Category: Statistics

Diabetes Care. 2021 Apr 19:dc202877. doi: 10.2337/dc20-2877. Online ahead of print.

ABSTRACT

OBJECTIVE: Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine U100 (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications.

RESEARCH DESIGN AND METHODS: This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal insulin-treated (total daily dose 10-50 units) people with type 2 diabetes (HbA_1c 7.0-10.0% [53.0-85.8 mmol/mol]) to icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks. Primary end point was percent time in range (TIR; 3.9-10.0 mmol/L [70-180 mg/dL]) during weeks 15 and 16, measured using continuous glucose monitoring. Key secondary end points included HbA_1c, adverse events (AEs), and hypoglycemia.

RESULTS: Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n = 54), 66.0% (icodec NLD; n = 50), and 65.0% (IGlar U100; n = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9%]). Mean HbA_1c reduced from 7.9% (62.8 mmol/mol) at baseline to 7.1% (54.4 mmol/mol icodec LD) and 7.4% (57.6 mmol/mol icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable.

CONCLUSIONS: Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to once-weekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.

PMID:33875485 | DOI:10.2337/dc20-2877

Diabetes Care. 2021 Apr 19:dc202607. doi: 10.2337/dc20-2607. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the effects of alcohol abstinence on prevention of new-onset atrial fibrillation (AF) in patients with type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS: A total of 1,112,682 patients newly diagnosed with T2DM between 2011 and 2014 were identified from the Korean National Health Insurance Service database. After excluding those with a history of AF, 175,100 patients were included. The primary outcome was new-onset AF.

RESULTS: During a mean follow-up of 4.0 years, AF occurred in 4,174 patients. Those with heavy alcohol consumption (alcohol intake ≥40 g/day) before T2DM diagnosis had a higher risk of AF (adjusted hazard ratio [aHR] 1.22; 95% CI 1.06-1.41) compared with patients with no alcohol consumption. After T2DM diagnosis, those with moderate to heavy alcohol consumption (alcohol intake ≥20 g/day) who abstained from alcohol had a lower risk of AF (aHR 0.81; 95% CI 0.68-0.97) compared with constant drinkers. Alcohol abstinence showed consistent trends toward lower incident AF in all subgroups and was statistically significant in men (aHR 0.80; 95% CI 0.67-0.96), those aged >65 years (aHR 0.69; 95% CI 0.52-0.91), those with CHA₂DS₂-VASc score <3 points (aHR 0.71; 95% CI 0.59-0.86), noninsulin users (aHR 0.77; 95% CI 0.63-0.94), and those with BMI <25 kg/m² (aHR 0.68; 95% CI 0.53-0.88).

CONCLUSIONS: In patients with newly diagnosed T2DM, alcohol abstinence was associated with a low risk of AF development. Lifestyle modifications, such as alcohol abstinence, in patients newly diagnosed with T2DM should be recommended to reduce the risk of AF.

PMID:33875486 | DOI:10.2337/dc20-2607

Cogn Sci. 2021 Apr;45(4):e12972. doi: 10.1111/cogs.12972.

ABSTRACT

A fundamental question in the study of human cognition is how people learn to predict the category membership of an example from its properties. Leading approaches account for a wide range of data in terms of comparison to stored examples, abstractions capturing statistical regularities, or logical rules. Across three experiments, participants learned a category structure in a low-dimension, continuous-valued space consisting of regularly alternating regions of class membership (A B A B). The dependent measure was generalization performance for novel items outside the range of the training space. Human learners often extended the alternation pattern–a finding of critical interest given that leading theories of categorization based on similarity or dimensional rules fail to predict this behavior. In addition, we provide novel theoretical interpretations of the observed phenomenon.

PMID:33873244 | DOI:10.1111/cogs.12972

Adv Nutr. 2021 Apr 19:nmab037. doi: 10.1093/advances/nmab037. Online ahead of print.

ABSTRACT

Numerous observational studies have investigated the role of the Dietary Inflammatory Index (DII®) in chronic disease risk. The aims of this umbrella review and integrated meta-analyses were to systematically synthesize the observational evidence reporting on the associations between the DII and health outcomes based on meta-analyses, and to assess the quality and strength of the evidence for each associated outcome. This umbrella review with integrated meta-analyses investigated the association between the DII and a range of health outcomes based on meta-analyses of observational data. A credibility assessment was conducted for each outcome using the following criteria: statistical heterogeneity, 95% prediction intervals, evidence for small-study effect and/or excess significance bias, as well as effect sizes and P values using calculated random effects meta-analyses. In total, 15 meta-analyses reporting on 38 chronic disease-related outcomes were included, incorporating a total population of 4,360,111 subjects. Outcomes (n = 38) were examined through various study designs including case-control (n = 8), cross-sectional (n = 5), prospective (n = 5), and combination (n = 20) study designs. Adherence to a pro-inflammatory dietary pattern had a significant positive association with 27 (71%) of the included health outcomes (P value < 0.05). Using the credibility assessment, Class I (Convincing) evidence was identified for myocardial infarction only, Class II (Highly suggestive) evidence was identified for increased risk of all-cause mortality, overall risk of incident cancer, and risk of incident site-specific cancers (colorectal, pancreatic, respiratory, and oral cancers) with increasing (more pro-inflammatory) DII score. Most outcomes (n = 31) presented Class III (Suggestive) or lower evidence (Weak or No association). Pro-inflammatory dietary patterns were nominally associated with an increased risk of many chronic disease outcomes. However, the strength of evidence for most outcomes was limited. Further prospective studies are required to improve the precision of the effect size.

PMID:33873204 | DOI:10.1093/advances/nmab037

J Am Acad Audiol. 2021 Apr 19. doi: 10.1055/s-0041-1722983. Online ahead of print.

ABSTRACT

BACKGROUND: Temporal resolution is essential to speech acoustic perception. However, it may alter in individuals with auditory disorders, impairing the development of spoken and written language. The envelope of speech signals contains amplitude modulation (AM) that has critical information. Any problem reducing the listener’s sensitivity to these amplitude variations (auditory temporal acuity) is likely to cause speech comprehension problems. The modulation detection threshold (MDT) test is a measure for evaluating temporal resolution. However, this test cannot be used for patients with poor cooperation; therefore, objective evaluation of MDT is essential.

PURPOSE: The main aim of this study is to find the association between the auditory steady-state response (ASSR) and psychoacoustic measurement of MDT at different intensity levels and to assess the amplitude and phase of ASSR as a function of modulation depth.

DESIGN: This was a correlational research.

STUDY SAMPLE: Eighteen individuals (nine males and nine females) with normal hearing sensitivity, aged between 18 and 23 years, participated in this study.

DATA COLLECTION AND ANALYSIS: ASSR was recorded at fixed AM rates and variable AM depths for carrier frequencies of 1,000 and 2,000 Hz with varying intensities. The least AM depth, efficient to evoke an ASSR response, was interpreted as the physiological detection threshold of AM. The ASSR amplitude and phase, as a function of AM depth, were also evaluated at an intensity level of 60 dB hearing level (HL) with modulation rates of 40 and 100 Hz. Moreover, the Natus instrument (Biologic Systems) was used for the electrophysiological measurements. An AC40 clinical audiometer (Intra-acoustic, Denmark) was also used for the psychoacoustic measurement of MDT in a similar setting to ASSR, using the two-alternative forced choice method. Pearson’s correlation test and linear regression model and paired t-test were used for statistical analyses.

RESULTS: A significant positive correlation was found between psychoacoustic and electrophysiological measurements at a carrier frequency of 1000 Hz, with a modulation rate of 40 Hz at intensity levels of 60 dB HL (r = 0.63, p = 0.004), 50 dB HL (r = 0.52, p = 0.02). A significant positive correlation was also found at a carrier frequency of 2000 Hz, with a modulation rate of 47 Hz at 60 dB HL (r = 0.55, p = 0.01) and 50 dB HL (r = 0.67, p = 0.002) and a modulation rate of 97 Hz at 60 dB HL (r = 0.65, p = 0.003). Moreover, a significant association was found between the modulation depth and ASSR amplitude and phase increment at carrier frequencies of 1,000 and 2000 Hz, with modulation rates of 40 and 100 Hz.

CONCLUSION: There was a significant correlation between ASSR and behavioral measurement of MDT, even at low intensities with low modulation rates of 40 and 47 Hz. The ASSR amplitude and phase increment was a function of modulation depth increase. The findings of this study can be used as a basis for evaluating the relationship between two approaches in the clinical population.

PMID:33873218 | DOI:10.1055/s-0041-1722983

J Am Acad Audiol. 2021 Apr 19. doi: 10.1055/s-0041-1723039. Online ahead of print.

ABSTRACT

BACKGROUND: How significant asymmetries in otolith organ function in the presence of symmetrical and asymmetrical semicircular canal function influence skull vibration-induced nystagmus testing (SVINT) has not been well described.

PURPOSE: The aim of the study is to examine the agreement between SVINT and caloric testing, ocular vestibular-evoked myogenic potentials (oVEMP), and cervical vestibular-evoked myogenic potentials (cVEMP) for detecting asymmetric vestibular function.

RESEARCH DESIGN: This is a retrospective study of patients presenting with the chief complaint of vertigo, dizziness, or imbalance.

STUDY SAMPLE: A total of 812 patients were studied with a median age at testing of 59 years (interquartile range 46-70; range 18-93) and included 475 (59%) women.

INTERVENTION: Either the monothermal warm caloric test or alternate binaural bithermal caloric test, oVEMP, and cVEMP tests were administered to all patients. All patients underwent the SVINT prior to vestibular laboratory testing.

DATA COLLECTION AND ANALYSIS: Agreement between tests categorized as normal versus abnormal was summarized using percent concordance (PC). Sensitivity and specificity values were calculated for SVINT compared with other tests of vestibular function.

RESULTS: There was higher agreement between ipsilateral and contralateral SVINT with the caloric test (PC = 80% and 81%, respectively) compared with oVEMP (PC = 63% and 64%, respectively) and cVEMP (PC = 76% and 78%, respectively). Ipsilateral and contralateral SVINT showed higher sensitivity for the caloric test (sensitivity = 47% and 36%, respectively) compared with oVEMP (sensitivity = 26% and 21%, respectively), or cVEMP (sensitivity = 33% vs. 27%, respectively). Specificity of SVINT was high (>80%) for all assessments of vestibular function.

CONCLUSION: The presence of SVIN is a useful indicator of the asymmetry of vestibular function between the two ears when making judgments about semicircular canal asymmetry but is less sensitive to asymmetries in otolith organ function.

PMID:33873220 | DOI:10.1055/s-0041-1723039

Accid Anal Prev. 2021 Apr 16;156:106141. doi: 10.1016/j.aap.2021.106141. Online ahead of print.

ABSTRACT

Drivers age 65 and over have higher rates of crashes and crash-related fatalities than other adult drivers and are especially over-represented in crashes during left turns at intersections. This research investigated the use of SHRP2 Naturalistic Driving Study (NDS) data to assess infrastructure and other factors contributing to left turn crashes at signalized intersections, and how to improve older driver safety during such turns. NDS data for trips involving signalized intersections and crash or near-crash events were obtained for two driver age groups: drivers age 65 and over (older drivers) and a sample of drivers age 30-49, along with NDS pre-screening and questionnaire data. Video scoring of all trips was performed to collect additional information on intersection and trip conditions. To identify the most influential factors of crash risk during left turns at signalized intersections, machine learning and regression models were used. The results found that in the obtained NDS dataset, there was a relatively small volume of crashes during left turns at signalized intersections. Further, model results found the statistically significant variables of crash risk for older drivers were associated more with health and cognitive factors rather than the infrastructure or design of the intersections. The results suggest that a study using only SHRP2 NDS data will not lead to definitive findings or recommendations for infrastructure changes to increase safety for older drivers at signalized intersections and during left turns. Moreover, the findings of this study indicates the need to consider other data sources and data collection methods to address this critical literature gap in older driver safety.

PMID:33873135 | DOI:10.1016/j.aap.2021.106141

J Neural Eng. 2021 Apr 19. doi: 10.1088/1741-2552/abf97c. Online ahead of print.

ABSTRACT

OBJECTIVE: Transcranial photobiomodulation (tPBM) is a recently proposed non-invasive brain stimulation approach with various effects on the nervous system from the cells to the whole brain networks. Specially in the neural network level, tPBM may alter the topology and synchronizability of functional brain networks. However, the functional properties of the neural networks after tPBM are still poorly clarified.

APPROACH: Here, we employed electroencephalography (EEG) and different methods (conventional and spectral) in the graph theory analysis to track the significant effects of tPBM on the resting state brain networks. The non-parametric statistical analysis showed that just one short-term tPBM session over right medial frontal pole can significantly change both topological (i.e., clustering coefficient, global efficiency, local efficiency, eigenvector centrality) and dynamical (i.e., energy, largest eigenvalue, and entropy) features of resting state brain networks.

MAIN RESULTS: The topological results revealed that tPBM can reduce local processing, centrality, and laterality. Furthermore, the increased centrality of central electrode (Cz) was observed.

SIGNIFICANCE: These results suggested that tPBM may alter topology of resting state brain network to facilitate the neural information processing. However, the reduction of local processing after tPBM can be assumed as a negative point for this approach. On the other hand, the dynamical results showed that tPBM reduced stability of synchronizability but increased complexity in the resting state brain networks. These effects can be considered in association with the increased complexity of connectivity patterns among brain regions and the enhanced information propagation in the resting state brain networks. Overall, both topological and dynamical features of brain networks suggest that although tPBM decreases local processing and disrupts synchronizability of network, but it can increase the level of information transferring and processing in the brain network.

PMID:33873167 | DOI:10.1088/1741-2552/abf97c

Urol Int. 2021 Apr 19:1-6. doi: 10.1159/000515652. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of our study is to evaluate the predictive factors affecting the success of treatment with nephrectomy in patients with poorly functioning kidney and nephrogenic hypertension.

METHODS: Data for patients who underwent nephrectomy with a diagnosis of nephrogenic hypertension in 3 centers between May 2010 and January 2020 were analyzed. In the postoperative period, if the blood pressure (BP) was below 140/90 mm Hg without medical treatment, it was accepted as complete response; if the arterial BP was below 140/90 mm Hg with medical treatment or less medication, it was accepted as partial response; and if BP did not decrease to normal values, it was accepted as unresponsive. Demographic characteristics, duration of hypertension, preoperative and postoperative BP values, and presence of metabolic syndrome were statistically evaluated.

RESULTS: Our study consisted of 91 patients with a mean preoperative hypertension duration of 23.3 ± 12.1 months. Among patients, 42 (46.2%) had complete response, 18 (19.8%) had partial response, and 31 (34.0%) had no response. Preoperative systolic and diastolic BP values were not effective on treatment success (p = 0.071, p = 0.973, respectively), but the increase in age and hypertension duration (p = 0.030 and p < 0.001, respectively) and the presence of metabolic syndrome (p = 0.002) significantly decreased the complete response rates.

CONCLUSIONS: Preoperative hypertension duration, advanced age, and presence of metabolic syndrome are predictive factors affecting the response to treatment in patients who undergo nephrectomy due to nephrogenic hypertension.

PMID:33873196 | DOI:10.1159/000515652

J Biomech. 2021 Apr 9;121:110428. doi: 10.1016/j.jbiomech.2021.110428. Online ahead of print.

ABSTRACT

We examined the impact of lung-volume levels on the vertical center of mass (CoM) position and kinematics during submaximal front-crawl swimming at constant velocity. Thirteen well-trained male swimmers (21.2 ± 2.0 years) swam the front-crawl for 15 m at a target velocity of 1.20 m s^-1 while holding one of three lung-volume levels: maximal inspiration (MAX), maximal expiration (MIN), and intermediate between these (MID). The three-dimensional positions of 25 reflective markers attached to each participant’s body were recorded using an underwater motion capture system and then used to estimate the body’s CoM. The swimming velocity and the vertical CoM position relative to the water’s surface were calculated and averaged for one stroke cycle. Stroke rate, stroke length, kick rate, kick amplitude, kick velocity, and trunk inclination were also calculated for one stroke cycle. Swimming velocity was statistically comparable among the three different lung-volume levels (ICC [2,3] = 0.875). The vertical CoM position was significantly decreased with the lower lung-volume level (MAX: -0.152 ± 0.009 m, MID: -0.163 ± 0.009 m, MIN: -0.199 ± 0.007 m, P < 0.001). Stroke rate, kick rate, kick amplitude, kick velocity, and trunk inclination were significantly higher in MIN than in MAX and MID, whereas the stroke length was significantly lower (all P < 0.05). These results indicate that a lower lung-volume level during submaximal front-crawl swimming induces a lower vertical CoM position that is accompanied by a modulation of the swimming kinematics to overcome the increased drag arising from a larger projected frontal area.

PMID:33873108 | DOI:10.1016/j.jbiomech.2021.110428