Does Offloading with Felt Foot Plates Heal Diabetic Foot Ulcers?

OBJECTIVE: To determine (1) if offloading with a felt foot plate heals a diabetic foot ulcer, (2) the rate of healing with the felt foot plate, and (3) the impact on rate of healing from the confounding factors of patient weight and growth factors on healing times. METHODS: The researchers conducted a retrospective chart cohort review over 3 years. RESULTS: Using a multivariable linear and logistic regression model, the data showed a statistically significant reduction in the diabetic foot ulcer area over time. Confounding factors of patient weight and growth factors did not impact healing times. CONCLUSIONS: Offloading a diabetic foot ulcer with a felt foot plate is adequate for healing.

A pilot study on predictors of length of stay in a geriatric psychiatric hospital.

BACKGROUND: We wanted to determine the factors that influence geriatric psychiatric hospitalization length of stay (LOS). METHODS: We conducted a retrospective cohort study of a sample of hospital admission records from 2012 to 2018. The hospital records were the geriatric inpatient records of St. John's Hospital, Springfield, Illinois. The data collection was based on the inclusion criteria as approved by the Southern Illinois University School of Medicine Institutional Review Board. To be eligible, participants had to have at least 1 inpatient hospitalization between 2012 and 2017. For the purposes of this study, psychiatric diagnosis was based on DSM-IV criteria. RESULTS: The 141 participants' average age was 71.7 years, and approximately 57% were female; average length of stay was 16 days (range: 1 to 116 days). Indications for current admission included depression and suicidal ideation (45%), psychosis (30%), psychosis and agitation (22%), and mania (3%). Results indicate that having a major depressive disorder (MDD) diagnosis (vs bipolar disorder and schizophrenia) was significantly associated with shorter LOS (P < .001). Other significant predictors were psychosis (P = .03), using mood stabilizers (P = .02), using antidepressants (P = .05), and use of ≥2 (vs 1 or 0) psychotropic medications (P = .02). CONCLUSIONS: Geriatric psychiatric hospitalization was longer in patients with psychosis, but shorter for patients with MDD. Patients receiving mood stabilizers, as well as those receiving ≥2 psychotropics, had longer LOS, while those receiving antidepressants had shorter LOS. This highlights the idea that patients with serious mental illnesses may have longer LOS.

Guidelines for Reporting of Figures and Tables for Clinical Research in Urology.

In an effort to improve the presentation of and information within tables and figures in clinical urology research, we propose a set of appropriate guidelines. We introduce six principles: (1) include graphs only if they improve the reader's ability to understand the study findings; (2) think through how a graph might best convey information, do not just select a graph from preselected options on statistical software; (3) do not use graphs to replace reporting key numbers in the text of a paper; (4) graphs should give an immediate visual impression of the data; (5) make it beautiful; and (6) make the labels and legend clear and complete. We present a list of quick "dos and don'ts" for both tables and figures. Investigators should feel free to break any of the guidelines if it would result in a beautiful figure or a clear table that communicates data effectively. That said, we believe that the quality of tables and figures in the medical literature would improve if these guidelines were to be followed. Patient summary: A set of guidelines were developed for presenting figures and tables in urology research. The guidelines were developed by a broad group of statistical experts with special interest in urology.

Guidelines for Reporting of Figures and Tables for Clinical Research in Urology.

In an effort to improve the presentation of and information within tables and figures in clinical urology research, we propose a set of appropriate guidelines. We introduce six principles: (1) include graphs only if they improve the reader's ability to understand the study findings; (2) think through how a graph might best convey information, do not just select a graph from preselected options on statistical software; (3) do not use graphs to replace reporting key numbers in the text of a paper; (4) graphs should give an immediate visual impression of the data; (5) make it beautiful; and (6) make the labels and legend clear and complete. We present a list of quick "dos and don'ts" for both tables and figures. Investigators should feel free to break any of the guidelines if it would result in a beautiful figure or a clear table that communicates data effectively. That said, we believe that the quality of tables and figures in the medical literature would improve if these guidelines were to be followed. PATIENT SUMMARY: A set of guidelines were developed for presenting figures and tables in urology research. The guidelines were developed by a broad group of statistical experts with special interest in urology.

Guidelines for reporting of statistics for clinical research in urology.

In an effort to improve the quality of statistics in the clinical urology literature, statisticians at European Urology, The Journal of Urology, Urology and BJU International came together to develop a set of guidelines to address common errors of statistical analysis, reporting, and interpretation. Authors should 'break any of the guidelines if it makes scientific sense to do so', but would need to provide a clear justification. Adoption of the guidelines will in our view not only increase the quality of published papers in our journals but improve statistical knowledge in our field in general.

Young adults with depression are at increased risk of sexually transmitted disease.

Sexually transmitted diseases (STDs) and depression impact millions of individuals each year in the United States, with direct medical costs exceeding $41 billion. While the interactions of these conditions are poorly understood, they are increasingly addressed in primary care whereas historically they have been addressed separately. We analyzed data associated with the 18-25year age group from the 2014 National Survey of Drug Use and Health, a cross-sectional survey of the civilian, non-institutionalized US population aged ≥12years for factors associated with past year diagnosis of STD (STDy). Independent variables included participant demographics; lifetime diagnosis of major depressive episode (MDE); participant behaviors associated with STD risk (patient-provided); and medical record data associated with mental illness treatment (clinically-observed). Of 18,142 participants, the prevalence of MDE and STD was 15.3% and 2.4%, respectively, with significant differences by gender and race. MDE was associated with increased risk of STDy among females (odds ratio [OR]=1.61; 95% confidence interval [CI]=1.18-2.20), males (OR=2.32; CI=1.15-4.70), those of white race (OR=3.02; CI=2.02-4.53), and lower income levels and insurance status. Univariate modeling found that receiving mental health treatment, and use of marijuana, alcohol, and illegal drugs were each associated with significantly increased STDy. In a multivariate logistic regression, receiving mental health treatment became protective for STDy (AOR=0.55; CI=0.32-0.95]). Individuals with a history of depression are at increased risk of STDy, with this risk modified by factors readily ascertained within primary care. As depression treatment is increasingly incorporated into primary care there are means to more effectively target intervention resources.

A Meta-Analysis Comparing All-Polyethylene Tibial Component to Metal-Backed Tibial Component in Total Knee Arthroplasty: Assessing Survivorship and Functional Outcomes.

BACKGROUND: This meta-analysis compares the clinical performance of all-polyethylene tibial (APT) to the metal-backed tibial (MBT) components. METHODS: We included comparative studies in primary total knee arthroplasty involving APT and MBT implant components. The primary outcomes were function, durability, and reports of adverse events. RESULTS: Twenty-eight articles with 95 847 knees were available for synthesis. The meta-analysis showed an association of APT with lower revision rates (incidence rate ratio, 0.709; P = .002) and adverse events (incidence rate ratio, 0.785; P = .204). Moderator analyses were performed to determine the effect of posterior cruciate ligament status on outcome, and no statistically significant effect was found for revision risk or adverse events incidence. CONCLUSION: All-polyethylene tibial components seem to be an equal option, with less financial burden than the MBT.

Gender-specific relationships between socioeconomic disadvantage and obesity in elementary school students.

OBJECTIVE: To assess the gender-specific effect of socioeconomic disadvantage on obesity in elementary school students. METHODS: We evaluated body mass index (BMI) data from 2,648 first- and fourth-grade students (1,377 male and 1,271 female students) in eight elementary schools in Springfield, Illinois, between 2012 and 2014. Other factors considered in analysis were grade level, year of data collection, school, race/ethnicity, gender, and socioeconomic disadvantage (SD). Students were considered SD if they were eligible for free/reduced price lunch, a school-based poverty measure. We performed Fisher's exact test or chi-square analysis to assess differences in gender and obesity prevalence by the other factors and gender-stratified logistic regression analysis to determine if SD contributed to increased odds of obesity. RESULTS: A higher proportion of SD female students (20.8%) were obese compared to their non-SD peers (15.2%) (p=0.01). Unadjusted and adjusted logistic regression analysis indicated no difference in obesity in SD and non-SD male students. However, in both unadjusted and adjusted analyses, SD female students had higher odds of obesity than their peers. Even after controlling for grade level, school, year of data collection, and race/ethnicity, SD female students had 49% higher odds of obesity than their non-SD classmates (odds ratio:1.49; 95% confidence interval: 1.09-2.04). CONCLUSIONS: Obesity was elevated in SD female students, even after controlling for factors such as race/ethnicity, but such an association was not seen in male students. Further study is warranted to determine the cause of this disparity, and interventions should be developed to target SD female students.

Counseling on sexual side effects from TURP.

INTRODUCTION: We designed a pilot study to measure preoperative sexual dysfunction risk counseling between sexual medicine experts (SME) and general urologists between monopolar/bipolar transuretheral resection of the prostate (TURP) and laser TURP (LT). MATERIALS AND METHODS: An emailed electronic survey was distributed to members of the North Central Section (NCS) of the American Urologic Association and the Sexual Medicine Society of North America (SMSNA). Overall, 260 (12.3%) completed the survey. Counseling for ejaculatory disorder (EjD), erectile dysfunction (ED), stricture formation and incontinence was assessed. Additional subset analysis between those SME's versus general urologist was done. RESULTS: Overall, 82% (224) identified as general urologists and 18% (49) as SME. Two-thirds were in private practice versus academic. Over 90% of all practitioners 'almost always' counsel about the possibility of EjD, with varied risk rate for LT. Overall, 62%(140) for monopolar TURP (MBT) and 60% (110) for LT 'almost always' counsel about ED. There was no statistical difference between groups counseling on incontinence, strictures, EjD or ED between SME and general urologists. CONCLUSIONS: Sexual side effects of treatment for LUTS/BPH are appreciated by urologists. Most practitioners counsel about EjD, however the incidence varies between MBT and LT. Practitioners counsel their patients on ED less often than EjD. Counseling rates are not improved with those specializing in sexual medicine independent of TURP technique.

Impact of Physician Characteristics on Late-Onset Sepsis (LOS) Evaluation in the NICU.

The threshold for a late-onset sepsis (LOS) evaluation varies considerably across NICUs. This unexplained variability is probably related in part to physician bias regarding when sepsis should be "ruled out". The aim of this study is to determine if physician characteristics (race, gender, immigration status, years of experience and academic rank) effect LOS evaluation in the NICU. This study includes a retrospective chart review of all Level III NICU infants who had a LOS evaluation over 54 months. Physician characteristics were compared between positive and negative blood culture groups and whether CBC and CRP were obtained at LOS evaluations. There were 341 LOS evaluations performed during the study period. Two patients were excluded due to a contaminant. Patients in this study had a birth weight of [median (Q1, Q3)]+ 992 (720, 1820) grams and birth gestation of [median (Q1, Q3)] 276/7 (252/7, 330/7) weeks. There are 10 neonatologists in the group, 5/10 being female and 6/10 being immigrant physicians. Experienced physicians were more likely to obtain a CBC at the time of LOS evaluation. Physician characteristics of race, gender and immigration status impacted whether to include a CRP as part of a LOS evaluation but otherwise did not influence LOS evaluation, including the likelihood of bacteremia.

Incidentally diagnosed mammary gland tumors are less likely to be malignant than nonincidental mammary gland tumors.

OBJECTIVE: To compare malignancy rates of canine mammary gland tumors diagnosed incidentally and nonincidentally. ANIMALS: 96 female dogs from which mammary gland tumors were removed. METHODS: Medical records of all female dogs from which mammary gland tumors were removed at a privately owned referral institution between 2018 and 2021 were reviewed. Data were obtained on signalment for each dog, histopathologic results for each tumor, and the primary reason for each dog's presentation to the hospital. The proportion of malignant tumors was compared between dogs that were presented with nonincidental MGTs and dogs that were presented for a different primary condition and had incidental MGTs found on examination. RESULTS: A total of 195 tumors were removed from the 96 dogs in this study. In dogs with incidental MGTs, 82 of 88 (93%) tumors were benign and 6 of 88 (7%) were malignant. In dogs with nonincidental MGTs, 75 of 107 (70%) tumors were benign and 32 of 107 (30%) were malignant. Nonincidental MGTs were significantly (OR, 5.83; 95% CI, 2.31 to 14.73; P = .001) more likely to be malignant compared with incidental MGTs. Dogs with nonincidental MGTs were 6.84 times as likely to have a malignant MGT removed compared with dogs with incidental MGTs (OR, 6.84; 95% CI, 2.47 to 18.94; P < .001). The likelihood of malignancy increased by 5% for each 1-kg increase in body weight (OR, 1.05; 95% CI, 1.01 to 1.09; P = .013). Larger tumors were more likely to be malignant than smaller tumors (P = .001). CLINICAL RELEVANCE: Most incidentally diagnosed MGTs are benign and allow for a good prognosis after excision. Small dogs and dogs with MGTs < 3 cm in diameter are the least likely to have a malignancy.

Prediction of Recurrence of Atrial Fibrillation Post-ablation Based on Atrial Fibrosis Seen on Late Gadolinium Enhancement MRI: A Metaanalysis.

OBJECTIVES: This meta-analysis aims to investigate the recurrence of atrial fibrillation (AF) post-ablation based on the various stages of fibrosis seen in the late gadolinium enhancement magnetic resonance imaging (LGE-MRI). METHODS: Electronic databases were searched using specific terms and identified nine studies that met the inclusion criteria. A total of 1,787 patients underwent LGE-MRI to assess atrial fibrosis before catheter ablation for AF. We performed three analyses: first, we compared stage IV versus stage I (reference group). The second set examined the combined stages III and IV versus stages I and II (reference group). The third set compared stage IV versus combined stages I, II, and III. The metanalysis relied on a random-effects model to pool the odds ratios (OR) and 95% confidence intervals (CI) using the DerSimonian and Laird method. The data was analyzed using StatsDirect software in England. RESULTS: The study showed a higher rate of AF recurrence after ablation in stage IV atrial fibrosis than in stage I (OR, 9.54; 95% CI, 3.81 to 28.89; P<00001). Also, in patients with combined stages III & IV of atrial fibrosis, AF recurrence was significantly higher after ablation than in stages I & II groups (OR, 2.37; 95% CI, 1.61 to 3.50; P<00001). Similarly, compared to combined stages I, II, and III, patients with stage IV have higher odds of recurrence post-ablation (OR, 4.24; 95% CI, 2.39- 7.52, P < 0.001). CONCLUSION: This metanalysis demonstrates the strong association between left atrial fibrosis in LGE-MRI and AF post-ablation recurrence. The finding of this study will further assist clinicians in predicting the recurrence rate of AF based on the amount of fibrosis and tailor therapeutic decisions for further management.

Impact of Perioperative Dexamethasone on Hospital Length of Stay and Glycemic Control in Patients With Type 2 Diabetes Undergoing Total Hip Arthroplasty.

Purpose: This study aimed to evaluate effects of perioperative dexamethasone on hospital length of stay (LOS) and glycemic control for patients with type 2 diabetes mellitus undergoing total hip arthroplasty (THA). Methods: We performed retrospective case review of THA performed in adults (≥18 years old) with type 2 diabetes at Springfield Memorial Hospital (Springfield, IL) immediately before (2013), during (2014), and after (2015) publication of consensus guidelines for use of perioperative dexamethasone. Hospital LOS was the primary endpoint. Capillary blood glucose by hospital day, proportion of patients treated with insulin, and median insulin dose by hospital day were secondary endpoints. Results: A total of 209 patients were included: 109 not dosed with dexamethasone ("no dexamethasone"), and 100 treated with perioperative dexamethasone. The most common dose of dexamethasone was 4 mg (63% of patients). Mean (95% CI) reduction in adjusted hospital LOS for dexamethasone-treated patients, compared to controls, was -2.8 (-3.7 to -1.9) days for all patients, -1.6 (-2.7 to -0.5) days for those with arthritis as the indication for THA, and -4.0 (-5.9 to -2.1) days for those with fracture as indication for THA (P<0.001 for all). Glycemic control measured by median capillary blood glucose was no different or slightly better in the dexamethasone group than the no dexamethasone group, except for postoperative day 1 among patients treated with insulin prior to surgery. Conclusions: Perioperative dexamethasone significantly reduces hospital LOS for patients with type 2 diabetes undergoing THA, with modest effects on hyperglycemia.

Outcomes of catheter ablation versus antiarrhythmic therapy in patients with atrial fibrillation: a systematic review and meta-analysis.

BACKGROUND: Recent data have shown an advantage of rhythm control over rate control for the treatment of atrial fibrillation (AF). Nevertheless, the data regarding efficacy of catheter ablation (CA) compared with antiarrhythmic drugs (AADs) in patients with AF is lacking. Therefore, we sought to evaluate recurrence of arrhythmia, all-cause mortality, cardiovascular deaths, stroke/TIA, and all-cause readmissions of CA compared with AAD in patients with AF. METHODS: Systematically searched through PubMed, Google Scholar, EMBASE, and Cochrane for randomized control trials that compared CA and AAD in atrial fibrillation patients. Review Manager 5.4 and OpenMetaAnalyst were used to analyze the data. Data was pooled for the outcomes using random-effect models (DerSimonian and Laird) and reported as pooled odds ratio (OR). RESULTS: A total of 4822 patients were included. The CA group had 2417 patients while the AAD group included 2405 patients. Pooled data demonstrated that the CA arm had a statistically significant decrease in risk for recurrence of arrhythmia as compared to AAD (OR 0.25; [95% CI, 0.18-0.36]; p < 0.001). All-cause readmission was statistically significantly lower in CA as compared to AAD (OR 0.33; [95%CI, 0.17-0.63]; p < 0.001). For other secondary outcomes, there was no statistically significant difference between CA and AAD with regard to all-cause mortality (OR 0.75; [95% CI, 0.55-1.03]), cardiovascular death (OR 0.76; [95% CI, 0.22-2.54]), bleeding (OR 1.09, [95% CI 0.74, 1.61]), or stroke/TIA outcome (OR 0.90, [95% CI, 0.59-1.37]). CONCLUSIONS: In this study of pooled data from 16 RCTs, CA utilization for atrial fibrillation had improved freedom from arrhythmia as well as reduced all-cause readmission compared with AAD.

A Mini-Mental State Examination Formula May Help to Distinguish Alzheimer's Disease from Dementia with Lewy Bodies.

BACKGROUND: Alzheimer's disease (AD) and dementia with Lewy bodies (DLB) differ in their memory, attention, and visuoconstructional characteristics. The subscales of the well-known Mini-Mental State Examination (MMSE) provide an opportunity to assess these characteristics. Previous research has shown that analysis of the MMSE subscale performance of AD and DLB patients helps to differentiate them. OBJECTIVE: Study the MMSE scores of AD and DLB patients to see if the ability of previously reported analyses to differentiate them could be improved. Include other dementia patients for perspective. METHODS: We studied the MMSEs of all patients seen in our clinics during an 18-month period. Different equations were studied, derived from the subscales of Memory (M, 3 points maximum), Attention (A, 5 points maximum), and Pentagon-copying (P, 1 point maximum). RESULTS: We obtained 400 MMSEs, 136 from AD patients and 24 from DLB patients, scoring range 1-30. The equation P minus M provided the best discrimination between AD and DLB. Using a P-M score = 1 to identify AD, the positive predictive value was 0.97, negative predictive value 0.22, specificity 0.92, and sensitivity 0.43. As a secondary finding, the P-M = 1 equation was also helpful to differentiate AD from Parkinson's disease dementia. CONCLUSION: Considering AD versus DLB in our clinic population, a demented patient who was unable to recall the three memory words on the MMSE but able to copy the intersecting pentagons had a 97% likelihood of having AD. Additional work is needed to improve the sensitivity of the P-M = 1 equation.

Cognitive Component Structure of a Neuropsychological Battery Administered to Cognitively-Normal Adults in the SIU Longitudinal Cognitive Aging Study.

We used principal component analysis (PCA) to examine the component structure of a neuropsychological test battery administered to 943 cognitively-normal adults enrolled in the Southern Illinois University (SIU) Longitudinal Cognitive Aging Study (LCAS). Four components explaining the most variance (63.9%) in the dataset were identified: speed/cognitive flexibility, visuospatial skills, word-list learning/memory, and story memory. Regression analyses confirmed that increased age was associated with decreased component scores after controlling for gender and education. Our identified components differ slightly from previous studies using PCA on similar test batteries. Factors such as the demographic characteristics of the study sample, the inclusion of mixed patient and control samples, the inclusion of different test measures in previous studies, and the fact that many neuropsychological test measures assess multiple cognitive processes simultaneously, may help to explain these inconsistencies.

Adverse Health Outcomes Associated With Refractory and Treatment-Resistant Hypertension in the Chronic Renal Insufficiency Cohort.

Refractory hypertension (RfH) is a severe phenotype of antihypertension treatment failure. Treatment-resistant hypertension (TRH), a less severe form of difficult-to-treat hypertension, has been associated with significantly worse health outcomes. However, no studies currently show how health outcomes may worsen upon progression to RfH. RfH and TRH were studied in 3147 hypertensive participants in the CRIC (Chronic Renal Insufficiency Cohort study). The hypertensive phenotype (ie, no TRH or RfH, TRH, or RfH) was identified at the baseline visit, and health outcomes were monitored at subsequent visits. Outcome risk was compared using Cox proportional hazards models with time-varying covariates. A total of 136 (4.3%) individuals were identified with RfH at baseline. After adjusting for participant characteristics, individuals with RfH had increased risk for the composite renal outcome across all study years (50% decline in estimated glomerular filtration rate or end-stage renal disease; hazard ratio for study years 0-10=1.73 [95% CI, 1.42-2.11]) and the composite cardiovascular disease outcome during later study years (stroke, myocardial infarction, or congestive heart failure; hazard ratio for study years 0-3=1.25 [0.91-1.73], for study years 3-6=1.50 [0.97-2.32]), and for study years 6-10=2.72 [1.47-5.01]) when compared with individuals with TRH. There was no significant difference in all-cause mortality between those with refractory versus TRH. We provide the first evidence that RfH is associated with worse long-term health outcomes compared with TRH.

A 2-Hour Diabetes Self-Management Education Program for Patients With Low Socioeconomic Status Improves Short-Term Glycemic Control.

Diabetes self-management education (DSME) improves glycemic control, but patients with low socioeconomic status face institutional and personal barriers to receiving DSME. A retrospective single cohort study of a 2-hour group DSME program prioritizing accessibility and completion of a tightly focused curriculum was performed to determine if glycemic control improved and whether a longer, more comprehensive, prospective evaluation of the program is indicated. All patients who participated in the program from September 2017 to December 2018 were included in the analysis. The primary study endpoint was change in hemoglobin A1c (HbA1c) from baseline. A total of 58 out of 94 patients (61.7%) had paired measurements of HbA1c. Mean HbA1c improved from 9.8% ± 2.2% (83.5 ± 24.2 mmol/mol) to 8.3% ± 2.0% (67.7 ± 22.0 mmol/mol) at a median of 4 months after participation in the program (P<0.001). The proportion of patients with any improvement in HbA1c was 75.9% (44 of 58; P=0.003), and 65.5% of patients (38 of 58; P=0.066) had an improvement in HbA1c of ≥0.5%. These results demonstrate the benefit of highly targeted DSME for low-income patients and justify a longer-term and prospective evaluation of the program.

Serious Adverse Events Cluster in Participants Experiencing the Primary Composite Cardiovascular Endpoint: A Post Hoc Analysis of the SPRINT Trial.

BACKGROUND: Intensively treated participants in the SPRINT study experienced fewer primary cardiovascular composite study endpoints (CVD events) and lower mortality, although 38% of participants experienced a serious adverse event (SAE). The relationship of SAEs with CVD events is unknown. METHODS: CVD events were defined as either myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes. Cox models were utilized to understand the occurrence of SAEs with CVD events according to baseline atherosclerotic cardiovascular disease (ASCVD) risk. RESULTS: SAEs occurred in 96% of those experiencing a CVD event but only in 34% (P < 0.001) of those not experiencing a CVD event. Occurrence of SAEs monotonically increased across the range of baseline ASCVD risk being approximately twice as great in the highest compared with the lowest risk category. SAE occurrence was strongly associated with ASCVD risk but was similar within risk groups across treatment arms. In adjusted Cox models, experiencing a CVD event was the strongest predictor of SAEs in all risk groups. By the end of year 1, the hazard ratios for the low, middle, and high ASCVD risk tertiles, and baseline clinical CVD group were 2.56 (95% CI = 1.39-4.71); 2.52 (1.63-3.89); 3.61 (2.79-4.68); 1.86 (1.37-2.54), respectively-a trend observed in subsequent years until study end. Intensive treatment independently predicted SAEs only in the second ASVCD risk tertile. CONCLUSIONS: The occurrence of SAEs is multifactorial and mostly related to prerandomization patient characteristics, most prominently ASCVD risk, which, in turn, relates to in-study CVD events.