critical care transfer teams.

ERANET JTC 2011: Submission and Activation of an International Academic Translational Project in Advanced Breast Cancer. Experience From the ET-FES Study

Background: Academic research is important to face unmet medical needs. The Oncological community encounters many hurdles in setting up multicenter investigator-driven trials mainly due to administrative complexity. The purpose of a network organization at a multinational level is to facilitate clinical trials through standardization, coordination, and education for drug development and regulatory approval.Methods: The application of an European grant foresees the creation of a consortium which aims at facilitating multi-center academic clinical trials.Results: The ERA-NET TRANSCAN Call 2011 on “Validation of biomarkers for personalized cancer medicine” was released on December 2011. This project included Italian, Spanish, French and German centers. The approval process included Consortium constitution, project submission, Clinical Trial Submission, and activation on a national level. The different timescales for submitting study documents in each Country and the misalignment of objections by each Competent Authority CA, generated several requests for changes to the study documents which meant amendments had to be made; as requested by the 2001/20/EC Directive, the alignment of core documents is mandatory. This procedure impacted significantly on study activation timelines. Time to first patient in was 14, 10, 28, and 31 months from the date of submission in Italy, France, Spain, and Germany, respectively. Accrual was stopped on 22nd January 2021 due to an 18F FES shortage as the primary reason but also for having exceeded the project deadlines with consequent exhaustion of the funds allocated for the project.Conclusions: Pharmaceutical companies might be reluctant to fund research projects aimed at treatment individualization if the approval for a wider indication has already been achieved. Academic trials therefore become fundamental for promoting trials which are not attractive to big pharma. It was very difficult and time consuming to activate an academic clinical trial, for this reason, a study may become “old” as new drugs entered into the market. National institutions should promote the development of clinical research infrastructures and network with competence in regulatory, ethical, and legal skills to speed up academic research.

Dealing With Brain MRI Findings in Pediatric Patients With Endocrinological Conditions: Less Is More?

Neuroimaging is a key tool in the diagnostic process of various clinical conditions, especially in pediatric endocrinology. Thanks to continuous and remarkable technological developments, magnetic resonance imaging can precisely characterize numerous structural brain anomalies, including the pituitary gland and hypothalamus. Sometimes the use of radiological exams might become excessive and even disproportionate to the patients’ medical needs, especially regarding the incidental findings, the so-called “incidentalomas”. This unclarity is due to the absence of well-defined pediatric guidelines for managing and following these radiological findings. We review and summarize some indications on how to, and even if to, monitor these anomalies over time to avoid unnecessary, expensive, and time-consuming investigations and to encourage a more appropriate follow-up of brain MRI anomalies in the pediatric population with endocrinological conditions.

Repurposing – second life for drugs

Drug repurposing refers to finding new indications for existing drugs. The paradigm shift from traditional drug discovery to drug repurposing is driven by the fact that new drug pipelines are getting dried up because of mounting Research & Development (R&D) costs, long timeline for new drug development, low success rate for new molecular entities, regulatory hurdles coupled with revenue loss from patent expiry and competition from generics. Anaemic drug pipelines along with increasing demand for newer effective, cheaper, safer drugs and unmet medical needs call for new strategies of drug discovery and, drug repurposing seems to be a promising avenue for such endeavours. Drug repurposing strategies have progressed over years from simple serendipitous observations to more complex computational methods in parallel with our ever-growing knowledge on drugs, diseases, protein targets and signalling pathways but still the knowledge is far from complete. Repurposed drugs too have to face many obstacles, although lesser than new drugs, before being successful.

Perspective Chapter: Psychological Effects of COVID-19 Pandemic

COVID-19, the viral pneumonia seen in China towards the end of 2019, was declared a global pandemic in March 2020 since it spread almost all over the world. While such pandemic situations that are concerned with public health cause a sense of insecurity, confusion, loneliness and stigmatization among individuals, it can result in economic losses, closure of workplaces and schools, insufficient resources for medical needs and inadequate satisfaction of needs in societies. The economic crisis, which is one of the most important problems in pandemic periods, and the concomitant uncertainties can also cause suicidal thoughts. As a result, how the society responds psychologically during epidemics has an important role in shaping the spread of the disease, emotional difficulties and social problems during and after the epidemic. It often appears that no resources are allocated to manage, or at least mitigate the effects of epidemics on psychological health and well-being. In the acute phase of the epidemic, health system administrators prioritize testing, preventing contagion and providing patient care, but psychological needs should not be disregarded either.

Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

New Jersey FQHC Process Improvement Increases Oral Health Access for HIV Patients

Introduction: Patients living with HIV/AIDS (PLWHA) have more unmet oral health care needs than the general population, outpacing unmet medical needs [1]. Poor oral health can impact a person’s confidence and ability to speak, eat, work, sleep, and socialize [2]. Lack of access to dental care is a national issue for HIV patients; providing access is a challenge faced by many health centers and practices, including Zufall Health in New Jersey, a federally qualified health center (FQHC). In collaboration with Northeast/Caribbean AIDS Education and Training Center (NECA AETC), Zufall embarked on an initiative to improve access to quality dental care for PLWHA. AETC is the training component of the Ryan White Program, a federally funded program that provides medical care, support services, and medications for PLWHA who are low income, uninsured, or underserved [3-5]. Materials and Methods: In 2019, Zufall Health launched a quality improvement project to increase oral health access and services for Ryan White patients by integrating all partners involved in providing health care: medical, dental, psychological, behavioral, and HIV/AIDS providers and case managers. The project goal was to increase the number of patients receiving dental care to improve oral and overall health. Results/Observations: As a result of the project, there were significant quantitative and qualitative improvements in the oral health and quality of life of PLWHA: more dental encounters, a higher percentage of patients with a dental home, and the surpassing of the project goal of a 10% increase in dental referrals.

Smart E-Textile Systems: A Review for Healthcare Applications

E-textiles is a new hybrid field developed with the help of the integration of electronic components into our daily usage of textile products. These wearable e-textiles provide user-defined applications as well as normal textile clothing. The medical field is one of the major leading areas where these new hybrid products are being implemented, and relatively mature products can be observed in the laboratory as well as in commercial markets. These products are developed for continuous patient monitoring in large-scale hospital centers as well as for customized patient requirements. Meanwhile, these products are also being used for complex medical treatments and the replacement of conventional methods. This review manuscript contains a basic overview of e-textile systems, their components, applications, and usages in the field of medical innovations. E-textile systems, integrated into customized products for medical needs, are discussed with their proposed properties and limitations. Finally, some recommendations to enhance the e-textile system’s integration into the medical field are argued.