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6. A Randomized, Double-Blind, Placebo-Controlled Decentralized Trial to Assess Sleep, Health Outcomes, and Overall Well-Being in Healthy Adults Reporting Disturbed Sleep, Taking a Melatonin-Free Supplement.

Author

Kolobaric, Antonija, Hewlings, Susan, Bryant, Corey, Colwell, Christopher, R DAdamo, Christopher, Rosner, Bernard, Chen, Jeff, and Pauli, Emily

Subjects
PROMIS, botanical synergy, cannabinoids, health related quality of life, sleep, Humans, Adult, Sleep, Sleep Deprivation, Anxiety, Drug-Related Side Effects and Adverse Reactions, Sleep Wake Disorders, Outcome Assessment, Health Care
Abstract

Inadequate sleep is a global health concern. Sleep is multidimensional and complex; new multi-ingredient agents are needed. This study assessed the comparative effects of two multi-ingredient supplements on sleep relative to placebo. Adults (N = 620) seeking better sleep were randomly assigned to receive one of three study products. Sleep A (contained lower (0.35 mg THC and higher levels of botanicals (75 mg each hops oil and valerian oil), Sleep B (contained higher THC (0.85 mg) and lower botanicals (20 mg each hops oil and valerian oil) or placebo) for 4 weeks. Sleep disturbance was assessed at baseline and weekly using NIHs Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8A survey. Anxiety, stress, pain, and well-being were assessed using validated measures at baseline and weekly. A linear mixed-effects regression model was used to assess the change in health outcome score between active product groups and the placebo. There was a significant difference in sleep disturbance, anxiety, stress, and well-being between Sleep A and placebo. There was no significant difference in any health parameter between Sleep B and placebo. Side effects were mild or moderate. There were no significant differences in the frequency of side effects between the study groups. A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals that reported better sleep as a primary health concern.

Published
2023

7. Analytical method for detecting outlier evaluators

Author

Wu, Yujie, Curhan, Sharon, Rosner, Bernard, Curhan, Gary, and Wang, Molin

Subjects
Statistics - Applications
Abstract

Epidemiologic and medical studies often rely on evaluators to obtain measurements of exposures or outcomes for study participants, and valid estimates of associations depends on the quality of data. Even though statistical methods have been proposed to adjust for measurement errors, they often rely on unverifiable assumptions and could lead to biased estimates if those assumptions are violated. Therefore, methods for detecting potential `outlier' evaluators are needed to improve data quality during data collection stage. In this paper, we propose a two-stage algorithm to detect `outlier' evaluators whose evaluation results tend to be higher or lower than their counterparts. In the first stage, evaluators' effects are obtained by fitting a regression model. In the second stage, hypothesis tests are performed to detect `outlier' evaluators, where we consider both the power of each hypothesis test and the false discovery rate (FDR) among all tests. We conduct an extensive simulation study to evaluate the proposed method, and illustrate the method by detecting potential `outlier' audiologists in the data collection stage for the Audiology Assessment Arm of the Conservation of Hearing Study, an epidemiologic study for examining risk factors of hearing loss in the Nurses' Health Study II. Our simulation study shows that our method not only can detect true `outlier' evaluators, but also is less likely to falsely reject true `normal' evaluators. Our two-stage `outlier' detection algorithm is a flexible approach that can effectively detect `outlier' evaluators, and thus data quality can be improved during data collection stage.

Published
2022

11. A repeated measures approach to pooled and calibrated biomarker data

Author

Sloan, Abigail, Cheng, Chao, Rosner, Bernard, Ziegler, Regina G., Smith-Warner, Stephanie A., and Wang, Molin

Subjects
Statistics - Methodology
Abstract

Participant level meta-analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of interest, investigators must first calibrate the data to address measurement variability arising from usage of different laboratories and/or assays. In practice, the calibration process involves reassaying a random subset of biospecimens from each study at a central laboratory and fitting models that relate the study-specific "local" and central laboratory measurements. Previous work in this area treats the calibration process from the perspective of measurement error techniques and imputes the estimated central laboratory value among individuals with only a local laboratory measurement. In this work, we propose a repeated measures method to calibrate biomarker measurements pooled from multiple studies with study-specific calibration subsets. We account for correlation between measurements made on the same person and between measurements made at the same laboratory. We demonstrate that the repeated measures approach provides valid inference, and compare it to existing calibration approaches grounded in measurement error techniques in an example describing the association between circulating vitamin D and stroke., Comment: 25 pages, 2 figures, 3 tables

Published
2021

21. Incidence of and Risk Factors for Cataract in Anterior Uveitis

Author

Papaliodis, George N., Rosner, Bernard A., Dreger, Kurt A., Fitzgerald, Tonetta D., Artornsombudh, Pichaporn, Kothari, Srishti, Gangaputra, Sapna S., Levy-Clarke, Grace A., Nussenblatt, Robert B., Rosenbaum, James T., Sen, H. Nida, Suhler, Eric B., Thorne, Jennifer E., Bhatt, Nirali P., Foster, C. Stephen, Jabs, Douglas A., Pak, Clara M., Ying, Gui-shuang, and Kempen, John H.

Published
2023
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34. Wilcoxon Rank-Based Tests for Clustered Data with R Package clusrank

Author

Jiang, Yujing, He, Xin, Lee, Mei-Ling Ting, Rosner, Bernard, and Yan, Jun

Subjects
Statistics - Computation
Abstract

Wilcoxon Rank-based tests are distribution-free alternatives to the popular two-sample and paired t-tests. For independent data, they are available in several R packages such as stats and coin. For clustered data, in spite of the recent methodological developments, there did not exist an R package that makes them available at one place. We present a package clusrank where the latest developments are implemented and wrapped under a unified user-friendly interface. With different methods dispatched based on the inputs, this package offers great flexibility in rank-based tests for various clustered data. Exact tests based on permutations are also provided for some methods. Details of the major schools of different methods are briefly reviewed. Usages of the package clusrank are illustrated with simulated data as well as a real dataset from an ophthalmological study. The package also enables convenient comparison between selected methods under settings that have not been studied before and the results are discussed.

Published
2017

35. Antepartum Intimate Partner Violence: Development of a Risk Prediction Model.

Author

Prakash, Jaya, Fay, Kathryn, Gujrathi, Rahul, Rosner, Bernard, Nour, Nawal, and Khurana, Bharti

Subjects
RISK assessment, SELF-evaluation, SEXUALLY transmitted diseases, URINARY tract infections, CESAREAN section, INTIMATE partner violence, PREDICTION models, RESEARCH funding, PUERPERIUM, FISHER exact test, LOGISTIC regression analysis, PREMATURE infants, PREGNANT women, CHI-squared test, DESCRIPTIVE statistics, ODDS ratio, SOCIAL skills, ELECTRONIC health records, MEDICAL records, ACQUISITION of data, CONFIDENCE intervals, WOMEN'S health, MEDICAL screening
Abstract

Objectives: To explore socio-behavioral, clinical, and imaging findings associated with antepartum intimate partner violence (IPV) and aid in risk stratification of at-risk individuals. Methods: We analyzed electronic medical records during indexed pregnancies for 108 pregnant patients who self-reported antepartum IPV (cases) and 106 age-matched pregnant patients who did not self-report antepartum IPV (controls). Sociodemographic, clinical, and radiology data were analyzed via chi-squared and Fisher's exact tests with p < 0.05 as the threshold for significance. Stepwise logistic regression was applied to derive a risk prediction model. Results: The proportion of cases reporting emotional IPV (76% vs. 52%) and/or physical IPV (45% vs. 31%) during pregnancy significantly increased from prior to pregnancy. Cases were significantly more likely to report prepregnancy substance use (odds ratio [OR] = 2.60; 95% confidence interval [CI]: 1.13–5.98), sexually transmitted infections (OR = 3.48; 95%CI: 1.64–7.37), abortion (OR = 3.17; 95%CI: 1.79, 5.59), and preterm birth (OR = 5.97; 95%CI: 1.69–21.15). During pregnancy, cases were more likely to report unstable housing (OR = 5.26; 95%CI: 2.67–10.36), multigravidity (OR = 2.83; 95%CI: 1.44–5.58), multiparity (OR = 3.75; 95%CI: 1.72–8.20), anxiety (OR = 3.35; 95%CI: 1.85–6.08), depression (OR = 5.58; 95%CI: 3.07–10.16), substance use (OR = 2.92; 95%CI: 1.28–6.65), urinary tract infection (UTI) (OR = 3.26; 95%CI: 1.14–9.32), intrauterine growth restriction (OR = 10.71; 95%CI: 1.35–85.25), and cesarean delivery (OR = 2.25; 95%CI: 1.26–4.02). Cases had significantly more OBGYN abnormalities on imaging and canceled more radiological studies (OR = 5.31). Logistic regression found housing status, sexually transmitted infection history, preterm delivery history, abortion history, depression, and antepartum UTI predictive of antepartum IPV. The risk prediction model achieved good calibration with an area under the curve of 0.79. Conclusions: This study identifies significant disparities among patients experiencing antepartum IPV, and our proposed risk prediction model can inform risk assessment in this setting. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Testosterone Pathway Genetic Polymorphisms in Relation to Primary Open-Angle Glaucoma: An Analysis in Two Large Datasets

Author

Cooke Bailey, Jessica N, Gharahkhani, Puya, Kang, Jae H, Butkiewicz, Mariusz, Sullivan, David A, Weinreb, Robert N, Aschard, Hugues, Allingham, R Rand, Ashley-Koch, Allison, Lee, Richard K, Moroi, Sayoko E, Brilliant, Murray H, Wollstein, Gadi, Schuman, Joel S, Fingert, John H, Budenz, Donald L, Realini, Tony, Gaasterland, Terry, Scott, William K, Singh, Kuldev, Sit, Arthur J, Igo, Robert P, Song, Yeunjoo E, Hark, Lisa, Ritch, Robert, Rhee, Douglas J, Vollrath, Douglas, Zack, Donald J, Medeiros, Felipe, Vajaranant, Thasarat S, Chasman, Daniel I, Christen, William G, Pericak-Vance, Margaret A, Liu, Yutao, Kraft, Peter, Richards, Julia E, Rosner, Bernard A, Hauser, Michael A, Craig, Jamie E, Burdon, Kathryn P, Hewitt, Alex W, Mackey, David A, Haines, Jonathan L, MacGregor, Stuart, Wiggs, Janey L, and Pasquale, Louis R

Subjects
Genetics, Neurodegenerative, Aging, 2.1 Biological and endogenous factors, Aetiology, Datasets as Topic, Female, Gene Frequency, Genome-Wide Association Study, Genotype, Glaucoma, Open-Angle, Humans, Intraocular Pressure, Low Tension Glaucoma, Male, Metabolic Networks and Pathways, Middle Aged, Polymorphism, Single Nucleotide, Testosterone, primary open-angle glaucoma, testosterone, genetics, pathway analysis, Australian and New Zealand Registry of Advanced Glaucoma (ANZRAG) Consortium, Biological Sciences, Medical and Health Sciences, Ophthalmology & Optometry
Abstract

Purpose:Sex hormones may be associated with primary open-angle glaucoma (POAG), although the mechanisms are unclear. We previously observed that gene variants involved with estrogen metabolism were collectively associated with POAG in women but not men; here we assessed gene variants related to testosterone metabolism collectively and POAG risk. Methods:We used two datasets: one from the United States (3853 cases and 33,480 controls) and another from Australia (1155 cases and 1992 controls). Both datasets contained densely called genotypes imputed to the 1000 Genomes reference panel. We used pathway- and gene-based approaches with Pathway Analysis by Randomization Incorporating Structure (PARIS) software to assess the overall association between a panel of single nucleotide polymorphisms (SNPs) in testosterone metabolism genes and POAG. In sex-stratified analyses, we evaluated POAG overall and POAG subtypes defined by maximum IOP (high-tension [HTG] or normal tension glaucoma [NTG]). Results:In the US dataset, the SNP panel was not associated with POAG (permuted P = 0.77), although there was an association in the Australian sample (permuted P = 0.018). In both datasets, the SNP panel was associated with POAG in men (permuted P ≤ 0.033) and not women (permuted P ≥ 0.42), but in gene-based analyses, there was no consistency on the main genes responsible for these findings. In both datasets, the testosterone pathway association with HTG was significant (permuted P ≤ 0.011), but again, gene-based analyses showed no consistent driver gene associations. Conclusions:Collectively, testosterone metabolism pathway SNPs were consistently associated with the high-tension subtype of POAG in two datasets.

Published
2018

39. Testosterone Pathway Genetic Polymorphisms in Relation to Primary Open-Angle Glaucoma: An Analysis in Two Large Datasets.

Author

Bailey, Jessica N Cooke, Gharahkhani, Puya, Kang, Jae H, Butkiewicz, Mariusz, Sullivan, David A, Weinreb, Robert N, Aschard, Hugues, Allingham, R Rand, Ashley-Koch, Allison, Lee, Richard K, Moroi, Sayoko E, Brilliant, Murray H, Wollstein, Gadi, Schuman, Joel S, Fingert, John H, Budenz, Donald L, Realini, Tony, Gaasterland, Terry, Scott, William K, Singh, Kuldev, Sit, Arthur J, Igo, Robert P, Song, Yeunjoo E, Hark, Lisa, Ritch, Robert, Rhee, Douglas J, Vollrath, Douglas, Zack, Donald J, Medeiros, Felipe, Vajaranant, Thasarat S, Chasman, Daniel I, Christen, William G, Pericak-Vance, Margaret A, Liu, Yutao, Kraft, Peter, Richards, Julia E, Rosner, Bernard A, Hauser, Michael A, Craig, Jamie E, Burdon, Kathryn P, Hewitt, Alex W, Mackey, David A, Haines, Jonathan L, MacGregor, Stuart, Wiggs, Janey L, Pasquale, Louis R, and Australian and New Zealand Registry of Advanced Glaucoma (ANZRAG) Consortium

Subjects
Australian and New Zealand Registry of Advanced Glaucoma (ANZRAG) Consortium, Humans, Glaucoma, Open-Angle, Testosterone, Intraocular Pressure, Gene Frequency, Genotype, Polymorphism, Single Nucleotide, Middle Aged, Female, Male, Metabolic Networks and Pathways, Genome-Wide Association Study, Low Tension Glaucoma, Datasets as Topic, primary open-angle glaucoma, testosterone, genetics, pathway analysis, Glaucoma, Open-Angle, Polymorphism, Single Nucleotide, Biological Sciences, Medical and Health Sciences, Ophthalmology & Optometry
Abstract

Purpose:Sex hormones may be associated with primary open-angle glaucoma (POAG), although the mechanisms are unclear. We previously observed that gene variants involved with estrogen metabolism were collectively associated with POAG in women but not men; here we assessed gene variants related to testosterone metabolism collectively and POAG risk. Methods:We used two datasets: one from the United States (3853 cases and 33,480 controls) and another from Australia (1155 cases and 1992 controls). Both datasets contained densely called genotypes imputed to the 1000 Genomes reference panel. We used pathway- and gene-based approaches with Pathway Analysis by Randomization Incorporating Structure (PARIS) software to assess the overall association between a panel of single nucleotide polymorphisms (SNPs) in testosterone metabolism genes and POAG. In sex-stratified analyses, we evaluated POAG overall and POAG subtypes defined by maximum IOP (high-tension [HTG] or normal tension glaucoma [NTG]). Results:In the US dataset, the SNP panel was not associated with POAG (permuted P = 0.77), although there was an association in the Australian sample (permuted P = 0.018). In both datasets, the SNP panel was associated with POAG in men (permuted P ≤ 0.033) and not women (permuted P ≥ 0.42), but in gene-based analyses, there was no consistency on the main genes responsible for these findings. In both datasets, the testosterone pathway association with HTG was significant (permuted P ≤ 0.011), but again, gene-based analyses showed no consistent driver gene associations. Conclusions:Collectively, testosterone metabolism pathway SNPs were consistently associated with the high-tension subtype of POAG in two datasets.

Published
2018

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