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Sodium Intake during Pregnancy, but Not Other Diet Recommendations Aimed at Preventing Cardiovascular Disease, Is Positively Related to Risk of Hypertensive Disorders of Pregnancy

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JOURNAL OF NUTRITION 2020年第1期150卷 159-166页

作者： Arvizu, Mariel Bjerregaard, Anne A. Madsen, Marie T. B. Granstrom, Charlotta Halldorsson, Thorhallur, I Olsen, Sjurdur F. Gaskins, Audrey J. Rich-Edwards, Janet W. Rosner, Bernard A. Chavarro, Jorge E. Harvard TH Chan Sch Publ Hlth Dept Nutr Boston MA 02115 USA Statens Serum Inst Ctr Fetal Programming Copenhagen Denmark Univ Iceland Fac Food Sci & Nutr Sch Hlth Sci Unit Nutr Res Reykjavik Iceland Brigham & Womens Hosp Channing Div Network Med 75 Francis St Boston MA 02115 USA Harvard Med Sch Boston MA 02115 USA Emory Univ Rollins Sch Publ Hlth Dept Epidemiol Atlanta GA 30322 USA Harvard TH Chan Sch Publ Hlth Dept Epidemiol Boston MA 02115 USA Brigham & Womens Hosp Dept Med Div Womens Hlth 75 Francis St Boston MA 02115 USA Harvard TH Chan Sch Publ Hlth Dept Biostat Boston MA USA

Background: The role of diet on hypertensive disorders of pregnancy (HDPs), including preeclampsia and gestational hypertension (GHTN), remains unclear. Objectives: We evaluated whether adherence during pregnancy to dietary recommendations that reduce cardiovascular disease (CVD) in the general population is related to the risk of HDPs. Methods: We followed 66,651 singleton pregnancies from 62,774 women participating in the Danish National Birth Cohort. Diet was assessed during week of gestation 25 with an FFQ from which we created 2 dietary pattern scores: 1) AHA, based on the diet recommendations from the AHA 2020 Strategic Impact Goals;and 2) the Dietary Approaches to Stop Hypertension (DASH) diet. Cases of HDPs were identified through linkage with the Danish National Patient Registry. RRs and 95% CIs of HDPs were estimated by increasing quintiles of adherence to the AHA and DASH scores using log-Poisson regression models with generalized estimating equations-to account for repeated pregnancies per woman-while adjusting for potential confounders. Results: We identified 1809 cases of HDPs: n = 1310 preeclampsia (n = 300 severe preeclampsia) and n = 499 cases of GHTN. Greater adherence to AHA or DASH scores was not related to the risk of HDPs. However, when each component of the scores was separately evaluated, there were positive linear relations of sodium intake with HDPs (P-linearity < 0.01). Women with the highest sodium intake [median 3.70 g/d (range: 3.52, 7.52 g/d)] had 54% (95% CI:16%, 104%) higher risk of GHTN and 20% (95% CI:1%, 42%) higher risk of preeclampsia than women with the lowest intake [median 2.60 g/d (range: 0.83, 2.79 g/d)]. In addition, intake of whole grains was positively related to the risk of GHTN but not to preeclampsia (P-heterogeneity = 0.002). Conclusion: Sodium intake during pregnancy, but no other diet recommendations to prevent CVD among nonpregnant adults, is positively related to the occurrence of HDPs among pregnant Danish women

关键词： preeclampsia sodium AHA 2020 goals DASH pregnancy gestational hypertension dietary patterns

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Sex-specific differences in Juniperus communis: essential oil yield, growth-defence conflict and population sex ratio

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AOB PLANTS 2021年第3期13卷 plab021页

作者： Marko, Gabor Nemeth, Istvan Gyuricza, Veronika Altbacker, Vilmos Hungarian Univ Agr & Life Sci Inst Plant Protect Dept Plant Pathol Menesi Ut 44 H-1118 Budapest Hungary Eotvos Lorand Univ Dept Systemat Zool & Ecol Behav Ecol Grp Pazmany Peter Setany 1-C H-1117 Budapest Hungary Parexel Int Biotech Biostat & Programming Hermina Ut 17 H-1146 Budapest Hungary Eotvos Lorand Univ Inst Biol Dept Ethol Pazmany Peter Setany 1-C H-1117 Budapest Hungary Hungarian Univ Agr & Life Sci Inst Game Management & Nat Protect Dept Nat Conservat Guba Sandor Utca 40 H-7400 Kaposvar Hungary

In plants, biomass and nutrient allocation often generate trade-offs between the different biochemical pathways conflicting the utilization of the common source among growth, reproduction and chemical defence. However, in dioecious plant species, these trade-off patterns could appear as a more contrasted problem between males and females due to the dissimilar reproduction investment. Generally, the growth ratio is higher in males than females, while females have a stronger defence than males. To understand the possible role of the sex-specific dissimilarities within the growth-defence conflict framework, we investigated the possible causes of the high variance of the essential oil yield in a dioecious evergreen species, Juniperus communis. Specifically, we tested the correlations between the essential oil yield with other individual-specific traits (e.g. sex, age), the presence of the growth-defence trade-off, and the differential growth and survival patterns between males and females through an extensive field survey with sample collection in three natural populations (Kiskunsag National Park, Hungary). The individual-specific essential oil yield was also measured and served as a proxy to describe the degree of chemical defence. We found that the essential oil yield showed strong and consistent sexspecific patterns decreasing with age in adults. Contrary to the predictions, the males showed a consistently higher yield than the females. We also observed a growth-defence trade-off in males but not in females. Consistently with the growthdefence conflict hypothesis, the populations' sex ratio was male-biased, and this pattern was more evident with ageing modifying the demographic structure due to the sexually dissimilar lifespan. Our juniper study revealed a contrasting and unique essential oil accumulation driven by the complex allocation trade-off mechanisms within individuals, which could be a flexible and adaptive defence response against the increasing biotic and

关键词： Chemical defence dioecy plant secondary metabolites resource acquisition sexual dimorphism terpenes

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On power and sample size of the ANOVA-type rank test

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COMMUNICATIONS IN STATISTICS-SIMULATION AND COMPUTATION 2017年第4期46卷 3224-3241页

作者： Fan, Chunpeng Zhang, Donghui Sanofi US Inc Dept Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA

When using nonparametric methods to analyze factorial designs with repeated measures, the ANOVA-type rank test has gained popularity due to its robustness and appropriate type I error control. This article proposes power and sample size calculation formulas under two scenarios where the nonparametric regression coefficients are known or they are unknown but a pilot study is available. When a pilot study is available, the formulas do not need any assumption on the underlying population distributions. Simulation results confirm the accuracy of the proposed methods. An STZ rat excisional wound study is used to demonstrate the application of the methods.

关键词： ANOVA-type statistic ATS Small sample Wald-type rank test Wald-type statistic WTS

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Performance of epistasis detection methods in semi-simulated GWAS

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BMC BIOINFORMATICS 2018年第1期19卷 1-17页

作者： Chatelain, Clement Durand, Guillermo Thuillier, Vincent Auge, Franck SANOFI R&D Translat Sci F-91385 Chilly Mazarin France Univ Paris 06 Lab Probabilites Modeles Aleatoires 4 Pl Jussieu F-75252 Paris 05 France SANOFI R&D Biostat & Programming F-91385 Chilly Mazarin France

Background: Part of the missing heritability in Genome Wide Association Studies (GWAS) is expected to be explained by interactions between genetic variants, also called epistasis. Various statistical methods have been developed to detect epistasis in case-control GWAS. These methods face major statistical challenges due to the number of tests required, the complexity of the Linkage Disequilibrium (LD) structure, and the lack of consensus regarding the definition of epistasis. Their limited impact in terms of uncovering new biological knowledge might be explained in part by the limited amount of experimental data available to validate their statistical performances in a realistic GWAS context. In this paper, we introduce a simulation pipeline for generating real scale GWAS data, including epistasis and realistic LD structure. We evaluate five exhaustive bivariate interaction methods, fastepi, GBOOST, SHEsisEpi, DSS, and IndOR. Two hundred thirty four different disease scenarios are considered in extensive simulations. We report the performances of each method in terms of false positive rate control, power, area under the ROC curve (AUC), and computation time using a GPU. Finally we compare the result of each methods on a real GWAS of type 2 diabetes from the Welcome Trust Case Control Consortium. Results: GBOOST, SHEsisEpi and DSS allow a satisfactory control of the false positive rate. fastepi and IndOR present an increase in false positive rate in presence of LD between causal SNPs, with our definition of epistasis. DSS performs best in terms of power and AUC in most scenarios with no or weak LD between causal SNPs. All methods can exhaustively analyze a GWAS with 6.10(5) SNPs and 15,000 samples in a couple of hours using a GPU. Conclusion: This study confirms that computation time is no longer a limiting factor for performing an exhaustive search of epistasis in large GWAS. For this task, using DSS on SNP pairs with limited LD seems to be a good strategy to achiev

关键词： Genome-wide association studies Epistasis Simulation

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Rank repeated measures analysis of covariance

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COMMUNICATIONS IN STATISTICS-THEORY AND METHODS 2017年第3期46卷 1158-1183页

作者： Fan, Chunpeng Zhang, Donghui Sanofi US Inc Dept Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA

When analyzing a response variable at the presence of both factors and covariates, with potentially correlated responses and violated assumptions of the normal residual or the linear relationship between the response and the covariates, rank-based tests can be an option for inferential procedures instead of the parametric repeated measures analysis of covariance (ANCOVA) models. This article derives a rank-based method for multi-way ANCOVA models with correlated responses. The generalized estimating equations (GEE) technique is employed to construct the proposed rank tests. Asymptotic properties of the proposed tests are derived. Simulation studies confirmed the performance of the proposed tests.

关键词： ANCOVA ANOVA-type test GEE generalized estimating equations longitudinal data Wald-type test 62G08

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Risk Factors and Complications Following Arthroscopic Tenotomy of the Long Head of the Biceps Tendon

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ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE 2020年第2期8卷 2325967120904361页

作者： Mirzayan, Raffy McCrum, Christopher Butler, Rebecca K. Alluri, Ram Kiran Dept Orthopaed Surg 1011 Baldwin Pk Blvd Baldwin Pk CA 91706 USA Kaiser Permanente Southern Calif Dept Orthopaed Surg Baldwin Pk CA USA UT Southwestern Med Ctr Dept Orthopaed Surg Dallas TX USA Kaiser Permanente Dept Biostat Programming & Res Database Serv Pasadena CA USA Univ Southern Calif Keck Sch Med Dept Orthopaed Surg Los Angeles CA 90007 USA

Background: Controversy exits regarding performing a tenotomy versus a tenodesis of the long head of the biceps tendon (LHBT). Purpose: To evaluate the complications after arthroscopic tenotomy of the LHBT and characterize the incidence of cosmetic deformity, cramping, subjective weakness, and continued anterior shoulder pain (ASP). Additionally, to identify patient-related factors that may predispose a patient to these complications. Study Design: Case-control study;Level of evidence, 3. Methods: Records of patients who underwent an arthroscopic LHBT tenotomy at an integrated health care system under the care of 55 surgeons were retrospectively reviewed. Exclusion criteria included LHBT tenodesis, arthroplasty, neoplastic, or fracture surgery;age younger than 18 years;incomplete documentation of physical examination;or incomplete operative reports. Characteristic data, concomitant procedures, LHBT morphology, and postoperative complications were recorded. Patients with and without postoperative complications-including cosmetic deformity, subjective weakness, continued ASP, and cramping-were analyzed by age, sex, dominant arm, body mass index (BMI), smoking status, workers' compensation status, and intraoperative LHBT morphology to identify risk factors for developing these postoperative complications. Results: A total of 192 patients who underwent LHBT tenotomy were included in the final analysis. Tenotomy was performed with concomitant shoulder procedures in all but 1 individual. The mean +/- SD patient age was 60.6 +/- 9.5 years, and 55% were male. The overall complication rate was 37%. The most common postoperative complications include cosmetic (Popeye) deformity (14.1%), subjective weakness (10.4%), cramping (10.4%), and continued postoperative ASP over the bicipital groove (7.8%). Every 10-year increase in age was associated with 0.52 (95% CI, 0.28-0.94) times the odds of continued ASP and 0.59 (95% CI, 0.36-0.98) times the odds of cramping pain. Male patient

关键词： biceps tenotomy long head of the biceps tendon shoulder arthroscopy tenodesis biceps release

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Long-term immunogenicity and safety of tetravalent dengue vaccine (CYD-TDV) in healthy populations in Singapore and Vietnam: 4-year follow-up of randomized, controlled, phase II trials

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HUMAN VACCINES & IMMUNOTHERAPEUTICS 2019年第10期15卷 2315-2327页

作者： Ngoc Huu Tran Chansinghakul, Danaya Chong, Chia Yin Low, Chian Yong Shek, Lynette P. Chan Quang Luong Fargo, Carina Wartel, T. Anh Sun, Sunny Skipetrova, Anna Bouckenooghe, Alain Pasteur Inst Ho Chi Minh City Dept Dis Control & Prevent Ho Chi Minh City Vietnam Sanofi Pasteur Clin Sci Pathumwan Thailand KK Womens & Childrens Hosp Dept Pediat Infect Dis Singapore Singapore Singapore Gen Hosp Dept Infect Dis Singapore Singapore Natl Univ Singapore Dept Pediat Singapore Singapore Sanofi Pasteur Clin Sci & Med Affairs Dept Singapore Singapore Sanofi Biostat & Programming Dept Beijing Peoples R China Sanofi Pasteur Global Pharmacovigilance Lyon France

Dengue is prevalent in the Asia-Pacific region. Participants of two immunogenicity and safety phase II studies conducted in Singapore and Vietnam (NCT0088089 and NCT00875524, respectively) were followed for up to four years after third vaccine dose of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV). Participants (2-45 years) received three doses of CYD-TDV or control at 0, 6, and 12 months. Dengue plaque reduction neutralization test (PRNT50) antibody titers were measured in both studies. Cytokine-producing antigen-specific CD4+ and CD8+ T-cells were quantified to assess cell-mediated immunity (CMI) in Singapore. Post-hoc analyses were carried out for participants aged <9 and >= 9 years old. Related and fatal serious adverse events (SAEs) were collected during long-term follow-up. Of participants who received >= 1 CYD-TDV injection in Singapore (n = 1198) and Vietnam (n = 180), 87% and 92% participants completed long-term follow-up, respectively. At four years, geometric mean titers (GMTs) in participants who received CYD-TDV ranged from 30.2 1/dil (95% CI 23.9-38.3) to 73.7 (49.3-110) 1/dil in Vietnam and 9.73 1/dil (95% CI 8.28-11.4) to 21.8 (18.9-25.1) 1/dil in Singapore. Interferon and interleukin-13 levels were lower at four years than one year post-vaccination but were still present. Tumor necrosis factor-alpha levels at four years were similar to those after the third vaccine dose. Seropositivity rates were higher at year four in participants who were seropositive vs. seronegative at baseline in both studies. No safety concerns were identified. CYD-TDV demonstrated long-term immunogenicity and was well-tolerated for four years after the third vaccine dose.

关键词： Dengue CYD-TDV immunogenicity safety cell-mediated immunity follow-up Singapore Vietnam

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Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial

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JOURNAL OF CLINICAL LIPIDOLOGY 2019年第1期13卷 138-147页

作者： Dufour, Robert Hovingh, G. Kees Guyton, John R. Langslet, Gisle Baccara-Dinet, Marie T. Din-Bell, Chantal Manvelian, Garen Farnier, Michel Inst Rech Clin Montreal Montreal PQ Canada Univ Montreal Montreal PQ Canada Acad Med Ctr Dept Vasc Med Amsterdam Netherlands Duke Univ Med Ctr Durham NC USA Oslo Univ Hosp Lipid Clin Oslo Norway Sanofi Clin Dev R&D Montpellier France Sanofi Biostat & Programming Chilly Mazarin France Regeneron Pharmaceut Tarrytown NY USA CHU Dijon Bourgogne Point Med Lipid Clin Dijon France CHU Dijon Bourgogne Dept Cardiol Dijon France

BACKGROUND: Patients with heterozygous familial hypercholesterolemia (HeFH) who completed the double-blind ODYSSEY LONG TERM parent trial and subsequently enrolled in the open-label extension (OLE) study, ODYSSEY OLE (NCT01954394), provide a unique opportunity to investigate effects of 2 doses of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, within the same patient cohort. OBJECTIVE: The aim of the study was to characterize long-term efficacy and safety of 2 alirocumab dosages and utility of a dose titration strategy in patients with HeFH. METHODS: After an 8-week washout period, patients with HeFH who completed the LONG TERM study (receiving alirocumab 150 mg every 2 weeks [Q2W]) were eligible to enroll in OLE (n = 214) for up to 40 months' treatment duration. In OLE, patients started on alirocumab 75 mg Q2W. From Week 12, dose adjustment from 75 to 150 mg Q2W or vice versa was possible based on physician's clinical judgment. RESULTS: During the LONG TERM trial, alirocumab 150 mg Q2W reduced mean low-density lipoprotein cholesterol (LDL-C) from baseline (162.3 mg/dL) to Week 8 by 63.1%;during OLE, alirocumab 75 mg Q2W reduced mean LDL-C from baseline (166.6 mg/dL) by 47.3% within the same patient cohort. At Week 96, mean LDL-C reduction from OLE baseline was 55.4% vs 46.8% for patients with or without alirocumab dose increase, respectively. Treatment-emergent adverse events leading to permanent treatment discontinuation were observed in 4 patients (1.9%). CONCLUSIONS: In patients with HeFH, both alirocumab dosages provided consistent LDL-C reductions over a treatment duration of up to 4 years (including 1.5 years of the LONG TERM trial), allowing an individualized approach to LDL-C lowering, depending on baseline LDL-C levels. (C) 2018 National Lipid Association. Published by Elsevier Inc.

关键词： Alirocumab Familial hypercholesterolemia LDL-C Open-label extension PCSK9

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An efficient monotone data augmentation algorithm for multiple imputation in a class of pattern mixture models

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2017年第4期27卷 620-638页

作者： Tang, Yongqiang Shire Dept Biostat & Stat Programming 300 Shire Way Lexington MA 02421 USA

We develop an efficient Markov chain Monte Carlo algorithm for the mixed-effects model for repeated measures (MMRM) and a class of pattern mixture models (PMMs) via monotone data augmentation (MDA). The proposed algorithm is particularly useful for multiple imputation in PMMs and is illustrated by the analysis of an antidepressant trial. We also describe the full data augmentation (FDA) algorithm for MMRM and PMMs and show that the marginal posterior distributions of the model parameters are the same in the MDA and FDA algorithms.

关键词： Controlled imputations delta-adjusted imputations Markov chain Monte Carlo mixed-effects model for repeated measures monotone data augmentation

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Direct Estimation for Adaptive Treatment Length Policies: Methods and Application to Evaluating the Effect of Delayed PEG Insertion

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BIOMETRICS 2017年第3期73卷 981-989页

作者： Lu, Xin Johnson, Brent A. Sanofi Dept Biostat & Programming Bridgewater NJ 08807 USA Univ Rochester Dept Biostat & Computat Biol 601 Elmwood Ave Rochester NY 14642 USA

Dysphagia is a primary cause of death among patients diagnosed with amyotrophic lateral sclerosis (ALS), and percutaneous endoscopic gastrostomy (PEG) is a procedure to insert a tube into the stomach to assist or replace oral feeding. It is believed that PEG is beneficial and, generally, earlier insertion is preferable to later. However, gathering clinical evidence to support these beliefs on the use and timing of PEG is challenging because controlled clinical trials are not feasible and clinical endpoints are confounded with PEG in observational data. Moreover, the confounders are time-varying and time to PEG insertion may be only partially observed. We show how one can view this problem as an adaptive treatment length policy and propose a new estimator via g-computation. We show that our estimator is consistent and asymptotically normal for the causal estimand and explore its finite sample properties in simulation studies. Finally, using more than 10 years of data from Emory ALS clinic registry, we found no evidence to suggest that earlier PEG reduced 4-year mortality;thus, our results do not support the hypothesis and belief that initiating palliative care earlier extends life, on average. At the same, we cannot be certain that all important confounding variables are collected and observed to ensure our modeling assumptions are correct, so more work is needed to address these important end-of-life questions for ALS patients.

关键词： Competing risks Dynamic regime g-computation Informative censoring Structural nested models

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