Tag: statistics

Blood Adv. 2021 Dec 8:bloodadvances.2021005260. doi: 10.1182/bloodadvances.2021005260. Online ahead of print.

ABSTRACT

Hemophilia is a congenital bleeding disorder caused by low clotting factor VIII or IX levels. Life expectancy of people with hemophilia (PWH) has increased with the availability of clotting factor concentrates. At the same time, the incidence of cardiovascular disease (CVD) has increased. In retrospective studies there are conflicting data if, despite this increase, the incidence is still lower than in the general population. We prospectively compared the incidence of CVD in PWH with the predicted incidence. This prospective, multicenter, observational study included adult PWH (>30y) from the Netherlands and United Kingdom (UK). They were followed for a 5-year period and CVD incidence was compared with a predicted event rate based on the QRISK2-2011 CVD risk model. The primary endpoint was the observed fatal and nonfatal CVD incidence after 5 years compared to the estimated events and in relation to severity of hemophilia. The study included 709 patients, of whom 687 (96.9%) completed 5 years follow up or reached an endpoint. For 108 patients the QRISK score could not be calculated at inclusion. For the remaining 579 fewer CVD events were observed than predicted: 9 versus 24 (RR 0.38; 95% CI: 0.18 – 0.80 p=0.01), corresponding with an absolute risk reduction of 2.4%. Severe hemophilia treated on demand had the highest risk reduction. There was no statistical significant relation between severity of hemophilia and incidence of CVD. In hemophilia a lower than predicted CVD incidence was found, supporting the theory that hemophilia protects against CVD. The study is registered at www.clinicaltrials.gov (identification number NCT01303900).

PMID:34879394 | DOI:10.1182/bloodadvances.2021005260

Comput Methods Programs Biomed. 2021 Nov 21;214:106537. doi: 10.1016/j.cmpb.2021.106537. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Longitudinal analysis of patient-reported outcome (PRO) data remains challenging, as no standardization of statistical methods has been proposed, making comparison of PRO results between clinical trials difficult. In this context, the time to deterioration approach has recently been proposed and is regularly used as a modality of longitudinal PRO analysis in oncology.

METHODS: Two new SAS macro programs were developed, %TTD and %TUDD, which implement longitudinal analysis of PRO data according to the time to deterioration approach. These programs implement the recommended deterioration definitions. We described the programs with their different functionalities.

RESULTS: The %TTD macro calculates the time to first or transient deterioration, and the %TUDD macro calculates the time until definitive deterioration. These macros allow to obtain the survival variables from the time to deterioration approach. We illustrate our programs by presenting different applications on the randomized phase II AFUGEM GERCOR clinical trial.

CONCLUSION: The implementation of the deterioration definitions in SAS software allows the dissemination of this approach, in order to move toward the goal of standardization of longitudinal PRO analysis in oncology clinical trials.

PMID:34879326 | DOI:10.1016/j.cmpb.2021.106537

Phys Med Biol. 2021 Dec 8. doi: 10.1088/1361-6560/ac4123. Online ahead of print.

ABSTRACT

OBJECTIVE: A multi-discriminator-based cycle generative adversarial network (MD-CycleGAN) model was proposed to synthesize higher-quality pseudo-CT from MRI.

APPROACH: The MRI and CT images obtained at the simulation stage with cervical cancer were selected to train the model. The generator adopted the DenseNet as the main architecture. The local and global discriminators based on convolutional neural network jointly discriminated the authenticity of the input image data. In the testing phase, the model was verified by four-fold cross-validation method. In the prediction stage, the data were selected to evaluate the accuracy of the pseudo-CT in anatomy and dosimetry, and they were compared with the pseudo-CT synthesized by GAN with generator based on the architectures of ResNet, sU-Net, and FCN.

MAIN RESULTS: There are significant differences(P<0.05) in the four-fold-cross validation results on peak signal-to-noise ratio and structural similarity index metrics between the pseudo-CT obtained based on MD-CycleGAN and the ground truth CT (CTgt). The pseudo-CT synthesized by MD-CycleGAN had closer anatomical information to the CTgt with root mean square error of 47.83±2.92 HU and normalized mutual information value of 0.9014±0.0212 and mean absolute error value of 46.79±2.76 HU. The differences in dose distribution between the pseudo-CT obtained by MD-CycleGAN and the CTgt were minimal. The mean absolute dose errors of Dosemax, Dosemin and Dosemean based on the planning target volume were used to evaluate the dose uncertainty of the four pseudo-CT. The u-values of the Wilcoxon test were 55.407, 41.82 and 56.208, and the differences were statistically significant. The 2%/2 mm-based gamma pass rate (%) of the proposed method was 95.45±1.91, and the comparison methods (ResNet_GAN, sUnet_GAN and FCN_GAN) were 93.33±1.20, 89.64±1.63 and 87.31±1.94, respectively.

SIGNIFICANCE: The pseudo-CT obtained based on MD-CycleGAN have higher imaging quality and are closer to the CTgt in terms of anatomy and dosimetry than other GAN models.

PMID:34879356 | DOI:10.1088/1361-6560/ac4123

Public Health. 2021 Dec 5;202:26-31. doi: 10.1016/j.puhe.2021.10.016. Online ahead of print.

ABSTRACT

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is one of the most common lower respiratory chronic diseases. The aim of this study was to analyze the COPD mortality trends in Croatia for the period 2010-2019 and to identify possible changes and differences by age group and gender.

STUDY DESIGN AND METHODS: In data analysis were included COPD death cases for the period 2010-2019 defined as ICD-10 code J44.0 – J44.9. Mortality data were obtained from the Croatian Institute of Public Health based on death certificates. To model temporal changes in mortality rates joinpoint regression analysis was carried out.

RESULTS: The number of COPD deaths increased in men from 878 in 2010 to 1083 in 2019 and in women from 520 in 2010 to 737 in 2019. Over the 10-year period, there was a stable age-standardized COPD mortality rate among men and statistically significant increasing age-standardized COPD mortality rate among women at the national level.

CONCLUSIONS: The findings show a narrowing of the gender gap of COPD mortality. Observed higher COPD mortality rates with age in both men and women confirm previous data and imply that the number of COPD deaths will continue to increase in the future. The healthcare system should focus on the improvement of the quality of care and investment in health promotion and prevention programs aimed at reducing risk factors for COPD, especially tobacco smoking, as well as raising awareness and knowledge about COPD as a chronic disease.

PMID:34879319 | DOI:10.1016/j.puhe.2021.10.016

Respir Med. 2021 Dec 2;191:106705. doi: 10.1016/j.rmed.2021.106705. Online ahead of print.

ABSTRACT

Diffusing capacity for carbon monoxide (DLCO) was measured in a phase I single ascending dose study after inhalation of AZD8154 or placebo in healthy participants at baseline (DLCO_Baseline) and follow-up (DLCO_Follow-up) 6 days after dosing. Initially, DLCO_Follow-up timepoint was 2 h earlier than the DLCO_Baseline timepoint and clinically significant decreases in DLCO_Follow-up (absolute change up to 19% from baseline and DLCO_%predicted values less than 70) were observed then. The observed reduction in DLCO_Follow-up was confirmed as a false positive finding after alignment of DLCO timings. As a consequence, when DLCO is used in clinical studies, measurements should be strictly standardized in relation to time of the day.

PMID:34879298 | DOI:10.1016/j.rmed.2021.106705

J Stroke Cerebrovasc Dis. 2021 Dec 5;31(2):106205. doi: 10.1016/j.jstrokecerebrovasdis.2021.106205. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to make a reasonable and accurate assessment of the prognosis of patients with pontine infarction. We assessed the changes in structure and function in the whole brain after pontine infarction from the acute to chronic phase using diffustion tensor imaging and functional magnetic resonance imaging.

MATERIALS AND METHODS: Sixteen individuals with a recent pontine infarction and sixteen healthy controls were recruited and underwent 3.0T DTI, resting-state fMRI and upper extremity Fugl-Myer (UE-FM) functional evaluation at five time points: within one week (T1), half a month (T2), one month (T3), three months (T4), and six months (T5) after onset. Tract-based spatial statistics was used to conduct a voxelwise analysis.

RESULTS: The fractional anisotropy (FA) values were significantly lower in the pontine infarction group than in the control group. Then, specific ROIs were analyzed. The FA values of 10 regions of interest were significantly increased at T2 compared with those at T1. The FA value of the corticospinal tract was significantly increased at T3 compared with that at T2. Regional brain activity results showed that the amplitude of low frequency fluctuations value of the frontal lobe decreased at T1, then increased. Finally, The UE-FM scores showed the same increased trend.

CONCLUSION: These findings show that the microstructure changes most significantly within half a month after pontine infarction and stabilizes after one month. The recovery of motor function in the later period is mainly caused by changes in the cortex. This facilitates more treatment options.

PMID:34879300 | DOI:10.1016/j.jstrokecerebrovasdis.2021.106205

Photodiagnosis Photodyn Ther. 2021 Dec 5:102674. doi: 10.1016/j.pdpdt.2021.102674. Online ahead of print.

ABSTRACT

PURPOSE: To compare the differences in retinal vascular structure and choroidal thickness between the active disease and post-recovery periods in COVID-19 patients and healthy controls.

MATERIAL AND METHODS: This prospective, cross-sectional study included 30 eyes from 30 patients with severe COVID-19 and 30 eyes of 30 sex-matched healthy controls. Central macular thickness (CMT), subfoveal choroidal thickness (CT) and retinal vascular changes of patients were measured after positive polymerase chain reaction (PCR) (where the patient had COVID-19-related symptoms) and then three months after two negative PCRs. Laboratory parameters, including C-reactive protein and D-dimer levels, were also recorded.

RESULTS: The mean age of the patients was 47.90 ± 9.06 years in patients group, 49.07 ± 8.41 years in control goups (p=0.467). In terms of choroidal thicknesses subfoveal, nasal and temporal region were significantly higher in the active disease period than control group (p=0.019, p=0.036, p=0.003, respectively). When the after recovery period was compared with the control group in terms of choroidal thickness, although the choroidal thickness was higher in all regions, this difference was not found statistically significant. There was no statistically significant difference in CMT between groups (p=0.506).The mean venous and arterial wall thicknesses were significantly higher in the active period than after recovery (p=0.023, p=0.013, respectively) but there were no differences between after recovery and control groups in the pairwise comparison (p=0.851, p=0.715, respectively).

CONCLUSION: In patients with severe COVID-19, there are changes in thickness of the choroid and retinal vessel walls. While vascular wall thickness increases due to inflammation, the absence of lumen changes may be associated with hemodynamic variables.

PMID:34879296 | DOI:10.1016/j.pdpdt.2021.102674

J Gynecol Obstet Hum Reprod. 2021 Dec 5:102281. doi: 10.1016/j.jogoh.2021.102281. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the thymic-thoracic ratio (TT ratio) on fetal ultrasound and its association with conotruncal heart defects.

METHODS: A case control study was carried out to retrospectively assess the TT ratio on fetal echocardiograms performed between 19 and 39 weeks of gestation, showing congenital heart defects, from January to December 2018. The control group was comprised of fetuses with no echocardiogram evidence of congenital cardiac malformations. Cases of multiple pregnancies and patients where the TT ratio could not be established have been excluded.

RESULTS: A total of 338 pregnancies have been analysed. Fifty-two pregnancies were diagnosed with fetal heart defects (15%), 17 of which showed conotruncal heart defects (32.7%). The TT ratio in normal fetuses (286 pregnancies) increased with gestational age, and had an average of 0.43 ± 0.06. Compared to the control group (normal fetuses), fetuses with conotruncal heart defects had significantly lower mean TT ratio (0.33 ± 0.07). Those that were diagnosed with nonconotruncal heart defects did not show any statistically significant difference in the TT ratios compared with the control group (0.40 ± 0.09 vs. 0.43 ± 0.06, respectively).

CONCLUSION: The TT ratio was significantly lower in fetuses with conotruncal heart defects compared with both the control group (normal fetuses) and the fetuses with nonconotruncal heart defects.

PMID:34879297 | DOI:10.1016/j.jogoh.2021.102281

J Affect Disord. 2021 Dec 5:S0165-0327(21)01326-4. doi: 10.1016/j.jad.2021.12.009. Online ahead of print.

ABSTRACT

OBJECTIVE: The present study aims to investigate the association between PM_2.5 exposure and major depressive disorder, and to examine whether vitamin D and physical activity could attenuate the impact of PM_2.5 on major depressive disorder.

METHODS: 39168 elderly adults (age≥60 years) who had valid estimates on exposure of PM_2.5 in 2010 and data on major depressive disorder were extracted from the UK Biobank. Major depressive disorder was assessed by lifetime experience of mild, moderate, and severe major depression with validated instruments. Logistic regression models were used to estimate the association between PM_2.5 exposure and major depressive disorder.

RESULTS: A total of 9079 participants had major depressive disorder, with a prevalence of 23.2%. The odds ratio (OR) of major depressive disorder was 1.096 (1.023, 1.175) for participants in the highest quartile compared with the lowest quartile of PM_2.5. The correlation of PM_2.5 with major depressive disorder generally increased with the decreasing levels of vitamin D. For instance, in participants with the highest quartile of PM_2.5, the corresponding ORs were 1.141 (0.951, 1.369), 1.232 (1.027, 1.478), 1.286 (1.072, 1.543), and 1.390 (1.159, 1.667) for those who had adequate, desirable, insufficient, and deficient levels of vitamin D, respectively. Additionally, significant modification effects of physical activity on the relationship between PM_2.5 and major depressive disorder were also observed.

CONCLUSIONS: Our study suggests that high levels of vitamin D and physical activity may attenuate the relationship between PM_2.5 and major depressive disorder among elderly adults.

PMID:34879260 | DOI:10.1016/j.jad.2021.12.009

Int J Infect Dis. 2021 Dec 5:S1201-9712(21)01204-2. doi: 10.1016/j.ijid.2021.12.310. Online ahead of print.

NO ABSTRACT

PMID:34879227 | DOI:10.1016/j.ijid.2021.12.310