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  1. Article ; Online: Is inadequate risk stratification diluting hazard ratio estimates in randomized clinical trials?

    Mehrotra, Devan V / West, Rachel Marceau

    Clinical trials (London, England)

    2024  , Page(s) 17407745231222448

    Abstract: In randomized clinical trials, analyses of time-to-event data without risk stratification, or with stratification based on pre-selected factors revealed at the end of the trial to be at most weakly associated with risk, are quite common. We caution that ... ...

    Abstract In randomized clinical trials, analyses of time-to-event data without risk stratification, or with stratification based on pre-selected factors revealed at the end of the trial to be at most weakly associated with risk, are quite common. We caution that such analyses are likely delivering hazard ratio estimates that unwittingly dilute the evidence of benefit for the test relative to the control treatment. To make our case, first, we use a hypothetical scenario to contrast risk-unstratified and risk-stratified hazard ratios. Thereafter, we draw attention to the previously published 5-step stratified testing and amalgamation routine (5-STAR) approach in which a pre-specified treatment-blinded algorithm is applied to survival times from the trial to partition patients into well-separated risk strata using baseline covariates determined to be jointly strongly prognostic for event risk. After treatment unblinding, a treatment comparison is done within each risk stratum and stratum-level results are averaged for overall inference. For illustration, we use 5-STAR to reanalyze data for the primary and key secondary time-to-event endpoints from three published cardiovascular outcomes trials. The results show that the 5-STAR estimate is typically smaller (i.e. more in favor of the test treatment) than the originally reported (traditional) estimate. This is not surprising because 5-STAR mitigates the presumed dilution bias in the traditional hazard ratio estimate caused by no or inadequate risk stratification, as evidenced by two detailed examples. Pre-selection of stratification factors at the trial design stage to achieve adequate risk stratification for the analysis will often be challenging. In such settings, an objective risk stratification approach such as 5-STAR, which is partly aligned with guidance from the US Food and Drug Administration on covariate-adjustment in clinical trials, is worthy of consideration.
    Language English
    Publishing date 2024-02-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/17407745231222448
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5831: Show issues Location:
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  2. Article: Neurogenic Cell Behavior in 3D Culture Enhanced Within a Highly Compliant Synthetic Hydrogel Platform Formed via Competitive Crosslinking.

    Chapla, Rachel / Katz, Rachel R / West, Jennifer L

    Cellular and molecular bioengineering

    2024  Volume 17, Issue 1, Page(s) 35–48

    Abstract: Purpose: Scaffold materials that better support neurogenesis are still needed to improve cell therapy outcomes for neural tissue damage. We have used a modularly tunable, highly compliant, degradable hydrogel to explore the impacts of hydrogel ... ...

    Abstract Purpose: Scaffold materials that better support neurogenesis are still needed to improve cell therapy outcomes for neural tissue damage. We have used a modularly tunable, highly compliant, degradable hydrogel to explore the impacts of hydrogel compliance stiffness on neural differentiation. Here we implemented competitive matrix crosslinking mechanics to finely tune synthetic hydrogel moduli within soft tissue stiffnesses, a range much softer than typically achievable in synthetic crosslinked hydrogels, providing a modularly controlled and ultrasoft 3D culture model which supports and enhances neurogenic cell behavior.
    Methods: Soluble competitive allyl monomers were mixed with proteolytically-degradable poly(ethylene glycol) diacrylate derivatives and crosslinked to form a matrix, and resultant hydrogel stiffness and diffusive properties were evaluated. Neural PC12 cells or primary rat fetal neural stem cells (NSCs) were encapsulated within the hydrogels, and cell morphology and phenotype were investigated to understand cell-matrix interactions and the effects of environmental stiffness on neural cell behavior within this model.
    Results: Addition of allyl monomers caused a concentration-dependent decrease in hydrogel compressive modulus from 4.40 kPa to 0.26 kPa (natural neural tissue stiffness) without influencing soluble protein diffusion kinetics through the gel matrix. PC12 cells encapsulated in the softest hydrogels showed significantly enhanced neurite extension in comparison to PC12s in all other hydrogel stiffnesses tested. Encapsulated neural stem cells demonstrated significantly greater spreading and elongation in 0.26 kPa alloc hydrogels than in 4.4 kPa hydrogels. When soluble growth factor deprivation (for promotion of neural differentiation) was evaluated within the neural stiffness gels (0.26 kPa), NSCs showed increased neuronal marker expression, indicating early enhancement of neurogenic differentiation.
    Conclusions: Implementing allyl-acrylate crosslinking competition reduced synthetic hydrogel stiffness to provide a supportive environment for 3D neural tissue culture, resulting in enhanced neurogenic behavior of encapsulated cells. These results indicate the potential suitability of this ultrasoft hydrogel system as a model platform for further investigating environmental factors on neural cell behavior.
    Supplementary information: The online version contains supplementary material available at 10.1007/s12195-024-00794-2.
    Language English
    Publishing date 2024-02-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2416037-4
    ISSN 1865-5033 ; 1865-5025
    ISSN (online) 1865-5033
    ISSN 1865-5025
    DOI 10.1007/s12195-024-00794-2
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  3. Article ; Online: Sex differences in innate and adaptive immunity impact fetal, placental, and maternal health†.

    Baines, Kelly J / West, Rachel C

    Biology of reproduction

    2023  Volume 109, Issue 3, Page(s) 256–270

    Abstract: The differences between males and females begin shortly after birth, continue throughout prenatal development, and eventually extend into childhood and adult life. Male embryos and fetuses prioritize proliferation and growth, often at the expense of the ... ...

    Abstract The differences between males and females begin shortly after birth, continue throughout prenatal development, and eventually extend into childhood and adult life. Male embryos and fetuses prioritize proliferation and growth, often at the expense of the fetoplacental energy reserves. This singular focus on growth over adaptability leaves male fetuses and neonates vulnerable to adverse outcomes during pregnancy and birth and can have lasting impacts throughout life. Beyond this prioritization of growth, male placentas and fetuses also respond to infection and inflammation differently than female counterparts. Pregnancies carrying female fetuses have a more regulatory immune response, whereas pregnancies carrying male fetuses have a stronger inflammatory response. These differences can be seen as early as the innate immune response with differences in cytokine and chemokine signaling. The sexual dimorphism in immunity then continues into the adaptive immune response with differences in T-cell biology and antibody production and transfer. As it appears that these sex-specific differences are amplified in pathologic pregnancies, it stands to reason that differences in the placental, fetal, and maternal immune responses in pregnancy contribute to increased male perinatal morbidity and mortality. In this review, we will describe the genetic and hormonal contributions to the sexual dimorphism of fetal and placental immunity. We will also discuss current research efforts to describe the sex-specific differences of the maternal-fetal interface and how it impacts fetal and maternal health.
    MeSH term(s) Adult ; Infant, Newborn ; Pregnancy ; Female ; Male ; Humans ; Child ; Placenta/pathology ; Sex Characteristics ; Maternal Health ; Fetus ; Immunity, Innate ; Adaptive Immunity
    Language English
    Publishing date 2023-07-07
    Publishing country United States
    Document type Review ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1118-6
    ISSN 1529-7268 ; 0006-3363
    ISSN (online) 1529-7268
    ISSN 0006-3363
    DOI 10.1093/biolre/ioad072
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    Zs.A 551: Show issues Location:
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  4. Article: Reductionist Three-Dimensional Tumor Microenvironment Models in Synthetic Hydrogels.

    Katz, Rachel R / West, Jennifer L

    Cancers

    2022  Volume 14, Issue 5

    Abstract: The tumor microenvironment (TME) plays a determining role in everything from disease progression to drug resistance. As such, in vitro models which can recapitulate the cell-cell and cell-matrix interactions that occur in situ are key to the ... ...

    Abstract The tumor microenvironment (TME) plays a determining role in everything from disease progression to drug resistance. As such, in vitro models which can recapitulate the cell-cell and cell-matrix interactions that occur in situ are key to the investigation of tumor behavior and selecting effective therapeutic drugs. While naturally derived matrices can retain the dimensionality of the native TME, they lack tunability and batch-to-batch consistency. As such, many synthetic polymer systems have been employed to create physiologically relevant TME cultures. In this review, we discussed the common semi-synthetic and synthetic polymers used as hydrogel matrices for tumor models. We reviewed studies in synthetic hydrogels which investigated tumor cell interactions with vasculature and immune cells. Finally, we reviewed the utility of these models as chemotherapeutic drug-screening platforms, as well as the future directions of the field.
    Language English
    Publishing date 2022-02-26
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers14051225
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  5. Article ; Online: Tunable PEG Hydrogels for Discerning Differential Tumor Cell Response to Biomechanical Cues.

    Katz, Rachel R / West, Jennifer L

    Advanced biology

    2022  Volume 6, Issue 12, Page(s) e2200084

    Abstract: Increased extracellular matrix (ECM) density in the tumor microenvironment has been shown to influence aspects of tumor progression such as proliferation and invasion. Increased matrix density means cells experience not only increased mechanical ... ...

    Abstract Increased extracellular matrix (ECM) density in the tumor microenvironment has been shown to influence aspects of tumor progression such as proliferation and invasion. Increased matrix density means cells experience not only increased mechanical properties, but also a higher density of bioactive sites. Traditional in vitro ECM models like Matrigel and collagen do not allow these properties to be investigated independently. In this work, a poly(ethylene glycol)-based scaffold is used which modifies with integrin-binding sites for cell attachment and matrix metalloproteinase 2 and 9 sensitive sites for enzyme-mediated degradation. The polymer backbone density and binding site concentration are independently tuned and the effect each of these properties and their interaction have on the proliferation, invasion, and focal complex formation of two different tumor cell lines is evaluated. It is seen that the cell line of epithelial origin (Hs 578T, triple negative breast cancer) proliferates more, invades less, and forms more mature focal complexes in response to an increase in matrix adhesion sites. Conversely, the cell line of mesenchymal origin (HT1080, fibrosarcoma) proliferates more in 2D culture but less in 3D culture, invades less, and forms more mature focal complexes in response to an increase in matrix stiffness.
    MeSH term(s) Hydrogels/analysis ; Matrix Metalloproteinase 2/analysis ; Cues ; Extracellular Matrix/chemistry ; Biocompatible Materials/analysis ; Cell Line, Tumor
    Chemical Substances Hydrogels ; Matrix Metalloproteinase 2 (EC 3.4.24.24) ; Biocompatible Materials
    Language English
    Publishing date 2022-08-22
    Publishing country Germany
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ISSN 2701-0198
    ISSN (online) 2701-0198
    DOI 10.1002/adbi.202200084
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  6. Article ; Online: To AI or Not to AI: That Is the Question in Mental Health Nurse Recruitment.

    Hockley, Janine / Irwin, Pauletta / Kornhaber, Rachel / West, Sancia / Stanton, Robert / Hungerford, Catherine / Cleary, Michelle

    Issues in mental health nursing

    2024  , Page(s) 1–4

    Language English
    Publishing date 2024-04-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 603180-8
    ISSN 1096-4673 ; 0161-2840
    ISSN (online) 1096-4673
    ISSN 0161-2840
    DOI 10.1080/01612840.2024.2341043
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    In stock of ZB MED Cologne/Königswinter

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  7. Article ; Online: Autism, Discrimination and Masking: Disrupting a Recipe for Trauma.

    Cleary, Michelle / West, Sancia / Kornhaber, Rachel / Hungerford, Catherine

    Issues in mental health nursing

    2023  Volume 44, Issue 9, Page(s) 799–808

    Abstract: Outcomes of discrimination for autistic people include masking, social isolation and exclusion, trauma, and mental health problems. This discursive paper discusses the discrimination experienced by autistic people in health, education, employment, and ... ...

    Abstract Outcomes of discrimination for autistic people include masking, social isolation and exclusion, trauma, and mental health problems. This discursive paper discusses the discrimination experienced by autistic people in health, education, employment, and media settings; and considers how to reduce the impact of discrimination. Addressing the impact of discrimination requires an improved understanding of the lived experience of the autistic person, the embedding of inclusive practices in communities, developing the person's life skills and supports, and enabling the person to work through their psychological trauma. Further research can aid in minimizing and preventing discrimination against people with autism.
    MeSH term(s) Humans ; Autistic Disorder ; Employment ; Educational Status
    Language English
    Publishing date 2023-08-24
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 603180-8
    ISSN 1096-4673 ; 0161-2840
    ISSN (online) 1096-4673
    ISSN 0161-2840
    DOI 10.1080/01612840.2023.2239916
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  8. Article ; Online: Compassionate communities interventions: a scoping review.

    Roleston, Caity / Shaw, Rachel / West, Karen

    Annals of palliative medicine

    2023  Volume 12, Issue 5, Page(s) 936–951

    Abstract: Background: The compassionate communities (CC) movement is an emergent health promotion approach to palliative care that views illness, dying, death, and loss as universal experiences, and challenges the notion that disease precludes one from health ... ...

    Abstract Background: The compassionate communities (CC) movement is an emergent health promotion approach to palliative care that views illness, dying, death, and loss as universal experiences, and challenges the notion that disease precludes one from health care attention and interest. It seeks to normalise these phenomena and reorientate care to communities by activating naturally occurring networks and mobilising community resources. A surge of interventions aligned with the ethos of CC has been observed over the last decade. This scoping review seeks to synthesise what is currently known about the design, efficacy, and impact of CC interventions.
    Methods: Cochrane, PubMed, Scopus, and Web of Science were systematically searched. Hand searching was performed on three key journals, reference lists and citation lists of included articles, and relevant review articles. Two levels of analysis were conducted. First, a numerical presentation of the characteristics of CC interventions. Second, a thematically orientated narrative analysis of intervention efficacy.
    Results: A total of 1,882 records were screened; 62 papers were included. Most were implemented by palliative care organisations in Europe, North America, and Australia. Included studies were mapped against Clark et al.'s taxonomy of end-of-life interventions: educational (n=17); service (n=20); clinical (n=3); cultural (n=4); and multi-dimensional (n=18) interventions are discussed. While preliminary findings are positive, claims of efficacy are limited due to methodological paucity in the field.
    Conclusions: We argue that the field would benefit from more transparent and theoretically driven CC interventions in order to explicate the mechanism(s) for successful intervention implementation.
    MeSH term(s) Humans ; Palliative Care/methods ; Australia ; Europe
    Language English
    Publishing date 2023-07-17
    Publishing country China
    Document type Systematic Review ; Journal Article
    ZDB-ID 2828544-X
    ISSN 2224-5839 ; 2224-5839
    ISSN (online) 2224-5839
    ISSN 2224-5839
    DOI 10.21037/apm-22-867
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  9. Article ; Online: Dispersed Responsibility of a Collective Problem: Autism, Suicidality and the Failure of Knowledge Translation.

    Cleary, Michelle / West, Sancia / Kornhaber, Rachel / Mclean, Loyola

    Issues in mental health nursing

    2022  Volume 44, Issue 8, Page(s) 787–792

    MeSH term(s) Humans ; Autistic Disorder ; Suicide ; Translational Science, Biomedical ; Suicidal Ideation ; Social Behavior
    Language English
    Publishing date 2022-09-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 603180-8
    ISSN 1096-4673 ; 0161-2840
    ISSN (online) 1096-4673
    ISSN 0161-2840
    DOI 10.1080/01612840.2022.2122642
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  10. Article ; Online: Incivility and Nursing Academia: Fouling the Proverbial Nest.

    Anderson, Judith / Kornhaber, Rachel / West, Sancia / Cleary, Michelle

    Issues in mental health nursing

    2022  Volume 43, Issue 12, Page(s) 1160–1162

    MeSH term(s) Humans ; Incivility ; Education, Nursing, Baccalaureate ; Students, Nursing ; Faculty, Nursing ; Education, Nursing
    Language English
    Publishing date 2022-02-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 603180-8
    ISSN 1096-4673 ; 0161-2840
    ISSN (online) 1096-4673
    ISSN 0161-2840
    DOI 10.1080/01612840.2021.2023715
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