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  1. Article ; Online: The Registry-Based Randomized Trial - A Pragmatic Study Design.

    Troxel, Andrea B / Hade, Erinn M

    NEJM evidence

    2024  Volume 3, Issue 2, Page(s) EVIDe2300310

    Abstract: Randomized controlled trials are the gold standard of clinical research for comparing therapies in well-defined groups of participants. ...

    Abstract Randomized controlled trials are the gold standard of clinical research for comparing therapies in well-defined groups of participants.
    MeSH term(s) Humans ; Research Design ; Patient Selection ; Registries ; Causality ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2024-01-23
    Publishing country United States
    Document type Editorial
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDe2300310
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Partial-linear single-index transformation models with censored data.

    Lee, Myeonggyun / Troxel, Andrea B / Liu, Mengling

    Lifetime data analysis

    2024  

    Abstract: In studies with time-to-event outcomes, multiple, inter-correlated, and time-varying covariates are commonly observed. It is of great interest to model their joint effects by allowing a flexible functional form and to delineate their relative ... ...

    Abstract In studies with time-to-event outcomes, multiple, inter-correlated, and time-varying covariates are commonly observed. It is of great interest to model their joint effects by allowing a flexible functional form and to delineate their relative contributions to survival risk. A class of semiparametric transformation (ST) models offers flexible specifications of the intensity function and can be a general framework to accommodate nonlinear covariate effects. In this paper, we propose a partial-linear single-index (PLSI) transformation model that reduces the dimensionality of multiple covariates into a single index and provides interpretable estimates of the covariate effects. We develop an iterative algorithm using the regression spline technique to model the nonparametric single-index function for possibly nonlinear joint effects, followed by nonparametric maximum likelihood estimation. We also propose a nonparametric testing procedure to formally examine the linearity of covariate effects. We conduct Monte Carlo simulation studies to compare the PLSI transformation model with the standard ST model and apply it to NYU Langone Health de-identified electronic health record data on COVID-19 hospitalized patients' mortality and a Veteran's Administration lung cancer trial.
    Language English
    Publishing date 2024-04-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1479719-7
    ISSN 1572-9249 ; 1380-7870
    ISSN (online) 1572-9249
    ISSN 1380-7870
    DOI 10.1007/s10985-024-09624-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Correction: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

    Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

    Prevention science : the official journal of the Society for Prevention Research

    2024  

    Language English
    Publishing date 2024-01-06
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 2251270-6
    ISSN 1573-6695 ; 1389-4986
    ISSN (online) 1573-6695
    ISSN 1389-4986
    DOI 10.1007/s11121-024-01645-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Correction: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

    Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

    Prevention science : the official journal of the Society for Prevention Research

    2024  

    Language English
    Publishing date 2024-02-16
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 2251270-6
    ISSN 1573-6695 ; 1389-4986
    ISSN (online) 1573-6695
    ISSN 1389-4986
    DOI 10.1007/s11121-024-01652-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

    Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

    Prevention science : the official journal of the Society for Prevention Research

    2023  

    Abstract: The stepped wedge design is often used to evaluate interventions as they are rolled out across schools, health clinics, communities, or other clusters. Most models used in the design and analysis of stepped wedge trials assume that the intervention ... ...

    Abstract The stepped wedge design is often used to evaluate interventions as they are rolled out across schools, health clinics, communities, or other clusters. Most models used in the design and analysis of stepped wedge trials assume that the intervention effect is immediate and constant over time following implementation of the intervention (the "exposure time"). This is known as the IT (immediate treatment effect) assumption. However, recent research has shown that using methods based on the IT assumption when the treatment effect varies over exposure time can give extremely misleading results. In this manuscript, we discuss the need to carefully specify an appropriate measure of the treatment effect when the IT assumption is violated and we show how a stepped wedge trial can be powered when it is anticipated that the treatment effect will vary as a function of the exposure time. Specifically, we describe how to power a trial when the exposure time indicator (ETI) model of Kenny et al. (Statistics in Medicine, 41, 4311-4339, 2022) is used and the estimand of interest is a weighted average of the time-varying treatment effects. We apply these methods to the ADDRESS-BP trial, a type 3 hybrid implementation study designed to address racial disparities in health care by evaluating a practice-based implementation strategy to reduce hypertension in African American communities.
    Language English
    Publishing date 2023-09-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2251270-6
    ISSN 1573-6695 ; 1389-4986
    ISSN (online) 1573-6695
    ISSN 1389-4986
    DOI 10.1007/s11121-023-01587-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings: A Randomized Clinical Trial.

    Rummo, Pasquale E / Roberto, Christina A / Thorpe, Lorna E / Troxel, Andrea B / Elbel, Brian

    JAMA network open

    2023  Volume 6, Issue 3, Page(s) e232371

    Abstract: Importance: Despite recent growth in online redemption of Supplemental Nutrition Assistance Program (SNAP) benefits, no previous work has tested the impact of economic and behavioral economic strategies on food purchasing behaviors in an online grocery ... ...

    Abstract Importance: Despite recent growth in online redemption of Supplemental Nutrition Assistance Program (SNAP) benefits, no previous work has tested the impact of economic and behavioral economic strategies on food purchasing behaviors in an online grocery retail setting among adults with low income.
    Objective: To examine the extent to which financial incentives and default shopping cart options influence fruit and vegetable purchases.
    Design, setting, and participants: This randomized clinical trial used an experimental online grocery store for adults who currently or have ever received SNAP benefits. From October 7 to December 2, 2021, participants were instructed to shop for a week's worth of groceries for their household, with a budget tailored to household size; no payment was taken.
    Interventions: Random assignment to 1 of 4 conditions: no intervention, 50% discount on eligible fruits and vegetables, prefilled shopping carts with tailored fruit and vegetable items (ie, default options), or a combination of the discount and default options.
    Main outcomes and measures: The primary outcome was the percentage of nondiscounted dollars spent on eligible fruit and vegetables per basket.
    Results: Of 2744 participants, mean (SD) age was 46.7 (16.0) years, and 1447 (52.7%) identified as women. A total of 1842 participants (67.1%) reported currently receiving SNAP benefits and 1492 (54.4%) reported shopping online for groceries in the previous 12 months. Participants spent a mean (SD) 20.5% (23.5%) of total dollars on eligible fruits and vegetables. Compared with no intervention, those in the discount condition spent 4.7% (98.3% CI, 1.7%-7.7%) of more total dollars on eligible fruits and vegetables; those in the default condition, 7.8% (98.3% CI, 4.8%-10.7%) more; and those in the combination condition, 13.0% (98.3% CI, 10.0%-16.0%) more (P < .001 for all). There was no difference between the discount and the default conditions (P = .06), but the effect in the combination condition was significantly larger than both discount and default conditions (P < .001). Default shopping cart items were purchased by 679 participants (93.4%) in the default condition and 655 (95.5%) in the combination condition, whereas 297 (45.8%) in the control and 361 (52.9%) in the discount conditions purchased those items (P < .001). No variation was observed by age, sex, or race and ethnicity, and results were similar when those who reported never shopping online for groceries were excluded.
    Conclusions and relevance: In this randomized clinical trial, financial incentives for fruits and vegetables and default options, especially in combination, led to meaningful increases in online fruit and vegetable purchases among adults with low income.
    Trial registration: ClinicalTrials.gov Identifier: NCT04766034.
    MeSH term(s) Adult ; Humans ; Female ; Middle Aged ; Motivation ; Vegetables ; Fruit ; Poverty ; Family Characteristics
    Language English
    Publishing date 2023-03-01
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2023.2371
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: The National Institutes of Health COVID-19 NeuroDatabank and NeuroBiobank: A National Resource for Learning, Discovery, and Progress.

    Troxel, Andrea B / Frontera, Jennifer A / Mendoza-Puccini, Carolina

    Frontiers in neurology

    2021  Volume 11, Page(s) 615061

    Abstract: Patients suffering from COVID-19 experience a wide range of symptoms and sequelae, including increasingly recognized neurological problems. A concerted effort is necessary to identify and characterize these issues, whether newly appearing as a result of ... ...

    Abstract Patients suffering from COVID-19 experience a wide range of symptoms and sequelae, including increasingly recognized neurological problems. A concerted effort is necessary to identify and characterize these issues, whether newly appearing as a result of COVID-19 disease or exacerbations of underlying conditions. A national resource to collect information and/or biospecimens regarding neurological complications of COVID-19 offers an opportunity for broad representation, harmonization, and rapid learning, all while ensuring robust protection of confidential information through the use of global unique identifiers to protect patient privacy.
    Language English
    Publishing date 2021-01-15
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2564214-5
    ISSN 1664-2295
    ISSN 1664-2295
    DOI 10.3389/fneur.2020.615061
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Behavioral Economics and Tobacco Control: Current Practices and Future Opportunities.

    Littman, Dalia / Sherman, Scott E / Troxel, Andrea B / Stevens, Elizabeth R

    International journal of environmental research and public health

    2022  Volume 19, Issue 13

    Abstract: Despite considerable progress, smoking remains the leading preventable cause of death in the United States. To address the considerable health and economic burden of tobacco use, the development of improved tobacco control and treatment interventions is ... ...

    Abstract Despite considerable progress, smoking remains the leading preventable cause of death in the United States. To address the considerable health and economic burden of tobacco use, the development of improved tobacco control and treatment interventions is critical. By combining elements of economics and psychology, behavioral economics provides a framework for novel solutions to treat smokers who have failed to quit with traditional smoking cessation interventions. The full range of behavioral economic principles, however, have not been widely utilized in the realm of tobacco control and treatment. Given the need for improved tobacco control and treatment, the limited use of other behavioral economic principles represents a substantial missed opportunity. For this reason, we sought to describe the principles of behavioral economics as they relate to tobacco control, highlight potential gaps in the behavioral economics tobacco research literature, and provide examples of potential interventions that use each principle.
    MeSH term(s) Economics, Behavioral ; Humans ; Smoking Cessation/psychology ; Nicotiana ; Tobacco Products ; Tobacco Smoking ; United States
    Language English
    Publishing date 2022-07-04
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2175195-X
    ISSN 1660-4601 ; 1661-7827
    ISSN (online) 1660-4601
    ISSN 1661-7827
    DOI 10.3390/ijerph19138174
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  9. Article ; Online: Pooling Data From Individual Clinical Trials in the COVID-19 Era.

    Petkova, Eva / Antman, Elliott M / Troxel, Andrea B

    JAMA

    2020  Volume 324, Issue 6, Page(s) 543–545

    MeSH term(s) Betacoronavirus ; COVID-19 ; Cooperative Behavior ; Coronavirus Infections ; Datasets as Topic ; Humans ; Information Dissemination/methods ; Pandemics ; Pneumonia, Viral ; Randomized Controlled Trials as Topic ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-07-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.13042
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  10. Article ; Online: Zoster Eye Disease Study: Rationale and Design.

    Cohen, Elisabeth J / Hochman, Judith S / Troxel, Andrea B / Colby, Kathryn A / Jeng, Bennie H

    Cornea

    2022  Volume 41, Issue 5, Page(s) 562–571

    Abstract: Purpose: The purpose of this study was to describe the rationale and design of the Zoster Eye Disease Study (ZEDS).: Methods: ZEDS is a National Eye Institute-supported randomized clinical trial designed to determine whether 1 year of suppressive ... ...

    Abstract Purpose: The purpose of this study was to describe the rationale and design of the Zoster Eye Disease Study (ZEDS).
    Methods: ZEDS is a National Eye Institute-supported randomized clinical trial designed to determine whether 1 year of suppressive valacyclovir in patients with herpes zoster ophthalmicus (HZO) reduces complications because there is currently no high-quality evidence to support its use. Eligible patients are 18 years and older, immunocompetent, have a history of a typical rash at disease onset, and have had a record of active epithelial or stromal keratitis or iritis within 1 year before enrollment. Exclusion criteria include estimated glomerular filtration rate less than 45 or pregnancy. The primary endpoint is the time to first occurrence of new or worsening dendriform epithelial keratitis, stromal keratitis without or with ulceration, endothelial keratitis, or iritis due to HZO during 12 months of study treatment requiring prespecified treatment changes. The study has 80% power to detect a 30% difference between treatment groups, with a 30% rate of endpoints by 1 year assumed among controls. Secondary and exploratory questions include whether there is a persistent treatment benefit during the 6 months after treatment, whether development of postherpetic neuralgia varies by treatment group, and whether vaccinations against herpes zoster affect study outcomes and coronavirus disease 19 status.
    Results: Over approximately 4 years, over 400 study participants have been enrolled.
    Conclusions: ZEDS aims to provide scientific evidence on whether suppressive valacyclovir treatment improves outcomes in HZO and should become the standard of care.
    MeSH term(s) Antiviral Agents/therapeutic use ; COVID-19 ; Herpes Zoster ; Herpes Zoster Ophthalmicus/complications ; Herpes Zoster Ophthalmicus/diagnosis ; Herpes Zoster Ophthalmicus/drug therapy ; Humans ; Neuralgia, Postherpetic/diagnosis ; Neuralgia, Postherpetic/drug therapy ; Neuralgia, Postherpetic/epidemiology ; Valacyclovir/therapeutic use
    Chemical Substances Antiviral Agents ; Valacyclovir (MZ1IW7Q79D)
    Language English
    Publishing date 2022-02-15
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 604826-2
    ISSN 1536-4798 ; 0277-3740
    ISSN (online) 1536-4798
    ISSN 0277-3740
    DOI 10.1097/ICO.0000000000002743
    Database MEDical Literature Analysis and Retrieval System OnLINE

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