Collaborative Cohort of Cohorts for COVID-19 Research (C4R) Study: Study Design

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Abstract

The Collaborative Cohort of Cohorts for COVID-19 Research (C4R) is a national prospective study of adults comprising 14 established US prospective cohort studies. Starting as early as 1971, investigators in the C4R cohort studies have collected data on clinical and subclinical diseases and their risk factors, including behavior, cognition, biomarkers, and social determinants of health. C4R links this pre–coronavirus disease 2019 (COVID-19) phenotyping to information on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute and postacute COVID-related illness. C4R is largely population-based, has an age range of 18–108 years, and reflects the racial, ethnic, socioeconomic, and geographic diversity of the United States. C4R ascertains SARS-CoV-2 infection and COVID-19 illness using standardized questionnaires, ascertainment of COVID-related hospitalizations and deaths, and a SARS-CoV-2 serosurvey conducted via dried blood spots. Master protocols leverage existing robust retention rates for telephone and in-person examinations and high-quality event surveillance. Extensive prepandemic data minimize referral, survival, and recall bias. Data are harmonized with research-quality phenotyping unmatched by clinical and survey-based studies; these data will be pooled and shared widely to expedite collaboration and scientific findings. This resource will allow evaluation of risk and resilience factors for COVID-19 severity and outcomes, including postacute sequelae, and assessment of the social and behavioral impact of the pandemic on long-term health trajectories.

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  1. SciScore for 10.1101/2021.03.19.21253986: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Additional consent for ascertainment of COVID-19 data, including the serosurvey, is being obtained according to cohort-specific procedures, including verbal, remote, and traditional written informed consent.
    RandomizationTen percent of event reviews will be randomly selected for re-review.
    BlindingSerological assays will be repeated on a random 5% sub- sample of blind duplicates.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The BVL performs a SARS-CoV-2 IgG Microsphere Immunoassay using Luminex bead technology for qualitative detection of human IgG antibodies to SARS-CoV-2 nucleocapsid (N) and spike subunit 1 (S1) antigens.
    human IgG
    suggested: None
    SARS-CoV-2 nucleocapsid ( N ) and spike subunit 1 ( S1 ) antigens .
    suggested: None
    Software and Algorithms
    SentencesResources
    Four multi-ethnic cohorts were established to study respiratory epidemiology: the Genetic Epidemiology of COPD (COPDGene) Study (34) and the SubPopulations and InteRmediate Outcome Measures in COPD Study (SPIROMICS) (35) were established as longitudinal case-control studies of cigarette smokers with and without COPD; Prevent Pulmonary Fibrosis (PrePF) is a study of early and established interstitial lung disease; and, the Severe Asthma Research Program (SARP) is a study of the entire range of mild to severe asthma, enriched for severe disease (36).
    Severe Asthma Research Program
    suggested: (Karolisnka Biobank, RRID:SCR_004355)
    Electronic data collection forms are being programmed into REDCap for use or adaptation by the cohort coordinating centers.
    REDCap
    suggested: (REDCap, RRID:SCR_003445)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.