Article
Peripheral Vascular Disease
Olutobi A. Sanuade, Boni M. Ale, Abigail S. Baldridge, Ikechukwu A. Orji, Gabriel L. Shedul, Tunde M. Ojo, Grace Shedul, Eugenia N. Ugwuneji, Nonye Egenti, Kasarachi Omitiran, Rosemary Okoli, Helen Eze, Ada Nwankwo, Lisa R. Hirschhorn, Aashima Chopra, Jiancheng Ye, Priya Tripathi, Bolanle Banigbe, Namratha R. Kandula, Mark D. Huffman, Dike B. Ojji
Summary: This study evaluates the effectiveness of fixed-dose combination therapy for hypertension management and finds no significant advantage over free pill combination therapy. Further research is needed to confirm the efficacy and efficiency of upfront FDC therapy in improving hypertension control rates.
JOURNAL OF CLINICAL HYPERTENSION
(2023)
Article
Psychology, Mathematical
John M. Ferron, Diep Nguyen, Robert F. Dedrick, Shannon M. Suldo, Elizabeth Shaunessy-Dedrick
Summary: The researchers developed an adaptive, low-assumption, and statistically valid method to test for intervention effects. By applying masked visual analysis techniques to cluster RCTs, they demonstrated the benefits of testing effects in small-scale cluster RCTs without a priori specification of a statistical model or test statistic.
BEHAVIOR RESEARCH METHODS
(2022)
Article
Medicine, General & Internal
Zhao-Yan Song, Moo-Hyun Kim, Han-Cheol Lee, Sung-Ji Park, Moo-Yong Rhee, Jong-Il Choi, Sang-Hyun Kim, In-Ho Chae, Young-Joon Hong, Nam-Ho Lee, Gyo-Seung Hwang, Seung-Ho Hur, Jung-Woo Son, Jei-Keon Chae, Hyo-Soo Kim
Summary: In this study, it was found that the combination therapy of ezetimibe-rosuvastatin and telmisartan can effectively reduce systolic blood pressure and low-density lipoprotein cholesterol levels, and is safe.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Public, Environmental & Occupational Health
Karla Hemming, Monica Taljaard
Summary: Cluster randomized trials require larger sample size and face additional complexities. The potential for contamination justifies the use of cluster randomization, but the risk of contamination should be weighed against the problem of questionable scientific validity in settings with post-randomization identification or recruitment of unblinded participants. Guidelines are provided to minimize bias and maximize statistical efficiency in conducting cluster trials, emphasizing that methods for individually randomized trials rarely apply. Cluster randomization should be used when necessary, balancing its benefits, risks, and sample size. Clustering, restricted randomization, and adjustment for covariates should be considered, and recruitment should preferably be done before randomizing clusters.
INTERNATIONAL JOURNAL OF EPIDEMIOLOGY
(2023)
Article
Medicine, Research & Experimental
Gerezgiher Buruh Abera, Solomon Mekonen Abebe, Abebaw Gebeyehu Worku
Summary: This study reveals that health education intervention can increase women's demand for cervical cancer screening, emphasizing the importance of incorporating health education into healthcare planning and service provision.
Review
Cardiac & Cardiovascular Systems
Mohamed M. G. Mohamed, Mohammed Osman, Babikir Kheiri, Maryam Saleem, Alexandre Lacasse, Mohamad Alkhouli
Summary: This meta-analysis demonstrates that the use of polypills is significantly associated with reductions in blood pressure and blood lipid levels compared to standard of care, leading to a significant decrease in cardiovascular events.
INTERNATIONAL JOURNAL OF CARDIOLOGY
(2022)
Article
Medicine, Research & Experimental
Jidong Sung, Kye Taek Ahn, Byung-Ryul Cho, Sung Yun Lee, Byung Jin Kim, Dae Kyeong Kim, Joong-il Park, Wang-Soo Lee
Summary: The study confirmed that a single-pill combination for hypertension treatment leads to better adherence compared to an equivalent two-pill regimen, which suggests that reducing pill burden can improve patient compliance to medication.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE
(2021)
Article
Peripheral Vascular Disease
Jamie A. Kitt, Rachael L. Fox, Alexandra E. Cairns, Jill Mollison, Holger H. Burchert, Yvonne Kenworthy, Annabelle McCourt, Katie Suriano, Adam J. Lewandowski, Lucy Mackillop, Katherine L. Tucker, Richard J. McManus, Paul Leeson
Summary: Women with hypertensive pregnancies who engage in postpartum blood pressure self-management demonstrate significantly lower diastolic blood pressure levels 3.6 years later. This intervention shows promise in improving long-term blood pressure control and reducing the risk of chronic hypertension and cardiovascular events in this high-risk population.
Article
Mathematical & Computational Biology
Kim May Lee, Rebecca M. Turner, Guy E. Thwaites, A. Sarah Walker, Ian R. White
Summary: The Personalised Randomized Controlled Trial design allows each participant to be randomized between a personalised randomization list of treatments that are suitable for them. It aims to produce treatment rankings that can guide choice of treatment. We used simulation to evaluate different analysis approaches for this innovative trial design, including a network meta-analysis approach. The proposed approach performs well with respect to estimation bias and coverage, providing an overall treatment ranking list with reasonable precision and likely to improve outcome if used for intervention policies and clinical decisions.
STATISTICS IN MEDICINE
(2023)
Article
Peripheral Vascular Disease
Azusa Shima, Hisatomi Arima, Katsuyuki Miura, Yukako Tatsumi, Takayoshi Ohkubo, Yuichiro Kawatsu, Ayumi Morino, Takashi Kimura, Kayo Godai, Saori Azuma, Naomi Miyamatsu
Summary: The study highlights the importance of early promotion using referral letters in increasing clinic visits among patients with untreated hypertension, leading to significant improvements in treatment rates within a 6-month period. This approach could serve as a valuable strategy for enhancing the management of hypertension and improving patient outcomes.
HYPERTENSION RESEARCH
(2021)
Article
Gastroenterology & Hepatology
Yong Lv, Hui Chen, Bohan Luo, Wei Bai, Kai Li, Zhengyu Wang, Dongdong Xia, Wengang Guo, Qiuhe Wang, Xiaomei Li, Jie Yuan, Hongwei Cai, Jielai Xia, Zhanxin Yin, Daiming Fan, Guohong Han
Summary: In patients with cirrhosis and variceal bleeding, simultaneous embolization of large spontaneous portosystemic shunt (SPSS) during transjugular intrahepatic portosystemic shunt (TIPS) placement can reduce the incidence of hepatic encephalopathy (HE) without increasing other complications.
Article
Pharmacology & Pharmacy
Bo Qiu, Haojing Song, Congyang Ding, Xue Sun, Runxuan Du, Haotian Yang, Wanjun Bai, Zhanjun Dong
Summary: This study demonstrates the bioequivalence of test and reference valsartan/amlodipine formulations under fasting and postprandial conditions through a clinical trial. The participants were randomly divided into three sequences and underwent crossover administration. The average bioequivalence and reference-scaled average bioequivalence methods were used to evaluate the pharmacokinetic parameters.
FRONTIERS IN PHARMACOLOGY
(2023)
Review
Food Science & Technology
Ana Maria Garcia-Munoz, Ana I. Garcia-Guillen, Desiree Victoria-Montesinos, Maria Salud Abellan-Ruiz, Begona Alburquerque-Gonzalez, Fernando Canovas
Summary: Metabolic syndrome is linked to increased risks of cardiovascular disease and type 2 diabetes, further exacerbated by a sedentary lifestyle and situations like the COVID-19 pandemic. Recent studies suggest that consumption of polyphenol-rich fruits and vegetables has a protective effect in reducing cardiovascular risk. Hibiscus sabdariffa (HS) in combination with other plant extracts has been gaining attention for its potential in treating metabolic syndrome. A systematic review and meta-analysis of randomized clinical trials were conducted to examine the effects of HS with other plant extracts on metabolic syndrome prevention, revealing improvements in anthropometric parameters, blood pressure, and lipid profile.
Article
Peripheral Vascular Disease
JungMin Choi, Ki-Chul Sung, Sang-Hyun Ihm, Chang-Hwan Yoon, Seung Woo Park, Sung-Ha Park, Jang-Young Kim, Sung-Uk Kwon, Hae-Young Lee
Summary: This study aimed to evaluate the safety and efficacy of telmisartan/rosuvastatin single-pill combination therapy in reducing central blood pressure compared to telmisartan monotherapy. The results showed that the combination therapy was more effective in lowering central blood pressure, indicating the potential benefit of adding statin therapy for hypertensive patients with dyslipidemia. Both groups showed high compliance and no significant difference in adverse events.
JOURNAL OF CLINICAL HYPERTENSION
(2021)
Article
Mathematical & Computational Biology
Yunji Zhou, Elizabeth L. Turner, Ryan A. Simmons, Fan Li
Summary: This study focuses on the method of constrained randomization and evaluates the statistical properties in multi-arm cRCTs. The results show that both model-based and randomization-based analyses could gain power under constrained randomization, while maintaining the nominal type I error rate. However, randomization-based analyses are more robust against violations of distributional assumptions.
STATISTICS IN MEDICINE
(2022)
Letter
Gastroenterology & Hepatology
Jurij Hanzel, Christopher Ma, Guangyong Zou, Siddharth Singh, Parambir S. Dulai, Brian G. Feagan, Geert R. D'Haens, William J. Sandborn, Vipul Jairath
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
(2022)
Review
Gastroenterology & Hepatology
Jurij Hanzel, Rocio Sedano, Jenny Jeyarajah, Guangyong Zou, Stefanie C. McFarlane, Christopher Ma, Vipul Jairath
Summary: We conducted a systematic review and metaregression of pivotal Crohn's disease trials, finding that the speed of clinical improvement in Crohn's Disease Activity Index scores is similar among different biologic drug classes.
INFLAMMATORY BOWEL DISEASES
(2022)
Article
Gastroenterology & Hepatology
Ahmed Almradi, Rocio Sedano, Malcolm Hogan, G. Y. Zou, John K. MacDonald, Claire E. Parker, Jurij Hanzel, Eileen Crowley, Siddharth Singh, Geert D'Haens, William J. Sandborn, Brian G. Feagan, Christopher Ma, Vipul Jairath
Summary: This study quantifies the placebo rates in Crohn's disease trials and identifies factors influencing these rates. The findings suggest that placebo remission and response rates vary based on the trial phase, endpoint assessed, and induction or maintenance design.
JOURNAL OF CROHNS & COLITIS
(2022)
Article
Chemistry, Analytical
Lynn Zhu, Patrick Boissy, Christian Duval, Guangyong Zou, Mandar Jog, Manuel Montero-Odasso, Mark Speechley
Summary: Wearable GPS technology can assist in monitoring and maintaining the mobility level of older populations and people with movement disorders. This study recommends a standard minimum duration for GPS recording based on empirical evidence from older adults with Parkinson's disease.
Article
Health Care Sciences & Services
Alexandria Ratzki-Leewing, Bridget L. Ryan, Guangyong Zou, Susan Webster-Bogaert, Jason E. Black, Kathryn Stirling, Kristina Timcevska, Nadia Khan, John D. Buchenberger, Stewart B. Harris
Summary: The iNPHORM study aims to measure the incidence of severe and nonsevere hypoglycemia in American adults with diabetes and develop prognostic models for predicting hypoglycemia using self-reported survey data. Additionally, the study investigates the effects of different antihyperglycemic medications on hypoglycemia rates. Preliminary results indicate high participation rates and the analysis of data is currently ongoing, with published results expected in fall 2022.
JMIR RESEARCH PROTOCOLS
(2022)
Meeting Abstract
Endocrinology & Metabolism
Alexandria Ratzki-Leewing, Stewart B. Harris, Jason E. Black, Guangyong Zou, Susan Webster-Bogaert, Bridget L. Ryan
Meeting Abstract
Endocrinology & Metabolism
Alexandria Ratzki-Leewing, Stewart B. Harris, Jason E. Black, Guangyong Zou, Susan Webster-Bogaert, Bridget L. Ryan
Article
Gastroenterology & Hepatology
Rish K. Pai, Vipul Jairath, Malcolm Hogan, Guangyong Zou, Oyedele A. Adeyi, Quentin M. Anstee, Bashar A. Aqel, Cynthia Behling, Elizabeth J. Carey, Andrew D. Clouston, Kathleen Corey, Brian G. Feagan, David E. Kleiner, Christopher Ma, Stefanie C. McFarlane, Mazen Noureddin, Vlad Ratziu, Mark A. Valasek, Zobair M. Younossi, Stephen A. Harrison, Rohit Loomba
Summary: After extensive training and discussion among a group of experienced pathologists, we improved the reliability of multiple existing NAFLD histologic indices and fibrosis staging systems. Hepatocyte ballooning and MDBs showed the strongest correlation with disease activity and were used to develop the expanded NAS. Further validation, including evaluation of responsiveness, is still needed.
Article
Pharmacology & Pharmacy
Guangyong Zou, Emma Smith, Vipul Jairath
Summary: Concordance refers to the probability that high values on one variable are also observed on another variable. This index has various applications in practice, such as measuring effect size, evaluating accuracy, and assessing discrimination in prediction models. In this paper, the authors propose a unified framework for statistical inference of concordance indices for binary, ordinal, and continuous variables. Confidence interval procedures are developed for single and correlated indices, and simulation results demonstrate the effectiveness of the proposed methods.
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
(2022)
Editorial Material
Gastroenterology & Hepatology
Natalie Nightingale, Guangyong Zou, Michael F. Murphy, Vipul Jairath
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
(2023)
Article
Gastroenterology & Hepatology
Rocio Sedano, Malcolm Hogan, Guangyong Zou, Neeraj Narula, Siddharth Singh, Christopher Ma, Brian G. Feagan, Vipul Jairath
Summary: This systematic review and quantitative analysis of placebo-controlled ulcerative colitis induction trials showed higher histologic remission rates compared to clinical and endoscopic remission rates at the same timepoint, and there were no significant differences in relative risks for these outcomes between treatment groups. This supports the concept that histologic remission is as sensitive as clinical or endoscopic remission.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Pharmacology & Pharmacy
Guangyong Zou, Lily Zou, Shi-fang Qiu
Summary: Data on Likert scale is commonly used in medical research, specifically in randomized trials. This article compares the performance of parametric and nonparametric methods for analyzing Likert data and finds that the nonparametric approach is more suitable for two-group randomization trials.
PHARMACEUTICAL STATISTICS
(2023)
Article
Endocrinology & Metabolism
Alexandria Ratzki-Leewing, Jason E. Black, Anna R. Kahkoska, Bridget L. Ryan, Guangyong Zou, Neil Klar, Kristina Timcevska, Stewart B. Harris
Summary: This study aimed to investigate the real-world descriptive epidemiology of iatrogenic severe hypoglycemia in adults with insulin- and/or secretagogue-treated diabetes in the United States. The results showed that hypoglycemia events were alarmingly frequent, irrespective of diabetes type, and concentrated in a small subsample.
DIABETES OBESITY & METABOLISM
(2023)
Meeting Abstract
Gastroenterology & Hepatology
Florian Rieder, Mark E. Baker, David H. Bruining, Jeff L. Fidler, Shannon P. Sheedy, Jay Heiken, Eric C. Ehman, Justin Ream, David Holmes, Akitoshi Inoue, Yong Lee, Stuart Taylor, Jaap Stoker, Guangyong Zou, Zhongya Wang, Ronald K. Ottichilo, Julian Panes, Jordi Rimola, Vipul Jairath, Brian G. Feagan, Joel G. Fletcher
Meeting Abstract
Gastroenterology & Hepatology
Rocio Sedano, Malcolm Hogan, G. Y. Zou, Neeraj Narula, Siddharth Singh, Christopher Ma, Brian G. Feagan, Vipul Jairath