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Article ; Online: Calculating power for the Finkelstein and Schoenfeld test statistic for a composite endpoint with two components.

Zhou, Thomas J / LaValley, Michael P / Nelson, Kerrie P / Cabral, Howard J / Massaro, Joseph M

2022 Volume 41, Issue 17, Page(s) 3321–3335

Abstract: The Finkelstein and Schoenfeld (FS) test is a popular generalized pairwise comparison approach to analyze prioritized composite endpoints (eg, components are assessed in order of clinical importance). Power and sample size estimation for the FS test, ... ...

Abstract	The Finkelstein and Schoenfeld (FS) test is a popular generalized pairwise comparison approach to analyze prioritized composite endpoints (eg, components are assessed in order of clinical importance). Power and sample size estimation for the FS test, however, are generally done via simulation studies. This simulation approach can be extremely computationally burdensome, compounded by increasing number of composite endpoints and with increasing sample size. Here we propose an analytical solution to calculate power and sample size for commonly encountered two-component hierarchical composite endpoints. The power formulas are derived assuming underlying distributions in each of the component outcomes on the population level, which provide a computationally efficient and practical alternative to the standard simulation approach. Monte Carlo simulation results demonstrate that performance of the proposed power formulas are consistent with that of the simulation approach, and have generally desirable objective properties including robustness to mis-specified distributional assumptions. We demonstrate the application of the proposed formulas by calculating power and sample size for the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial.
MeSH term(s)	Computer Simulation ; Endpoint Determination/methods ; Humans ; Monte Carlo Method ; Sample Size
Language	English
Publishing date	2022-04-29
Publishing country	England
Document type	Journal Article
ZDB-ID	843037-8
ISSN	1097-0258 ; 0277-6715
ISSN (online)	1097-0258
ISSN	0277-6715
DOI	10.1002/sim.9419
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Zs.A 1756: Show issues

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Article ; Online: Effects of Weather on Coronavirus Pandemic.

Bukhari, Qasim / Massaro, Joseph M / D'Agostino, Ralph B / Khan, Sheraz

International journal of environmental research and public health

2020 Volume 17, Issue 15

Abstract: The novel coronavirus (SARS-CoV-2) has spread globally and has been declared a pandemic by the World Health Organization. While influenza virus shows seasonality, it is unknown if COVID-19 has any weather-related affect. In this work, we analyze the ... ...

Abstract	The novel coronavirus (SARS-CoV-2) has spread globally and has been declared a pandemic by the World Health Organization. While influenza virus shows seasonality, it is unknown if COVID-19 has any weather-related affect. In this work, we analyze the patterns in local weather of all the regions affected by COVID-19 globally. Our results indicate that approximately 85% of the COVID-19 reported cases until 1 May 2020, making approximately 3 million reported cases (out of approximately 29 million tests performed) have occurred in regions with temperature between 3 and 17 °C and absolute humidity between 1 and 9 g/m
MeSH term(s)	Betacoronavirus ; COVID-19 ; Cities ; Coronavirus Infections/transmission ; Humans ; Pandemics ; Pneumonia, Viral/transmission ; Public Health ; SARS-CoV-2 ; Seasons ; Temperature ; Weather
Keywords	covid19
Language	English
Publishing date	2020-07-27
Publishing country	Switzerland
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph17155399
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Article ; Online: Perihematomal Edema and Clinical Outcome After Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis.

Marchina, Sarah / Trevino-Calderon, Jorge A / Hassani, Sara / Massaro, Joseph M / Lioutas, Vasileios-Arsenios / Carvalho, Filipa / Selim, Magdy

Neurocritical care

2022 Volume 37, Issue 1, Page(s) 351–362

Abstract: Background: Perihematomal edema (PHE) has been proposed as a radiological marker of secondary injury and therapeutic target in intracerebral hemorrhage (ICH). We conducted a systematic review and meta-analysis to assess the prognostic impact of PHE on ... ...

Abstract	Background: Perihematomal edema (PHE) has been proposed as a radiological marker of secondary injury and therapeutic target in intracerebral hemorrhage (ICH). We conducted a systematic review and meta-analysis to assess the prognostic impact of PHE on functional outcome and mortality in patients with ICH. Methods: We searched major databases through December 2020 using predefined keywords. Any study using logistic regression to examine the association between PHE or its growth and functional outcome was included. We examined the overall pooled effect and conducted secondary analyses to explore the impact of individual PHE measures on various outcomes separately. Study quality was assessed by three independent raters using the Newcastle-Ottawa Scale. Odds ratios (per 1-unit increase in PHE) and their confidence intervals (CIs) were log transformed and entered into a DerSimonian-Laird random-effects meta-analysis to obtain pooled estimates of the effect. Results: Twenty studies (n = 6633 patients) were included in the analysis. The pooled effect size for overall outcome was 1.05 (95% CI 1.02-1.08; p < 0.00). For the following secondary analyses, the effect size was weak: mortality (1.01; 95% CI 0.90-1.14), functional outcome (1.04; 95% CI 1.02-1.07), both 90-day (1.06; 95% CI 1.02-1.11), and in-hospital assessments (1.04; 95% CI 1.00-1.08). The effect sizes for PHE volume and PHE growth were 1.04 (95% CI 1.01-1.07) and 1.14 (95% CI 1.04-1.25), respectively. Heterogeneity across studies was substantial except for PHE growth. Conclusions: This meta-analysis demonstrates that PHE volume within the first 72 h after ictus has a weak effect on functional outcome and mortality after ICH, whereas PHE growth might have a slightly larger impact during this time frame. Definitive conclusions are limited by the large variability of PHE measures, heterogeneity, and different evaluation time points between studies.
MeSH term(s)	Brain Edema ; Cerebral Hemorrhage/complications ; Cerebral Hemorrhage/diagnostic imaging ; Cerebral Hemorrhage/therapy ; Edema/complications ; Humans ; Prognosis ; Retrospective Studies
Language	English
Publishing date	2022-05-16
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Review ; Systematic Review ; Research Support, N.I.H., Extramural
ZDB-ID	2381896-7
ISSN	1556-0961 ; 1541-6933
ISSN (online)	1556-0961
ISSN	1541-6933
DOI	10.1007/s12028-022-01512-4
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Zs.A 6538: Show issues

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Article ; Online: Distribution, Determinants and Normal Reference Values of Aortic Arch Width: Thoracic Aortic Geometry in the Framingham Heart Study.

Qazi, Saadia / Gona, Philimon N / Musgrave, Rebecca M / Fox, Caroline S / Massaro, Joseph M / Hoffmann, Udo / Chuang, Michael L / O'Donnell, Christopher J

American heart journal plus : cardiology research and practice

2022 Volume 26

Abstract: Study objective: Aortic arch geometry changes with age, including an increase in aortic arch width (AAW). High AAW is a predictor of incident adverse cardiovascular disease (CVD) events, but its distribution and determinants are unknown. We hypothesized ...

Abstract	Study objective: Aortic arch geometry changes with age, including an increase in aortic arch width (AAW). High AAW is a predictor of incident adverse cardiovascular disease (CVD) events, but its distribution and determinants are unknown. We hypothesized that traditional CVD risk factors, in addition to age, are associated with increased AAW in community-dwelling adults. Study design: Framingham Offspring and Third Generation cohort participants (N=3026, 52% Men) underwent thoracic multidetector computed tomography (MDCT). A referent group (733M, 738W) free of clinical CVD, hypertension, dyslipidemia, smoking, and diabetes was used to generate sex and 10-year age-group specific upper 90th percentile (P90) cut-points for AAW. AAW was measured as the distance between the cross-sectional centroids of the ascending and descending thoracic aorta. Multivariable logistic regression models were used to identify clinical correlates of high AAW (≥referent P90) in the overall study group. Results: Among referent participants, AAW increased with greater age-group, p for trend <0.0001 in each sex. Overall and within each age group, AAW was greater in men than women, p<0.0001 all comparisons. Across all participants, high AAW was associated with greater age (odds ratio, OR=1.34/10y; 95% confidence interval 1.20 - 1.50), body surface area (OR=1.97/SD; 1.62 - 2.40), diastolic blood pressure (OR=1.59/10mmHg; 1.40 - 1.81), pack-years smoked (OR=1.07; 1.02 - 1.13), and prevalent CVD (OR=1.64; 1.08 - 2.49). Conclusion: AAW increases with greater age, body size, diastolic blood pressure and burden of smoking. High AAW (≥referent P90) is also associated with prevalent (clinically apparent) CVD. AAW is often seen on and easily measured from tomographic thoracic images and has prognostic value.
Language	English
Publishing date	2022-12-31
Publishing country	United States
Document type	Journal Article
ISSN	2666-6022
ISSN (online)	2666-6022
DOI	10.1016/j.ahjo.2022.100247
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Article ; Online: Periodic Oscillations in Daily Reported Infections and Deaths for Coronavirus Disease 2019.

Bukhari, Qasim / Jameel, Yusuf / Massaro, Joseph M / D'Agostino, Ralph B / Khan, Sheraz

JAMA network open

2020 Volume 3, Issue 8, Page(s) e2017521

MeSH term(s)	Betacoronavirus ; COVID-19 ; Coronavirus ; Coronavirus Infections/epidemiology ; Coronavirus Infections/virology ; Epidemics ; Humans ; Pandemics ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/virology ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-08-03
Publishing country	United States
Document type	Journal Article
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2020.17521
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Article ; Online: Increasing liver fat is associated with progression of cardiovascular risk factors.

Brunner, Katherine T / Pedley, Alison / Massaro, Joseph M / Hoffmann, Udo / Benjamin, Emelia J / Long, Michelle T

Liver international : official journal of the International Association for the Study of the Liver

2020 Volume 40, Issue 6, Page(s) 1339–1343

Abstract: Background: Nonalcoholic fatty liver disease is associated with cardiovascular risk factors in cross-sectional analyses. However, less is known about how changes in liver fat associate with the progression of cardiovascular risk factors.: Methods: A ... ...

Abstract	Background: Nonalcoholic fatty liver disease is associated with cardiovascular risk factors in cross-sectional analyses. However, less is known about how changes in liver fat associate with the progression of cardiovascular risk factors. Methods: A substudy (n = 808) drawn from the Framingham Heart Study underwent serial computed tomography scans 6 years apart. We performed multivariable-adjusted regression to determine the association between changes in liver fat and progression of cardiovascular risk factors. Results: Each standard deviation increase in liver fat was associated with adverse progression of systolic blood pressure, diastolic blood pressure, fasting glucose, high-density lipoprotein and log triglycerides. After adjusting for baseline cardiovascular risk, baseline body mass index (BMI), and change in BMI, increasing liver fat was significantly associated with adverse changes in fasting glucose and triglycerides. Conclusions: In a longitudinal cohort, increasing liver fat over 6 years was associated with progression of cardiovascular risk factors, even after accounting for BMI changes.
MeSH term(s)	Blood Glucose ; Blood Pressure ; Body Mass Index ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Cross-Sectional Studies ; Heart Disease Risk Factors ; Humans ; Liver/diagnostic imaging ; Non-alcoholic Fatty Liver Disease/epidemiology ; Risk Factors
Chemical Substances	Blood Glucose
Language	English
Publishing date	2020-04-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.14472
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Zs.A 1632: Show issues

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Article ; Online: Meta-analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin.

McMurray, John J V / Solomon, Scott D / Lock, J Paul / Massaro, Joseph M / Zhu, Fang / Zhou, Wenjiong / Skali, Hicham / Lewis, Eldrin F / Freeman, Mason W / Halvorsen, Yuan-Di C

Diabetes, obesity & metabolism

2023 Volume 26, Issue 3, Page(s) 971–979

Abstract: Aim: To explore the risk of major adverse cardiovascular events (MACE) associated with exposure to bexagliflozin.: Methods: The analysis included 4090 participants with type 2 diabetes (T2D) enrolled in nine phase 2 and 3 double-blind randomized ... ...

Abstract	Aim: To explore the risk of major adverse cardiovascular events (MACE) associated with exposure to bexagliflozin. Methods: The analysis included 4090 participants with type 2 diabetes (T2D) enrolled in nine phase 2 and 3 double-blind randomized controlled trials. All potential MACE were adjudicated by a blinded committee. The primary endpoint for the meta-analysis was the hazard ratio (HR) for the time to first occurrence of non-fatal stroke, non-fatal myocardial infarction (MI), cardiovascular (CV) death or hospitalization for unstable angina (MACE+), tested for non-inferiority to a ratio of 1.8. The secondary endpoints were time to first occurrence of (i) non-fatal stroke, non-fatal MI or CV death (MACE), tested for non-inferiority to a ratio of 1.3; and (ii) CV death or hospitalization for heart failure, tested for superiority. Results: The HR for the primary endpoint of MACE+ was 0.80 (95% confidence interval [CI] 0.58, 1.09), which fulfilled the non-inferiority objective with a P value of less than 0.0001. Non-inferiority for the first key secondary endpoint of MACE was also shown (HR = 0.82; 95% CI 0.59, 1.13; P = 0.0023). Superiority for time to CV death or first hospitalization for heart failure was not shown. Conclusions: Bexagliflozin did not increase the risk of MACE in participants with T2D when compared with placebo or active control. Both the preapproval and postapproval thresholds for CV safety were met and bexagliflozin has been approved by the US Food and Drug Administration.
MeSH term(s)	Adult ; Humans ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/chemically induced ; Cardiovascular System ; Myocardial Infarction/epidemiology ; Heart Failure/epidemiology ; Heart Failure/complications ; Stroke/epidemiology ; Cardiovascular Diseases/chemically induced ; Cardiovascular Diseases/epidemiology ; Hypoglycemic Agents/therapeutic use ; Randomized Controlled Trials as Topic ; Pyrans
Chemical Substances	bexagliflozin (EY00JF42FV) ; Hypoglycemic Agents ; Pyrans
Language	English
Publishing date	2023-12-27
Publishing country	England
Document type	Meta-Analysis ; Journal Article
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.15394
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Zs.A 5442: Show issues

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Article ; Online: Sex Differences in the Associations of Visceral Adipose Tissue and Cardiometabolic and Cardiovascular Disease Risk: The Framingham Heart Study.

Kammerlander, Andreas A / Lyass, Asya / Mahoney, Taylor F / Massaro, Joseph M / Long, Michelle T / Vasan, Ramachandran S / Hoffmann, Udo

Journal of the American Heart Association

2021 Volume 10, Issue 11, Page(s) e019968

Abstract: Background Men and women are labeled as obese on the basis of a body mass index (BMI) using the same criterion despite known differences in their fat distributions. Subcutaneous adipose tissue and visceral adipose tissue (VAT), as measured by computed ... ...

Abstract	Background Men and women are labeled as obese on the basis of a body mass index (BMI) using the same criterion despite known differences in their fat distributions. Subcutaneous adipose tissue and visceral adipose tissue (VAT), as measured by computed tomography, are advanced measures of obesity that closely correlate with cardiometabolic risk independent of BMI. However, it remains unknown whether prognostic significance of anthropometric measures of adiposity versus VAT varies in men versus women. Methods and Results In 3482 FHS (Framingham Heart Study) participants (48.1% women; mean age, 50.8±10.3 years), we tested the associations of computed tomography-based versus anthropometric measures of fat with cardiometabolic and cardiovascular disease (CVD) risk. Mean follow-up was 12.7±2.1 years. In men, VAT, as compared with BMI, had a similar strength of association with incident cardiometabolic risk factors (eg, adjusted odds ratio [OR], 2.36 [95% CI, 1.84-3.04] versus 2.66 [95% CI, 2.04-3.47] for diabetes mellitus) and CVD events (eg, adjusted hazard ratio [HR], 1.32 [95% CI, 0.97-1.80] versus 1.74 [95% CI, 1.14-2.65] for CVD death). In women, however, VAT, when compared with BMI, conferred a markedly greater association with incident cardiometabolic risk factors (eg, adjusted OR, 4.51 [95% CI, 3.13-6.50] versus 2.33 [95% CI, 1.88-3.04] for diabetes mellitus) as well as CVD events (eg, adjusted HR, 1.85 [95% CI, 1.26-2.71] versus 1.19 [95% CI, 1.01-1.40] for CVD death). Conclusions Anthropometric measures of obesity, including waist circumference and BMI, adequately capture VAT-associated cardiometabolic and cardiovascular risk in men but not in women. In women, abdominal computed tomography-based VAT measures permit more precise assessment of obesity-associated cardiometabolic and cardiovascular risk.
MeSH term(s)	Adiposity/physiology ; Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/epidemiology ; Female ; Follow-Up Studies ; Humans ; Incidence ; Intra-Abdominal Fat/diagnostic imaging ; Male ; Metabolic Syndrome/diagnosis ; Metabolic Syndrome/epidemiology ; Middle Aged ; Multidetector Computed Tomography/methods ; Retrospective Studies ; Sex Distribution ; Sex Factors ; United States/epidemiology
Language	English
Publishing date	2021-05-15
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2653953-6
ISSN	2047-9980 ; 2047-9980
ISSN (online)	2047-9980
ISSN	2047-9980
DOI	10.1161/JAHA.120.019968
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Article ; Online: Assessing Cardiovascular Risk in People Living with HIV: Current Tools and Limitations.

Achhra, Amit C / Lyass, Asya / Borowsky, Leila / Bogorodskaya, Milana / Plutzky, Jorge / Massaro, Joseph M / D'Agostino, Ralph B / Triant, Virginia A

Current HIV/AIDS reports

2021 Volume 18, Issue 4, Page(s) 271–279

Abstract: Purpose of review: To provide the current state of the development and application of cardiovascular disease (CVD) prediction tools in people living with HIV (PLWH).: Recent findings: Several risk prediction models developed on the general population ...

Abstract	Purpose of review: To provide the current state of the development and application of cardiovascular disease (CVD) prediction tools in people living with HIV (PLWH). Recent findings: Several risk prediction models developed on the general population are available to predict CVD risk, the most notable being the US-based pooled cohort equations (PCE), the Framingham risk functions, and the Europe-based SCORE (Systematic COronary Risk Evaluation). In validation studies in cohorts of PLWH, these models generally underestimate CVD risk, especially in individuals who are younger, women, Black race, or predicted to be at low/intermediate risk. An HIV-specific CVD prediction model, the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) model, is available, but its performance is modest, especially in US-based cohorts. Enhancing CVD prediction with novel biomarkers of inflammation or coronary artery calcification is of interest but has not yet been evaluated in PLWH. Finally, studies on CVD risk prediction are lacking in diverse PLWH globally. While available risk models for CVD prediction in PLWH remain suboptimal, clinicians should remain vigilant of higher CVD risk in this population and should use any of these risk scores for risk stratification to guide preventive interventions. Focus on established traditional risk factors such as smoking remains critical in PLWH. Risk prediction functions tailored to PLWH in diverse settings will enhance clinicians' ability to deliver optimal preventive care.
MeSH term(s)	Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Female ; HIV Infections/complications ; Heart Disease Risk Factors ; Humans ; Risk Assessment ; Risk Factors
Language	English
Publishing date	2021-07-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2151206-1
ISSN	1548-3576 ; 1548-3568
ISSN (online)	1548-3576
ISSN	1548-3568
DOI	10.1007/s11904-021-00567-w
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Zs.A 5920: Show issues

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Article ; Online: Relations of liver fat with prevalent and incident chronic kidney disease in the Framingham Heart Study: A secondary analysis.

Wilechansky, Robert M / Pedley, Alison / Massaro, Joseph M / Hoffmann, Udo / Benjamin, Emelia J / Long, Michelle T

Liver international : official journal of the International Association for the Study of the Liver

2019 Volume 39, Issue 8, Page(s) 1535–1544

Abstract: Background & aims: Prior studies demonstrated an association between non-alcoholic fatty liver disease and chronic kidney disease (CKD), though data are conflicting. We examined the association between liver fat and prevalent and incident CKD in the ... ...

Abstract	Background & aims: Prior studies demonstrated an association between non-alcoholic fatty liver disease and chronic kidney disease (CKD), though data are conflicting. We examined the association between liver fat and prevalent and incident CKD in the Framingham Heart Study (FHS). Methods: We included FHS participants who underwent computed tomography (CT) from 2002 to 2005 (n = 1315). After excluding heavy alcohol use (n = 211) and missing covariates (n = 117), the final sample included 987 participants. For the incident CKD analysis, we excluded 73 participants with prevalent CKD. Liver fat was measured by the average liver attenuation on CT. Estimated glomerular filtration rate (eGFR) was obtained using the CKD Epidemiology Collaboration Creatinine-Cystatin C equation, and CKD was defined as eGFR < 60 ml/min/1.73 m Results: The prevalence of hepatic steatosis and CKD were 19% and 14% respectively (55.9% women, mean age 60 ± 9 years). After adjusting for covariates, we observed no significant associations between liver fat and CKD, microalbuminuria or eGFR in cross-sectional analyses. We observed positive associations between liver fat, incident microalbuminuria and reduced eGFR in age- and sex-adjusted models; these relationships were not significant in multivariable-adjusted models. Conclusions: In this community-based cohort study, we did not observe significant associations between liver fat and prevalent or incident CKD with a median follow-up time of 12.5 years. The association between NAFLD and CKD may be accounted for by shared risk factors; confirmatory studies are needed.
MeSH term(s)	Aged ; Albuminuria/etiology ; Female ; Humans ; Incidence ; Longitudinal Studies ; Male ; Massachusetts/epidemiology ; Middle Aged ; Multidetector Computed Tomography ; Non-alcoholic Fatty Liver Disease/complications ; Non-alcoholic Fatty Liver Disease/diagnostic imaging ; Non-alcoholic Fatty Liver Disease/epidemiology ; Prevalence ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/epidemiology
Language	English
Publishing date	2019-05-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.14125
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