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  1. Article ; Online: The Composite Quality Score (CQS) as a trial appraisal tool: inter-rater reliability and rating time.

    Mickenautsch, Steffen / Miletić, Ivana / Rupf, Stefan / Renteria, Jone / Göstemeyer, Gerd

    Clinical oral investigations

    2021  Volume 25, Issue 10, Page(s) 6015–6023

    Abstract: Objective: To establish the CQS inter-rater reliability and rating time and to compare both against that of the Jadad scale and Cochrane's Risk of Bias Tool (ROBT).: Material and methods: Four independent raters rated 45 trial reports. The inter- ... ...

    Abstract Objective: To establish the CQS inter-rater reliability and rating time and to compare both against that of the Jadad scale and Cochrane's Risk of Bias Tool (ROBT).
    Material and methods: Four independent raters rated 45 trial reports. The inter-rater reliability was established by use of the Brennan-Prediger coefficient (BPC). The coefficients were compared using the two-sample z-test. Secondary analysis included comparison of the inter-rater reliability of the randomization component of all tools, as well as of the allocation concealment component of the CQS to that of the ROBT. The mean rating time with standard deviation (SD) for each tool was determined using one-way repeated measures analysis of variance. Post hoc comparisons were made using the Tukey-Kramer adjustment for three pair-wise multiple comparisons.
    Results: The inter-rater reliability was significantly higher for the CQS (BPC, 95% CI: 0.95, 0.87-1.00) compared to Jadad (0.70, 0.58-0.82) (adjusted p = 0.0005) and most components of ROBT. The mean (SD) time to complete the CQS (4.0 (1.0) min) did not differ significantly from that of the Jadad scale 4.8 (1.1) min (adjusted p = 0.11), but was significantly shorter compared to that of the ROBT 15.3 (5.9) min (adjusted p < 0.0001).
    Conclusions: The results suggest the CQS to be a very reliable and fast trial appraisal tool. Clinical relevance The higher the inter-rater reliability, the higher the probability that trial results reflect therapeutic truth. The CQS will need to take further bias sources into consideration, in order to increase its utility.
    MeSH term(s) Humans ; Observer Variation ; Reproducibility of Results
    Language English
    Publishing date 2021-08-11
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1364490-7
    ISSN 1436-3771 ; 1432-6981
    ISSN (online) 1436-3771
    ISSN 1432-6981
    DOI 10.1007/s00784-021-04099-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Family Functioning in the Time of COVID-19 Among Economically Vulnerable Families: Risks and Protective Factors.

    He, Minxuan / Cabrera, Natasha / Renteria, Jone / Chen, Yu / Alonso, Angelica / McDorman, S Alexa / Kerlow, Marina A / Reich, Stephanie M

    Frontiers in psychology

    2021  Volume 12, Page(s) 730447

    Abstract: The ongoing COVID-19 crisis has been particularly harmful to economically vulnerable families with young children. We surveyed 247 low-income mothers and fathers from 142 families in the United States about changes in their family life following the ... ...

    Abstract The ongoing COVID-19 crisis has been particularly harmful to economically vulnerable families with young children. We surveyed 247 low-income mothers and fathers from 142 families in the United States about changes in their family life following the economic and social restrictions imposed by the pandemic. We examined the associations between pandemic-related risk factors such as economic stressors (e.g., loss of job) and social stressors (e.g., exposure to the virus) on family functioning (e.g., parents' mental health, parent engagement, and children's socioemotional behaviors) and the degree to which coparenting support and parents' positivity protected families from the negative effects of these stressors on their wellbeing. We found both positive and negative associations. Mothers and fathers who reported more economic stressors since the pandemic also observed that their children behaved more prosocially and that fathers experienced more mental health difficulties during the pandemic. Mothers and fathers who reported more social stressors reported that they were less engaged with their children and their children exhibited more behavior problems compared to before the pandemic. We also found that mothers and fathers who reported feeling more positive also reported feeling less depressed and stressed during the pandemic and observed that their children had more prosocial behaviors compared to before the pandemic. Compared to before the pandemic, mothers and fathers who reported a more supportive coparenting relationship also reported more parent engagement and observed more prosocial behaviors in their children. In terms of protective factors, high levels of parent positivity during the pandemic protected mothers (less mental health difficulties) whereas high levels of coparenting support protected fathers (less mental health difficulties) from the negative effects of economic stress on their mental health during the pandemic. These findings highlight family processes that could promote resilience in mothers and fathers in the face of pandemic-related economic and social stressors.
    Language English
    Publishing date 2021-10-06
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2563826-9
    ISSN 1664-1078
    ISSN 1664-1078
    DOI 10.3389/fpsyg.2021.730447
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Persistence of antibody responses to COVID-19 vaccines among participants in the COVID-19 Community Research Partnership.

    Berry, Andrea A / Tjaden, Ashley H / Renteria, Jone / Friedman-Klabanoff, DeAnna / Hinkelman, Amy N / Gibbs, Michael A / Ahmed, Amina / Runyon, Michael S / Schieffelin, John / Santos, Robert P / Oberhelman, Richard / Bott, Matthew / Correa, Adolfo / Edelstein, Sharon L / Uschner, Diane / Wierzba, Thomas F

    Vaccine: X

    2023  Volume 15, Page(s) 100371

    Abstract: Introduction: High levels of immunity to SARS-CoV-2 in the community correlate with protection from COVID-19 illness. Measuring COVID-19 antibody seroprevalence and persistence may elucidate the level and length of protection afforded by vaccination and ...

    Abstract Introduction: High levels of immunity to SARS-CoV-2 in the community correlate with protection from COVID-19 illness. Measuring COVID-19 antibody seroprevalence and persistence may elucidate the level and length of protection afforded by vaccination and infection within a population.
    Methods: We measured the duration of detectable anti-spike antibodies following COVID-19 vaccination in a multistate, longitudinal cohort study of almost 13,000 adults who completed daily surveys and submitted monthly dried blood spots collected at home.
    Results: Overall, anti-spike antibodies persisted up to 284 days of follow-up with seroreversion occurring in only 2.4% of the study population. In adjusted analyses, risk of seroreversion increased with age (adults aged 55-64: adjusted hazard ratio [aHR] 2.19 [95% confidence interval (CI): 1.22, 3.92] and adults aged > 65: aHR 3.59 [95% CI: 2.07, 6.20] compared to adults aged 18-39). Adults with diabetes had a higher risk of seroreversion versus nondiabetics (aHR 1.77 [95% CI: 1.29, 2.44]). Decreased risk of seroreversion was shown for non-Hispanic Black versus non-Hispanic White (aHR 0.32 [95% CI: 0.13, 0.79]); college degree earners versus no college degree (aHR 0.61 [95% CI: 0.46, 0.81]); and those who received Moderna mRNA-1273 vaccine versus Pfizer-BioNTech BNT162b2 (aHR 0.35 [95% CI: 0.26, 0.47]). An interaction between healthcare worker occupation and sex was detected, with seroreversion increased among male, non-healthcare workers.
    Conclusion: We established that a remote, longitudinal, multi-site study can reliably detect antibody durability following COVID-19 vaccination. The survey platform and measurement of antibody response using at-home collection at convenient intervals allowed us to explore sociodemographic factors and comorbidities and identify predictors of antibody persistence, which has been demonstrated to correlate with protection against disease. Our findings may help inform public health interventions and policies to protect those at highest risk for severe illness and assist in determining the optimal timing of booster doses.Clinical trials registry: NCT04342884.
    Language English
    Publishing date 2023-08-11
    Publishing country England
    Document type Journal Article
    ISSN 2590-1362
    ISSN (online) 2590-1362
    DOI 10.1016/j.jvacx.2023.100371
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  4. Article ; Online: A roadmap to using randomization in clinical trials.

    Berger, Vance W / Bour, Louis Joseph / Carter, Kerstine / Chipman, Jonathan J / Everett, Colin C / Heussen, Nicole / Hewitt, Catherine / Hilgers, Ralf-Dieter / Luo, Yuqun Abigail / Renteria, Jone / Ryeznik, Yevgen / Sverdlov, Oleksandr / Uschner, Diane

    BMC medical research methodology

    2021  Volume 21, Issue 1, Page(s) 168

    Abstract: Background: Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with respect to important known and unknown confounders, and contributes to the ... ...

    Abstract Background: Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with respect to important known and unknown confounders, and contributes to the validity of statistical tests. Various restricted randomization procedures with different probabilistic structures and different statistical properties are available. The goal of this paper is to present a systematic roadmap for the choice and application of a restricted randomization procedure in a clinical trial.
    Methods: We survey available restricted randomization procedures for sequential allocation of subjects in a randomized, comparative, parallel group clinical trial with equal (1:1) allocation. We explore statistical properties of these procedures, including balance/randomness tradeoff, type I error rate and power. We perform head-to-head comparisons of different procedures through simulation under various experimental scenarios, including cases when common model assumptions are violated. We also provide some real-life clinical trial examples to illustrate the thinking process for selecting a randomization procedure for implementation in practice.
    Results: Restricted randomization procedures targeting 1:1 allocation vary in the degree of balance/randomness they induce, and more importantly, they vary in terms of validity and efficiency of statistical inference when common model assumptions are violated (e.g. when outcomes are affected by a linear time trend; measurement error distribution is misspecified; or selection bias is introduced in the experiment). Some procedures are more robust than others. Covariate-adjusted analysis may be essential to ensure validity of the results. Special considerations are required when selecting a randomization procedure for a clinical trial with very small sample size.
    Conclusions: The choice of randomization design, data analytic technique (parametric or nonparametric), and analysis strategy (randomization-based or population model-based) are all very important considerations. Randomization-based tests are robust and valid alternatives to likelihood-based tests and should be considered more frequently by clinical investigators.
    MeSH term(s) Computer Simulation ; Humans ; Likelihood Functions ; Random Allocation ; Sample Size ; Selection Bias
    Language English
    Publishing date 2021-08-16
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-021-01303-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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