Maize and Risk of Cancers of the Oral Cavity, Pharynx, and Esophagus in Northeastern Italy

The relationship between maize consumption and risk of cancer of the upper digestive tract was investigated in 107 patients with oral cancer, 107 with pharyngeal cancer, 68 with esophageal cancer, and 505 hospital controls who permanently resided in Pordenone Province in the northeastern part of Italy. The analysis was restricted to males. The population of this province has a high incidence of these neoplasms and shows particularly elevated levels of alcohol and tobacco use, in addition to high maize consumption. Highly significant associations with frequent intake of maize emerged for oral cancer, pharyngeal cancer, and esophageal cancer (odds ratios = 3.3, 3.2, and 2.8, respectively). The risk elevation could not be explained in terms of differences in education, occupation, tobacco use, or consumption of fresh fruits and vegetables. The unfavorable effect of maize on risk of cancer of the upper digestive tract, however, was evident only in those individuals who reported heavy drinking (i.e., ≥42 alcoholic drinks/wk). The present findings are likely to be related to the fact that maize can cause deficiencies of various micronutrients (chiefly, niacin and riboflavin) and agree with previous observations from Africa, the People's Republic of China, the United States, and Italy. [J Natl Cancer Inst 82:1407-1411, 1990

Cancer and Non-Cancer Controls in Studies on the Effect of Tobacco and Alcohol Consumption

A comparison of risk estimates using controls with other cancers versus controls with acute diseases unrelated to tobacco and alcohol consumption in the study of the effect of these two factors has been performed using data on tumours of the oral cavity and pharynx from an ongoing case-control surveillance programme in Northeastern Italy. Similar results were obtained using either type of controls: as compared to never smokers, moderate smokers (≤14 cigarettes/day) showed age-and sex-adjusted odds ratio (OR)=5.2 (95% confidence interval (CI): 2.9-9.2) when using cancer controls and 5.8 (95% CI: 3.3-10.1) when using non-cancer controls. Similarly, those who had smoked for 40 years or longer showed ORs of 7.4(95% CI: 4.0-13.6) and 8.8 (95% CI: 4.9-15.6), respectively, using cancer and non-cancer controls: For moderate drinkers of alcoholic beverages (21-34 drinks/week) and heavy drinkers (≥84 drinks/ week) the ORs, as compared to individuals who drank <21 drinks/week, were 1.9 (95%CI: 1.0-3.6) and 2.2 (95% CI: 1.2-4.0) and 10.6(95% CI: 5.5-20.6) and 11.4(95% CI: 6.0-21.4) using cancer and non-cancer controls, respectively. The same comparability of ORs for tobacco- and alcohol-related variables using either type of controls was observed when separate analyses of the two sexes were performed. The close similarity between cancer and non-cancer controls in studies on tabacco- and alcohol-related risks may be exploited when the choice of other types of controls would increase the costs and the feasibility of the study, and thus hamper its statistical power. Moreover, this investigation provides some reassurance about the validity of risk estimates using carefully selected groups of hospital control

Variation in contrast-associated acute kidney injury prophylaxis for percutaneous coronary intervention: Insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) program

BACKGROUND: Contrast-Associated Acute Kidney Injury (CA-AKI) is a serious complication associated with percutaneous coronary intervention (PCI). Patients with chronic kidney disease (CKD) have an elevated risk for developing this complication. Although CA-AKI prophylactic measures are available, the supporting literature is variable and inconsistent for periprocedural hydration and N-acetylcysteine (NAC), but is stronger for contrast minimization. METHODS: We assessed the prevalence and variability of CA-AKI prophylaxis among CKD patients undergoing PCI between October 2007 and September 2015 in any cardiac catheterization laboratory in the VA Healthcare System. Prophylaxis included periprocedural hydration with normal saline or sodium bicarbonate, NAC, and contrast minimization (contrast volume to glomerular filtration rate ratio ≤ 3). Multivariable hierarchical logistic regression models quantified site-specific prophylaxis variability. As secondary analyses, we also assessed CA-AKI prophylaxis measures in all PCI patients regardless of kidney function, periprocedural hydration in patients with comorbid CHF, and temporal trends in CA-AKI prophylaxis. RESULTS: From 2007 to 2015, 15,729 patients with CKD underwent PCI. 6928 (44.0%) received periprocedural hydration (practice-level median rate 45.3%, interquartile range (IQR) 35.5-56.7), 5107 (32.5%) received NAC (practice-level median rate 28.3%, IQR 22.8-36.9), and 4656 (36.0%) received contrast minimization (practice-level median rate 34.5, IQR 22.6-53.9). After adjustment for patient characteristics, there was significant site variability with a median odds ratio (MOR) of 1.80 (CI 1.56-2.08) for periprocedural hydration, 1.95 (CI 1.66-2.29) for periprocedural hydration or NAC, and 2.68 (CI 2.23-3.15) for contrast minimization. These trends were similar among all patients (with and without CKD) undergoing PCI. Among patients with comorbid CHF (n = 5893), 2629 (44.6%) received periprocedural hydration, and overall had less variability in hydration (MOR of 1.56 (CI 1.38-1.76)) compared to patients without comorbid CHF (1.89 (CI 1.65-2.18)). Temporal trend analysis showed a significant and clinically relevant decrease in NAC use (64.1% of cases in 2008 (N = 1059), 6.2% of cases in 2015 (N = 128, p = \u3c 0.0001)) and no significant change in contrast-minimization (p = 0.3907). CONCLUSIONS: Among patients with CKD undergoing PCI, there was low utilization and significant site-level variability for periprocedural hydration and NAC independent of patient-specific risk. This low utilization and high variability, however, was also present for contrast minimization, a well-established measure. These findings suggest that a standardized approach to CA-AKI prophylaxis, along with continued development of the evidence base, is needed

Sex-based differences in veterans with pulmonary hypertension: Results from the veterans affairs-clinical assessment reporting and tracking database

Women have an increased risk of pulmonary hypertension (PH) but better survival compared to men. Few studies have explored sex-based differences in population-based cohorts with PH. We sought to determine whether sex was associated with hemodynamics and survival in US veterans with PH (mean pulmonary artery pressure [mPAP] ≥ 25 mm Hg) from the Veterans Affairs Clinical Assessment, Reporting, and Tracking database. The relationship between sex and hemodynamics was assessed with multivariable linear mixed modeling. Cox proportional hazards models were used to compare survival by sex for those with PH and precapillary PH (mPAP ≥ 25 mm Hg, pulmonary artery wedge pressure [PAWP] ≤ 15 mm Hg and pulmonary vascular resistance [PVR] > 3 Wood units) respectively. The study population included 15,464 veterans with PH, 516 (3%) of whom were women; 1,942 patients (13%) had precapillary PH, of whom 120 (6%) were women. Among those with PH, women had higher PVR and pulmonary artery pulse pressure, and lower right atrial pressure and PAWP (all p <0.001) compared with men. There were no significant differences in hemodynamics according to sex in veterans with precapillary PH. Women with PH had 18% greater survival compared to men with PH (adjusted HR 0.82, 95% CI 0.69–0.97, p = 0.020). Similarly, women with precapillary PH were 29% more likely to survive as compared to men with PH (adjusted HR 0.71, 95% CI 0.52–0.98, p = 0.040). In conclusion, female veterans with PH have better survival than males despite higher pulmonary afterload

Transitions of Care Among Patients Undergoing Percutaneous Coronary Intervention for Stable Angina: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Program

Background Effective transitions from the procedural to outpatient setting are essential to ensure high‐quality cardiovascular care across health care systems, particularly among patients undergoing invasive cardiac procedures. We evaluated the association of postprocedural follow‐up visits and antiplatelet prescriptions with clinical outcomes among patients undergoing percutaneous coronary intervention for stable angina at community or Veterans Affairs (VA) hospitals. Methods and Results Patients who actively received care within the VA Healthcare System and underwent percutaneous coronary intervention for stable angina at a community or VA hospital between October 1, 2015, and September 30, 2019, were identified. We compared mortality for patients receiving community or VA care, and among subgroups of community‐treated patients by the presence of a postprocedural follow‐up visit within 30 days or prescription for antiplatelet (P2Y12) medication within 120 days of the procedure. Among 12 837 patients who survived the first 30 days, 5133 were treated at community hospitals, and 7704 were treated in the VA. Prescriptions for antiplatelet therapy were less common for those treated in the community (85%) compared with the VA at 1 year (95%; hazard ratio [HR], 0.46; 95% CI, 0.44–47). Compared with VA‐treated patients, the hazards for death were similar for patients treated in the community with a follow‐up visit (HR, 1.17; 95% CI, 0.97–1.40) or with a fill for an antiplatelet therapy (HR, 1.08; 95% CI, 0.90–1.30). However, patients treated in the community without a follow‐up visit had an 86% (HR, 1.86; 95% CI, 1.40–2.48) increased hazard of death, and those without antiplatelet prescription fill had a 144% increased hazard of death (HR, 2.44; 95% CI, 1.85–3.21) compared with all VA‐treated patients. Conclusions Patients treated at community facilities have a decreased chance of receiving antiplatelet prescriptions after percutaneous coronary intervention with a concordant increased hazard of mortality, emphasizing the importance of transitions of care across health care systems when assessing cardiovascular quality

The Wilcoxon–Mann–Whitney Procedure Fails as a Test of Medians

<p>To illustrate and document the tenuous connection between the Wilcoxon–Mann–Whitney (WMW) procedure and medians, its relationship to mean ranks is first contrasted with the relationship of a <i>t</i>-test to means. The quantity actually tested: <math><mrow><mi> Pr </mi><mo>^</mo><mrow><mo>(</mo><msub><mi>X</mi><mn>1</mn></msub><mo><</mo><msub><mi>X</mi><mn>2</mn></msub><mo>)</mo></mrow><mo>+</mo><mi> Pr </mi><mo>^</mo><mrow><mo>(</mo><msub><mi>X</mi><mn>1</mn></msub><mo>=</mo><msub><mi>X</mi><mn>2</mn></msub><mo>)</mo></mrow><mo>/</mo><mn>2</mn></mrow></math> is then described and recommended as the basis for an alternative summary statistic that can be employed instead of medians. In order to graphically represent an estimate of the quantity: Pr(<i>X</i>₁ < <i>X</i>₂) + Pr(<i>X</i>₁ = <i>X</i>₂)/2, use of a bubble plot, an ROC curve and a dominance diagram are illustrated. Several counter-examples (real and constructed) are presented, all demonstrating that the WMW procedure fails to be a test of medians. The discussion also addresses another, less common and perhaps less clear cut, but potentially even more important misconception: that the WMW procedure requires continuous data in order to be valid. Discussion of other issues surrounding the question of the WMW procedure and medians is presented, along with the authors' teaching experience with the topic. SAS code used for the examples is included as supplementary material.</p

GLIMMPSE: Online Power Computation for Linear Models with and without a Baseline Covariate

GLIMMPSE is a free, web-based software tool that calculates power and sample size for the general linear multivariate model with Gaussian errors (http://glimmpse.SampleSizeShop.org/). GLIMMPSE provides a user-friendly interface for the computation of power and sample size. We consider models with fixed predictors, and models with fixed predictors and a single Gaussian covariate. Validation experiments demonstrate that GLIMMPSE matches the accuracy of previously published results, and performs well against simulations. We provide several online tutorials based on research in head and neck cancer. The tutorials demonstrate the use of GLIMMPSE to calculate power and sample size