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Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol.
No full text20.500.12530/87909Compared with the operating room, tracheal intubations in the intensive care unit (ICU) are associated with worsened glottic view, decreased first-time success rate and increase in the technical difficulty of intubation and incidence of complications. Videolaryngoscopes (VLs) have been proposed to improve airway management, and while recent studies have confirmed that VLs improve intubation conditions in this patient population, there remains a lack of clarity regarding the selection between a standard Macintosh blade or a hyperangulated one, to determine which yields the best outcomes. The purpose of this study was to compare successful intubation on the first attempt with the Macintosh VL versus the hyperangulated VL during tracheal intubation in ICU patients. We hypothesise that tracheal intubation using the hyperangulated VL will improve the frequency of successful intubation on the first attempt. The INtubation VIdeolaryngoscopy BLADE-ICU trial is a prospective, multicentre, open-label, interventional, randomised, controlled superiority study conducted in 29 ICUs in Spain. Patients will be randomly assigned in a 1:1 ratio to undergo intubation using a Macintosh VL (control group) or a hyperangulated VL (experimental group) for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcomes include the time to intubation, attempts for successful intubation, laryngoscopic vision assessed with the modified Cormack-Lehane scale, the need for adjuvant airway devices for intubation, difficulty assessed by the anaesthesiologist and complications during tracheal intubation. Enrolment began on 1 May 2024 and is expected to be completed in 2025. The study protocol was approved on 29 February 2024, by the Ethics Committee of Galicia (CEImG, code No. 2024-031).The results will be submitted for publication in a peer-reviewed journal. NCT06322719
An intragenic duplication in the AFF2 gene associated with Cornelia de Lange syndrome phenotype.
No full text20.500.12530/87913Cornelia de Lange syndrome (CdLS, OMIM #122470, #300590, #300882, #610759, and #614701) is a rare congenital disorder that affects the development of multiple organs and is characterized by physical abnormalities and cognitive and behavioral disabilities. Its molecular basis is mainly based on alterations in genes encoding structural and regulatory proteins related to the cohesin complex. Moreover, other transcriptional regulatory factors have been linked to this syndrome. However, additional causative genes are still unknown, since many patients still lack a molecular diagnosis. Herein, we describe a case with multiple affected family members presenting with an intragenic duplication in the AFF2 gene. The direct tandem intragenic duplication of exons 10, 11 and 12 was detected through high-resolution array Comparative Genomic Hybridization and next-generation sequencing technologies. Confirming the X-linked inheritance pattern, the duplication was found in the patient, his mother and his maternal aunt affected (dizygotic twins). Targeted sequencing with Oxford Nanopore Technologies revealed an aberrant transcript which is predominantly expressed in the patient and his aunt. Along with these results, a significant reduction in AFF2 gene expression levels was detected in these two individuals. Clinically both subjects exhibit a classic CdLS phenotype, whereas the mother is mostly unaffected. Consistent with the phenotypical differences observed between the mother and the aunt, there is a marked difference in X-inactivation patterns skewing. Given the crucial role of AFF2 in transcriptional regulation, it is not surprising that AFF2 variants can give rise to CdLS phenotypes. Therefore, the AFF2 gene should be considered for the molecular diagnosis of this syndrome
Differences in the Communication of Cancer Diagnoses by Different Health Professionals and the Impact of Oncologist Communication on Patients' Emotions.
No full text20.500.12530/87912The field of healthcare is increasingly adopting a humanistic perspective in the physician-patient relationship. One of the more salient aspects being studied is the communication between the two. This study serves a dual purpose. Our initial aim was to study how a cancer diagnosis is disclosed to patients by different physicians (GPs/other specialists/oncologists). Secondly, we set out to study how the way in which oncologists normally communicate with their patients impacts variables such as a patient's anxiety, depression, coping mechanisms, and perception of both their health and their quality of life. A total of 177 patients answered a battery of questionnaires on sociodemographic and disease data: the SPIKES protocol, the EORTCQLQ-COMU26, and the ADAF screening questionnaire. The analyses recorded medium or high scores for some of the steps in the SPIKES protocol when delivering the diagnosis, and significant differences were observed for some of them among different physicians. The level of a cancer patient's satisfaction with the communication by oncologists was related to their levels of anxiety, depression, vulnerability, and perception of their health and quality of life. Better communication strategies are called for among all healthcare professionals to facilitate the task of breaking bad news to their patients
Navigating the Digital Neurolandscape: Analyzing the Social Perception of and Sentiments Regarding Neurological Disorders through Topic Modeling and Unsupervised Research Using Twitter
No full text20.500.12530/87887Neurological disorders represent the primary cause of disability and the secondary cause of mortality globally. The incidence and prevalence of the most notable neurological disorders are growing rapidly. Considering their social and public perception by using different platforms like Twitter can have a huge impact on the patients, relatives, caregivers and professionals involved in the multidisciplinary management of neurological disorders. In this study, we collected and analyzed all tweets posted in English or Spanish, between 2007 and 2023, referring to headache disorders, dementia, epilepsy, multiple sclerosis, spinal cord injury or Parkinson's disease using a search engine that has access to 100% of the publicly available tweets. The aim of our work was to deepen our understanding of the public perception of neurological disorders by addressing three major objectives: (1) analyzing the number and temporal evolution of both English and Spanish tweets discussing the most notable neurological disorders (dementias, Parkinson's disease, multiple sclerosis, spinal cord injury, epilepsy and headache disorders); (2) determining the main thematic content of the Twitter posts and the interest they generated temporally by using topic modeling; and (3) analyzing the sentiments associated with the different topics that were previously collected. Our results show that dementias were, by far, the most common neurological disorders whose treatment was discussed on Twitter, and that the most discussed topics in the tweets included the impact of neurological diseases on patients and relatives, claims to increase public awareness, social support and research, activities to ameliorate disease development and existent/potential treatments or approaches to neurological disorders, with a significant number of the tweets showing negative emotions like fear, anger and sadness, and some also demonstrating positive emotions like joy. Thus, our study shows that not only is Twitter an important and active platform implicated in the dissemination and normalization of neurological disorders, but also that the number of tweets discussing these different entities is quite inequitable, and that a greater intervention and more accurate dissemination of information by different figures and professionals on social media could help to convey a better understanding of the current state, and to project the future state, of neurological diseases for the general public
Effectiveness of combined first-line medical treatment in acromegaly with prolactin cosecretion.
No full text20.500.12530/87909The aim of this study is to compare the response to first-line medical treatment in treatment-naive acromegaly patients with pure growth hormone (GH)-secreting pituitary adenoma (GH-PA) and those with GH and prolactin cosecreting PA (GH&PRL-PA). This is a retrospective multicentric study of acromegaly patients followed from 2003 to 2023 in 33 tertiary Spanish hospitals with at least 6 months of first-line medical treatment. Baseline characteristics, first-line medical treatment strategies, and outcomes were analyzed. We employed a multiple logistic regression full model to estimate the impact of some baseline characteristics on disease control after each treatment modality. Of the 144 patients included, 72.9% had a GH-PA, and 27.1% had a GH&PRL-PA. Patients with GH&PRL-PA were younger (43.9 ± 15.0 vs 51.9 ± 12.7 years, P In GH&PRL-PA, the biochemical control achieved with fgSRL as monotherapy is substantially worse than in patients harboring GH-PA, supporting the inclusion of cabergoline as first-line medical treatment in combination with fgSRLs in these subgroups of patients
Update on the management of older patients with pancreatic adenocarcinoma: a perspective from medical oncology.
No full text20.500.12530/87913In the context of pancreatic cancer, surgical intervention is typically recommended for localized tumours, whereas chemotherapy is the preferred approach in the advanced and/or metastatic setting. However, pancreatic cancer is closely linked to ageing, with an average diagnosis at 72 years. Paradoxically, despite its increased occurrence among older individuals, this population is often underrepresented in clinical studies, complicating the decision-making process. Age alone should not determine the therapeutic strategy but, given the high comorbidity and mortality of this disease, a comprehensive geriatric assessment (CGA) is necessary to define the best treatment, prevent toxicity, and optimize older patient care. In this review, a group of experts from the Oncogeriatrics Section of the Spanish Society of Medical Oncology (Sociedad Española de Oncología Médica, SEOM), the Spanish Cooperative Group for the Treatment of Digestive Tumours (Grupo Español de Tratamiento de los Tumores Digestivos, TTD), and the Multidisciplinary Spanish Group of Digestive Cancer (Grupo Español Multidisciplinar en Cáncer Digestivo, GEMCAD) have assessed the available scientific evidence and propose a series of recommendations on the management and treatment of the older population with pancreatic cancer
Outcomes after intensive chemotherapy for secondary and myeloid-related changes acute myeloid leukemia patients aged 60 to 75 years old: a retrospective analysis from the PETHEMA registry.
No full text20.500.12530/87907Treatment options for patients with secondary acute myeloid leukemia (sAML) and AML with myeloid-related changes (AMLMRC) aged 60 to 75 years are scarce and unsuitable. A pivotal trial showed that CPX-351 improved complete remission with/without incomplete recovery (CR/CRi) and overall survival (OS) as compared with standard "3+7" regimens. We retrospectively analyze outcomes of 765 patients with sAML and AML-MRC aged 60 to 75 years treated with intensive chemotherapy, reported to the PETHEMA registry before CPX-351 became available. The CR/CRi rate was 48%, median OS was 7.6 months (95% confidence interval [CI]: 6.7-8.5) and event-free survival (EFS) 2.7 months (95% CI: 2-3.3), without differences between intensive chemotherapy regimens and AML type. Multivariate analyses identified age ≥70 years, Eastern Cooperative Oncology Group performance status ≥1 as independent adverse prognostic factors for CR/CRi and OS, while favorable/intermediate cytogenetic risk and NPM1 were favorable prognostic factors. Patients receiving allogeneic stem cell transplant (HSCT), autologous HSCT, and those who completed more consolidation cycles showed improved OS. This large study suggests that classical intensive chemotherapy could lead to similar CR/CRi rates with slightly shorter median OS than CPX-351
Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III.
No full text20.500.12530/87857The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential
Interrater reliability and agreement of the NEUMOBACT checklist about infection-prevention performance of intensive care nurses in simulation-based scenarios.
No full textTo analyse the interrater reliability of the NEUMOBACT checklist and verify whether consistent results are reproducible. A validation study with a cross-sectional design, compliant with the GRRAS checklist, among ICU nurses attending a SIMULAZERO course with an Objective Structured Clinical Evaluation simulation format, to verify transfer from theory to clinical practice of knowledge and skills in ventilator-associated pneumonia (VAP) and catheter-related bacteraemia (CRB) prevention. A minimum sample size of 111 pairs of nurse raters was calculated. Interrater agreement was analysed using Gwet's AC1 for each item and as a total for each of the three checklists in the NEUMOBACT instrument. A total of 95 pairs of valid NEUMOBACT checklists were completed by 190 raters with a median age of 29 [25-35] years, 93.7% were female. At the Central Venous Catheter insertion station, Gwet's AC1 was 0.934 (95% CI [0.919-0.949]). Only 2 of the 17 items scored below 0.9. At the Endotracheal Suctioning station, Gwet's AC1 was 0.869 (95% CI [0.851-0.886]). Of the 26 items that made up this station, 16 had an agreement percentage above 0.9, a further 9 were between 0.821 and 0.884, and item 13 had a value of 0.789. At the Patient Care station, Gwet's AC1 was 0.911 (95% CI [0.896-0.927]). Of the 21 items, 17 showed an agreement percentage above 0.9 and 4 were between 0.810 and 0.894. The interrater reliability of the NEUMOBACT checklist shows substantial agreement between pairs of raters and is therefore validated in this large sample of ICU nurses. The NEUMOBACT checklist can be useful for assessing skills before and after training in VAP and CRB prevention measures and during debriefing (post-simulation feedback), to reinforce the scientific evidence behind actions and decisions for items that have been performed incorrectly, thus consolidating training already received