Category: Statistics

HIV Med. 2023 Aug 17. doi: 10.1111/hiv.13533. Online ahead of print.

ABSTRACT

INTRODUCTION: Decreased physical activity is a major cardiovascular risk factor that is particularly pronounced in people living with HIV (PLHIV), who are more susceptible to endothelial dysfunction and accelerated atherosclerosis than the general population due to multiple mechanisms. The aim of the present study was to analyse whether regular physical activity is capable of improving endothelial function measured by flow-mediated dilatation (FMD) in PLHIV.

METHODS: We performed FMD measurement in 38 PLHIV, along with the assessment of their regular physical activity level using the International Physical Activity Questionnaire (IPAQ).

RESULTS: Flow-mediated dilatation results in PLHIV were 0.31 ± 0.06 mm and 7.34% ± 1.41% for absolute and relative FMD, respectively. IPAQ results showed that the average weekly level of physical activity was 3631.1 ± 1526.7 MET-min/week, whereas the average daily sitting time was 287.3 ± 102.7 min/day. Predictors jointly accounted for 48% (adjusted value 42%) of FMD variance. Bootstrapped confidence levels revealed that physical activity had a statistically significant effect on the outcome [beta = 0.517, 2.5% confidence interval (CI) = 0.205, 97.5% CI = 0.752].

CONCLUSION: Physical activity represents a widely available and uncostly tool that is capable of improving endothelial function and overall cardiovascular health in PLHIV.

PMID:37589182 | DOI:10.1111/hiv.13533

Health Promot Pract. 2023 Aug 17:15248399231192992. doi: 10.1177/15248399231192992. Online ahead of print.

ABSTRACT

Homelessness among older individuals is increasing and women experiencing homelessness have been previously shown to have poorer health outcomes than their male counterparts. To address these concerns, the Bridges to Elders (BTE) program was developed to improve health and social outcomes for older women experiencing or at risk for homelessness. BTE consisted of a nurse practitioner (NP) and community health worker (CHW) dyad who provided intensive case management services for women 55+ with housing instability. This evaluation used a pretest/posttest design to examine three main outcomes from BTE: change in housing status, enrollment with a primary care provider (PCP), and diagnosis of uncontrolled chronic condition. The sample included 96 BTE participants enrolled from January 2017 to December 2018. The average age of participants was 66 years and had a mean BTE enrollment time of 7.6 months. Statistically significant improvements were achieved in all three outcomes measured: 17% (p < .009) increase in stable housing, 35% (p < .001) increase in PCP enrollment, and 47% (p < .001) decrease in the diagnosis of an uncontrolled chronic condition. The results indicated an NP/CHW dyad improved housing status, primary care access, and targeted health outcomes for older women who are experiencing or at risk for homelessness. Future studies examining the impact of NP/CHW dyads on additional social determinants of health and their impact on health outcomes are recommended.

PMID:37589174 | DOI:10.1177/15248399231192992

Europace. 2023 Aug 17:euad255. doi: 10.1093/europace/euad255. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Premature Ventricular Beats (PVBs) in athletes are often benign but sometimes they may be the sign of an underlying disease. We evaluated prevalence, burden, and morphology of PVBs in healthy voluntary athletes and controls with the main purpose of defining if certain PVB patterns are “common” and “training related” and, as such, are more likely benign.

METHODS: We recruited healthy competitive athletes and sedentary subjects who volunteered to undergo a 12-lead 24-hour ambulatory ECG monitoring (24H-ECG), with a training session in athletes. Ventricular arrhythmias were evaluated in terms of number, complexity (i.e. couplet, triplet or non-sustained ventricular tachycardia), exercise-inducibility and morphology.

RESULTS: We studied 433 healthy competitive athletes (median age 27 (18-43) years, 74% males) that were compared with 261 age- and sex-matched sedentary subjects. 86% of athletes and controls exhibited a total of ≤10 PVBs/24-hour, and more than 90% did not show any couplets, triplets or run of NSVT >3 beats. Sex and level of training was not associated to the number of PVBs, which rather resulted to be dependent only to age (p < 0.01). The most frequent morphologies were the infundibular and fascicular ones. In a comparison between athletes versus sedentary individuals, and male versus female athletes, no statistically significant differences were found in PVBs morphologies.

CONCLUSION: The prevalence and complexity of ventricular arrhythmias at 24H-ECG did not differ between athletes and sedentary controls and were not related to type and amount of sport or sex. Age was the only variable associated to an increased PVBs burden. Thus, no PVBs pattern in the athlete can be considered “common” or “training related” (Graphical abstract).

PMID:37589170 | DOI:10.1093/europace/euad255

J Prosthodont. 2023 Aug 17. doi: 10.1111/jopr.13746. Online ahead of print.

ABSTRACT

PURPOSE: Facial disfigurement may affect the quality of life of many patients. Facial prostheses are often used as an adjuvant to surgical intervention and may sometimes be the only viable treatment option. Traditional methods for designing soft-tissue facial prostheses are time-consuming and subjective, while existing digital techniques are based on mirroring of contralateral features of the patient, or the use of existing feature templates/models that may not be readily available. We aim to support the objective and semi-automated design of facial prostheses with primary application to midline or bilateral defect restoration where no contralateral features are present. Specifically, we developed and validated a statistical shape model (SSM) for estimating the shape of missing facial soft tissue segments, from any intact parts of the face.

MATERIALS AND METHODS: An SSM of 3D facial variations was built from meshes extracted from computed tomography and cone beam computed tomography images of a black South African sample (n = 235) without facial disfigurement. Various types of facial defects were simulated, and the missing parts were estimated automatically by a weighted fit of each mesh to the SSM. The estimated regions were compared to the original regions using color maps and root-mean-square (RMS) distances.

RESULTS: Root mean square errors (RMSE) for defect estimations of one orbit, partial nose, cheek, and lip were all below 1.71 mm. Errors for the full nose, bi-orbital defects, as well as small and large composite defects were between 2.10 and 2.58 mm. Statistically significant associations of age and type of defect with RMSE were observed, but not with sex or imaging modality.

CONCLUSION: This method can support the objective and semi-automated design of facial prostheses, specifically for defects in the midline, crossing the midline or bilateral defects, by facilitating time-consuming and skill-dependent aspects of prosthesis design. This article is protected by copyright. All rights reserved.

PMID:37589169 | DOI:10.1111/jopr.13746

Hypertension. 2023 Aug 17. doi: 10.1161/HYPERTENSIONAHA.123.21612. Online ahead of print.

ABSTRACT

BACKGROUND: This UK Biobank study uses a mendelian randomization approach to mitigate the variability and confounding that has affected previous analyses of the relationship between measured blood pressure (BP) and cognition and thus delineate the true association between the two.

METHODS: Systolic BP (SBP) and diastolic BP polygenic risk scores (PRSs) were calculated using summary statistics from the International Consortium of Blood Pressure-Genome Wide Association Study (n=299 024). Adjusted nonlinear mixed-effects regression models were used, including a natural splines term for BP-PRS with outcomes of fluid intelligence, reaction time (RT), and composite attention score. Moderating effects of age, sex, and antihypertensive use were assessed in separate models.

RESULTS: There were 448 575 participants (mean age, 56.3 years; age range, 37-72 years) included in the analysis after genetic and neurological disease exclusions. Genetic propensity for high SBP had an approximately linear association with worsened fluid intelligence (P=0.0018). This relationship was significantly moderated by age (P<0.0001). By contrast, genetic propensity for high and low SBP and diastolic BP predicted worse attention function (P=0.0099 and P=0.0019), with high PRSs predicting worse function than low PRSs. Genetic propensity for low SBP and diastolic BP was associated with considerably worse RTs, while for high SBP-PRSs, the RT plateaued (P<0.0001). The relationships between RT and the PRSs were significantly moderated by sex (P<0.0001) and antihypertensive use (P<0.0001).

CONCLUSIONS: Genetic propensity for high and low BP impacts on midlife cognition in subtle ways and differentially affects cognitive domains. While a genetic propensity to low BP may preserve nontimed tests in midlife, it may come at a trade-off with worsened attention scores and RT.

PMID:37589153 | DOI:10.1161/HYPERTENSIONAHA.123.21612

Clin Trials. 2023 Aug 17:17407745231193137. doi: 10.1177/17407745231193137. Online ahead of print.

ABSTRACT

BACKGROUND/AIMS: There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, we used linked claims and electronic health record data to emulate two ongoing randomized controlled trials, characterizing the populations and results of each randomized controlled trial prior to publication of its results. Here, our objective was to compare the populations and results from the emulated trials with those of the now-published randomized controlled trials.

METHODS: This study compared participants’ demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published PRONOUNCE and GRADE trials. First, we examined the feasibility of implementing the baseline participant characteristics included in the published PRONOUNCE and GRADE trials’ using real-world data and classified each variable as ascertainable, partially ascertainable, or not ascertainable. Second, we compared the emulated trials and published randomized controlled trials for baseline patient characteristics (concordance determined using standardized mean differences <0.20) and results of the primary and secondary endpoints (concordance determined by direction of effect estimates and statistical significance).

RESULTS: The PRONOUNCE trial enrolled 544 participants, and the emulated trial included 2226 propensity score-matched participants. In the PRONOUNCE trial publication, one of the 32 baseline participant characteristics was listed as an exclusion criterion on ClinicalTrials.gov but was ultimately not used. Among the remaining 31 characteristics, 9 (29.0%) were ascertainable, 11 (35.5%) were partially ascertainable, and 10 (32.2%) were not ascertainable using structured data from OptumLabs. For one additional variable, the PRONOUNCE trial did not provide sufficient detail to allow its ascertainment. Of the nine variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 6 (66.7%). The primary endpoint of time from randomization to the first major adverse cardiovascular event and secondary endpoints of nonfatal myocardial infarction and stroke were concordant between the emulated trial and published randomized controlled trial. The GRADE trial enrolled 5047 participants, and the emulated trial included 7540 participants. In the GRADE trial publication, 8 of 34 (23.5%) baseline participant characteristics were ascertainable, 14 (41.2%) were partially ascertainable, and 11 (32.4%) were not ascertainable using structured data from OptumLabs. For one variable, the GRADE trial did not provide sufficient detail to allow for ascertainment. Of the eight variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 4 (50.0%). The primary endpoint of time to hemoglobin A1c ≥7.0% was mostly concordant between the emulated trial and the published randomized controlled trial.

CONCLUSION: Despite challenges, observational methods and real-world data can be leveraged in certain important situations for a more timely evaluation of drug effectiveness and safety in more diverse and representative patient populations.

PMID:37589143 | DOI:10.1177/17407745231193137

J Am Heart Assoc. 2023 Aug 17:e030031. doi: 10.1161/JAHA.123.030031. Online ahead of print.

ABSTRACT

Background Stress experienced in a marriage or committed relationship may be associated with worse patient-reported outcomes after acute myocardial infarction (AMI), but little is known about this association in young adults (≤55 years) with AMI. Methods and Results We used data from VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), an observational cohort study that enrolled individuals aged 18 to 55 years with AMI (2008-2012). Marital stress was self-reported 1 month after AMI using the Stockholm Marital Stress Scale (categorized as absent/mild, moderate, and severe). Outcomes were physical/mental health (Short Form-12), generic health status (EuroQol-5 Dimensions), cardiac-specific quality of life and angina (Seattle Angina Questionnaire), depressive symptoms (Patient Health Questionnaire-9), and all-cause readmission 1 year after AMI. Regression models were sequentially adjusted for baseline health, demographics (sex, age, race or ethnicity), and socioeconomic factors (education, income, employment, and insurance). Sex and marital stress interaction was also tested. Among 1593 married/partnered participants, 576 (36.2%) reported severe marital stress, which was more common in female than male participants (39.4% versus 30.4%, P=0.001). Severe marital stress was significantly associated with worse mental health (beta=-2.13, SE=0.75, P=0.004), generic health status (beta=-3.87, SE=1.46, P=0.008), cardiac-specific quality of life (beta=-6.41, SE=1.65, P<0.001), and greater odds of angina (odds ratio [OR], 1.49 [95% CI, 1.06-2.10], P=0.023) and all-cause readmissions (OR, 1.45 [95% CI, 1.04-2.00], P=0.006), after adjusting for baseline health, demographics, and socioeconomic factors. These associations were similar across sexes (P-interaction all >0.05). Conclusions The association between marital stress and worse 1-year health outcomes was statistically significant in young patients with AMI, suggesting a need for routine screening and the creation of interventions to support patients with stress recovering from an AMI.

PMID:37589125 | DOI:10.1161/JAHA.123.030031

Circ Arrhythm Electrophysiol. 2023 Aug 17:e010891. doi: 10.1161/CIRCEP.122.010891. Online ahead of print.

ABSTRACT

BACKGROUND: Pathogenic variants in genes encoding CaM (calmodulin) are associated with a life-threatening ventricular arrhythmia syndrome (calmodulinopathy). The in vivo consequences of CaM variants have not been studied extensively and there is incomplete understanding of the genotype-phenotype relationship for recurrent variants. We investigated effects of different factors on calmodulinopathy phenotypes using 2 mouse models with a recurrent pathogenic variant (N98S) in Calm1 or Calm2.

METHODS: Genetically engineered mice with heterozygous N98S pathogenic variants in Calm1 or Calm2 genes were generated. Differences between the sexes and affected genes were assessed using multiple physiological assays at the cellular and whole animal levels. Statistical significance among groups was evaluated using 1-way ANOVA or the Kruskal-Wallis test when data were not normally distributed.

RESULTS: Calm1^N98S/+ (Calm1^S/+) or Calm2 ^N98S/+ (Calm2^S/+) mice exhibited sinus bradycardia and were more susceptible to arrhythmias after exposure to epinephrine and caffeine. Male Calm1^S/+ mice had the most severe arrhythmia phenotype with evidence of early embryonic lethality, greater susceptibility for arrhythmic events, frequent premature beats, corrected QT prolongation, and more heart rate variability after epinephrine and caffeine than females with the same genotype. Calm2^S/+ mice exhibited a less severe phenotype, with female Calm2^S/+ mice having the least severe arrhythmia susceptibility. Flecainide was not effective in preventing arrhythmias in heterozygous CaM-N98S mice. Intracellular Ca²⁺ transients observed in isolated ventricular cardiomyocytes from male heterozygous CaM-N98S mice had lower peak amplitudes and slower sarcoplasmic reticulum Ca²⁺ release following in vitro exposure to epinephrine and caffeine, which were not observed in cardiomyocytes from heterozygous female CaM-N98S mice.

CONCLUSIONS: We report heterogeneity in arrhythmia susceptibility and cardiomyocyte Ca²⁺ dynamics among male and female mice heterozygous for a recurrent pathogenic variant in Calm1 or Calm2, illustrating a complex calmodulinopathy phenotype in vivo. Further investigation of sex and genetic differences may help identify the molecular basis for this heterogeneity.

PMID:37589122 | DOI:10.1161/CIRCEP.122.010891

Pol Merkur Lekarski. 2023;51(3):250-254. doi: 10.36740/Merkur202303111.

ABSTRACT

OBJECTIVE: Aim: To study the risk factors in patients with prediabetes that can lead to the progression of impaired glucose tolerance in the form of type 2 diabetes mellitus.

PATIENTS AND METHODS: Materials and methods: The selection of patients for this study was carried out on an outpatient basis at the Department of Therapy and Family Medicine, Uzhhorod National University. Patients with prediabetes were identified based on the American Diabetes Association criteria. Informed consent was obtained from all patients before the start of the study. Patients were randomly assigned to one of two groups: Group 1 (n=37) that received typical treatment according to the recommendations of the American Diabetes Association and the control Group 2 (n=42). At the 3rd year of the study, we determined the body mass index, glucose levels and glycated hemoglobin levels of the patients, also their medical documentation was analyzed and patients were interviewed about concomitant diseases.

RESULTS: Results: Analyzing the 3-year follow-up of patients with prediabetes, cases of type 2 diabetes mellitus were detected in both groups, but there is no statistically significant difference when comparing the indicators between the groups (p>0.05).

CONCLUSION: Conclusions: In our study, we analyzed the risk factors in patients with prediabetes that can lead to type 2 diabetes. During a 3-year follow-up, we identified cases of type 2 diabetes mellitus.

PMID:37589111 | DOI:10.36740/Merkur202303111

Pol Merkur Lekarski. 2023;51(3):245-249. doi: 10.36740/Merkur202303110.

ABSTRACT

OBJECTIVE: Aim: To study the risk factors in patients with prediabetes that can lead to the progression of impaired glucose tolerance in the form of type 2 diabetes mellitus.

PATIENTS AND METHODS: Materials and methods: The selection of patients for this study was carried out on an outpatient basis at the Department of Therapy and Family Medicine, Uzhhorod National University. Patients with prediabetes were identified based on the American Diabetes Association criteria. Informed consent was obtained from all patients before the start of the study. Patients were randomly assigned to one of two groups: Group 1 (n=37) that received typical treatment according to the recommendations of the American Diabetes Association and the control Group 2 (n=42). At the 3rd year of the study, we determined the body mass index, glucose levels and glycated hemoglobin levels of the patients, also their medical documentation was analyzed and patients were interviewed about concomitant diseases.

RESULTS: Results: Analyzing the 3-year follow-up of patients with prediabetes, cases of type 2 diabetes mellitus were detected in both groups, but there is no statistically significant difference when comparing the indicators between the groups (p>0.05).

CONCLUSION: Conclusions: In our study, we analyzed the risk factors in patients with prediabetes that can lead to type 2 diabetes. During a 3-year follow-up, we identified cases of type 2 diabetes mellitus.

PMID:37589110 | DOI:10.36740/Merkur202303110