Relative versus absolute rises in T/QRS ratio by ST analysis of fetal electrocardiograms in labour:A case-control pilot study

INTRODUCTION: The additional value of ST analysis during labour is uncertain. In ST analysis, a T/QRS baseline value is calculated from the fetal electrocardiogram and successive T/QRS ratios are compared to this baseline. However, variation in the orientation of the electrical heart axis between fetuses may yield different T/QRS baseline values. In case of a higher T/QRS baseline value more ST events are encountered, although not always related to perinatal outcome. We hypothesised that we can partly correct for this effect by analysing T/QRS rises as a percentage from baseline (relative ST analysis). This study aimed to explore whether relative ST analysis has better diagnostic value for cord acidaemia compared to conventional ST analysis, where predefined fixed T/QRS ratios are used.METHODS AND MATERIALS: A case-control study was performed in 20 term human fetuses during labour; 10 cases (umbilical cord artery pH &lt;7.05 at birth, defining acidaemia) and 10 controls (pH &gt;7.20) were included. The fetal electrocardiogram was recorded using a STAN monitor. We electronically extracted all T/QRS values, baseline and episodic ST events from the STAN monitor and calculated the relative T/QRS changes. The cut-off for relative ST events was determined in a receiver operator characteristic (ROC) curve at optimal specificity for cord acidaemia. Parameters of interest were area under the curve (AUC) of the ROC curve for relative ST events and test performance of both conventional and relative ST analysis.RESULTS: Relative ST analysis showed an AUC of 0.99. The optimal cut-off value for relative T/QRS rise was determined at 0.70. Relative vs conventional (absolute) ST analysis showed a specificity of 100% vs 40% (p = 0.031); sensitivity 90% vs 90%; positive likelihood ratio infinity vs 1.5; negative likelihood ratio 0.10 vs 0.25, respectively.CONCLUSION: Relative ST analysis seems to be a promising method to detect impending fetal acidaemia during labour. Further studies are required to determine the diagnostic accuracy.</p

Slow recruitment in the HIMALAIA study:lessons for future clinical trials in patients with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage based on feasibility data

Background : Our randomized clinical trial on induced hypertension in patients with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH) was halted prematurely due to unexpected slow recruitment rates. This raised new questions regarding recruitment feasibility. As our trial can therefore be seen as a feasibility trial, we assessed the reasons for the slow recruitment, aiming to facilitate the design of future randomized trials in aSAH patients with DCI or other critically ill patient categories. Methods : Efficiency of recruitment and factors influencing recruitment were evaluated, based on the patient flow in the two centers that admitted most patients during the study period. We collected numbers of patients who were screened for eligibility, provided informed consent, and developed DCI and who eventually were randomized. Results : Of the 862 aSAH patients admitted in the two centers during the course of the trial, 479 (56%) were eligible for trial participation of whom 404 (84%) were asked for informed consent. Of these, 188 (47%) provided informed consent, of whom 50 (27%) developed DCI. Of these 50 patients, 12 (24%) could not be randomized due to a logistic problem or a contraindication for induced hypertension emerging at the time of randomization, and four (8%) were missed for randomization. Eventually, 34 patients were randomized and received intervention or control treatment. Conclusions : Enrolling patients in a randomized trial on a treatment strategy for DCI proved unfeasible: only 1 out of 25 admitted and 1 out of 14 eligible patients could eventually be randomized. These rates, caused by a large proportion of ineligible patients, a small proportion of patients providing informed consent, and a large proportion of patients with contraindications for treatment, can be used to make sample size calculations for future randomized trials in DCI or otherwise critically ill patients. Facilitating informed consent through improved provision of information on risks, possible benefits, and study procedures may result in improved enrolment

An action framework for the participatory assessment of nature-based solutions in cities

Impact assessment is a key step in mainstreaming urban nature-based solutions (NBS). Yet, it remains unclear if and how assessment frameworks influence urban planning, design and management. We contend that the potential of current NBS assessment frameworks is not fully exploited due to: (1) limited contextualisation of monitoring and assessment to place-specific contexts and (2) the depoliticisation of co-production. To address this, we present a practical five-step action framework to guide inclusive participation across different stages of monitoring and assessment of urban NBS, including indicator selection. Unlike previous approaches, applying selection criteria at the level of individual indicators, we also use criteria at the aggregate level of the indicator set. We conclude that participatory assessment contributes to mainstreaming urban NBS for sustainable and just cities, provided data is contextualised to local decision-making contexts and the process is designed to amplify marginalised voices

Ethical development of artificial amniotic sac and placenta technology: a roadmap

In this paper we present an initial roadmap for the ethical development and eventual implementation of artificial amniotic sac and placenta technology in clinical practice. We consider four elements of attention: (1) framing and societal dialogue; (2) value sensitive design, (3) research ethics and (4) ethical and legal research resulting in the development of an adequate moral and legal framework. Attention to all elements is a necessary requirement for ethically responsible development of this technology. The first element concerns the importance of framing and societal dialogue. This should involve all relevant stakeholders as well as the general public. We also identify the need to consider carefully the use of terminology and how this influences the understanding of the technology. Second, we elaborate on value sensitive design: the technology should be designed based upon the principles and values that emerge in the first step: societal dialogue. Third, research ethics deserves attention: for proceeding with first-in-human research with the technology, the process of recruiting and counseling eventual study participants and assuring their informed consent deserves careful attention. Fourth, ethical and legal research should concern the status of the subject in the AAPT. An eventual robust moral and legal framework for developing and implementing the technology in a research setting should combine all previous elements. With this roadmap, we emphasize the importance of stakeholder engagement throughout the process of developing and implementing the technology; this will contribute to ethically and responsibly innovating health care.Research into fetal development and medicin

Selective laser melting-produced porous titanium scaffolds regenerate bone in critical size cortical bone defects

Porous titanium scaffolds have good mechanical properties that make them an interesting bone substitute material for large bone defects. These scaffolds can be produced with selective laser melting, which has the advantage of tailoring the structure's architecture. Reducing the strut size reduces the stiffness of the structure and may have a positive effect on bone formation. Two scaffolds with struts of 120-μm (titanium-120) or 230-μm (titanium-230) were studied in a load-bearing critical femoral bone defect in rats. The defect was stabilized with an internal plate and treated with titanium-120, titanium-230, or left empty. In vivo micro-CT scans at 4, 8, and 12 weeks showed more bone in the defects treated with scaffolds. Finally, 18.4 ± 7.1 mm3(titanium-120, p = 0.015) and 18.7 ± 8.0 mm3(titanium-230, p = 0.012) of bone was formed in those defects, significantly more than in the empty defects (5.8 ± 5.1 mm3). Bending tests on the excised femurs after 12 weeks showed that the fusion strength reached 62% (titanium-120) and 45% (titanium-230) of the intact contralateral femurs, but there was no significant difference between the two scaffolds. This study showed that in addition to adequate mechanical support, porous titanium scaffolds facilitate bone formation, which results in high mechanical integrity of the treated large bone defects. Copyrigh

Brain stem encephalitis is a rare complication of COVID-19

Here, we describe the clinical phenotype of SARS-CoV-2-related CNS disease and evaluate the SARS-CoV-2 antibody index as a tool to differentiate between a direct (viral) and indirect etiology. Out of >4000 hospitalized patients with COVID-19, we included 13 patients with neurological symptoms with suspicion of neuroinflammation. On clinical grounds, eight were classified as having a possible/probable relationship between neurological symptoms and COVID-19. A clinically distinctive phenotype of brainstem and cerebellar symptoms was seen in 6/8 patients. As we found a positive SARS-CoV-2 antibody index in 3/5 patients, indicating specific intrathecal SARS-CoV-2 IgG production, a direct link with SARS-CoV-2 is likely

Variation in guideline implementation and adherence regarding severe traumatic brain injury treatment: a CENTER-TBI survey study in Europe

Guidelines may reduce practice variation and optimize patient care. We aimed to study differences in guideline use in the management of traumatic brain injury (TBI) patients and analyze reasons for guideline non-adherence. As part of a prospective, observational, multi-center European cohort study, participants from 68 centers in 20 countries were asked to complete 72-item questionnaires regarding their management of severe TBI. Six questions with multiple sub-questions focused on guideline use and implementation. Questionnaires were completed by 65 centers. Of these, 49 (75%) reported use of the Brain Trauma Foundation Guidelines for the medical management of TBI or related institutional protocols, 11 (17%) used no guidelines and 5 used other guidelines (8%). Of 54 centers reporting use of any guidelines, 41 (75%) relied on written guidelines. Four centers of the 54 (7%) reported no formal implementation efforts. Structural attention to the guidelines during daily clinical rounds was reported by 21 centers (38%). The most often reported reasons for non-adherence were ‘every patient is unique’ and the presence of extracranial injuries, both for centers that did and did not report the use of guidelines. There is substantial variability in the use and implementation of guidelines in neurotrauma centers in Europe. Further research is needed to strengthen the evidence underlying guidelines and to overcome implementation barriers