Tag: statistics

Circulation. 2022 Oct 18:101161CIRCULATIONAHA122059606. doi: 10.1161/CIRCULATIONAHA.122.059606. Online ahead of print.

ABSTRACT

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over a bare metal stent (BMS) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMS for the treatment of femoropopliteal artery lesions.

METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization. Health-related quality of life and walking function were assessed.

RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMS (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15).

CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal disease.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT02921230.

PMID:36254728 | DOI:10.1161/CIRCULATIONAHA.122.059606

Australas J Ageing. 2022 Oct 18. doi: 10.1111/ajag.13140. Online ahead of print.

ABSTRACT

OBJECTIVES: It is well known that there are associations between overall health, age, socioeconomic status and rural residency. The objective of this study was to determine the distribution of Australia’s aged population by socioeconomic status, as well as remoteness.

METHODS: The study employed the Australian Statistical Geography Standard (Statistical Area Level 1 and Remoteness Areas). The database of the geographic boundaries was integrated into the ageing population and socioeconomic data using the Geographic Information System. The socioeconomic data was analysed through the Index of Relative Socioeconomic Disadvantage.

RESULTS: Over a decade, the older population in Australia has increased noticeably. In 2016, there was a high percentage of older people (≥65 years) in Tasmania (Tas), 19%, while the lowest percentage was recorded in the Northern Territory (NT), 7%. Across the country, Tasmania had the highest percentage of older citizens living in the most disadvantaged areas since 2006, with 48% recorded in 2016. There was an association between the remoteness areas and the education and income levels of the ageing cohort. However, this association differed between the states and territories. This socioeconomic gap becomes more evident in the very remote areas of the country.

CONCLUSIONS: The ageing population in Australia is increasing rapidly; this was associated with an evolving socioeconomic disparity among this ageing society. Our results demonstrated that socioeconomic inequalities were to be found among the older people based on their distribution over the remoteness areas in Australia. This information should be used to target healthcare and ageing policies that meet the specific needs of older people.

PMID:36254700 | DOI:10.1111/ajag.13140

Palliat Support Care. 2022 Oct 18:1-10. doi: 10.1017/S1478951522001237. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the spiritual care needs and their attributes among Chinese elders hospitalized for severe chronic heart failure (CHF) based on the Kano model, in order to provide a reference for improving the quality and satisfaction of spiritual care.

METHODS: An observational design was implemented, and the STROBE Checklist was used to ensure quality reporting of the study. The demographic characteristics questionnaire, the Nurse Spiritual Therapeutics Scale, and the Kano model-based Nurse Spiritual Therapeutics Attributes Scale were used. A convenience sample of 451 patients were selected from 2 hospitals. Descriptive statistics, and Kano model were used to analyze the data.

RESULTS: The total score of spiritual care needs was 29.95 ± 7.51. Among the 12 items, 3 items were attractive attributes, all of which were located in Reserving Zone IV; 5 items were one-dimensional attributes, of which 3 were located in Predominance Zone I and 2 were located in Improving Zone II; 2 items were must-be attributes, all of which were located in Improving Zone II; and 2 items were indifference attributes, all of which were located in Secondary Improving Zone III.

SIGNIFICANCE OF RESULTS: The spiritual care needs among Chinese elders hospitalized for severe CHF were moderate. The must-be and one-dimensional attributes mainly focus on “creating a good atmosphere” and “sharing self-perception” dimensions, while attractive attributes mainly focus on “sharing self-perception” and “helping thinking” dimensions. It is suggested that hospital authority should develop and innovate attractive attributes on the basis of maintaining and perfecting must-be and one-dimensional attributes, and objectively analyze and optimize indifference attributes.

PMID:36254699 | DOI:10.1017/S1478951522001237

Acta Otorhinolaryngol Ital. 2022 Aug;42(4):380-387. doi: 10.14639/0392-100X-N0612.

ABSTRACT

OBJECTIVE: Otosclerosis is an osteodystrophic disease of the otic capsule, determining conductive or mixed hearing loss, which can be successfully treated with stapedotomy. The aim of the present multicentric retrospective study was to identify prognostic factors related to better auditory outcomes in stapes surgery.

METHODS: 581 patients affected by otosclerosis were submitted to stapedotomy under local anaesthesia in two different hospitals. Both Teflon and titanium prostheses were adopted.

RESULTS: A statistically significant decrease of postoperative air-conduction thresholds and air-bone gap (ABG) values was seen, whereas the mean bone-conduction threshold did not differ from the preoperative condition. Among the various parameters investigated, the prosthetic material, duration of surgery and intraoperative detection of unexpected anatomical anomalies of the middle ear were found to be related to lower postoperative ABG values.

CONCLUSIONS: All the previously mentioned parameters played a significant role in determining the postoperative auditory outcomes and can therefore be considered prognostic factors for the success of the stapedotomy.

PMID:36254654 | DOI:10.14639/0392-100X-N0612

Bratisl Lek Listy. 2022;123(11):846-852. doi: 10.4149/BLL_2022_135.

ABSTRACT

BACKGROUND: Abnormal neutrophil extracellular traps are associated with lung diseases, thrombosis, increased mucosal secretion in the airways. The aim of this study is to evaluate the possible place of the most specific NETosis marker Cit-H3 protein in diagnostic algorithms by revealing its relationship with the severity, mortality and prognosis of SARS-CoV-2 pneumonia.

PATIENTS AND METHODS: Patients (n = 78) who applied to the Emergency Department between March 11, 2020 and June 10, 2020, with positive SARS-CoV-2 polymerase chain reaction (PCR) test and lung involvement were included in the prospective study. Serum Cit-H3 levels and critical laboratory parameters were measured at baseline on the day of clinical deterioration and before recovery/discharge/death. Cit-C3 levels were determined by enzyme immunassay method.

RESULTS: Cit-H3 levels in patients with SARS-CoV-2 pneumonia during their first admission to the hospital were significantly higher compared to the healthy control group (p < 0.05). Repeated measurements of Cit-H3 levels of the patients significantly correlated with D-dimer, procalcitonin, Neutrophil/ Lymphocyte ratio, lymphocyte, CRP, and oxygen saturation. Cit-H3 levels of the patients who died were significantly higher than that of those who survived (p < 0.05). Cit-H3 levels were found to be statistically significantly higher in patients who developed acute respiratory distress syndrome, were admitted to the intensive care unit, and had mortality (p < 0.05).

CONCLUSIONS: Cit-H3 plays a role in inflammatory processes in SARS-CoV-2 pneumonia, and changes in serum Cit-H3 levels of these patients can be used to determine prognosis and mortality (Tab. 5, Fig. 1, Ref. 21).

PMID:36254644 | DOI:10.4149/BLL_2022_135

Bratisl Lek Listy. 2022;123(11):840-845. doi: 10.4149/BLL_2022_134.

ABSTRACT

OBJECTIVES: We aimed to assist in the diagnosis of cerebral venous sinus thrombosis (CVST) with the neutrophil-lymphocyte ratio (NLR).

BACKGROUND: Diagnosis of CVST is difficult.

METHODS: Patients, who visited the emergency department between March 1, 2013 and March 1, 2021 and underwent magnetic resonance (MR) venography were included. The patients’ MR venography results, ages, gender, NLR, were collected. The patients were categorized according to their CVST diagnosis status, and NLR were compared.

RESULTS: Of the 530 patients included in the study, 366 (69.1 %) were female, and the median age was 40 (31-58) years. CVST was detected in 57 (10.8 %) patients, no pathological diagnosis was detected in 251 (47.4 %) patients. The median NLR of the patients with CVST was statistically significantly higher than in the patients without CVST and in the patients without any diagnosis ((3.94 [2.5-6.47] vs 3.03 [1.93-5.43], p = 0.023) (3.94 [2.5-6.47] vs 2.92 [1.86-4.95], p = 0.009). In the ROC analysis performed with reference to the patients without any diagnosis, NLR obtained 0.612 AUC.

CONCLUSION: Significantly higher NLR levels were found in CVST patients compared to the patients, who were not diagnosed with CVST and the patients without any diagnosis (Tab. 5, Fig. 2, Ref. 22).

PMID:36254643 | DOI:10.4149/BLL_2022_134

Bratisl Lek Listy. 2022;123(11):833-839. doi: 10.4149/BLL_2022_133.

ABSTRACT

BACKGROUND AND OBJECTIVES: Numerous studies have been conducted on the psychological effects of the COVID-19 pandemic. However, how the mental health of health workers will be affected among the number of peaks during the pandemic has not been evaluated yet. The study aims to investigate the effects of the first, second, and third peaks of COVID-19 on anxiety, depression, and stress symptoms in healthcare workers.

METHODS: The current study included 4031 healthcare workers, 1051 during the first peak period, 1409 during the second peak period, and 1571 during the third peak period. The Depression-anxiety-stress scale-21(DASS-21) was used to assess the participants’ levels of anxiety, depression, and stress symptoms.

RESULTS: The mean age of the participants was 33.74 ± 7.95, and 2634 (66.3 %) were female. 36.9 %(n = 1486) of the participants were physicians, 41.1 % (n = 1655) were nurses and 22.1 % (n = 890) were other healthcare workers. A statistically significant difference was documented in the DASS-21 anxiety (F(2:4028) = 502.893, p 2. Peak > 1. Peak), DASS-21 depression (F(2:4028) = 46.034, p 2. Peak > 1. Peak), DASS-21 stress (F(2:4028) = 65.548, p 1. Peak), and DASS-21 total scores (F(2:4028) = 156.860, p 2. Peak > 1. Peak) of healthcare workers during all three peak periods.

CONCLUSIONS: Our findings show that as the peak number rises, so do the levels of anxiety and depression among healthcare workers. As a result, it is possible to assert that prolongation of the COVID-19 pandemic worsens mental problems (Tab. 2, Fig. 3, Ref. 35).

PMID:36254642 | DOI:10.4149/BLL_2022_133

Andrology. 2022 Oct 18. doi: 10.1111/andr.13317. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVE: Conventional serum tumor markers (STMs) for testicular germ cell tumors (GCTs) offer limited performance with particularly poor sensitivity in cases of minimal residual disease and pure seminoma. While growing evidence has indicated miR-371a-3p to be a superior biomarker, its utility in detecting pure seminoma at recurrence has not been extensively explored. This study’s objective was to explore miR-371a-3p’s utility in detecting metastatic pure seminoma at retroperitoneal lymph node dissection (RPLND).

METHODS: RNA was isolated from patient serum samples collected pre-RPLND. Fifteen patients were assigned to our ‘Benign’ (n = 6) or ‘Seminoma’ (n = 9) group based on pathological confirmation of viable seminoma. Five of the patients received chemotherapy before RPLND (PC-RPLND) and ten were chemotherapy naïve. MiR-371a-3p expression was quantified via RT-qPCR. The Cq values were statistically evaluated to obtain performance measurements.

RESULTS: Median relative expression of miR-371a-3p was higher in the Seminoma group than the Benign, but this difference was not statistically significant (Rq = 3705 and 241, respectively, p = 0.2844). Of the 10 chemotherapy naïve patients, 9 had viable seminoma at RPLND and 7 had elevated miR-371a-3p expression. Among the 5 post-chemotherapy patients, 0 had viable GCT at RPLND and 2 had elevated miR-371a-3p expression. The primary RPLND group presented 78% sensitivity and 100% specificity. Specificity in the PC-RPLND group was 60%. An optimal Rq threshold of 28.62 was determined by Youden’s J statistic, yielding 78% sensitivity and 67% specificity. ROC analysis provided an AUC of 0.704 (95% CI: 0.43-0.98, p = 0.1949). Despite modest performance, miR-371a-3p exhibited improved sensitivity and specificity compared with conventional STMs.

CONCLUSIONS: MiR-371a-3p outperformed STMs in the primary RPLND settings. However, miR-371a-3p was not a robust predictor of pathology in the post-chemotherapy setting. These results suggest that pure seminoma at RPLND is a clinical context wherein the miRNA assay may require further refinement. This article is protected by copyright. All rights reserved.

PMID:36254623 | DOI:10.1111/andr.13317

Cogn Behav Ther. 2022 Oct 18:1-20. doi: 10.1080/16506073.2022.2130820. Online ahead of print.

ABSTRACT

Self-compassion is the ability to offer oneself kindness and compassion in response to failure, suffering, or insecurity. Learning how to be self-compassionate through self-compassion training appears effective for improving psychological well-being in community samples and promising for clinical populations. The current randomized controlled trial was designed to (a) examine the effectiveness of a self-guided self-compassion training program; and (b) determine whether self-compassion training can help mitigate social anxiety disorder (SAD) symptoms. Adults with SAD (n = 63; Mage = 34.3, SD = 11.4; 67.8% female; 84.7% Caucasian) were randomized to a waitlist control condition, a self-guided self-compassion training condition, or a self-guided applied relaxation training condition for six weeks. Outcome measures of SAD symptoms and self-compassion were completed pre-, mid-, and post-treatment, as well as at 3-months follow-up. Multilevel linear modelling results suggested the self-compassion training program was statistically superior at improving outcome measures relative to the waitlist control condition (ps < .05; η²_ps = .12-.33), but not relative to the applied relaxation training condition (ps > .05; η²_ps = .01-.05). Self-compassion training produced greater clinically significant gains in self-compassion and reductions in fear of self-compassion compared to both the waitlist condition and applied relaxation training. The current trial provides preliminary evidence for the effectiveness of a self-help self-compassion training program and provides evidence that self-compassion training may be beneficial for managing clinically significant SAD symptoms.

PMID:36254613 | DOI:10.1080/16506073.2022.2130820

J Prosthodont. 2022 Oct 18. doi: 10.1111/jopr.13612. Online ahead of print.

ABSTRACT

PURPOSE: To assess the effect of CAD-CAM technique (monolithic, CAD-on, or CAD-on cemented) and thermomechanical fatigue on the marginal discrepancy and fracture load of ceramic crowns.

MATERIAL AND METHODS: A total of 90 brass master dies were fabricated to investigate marginal adaptation and fracture load. A mandibular first molar crown’s median measurements were loaded into CAD software and divided into 2 crown design groups: Monolithic (M)(IPS e.max zirCAD)(n = 30) or CAD-on core (IPS e.max zirCAD) and lithium disilicate veneer (IPS e.max CAD) (n = 60). The crowns and cores were milled, seated on their respective dies, and marginal discrepancy values were measured by using microcomputed tomography. After veneers were milled, the cores in veneer groups were divided into 2 groups; veneers bonded with fusion glass-ceramic (IPS e.max CAD Crystal) in CAD-on group (CO) and CAD-on cemented group (CO-C) where veneers were cemented (RelyX U200) onto cores (CO-C). The marginal discrepancy measurements were remade and the crowns were subjected to thermomechanical fatigue (TMF) by using a chewing simulator and thermocycling (5-55°C, 1,200,000 cycles). Marginal discrepancy measurements were repeated and the crowns were subjected to fracture load test by using a universal test device. Data were analyzed statistically by analysis of variance (ANOVA) and Tukey’s honestly significant difference test (α = 0.05).

RESULTS: All crown groups had similar marginal discrepancy before veneering. Veneering and cementation on die increased the marginal discrepancy of crowns in cemented CAD-on group. Thermomechanical fatigue increased the marginal discrepancy of both CAD-on groups. Monolithic crown group had the lowest marginal discrepancy after thermomechanical fatigue (P<0.001), and the highest fracture load (P<0.001) CONCLUSIONS: Fabrication technique affected the marginal fit and fracture load of CAD-CAM crowns after thermomechanical fatigue. All crowns survived the thermomechanical fatigue test without dislodgement or fracture. Monolithic crowns had the best fit and highest fracture load after fatigue testing. The CAD-on systems had similar marginal discrepancies, and static loading reproduced veneer chipping. This article is protected by copyright. All rights reserved.

PMID:36254611 | DOI:10.1111/jopr.13612