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  1. Article ; Online: Response by Franklin and Schneeweiss to Letters Regarding Article, "Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative".

    Franklin, Jessica M / Schneeweiss, Sebastian

    Circulation

    2021  Volume 144, Issue 8, Page(s) e162–e163

    MeSH term(s) Humans ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2021-08-23
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 80099-5
    ISSN 1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
    ISSN (online) 1524-4539
    ISSN 0009-7322 ; 0069-4193 ; 0065-8499
    DOI 10.1161/CIRCULATIONAHA.121.055681
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    Ui IV Zs.60: Show issues Location:
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  2. Article ; Online: Massed written exposure therapy delivered to veterans with posttraumatic stress symptoms on an acute inpatient mental health unit.

    Ennis, Chelsea R / Raines, Amanda M / Boffa, Joseph W / Shapiro, Mary O / Dornbach-Bender, Allison / Ferrie, Mara L / Fondren, Alana H / Vidaurri, Desirae N / Walton, Jessica L / Chambliss, Jessica L / Franklin, C Laurel

    Journal of traumatic stress

    2024  

    Abstract: Written exposure therapy (WET) is a brief, manualized trauma-focused treatment typically delivered in five individual weekly sessions. Given the brevity and effectiveness of WET, researchers have begun to focus on its delivery in a massed format. However, ...

    Abstract Written exposure therapy (WET) is a brief, manualized trauma-focused treatment typically delivered in five individual weekly sessions. Given the brevity and effectiveness of WET, researchers have begun to focus on its delivery in a massed format. However, only one case study examining massed delivery has been published to date. As such, the objective of the current study was to examine the acceptability, feasibility, and preliminary effectiveness of massed WET among veterans with a trauma- and stressor-related disorder receiving care on an acute inpatient mental health unit. Veterans (N = 26) were assessed prior to, immediately after, and 1 month following massed WET. Most veterans found massed WET to be useful and acceptable. Recruitment and retention rates suggested that the treatment was feasible. Notably, the results revealed statistically significant reductions in overall posttraumatic stress symptoms, η
    Language English
    Publishing date 2024-04-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 639478-4
    ISSN 1573-6598 ; 0894-9867
    ISSN (online) 1573-6598
    ISSN 0894-9867
    DOI 10.1002/jts.23042
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  3. Article ; Online: P-values and decision-making: discussion of 'Limitations of empirical calibration of p-values using observational data'.

    Franklin, Jessica M

    Statistics in medicine

    2016  Volume 35, Issue 22, Page(s) 3889–3891

    Abstract: Gruber and Tchetgen Tchetgen bring up many important limitations of p-value calibration as applied to the assessment of the safety and effectiveness of medications in secondary administrative data. In this discussion, I further examine the role of study ... ...

    Abstract Gruber and Tchetgen Tchetgen bring up many important limitations of p-value calibration as applied to the assessment of the safety and effectiveness of medications in secondary administrative data. In this discussion, I further examine the role of study design and selection of comparators in interpreting p-value calibration results, and we consider the advantages and disadvantages of automation in the epidemiology of medications, including p-value calibration. Copyright © 2016 John Wiley & Sons, Ltd.
    Language English
    Publishing date 2016-09-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.6984
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  4. Article ; Online: Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners.

    Desai, Rishi J / Franklin, Jessica M

    BMJ (Clinical research ed.)

    2019  Volume 367, Page(s) l5657

    MeSH term(s) Confounding Factors (Epidemiology) ; Data Interpretation, Statistical ; Humans ; Logistic Models ; Observational Studies as Topic/methods ; Observational Studies as Topic/standards ; Practice Guidelines as Topic ; Propensity Score ; Research Design/standards ; Survival Rate ; Treatment Outcome
    Language English
    Publishing date 2019-10-23
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.l5657
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  5. Article ; Online: Understanding the confluence of injury and obesity in a Grade 2 obesity and above population.

    Franklin, Richard C / Franklin, Janet L / Swinbourne, Jessica M / Manson, Elisia / Loughnan, Georgina / Markovic, Tania / Hocking, Samantha

    Australian and New Zealand journal of public health

    2023  Volume 47, Issue 1, Page(s) 100008

    Abstract: ... kg) and height (m) were measured by clinicians for patients attending a weight loss group program ... participants (67.1% female), mean age 49.3 years and Body Mass Index 47.2 kg/m: Conclusions: People ...

    Abstract Objective: Obesity and injury are major inter-related public health challenges. The objective of this study was to explore the perceptions of injury in people with severe obesity.
    Methods: A cross-sectional design was employed to capture injury perception and lifestyle habits via questionnaires. Weight (kg) and height (m) were measured by clinicians for patients attending a weight loss group program. Univariate, chi-square, ANOVA and ordinal regression analyses were undertaken.
    Results: There were 292 participants (67.1% female), mean age 49.3 years and Body Mass Index 47.2 kg/m
    Conclusions: People with obesity fear injury and falling, which limits their willingness to exercise. Anxiety symptoms appear to exacerbate this connection.
    Implications for public health: In individuals with obesity, anxiety, sleepiness and depression are associated with a fear of being injured. Addressing fear and reducing anxiety may decrease barriers to participating in physical activity.
    MeSH term(s) Humans ; Female ; Middle Aged ; Male ; Sleepiness ; Cross-Sectional Studies ; Obesity/epidemiology ; Anxiety/complications ; Anxiety/epidemiology ; Body Mass Index ; Weight Loss
    Language English
    Publishing date 2023-01-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1323548-5
    ISSN 1753-6405 ; 1326-0200
    ISSN (online) 1753-6405
    ISSN 1326-0200
    DOI 10.1016/j.anzjph.2022.100008
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  6. Article ; Online: Reduced immunogenicity of a live

    Allen, Jessica C / Toapanta, Franklin R / Baliban, Scott M / Sztein, Marcelo B / Tennant, Sharon M

    Frontiers in immunology

    2023  Volume 14, Page(s) 1190339

    Abstract: Introduction: Non-typhoidal : Methods: In this study, adult (six-to-eight-week-old) and aged (18-month-old) C57BL/6 mice received two doses of CVD 1926 (10: Results: Compared to PBS-immunized mice, adult mice immunized with CVD 1926 had ... ...

    Abstract Introduction: Non-typhoidal
    Methods: In this study, adult (six-to-eight-week-old) and aged (18-month-old) C57BL/6 mice received two doses of CVD 1926 (10
    Results: Compared to PBS-immunized mice, adult mice immunized with CVD 1926 had significantly lower
    Conclusion: These data suggest that our candidate live attenuated
    MeSH term(s) Humans ; Mice ; Animals ; Aged ; Infant ; Salmonella enterica ; Vaccines, Attenuated ; Serogroup ; Tumor Necrosis Factor-alpha ; Salmonella Vaccines ; Mice, Inbred C57BL ; Salmonella Infections/prevention & control ; Salmonella typhimurium ; Typhoid-Paratyphoid Vaccines ; Cardiovascular Diseases
    Chemical Substances Vaccines, Attenuated ; Tumor Necrosis Factor-alpha ; Salmonella Vaccines ; Typhoid-Paratyphoid Vaccines
    Language English
    Publishing date 2023-05-03
    Publishing country Switzerland
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2023.1190339
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  7. Article ; Online: Assessing Area-Level Deprivation as a Proxy for Individual-Level Social Risks.

    Brown, Erika M / Franklin, Stephanie M / Ryan, Jessica L / Canterberry, Melanie / Bowe, Andy / Pantell, Matt S / Cottrell, Erika K / Gottlieb, Laura M

    American journal of preventive medicine

    2023  Volume 65, Issue 6, Page(s) 1163–1171

    Abstract: Introduction: Concerns about the opportunity costs of social screening initiatives have led some healthcare organizations to consider using social deprivation indices (area-level social risks) as proxies for self-reported needs (individual-level social ... ...

    Abstract Introduction: Concerns about the opportunity costs of social screening initiatives have led some healthcare organizations to consider using social deprivation indices (area-level social risks) as proxies for self-reported needs (individual-level social risks). Yet, little is known about the effectiveness of such substitutions across different populations.
    Methods: This analysis explores how well the highest quartile (cold spot) of three different area-level social risk measures-the Social Deprivation Index, Area Deprivation Index, and Neighborhood Stress Score-corresponds with six individual-level social risks and three risk combinations among a national sample of Medicare Advantage members (N=77,503). Data were derived from area-level measures and cross-sectional survey data collected between October 2019 and February 2020. Agreement between individual and individual-level social risks, sensitivity values, specificity values, positive predictive values, and negative predictive values was calculated for all measures in summer/fall 2022.
    Results: Agreement between area and individual-level social risks ranged from 53% to 77%. Sensitivity for each risk and risk category never exceeded 42%; specificity values ranged from 62% to 87%. Positive predictive values ranged from 8% to 70%, and negative predictive values ranged from 48% to 93%. There were modest performance discrepancies across area-level measures.
    Conclusions: These findings provide additional evidence that area-level deprivation indices may be inconsistent indicators of individual-level social risks, supporting policy efforts to promote individual-level social screening programs in healthcare settings.
    MeSH term(s) Aged ; Humans ; Cross-Sectional Studies ; Health Facilities ; Medicare ; Policy ; United States ; Social Deprivation ; Risk-Taking
    Language English
    Publishing date 2023-06-10
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 632646-8
    ISSN 1873-2607 ; 0749-3797
    ISSN (online) 1873-2607
    ISSN 0749-3797
    DOI 10.1016/j.amepre.2023.06.006
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    Zs.A 2096: Show issues Location:
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  8. Article ; Online: Emulation Differences vs. Biases When Calibrating Real-World Evidence Findings Against Randomized Controlled Trials.

    Franklin, Jessica M / Glynn, Robert J / Suissa, Samy / Schneeweiss, Sebastian

    Clinical pharmacology and therapeutics

    2020  Volume 107, Issue 4, Page(s) 735–737

    MeSH term(s) Bias ; Calibration ; Data Science/methods ; Humans ; Randomized Controlled Trials as Topic/methods
    Language English
    Publishing date 2020-02-12
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.1793
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  9. Article ; Online: A correlation analysis to assess event-free survival as a trial-level surrogate for overall survival in early breast cancer.

    Gyawali, Bishal / D'Andrea, Elvira / Franklin, Jessica M / Kesselheim, Aaron S

    EClinicalMedicine

    2021  Volume 32, Page(s) 100730

    Abstract: Background: Event-free survival (EFS) has been listed on the FDA Table of Surrogate Endpoints as a surrogate measure that can be considered for accelerated or traditional approval in breast cancer. However, no studies have evaluated the correlation ... ...

    Abstract Background: Event-free survival (EFS) has been listed on the FDA Table of Surrogate Endpoints as a surrogate measure that can be considered for accelerated or traditional approval in breast cancer. However, no studies have evaluated the correlation between the treatment effects on EFS and treatment effects on overall survival (OS).
    Methods: We performed a systematic search of the literature until May 2020 according to the PRISMA guideline for all published randomized controlled trials (RCTs) in early breast cancer in the neoadjuvant setting. Data on EFS and OS, including the hazard ratio (HR) and 95% confidence intervals (CI), were extracted from each study and the association between the trial-level EFS HR and the trial-level OS HR was estimated using a linear mixed-effects model on the log scale.
    Findings: Of the 7 RCTs (
    Interpretation: Treatment effects in EFS are moderately correlated with treatment effects in OS in early breast cancer in the neoadjuvant setting, but the association was not significant. Thus, there is currently insufficient evidence to support EFS for use as a surrogate endpoint for traditional approval, although it may be considered for accelerated approval.
    Funding: Arnold Ventures.
    Language English
    Publishing date 2021-01-29
    Publishing country England
    Document type Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2021.100730
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  10. Article ; Online: Behavioural and psychological symptoms of dementia in mouse models of Alzheimer's disease-related pathology.

    Kosel, Filip / Pelley, Jessica M S / Franklin, Tamara B

    Neuroscience and biobehavioral reviews

    2020  Volume 112, Page(s) 634–647

    Abstract: Transgenic mouse models have been used extensively to model the cognitive impairments arising from Alzheimer's disease (AD)-related pathology. However, less is known about the relationship between AD-related pathology and the behavioural and ... ...

    Abstract Transgenic mouse models have been used extensively to model the cognitive impairments arising from Alzheimer's disease (AD)-related pathology. However, less is known about the relationship between AD-related pathology and the behavioural and psychological symptoms of dementia (BPSD) commonly presented by patients. This review discusses the BPSD-like behaviours recapitulated by several mouse models of AD-related pathology, including the APP/PS1, Tg2576, 3xTg-AD, 5xFAD, and APP23 models. Current evidence suggests that social withdrawal and depressive-like behaviours increase with progressive neuropathology, and increased aggression and sleep-wake disturbances are present even at early stages; however, there is no clear evidence to support increased anxiety-like behaviours, agitation (hyperactivity), or general apathy. Overall, transgenic mouse models of AD-related pathology recapitulate some of the BPSD-like behaviours associated with AD, but these behaviours vary by model. This reflects the patient population, where AD patients typically exhibit one or more BPSD, but rarely all symptoms at once. As a result, we suggest that transgenic mouse models are an important tool to investigate the pathology underlying BPSD in human AD patients.
    MeSH term(s) Alzheimer Disease/physiopathology ; Alzheimer Disease/psychology ; Animals ; Behavior, Animal/physiology ; Disease Models, Animal ; Mice ; Mice, Transgenic ; Social Behavior
    Language English
    Publishing date 2020-02-15
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 282464-4
    ISSN 1873-7528 ; 0149-7634
    ISSN (online) 1873-7528
    ISSN 0149-7634
    DOI 10.1016/j.neubiorev.2020.02.012
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