Association of heavy menstrual bleeding with cardiovascular disease in US female hospitalizations.

BACKGROUND: Heavy menstrual bleeding (HMB) is a common menstrual disorder associated with multiple risk factors of cardiovascular disease (CVD) in women. In addition, HMB is often present with irregular menstruation (IM) which is a risk factor for CVD outcomes. However, the relationship between HMB and CVD outcomes is unexplored in the presence or absence of IM. We determined the association of HMB with multiple CVD outcomes using a nationally representative sample of female hospitalizations in the US. METHODS: All hospitalizations of females with HMB diagnosis and normal menstrual cycles from ages of 18 to 70 years were extracted from the National Inpatient Sample Database, 2017. The HMB was defined using the International Classification of Diseases (ICD)-10 for excessive and frequent menstruation bleeding and included any current or history of HMB diagnosis. Outcomes including major adverse cardiovascular events (MACE), coronary heart disease (CHD), stroke, heart failure (HF), atrial fibrillation (AF) or arrhythmia, myocardial infarction (MI), and diabetes (DM) were defined using ICD-10 codes. Adjusted logistic regression and prosperity scores-matched logistic regression analyses were conducted to summarize adjusted associations with an odds ratio (OR) and a 95% confidence interval (CI). RESULTS: Among 2,430,851 hospitalizations, HMB was observed in 7762 (0.68%) females with age ≤ 40 years and 11,164 (0.86%) females with age > 40 years. Among hospitalizations with age ≤ 40 years, HMB was significantly associated with increased odds of CVD outcomes including MACE (OR = 1.61; 95% CI: 1.25, 2.08), CHD (OR = 1.72; 95% CI: 1.10, 2.71), stroke (OR = 1.95; 95% CI: 1.12, 3.40), HF (OR = 1.53; 95% CI: 1.15, 2.03), and AF/arrhythmia (OR = 1.84; 95% CI: 1.34, 2.54). These associations were confirmed in multiple sensitivity analyses. In contrast, HMB was not robustly associated with CVD events among hospitalizations of women with age > 40 years. HMB without IM was strongly associated with DM, HF, AF, and MACE outcomes while HMB with IM was strongly associated with CHD and AF outcomes in hospitalizations of young women. CONCLUSIONS: HMB is associated with CVD events among US hospitalizations of young women. A routine investigation and screening of menstrual disorders, especially HMB, is useful for CVD risk stratification and management in young women.

Associations of sex hormone ratios with metabolic syndrome and inflammation in US adult men and women.

Background: Sex hormones play a critical role in sex differences and cardiovascular disease risk associated with metabolic syndrome (MS) and inflammation. However, the associations of sex hormone ratios with metabolic and inflammatory markers are unclear according to sex and age differences. We evaluated the associations of sex hormone ratios with MS and inflammation among males and females. Methods: A retrospective cross-sectional study was conducted by including all adults from the National Health and Nutrition Examination Survey cycles 2013-2016 and excluding any pregnant women, heart disease, diabetes, and those currently taking insulin. MS was defined using the National Cholesterol Education Program criteria and a high-sensitivity C-reactive protein (CRP) level>3 mg/L was defined as a high CRP. Measures of MS components and CRP concentrations were also analyzed. The primary exposures were testosterone to estradiol (excess androgen index), testosterone to sex hormone-binding globulin (free androgen index), and estradiol to sex hormone-binding globulin (free estradiol index). The adjusted associations were summarized with a relative risk (RR) and 95% confidence interval (CI). Results: This study included 9167 subjects with 4360 males and 4807 females. Increases in free estradiol index were positively associated with MS (RR=1.48; 95%CI: 1.39, 1.58; RR=1.31; 95%CI: 1.22, 1.40) and high CRP (RR=1.49; 95%CI: 1.25, 1.77; RR=1.26; 95%CI: 1.06, 1.50) in men with age<50 years and age≥50 years, respectively. Similarly, higher free estradiol index was also robustly associated with increased prevalence of MS (RR=1.22; 95%CI: 1.15, 1.28) and high CRP (RR=1.68; 95%CI: 1.48, 1.90) in women with age ≥50 years. Among women with age<50 years, a higher free androgen index was associated with MS (RR=1.34; 95%CI: 1.25, 1.42) and high CRP (RR=1.13; 95%CI: 1.02, 1.25). These associations were unchanged even after adjusting for all sex hormones. Conclusion: Free estradiol index was consistently and positively associated with MS and high CRP in males of all ages and older females. Free androgen index was positively associated with MS and high CRP in females with age<50 years.

Polycystic Ovary Syndrome, Insulin Resistance, and Cardiovascular Disease.

PURPOSE OF REVIEW: Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in women of reproductive age. It has been associated with metabolic, reproductive, and psychiatric disorders. Despite its association with insulin resistance (IR) and cardiovascular disease (CVD) risk factors, the association between PCOS and CVD outcomes has been conflicting. This review reports the updated evidence between PCOS, insulin resistance, and CVD events. RECENT FINDINGS: IR is highly prevalent occurring in 50 to 95% of general and obese PCOS women. The etiology of PCOS involves IR and hyperandrogenism, which lead to CVD risk factors, subclinical CVD, and CVD outcomes. Multiple studies including meta-analysis confirmed a strong association between PCOS and CVD events including ischemic heart disease, stroke, atrial fibrillation, and diabetes, particularly among premenopausal women, and these associations were mediated by metabolic abnormalities. PCOS is highly familial and has substantial CVD risk and transgenerational effects regardless of obesity. A personalized approach to the CVD risk assessment and management of symptom manifestations should be conducted according to its phenotypes. Lifestyle modifications and reduction in environmental stressors should be encouraged for CVD prevention among PCOS women.

EXPRESS: Effectiveness of HMG-CoA reductase inhibitors on inflammation and metabolic markers in the US-Mexico border Hispanic population.

HMG-CoA reductase inhibitors (statins) are commonly used for dyslipidemia management to reduce the risk of cardiovascular disease (CVD). High-sensitivity C-reactive protein (hs-CRP) is an emerging systematic low-grade inflammatory marker associated with atherosclerotic CVD development. Despite racial/ethnic disparities in the use and response of statins and the anti-inflammatory effects of statins, the effectiveness of statins on inflammation and metabolic markers is unknown among Hispanics. We performed a retrospective cohort study using 150 adult patients scheduled for an annual physical exam at a family medicine clinic between January 1, 2021, and December 31, 2021. Effect size with a 95% confidence interval (CI) was estimated using adjusted regression analyses. Among 150 patients, 52 (34.67%) received statins. Patients who received statins had significantly reduced median hs-CRP (1.9 vs. 3.2, p=0.007), mean low-density lipoprotein (LDL-C) (101.18 vs. 124.6, p<0.001), and total cholesterol (172.6 vs. 194.5, p<0.001) concentrations compared to those who did not receive statins. In the propensity-scores matched analysis, lower concentrations of log-transformed hs-CRP (regression coefficient [RC], -0.48; 95%CI: -0.89, -0.07), LDL-C (RC, -19.57; 95%CI: -33.04, -6.1), and total cholesterol (RC, -23.47; 95%CI: -38.96, -7.98) were associated with statin use. In addition, hepatic steatosis (adjusted relative risk [aRR]=0.25; 95%CI: 0.08, 0.78, p= 0.017) was significantly lower among patients with the use of statins. Our study suggests that HMG-CoA reductase inhibitors may help reduce inflammation among Hispanic patients with dyslipidemia and hypertension. These findings have useful implications for preventing risk and disparities associated with cardiovascular and other inflammatory-induced diseases among the fastest-growing US Hispanic minorities.

Evaluation of Four Validated Risk Scores to Predict Outcomes in Hispanic Patients With Acute Pulmonary Embolism.

Risk stratification plays an essential role in the management of acute pulmonary embolism (PE). Several risk scores have been studied to support risk stratification and management. While ethnic differences in acute PE risk factors exist, current risk scores lack validation for Hispanic patients. Therefore, the present study retrospectively investigated the performance of the pulmonary embolism severity index (PESI), simplified PESI (sPESI), the European Society of Cardiology risk assessment (ESC), and the Bova score, to predict 30-day mortality in Hispanic patients presenting with an acute PE. Among 437 patients admitted with acute PE, 30-day mortality was 10.8%; 30-day mortality in low-risk groups ranged from 0% (sPESI, ESC) to 0.2% (PESI, Bova), and 3.0% (Bova) to 5.7% (PESI) in the highest risk groups, respectively. All four scores produced statistically significant discrimination between different risk strata. However, no single scoring system was able to identify all patients with 30-day mortality. The findings of the present study suggest that PESI, sPESI, ESC, and Bova scores provide important information about 30-day mortality in Hispanic in-patients presenting with acute PE. However, additional clinical information could further improve predictability that is not provided by a single scoring system.

Prevalence and clinical significance of deep vein thrombosis in Hispanic patients with acute pulmonary embolism.

The prevalence of concomitant deep vein thrombosis (DVT) and its impact on 30-day outcomes in Hispanic patients with acute pulmonary embolism (PE) is unknown. We retrospectively studied a cohort of Hispanic patients admitted for acute PE to determine the relationship of concomitant DVT to clot burden on chest computer tomography (CT), right heart strain, and 30-day mortality. We identified 391 patients admitted with acute PE; 168 (42.9%) had concomitant DVTs on admission; 39 patients (9.9%) died during the 30-day follow-up: 12 patients without concomitant DVT and 27 with concomitant DVT, respectively (p < .001). The presence of a proximal DVT independently predicted 30-day mortality even after adjusting for age, gender and admission PE severity index scores (PESI) (hazard ratio [HR] 2.0; 95% confidence interval [CI]: 1.4-3.0, p = .001). Proximal DVTs remained a significant predictor of 30-day mortality in patients with low and intermediate PESI scores (HR 2.5; 95% CI: 1.1-6.0, p = .035). The prevalence of concomitant DVT in Hispanic patients presenting with acute DVT is relatively lower than other ethnic groups. However, a proximal location of a DVT is of significant prognostic relevance. Hispanic patients with acute PE should routinely undergo compression doppler ultrasonography (CDUS) of the lower extremities.

Association of polycystic ovary syndrome with cardiovascular disease among female hospitalizations in the United States.

OBJECTIVE: Polycystic ovary syndrome (PCOS) is a complex disorder characterized by a wide range of symptoms related to ovulatory dysfunction and androgen overproduction. Although PCOS is associated with multiple cardiovascular disease (CVD)-risk factors, previous studies have reported controversial associations between PCOS and different types of CVD events. We sought to determine the association of PCOS with various CVD outcomes among hospitalized women. METHODS: All women hospitalizations between the ages of 15 and 65 years recorded in the National Inpatient Sample database, 2017 were analyzed with sampling-weighted logistic regression analysis. The International Classification of Diseases, 10th revision, codes were used to define outcomes including composite CVD, major adverse cardiovascular events (MACEs), coronary heart disease (CHD), stroke/cerebrovascular accident (CVA), heart failure (HF), arterial fibrillation (AF) or arrhythmia, pulmonary heart disease (PHD), myocardial infarction, cardiac arrest, and diabetes. RESULTS: Among the total hospitalizations of women, 13 896 (0.64) had a PCOS diagnosis. Polycystic ovary syndrome was found to be associated with most CVD outcomes, including composite CVD (adjusted odds ratio [aOR] = 1.73, 95% CI, 1.55-1.93, P < .001), MACE (aOR = 1.31, 95% CI, 1.12-1.53, P < .001), CHD (aOR = 1.65, 95% CI, 1.35-2.01, P < .001), stroke/CVA (aOR = 1.46, 95% CI, 1.08-1.98, P = .014), HF (aOR = 1.30, 95% CI, 1.07-1.57, P = .007), AF/arrhythmia (aOR = 2.20, 95% CI, 1.88-2.57, P < .001), and PHD (aOR = 1.58, 95% CI, 1.23-2.03, P < .001) among hospitalized women with an age of ≤40 years. However, the associations between PCOS and CVD outcomes were mediated by obesity and metabolic syndrome conditions. CONCLUSIONS: Polycystic ovary syndrome is associated with CVD events and the association is mediated by obesity and metabolic syndrome conditions, particularly among hospitalized women aged ≤40 years in the United States.

Common Variables That Influence Sepsis Mortality in Mice.

Introduction: Sepsis is characterized by a dysregulated host immune response to infection, leading to organ dysfunction and a high risk of death. The cecal ligation and puncture (CLP) mouse model is commonly used to study sepsis, but animal mortality rates vary between different studies. Technical factors and animal characteristics may affect this model in unanticipated ways, and if unaccounted for, may lead to serious biases in study findings. We sought to evaluate whether mouse sex, age, weight, surgeon, season of experiments, and timing of antibiotic administration influenced mortality in the CLP model. Methods: We created a comprehensive dataset of C57BL/6J mice that had undergone CLP surgery within our lab during years 2015-2020 from published and unpublished studies. The primary outcome was defined as the time from sepsis induction to death or termination of study (14 days). The Log rank test and Cox regression models were used to analyze the dataset. The study included 119 mice, of which 43% were female, with an average age of 12.6 weeks, an average weight of 25.3 g. 38 (32%) of the animals died. Results: In the unadjusted analyses, experiments performed in the summer and higher weight predicted a higher risk of mortality. In the stratified Cox model by sex, summer season (adjusted hazard ratio [aHR]=5.61, p=0.004) and delayed antibiotic administration (aHR=1.46, p=0.029) were associated with mortality in males, whereas higher weight (aHR=1.52, p=0.005) significantly affected mortality in females. In addition, delayed antibiotic administration (HR=1.42, p=0.025) was associated with mortality in the non-summer seasons, but not in the summer season. Discussion: In conclusion, some factors specific to sex and season have a significant influence on sepsis mortality in the CLP model. Consideration of these factors along with appropriate group matching or adjusted analysis is critical to minimize variability beyond the experimental conditions within a study.

A phase 1 open-label trial evaluating focused ultrasound unilateral anterior thalamotomy for focal onset epilepsy.

OBJECTIVE: Focused ultrasound ablation (FUSA) is an emerging treatment for neurological and psychiatric diseases. We describe the initial experience from a pilot, open-label, single-center clinical trial of unilateral anterior nucleus of the thalamus (ANT) FUSA in patients with treatment-refractory epilepsy. METHODS: Two adult subjects with treatment-refractory, focal onset epilepsy were recruited. The subjects received ANT FUSA using the Exablate Neuro (Insightec) system. We determined the safety and feasibility (primary outcomes), and changes in seizure frequency (secondary outcome) at 3, 6, and 12 months. Safety was assessed by the absence of side effects, that is, new onset neurological deficits or performance deterioration on neuropsychological testing. Feasibility was defined as the ability to create a lesion within the anterior nucleus. The monthly seizure frequency was compared between baseline and postthalamotomy. RESULTS: The patients tolerated the procedure well, without neurological deficits or serious adverse events. One patient experienced a decline in verbal fluency, attention/working memory, and immediate verbal memory. Seizure frequency reduced significantly in both patients; one patient was seizure-free at 12 months, and in the second patient, the frequency reduced from 90-100 seizures per month to 3-6 seizures per month. SIGNIFICANCE: This is the first known clinical trial to assess the safety, feasibility, and preliminary efficacy of ANT FUSA in adult patients with treatment-refractory focal onset epilepsy.

Ethnic/racial differences in risk factors and clinical outcomes among patients with amyloidosis.

BACKGROUND: Cardiac amyloidosis is caused by abnormal extracellular deposition of insoluble fibrils in cardiac tissue. It can be fatal when untreated and is often underdiagnosed. Understanding the ethnic/racial differences in risk factors is critical for early diagnosis and treatment to improve clinical outcomes. METHODS: We performed a retrospective cross-sectional study utilizing the National Inpatient Sample database from 2015 to 2018 using ICD-10-CM codes. The primary variables of interest were race/ethnicity and amyloidosis subtypes, while the primary outcomes were in-hospital mortality, gastrointestinal bleeding, renal failure, and hospital length-of-stay. RESULTS: Amyloidosis was reported in 0.17% of all hospitalizations (N  =  19,678,415). Of these, 0.09% were non-Hispanic whites, 0.04% were non-Hispanic blacks, and 0.02% were Hispanic. Hospitalizations with ATTR amyloidosis subtype were frequently observed in older individuals and males with coronary artery disease, whereas AL amyloidosis subtype was associated with non-Hispanic whites, congestive heart failure, and longer hospital length of stay. Renal failure was associated with non-Hispanic blacks (adjusted relative risk [RR]  =  1.31, p < 0.001), Hispanics (RR  =  1.08, p  =  0.028) and had an increased risk of mortality. Similarly, the hospital length of stay was longer with non-Hispanic blacks (RR  =  1.19, p < 0.001) and Hispanics (RR  =  1.05, p  =  0.03) compared to non-Hispanic whites. Hispanics had a reduced risk of mortality (RR  =  0.77, p  =  0.028) compared to non-Hispanic whites and non-Hispanic blacks, and no significant difference in mortality was seen between non-Hispanic whites and non-Hispanic blacks (RR  =  1.00, p  =  0.963). CONCLUSIONS: Our findings highlight significant ethnic/racial differences in risk factors and outcomes among amyloidosis-related US hospitalizations that can possibly be used for early detection, treatment, and better clinical outcomes.

Standardized uptake value of normal organs on routine clinical [18F]FDG PET/CT: impact of tumor metabolism and patient-related factors.

BACKGROUND: To evaluate the effect of patient-related factors such as age, gender, body mass index (BMI), blood glucose (BG), diabetes, serum creatinine and injected dose on 18F-Fluorodeoxyglucose ([18F]FDG) uptake of tumor and normal organs, as well impact of [18F]FDG uptake of tumor on normal organs, in clinical positron emission tomography-computed tomography (PET/CT). MATERIAL AND METHODS: In this retrospective study, data of 200 patients who underwent clinical [18F]FDG PET/CT with (n = 192) and without (n = 8) intravenous contrast was evaluated. Ten target organs and tumor [18F]FDG uptake were measured with a standardized uptake value maximum (SUVmax). Pearson correlation coefficient was calculated for continuous variables while t-test/Wilcoxon rank sum tests were used to compare continuous outcomes. Multivariate linear regression analysis was done to exclude covariates, followed by posthoc multiple linear regression analysis after adjusting the levels of significance. RESULTS: Significant but weak positive correlation was seen between tumor [18F]FDG uptake with uptake in the pancreas (r = 0.43, p < 0.001) and heart (r = 0.19, p = 0.049), but not other organs. With age, a significant negative correlation was seen with the brain (r = -0.183, p = 0.009) and a positive correlation was seen with the blood pool (r = 0.205, p = 0.003). With BG, significant negative correlation was seen with the brain (r = -0.449, p < 0.0001) and heart (r = -0.15, p = 0.033), while a positive correlation was seen with fat (r = 0.143, p = 0.043). BMI showed a significant positive correlation with [18F]FDG uptake of all organs except the pancreas and heart, as well as tumor. No significant correlation was seen with serum creatinine and injected [18F]FDG dose. Significantly higher uptake was seen in the brain, spleen, and muscles of females. Between obese and non-obese, a significant difference was seen for all organs except for the pancreas and heart, and tumor. Comparison between non-diabetic and diabetic patients showed significant differences only for bone. Multivariate linear analysis adjusting for cofactors showed only BMI (p = 0.0009) and BG (p = 0.0002) to be independently correlated with [18F]FDG uptake. Post-hoc multiple regression analysis showed a significant positive correlation between [18F]FDG uptake of the brain (ß = 0.118, p < 0.001), liver (ß = 0.02, p = 0.002), and fat (ß = 0.01, p < 0.0006) with BMI, and significant negative correlation of brain uptake with BG (ß = 0.03, p < 0.0001). CONCLUSIONS: Tumor [18F]FDG uptake has no significant effect on the uptake in organs, except for the pancreas and heart. Age, gender, BMI, and BG, but not creatinine and injected [18F]FDG dose show correlation with uptake in tumor and organs. BG and BMI are independent significant factors, with a positive correlation of BMI with the brain, hepatic and fat uptake, and a negative correlation of BG with brain uptake.

Frequency of GLP-1 receptor agonists use in diabetic patients diagnosed with delayed gastric emptying and their demographic profile.

Advances in the management of diabetes mellitus have come a long way in the 21st century. One of the most important developments in diabetes management has been the discovery of glucagon-like peptide-1 (GLP-1) receptor agonists. The most common side effects of GLP-1 receptor (GLP-1R) agonists are nausea and vomiting which have been attributed to delayed gastric emptying. While the effects of GLP-1R agonists on gastric emptying have prompted further research in this field, there are limited studies evaluating their effects on patients with pre-existing gastroparesis. Additionally, the frequency of GLP-1R agonist use among patients with gastroparesis has not been assessed in the past and this study aims to identify that percentage along with evaluating for possible iatrogenic gastroparesis. A retrospective review of all the gastric emptying studies performed at one academic medical center between January 2019 and January 2021 was performed. We found that although patients on GLP-1R agonists were more likely to have delayed gastric emptying, we could not establish a statistical significance. This could be due to the small sample size in the study. However, GLP-1R agonists use was associated with delayed gastric emptying in patients with diabetes for <10 years. Moreover, a significant proportion (24%) of patients with diabetes with delayed gastric emptying were on a GLP-1R agonist. Recently, semaglutide (GLP-1R agonist) gained Food and Drug Administration approval as a weight loss medication in both patients with and without diabetes. This should prompt further research to evaluate the safety profile of these medications in patients with and without pre-existing gastroparesis.

Air Pollution and the Heart: Updated Evidence from Meta-analysis Studies.

PURPOSE OF REVIEW: Although environmental exposure such as air pollution is detrimental to cardiovascular disease (CVD), the effects of different air pollutants on different CVD endpoints produced variable findings. We provide updated evidence between air pollutants and CVD outcomes including mitigation strategies with meta-analytic evidence. RECENT FINDINGS: An increased exposure to any class of air pollutants including particulate matter (PM), gas, toxic metals, and disruptive chemicals has been associated with CVD events. Exposure to PM < 2.5 µm has been consistently associated with most heart diseases and stroke as well as CVDs among at-risk individuals. Despite this, there is no clinical approach available for systemic evaluation of air pollution exposure and management. A large number of epidemiological evidence clearly suggests the importance of air pollution prevention and control for reducing the risk of CVDs and mortality. Cost-effective and feasible strategies for air pollution monitoring, screening, and necessary interventions are urgently required among at-risk populations and those living or working, or frequently commuting in polluted areas.

Effects of statins on outcomes in Hispanic patients with COVID-19.

The Hispanic population is regarded among those who are at greater risk of adverse prognoses due to higher rates of diabetes and obesity in the USA during the COVID-19 pandemic. Statin medications are speculated to help treat the infection by decreasing inflammation caused by COVID-19. In this retrospective, observational study, outcomes of statin use were assessed among Hispanic patients with COVID-19 by screening all patients hospitalized between March, 2020 and March, 2021 at a tertiary care hospital in El Paso, Texas, resulting in a total of 1039 patients. The patients were categorized into a group of either being on statins or not. The considered outcomes were mechanical ventilation, intensive care unit (ICU) hospitalization, oxygen supplementation at discharge, hospital length of stay, and mortality. Patients receiving statins were observed to be older with more comorbidities. In the propensity-scores adjusted analysis, no association was found between statin use and: mortality (adjusted risk ratio (aRR)=0.96, p=0.754), mechanical ventilation (aRR=0.91, p=0.503), ICU transfer (aRR=0.96, p=0.395), and O2 supplementation at discharge (aRR=1.03, p=0.729). These outcomes were also evaluated in patients who had myocardial infarction and stroke with COVID-19. Among these patients, association was found between statin use and: a reduced risk of mortality (aRR=0.61, p=0.005), mechanical ventilation (aRR=0.53, p=0.012) and ICU transfers (aRR=0.81, p=0.005). These results may not give us a reason to start patients on statins for the specific treatment of COVID-19, but it may be sufficient evidence to suggest statins should not be discontinued during hospitalization due to COVID-19.

How to write statistical analysis section in medical research.

Reporting of statistical analysis is essential in any clinical and translational research study. However, medical research studies sometimes report statistical analysis that is either inappropriate or insufficient to attest to the accuracy and validity of findings and conclusions. Published works involving inaccurate statistical analyses and insufficient reporting influence the conduct of future scientific studies, including meta-analyses and medical decisions. Although the biostatistical practice has been improved over the years due to the involvement of statistical reviewers and collaborators in research studies, there remain areas of improvement for transparent reporting of the statistical analysis section in a study. Evidence-based biostatistics practice throughout the research is useful for generating reliable data and translating meaningful data to meaningful interpretation and decisions in medical research. Most existing research reporting guidelines do not provide guidance for reporting methods in the statistical analysis section that helps in evaluating the quality of findings and data interpretation. In this report, we highlight the global and critical steps to be reported in the statistical analysis of grants and research articles. We provide clarity and the importance of understanding study objective types, data generation process, effect size use, evidence-based biostatistical methods use, and development of statistical models through several thematic frameworks. We also provide published examples of adherence or non-adherence to methodological standards related to each step in the statistical analysis and their implications. We believe the suggestions provided in this report can have far-reaching implications for education and strengthening the quality of statistical reporting and biostatistical practice in medical research.

Repetitive transcranial magnetic stimulation for generalized anxiety and panic disorders: A systematic review and meta-analysis.

BACKGROUND: Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved, noninvasive modality for treating major depressive disorder and obsessive-compulsive disorder. Earlier studies evaluating therapeutic effects of rTMS on symptom scores of patients with generalized anxiety disorder (GAD) and panic disorder (PD) have yielded inconsistent findings. METHODS: We performed a systematic review and meta-analysis of interventional studies assessing the effect of rTMS on symptom scores in patients with GAD or PD with or without psychiatric comorbidities using studies published up to April 2021. We used DerSimonian-Laird random effects models to obtain pooled standardized mean difference (SMD) and 95% CI. RESULTS: A total of 13 studies consisting of 677 participants (404 treated with rTMS and 273 without rTMS) were included in this meta-analysis. In GAD patients with or without any comorbidities, rTMS therapy demonstrated significant improvements in anxiety (SMD = 1.45; P < .001) and depression (SMD = 1.65; P < .001) scores regardless of rTMS parameters. Overall anxiety (SMD = 0.24; P = .48) and panic severity (SMD = 1.19; P = .054) scores did not significantly improve after rTMS therapy in patients with PD. CONCLUSIONS: rTMS is safe and improves anxiety and depression scores only in GAD patients, regardless of underlying comorbidities or rTMS parameters.

Associations of Glycemic Index and Glycemic Load with Cardiovascular Disease: Updated Evidence from Meta-analysis and Cohort Studies.

PURPOSE OF REVIEW: Diet and lifestyle patterns are considered major contributory factors for cardiovascular disease (CVD) and mortality. In particular, consuming a diet higher in carbohydrates (not inclusive of fruits and vegetables, but more processed carbohydrates) has been associated with metabolic abnormalities that subsequently may increase the risk of CVD and related mortality. Glycemic index (GI) and glycemic load (GL) are values given to foods based on how fast the body converts carbohydrates into glucose also referred to as the glycemic burden of carbohydrates from foods. Conflicting associations of how high GI and GL influence CVDs have been observed even in high-quality meta-analysis studies. We synthesize and report the associations of high GI and GL with various CVDs by sex, obesity, and geographical locations using an updated review of meta-analysis and observational studies. RECENT FINDINGS: We identified high GI or high GL is associated with an increased risk of CVD events including diabetes (DM), metabolic syndrome (MS), coronary heart disease (CHD), stroke, and stroke mortality in the general population, and the risk of CVD outcomes appears to be stratified by sex, obesity status, and preexisting CVD. Both high GI and GL are associated with DM and CHD in the general population. However, high GI is strongly associated with DM/MS, while high GL is strongly associated with an increased risk of CHD in females. In addition, high GL is also associated with incident stroke, and appears to be associated with CVD mortality in subjects with preexisting CVD or high BMI and all-cause mortality in non-obese DM subjects. However, high GI appears to be associated with CVD or all-cause mortality only in females without CVD. High GI/GL is an important risk factor for CVD outcomes in the general population. High GI seems to be markedly associated with DM/MS, and it may enhance the risk of CVD or all-cause mortality in both sexes and predominately females. Although both high GI and high GL are risk factors for CHD in females, high GL is associated with CVD outcomes in at-risk populations for CVD. These data suggest that while high GI increases the propensity of CVD risk factors and mortality in healthy individuals, high GL contributes to the risk of severe heart diseases including CVD or all-cause mortality, particularly in at-risk populations. These data indicate dietary interventions designed for focusing carbohydrate quality by lowering both GI and GL are recommended for preventing CVD outcomes across all populations.

Cervical Spinal Lesion, Completeness of Injury, Stress, and Depression Reduce the Efficiency of Mental Imagery in People With Spinal Cord Injury.

OBJECTIVES: The aims of this study were to assess the relationships of (1) clinical variables (age, level of injury, time since injury [TSI], and completeness of injury) and (2) psychological variables (stress and depression) with mental imagery ability in individuals with spinal cord injury. STUDY DESIGN: This was a cross-sectional study. Participants with spinal cord injury (N = 130) were requested to fill the Kinesthetic and Visual Imagery Questionnaire and Vividness of Motor Imagery Questionnaire. They also completed the Perceived Stress Scale and Patient Health Questionnaire 9 for the assessment of stress and depression, respectively. RESULTS: Mental imagery scores were found to be significantly low in cervical injuries (P < 0.001) as compared with thoracic injuries (P < 0.001). Furthermore, higher levels of spinal injuries resulted in lower mental imagery scores. Completeness of injury (according to Asia Impairment Scale) also had a significant relationship (P < 0.001) with the mental imagery ability among spinal cord injury participants. Presence of stress (P < 0.001) and depression (P < 0.001) also associated with reduced efficiency of mental imagery in these individuals. CONCLUSIONS: Injury type and psychological factors were associated with mental imagery in SCI patients. Imagery-based interventions should be designed after consideration of identified factors yielding effect on their outcomes. TO CLAIM CME CREDITS: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME. CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) Determine the impact of clinical variables such as level of injury, completeness and chronicity of injury on mental imagery ability in spinal cord injury; (2) Discuss the role of stress and depression on mental imagery ability in spinal cord injury; and (3) Describe the various dimensions of mental imagery ability and its variability among individuals who have spinal cord injury. LEVEL: Advanced. ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Pre-hospitalization proton pump inhibitor use and clinical outcomes in COVID-19.

INTRODUCTION: Severe acute respiratory syndrome coronavirus-2 may escape the inactivation by gastric acid because of hypochlorhydria caused by proton pump inhibitors (PPIs), which could predispose the patients to severe COVID-19. METHODS: We studied the association between prehospitalization PPI exposure and clinical outcomes among hospitalized COVID-19 patients. RESULTS: A total of 295 hospitalized COVID-19 patients were included in the study. 15.6% of hospitalized COVID-19 patients were on PPIs at home. Mortality among PPI-users was 2.3 times higher than non-users, along with 2.3 times higher risk of acute respiratory distress syndrome after adjusting for confounding variables. CONCLUSION: We found that prehospitalization PPI-exposure is independently associated with worse clinical outcomes, including mortality in COVID-19 patients, regardless of the presence of cardiovascular comorbidities.