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  1. NHLBI-CONNECTS Common Data Elements (CDE): COVID-19 Therapeutic Trial Common Data Elements
    Source: National Heart, Lung, and Blood Institute [National Institutes of Health] (NHLBI)
    Date Published: 12/16/2020
    Format: PDF
    Annotation: This document describes recommended data elements for all therapeutic clinical trials for COVID-19. With the multitude of COVID-19 research being conducted, a common set of data elements is essential for efficiency in the study design process, increased power for discovery through aggregated data, and improved accountability for generalizability and reproducibility. This set of data common data elements (CDEs) is being developed in collaboration with the NHLBI-CONNECTS Study Design Core and NHLBI-funded research networks such as SIREN and PETAL. Trials funded through NHLBI-CONNECTS will implement these CDEs and make their data available through NHLBI's BioData Catalyst data access and compute environment.

    Includes Common Data Elements From: Yes
    Population: Adults only
    Length: 277 questions
    Language(s): English
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    Available Formats: PDF

    Contact Information: info@nhlbi-connects.org
    Includes Research Tools: Yes.
    ID: 24228. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  2. Multicenter AIDS Cohort Study/Women's Interagency HIV Study Combined Cohort Study (MACS-WIHS)
    Source: National Heart, Lung, and Blood Institute [National Institutes of Health] (NHLBI)
    Date Published: 4/6/2020
    Format: PDF
    Annotation: The overarching aim of this application is to understand the impact of the coronavirus pandemic among U.S. men and women with or at risk for HIV infection. We propose to conduct bi-monthly telephone surveys with medical record abstraction for documentation/verification of COVID-19 incidence and clinical outcomes among men and women in the MACS and the WIHS.

    In order to collect key clinical and psychosocial data on the impact of coronavirus on existing study participants, study staff will attempt to conduct bimonthly remote semi-structured phone interviews with all existing WHIS and MACS participants until the end of the coronavirus pandemic. Ascertainment of key clinical events reported during interview – or via participant-initiated phone contact – will be attempted through collection of medical records. Key clinical events will include: Confirmed diagnosis of coronavirus; Medication prescribed for coronavirus treatment; and participant hospitalization as a result of coronavirus (confirmed) or respiratory distress.

    Population: Adults only
    High Risk/Special/Unique Populations
    Administered by: Trained Lay Examiner/Interviewer
    Language(s): English, Spanish

    MACS-WIHS Questionnaire: Full Survey https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS.pdf

    COVID-19 Symptoms, Testing, and Preventive Behaviors: Symptoms; Status; Health Care https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Symptoms_testing_behaviors.pdf
    COVID-19 Impact on Daily Life: Daily Life; Health Care https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Daily_Life.pdf
    COVID-19 Psychosocial Impact: Mental Health https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Psychosocial.pdf

    MACS-WIHS Questionnaire (Spanish): Full Survey https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_spanish.pdf
    COVID-19 Symptoms, Testing, and Preventive Behaviors (Spanish): Symptoms; Status; Health Care https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Symptoms_testing_behaviors_spanish.pdf
    COVID-19 Impact on Daily Life (Spanish): Daily Life; Health Care https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Daily_Life_spanish.pdf
    COVID-19 Psychosocial Impact (Spanish): Mental Health https://www.phenxtoolkit.org/toolkit_content/PDF/MACS-WIHS_Psychosocial_spanish.pdf
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Available Formats: PDF

    Contact Information: Christine Alden: calden@jhu.edu
    Includes Research Tools: Yes.
    ID: 22040. From: Disaster Lit®a database of the U.S. National Library of Medicine.

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