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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: 12/16/2020Format: PDFAnnotation: 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 ToolAccess Notes: Free/Publicly Available
Available Formats: PDF
Contact Information: info@nhlbi-connects.orgIncludes Research Tools: Yes.ID: 24228. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
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: 4/6/2020Format: PDFAnnotation: 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 ToolAccess Notes: Available Formats: PDF
Contact Information: Christine Alden: calden@jhu.eduIncludes Research Tools: Yes.ID: 22040. From: Disaster Lit®a database of the U.S. National Library of Medicine.
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