Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Guidelines for the use of flow cytometry and cell sorting in immunological studies (third edition)

The third edition of Flow Cytometry Guidelines provides the key aspects to consider when performing flow cytometry experiments and includes comprehensive sections describing phenotypes and functional assays of all major human and murine immune cell subsets. Notably, the Guidelines contain helpful tables highlighting phenotypes and key differences between human and murine cells. Another useful feature of this edition is the flow cytometry analysis of clinical samples with examples of flow cytometry applications in the context of autoimmune diseases, cancers as well as acute and chronic infectious diseases. Furthermore, there are sections detailing tips, tricks and pitfalls to avoid. All sections are written and peer‐reviewed by leading flow cytometry experts and immunologists, making this edition an essential and state‐of‐the‐art handbook for basic and clinical researchers.DFG, 389687267, Kompartimentalisierung, Aufrechterhaltung und Reaktivierung humaner Gedächtnis-T-Lymphozyten aus Knochenmark und peripherem BlutDFG, 80750187, SFB 841: Leberentzündungen: Infektion, Immunregulation und KonsequenzenEC/H2020/800924/EU/International Cancer Research Fellowships - 2/iCARE-2DFG, 252623821, Die Rolle von follikulären T-Helferzellen in T-Helferzell-Differenzierung, Funktion und PlastizitätDFG, 390873048, EXC 2151: ImmunoSensation2 - the immune sensory syste

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research

Mobile technologies such as smartphone applications, wearables, ingestibles, and implantables, are increasingly used in clinical research to capture study endpoints. On behalf of the Clinical Trials Transformation Initiative, we aimed to conduct a systematic scoping review and compile a database summarizing pilot studies addressing mobile technology sensor performance, algorithm development, software performance, and/or operational feasibility, in order to provide a resource for guiding decisions about which technology is most suitable for a particular trial. Our systematic search identified 275 publications meeting inclusion criteria. From these papers, we extracted data including the medical condition, concept of interest captured by the mobile technology, outcomes captured by the digital measurement, and details regarding the sensors, algorithms, and study sample. Sixty-seven percent of the technologies identified were wearable sensors, with the remainder including tablets, smartphones, implanted sensors, and cameras. We noted substantial variability in terms of reporting completeness and terminology used. The data have been compiled into an online database maintained by the Clinical Trials Transformation Initiative that can be filtered and searched electronically, enabling a user to find information most relevant to their work. Our long-term goal is to maintain and update the online database, in order to promote standardization of methods and reporting, encourage collaboration, and avoid redundant studies, thereby contributing to the design and implementation of efficient, high quality trials

Embedding a trauma hospitalist in the trauma service reduces mortality and 30-day trauma-related readmissions.

BACKGROUND: Recognizing the increasing age and comorbid conditions of patients admitted to our trauma service, we embedded a hospitalist on the trauma service at our Level I trauma center.This program was initiated in January 2013. This study was designed to investigate differences in outcomes between trauma patients who received care from the trauma hospitalist (THOSP) program and similarly medically complex trauma patients who did not receive THOSP care. METHODS: There were 566 patients comanaged with THOSP between December 2013 and November 2014. These patients were matched (1:2) with propensity scores to a contemporaneous control group based on age, Injury Severity Score (ISS), and comorbid conditions. Outcomes examined included mortality, trauma-related readmissions, upgrades to the intensive care unit, hospital length of stay, the development of in-hospital complications, and the frequency of obtaining medical subspecialist consultation. Differences in outcomes were compared with Mann-Whitney U-test or χ test as appropriate. RESULTS: High-quality matching resulted in the loss of 97 THOSP patients for the final analysis. Table 1 shows the balance between the two groups after matching. While there was a 1-day increase in hospital length of stay and an increase in upgrades to the intensive care unit, there was a reduction in mortality, trauma-related readmissions, and the development of renal failure after implementation of the THOSP program (Table 2). Implementation of this program made no significant difference in the frequency of cardiology, nephrology, neurology, or endocrinology consultations. There was also no difference in the development of the complications of venous thromboembolism, pneumonia, stroke, urinary tract infection, bacteremia, or alcohol withdrawal. CONCLUSION: Our study provides evidence that embedding a hospitalist on the trauma service reduces mortality and trauma-related readmissions. A reason for these improved outcomes may be related to THOSP vigilance. LEVEL OF EVIDENCE: Therapeutic/care management study, level IV

South Atlantic Crossing (SACROSS) - Cruise No. M133: 15.12.2016-13.01.2017, Cape Town (South Africa)-Stanley (Falklands)

The cruise M133 SACROSS (South Atlantic Crossing) was a multidisciplinary ocean survey of the South Atlantic gyre roughly along 34.5° S. This transect is covered by the international SAMOC moored array and also the path of the internationally agreed AX18 XBT line. Most of the measurements were based on using underway methods including near-surface water sampling for the determination of SST, and SSS as well as shipboard ADCP current observations. Moreover, an underway CTD allowed to sample the upper 300-400 m every hour. Chemical analysis of surface waters as well as atmospheric parameter were of scientific interest to both compare different regions with each other but also to document long term trends. At the western and eastern boundary current regime full water column water mass properties were measured. Upper ocean 10-700m plankton assemblages allow improving the calibration of sediment proxies. Water samples for later lab-based biodiversity analysis were taken. A number of smaller student projects were carried out as part of a global ocean learning and capacity building effort. Finally, continuous swath bathymetry mapping was made, and a number of floats and drifters were launched in support of the global ocean observing system arrays. The cruise was very successful, all objectives were reached, and the measurements were carried out as planned

L'éruption du volcan Hunga Tonga -Hunga Ha'apai le 15 janvier 2022 : un ébranlement du système Terre à l'échelle planétaire

L'éruption explosive du volcan Hunga Tonga - Hunga Ha’apai (HTHH), le 15 janvier 2022, a produit la plus puissante explosion enregistrée depuis les explosions du Krakatau et du Tambora dans les années 1800, libérant une énergie équivalente à 110 mégatonnes de TNT. Les ondes générées sesont propagées dans le sol, et dans l’atmosphère jusqu’à l’ionosphère. L'onde atmosphérique la plus énergétique observée sur les baromètres correspond au mode de Lamb. De période supérieure à 2000 s, son amplitude est comparable à celle observée lors de l’éruption du Krakatau en 1883. L’empreinte des perturbations atmosphériques a été caractérisée à l’échelle planétaire par des réseaux de mesures au sol, à bord de satellites ou de plateformes aéroportées. L’analyse combinée de ces observations a permis d’évaluer les conséquences à court terme de l'éruption du HTHH. Les méthodes d'investigation géophysiques présentées dans cette note montrent l’apport d’analyses interdisciplinaires pour caractériser la réponse impulsionnelle des enveloppes fluides planétaires (atmosphère, océans et mers) à une éruption d’une intensité exceptionnelle

L'éruption du volcan Hunga Tonga -Hunga Ha'apai le 15 janvier 2022 : un ébranlement du système Terre à l'échelle planétaire

L'éruption explosive du volcan Hunga Tonga - Hunga Ha’apai (HTHH), le 15 janvier 2022, a produit la plus puissante explosion enregistrée depuis les explosions du Krakatau et du Tambora dans les années 1800, libérant une énergie équivalente à 110 mégatonnes de TNT. Les ondes générées sesont propagées dans le sol, et dans l’atmosphère jusqu’à l’ionosphère. L'onde atmosphérique la plus énergétique observée sur les baromètres correspond au mode de Lamb. De période supérieure à 2000 s, son amplitude est comparable à celle observée lors de l’éruption du Krakatau en 1883. L’empreinte des perturbations atmosphériques a été caractérisée à l’échelle planétaire par des réseaux de mesures au sol, à bord de satellites ou de plateformes aéroportées. L’analyse combinée de ces observations a permis d’évaluer les conséquences à court terme de l'éruption du HTHH. Les méthodes d'investigation géophysiques présentées dans cette note montrent l’apport d’analyses interdisciplinaires pour caractériser la réponse impulsionnelle des enveloppes fluides planétaires (atmosphère, océans et mers) à une éruption d’une intensité exceptionnelle