Tag: statistics

Kidney Int. 2022 Oct 28:S0085-2538(22)00910-3. doi: 10.1016/j.kint.2022.08.040. Online ahead of print.

ABSTRACT

In FIDELITY, a pre-specified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies, finerenone was found to improve cardiorenal outcomes in patients with type 2 diabetes, a urine albumin-to creatinine ratio of 30-5000 mg/g, an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m² or more and also receiving optimized renin-angiotensin system blockade treatment. This present analysis focused on the efficacy and safety of finerenone on kidney outcomes. Among 13,026 patients with a median follow-up of three years, finerenone significantly reduced the hazard of a kidney composite outcome (time to kidney failure, sustained 57% or more decrease in eGFR from baseline, or kidney death) by 23% versus placebo (hazard ratio 0.77; 95% confidence interval 0.67-0.88), with a three-year absolute between group difference of (1.7%; 0.7-2.6). Hazard ratios were directionally consistent for a pre-specified baseline eGFR and urine albumin to creatinine ratio categories (P-interaction 0.62 and P-interaction 0.67, respectively), although there was a high degree of uncertainty in the 30-300 mg/g subgroup. Finerenone significantly reduced the hazard of kidney failure by 20% versus placebo (0.80; 0.64-0.99). Adverse events were similar between treatment arms although hyperkalemia, leading to treatment discontinuation, occurred significantly more frequently with finerenone versus placebo (2.4% vs 0.8% and 0.6% vs 0.3% in patients with eGFR under vs 60 ml/min/1.73 m² and over, respectively). Thus, finerenone improved kidney outcomes, reduced the hazard of kidney failure, and is well tolerated in patients with chronic kidney disease and type 2 diabetes.

PMID:36367466 | DOI:10.1016/j.kint.2022.08.040

Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.

ABSTRACT

Purpose To evaluate the short-term safety of a nonmetallic twinkle marker and compare its conspicuity at color Doppler US with that of standard breast biopsy clips and radioactive seeds by using B-mode US in axillary lymph nodes. Materials and Methods This prospective study (November 2020-July 2021) of participants with node-positive breast cancer who completed chemotherapy involved placing a twinkle marker at the time of preoperative radioactive seed localization. A five-point scoring system (1 = easiest, 5 = most difficult) was used to rate the ease of identifying the clip, seed, and twinkle marker on postlocalization sonograms, mammograms, specimen radiographs, and gross pathologic specimens. Descriptive statistics were used. Results Eight women (mean age, 57 years ± 16 [SD]) were enrolled. The median scores for US conspicuity of each device were 3.9 (range, 3.7-5.0) for the radioactive seed, 2.4 (range, 1.0-5.0) for the clip, and 2.0 (range, 1.0-4.3) for the twinkle marker. In six of eight participants, the twinkle marker was the most identifiable at US. The seeds, clips, and twinkle markers were scored “very easy” to identify on seven of eight postlocalization mammograms. The surgeon retrieved all eight twinkle markers 1-3 days after localization. In all 16 interpretations, the seeds, clips, and twinkle markers were rated as very easy to identify on specimen radiographs. The clip was the most difficult device to identify at pathologic examination in all participants, and the twinkle marker was the easiest to identify in seven of eight participants. Conclusion This pilot study demonstrates that the safety and ease of US detection of a twinkling tissue marker may be comparable to a biopsy clip. Keywords: Ultrasonography, US-Doppler, Breast, Localization, Surgery Clinical trial registration no. NCT04674852 © RSNA, 2022.

PMID:36367449 | DOI:10.1148/rycan.220053

J Exp Biol. 2022 Nov 11:jeb.244590. doi: 10.1242/jeb.244590. Online ahead of print.

ABSTRACT

We analysed the trajectories of freely foraging Gymnotus sp., a pulse type gymnotiform weakly electric fish, swimming in a dark arena. We compared the fish’s initial behaviour as it learned the relative location of landmarks and food, to its behaviour after learning was complete, i.e., after time/distance to locate food had reached a minimal asymptotic level. During initial exploration when the fish did not know the arena layout, trajectories included many sharp angle head turns that occurred at nearly completely random intervals. After spatial learning was complete, head turns became far smoother. Interestingly, the fish still did not take a stereotyped direct route to the food but instead took smooth but variable curved trajectories. We measured the fish’s heading angle error (heading angle – heading angle towards food). After spatial learning, the fish’s initial heading angle errors were strongly biased to zero, i.e., the fish mostly turned towards the food. As the fish approached closer to the food, they switched to a random search strategy with a more uniform distribution of heading angle errors.

PMID:36366924 | DOI:10.1242/jeb.244590

Ann Palliat Med. 2022 Nov 2:apm-22-637. doi: 10.21037/apm-22-637. Online ahead of print.

ABSTRACT

BACKGROUND: Palliative care (PC) skills are important when caring for patients with advanced illness in a broad range of settings. Students need to be trained in communication and empathy, both representing essential PC skills. Therefore, creative approaches could promote the understanding of relevant PC skills.

METHODS: In an online lecture about graphic medicine, different medical comics (MC) were used to introduce the field of graphic medicine and to illustrate relevant skills in PC. After the lecture, an online survey was conducted. The survey consisted of each respondent`s sociodemographic profile and a questionnaire on multiple aspects related to the field of MC. Spearman correlation coefficients and Cohen’s effect sizes were used for statistical analysis.

RESULTS: The survey respondents comprised 668 students, 337 female, 326 male and 5 diverse. The results showed that the students had never (27.2%) or had very rarely (31.9%) been involved in with the field of MC. The largest number would rate their interest as somewhat or very interested (58.8%). When considering the use of MC to understand different perspectives, the students mainly rated them as useful (54.6%) or very useful (23.4%). Women had a more positive attitude towards MC than men (P<0.001). Students who placed more importance on PC skills were more likely to recommend the use of MC in general medical education (r=0.11, P=0.005). The majority of the students (58.8%) moderately or strongly agreed on the use of MC as a teaching method in PC.

CONCLUSIONS: After a single lecture on graphic medicine, the students were positive about using MC for teaching PC skills. Since the lecture was short and the majority of the medical students stated that they had not been previously exposed to the field of MC, this study demonstrates that it is promising to further use and evaluate a set of visual and narrative illustrations as a teaching method in PC.

PMID:36366897 | DOI:10.21037/apm-22-637

Clin Transl Sci. 2022 Nov 10. doi: 10.1111/cts.13432. Online ahead of print.

ABSTRACT

Kidney transplantation remains the therapeutic option for patients with end-stage kidney disease. Current immunosuppressive regimens are efficient in combating acute kidney rejection. However, insights into chronic kidney allograft injury remains limited. Simultaneously, pregnancy is more common after kidney transplantation than during dialysis treatment. Due to ethical issues, comprehensive studies on the impact of immunosuppressive regimens on pregnancy are challenging. The study aimed to investigate the proteomic status of lymphocytes obtained from pregnant female rats under immunosuppressive treatment. The experiment involved a group of 10 female, pregnant Wistar rats, five of which were treated with tacrolimus, mofetil mycophenolate, and glucocorticosteroids; five were used as control. The lymphocytes were obtained and analyzed with mass spectrometry. Measurements were processed by a database search in the ProteinPilot software with a cutoff of 1% false discovery rate. The outcomes were verified statistically by a t-test (p value < 0.05) regarding proteins up- and downregulation. A total of 2082 proteins were identified in all experiments. Eight hundred five proteins were quantified in an absolute manner in a data-independent acquisition-total protein approach analysis. Ninety-five proteins were recognized as present at different concentrations in analyzed groups and were annotated to intracellular pathways. The proteins involved in nonsense-mediated decay and L13a-mediated translational silencing of ceruloplasmin expression were recognized as downregulated. The set of proteins clinically identified as acute phase proteins was upregulated. Despite the blockade of adaptive cellular immunity, the lymphocytes in the analyzed group reveal sustained proinflammatory status with decreased ability to regulate translation. This potentially affects pregnancy and immunity.

PMID:36366854 | DOI:10.1111/cts.13432

Int J Cancer. 2022 Nov 10. doi: 10.1002/ijc.34354. Online ahead of print.

ABSTRACT

Evidence regarding cancer risk after borderline ovarian tumors (BOTs) is limited. We conducted a nationwide cohort study examining the incidence of non-ovarian cancers in women with serous or mucinous BOTs compared to the general female population with up to 41 years of follow-up. Through the nationwide Pathology Registry, we identified nearly 5,000 women with BOTs (2,506 serous and 2,493 mucinous) in Denmark, 1978-2018. We computed standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) as relative risk estimates of specific non-ovarian cancers. Compared to general female population rates, women with serous BOTs had increased rates of particularly malignant melanoma (SIR=1.9; 95% CI: 1.3-2.6), thyroid cancer (SIR=3.0; 95% CI: 1.4-5.4) and myeloid leukemia (SIR=3.2; 95% CI: 1.5-5.8), and women with mucinous BOTs had elevated rates of lung cancer (SIR=1.7; 95% CI: 1.3-2.1), pancreatic cancer (SIR=1.9; 95% CI: 1.2-2.9) and myeloid leukemia (SIR=2.3; 95% CI: 0.9-4.7). We found no convincing association with neither breast nor colorectal cancer in women with BOTs. This is the first large nationwide study showing that women with specific types of BOTs have increased risks of several non-ovarian cancers, likely due to some shared risk factors or genetic characteristics. This article is protected by copyright. All rights reserved.

PMID:36366853 | DOI:10.1002/ijc.34354

Respiration. 2022 Nov 10:1-9. doi: 10.1159/000527308. Online ahead of print.

ABSTRACT

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged >80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations.

OBJECTIVES: The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged >80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated.

METHODS: An observational, retrospective, multicenter study was carried out in Italy.

RESULTS: 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged >80 years. FVC decline after 12 months of therapy was not significantly different (-45 mL [-170; 75] vs. -20 mL [-138; 110] mL; p: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. >80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different.

CONCLUSIONS: Nintedanib is effective and safe in patients with IPF aged >80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients.

PMID:36366821 | DOI:10.1159/000527308

Med Sci Law. 2022 Nov 10:258024221136687. doi: 10.1177/00258024221136687. Online ahead of print.

ABSTRACT

The purpose of this study is to assess the accuracy of two multivariate statistical approaches for estimating sex from human external ear anthropometry, namely, discriminant function analysis (DFA) and binary logistic regression (BLR). A cross-sectional sample of 497 participants (233 males and 264 females) aged 18-35 years (24.42 ± 5.17) was obtained from Himachal Pradesh state of North India. Both the ears of the participants (994) were examined for anthropometric measurements. A total of 12 anthropometric measurements were taken independently on the left and right ear of each individual with the help of a pair of sliding calipers using a standard method. The sex of the population groups was discriminated against using binary logistic regression and discriminant function analysis. The predictive percentage of sex estimation computed from both the models were substantially the same, that is, 76.3% from DFA and 76.2% from BLR, with nearly comparable (∼0.02) sensitivity, specificity, positive predictive value, and negative predictive values, whereas the values of correct predicted percentage were 0.1% higher in DFA than BLR. Moreover, the other comparison metrics, such as classification error, B-index, and Matthews correlation coefficient indicated that both models performed equally well. The study highlighted that if the assumptions of the statistical methods are met, both methods are equally capable of discriminating the population depending on sex. The study recommends that the discriminant function analysis and binary logistic regression may be used synonymously in forensic research and case-work pertaining to the estimation of sex and various other forensic situations.

PMID:36366800 | DOI:10.1177/00258024221136687

Stat Methods Med Res. 2022 Nov 10:9622802221129044. doi: 10.1177/09622802221129044. Online ahead of print.

ABSTRACT

The regression discontinuity design is a quasi-experimental design that estimates the causal effect of a treatment when its assignment is defined by a threshold for a continuous variable. The regression discontinuity design assumes that subjects with measurements within a bandwidth around the threshold belong to a common population, so that the threshold can be seen as a randomising device assigning treatment to those falling just above the threshold and withholding it from those who fall below. Bandwidth selection represents a compelling decision for the regression discontinuity design analysis as results may be highly sensitive to its choice. A few methods to select the optimal bandwidth, mainly from the econometric literature, have been proposed. However, their use in practice is limited. We propose a methodology that, tackling the problem from an applied point of view, considers units’ exchangeability, that is, their similarity with respect to measured covariates, as the main criteria to select subjects for the analysis, irrespectively of their distance from the threshold. We cluster the sample using a Dirichlet process mixture model to identify balanced and homogeneous clusters. Our proposal exploits the posterior similarity matrix, which contains the pairwise probabilities that two observations are allocated to the same cluster in the Markov chain Monte Carlo sample. Thus we include in the regression discontinuity design analysis only those clusters for which we have stronger evidence of exchangeability. We illustrate the validity of our methodology with both a simulated experiment and a motivating example on the effect of statins on cholesterol levels.

PMID:36366738 | DOI:10.1177/09622802221129044

Viruses. 2022 Nov 7;14(11):2465. doi: 10.3390/v14112465.

ABSTRACT

A total of 381 hepatitis B virus (HBV) DNA sequences collected from nine groups of Siberian native populations were phylogenetically analyzed along with 179 HBV strains sampled in different urban populations of former western USSR republics and 50 strains from Central Asian republics and Mongolia. Different HBV subgenotypes predominated in various native Siberian populations. Subgenotype D1 was dominant in Altaian Kazakhs (100%), Tuvans (100%), and Teleuts (100%) of southern Siberia as well as in Dolgans and Nganasans (69%), who inhabit the polar Taimyr Peninsula. D2 was the most prevalent subgenotype in the combined group of Nenets, Komi, and Khants of the northern Yamalo-Nenets Autonomous Region (71%) and in Yakuts (36%) from northeastern Siberia. D3 was the main subgenotype in South Altaians (76%) and Buryats (40%) of southeastern Siberia, and in Chukchi (51%) of the Russian Far East. Subgenotype C2 was found in Taimyr (19%) and Chukchi (27%), while subgenotype A2 was common in Yakuts (33%). In contrast, D2 was dominant (56%) in urban populations of the former western USSR, and D1 (62%) in Central Asian republics and Mongolia. Statistical analysis demonstrated that the studied groups are epidemiologically isolated from each other and might have contracted HBV from different sources during the settlement of Siberia.

PMID:36366563 | DOI:10.3390/v14112465