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Respiratory rate (RR) is an often underestimated and underreported vital sign with tremendous clinical value. As a predictor of cardiopulmonary arrest, chronic obstructive pulmonary disease (COPD) exacerbation or indicator of health state for example in COVID-19 patients, respiratory rate could be especially valuable in remote long-term patient monitoring, which is challenging to implement. Contactless devices for home use aim to overcome these challenges. In this study, the contactless Sleepiz One+ respiration monitor for home use during sleep was validated against the thoracic effort belt. The agreement of instantaneous breathing rate and breathing rate statistics between the Sleepiz One+ device and the thoracic effort belt was initially evaluated during a 20-min sleep window under controlled conditions (no body movement) on a cohort of 19 participants and secondly in a more natural setting (uncontrolled for body movement) during a whole night on a cohort of 139 participants. Excellent agreement was shown for instantaneous breathing rate to be within 3 breaths per minute (Brpm) compared to thoracic effort band with an accuracy of 100% and mean absolute error (MAE) of 0.39 Brpm for the setting controlled for movement, and an accuracy of 99.5% with a MAE of 0.48 Brpm for the whole night measurement, respectively. Excellent agreement was also achieved for the respiratory rate statistics over the whole night with absolute errors of 0.43, 0.39 and 0.67 Brpm for the 10th, 50th and 90th percentiles, respectively. Based on these results we conclude that the Sleepiz One+ can estimate instantaneous respiratory rate and its summary statistics at high accuracy in a clinical setting. Further studies are required to evaluate the performance in the home environment, however, it is expected that the performance is at similar level, as the measurement conditions for the Sleepiz One+ device are better at home than in a clinical setting.

Cervical artery dissection is a major cause of stroke in young people (aged <50 years). Historically, clinicians have preferred using oral anticoagulation with vitamin K antagonists for patients with cervical artery dissection, although some current guidelines—based on available evidence from mostly observational studies—suggest using aspirin. If proven to be non-inferior to vitamin K antagonists, aspirin might be preferable, due to its ease of use and lower cost. We aimed to test the non-inferiority of aspirin to vitamin K antagonists in patients with cervical artery dissection. We did a multicentre, randomised, open-label, non-inferiority trial in ten stroke centres across Switzerland, Germany, and Denmark. We randomly assigned (1:1) patients aged older than 18 years who had symptomatic, MRI-verified, cervical artery dissection within 2 weeks before enrolment, to receive either aspirin 300 mg once daily or a vitamin K antagonist (phenprocoumon, acenocoumarol, or warfarin; target international normalised ratio [INR] 2·0–3·0) for 90 days. Randomisation was computer-generated using an interactive web response system, with stratification according to participating site. Independent imaging core laboratory adjudicators were masked to treatment allocation, but investigators, patients, and clinical event adjudicators were aware of treatment allocation. The primary endpoint was a composite of clinical outcomes (stroke, major haemorrhage, or death) and MRI outcomes (new ischaemic or haemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment. Non-inferiority of aspirin would be shown if the upper limit of the two-sided 95% CI of the absolute risk difference between groups was less than 12% (non-inferiority margin). This trial is registered with ClinicalTrials.gov, NCT02046460. Between Sept 11, 2013, and Dec 21, 2018, we enrolled 194 patients; 100 (52%) were assigned to the aspirin group and 94 (48%) were assigned to the vitamin K antagonist group. The per-protocol population included 173 patients; 91 (53%) in the aspirin group and 82 (47%) in the vitamin K antagonist group. The primary endpoint occurred in 21 (23%) of 91 patients in the aspirin group and in 12 (15%) of 82 patients in the vitamin K antagonist group (absolute difference 8% [95% CI −4 to 21], non-inferiority p=0·55). Thus, non-inferiority of aspirin was not shown. Seven patients (8%) in the aspirin group and none in the vitamin K antagonist group had ischaemic strokes. One patient (1%) in the vitamin K antagonist group and none in the aspirin group had major extracranial haemorrhage. There were no deaths. Subclinical MRI outcomes were recorded in 14 patients (15%) in the aspirin group and in 11 patients (13%) in the vitamin K antagonist group. There were 19 adverse events in the aspirin group, and 26 in the vitamin K antagonist group. Our findings did not show that aspirin was non-inferior to vitamin K antagonists in the treatment of cervical artery dissection. Swiss National Science Foundation, Swiss Heart Foundation, Stroke Funds Basel, University Hospital Basel, University of Basel, Academic Society Basel.

In many medical applications, interpretable models with high prediction performance are sought. Often, those models are required to handle semi-structured data like tabular and image data. We show how to apply deep transformation models (DTMs) for distributional regression which fulfill these requirements. DTMs allow the data analyst to specify (deep) neural networks for different input modalities making them applicable to various research questions. Like statistical models, DTMs can provide interpretable effect estimates while achieving the state-of-the-art prediction performance of deep neural networks. In addition, the construction of ensembles of DTMs that retain model structure and interpretability allows quantifying epistemic and aleatoric uncertainty. In this study, we compare several DTMs, including baseline-adjusted models, trained on a semi-structured data set of 407 stroke patients with the aim to predict ordinal functional outcome three months after stroke. We follow statistical principles of model-building to achieve an adequate trade-off between interpretability and flexibility while assessing the relative importance of the involved data modalities. We evaluate the models for an ordinal and dichotomized version of the outcome as used in clinical practice. We show that both, tabular clinical and brain imaging data, are useful for functional outcome prediction, while models based on tabular data only outperform those based on imaging data only. There is no substantial evidence for improved prediction when combining both data modalities. Overall, we highlight that DTMs provide a powerful, interpretable approach to analyzing semi-structured data and that they have the potential to support clinical decision making.

A significant reduction in the Atlantic Meridional Overturning Circulation and rapid northern Hemisphere cooling 8200 years ago have been linked to the final melting of the Laurentide Ice Sheet. Although many studies associated this cold event with the drainage of Lake Agassiz-Ojibway, recent model simulations have shown that the Hudson Bay Ice Saddle collapse would have had much larger effects on the Atlantic Meridional Overturning Circulation than the lake outburst itself. Based on a combination of Mg/Ca and oxygen isotope ratios of benthic foraminifera, this study presents the first direct evidence of a major Labrador shelfwater freshening at 8.5 ka BP, which we associate with the Hudson Bay Ice Saddle collapse. The freshening is preceded by a subsurface warming of the western Labrador Sea, which we link to the strengthening of the West Greenland Current that could concurrently have accelerated the ice saddle collapse in Hudson Bay. The exact freshwater scenario that caused the 8.2 ka cold event is still debated. This study presents new evidence for a severe Labrador shelfwater freshening 8500 years ago that was caused by the Hudson Bay Ice Saddle collapse following a warming in subsurface waters.