Category: Statistics

Ann Noninvasive Electrocardiol. 2021 Jul 26:e12880. doi: 10.1111/anec.12880. Online ahead of print.

ABSTRACT

BACKGROUND: Several ECG criteria have been widely used for diagnosis of left ventricular hypertrophy (LVH) in clinical practice. However, their performance in a general Chinese population is limited.

METHODS AND RESULTS: A multi-stage, stratified cluster sampling across China was performed and 7415 representative Chinese adults aged 18-85 years were analyzed. ECG was collected by using GE MAC 5500 machine. The association between five ECG-LVH criteria (i.e., Peguero-Lo Presti, Cornell, Cornell product, Sokolow-Lyon and Sokolow-Lyon product) and echocardiographic LVH (Echo-LVH) was assessed by Pearson’s correlation, diagnostic statistics like predictive values, and receiver operating characteristics (ROC) curve. We found that the prevalence of the Echo-LVH was 11% while ECG-LVH ranged from 3% to 27%. All ECG-LVH criteria had high negative predictive value (NPV) (89%) and specificity (73-96%) but low positive predictive value (PPV) (12-24%) and sensitivity (4-29%). The newly Peguero-Lo Presti criteria had higher sensitivity (29%) but lower specificity (73%) and accuracy (68%) compared with other criteria. Cornell product had the best diagnostic performance (AUC: 0.59), as well as the highest specificity (96%) and accuracy (86%) but lowest sensitivity (4%). Among single-lead components of ECG criteria, R_aVL voltage and QRS duration performed relatively better than others. Hypertensive and older individuals had higher sensitivity but lower specificity and accuracy than their counterparts.

CONCLUSION: ECG-LVH criteria had high NPV to detect Echo-LVH. Though with higher sensitivity, Peguero-Lo Presti criteria did not have better diagnostic performance to detect Echo-LVH. R_aVL and QRS duration had stronger association with Echo-LVH among all single-lead components.

PMID:34310813 | DOI:10.1111/anec.12880

Pediatr Allergy Immunol. 2021 Jul 26. doi: 10.1111/pai.13605. Online ahead of print.

ABSTRACT

BACKGROUND: Childhood allergic rhinitis (AR) is clinically heterogeneous. We aimed to identify distinct phenotypes amongst children with AR using data-driven techniques, and to ascertain their association with patterns of symptoms, allergic sensitization and comorbidities.

METHODS: We recruited 510 children with physician-diagnosed AR, of whom 205 (40%) had asthma. Latent class analysis (LCA) was performed to identify latent structure within the data set using 17 variables (allergic conjunctivitis, eczema, asthma, family history of asthma, family history of allergic rhinitis, skin sensitization to 8 common allergens, tonsillectomy, adenoidectomy).

RESULTS: A four-class solution was selected as the optimal model based on statistical fit. We labeled latent classes as: (1) AR with grass mono-sensitization and conjunctivitis (n=361, 70.8%); (2) AR with house dust mite sensitization and asthma (n=75, 14.7%); (3) AR with pet and grass polysensitization and conjunctivitis (n=35, 6.9%) and (4) AR among children with tonsils and adenoids removed (n=39, 7.6%). Perennial AR was significantly more common among children in Class 2 (OR 5.83, 95%CI 3.42-9.94, p<0.001) and Class 3 (OR 2.88, 95%CI 1.36-6.13, p=0.006). Mild and intermittent AR symptoms were significantly more common in children in Class 2 compared to those in Class 1. AR was more severe in Class 1 compared to other 3 classes, indicating that upper respiratory symptoms are more severe among children with isolated seasonal rhinitis, than in those with rhinitis and coexisting asthma.

CONCLUSION: We have identified 4 phenotypes in school-age children with AR, which were associated with different patterns of clinical symptoms and comorbidities.

PMID:34310772 | DOI:10.1111/pai.13605

Transpl Int. 2021 Jul 26. doi: 10.1111/tri.13994. Online ahead of print.

ABSTRACT

With this issue, Transplant International (TI) reveals its new attires! A new logo, a new cover page design and a new style accompany a re-branding effort by ESOT, but also denote the new spirit and the new strategic positioning of our journal.

PMID:34310784 | DOI:10.1111/tri.13994

J Surg Oncol. 2021 Jul 26. doi: 10.1002/jso.26618. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Pancreatic neuroendocrine tumors (pNETs) in patients with hereditary cancer syndromes are typically multifocal. In contrast, sporadic pNETs are usually unifocal and the incidence of multifocal sporadic pNETs is unknown. The primary aim of this study was to investigate the incidence of multifocality in sporadic pNETs and any associated effect on recurrence risk and survival.

METHODS: Patients who underwent resection of pNETs at Mayo Clinic from 2000 to 2019 were identified and clinical data were obtained from medical records. Syndromic disease was defined as pNETs arising in the setting of a hereditary cancer syndrome. Statistical comparisons were made using χ² , Fisher’s exact, and Kruskal-Wallis tests and survival was assessed using the Kaplan-Meier method.

RESULTS: Six hundred and sixty-one patients with sporadic pNETs and fifty-nine with syndromic pNETs were identified. Multifocal disease was present in 4.8% of sporadic patients and 84.7% of syndromic patients (p < .001). Within patients with sporadic pNETs, clinicopathologic features and recurrence-free and overall survival were similar between patients with unifocal and multifocal disease.

CONCLUSIONS: Multifocal sporadic pNETs are rare and multifocality is not associated with worse survival or increased recurrence risk. Patients with multifocal sporadic pNETs can likely be safely managed with a combination of resection and observation as indicated for each tumor.

PMID:34310723 | DOI:10.1002/jso.26618

J Eur Acad Dermatol Venereol. 2021 Jul 26. doi: 10.1111/jdv.17533. Online ahead of print.

ABSTRACT

Therapeutic options for patients with metastatic melanoma have greatly improved with the introduction of immune checkpoint-inhibition (ICI) and targeted therapies (TT).(1-4) However, a substantial proportion of patients does not respond or experiences toxicities. Thus, prognostic and predictive biomarkers including metabolic host factors are needed. The modified Glasgow-prognostic-score (mGPS) is a well-established immuno-nutritional prognostic assessment in various cancers(5-8), but not yet assessed in melanoma.

PMID:34310762 | DOI:10.1111/jdv.17533

Acta Anaesthesiol Scand. 2021 Jul 26. doi: 10.1111/aas.13956. Online ahead of print.

ABSTRACT

BACKGROUND: Coronavirus disease (COVID-19) primarily affects the lungs and lower airways and may present as hypoxaemic respiratory failure requiring admission to an intensive care unit (ICU) for supportive treatment. Here, supplemental oxygen remains essential for COVID-19 patient management, but the optimal dosage is not defined. We hypothesise that targeting an arterial partial pressure of oxygen of 8 kPa throughout ICU admission is superior to targeting 12 kPa.

METHODS: The Handling Oxygenation Targets in ICU patients with COVID-19 (HOT-COVID) trial, is an investigator-initiated, pragmatic, multicentre, randomised, parallel-group trial comparing a lower oxygenation target versus a higher oxygenation target in adult ICU patients with COVID-19. The primary outcome is days alive without life-support (use of mechanical ventilation, renal replacement therapy, or vasoactive therapy) at day 90. Secondary outcomes are 90-day and 1-year mortality, serious adverse events in the ICU and days alive and out of hospital in the 90-day period, health-related quality-of-life at 1 year, and health economic analyses. One-year follow-up of cognitive and pulmonary function is planned in a subgroup of Danish patients. We will include 780 patients to detect or reject an absolute increase in days alive without life-support of seven days with an α of 5% and a β of 20%. An interim analysis is planned after 90-day follow-up of 390 patients.

CONCLUSIONS: The HOT-COVID trial will provide patient-important data on the effect of two oxygenation targets in ICU patients with COVID-19 and hypoxia. This protocol paper describes the background, design and statistical analysis plan for the trial.

PMID:34310694 | DOI:10.1111/aas.13956

Artif Organs. 2021 Jul 26. doi: 10.1111/aor.14043. Online ahead of print.

ABSTRACT

INTRODUCTION: In tracheal replacement transplantation, prelamination is a critical stage. Nowadays, the most widely used prelamination technique is the prethoracic fascia flap with lateral thoracic artery. We propose a flap based on the internal thoracic artery, which allows a relatively non-aggressive double organ implant, and we have tested its efficacy in decellularized tracheas.

MATERIAL AND METHODS: Tracheas of albino New Zealand rabbits were decellularized following a protocol that uses detergents and cryogenization, sterilized with 1kGy gamma radiation and tutorized with a stent. Bilateral pedicled flaps made of pectoral fascia and a muscular component were harvested through a longitudinal 3-cm central thoracic incision, wrapping the tracheas with them in 16 rabbits, remaining them implanted for 2, 4, 8 and 12 weeks. The tracheas were then studied histologically using standard stainings plus immunohistochemistry (CD31). The models were adjusted with Bayesian statistics using ordinal regression; results as odds ratios and credibility intervals. All analysis were performed using R software.

RESULTS: Acute inflammatory cell invasion was observed at 2 weeks, which almost disappeared in the week 8 after implant. Only macrophages and giant cells increased between weeks 8 and 12 (OR 10.487, IC [1.603-97.327]). The cartilage maintained its structure, with slight signs of ischemia in a few cases. New CD31-positive vessels were observed from week 2 and increasing thereafter, reaching a maximum peak at week 8.

CONCLUSION: We propose a bilateral implant technique that is viable and effective as a prelamination option for two concurrent tracheas, achieving perfect vascularization and integration of the organ with hardly any inflammatory response in the medium- or long-term.

PMID:34310703 | DOI:10.1111/aor.14043

Int J Cancer. 2021 Jul 26. doi: 10.1002/ijc.33747. Online ahead of print.

ABSTRACT

Secondary resection of metastases is recommended in metastatic colorectal cancer (mCRC). Data describing changes in mutational profiles of corresponding primary tumor and metastatic tissue after conversion treatment are limited. Next generation sequencing was performed in formalin-fixed mCRC samples from patients of the FIRE-3 trial (FOLFIRI plus cetuximab or bevacizumab) before treatment start (baseline) and after secondary resection of metastases (post baseline). Changes of mutational profiles and tumor mutational burden (TMB) were assessed within a post-hoc analysis. Median overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) were compared between treatment arms. Paired tumor samples were obtained from 25 patients (19 RAS wild-type, 6 RAS mutant by pyrosequencing). ORR (92.0% vs 58.0%) and OS (60.8 vs 35.4 months, hazard ratio = 0.39 [95% CI 0.14-1.12], P = 0.08) were higher for patients receiving cetuximab. After conversion therapy, 56 alterations (42 in the cetuximab and 14 in the bevacizumab arm) were newly observed in 18 patients (9 each treated with cetuximab or bevacizumab). Gains (n = 21) and losses (n = 21) of alterations occurred during cetuximab-based treatment, while mainly gains of alterations occurred during bevacizumab (n = 10). Three of nine patients treated with cetuximab that presented a change of mutational profiles, developed resistance to cetuximab. Mutational profiles were largely comparable before and after treatment with anti-VEGF or anti-EGFR directed monoclonal antibodies after secondary resection. Mutations associated with resistance to anti-EGFR antibodies were observed in only one third of patients.

PMID:34310714 | DOI:10.1002/ijc.33747

Eur J Clin Invest. 2021 Jul 26:e13658. doi: 10.1111/eci.13658. Online ahead of print.

ABSTRACT

BACKGROUND: Limited clinical data exist describing the use of Direct Oral Anticoagulants (DOACs) in patient with extreme body weight. Thus, the International Society of Thrombosis and Haemostasis (ISTH) recommends avoiding DOACs in patients with weight >120 Kg, on the other hand no restrictions exist for underweight patients.

OBJECTIVE: To evaluate the effects of extreme body weight on DOACs activity and to compare the clinical outcomes of patients with an extreme body weight versus patients with a normal weight (61-119 Kg) treated with DOACs.

METHODS: Single tertiary care Italian center multidisciplinary registry including non-valvular atrial fibrillation (NVAF) patients treated with DOACs. Based on weight, three sub-cohorts were defined: 1) underweight patients (≤60 Kg); 2) patients with a normal weight (61-119 Kg, as control group), and 3) overweight patients (≥120 Kg). Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test.

RESULTS: 812 NVAF patients were included, 108 patients weighed ≤60 Kg (13%, underweight), 688 weighed between 61 and 119 Kg (85%, normal weight) and 16 weighed ≥120 Kg (2%, overweight). In particular, among underweight patients, dabigatran was prescribed in 26% patients, apixaban in 27%, rivaroxaban in 28% and edoxaban in 22% ones. Instead, among overweight patients, 44% were treated with dabigatran, 25% with apixaban, 25% with rivaroxaban and 4% with edoxaban. Underweight patients were older, more frequently women, with lower creatinine clearance and a history of previous strokes, resulting in higher CHA2DS2-VASc score than in both remaining groups. Up to 2-year, no statistically significant difference was observed between the three groups of weight for thromboembolic events (p=0.765) and for overall bleeding (p=0.125), but a trend towards decreased overall bleeding rates was noticed as weight increased (24.1% vs 16.7% vs 12.5%, respectively).

CONCLUSION: In this tertiary care center registry 15% of patients treated with DOACs presented an extreme weight. Compared to patients with a normal weight, no significant rates of thromboembolic events were observed for underweight or overweight patients. A trend towards decreased overall bleeding frequency as weight increased was highlighted up to 2-year. The present results should be considered as preliminary and hypothesis generating.

PMID:34310688 | DOI:10.1111/eci.13658

PLoS One. 2021 Jul 26;16(7):e0255116. doi: 10.1371/journal.pone.0255116. eCollection 2021.

ABSTRACT

Although statistical regularities in the environment often go explicitly unnoticed, traces of implicit learning are evident in our neural activity. Recent perspectives have offered evidence that both pre-stimulus oscillations and peri-stimulus event-related potentials are reliable biomarkers of implicit expectations arising from statistical learning. What remains ambiguous, however, is the origination and development of these implicit expectations. To address this lack of knowledge and determine the temporal constraints of expectation formation, pre-stimulus increases in alpha/beta power were investigated alongside a reduction in the N170 and a suppression in peri-/post-stimulus gamma power. Electroencephalography was acquired from naive participants who engaged in a gender classification task. Participants were uninformed, that eight face images were sorted into four reoccurring pairs which were pseudorandomly hidden amongst randomly occurring face images. We found a reduced N170 for statistically expected images at left parietal and temporo-parietal electrodes. Furthermore, enhanced gamma power following the presentation of random images emphasized the bottom-up processing of these arbitrary occurrences. In contrast, enhanced alpha/beta power was evident pre-stimulus for expected relative to random faces. A particularly interesting finding was the early onset of alpha/beta power enhancement which peaked immediately after the depiction of the predictive face. Hence, our findings propose an approximate timeframe throughout which consistent traces of enhanced alpha/beta power illustrate the early prioritisation of top-down processes to facilitate the development of implicitly cued face-related expectations.

PMID:34310657 | DOI:10.1371/journal.pone.0255116