Business as (Un-) Usual: The Evolution of German Insurance Law and Especially Insurance Supervisory Law in the Time of COVID-19

The advent of COVID-19 had tremendous effects in Germany, as elsewhere if not probably everywhere. However, the COVID crisis brought to light problems and solutions which may aid in the betterment of insurance in the future, and increased preparedness for future crises. The German discussions pertaining to the pandemic was much focussed—as was the case in many other countries—on the question of cover by business closure and business interruption insurance. While this question was especially salient, it was far from being the only legal problem raised by the crisis in insurance law. Additionally, the crisis brought to mind an ancient legal instrument: the clausula rebus sic stantibus, or in the particular German iteration the Wegfall der Geschäftsgrundlage. In Germany this was not given a brought field of application, since the legislator passed statutes that would alleviate certain policyholders and insurers in a very particular way. Beyond the question of timely performance, relayed time limits regarding court procedures, etc., several other insurance products were touched. While this was rather neglected in Germany and elsewhere, the Corona crisis also had significant effects for insurers in the realm of insurance supervisory law. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator

Introduction: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator. Methods: Using previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic. Results: During the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator. Conclusions: The ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations.

The limits of burden-reducing policies: A case study of unemployment insurance during the COVID-19 crisis in Israel

This study examines policy efforts to reduce administrative burden and to increase accessibility to unemployment insurance (UI) during the COVID-19 crisis in Israel and the consequences of these for claimants. A mixed-method approach was applied, utilising administrative documents, interviews and survey data. The findings suggest a mixed trend: Burden-reducing measures were introduced but were constrained by the system's preexisting infrastructure. While some claimants experienced the process as simple, many others experienced it as onerous, primarily due to a lack of communication with authorities. Two key insights for successful implementation of burden-reduction policies are highlighted: A well-established infrastructure and bidirectional communication. © 2022 Policy Press.

Levosimendan in intensive care and emergency medicine: literature update and expert recommendations for optimal efficacy and safety

The inodilator levosimendan, in clinical use for over two decades, has been the subject of extensive clinical and experimental evaluation in various clinical settings beyond its principal indication in the management of acutely decompensated chronic heart failure. Critical care and emergency medicine applications for levosimendan have included postoperative settings, septic shock, and cardiogenic shock. As the experience in these areas continues to expand, an international task force of experts from 15 countries (Austria, Belgium, China, Croatia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Spain, Sweden, Switzerland, and the USA) reviewed and appraised the latest additions to the database of levosimendan use in critical care, considering all the clinical studies, meta-analyses, and guidelines published from September 2019 to November 2021. Overall, the authors of this opinion paper give levosimendan a “should be considered” recommendation in critical care and emergency medicine settings, with different levels of evidence in postoperative settings, septic shock, weaning from mechanical ventilation, weaning from veno-arterial extracorporeal membrane oxygenation, cardiogenic shock, and Takotsubo syndrome, in all cases when an inodilator is needed to restore acute severely reduced left or right ventricular ejection fraction and overall haemodynamic balance, and also in the presence of renal dysfunction/failure.

Développement et validation d’un nomogramme pour prédire l’acceptation de la vaccination contre le SARS-CoV2 chez les patients atteints de cancer

Introduction La vaccination contre le SARS-CoV-2 représente un espoir dans la lutte contre la pandémie actuelle. Les efforts internationaux de développement et d’approbation de plusieurs vaccins ont conduit au démarrage des campagnes de vaccination moins d’un an après l’émergence de cette pandémie. Les vaccins les plus efficaces montrent une efficacité>90 % et un excellent profil de tolérance. Les patients atteints d’un cancer actif présentent un risque accru de forme sévère de COVID-19 et devraient être par conséquence une population cible pour la vaccination. L’objectif de ce travail est de développer et de valider un nomogramme afin de prédire l’acceptabilité de la vaccination contre le SARS-CoV-2 chez des patients atteints de cancer. Méthodes Une enquête de cohorte a été menée dans quatre centres de cancérologie des Alpes-Maritimes entre novembre et décembre 2020. Les patients inclus étaient âgés de plus de 18 ans et traités pour un cancer par chimiothérapie ou radiothérapie ;sous hormonothérapie, ou étaient en surveillance de leur cancer. Un auto-questionnaire anonyme sur les déterminants de la future vaccination anti-COVID-19 a été administré à chaque patient. La cohorte a été séparée en deux cohortes distinctes : une cohorte d’apprentissage pour développer le modèle et une cohorte pour le valider. Les variables statistiquement significatives lors de l’analyse univariée (p<0,05) ont été introduites dans un modèle de régression logistique en suivant une procédure de sélection des variables de type pas à pas descendant utilisant le critère AIC. À partir du modèle multivarié final, un nomogramme a été développé afin de prédire l’acceptabilité des patients vis-à-vis de la vaccination contre le SARS-CoV-2. Toutes les analyses ont été réalisées à l’aide du logiciel R et du package DynNom pour la représentation graphique du nomogramme. Résultats Parmi les 1244 questionnaires administrés, 999 questionnaires ont été analysés (80,3 %). La population comprenait 56,1 % de femmes et l’âge médian était de 67 ans (extrêmes : 18–97). Parmi ces patients, 47 % étaient sous traitement actif (chimiothérapie, immunothérapie, radiothérapie), 40 % étaient sous surveillance et 13 % étaient sous hormonothérapie. La majorité avait reçu un vaccin contre la grippe en 2020 (54,3 %) ou les années précédentes (52,2 %). Une faible proportion des patients a affirmé avoir contracté la COVID-19 (2,8 %) et plus de 50 % des patients ont déclaré l’intention de vouloir se faire vacciner. Le sexe, l’âge et l’antécédent de vaccination contre la grippe ont été identifiés comme des facteurs indépendants significatifs prédictifs de la volonté de se faire vacciner contre le SARS-CoV-2 et ont été utilisés dans la construction du nomogramme. Avec une accuracy de 0,68 [IC95 % : 0,62–0,73], une sensibilité de 0,73, une spécificité de 0,62 et une AUC égale à 0,7 [IC95 % : 0,6–0,8], la validité du modèle peut-être jugée comme satisfaisante. Conclusion Ces premiers résultats montrent que le nomogramme développé permet de prédire la volonté individuelle de se faire vacciner contre la COVID-19 selon le sexe, l’âge et l’antécédent de vaccination contre la grippe. Cet outil graphique et simple d’utilisation pourrait être utilisé en routine par les cliniciens afin de mieux identifier les patients à cibler en vue d’augmenter la couverture vaccinale et par conséquence d’adapter le dialogue selon le cas considéré.

Evaluation of practice variation for cancer patients care in a French cancer center during the COVID-19 outbreak

Background: The COVID-19 pandemic rapidly spread in Europe and France. Cancer patients were identified at higher risk of infection and evolution to severe forms, especially those undergoing active treatment. Academic and experts’ recommendations proposed to protect cancer units and prioritize cancer treatment. In the same time, French authorities implemented a national lockdown from march 16, 2020. Most anti-cancer institutions have modified their organization, trying to combine cancer units COVID-free sanctuarization, continuity in priority care and precautionary principle. The impact of COVID-19 outbreak on global cancer care has not been formally evaluated. Methods: Data of oncological practice at the Antoine Lacassagne Center (mild-COVID-19 incidence rate area) were recorded (per week) for 3 periods, based on the timing of french lockdown: before (Jan-1 to Mar-15), during (Mar-16 to May-10) and after the end of lockdown (May-11 to Jul-12). We collected the number of chemotherapy and radiotherapy sessions, surgery procedures (senology and gynecology), blood products transfusions, on-site / telemedicine visits and inclusions in clinical trials. Results: Preliminary results compare period 1 (Jan-1 to Mar-15) to interim period 2 (Mar-16 to Apr-19, available data at the time of submission). Variation of practice is detailed in the table. Activities were negatively impacted by the lockdown, mostly reconstructive surgery (-90%), on-site oncology visits (-73%) and clinical research (-69%). In parallel, telemedicine visits were multiplied by 100. [Formula presented]. Conclusions: The evaluation of practice variation for cancer care is essential to understand the real impact of COVID-19 outbreak on global cancer management, so as to get prepared to further epidemic waves (for ex. implementation of telehealth innovations) or long-term consequences on cancer outcome. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: D. Borchiellini: Advisory/Consultancy, Research grant/Funding (institution): Astellas;Astra Zeneca;MSD;Novartis;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Janssen;Pfizer;Roche;Research grant/Funding (institution): Calithera;Exelixis;Infinity;Merck KGaA;Advisory/Consultancy: Ipsen;Sanofi. J-M. Hannoun-Levi: Advisory/Consultancy: Eckert & Ziegler BEBIG. E. Francois: Honoraria (self): Amgen;MSD;Novartis;Honoraria (self), Travel/Accommodation/Expenses: Servier;Advisory/Consultancy, Travel/Accommodation/Expenses: Roche. All other authors have declared no conflicts of interest.